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4 BioSpectrum | January 2015 | www.BioSpectrumAsia.com | An MM Activ Publication
BioEdit
T
he year 2014 was the sec-
ond best year for biotech
and lifesciences industry
in terms of fund raising
and new drug approvals. Inves-
tor appetite for lifescience compa-
nies was at a peak thanks to many
breakthrough technologies such as
drug to treat Hepatitis C. No won-
der investors opened the purse
strings to buy a slice of the industry
in record numbers.
A study by investment analysts Burrill LLC
based in San Francisco, the lifesciences indus-
try raised a record $104.2 billion in venture in-
vestment in 2014 against just $92.9 billion in
2013. The previous highest was $108.6 billion
raised by the industry in 2009. And much of
that record amount was tied to some large ac-
quisitions and not pure venture funding.
Summed up Burrill CEO, Mr Steven Burrill:
“In 2014 the biotechnology industry exceeded
expectations in its ability to raise money that
bodes well for the health of the industry and its
ability to drive innovative therapies from the
clinic to the market in the years ahead.”
What is more significant is that it was a good
year for initial public offerings (IPOs) by in-
novative lifescience companies. More than 126
companies raised over $10.4 billion. Majority
of these IPOs were in the US. But in 2015, Bur-
rill predicts that nearly 40 percent of the IPOs
will happen in Asia and Europe as companies
tap their home markets.
Why is the world gung ho about the lifesciences
industry? The US regulator FDA approved 41
new drugs and biologics in 2014 compared to
27 in 2013. This is the second highest year of
drug approval after 53 new drugs approved way
back in 1996.
Most of Mr Burrill’s predictions have been on
target for the past 30 years. Here is what he
predicts for 2015 globally.
 Innovative therapies like cancer immuno-
therapies, gene therapy, and regenerative med-
icines will take stronger route
 Investments in data analytics will grow as
all key players in the healthcare system will use
this as a competitive tool to gather, integrate
and analyze multiple, large databases to drive
decision making
 Next generation sequencing as a platform
technology will yield to technology as a service.
Pharma companies will make big investments
to refine the genomics toolbox to use the tech-
nology as diagnostic tests
 More point-of-care diagnostics will emerge
as genomics technologies are used to speed and
simplify tests
How will these global trends impact the life-
sciences industry in Asia-Pacific? Companies in
the region have been focused on markets in the
US and Europe so far to export their generics
products and offer various outsourced services.
At the same time, companies in developed na-
tions are looking at new markets in Asia, at-
tracted by the economic boom and increased
prosperity levels of citizens.
This trend has been witnessed in other indus-
trial sectors such as telecommunications and
computing devices. Some of the Asia-made
products have captured world markets and
Asia is the biggest market for many telecom
products and services.
The lifesciences industry leaders should take
the cue from the telecom counterparts and give
some focus to the Asian markets too and not be
left behind in quest to reach out to customers in
their own backyard. BS
Happy New Year
Narayanan Suresh
Group Editor
narayanan.suresh@mmactiv.in
Funding boom lifts biotech globally in 2014

An MM Activ Publication | www.BioSpectrumAsia.com | January 2015 | BioSpectrum 5
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BioMail
Fun Flashback!
I found cover story Flashback 2014
very informative in the last edition
of the magazine. It revived the en-
tire year for the pharma industry.
I congratulate the entire team for
such a brilliant work. Let’s hope
the industry will take its lessons
from the mistakes in the past year
and the New Year will be better
than the year went by.
Sui li, japan
Keep it up!
The news that JJ has opened its new APAC center in
Shanghai was a pleasant read. It adds another feather in
China’s cap, which is rightly the pharma hub. Other sto-
ries in the issue were equally good to read. All in all a nice
edition.
Lim Chin Weng, china
Wearable wishlist
I support author’s views in the article ‘designing Wear-
ables for healthcare’. Wearables are increasingly becom-
ing an important tool to monitor health. However, I think
we need better policies and a strong regulatory frame-
work so that the technology can be boon for the mankind.
Lucio Tan, Malaysia
Healthcare through satellite
The article “Healthcare through satellite” was very in-
sightful in the recent edition of the magazine. This tech-
nology if exploited in a right way can improve the health-
care scenario particularly in the rural areas.
Andrew Tan, Korea
MedTech mania
The article “MedTech to fuel future growth” was very in-
teresting. As rightly indicated by the Prof. Tan Sze Wee
Singapore need to revise its policies and provide the right
ecosystem for the medical devices start-ups.
Robert Ng, Singapore
Online articles
While your website covers a range of sections related to
bioscience, in the last few months the focus of your sto-
ries has been more towards biotech. Healthcare is not
getting as much attention. As one of the most prominent
fields, I think you should continue to focus on it.
Paramjeet Kaur, Delhi
Vol 10; Issue 1; January 2015
Vol 9; Issue 12;
December, 2014

BioContents
CoverStory12
Trends
market response
in 2015
Frost Sullivan forecasts that the global branded
pharma and biotech industry will generate nearly
$1.1 trillion revenue in 2015 and Asia would
experience a favorable period with innovations in
biotech sector and flourish of generics companies
due to patent expiry. BioSpectrum Asia speaks
to industry leaders and observers to seek their
opinion on trends and market dynamics in 2015.
BioColumn
Global pharmaceutical market could be
worth nearly $1.6 trillion by 2020 21
A look at the drug market in 2015 24
Asia-Pacific biopharma entering new era
of global leadership innovation 28
Mr Ross Horsburgh, MD, senior vice president,
Head of Clinical Development, Asia-Pacific, Quintiles
Many unmet medical needs
to be addressed 30
Mr Lance Little, MD, Asia Pacific region, Roche Diagnostics
28
30
28

BioEdit��04
BioNews��08
BioRD��11
BioSpecial��37
► Due to patent expiry companies may lose upto $65 billion by 2019
BioHealth��42
BioPeople��47
BioBuzz��48
BioComment��50
BioTalk 33
‘Oncology is the most
prevalent therapeutic area’
Mr Wei Ming Goh,
vice president, APAC, ICON
BioInformatics 35
‘Fundamental challenges in
Lifesciences similar around the world’
Mr Kevin Julian,
MD, Accenture Accelerated RD Services
SINGAPORE LAUNCHES DIAGNOSTIC HUB
BioEvent 46
BioSuppliers 39
Mr Syed Jafry
senior VP and president, APAC and
emerging markets, Thermo Fisher Scientific
Mr Amit Chopra
MD, VP/GM, India, Thermo Fisher Scientific
‘APAC has been the biggest contributor
to our growth’
twitter.com/BioSpectrumMag
facebook.com/BioSpectrumMagazine
bit.ly/BS-LinkedIn

GVK BIO ties up with CTC Life Science Japan
GVK announced its strategic tie up
with CTC Life Science Corporation
(CTCLS) to market and distribute
its proprietary ‘Drug Repurposing
Platform’. The drug repurposing
platform called GRIP (GVK Bio Re-
purposing Integrated Platform) is a
combination of several GVK Bio pro-
prietary and several public domain
databases.
It calls for reinvestigating the mar-
keted drugs, clinical and/or pre-clin-
ical candidates and can be applied to
many different compounds.
Apollo’s Medvarsity offers e-course
On-demand diagnostic platform launched
Apollo’s Medical e-learning initiative, Medvarsity, has tied up with Univer-
sity of New South Wales (UNSW),to offer postgraduate diploma courses in
healthcare management through the e-learning mode to the practicing medi-
cal professionals in India. According to Mr Dilip Mathai, dean, Apollo Insti-
tute of Medical Sciences and Research, the collaboration aimed at focusing on
infectious disease management as there is a dearth of specialists in this area
apart from a huge knowledge gap that exists in dealing with these disease
situations in the country.
The courses will be available for practicing medical professionals outside In-
dia as well, particularly in countries where Apollo has its hospital network.
Global biopharmaceutical firm, Roche, has launched a molecular diagnostic
platform, designed for on-demand testing in physician clinics, pharmacies
and hospital lab settings, known as cobas Liat System. Cobas Liat System is
a fully automated testing process designed to simplify workflow and enables
healthcare professionals to perform molecular testing in a variety of settings
with speed, reliability and minimal training. Definitive results are generated
in 20 minutes or less to aid a treatment decision.
“The cobas Liat System, enables us to extend the reach of PCR technology,”
said Mr Paul Brown, head of Roche Molecular Diagnostics. “This system of-
fers significant benefits in testing time and accuracy, over current methods.”
Taiwan inaugurates
country’s
third biotech park
Takeda files
NDA in Japan
Underscoring the Taiwan gov-
ernment’s determination to fos-
ter biotechnology and fast-track
the development of local health-
care sector, the government has
launched a new industrial incu-
bation center at Hsinchu Bio-
medical Science Park (HBSP).
The inauguration ceremony was
attended by MOEA deputy min-
ister Mr Cho Shih-chao, Science
and Technology, vice minister,
Mr Chen Ter-shing and Health
and Welfare vice minister Mr
Shiu Ming-neng.
The center is the third compre-
hensive biotech cluster in Tai-
wan following Pingtung Agri-
cultural Biotechnology Park in
Pingtung County and Taiwan
Orchid Plantation in Tainan
City.
Takeda Pharmaceutical has sub-
mitted a new drug application
(NDA) to the Japanese Ministry
of Health, Labour and Welfare
for glatiramer acetate (active
ingredient), for the relapse pre-
vention of multiple sclerosis. De-
veloped by Teva Pharmaceutical
located in Israel, glatiramer ac-
etate for injection is indicated for
the relapse prevention of mul-
tiple sclerosis.
Approved in 57 countries world-
wide, glatiramer acetate is a lead-
ing multiple sclerosis therapy..
Bio Bytes
BioNews

Bio Bytes
NantOmics Cancer
Genome Browser
BlackBerry and NantHealth
have announced the launch of a
new browser from their stable,
called the NantOmics Cancer
Genome Browser. It gives doc-
tors unprecedented access to pa-
tients’ genetic data on the Black-
Berry Passport smartphone.
It is the first in a series of in-
novative offerings being devel-
oped jointly by BlackBerry and
NantHealth for use by health-
care professionals.
Robots: The next weapon to curb Ebola
With the Ebola battle seeming endlessly long, the US military has planned to
introduce robots into the fight. The new germ killing weapon is a four-wheeled
robot that can disinfect a room in minutes with pulses of ultraviolet light. The
robots resemble a taller, but skinnier version of Star Wars and are already
operating at three military medical centers and about 250 other American
hospitals are using the machines to destroy pathogens. The robots use xenon,
a non-toxic gas, to create the ultraviolet rays that eradicate germs faster and
more thoroughly than any human cleaning crew, doctors and officials said.
Mr Alton Dunham, a spokesman for Langley Air Force Base, which acquired
one of the robots in October, said, ‘‘The robot, currently part of our Ebola
mitigation strategy, will be used to combat a variety of other pathogens.”
Abbott acquires Topera
Global biopharmaceutical com-
pany, Abbott, has acquired Top-
era, a private, venture-backed
medical device company focused
on developing innovative elec-
trophysiology technologies to
improve the diagnosis and treat-
ment of atrial fibrillation, one of
the most common heart rhythm
disorders in the world.
Catheter-based electrophysiol-
ogy is an approximately $3 bil-
lion global market that has been
growing annually at double-digit
rates.
Topera has developed a novel di-
agnostic catheter and mapping
software, or rotor identification
system, which helps physicians
identify and target patient-spe-
cific rotors.
GE, A*Star invest $20 mn in medtech
GI Dynamics trims 10 percent workforce
Singapore’s Agency for Science, Technology and Research (A*STAR) and
global healthcare company, GE Healthcare, have sealed a five-year technol-
ogy research and development collaboration agreement with an investment
of $20 million to co-develop the next generation of medical technologies.
The investment put together by A*STAR and GE Healthcare would be chan-
neled to co-innovate technologies in areas including patient monitoring,
Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
According to GE Healthcare, patient monitoring is expected to trend upwards
as more people gain access to health services via the internet through mobile
devices. Dr Raj Thampuran, managing director, A*STAR said, “This collab-
oration is testament to our deepening partnership with GE. It also demon-
strates Singapore’s growing attractiveness for MedTech companies as well as
the increasing significance of the MedTech industry.’’
GI Dynamics, a medical device company developing treatments for type 2
diabetes and obesity, has decided to axe its workforce by approximately 10
percent, in a restructuring strategy, including its chief financial officer, Mr
Robert W Crane.
“This restructuring has been made based on a re-evaluation of our corporate
strategy and the skills and resources we believe will be required by the compa-
ny in the future,” said Mr Michael Dale, president and chief executive officer,
GI Dynamics. GI Dynamics has developed EndoBarrier, an endoscopically-
delivered device therapy approved for the treatment of type 2 diabetes and/
or obesity.
BioNews

Bio Bytes Astella’s Xtandi variation
receives EU nod
The European Commission has amended the marketing authorization for
Xtandi, manufactured by the Japanese drug major Astellas pharma. The
amendment was made to include first-line treatment for men with metastatic
castration-resistant prostate cancer (mCRPC) after failure of androgen depri-
vation therapy.
The drug, Enzalutamide (trade name Xtandi) is now approved for the treat-
ment of adult men with metastatic castration-resistant prostate cancer
(mCRPC) who are asymptomatic or mildly symptomatic after failure of an-
drogen-deprivation therapy in whom chemotherapy is not yet clinically in-
dicated. The drug is found to reduce the risk of death by 81 percent. The ap-
proval of the variation is based on results from the pivotal Phase III PREVAIL
study.
Marketing application for thyroid cancer drug
Japan’s pharmaceutical company, Eisai, has submitted its application to the
regulatory authority in South Korea (Ministry of Food and Drug Safety) for
marketing approval of its novel in-house developed anticancer agent lenva-
tinib mesylate (lenvatinib) as a treatment for progressive radioiodine-refrac-
tory differentiated thyroid cancer.
Following the submission of marketing authorization applications in Japan,
the United States and Europe, this marks the first time Eisai has submitted a
marketing authorization application for lenvatinib in Asia.
Colorectal cancer market to touch $2.9 bn
Colorectal Cancer (CRC) therapeutics market in Asia-Pacific (APAC) is set
to increase in value, from $1.9 billion in 2013 to $2.9 billion by 2020, at a
Compound Annual Growth Rate (CAGR) of 6.5 percent, according to business
intelligence provider GBI Research.
According to GBI’s report, the colorectal cancer market in India, Australia,
China and Japan, will be driven by the increasing incident of population and
higher uptake of branded drugs and targeted therapies, as patient access to
these more expensive treatments improves.
The moderate uptake of late-stage pipeline products panitumumab and Xilo-
nix, following their expected approvals between 2016 and 2018, will also help
boost the market, a long with ramucirumab, TAS-102, TS-1 and MelCancer-
Vac.
China Jo-Jo Drugstores
acquires pharmacy
China Jo-Jo Drugstores, Chi-
na’s healthcare retail service
provider, has acquired Hang-
zhou Sanhao Grand Pharmacy,
a Hangzhou-based pharmacy
chain with 11 stores. Mr Lei
Liu, chairman of the Company,
stated, “The synergistic acquisi-
tion of Sanhao Drugstores will
increase our total store count to
over 60, from our current level
of 51 drugstores.”
CCM to sell its six
pharma units
Strides to set up a
biologics facility
Chemical Company of Malay-
sia (CCMB) recently announced
that the company is planning to
sell its six pharmaceutical units
in Malaysia, the Philippines
and Singapore to its subsidiary
CCM Duopharma Biotech Bhd
(CCMD) for RM133.3 million.
Stelis Biopharma, a wholly-
owned subsidiary of India’s
Strides Arcolab, has begun the
construction of its $60 million
biologics facility in Malaysia.
The 140,000-square-foot facil-
ity is expected to be completed
in the next two years, and will
employ about 180 people when
operating by mid-2017.
BioNews

Australia based Novogen’s lead candidate, TRXE-009,
developed for the treatment of brain cancers, and has
shown to be effective in melanoma treatment in pre-clin-
ical studies.
Based on the positive result in preclinical studies, Novo-
gen is considering TRXE-009 as an important new po-
tential treatment for melanoma, including for the treat-
ment of secondary brain cancers due to melanoma, for
which there currently are no effective therapies.
Brain cancer drug may be effective in melanoma treatment
TRXE-009 has been confirmed as a potential new treat-
ment for both adult and paediatric neural cancers. TRXE-
009 previously has been announced as a world-first in
having exceptionally high killing activity against adult
brain cancer (glioblastoma multiforme) stem cells, and
against the paediatric brain cancers - medulloblastoma
and DIPG (diffuse interstitial pontine glioma) - all tu-
mors that are highly resistant to known chemotherapies.
That same high potency is now confirmed against mela-
noma cells, with activity unaffected by the tumor’s BRAF
gene status.
BMS takes on combination
drug for cancer therapy
Japan’s Ono Pharmaceutical and Kyowa Hakko Kirin has
partnered with Bristol-Myers Squibbs for Phase 1 clinical
trial of Opdivo (nivolumab), a PD-1 immune checkpoint
inhibitor, and mogamulizumab, an anti-CCR4 antibody.
The study will
be conducted in
Japan and will
focus on evalu-
ating the safety,
tolerability and anti-tumor activity of combining Opdivo
and mogamulizumab as a potential treatment option for
patients with advanced or metastatic solid tumors. Opdi-
vo and mogamulizumab are part of a new class of cancer
treatments known as immunotherapies.
Novogen’s chemotherapeutic
agent set to enter human trial
Cantrixil, a first-in-class experimental chemotherapeutic,
developed by Australia/US-based biotech firm Novoge-
nis, is due to enter a first-in-man clinical study in 2015.
Cantrixil is a cytotoxic chemotherapy to be developed
specifically for injection into the body’s cavities. The peri-
toneal and pleural cavities are involved in a large propor-
tion of cancers, and yet the vast majority of chemothera-
pies continue to be administered in a way that delivers
chemotherapies to the cancer via the bloodstream.
Delivering the drug directly into the cavity where the can-
cer is spreading ensures cancer cells are exposed to lev-
els of drug some hundreds of times greater than via the
blood. Cantrixil has been developed jointly by Novogen
and Yale University and is owned by their joint-venture
company, CanTx Inc.
Cantrixil is a construct of active drug candidate, TRXE-
002, in a cyclodextrin shell. On injection into the cavity,
the shell dissolves to release the active drug. Cantrixil has
been designed to be non-irritant and to not be dose-lim-
iting due to side-effects.
Phylogica inks deal
with Genentech
Australia-based drug discovering company, Phylogica
has inked a pact with US-based Genentech, to discover
novel antibiotics. As per the terms of the agreement, Phy-
logica will receive an upfront payment of $500,000, and
milestone payments totaling up to $142 million.
Dr Richard Hopkins, CEO, Phylogica, said, “Through this
alliance we aim at addressing the unmet need for novel
antibiotics to treat bacterial infections including drug re-
sistant bugs.” Phylogica is a leading peptide drug discov-
ery company that utilises proprietary Phylomer peptide
libraries and screening methodologies to identify unique
peptide drug candidates for its pharmaceutical and bio-
technology partners.
BioNews
Bytes
in

CoverStory
Trends
market response
in 2015
Frost Sullivan forecasts that the global
branded pharma and biotech industry will
generate nearly $1.1 trillion revenue in
2015 and Asia would experience a favorable
period with innovations in biotech sector
and flourish of generics companies due to
patent expiry. Personalized medicine and
emergence of new therapies in areas such as
regenerative medicine and preventive healthcare
will be major focus areas for stakeholders.
Technology, innovation, public policy, and market
strategies together will play a key role in driving
the year ahead.
BioSpectrum Asia speaks to industry leaders and
observers to seek their opinion on trends and
market dynamics in 2015 in pharma, medtech,
biotech, and healthcare sectors.

Mr David Utama, president CEO, GE Healthcare ASEAN
O
ur legacy as a leader of big innovation was
enhanced by new products in MR and CT this
past year, with solutions aimed at lowering dose,
enhancing image quality to boost clinical confidence, and
helping clinicians deliver more efficient and personal-
ized care with diagnostic accuracy. As we look forward, the world of
healthcare is becoming more reliant on technology and data to save
clinicians time through efficient workflows, increased data sharing,
and analytics. We’re looking at providing new solutions that address
clinicians’ need for speed, improved image clarity, connectivity, and
data availability. These software advancements provide tools to help
clinicians improve speed of service and quality of care for patients.
With these latest innovations, doctors can move around more freely,
allowing them to be more nimble and get to a diagnosis quickly.
Machines are evolving year on year, but next year’s spotlight is
expected to continue to shift towards software and new ways to improve practice. With the advent
of Cloud Imaging and Big Data, the vast potential of the reams of patient information now available
to clinicians is only just being explored. The ubiquity of information technology has left us with an
untapped wealth of patient data that is now being used to streamline health services.
Mr Joydeep Goswami, president-Life Sciences Solutions,
Thermo Fisher Scientific, Asia Pacific and Japan
W
hen looking in to the Asia Pacific and Japan’s
lifesciences industries trend in 2015 and beyond,
the trend is towards full-fledged use of the omics
platforms and deeper search of the possibilities of synthetic
biology, which will become more active.
To accelerate innovation driven by science, the region’s ecosystem has
been attracting global companies and entrepreneurs to place its impor-
tant functions such as RD, design, and manufacturing. This allows our
region to lead the way in forming strategic partnerships between academ-
ia and industry to solve the biggest challenges facing humanity today.
Amid this environment, the demand for molecular biology platforms in
genetics, genomics, proteomics, and metabolomics will rise, especially
in the search to develop tools for comprehensive and early diagnosis,
treatment stratification based on individual’s genome and disease genet-
ics, and regenerative medicine.
Highly innovative genetic analysis technologies are changing our approach to curing and managing
complex diseases such as cancer, metabolic diseases like diabetes, and infectious diseases including
TB. Faster, cheaper and more accurate, genetic analysis solutions, as exemplified by the semiconduc-
tor based next generation sequencing will have an expanded role to play in screening genetic profiles for
drug candidate compounds or when enrolling patients into clinical trials for targeted
therapy.
CoverStory
2015
2015

CoverStory
Prof Paul Matsudaira,
head- Department of Biological
Sciences, National University
of Singapore
I
t is imperative
that Singa-
pore continues
to fund basic
research. With-
out a pipeline of
discoveries, the
pipeline feeding
novel technology will dry up quickly. Second, let
the talent decide the areas for basic and applied
research rather than targeting specific areas. By
restricting areas for research and development,
one inadvertently restricts the pipeline feeding into
technology.
I am excited
about the new
directions in engineered tissues and the begin-
nings of engineered organ technologies that will
require much more fundamental research into
basic cell and systems biology. Synthetic biology
is starting to emerge from a long lag phase as
more groups around the world move into this area.
It marks the beginning of a biological engineering
science era.
With regard to bioscience, mechanobiology has
now emerged with Singapore at the lead. Biology
mechanisms are controlled as much by mechani-
cal influences as by chemical interactions. Sec-
ond, it is difficult to keep pace of the discoveries
in brain and neurosciences. The wiring diagrams
are now being worked out. Once that is com-
plete, we’ll be able to begin to reverse engineer
the computational programs and the systems
architecture that form the basis of learning and
memory. The 2014 Nobel Prize recognized super-
resolution imaging but there are many more new
technologies that reinvent how a microscope is
being used.
Mr Simon Angeldorff,
CEO, Envirotainer
I
n 2015,
we see
in-
creasing
interest in
security,
quality
assured
training schemes (like Envirotainer’s QEP
program), and continuous data monitor-
ing. Pharmaceutical companies demand
a higher level of service and pro-activity
from all suppliers, which is a challenge we
embrace.
Our solutions are still breaking new barri-
ers across the globe. In new markets, the
trade, customs, and aviation policies are
not always transparent for all stake-holders,
which could limit supply. We see strong
international initiatives like the EU GDP as
important pillars on which a more transpar-
ent way of
working
with the
cold chain can be developed, for pharma-
ceutical companies, forwarders, airlines and
solution providers.
Our customers have always asked for
flexibility and capacity to serve a market
where needs can fluctuate from one week
to another and we see that need increas-
ing each year. For us to be able to meet
that need, we’ve invested substantially to
increase our fleet size enabling capacity to
support larger volumes also over shorter
peak periods
Initiatives among policy makers to align
guidelines across the globe are highly ap-
preciated and serves the whole industry.
2015
2015

CoverStory
Dr Anna Lavelle, CEO, AusBiotech, Australia
I
t is widely acknowledged that building Australia’s capacity
as a technologically innovative country is vital for our eco-
nomic future. Australia has a strong comparative advan-
tage in medical research and the calibre of its researchers,
and in its ability to specialize in niche manufacturing, and a
burgeoning biotechnology industry that is globally impressive by any
comparative measure.
Following the success of our campaign to introduce the RD tax Incen-
tive and to defeat the Private Members’ Bill that sought to ban patents
on all biological materials, work continues at a range of levels and
the AusBiotech’s role in public policy advocacy will focus on seeking
greater government investment in innovation, advanced manufacturing,
tax reform on the basis that a growing biotechnology and life sciences
industry will significantly boost Australia’s economic performance and
build our nation.
AusBiotech will continue to work towards retaining the RD Tax Incentive intact; Introduce the Australia
Innovation and Manufacturing (AIM) Incentive, a patent-box style incentive to enable Australian innovation
to be internationally competitive, and retain the associated benefits once our research reaches commer-
cialisation; Introduce fiscal incentives for investors in pre-revenue and start-up companies, to encourage
‘patient’ venture capital; and assisting in the consultation process to restore the Employee Share Scheme
to its pre-2009 form, especially for start-up companies.
Mr Anand Shirur, CMD, South Asia and China, Convatec
T
he year 2014 has been very favorable for Convatec
and we have experienced high double digit rate
growth. Currently, the market size is expanding. Ac-
ceptance of the products have increased with doctors,
nurses, and people.
In the coming years we are planning to expand our reach by invest-
ing in home healthcare and geriatric care. In 2015, we are planning
to launch few products like creams and lotions intended for hospital
purposes in the market. Next year will be very exciting for the company
and we are also planning to in-
crease the number of wound clinics
we have established in India. Our
major focus is customer satisfaction and we aim to reach more people
spread across tier-II and tier IV. In order to keep market exciting and doubling, Convatec will continue to
launch new products in the market. The new government in India is showing promising progress for the
biotech sector and this is a very good news for the industry. The trend is very encouraging for industries
and we can see a unique drive in this government. As an industry body, our expectations from the gov-
ernment include- one-window clearance for companies that wish to set up units in India, simplified tax
structure, encourage make in India, and also increase funding to further foster the sector.
2015
2015

Mr Richard Lipscombe, MD, Proteomic International Laboratories
T
here are two huge and overlapping trends happen-
ing in the healthcare sector—personalized medi-
cine and the rise of biosimilars (protein generics).
Advances in proteomics and genomics are leading to a
new generation of diagnostic tests and this is opening the
door to personalized medicine—moving away from a one-size fits-all
approach and instead matching patients to the best medication for
them as individuals.
With the biologics patent cliff steepening, there are more biosimilars
entering the market, and the effectiveness of many of these drugs
may ultimately be assessed using a personalized medicine ap-
proach. 2014 was a very exciting year for Proteomics International
Laboratories Limited (PILL). Revenue continued to drive upwards
and at the same time, PILL’s diagnostics technology moved into
commercialization phase.
Our diagnostics division completed a two year, $2 million clinical study for diabetic kidney disease,
which validated PILL’s biomarker panel, and we are now in advanced negotiations with a commerciali-
zation partner in China. PILL’s accredited Analytical Services unit caters to the biosimilars industry, and
in May, 2014 we were delighted to see the US FDA guidance for biosimilars that recommended exten-
sive and robust comparative structural studies, an area in which PILL has specialized since 2001. This
was on top of PILL entering a co-marketing agreement with inVentiv Health Clinical, a leading global
CRO, to offer broader engagement with the biosimilars industry and a unified pathway to bring new
drugs to market. Both will be catalysts for strong growth into the future. PILL will be focused on continu-
ing to increase its share of the biosimilars are each forecasted to exceed the $20 billion mark.
Mr Ananda Sen Gupta, CEO
Co-founder, Trackmybeat
T
here has
been
enor-
mous interest
in the use of
technology in
the healthcare
sector in recent
years. Advances in technology have coincided
with the rapid increase of ‘lifestyle diseases’ such
as hypertension, diabetes, and cardiovascular
disease. By using the former to manage and
eventually slow the alarming rise of the latter, we
get to put innovations into good use rather than
simply innovating for the sake of it. In fact, some of
the technology has existed for some time but we
can only leverage its uses now with the penetra-
tion of smart phones among developing countries.
By using this opportunity to disseminate as well as
gather data, TrackMyBeat hopes to address criti-
cal health issues in both urban and rural popula-
tions.
We are still in
the start-up
stage and have been concentrating on develop-
ing a core product. Fund-raising has also been a
major part of our activities during this past year.
TrackMyBeat will unroll its improved web portal
services along with several new devices in the
coming year.
CoverStory
2015
2015

CoverStory
Mr Saleem Mohammed,
director, Xcode Lifesciences
W
e at
Xcode
feel
that Digital
health is going
to take off in
a big way in
Asia. Personal
healthcare records be it genetics, biomedical
parameters, wearable devices, or apps will
come to vogue. All of these records will eventu-
ally contribute to bigdata through which accu-
rate personalized predictions can be made to
affect better health outcomes.
2014 was a great year for Xcode. We launched
our new product 100Life, which has been
quite well received in India and abroad. In the
short time that the product has been in the mar-
ket, we are already receiving positive feedback
on its effectiveness in weight loss and well-
ness improvements of our clients. Genomics is
coming of age in India and 2014 was a proof
that it is
here to stay.
Consumers
are knowledgeable, well informed and more
aware about the benefits of DNA analysis in
preventing illnesses. Currently, genomics is the
only way to prevent chronic illnesses before
the onset of symptoms. Clients can learn about
their predispositions and their unique nutritional
and fitness genomics and take charge of their
health, which is our mission.
We look forward to substantially scale our oper-
ations in 2015. In 2014, we established traction
across different products in various international
markets and are now ready to scale. Whether
it is the 100Life through corporates or Come
Alive through salons and direct marketing, we
have demonstrated month-on-month increase in
customers. We expect this trend to accelerate
in 2015.
Dr Robert Ryan,
PhD, CEO, Scioderm
T
here is
a clear
trend
throughout
the phar-
maceutical
industry to
focus efforts
on unmet medical needs. Historically, orphan
diseases have not received much drug devel-
opment attention. That has changed recently
especially in light of the incentives being pro-
moted among regulatory authorities in the US,
Europe, and few Asian countries. This trend is
likely to continue with regulators providing both
incentives, including Breakthrough Therapy
designation and Priority Review Vouchers,
along with more collegial interactions in sup-
port of programs addressing unmet medical
needs and pediatric diseases. The incentives
offered in the “Breakthrough Therapy” program
within the Food and Drug Administration (FDA)
and the incremental exclusivity the European
Medicines Agency (EMA) provided for pediatric
drug development will continue to influence
decisions that affect opportunity selection and
risk/reward-
based fund-
ing.
2014 was a very successful year for Scioderm
with the company accomplishing multiple no-
table milestones. The company’s Zorblisa was
granted orphan designation in Europe for the
treatment of EB, a rare genetic disease in which
patients experience painful blisters and wounds
over a substantial percentage of their bodies.
Scioderm was granted multiple patents in the
US.
As 2014 comes to a close, Scioderm is prepar-
ing for the initiation of its Phase 3 registration
program.
2015
2015

CoverStory
Mr Stan Erck, CEO, Novavax
E
merging
viruses
and
those with
pandemic
potential,
such as
Middle East
Respiratory Syndrome (MERS) and Ebola, were
an incredibly important global public health
issue this past year. Using recombinant nano-
particle technology, Novavax has demonstrated
both the ability and agility to rapidly respond
to these emerging threats. We announced the
publication of significant preclinical data on a
vaccine candidate to MERS in April of this year
and the first Ebola vaccine candidate based on
the 2014 Guinea Ebola strain in October. These
programs
build on
significant
momentum from 2013, when we initiated a clini-
cal trial of our H7N9 pandemic influenza vac-
cine candidate in humans a mere 91 days after
the RNA sequence was made available. The
encouraging data and speed with which it was
obtained was significant enough to merit publi-
cation in the New England Journal of Medicine.
We expect to initiate a Phase 1 clinical trial of
the Ebola vaccine candidate in the first quarter
of 2015.
2015 represents a significant inflection point
for Novavax. Respiratory syncytial virus (RSV)
preys on the vulnerable, infants, children and
the elderly, and is the major cause of hospitali-
zations of infants 0-12 months. Globally, RSV
is the second-leading cause of infant mortality
due to infectious disease behind only malaria.
We expect to report data on three key clinical
trials of our RSV F-protein vaccine in 2015We
also plan to report data on a phase 2 clinical
trial of our recombinant quadrivalent seasonal
influenza vaccine candidate.
2015
2015
Dr Darrin M Disley,
CEO, Horizon Discovery Group
T
he emer-
gence of
CRISPR
in 2014, an
RNA-guided
nuclease
based gene
editing tech-
nology, has revolutionized gene editing allowing
anyone to try and build better research models.
This year many labs started to try gene editing,
and are beginning to realize not only the power
of these models in their work, but also the chal-
lenges that still exist in their development. 2015
will continue to extend this trend as this exciting
technology moves from hype to practical use
through refinements and by combining CRISPR
with other technologies such as Horizon’s propri-
etary rAAV.
Horizon, as true experts in all
methods of in vitro and in vivo
gene editing are providing the
critical tools and services needed to support
customers in in their work. 2014 was a trans-
formational year for Horizon. In March 2014,
Horizon was floated on the UK Alternative Invest-
ment Market, raising £68.6 million, nearly triple
the target figure. This provided us with the funds
to actively pursue our goals, which were to help
expand Horizon’s reach to new customers, to ex-
pand our access to key intellectual property and
to grow our capabilities to cover all of the stages
of the drug development process.
Since the IPO, Horizon has completed two MA
transactions including the combination screen-
ing services business CombinatoRx based
in Cambridge, Massachusetts and the world-
leading in vivo gene-editing business SAGE
Labs based in St Louis, Missouri and Boyertown,
Pennsylvania. The acquisition of CombinatoRx
deepened our screening capabilities, allow-
ing us to offer high-throughput combination
screening to customers so that they can identify

5
CoverStory
Dr Villoo Morawala-Patell, founder and CMD,
Avesthagen
A
chieving predic-
tive preventive
and personalized
healthcare via the con-
vergence of food, pharma and popu-
lation genetics has been the mantra
of Avesthagen since a decade.
We are glad to see that the biotech
industry across the world are moving
towards this goal in their own ways.
We believe that this trend is going to
continue for the next several dec-
ades. 2014 has been an eventful year
for Avesthagen.
We are in the process of restructuring the company, and see that as the
way ahead for resurgence. We are in several important negotiations for
our biosimilars, algal DHA and other bioactives for metabolic disorders,
as well as for The Avestagenome. Two of our biosimilar molecules,
AVDESP and AVENT, are moving to clinical trials, and three of them are
ready for preclinicals.
These are our immediate priorities. Given the increased urbanization in
the country, the pressure on land and water resources are increasing.
Our technology for Environment Adjusted Crops with increased drought
and tolerance and salinity tolerance, would thus be one of the solutions
to deal with this problem.
Our vegetarian DHA, an omega-3-fatty acid, from an algal source,
and other Functional Foods would also be moving into the market. We
expect to complete the analysis of a few Parsi genome sequences. That
would give us major insights into
new SNPs and varia- tions within
this endogamous community.
We are also in discussions with a few international organizations for
collaboration on specific aspects of The Avestagenome project. There
are two major related challenges that the industry currently faces. One
is the tight noose of compliance and regulatory requirements that make
progress debilitating.
The other is the availability of funding. In both cases, the norms of the
software Industry which deals with mainly services, is applied to innova-
tive research and product development in the Life Science Industry.
This makes it counterproductive, since the two industries, the required
funding and the outputs, and especially the timelines are hugely very
different.
2015
combinations of drugs
or other factors that
lead to the optimal
therapeutic effect with
the lowest risk of side
effects, while the ac-
quisition of SAGE Labs
has allowed Horizon to
extend its offering to
include in vivo models,
critical tools for pre-
clinical research.
Horizon’s goal in 2015
is to further imple-
ment its strategy to
build a fully-integrated
life science business
company, becoming
the go-to company
for the provision of
integrated product,
service and research
solutions at all stages
of translational genom-
ics and personal-
ized medicine
research from
sequence to
treatment.
A particular focus is to
develop the platforms
and infrastructure to
industrialise gene
editing and functional
genomics making it
possible to increase
productivity (e.g. cell
line generation and
functional data genera-
tion and analysis) by a
factor of 10-100.
The lifescience sector
has been the strong-
est performing sector
in the public markets
for the past number of
years and we expect
this to continue.

CoverStory
Dr Subir K Basak,
president, Drug Discovery
Services, Jubilant Life Sciences
T
he trend
in Drug
Discov-
ery sector will
be soft with
more or less
all the major
pharmaceu-
ticals declaring their interests in late stage pipe-
line molecules. Biologics discovery is gaining
momentum with several deals being signed for
proprietary technology platforms and the major/
mid biotech/pharmas allocating a good amount
of their budget in this area. We are also observing
an increase in collaborations between academics
and pharma companies and the academics are
increasingly becoming the third key element in the
drug discovery sector. Accord-
ing to an industry report, the drug
discovery outsourcing market
for the current year is about $11.25 billion and is
expected to grow upto $25 billion by 2019. Having
said that, the biologics discovery is gaining impor-
tance in par with small molecules and is growing
at a phenomenal rate.
Both Jubilant Biosys and Jubilant Chemsys, whol-
ly owned subsidiaries of Jubilant Life Sciences
engaged in drug discovery and research services,
and are regularly conducting several collabora-
tive and integrated drug discovery programs. The
collaborative or partnership model is an integrated
discovery program across single or a portfolio of
molecules. 2014 was an exciting year wherein we
expanded our existing collaborations and signed
new discovery deals with large, mid cap and
start-up virtual pharmas spanning across multiple
therapeutic areas. Below are some highlights of
the deals signed in the year 2014:
 Jubilant Biosys and Orion Corporation, the
largest pharmaceutical company in Finland,
announced a drug discovery collaboration to
discover small molecule inhibitors in the neuro-
science therapeutic area.
 Jubilant Biosys also announced the expansion
of Drug Discovery alliance with Janssen Phar-
maceutica aimed to deliver preclinical candi-
dates to Janssen across multiple therapeutic
areas.
 Jubilant Chemsys, a wholly-owned subsidiary
of Jubilant Life Sciences, and one of the most
recognized drug discovery research services
organizations from Asia announced the exten-
sion of its collaborative partnership with Infec-
tious Disease Research Institute (IDRI) for TB
drug discovery.
Moving ahead, in the drug discovery space, we
look forward to expanding our customer base and
build long term partnerships so that we become
our clients’ offshore destination for innovation. We
aim to strengthen our therapeutic area expertise
by incremental investments into certain identi-
fied research areas and will continue investment
on technologies to cater to the needs of biotech/
pharma. We will be focusing on midcap/start-ups
virtual pharmas and with the already estab-
lished set-up we look to on-board few more dis-
covery programs to build a balanced portfolio with
a combination of large/midcap/
start-ups and virtual pharmas.
With well enabled capabilities in Oncology, Meta-
bolic Disorders, CNS, Pain, Inflammation, Fibrosis
and Respiratory diseases, Jubilant has emerged
as a leading collaborator for biotechnology and
pharmaceutical companies worldwide. We aim
to continue investing in translational research
area for Target Identification/Target Validation (TI/
TV) which is also becoming an integral part of
drug discovery research. Our focus areas in 2015
will be: antibody drug conjugates to leverage
on the growing demand for biologics discovery,
strengthening our therapeutic area specific dis-
ease biology by incrementally investing in in-vivo
models and exploring the possibilities to acquire
new technologies with incremental investments
or partnerships. We have also identified some
thrust areas in discovery chemistry where we
have already started investing and will continue
our investment in these areas to strengthen our
discovery chemistry.
2015

CoverStory
Global pharmaceutical
market could be worth
nearly $1.6 trillion
by 2020
Oncology
Cancer, with a death toll exceeding that of AIDS (Ac-
quired Immune Deficiency Syndrome), tuberculosis and
malaria collectively, accounted for 8.3 million deaths in
2013. With a skyrocketing incidence of 469.6 per 100,000
in the US alone, the oncology market is poised to grow at
a substantial CAGR of around seven percent to $109 bil-
lion by 2020.
Source: ABMRG
The total global annual market for next generation cancer
diagnostics was $776 million in 2010, and is growing at
a CAGR of 47 percent, to reach a forecast market size of
$5.3 billion in 2015.
Source: BCC Research
Registering a CAGR of 14.60 percent from 2011 to 2018,
the market for oncology biomarkers was valued at $13.16
billion in 2011 and is expected to be worth $29.78 billion in
2018. As cancer gains wide-spread prevalence across the
globe, there has also been a simultaneous rise in the trend
of personalized medicine. Cancer biomarkers are injected
FUTURE MARKET ANALYSIS

CoverStory
in the body to help diagnosis, prognosis, and ep-
idemiology. They are used to check the response
of the body to a treatment or condition.
Source: Transparency market research
Breast Cancer Drug
The increased use of targeted therapies, along
with a greater uptake of branded drugs and ris-
ing incidence population, will lead the breast
cancer therapeutics market value to grow from
$9.2 billion in 2013 to $13.1 billion by 2020.
The key targeted therapies include Roche’s
Perjeta and trastuzumab-DM1, Eisai’s Hala-
ven, Novartis’ Afinitor, Pfizer’s palbociclib and
neratinib, and Boehringer Ingelheim’s afatinib.
The approval of Roche’s Kadcyla, a biobetter of
Herceptin, for metastatic breast cancer in 2013
has also advanced the standard of care in this
market. Breast cancer pipeline is robust with
potential drug candidates in various phases of
clinical development. From a total of 612 ac-
tive progressing pipeline molecules, 259 (42
percent) are in the preclinical stage of develop-
ment, 100 (16 percent) are in Phase I, 130 (21
percent) are in Phase II and 52 (8 percent) are
in Phase III of clinical trials.
Source: GBI Research
Colorectal Cancer
Therapeutics
Colorectal Cancer (CRC) therapeutics market
in Asia-Pacific (APAC) is set to increase in val-
ue, from $1.9 billion in 2013 to $2.9 billion by
2020, at a CAGR of 6.5 percent. Market expan-
sion in India, Australia, China, and Japan will
be driven by the increasing incident population
and higher uptake of branded drugs and target-
ed therapies. The moderate uptake of late-stage
pipeline products panitumumab and Xilonix,
following their expected approvals between
2016 and 2018, will help boost the market.
However, the impressive growth in the APAC
CRC therapeutics market will be prevented by a
significant rise in patent expirations, including
those for Erbitux and Avastin in Japan during
2016 and 2020, respectively. This will create
a substantial opportunity for generic and bio-
similar manufacturers.
Melanoma
Therapeutics
Global melanoma therapeutics market was val-
ued at $1.3 billion in 2013 and will expand at a
CAGR of 15.4 percent to reach $3.6 billion by
2020. Majority of the increase, which relates to
eight major countries (US, Canada, Germany,
France, Italy, Spain, the UK, and Japan), will
occur in the US, where the market value will
rise from approximately $1 billion in 2013 to
$2.6 billion by the end of the forecast period.
The fastest growth will occur in Japan, where
the melanoma treatment market will increase
at a CAGR of 25.8 percent from $2.8 million in
2013 to $14.2 million by 2020.
Stem Cell
Therapies
There arearound 104 stem cell programs in
late-stage clinical development, paving way for
a market shift towards stem cell-based therapy
applications by 2017. Based on clinical trial
timelines, stem cells could reach the commer-
cialization threshold in the next few years.
The number of clinical trials has also picked up,
and currently, the top 20 developmental candi-
dates are undergoing a total of 170 clinical tri-
als across a range of different therapy areas and
indications. Despite high rates of clinical fail-
ure in emerging biotechnologies, the number
of therapeutic candidates under investigation
indicates the market potential for a raft of new
therapies emerging from the stem cell sector
for areas with high unmet need such as those
involving tissue regeneration. Source: Global-
Data
Global stem cell market earned revenues of
$40.01 billion in 2013 and is estimated to
nearly triple to $117.66 billion in 2018 at a
CAGR of 24.1 percent. While North America
is the market leader with more than half of the
global stem cell market share, the Asia-Pacific
is expected to record the highest growth rate.
APAC stem cell market, which was valued at
$5.60 billion in 2013, is projected to increase
to $18.71 billion by 2018.
Source: Frost Sullivan

CoverStory
Dengue Vaccine
Dengue vaccine market is estimated to grow
from $70 million in 2015 to $400 million by
2020, at a Compound Annual Growth Rate
(CAGR) of 42 percent contributed mostly by
Brazil, India, Mexico, Singapore, and Thailand.
Clinical and commercial positioning of live-
attenuated dengue vaccines, led by Sanofi’s
CYD-TDV and Takeda’s DENVax, would facili-
tate their market dominance. The rapid uptake
of dengue vaccines will be driven primarily by
the inclusion of live-attenuated vaccines in na-
tional immunization programs.
Source: GlobalData
Self-Monitoring
of Blood Glucose
APAC Self Monitoring of Blood Glucose
(SMBG) market earned $222.7 million in 2012
market and is expected to reach $358.7 million
in 2017. The strip segment earned revenues of
$1212.7 million 2012 and expects this to grow
to $2081.2 million in 2017.
Not even 10 percent of the diabetic population
in Asia-Pacific use SMBG products due to in-
adequate education and awareness, as well as
a lack of affordability and strict regulations.
To improve patient awareness, SMBG origi-
nal equipment manufacturers (OEMs), several
governmental and non-governmental organi-
zations, and hospitals need to conduct patient
awareness camps and drives throughout the
year.
Infectious
Disease Diagnostics
Global infectious disease diagnostics market
earned revenue of $7.91 billion in 2013 and is
estimated to reach $12.77 billion in 2018 driv-
en by diseases including hepatitis B, hepatitis
C, tuberculosis, and sepsis tests.
Molecular diagnostics is growing the fastest
among the infectious disease market segments,
clocking a compound annual growth of 15.30
percent, due to efficient and accurate result.
Molecular methods and immunodiagnostics
are expected to complement each other as the
need for accurate and rapid diagnostic tests
rises.
Cardiovascular
Information
and Imaging
solution
Cardiovascular information and imaging solu-
tion market in Asia was valued at $17.9 million
in 2013 and is expected to reach a CAGR of 8.4
percent from 2014 to 2019. Asia accounted for
a market share of 12.3 percent of global CVIS
market in 2013.
The government support for the development
of healthcare IT solutions and growing medical
tourism in the Asian countries are among the
major factors that are likely to drive the growth
of this market. The growing medical tourism
will increase the flow of patients to hospitals,
especially in the cardiac department, owing to
the increasing flow of patients. With the grow-
ing workload, an efficient system is required to
streamline and manage the workflow efficient-
ly, and this boosts the CVIS market in the Asian
region.
Source: MicroMarket Monitor
Type 2 Diabetes
Global Type 2 Diabetes Therapeutics market
is forecast to grow at 7.15 percent CAGR over
the period 2014-2019 and the value of type 2
diabetes market in Asia-Pacific is expected to
increase from $6.5 billion in 2013 to $10.5 bil-
lion in 2020 at a CAGR of 7.1 percent.
Among the four APAC type 2 diabetes markets,
Japan has the highest market share of 51 per-
cent followed by China with 30 percent and
India with 14 percent. In a best-case scenario,
the total market size is expected to grow at a
CAGR of 8.1 percent to $11.2 billion by the end
of 2020, while in a worst-case scenario it is ex-
pected to grow at a slower CAGR of 6.6 percent
to $10.2 billion by the end of 2020.
Source: ReportsnReports.com

CoverStory
A Look at the
drug market in 2015
S
pending on medicines will
reach nearly $1,100 billion
in 2015, reflecting a slowing
growth rate of 3-6 percent
over the five year period from 2010-
2015, as compared to 6.2 percent an-
nual growth rate in 2005-2010.
In the major developed markets,
spending on branded medicines will
remain essentially unchanged in
2015 from the level in 2010, since
all increases in spending on brands
will be offset by reduced spending
on those brands losing patent pro-
tection. Innovative products are
expected to be launched which will
bring important new treatment op-
tions to patients with cancer, diabe-
tes, thrombosis and debilitating dis-
eases of the central nervous system.
Additional important new therapies
with orphan drug designations or
narrow indications are also expected,
but will not be a major driver of in-
creased spending.
All of the increase in spending on
brands, both new and existing, will
be offset by patent expiries in the
period of 2010-15, will reduce brand
spending by $120 billion through
2015. Only spending on generics will
increase in developed markets over
the next five years. In high growth
emerging markets, spending will in-
crease by $150 billion, as improved
access and strengthening economies
drive higher demand, primarily for
generic drugs.
Policy-Driven Changes and
Impacts Through 2015
Significant policy changes, made in
2010, will have longer-term impacts
on the spending and usage of medi-
cines across many countries includ-
ing the passage of the Affordable
Care Act in the U.S., a sweeping re-
form of Japan's unique every-other-
KEY DRUG MARKET
 Global oncology spending
will reach $75 billion by 2015
 Global spending on diabe-
tes will increase by 4-7% from
$34.9 billion in 2010 to around
$43-$48 billion in 2015
Global Asthma/COPD market
is estimated to grow from $36.3
billion in 2010 to $41-46 billion
with a CAGR of 2-5%
Spending on global lipid reg-
ulators market will decline from
$37 bilion to $29-$34 billion
due to patent expiry of branded
products and shift of the use to
generic products

CoverStory
Source: Extracted from the
report 'The Global Use
of Medicines: Outlook
Through 2015' by IMS
Institute for Healthcare
Informatics, 2011
year price-cut system, and sev-
eral new reforms to rebalance
spending priorities in each ma-
jor European market. Impor-
tant steps were also taken in the
U.S. and Europe in the develop-
ment of scientific guidelines for
the approval of biosimilars.
Key Therapy Areas
Spending on most therapies will
grow at slower rates—or even
decline—through 2015. Spe-
cialty medicines will experience
continued growth in the medi-
um term driven by novel mech-
anisms, improved efficacy and
relatively large patient popula-
tions, leading to increased up-
take of these high-value medi-
cines. Global oncology spending
will reach $75 billion by 2015 as
existing targeted therapies have
already been widely adopted in
most developed markets, some
major products will be exposed
to generic competition, and new
products, with the potential to
extend lives, will add treatment
options in several major tu-
mors, but will not contribute to
significantly higher spending.
Global spending on diabetes
will increase by 4-7percent ac-
companying increased preva-
lence of Type 2 diabetes and
treatment rates especially in
countries such as China, India,
Mexico and Brazil.
Greater use of oral antidiabetic
agents is expected due to their
convenience and efficacy. An-
nual spending growth through
2010-2015 will slow to 2-5
percent for asthma and COPD
medicines compared to 9 per-
cent growth in the period of
2005-10.
Spending on lipid regulators
will fall to $31 billion in 2015
from $37 billion in 2010 and
patent expiries will limit angio-
tensin inhibitors growth to 1-4
percent. BS
DRUG
Generic
Name
Manufacturer Indication
Patent
Expiry
Sales Sales period
ABILIFY aripiprazole
Otsuka
Pharmaceutical
Schizophrenia
and bipolar
disorder
Apr-15
$6.9
billion
Apr-13-
March14
Copaxone
Glatiramer
acetate
Teva
Pharmaceutical
Multiple
sclerosis
Sep-15
$1.1
billion
Three qarters
ended in sept
2014
Gleevac
Imatinib
mesylate
Novartis
Chronic myeloid
leukemia
Jul-15
$4.6
billion
Apr-13-
March14
Namenda
memantine
HCI
Forest
Laboratories
(Now acquired by
Actavis)
Alzheimer’s
disease
Apr-15
$1.5
billion
Apr-13-
March14
Zyvox linezolid Pfizer Antibiotic May-15
$1.4
billion
Apr-13-
March14
Avodart dutasteride GSK
benign prostatic
hyperplasia
Sep-15 NA NA
DRUGS TO BE EXPIRED IN 2015
LEADING THERAPY CLASS IN 2015
Disease segment
Market estimate in
2015 (In $bn)
Oncology 75-80
Antidiabetics 43-48
Respiratory 41-46
Lipid regulators 29-34
Angiotensin inhibi-
tors
28-33
Autoimmune 27-32
HIV antivirals 20-24
Antipsychotics 18-22
Platelet aggrega-
tion inhibitors
18-22
Anti-ulcerants 18-22
Antidepressants 13-16
Anti-epileptics 13-16
Multiple sclerosis 12-15
Osteoporosis 11-13
Narcotic analge-
sics
10-12
Attention Deficit
Hyperactivity
Disorder
9-11

Mr Ross Horsburgh is a
senior VP head of clini-
cal develpment and SE
Asia, Australia/NZ, Korea,
and Taiwan markets
W
hat’s next for the Asia-
Pacific biopharmaceu-
tical landscape? Since
the mid-1980s, the re-
gion has gone through three phases:
the first trodden by pioneers willing
to accept risk, often because of pa-
tient recruitment struggles in Europe
and the US; the second marked by
multinational biopharma companies
seeking lower costs and faster trials;
and the current phase, where Asia is
a normal part of global development
plans for new products.
I believe Asia-Pacific is entering
phase four, one marked by global
leadership in clinical trial research
and by diffusion of Asian innovation
in both products and processes to
global markets.
I call this new phase the “Asia ad-
vantage.” It’s the result of a combi-
nation of factors, including the re-
gion’s huge population, with six in
10 people worldwide living here; its
growing number of local companies
with promising pipelines (primed
by strong government support for
RD); and its large numbers of high-
ly qualified graduates in technology
and the life-sciences.
In addition to significant funding
and governments making biopharma
sector growth a national priority,
the Asia advantage is powered by
the Asian mindset around partner-
ing and innovation. This is different
than the legacy mindset of the huge
vertically integrated Western multi-
nationals that dominated biopharma
in the 20th century.
Global Big Pharma faces the hurdle
of transforming from old to new ways
of working – a challenge local Asia-
Pacific companies don’t have. They are
building themselves ‘de novo’ by lever-
aging modern data analytics, technol-
ogy, outsourcing and partnering. They
don’t need to stop and turn around –
they’ve hit the ground running.
Top local biopharma companies also
are benefiting from quality and infra-
structure improvements across Asia
driven by Western multinationals
conducting trials to global standards.
These companies have invested
heavily in improving key investigator
sites, allowing local companies to le-
verage that quality infrastructure to
develop robust data.
Another part of Asia-Pacific’s emerg-
BioColumn
Asia-Pacific Biopharma
Entering New Era of Global
Leadership Innovation
Mr Ross Horsburgh
MD, senior vice president,
Head of Clinical Development,
Asia-Pacific, Quintiles

ing fourth phase – and one not lim-
ited to the region – involves making
a strategic choice between focusing
on costs (the old way) vs. value cre-
ation (the new way). For more than
50 years the industry model was to
conduct each step of clinical research
as cheaply as possible with the goal
of registration. The new way focuses
on value creation, with market access
as the goal.
Instead of a focus on cheaper delivery
of traditional approaches, we now see
new models of development aimed at
minimizing time to market and maxi-
mizing asset value.
Value-creation companies use so-
phisticated data analytics to gain
insights and make fast go/no-go de-
cisions, and leverage outsourcing to
remain lean and nimble – with end
goal being a competitively favorable
label and market access.
The need for evidence about the
value of products – which is essen-
tial for market access – is a driving
factor behind one of Quintiles’ fast-
growing business segments in Asia-
Pacific, its Real-World Late Phase
Research group. This group gathers
evidence about how drugs perform
post-approval, in the real world, out-
side the highly controlled clinical set-
development models.
Embracing the advantages of part-
nering will be essential to future suc-
cess. It’s a way for companies to focus
on their core strengths and outsource
non-core functions to world-class
providers. Companies can tap Quin-
tiles, for instance, for our expertise
and skills developed over the past 32
years. We can help our customers be
more successful.
Back in 2002 we investigated how
many of the previous year’s top 30
best-selling drugs we had helped de-
velop or commercialize. We found out
that we’d played a role in every one.
That has been true for all the top 30
best-selling drugs each year since then.
In 2013 we had worked on all the top
100 best-selling drugs. That’s a claim
no other company can make. It speaks
to the size of our customer base, the
breadth of our services, the depth of
our expertise, and our global scope.
But this is not just about confidence
around operational execution. It’s
about the impact on asset value. This
experience has delivered the knowl-
edge base which allows predicative
models mentioned above.
Faster, value-focused, better. That’s
the Asia advantage we are seeing. BS
BioColumn
ting. Its research provides healthcare
stakeholders with evidence to sup-
port regulatory, reimbursement and
pricing decisions. How safe is a new
drug in real-world use? What prac-
tices are really happening around a
drug? How does one drug compare
vs. another?
I see 2015 as an inflection point be-
tween the people who get it and the
people who don’t. The next genera-
tion of drug development is, I be-
lieve, going to be science-based, da-
ta-driven and built on a partnering
model. In Quintiles we have thou-
sands of people in India analyzing
data, providing insights to help our
customers improve their probability
of success. We can provide customers
with a view of data that can help pre-
dict what will happen using different
Global Big Pharma
faces the hurdle of
transforming from old
to new ways of working
– a challenge local
Asia-Pacific companies
don’t have

Lance Little became
the Managing Direc-
tor, Region Asia Pacific
for Roche Diagnostics
in 2012. Prior to that he
was the Managing Direc-
tor of Roche Diagnostics
India, where he was also
the head of the wider
Indian sub-region, which
includes the neighboring
markets of Bangladesh,
Bhutan, Nepal and Sri
Lanka. Prior to this, his
experience as Managing
Director extends to both
Roche Diagnostics Thai-
land and Roche Diagnos-
tics New Zealand
I
n most Asian countries there
is an increasing prevalence of
non-communicable diseases
and therefore there are many
un-met medical requirements that
need to be addressed. There is also
seeing increasing modernization of
healthcare infrastructure, especially
in emerging markets. On the regu-
latory side, we observe increasing
regulatory hurdles and also harmo-
nization of the ASEAN regulatory
framework. With the focus of many
counties to reduce costs by taking
people of the hospital system, we are
seeing a strong demand for Point of
care technology.
The year, 2014, was a great for Roche
Diagnostics in Asia Pacific. During
the first 9 months of 2014, the Roche
Diagnostics Division reported strong
global sales growth of 6 percent (7.8
billion Swiss francs) which was driv-
en by strong performance by Profes-
sional Diagnostics. All regions con-
tributed to growth and Asia–Pacific
was one of the key drivers of growth
at 15 percent.
Roche Diagnostics has identified a
number of focus countries for the
next years to come and much of our
attention will be placed here. At the
same time, we will be looking at areas
of growth for China. Furthermore,
we will focus as a whole region on
strengthening our commercial op-
erations.
We will also be launching a new Cen-
tre of Excellence in Singapore, which
along with China, will become the
training hub for the region. Asia Pa-
cific is a rapidly developing region
and there are still a lot of opportuni-
ties for the diagnostics industry. The
region will continue to experience low
double digit growth in 2015. Roche
Diagnostics plans to continue to grow
above the market in Asia Pacific.
Roche diagnostics
Manufacturing Site
In November 2014 Roche Diagnos-
tics announced the investment of
CHF 450 million (RMB 2.5 billion)
over the next three years in its first
Asia manufacturing site in Suzhou,
China. The new manufacturing site
sets out to address the continuously
growing demand for diagnostic tests
in China and the Asia Pacific region.
As a new addition to Roche’s global
diagnostic production network, the
Asia manufacturing facility will fo-
BioColumn
Many unmet medical
needs to be addressed
Mr Lance Little
MD, Asia Pacific region,
Roche Diagnostics

cus on producing Immunochemistry
and Clinical Chemistry tests, prod-
ucts that are crucial to clinical labo-
ratory testing. The site plans to build
a workforce of over 600 employees
over the next several years.
The new Roche Diagnostics manu-
facturing site will be the eighth
worldwide and the first in the Asia
Pacific Region. The facility will focus
on packaging operations in the first
phase and will be fully operational
by 2018. The new site will not only
strengthen the global manufactur-
ing network of Roche Diagnostics,
but also contribute to the company’s
strategy for sustaining its leadership
position in the region. Diagnostics
is an enabler. Physicians need di-
agnostics to help them provide the
best medical management for their
patients; Governments need diag-
nostics to help save healthcare costs;
Pharmaceuticals need diagnostics to
help them focus drugs to the right pa-
tient group.”
Key initiatives
planned for 2015
Being the leading in vitro Diagnos-
tics Company it’s certainly our goal
to maintain our leadership and fur-
ther expand it. Our market share in
Asia Pacific is around 20 percent,
more than double that of our closest
competitor.
Our goal is to continue to perform
 Laboratories require high through-
put systems which can increase the
efficiency and their productivity.
 In many markets healthcare
spending is under pressure and
therefore the overall efficiency of lab
testing is continuing to increase.
 To address this requirement we
have developed the two instruments
called cobas 6800/8800. These sys-
tems are fully automated molecular
testing systems for blood and plasma
donor screening as well as next-gen-
eration viral load testing assays.
These systems will help ensure a safe
blood supply and provide new diag-
nostic tools to advance the medical
community’s understanding about
viral disease and improve the ability
to treat patients.
 The new cobas 8100 automated
workflow solution will become avail-
able in Asia Pacific in 2015. It is the
result of 35 years of partnership be-
tween Roche and Hitachi High Tech-
nologies. The system gives labs full
and transparent control over their
operational and clinical processes in
both single as multisite set-ups.
Combined with Roche’s sample ar-
chiving solutions, cobas 8100 pro-
vides unprecedented flexibility and
connectivity, simplifying and speed-
ing up routines for analysis, archiving
BioColumn
well above the market. Roche con-
tinues to develop diagnostic solu-
tions with improved speed, accuracy
and reliability through automation,
improved workflow and IT integra-
tion. We enable laboratories to better
handle expanding testing and data
volumes.
We further drive laboratory efficien-
cy by providing our customers with
modular solutions and comprehen-
sive test menus.
Roche Diagnostics offers a menu of
more than 250 different tests. On our
highest throughput platforms can
process up to 20,000 samples every
day (800 an hour).
 The new cobas 6800 and cobas
8800 systems for fully automated
PCR testing will also be launched in
the region in 2015:
Many countries
are investing in the
implementation or
expansion of Universal
Healthcare programs;
restructuring healthcare
systems; and
modernizing healthcare
infrastructure
The Value of Diagnostics
Healthy Asymptomatic/Symptomatic disease Chronic disease
Diagnostics
Prevention Screening Diagnosis Prognosis Stratification Treatment Monitoring
Pharmaceuticals

and on-demand retrieval of blood
samples. Its industry-leading design
helps high-throughput laboratories
to consolidate processes.
The value of diagnostics
One of Roche’s main goals is to raise
awareness around the importance
of diagnostics. Diagnostics is a fun-
damental part of healthcare and
provides value beyond just diag-
nosis. Tests play an important role
in screening, diagnosis, prognosis,
patient stratification and treatment
monitoring, helping to improve clini-
cal practice and improve quality of
care. Diagnostics’ impact on the
healthcare system is broad, however
it is undervalued and underused.
In 2015 we plan to further increase
the awareness around HPV screen-
ing for cervical cancer; pre-eclampsia
testing for pregnant women; and the
Troponin T test which is a reliable in-
dicator for heart attack and the gold
standard worldwide in cardiac criti-
cal care.
HPV for cervical
cancer screening
As market leader, we want to ensure
women understand the importance
of regular cervical cancer screening
and the role of HPV testing, either as
a primary screening test or in addi-
tion to their regular pap screen.
Therefore we are exploring how to
create awareness among the general
public and how to empower them.
Background on the
Roche HPV test
Cervical cancer is the fourth most
common cancer in women worldwide
and there are often no symptoms as-
sociated with cervical pre-cancer. Yet
it is also preventable.
Roche has developed the innovative
cobas HPV test. The Roche ATHENA
study, including more than 47,000
women, showed that when the co-
bas® HPV Test was compared to cy-
tology (Pap test), significantly more
cervical disease was identified at
baseline than cytology-based screen-
ing. Nearly 1 in 7 women with nor-
mal cytology (NILM) who were HPV
16 positive actually had high-grade
cervical disease that was missed by
cytology. Furthermore, one in four
women positively tested for HPV 16
will develop cervical cancer within
the following three years.
 Troponin T to identify heart at-
tacks – new study results in 2015 -
main objective of the TRAPID-AMI
study is to document the safety and
efficacy of a one-hour algorithm us-
ing high-sensitivity cardiac Troponin
T measurements
Diagnosing heart attack in patients is
one of the most challenging problems
facing doctors in hospital emergency
departments. A heart attack requires
immediate and often serious inter-
vention. A blood test that can accu-
rately determine whether a patient
is having a heart attack can literally
mean the difference between life and
death. In the past, physicians had to
rely on symptoms and electrocardio-
grams (ECG), which could miss over
50% of heart attacks. Roche has de-
veloped an Elecsys Troponin T high-
sensitive test¹ which detects the pres-
ence of troponin T, a protein that is
released into the blood stream during
a heart attack. The Troponin tests are
reliable indicators of heart attack.
Other new products
 A new anti-Müllerian hormone
(AMH) blood test was launched in
September this year. This is the first
fully automated AMH test for assess-
ing a woman’s ovarian reserve for
in-vitro fertilisation. This test can
be incorporated into routine clinical
practice for faster and more reliable
results.
 HE600 system will launch in 2015
to further improve the safety and
lab efficiency for pathologists (tissue
samples)
Diagnostics is a fundamental part of
healthcare and provides value across
the whole healthcare continuum –
from diagnosis to prognosis to treat-
ment monitoring. However, while
Diagnostics provides information for
around 70 percent of healthcare de-
cisions, it’s estimated that it accounts
for only 2 percent of healthcare in-
vestment. BS
BioColumn
Asia Pacific is the home to many emerging
markets with significant changes occurring in
healthcare, which will continue through 2015

BioTalk
G
lobal contract research organization, ICON,
has been providing outsourced development
services including strategic development, man-
agement and analysis of clinical trial programs
to the pharmaceutical, biotechnology, and medical device
industries. Based in Hong Kong, Mr Mei Wing Goh, is
the vice-president of ICON in Asia-Pacific region and has
over 14 years of experience in the CRO industry. Having
worked with global outsourcing firms including Kendle
and Quintiles, Mr Goh shares with BioSpectrum Asia the
trend of APAC evolving as a preferred site for clinical trial
for global companies and how much the region has pro-
gressed to tap the surging opportunity.
How do you see Asia evolving as the site for
clinical trials? Is the regulatory structure
advancing with the onset of clinical trials in the
region?
A It is recognized that Asia has been rapidly gaining
importance in global clinical trials. As 60 percent of
the world’s population resides in Asia, it offers a tremen-
dous patient pool, which supports patient enrolment
strategies that can reduce timelines.
There have also been multiple initiatives introduced by
governments, research focused organizations and devel-
opment societies in the region to help support growth in
clinical research. The presence of a well-developed hos-
pital infrastructure and dedicated clinical trial centers in
some countries has also supported the growth of well-
educated and experienced study workforce.
The regulatory approval has improved drastically in
many Asian countries over the last decade. The clinical
trial environment has similar characteristics across the
region but drug registration requirements and processes
differ from country to country. For example it usually
takes less than two months to get regulatory approval of
a clinical trial in Singapore, Malaysia, Philippines and In-
donesia. However, the timeline of regulatory approval in
some other countries continue to be a challenge. In Chi-
na, the average approval timelines can range from 6 to
12 months. China Food and Drug Administration (CFDA)
is currently working to improve the application approval
process to give higher priority to innovative new drugs
and medical devices products. Fortunately, the regula-
tory delays can be somewhat offset by the availability of
treatment-naive populations in these areas.
Also, the government in Korea is reviewing closely the
quality of clinical trials. The Ministry of Food and Drug
Safety (MFDS), has set up a dedicated team to provide
oversight regarding the qualification of sponsors, CROs,
institutions, and it has also issued guidelines for the in-
spection and regulation of all parties involved in clinical
trials of new medicines and medical devices. The guide-
lines aim to protect the rights, safety, and well-being of
the patient, to ensure GCP compliance, and to increase
‘Oncology is the
most prevalent
therapeutic area’
Mr Wei Ming Goh
vice president, APAC, ICON
Interview

BioTalk
the credibility and integrity of the data. The government
has also enforced monitoring for post-marketing surveil-
lance studies. The newly-developed regulations and re-
vised guidelines provide stricter control of clinical trials
to ensure data quality.
What would be the main factors driving and
supporting the clinical research sector in Asia
in coming years?
A The biggest single driver for conducting trials in
Asia is the availability of large numbers of treat-
ment naïve patients—patients that have not previously
received treatment for a specific condition. While regula-
tory start up times can be challenging for some countries
the ability to recruit large numbers of patients once the
sites are up and running is a major benefit in terms of
meeting the timelines required for the overall regulatory
approval of the compound. In essence, start-up times can
be longer than in Europe or the US for some of countries
in Asia but this additional time is more than made up for
by the ability to rapidly recruit patients. This is especially
relevant for studies that have extended treatment periods
(e.g. longer term phase III studies) and enables more
rapid drug development and registration, which is a ma-
jor benefit to the pharmaceutical industry and of course
to patients.
There are lot of innovations in the medical
devices segment. Even integration of
pharmaceutical product and medical device
is welcomed as an effective approach. Is the
regulatory in Asia equipped to assess and
monitor clinical trials of such devices?
A According to the survey of WHO Baseline Country
Survey on Medical Devices, regulatory systems for
medical devices are less developed than those for new
drugs globally due to many of those governments that
have drafted regulations have made slow progress in im-
plementation. In Asia, the regulation for medical device
of clinical trial differs among the countries, however,
most countries require compliance to ICH GCP or local-
ised version of GCP in their regulations. For example,
Hong Kong currently does not have any regulation for Amrita Tejasvi
ICON aims to expedite
every aspect of the
oncology drug trial by
combining global experience
in all phases of oncology drug
development
medical device clinical trials and import of investigation-
al medical device for clinical use.
Do you find local CROs of the region as the real
competitors to multinational CROs as they have
access and reach to local population?
A We have seen global CROs forming partnerships
with local small to medium CROs to combine the
strengths of local knowledge and experience with global
footprint and experience. These partnerships can then
compete more effectively for global clinical development
programs.
What strategies has ICON taken to grow its
footprint in Asia?
A ICON has strong presence in Asia and we are con-
stantly reviewing our presence in line with custom-
er demand. We have increased our footprint with a com-
bination of organic growth, partnering and acquisition.
For example, the recent acquisition of Aptiv Solutions
enhances ICON’s capabilities in adaptive and medical de-
vice trials and in particular has strengthened our Oncol-
ogy expertise and experience in Japan. We believe by
combining Niphix’s local expertise and knowledge with
ICON’s global infrastructure and experience we can pro-
vide a unique offering to our local and global customers.
What are the diseases on which ICON is
focusing in Asia?
A Oncology is the most prevalent therapeutic area in
clinical trials and is currently ICON’s largest re-
quested therapeutic area in Asia. ICON aims to expedite
every aspect of the oncology drug trial by combining global
experience in all Phases of oncology drug development
with specialised expertise in tumor imaging, laboratory
services (including PK/PD and Biomarkers) IVRS and
IWRS, data management, and local regulatory insight. BS

BioInformatics
‘Fundamental
challenges in
Lifesciences
similar around
the world’
I
n October 2014, Accenture announced the launch
of Accenture Life Sciences Cloud (ALSC) for RD,
a platform developed with Oracle, which aggregates
and analyzes data from a variety of sources and
speeding up clinical development and drug discovery
process.
Accenture has also formed a Life Sciences Cloud Coali-
tion with pharmaceutical giants including Eisai, Merck
and Pfizer, aiming to bring about innovation and digi-
tally support various RD functions thereby accelerating
drug discovery process while maintaining quality and low
costs.
Mr Kevin Julian, managing director, Accenture Acceler-
ated RD Services, spoke exclusively to BioSpectrum’s
Raj Gunashekar, sharing his views on how the cloud can
improve patient outcomes, bolster RD efficiency and
the future of cloud in Life Sciences organizations.
Tell us the uniqueness of Accenture Life
Sciences Cloud.
A Mr Kevin Julian: This one started with a client
need. One of our clients made a strategic decision to
externalize RD, which prompted the need for a technol-
ogy platform to aggregate and analyze data from a variety
of sources. Accenture and Oracle partnered to address
the client need, and the result of this collaboration laid
the foundation of the ALSC.
There are several unique aspects to it including:
 Focus on the data: The cloud brings together multiple
internal and external data sources across clinical, safety,
regulatory, and operational functions into a single analyt-
ics platform. It doesn’t seek to replace existing valuable
technology systems but rather brings data for those sys-
tems together to create actionable insights to accelerate
drug development and improve patient outcomes.
 Built by the industry for the industry: The ALSC co-
alition was created along with the platform bringing to-
gether like-minded industry leaders to set the direction
for the platform and share the investment, risk and value.
Does this platform give strong competition to
IBM’s Watson?
A Our platform is a tailored solution that addresses
specific RD challenges and built together with
leading Life Sciences companies to address those chal-
lenges. While built on leading high performance hard-
ware and analytics solutions from Oracle, we feel the real
Mr Kevin Julian
MD, Accenture Accelerated RD Services

BioInformatics
Industry regulations, data
security and integrity
have been priorities since
companies started using
information technology to
support RD
Raj Gunashekar
value in our platform comes from the solutions it can pro-
vide to industry above and beyond its impressive process-
ing capabilities.
Do you intend to work with other drug makers
alongside Pfizer and others?
A Yes. Accenture has formed a Life Sciences Cloud
Coalition (LSCC) with pharmaceutical companies
like Eisai, Merck, Pfizer and others. There are other com-
panies involved in the coalition as well.
What trends do you see in digitizing RD in
lifesciences organizations?
A Today’s lifesciences organizations are under ever-
increasing pressure to improve productivity at less
cost and digital solutions will play a major role in that.
They serve to create collaborative platforms, advance the
consumerization of the healthcare industry, and further
create a data-driven enterprise.
For example, our cloud creates a platform for advanced
analytics to help improve the quality and speed of critical
decision making across the drug development life cycle.
This reduces the amount of time it takes health products
to get to market and improves the safety and efficacy of
those products when they get there.
What are the challenges in using the RD cloud
in terms of regulations?
A Industry regulations, data security, and integrity
have been priorities since companies started using
information technology to support RD.
These days, the chain of RD data crosses many bound-
aries as it follows the long path from research bench to
patient to regulatory authority—involving a variety of
mobile devices, web-based collection tools, databases,
external research partners, and offsite data centers along
the way. In this context, cloud-based solutions are just
another link in the data security chain, following the
same industry standards for physical and data security
as any other.We have been particularly thoughtful about
our approach including partnering with a trusted hosting
provider with significant experience serving this industry
and utilizing approaches including private cloud.
What are the advantages of using the cloud for
drug development RD?
A Clinical RD organizations can look to realize ben-
efits through the compilation of clinical, safety,
regulatory and operational data into one analytics plat-
form to provide data aggregation and improve the quality
and speed of decision-making.
How has been the interest for using the cloud
among lifesciences organizations?
A Apart from Eisai, Merck and Pfizer, we have seen
strong interest from all types of clients ranging
from large multinational pharmaceutical companies to
emerging biotechs, leading CROs and smaller Life Sci-
ences and biopharma companies around the world.
Tell us about the Accenture Accelerated RD
Services. How much of investment has gone
into it?
A Accelerated RD services is a business service fo-
cused on delivering streamlined and integrated
RD functions that will help pharmaceutical companies
bring new medications to patients using a more collab-
orative and efficient approach.
The company is investing more than $200 million to
deliver this fully-integrated, technology-enabled global
business services that will drive more efficient and effec-
tive development of pharmaceutical products for clients.
Accelerated RD Services will leverage capabilities of the
cloud, mobility and analytics to deliver integrated func-
tions across clinical development, regulatory submis-
sions, pharmacovigilance and market launch predicated
on delivering better patient outcomes. BS

BioSpecial
Due to patent expiry
companies may lose
upto $65 billion by 2019
A
ccording to research and
consulting firm, GlobalDa-
ta, pharmaceutical indus-
try will suffer an estimated
$65 billion drop in sales by 2019 due
to the patent expiries of several lead-
ing drugs.
According to the report, drug makers
hit hardest will include Otsuka, Eli
Lilly, and AstraZeneca (AZ), with a
significant proportion of losses com-
ing in the Central Nervous System
(CNS) treatment sector.
Mr Adam Dion, analyst, GlobalData
states that Eli Lilly and AZ have seen
profits fall in the CNS therapeutics
market since 2010, with the latter
losing the greatest share over the
past three years.
“AZ’s CNS segment has been bleed-
ing sales as a result of the company
BioSpectrum takes a
look at some of the
blockbuster drugs
that are on the verge
to lose patent in
2015.

BioSpecial
Amrita Tejasvi
DRUG
Generic
Name
Manufacturer Indication
Patent
Expiry
Sales
Sales
period
ABILIFY aripiprazole
Otsuka
Pharmaceutical
Schizophrenia
and bipolar
disorder
Apr-15
$6.9
billion
Apr-13-
March14
Copaxone
Glatiramer
acetate
Teva
Pharmaceutical
Multiple
sclerosis
Sep-15
$1.1
billion
Three qarters
ended in sept
2014
Gleevac
Imatinib
mesylate
Novartis
Chronic
myeloid
leukemia
Jul-15
$4.6
billion
Apr-13-
March14
Namenda
Memantine
HCI
Forest
Laboratories (Now
acquired by Actavis)
Alzheimer’s
disease
Apr-15
$1.5
billion
Apr-13-
March14
Zyvox linezolid Pfizer Antibiotic May-15
$1.4
billion
Apr-13-
March14
Avodart Dutasteride GSK
Benign
prostatic
hyperplasia
Sep-15 NA NA
losing its patent on Seroquel (que-
tiapine fumarate), a treatment for
bipolar disorder, which led to the
entry of cheaper generic alternatives
from Teva and Sandoz. GlobalData
estimates AZ’s share to have been
around 9 percent in 2010, which has
now fallen to only 3 percent in 2013.
Eli Lilly’s market share declined
from 14.3 percent in 2010 to 11.2
percent in 2013, primarily thanks to
decreasing sales of Zyprexa (olanzap-
ine), the company’s dopamine an-
tagonist used to treat schizophrenia
and bipolar disorder. Zyprexa sales
have plummeted from over $5 billion
to $1.2 billion over the same period,
as a result of the drug losing its US
patent exclusivity in 2011,” stated Mr
Dion.
The analyst added that while Otsu-
ka’s anti-psychotic drug Abilify (ar-
ipiprazole), which the company co-
markets with Bristol-Myers Squibb,
was the sales leader in the CNS arena
with $9.5 billion in 2013, the drug
faces a less positive future.
Mr Dion explained, “Otsuka benefit-
ed from higher annual sales across
most major markets in 2013 due to
reimbursement and label expan-
sions. In the US and Europe, pre-
scriptions increased for adjunctive
therapy in major depressive disorder
and manic episodes of bipolar disor-
der, while there were rising sales in
China, where the drug was included
in the national medical insurance
system.
“However, Abilify’s upcoming US
patent expiration in 2015 means the
drug will lose a massive $6.2 billion
by 2019 as the result of generic com-
petition, making it the biggest victim
of the pharmaceutical industry’s cur-
rent patent cliff.” BS
www.BioSpectrumAsia.comwww.BioSpectrumAsia.com

‘APAC has been the biggest
contributor to our growth’
Speaking exclusively to BioSpectrum at the launch of Thermo Fisher
Scientific’s new proteomics application center in Bangalore, Mr
Syed Jafry, senior vice president and president, APAC and emerging
markets, and Mr Amit Chopra, MD, VP/GM, India, shared the
company’s key strategies on investments, revenue, regulations,
supplier market trends and growth for emerging and mature markets
in the Asia Pacific region.
Mr Amit Chopra
MD, VP/GM, India, Thermo Fisher Scientific
Mr Syed Jafry
senior VP and president, APAC and
emerging markets, Thermo Fisher Scientific
BioSuppliers

BSA_Jan_2016

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