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Global Generic Pharmaceutical Market – Qualitative
and Quantitative Analysis

Aiswariya Chidambaram
Senior Research Analyst - Life Sciences

Pharma Tech, Ahmedabad
12-11-2013
Focus Points
Generics Lead the Way Ahead
Global Generic Pharmaceutical Market – Patent Cliff
Key Therapeutic Areas Overview
Key Therapeutic Areas Growth Analysis
Key Market Drivers and Challenges
Mergers & Acquisitions Outlook

Focus Points

Competitive Landscape Analysis
U.S. Generic Pharmaceutical Market Overview & Regulatory Analysis
European Generic Pharmaceutical Market Overview & Regulatory Analysis
Indian Generic Pharmaceutical Market Overview & Regulatory Analysis
Future Trends and Directions – Vision 2025
Strategic Recommendations

2
Generics Lead the Way Ahead

The global generic pharmaceutical market worth over $150
billion in 2013, growing at CAGR (2013 – 2018) of 8.4%

U.S world’s largest generics
market (45%).

India and China - huge generic
markets in production volume.

Over the next five
years
Emerging markets 15 % to 20% growth.
Matured markets – 6%
to 10% growth.

The top eight
global markets
comprise 80% of
the total generic
sales.

Blockbuster drugs
($150 billion) to lose
patents between 2010
and 2017.

The top ten global generic companies account for 47%
market share.

Source: Frost and Sullivan
Global Generic Pharmaceutical Market – Patent Cliff
Total Pharmaceutical Market: Sales Value of Drugs Losing Patent
Protection (Global), 2007 - 2017

 Generic companies have been proactive in
filing for marketing rights and exclusivity
well ahead of patent expiry.
42.11

45

 Ranbaxy was the first filer of ANDA for
generic Lipitor in November 2011 while
Watson Pharma was to sell authorised
generic version in the U.S.

Sales ($ Billion)

40
33.43

35
30
25
20

33.18

27.79
24.33
16.95

15.21

15
7.08

10

8.13 7.96
2.96

5
0

 Teva was awarded with 180 days
exclusivity to sell generic Losartan while Hi
Tech Pharmacal successfully challenged
J&J’s Levaquin (oral solution).

2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Year

 The U.S. patent for AstraZeneca’s Crestor
was challenged by Apotex, Mylan and
Sandoz.
Key Therapeutic Areas Overview
Generic Pharmaceutical Market: Percent Revenue Contribution by Therapeutic Segments (Global)
16.1%

35.1%

21.7%

0.2%

6.4%
3.4%

CNS

Cardiovascular

Dermatology

8.3%

Genitourinary/Hormonal Drugs

4.5%

4.3%

Respiratory

Rheumatology

Diabetes

Oncology

Others

Note: All figures are rounded;. Source: Frost & Sullivan

Others include Gastro-intestinal, HIV, Immunology and so on.

 Cardiovascular and CNS are the two largest market segments, constituting nearly 38% of the global generic
pharmaceutical market together.
 However, therapeutic segments such as Respiratory, CNS and Oncology are likely to witness significantly high
growth rates, attracting the attention of market participants.
 On the contrary, segments such as Diabetes and Genitourinary/ hormonal drugs are expected to decline by the
2017.
Key Therapeutic Areas – Growth Analysis
20%

14%

The patent expiry of several key
antipsychotics and anti-depressants
contribute to the rapid growth of CNS
drugs market between 2010 and 2017.
Development/
Fast Growing

12%

C
A
G
R

Fast
Growing

10%
8%

The reason behind such
enormous growth is the
massive
number
of
patent expiries. Almost
half of the global asthma
and COPD market drugs
are set to lose patent
protection by 2016.

Development/
Fast Growing

Fast
Growing

Growing

Growing

One of the promising
segments for generic
participants to venture
between 2010 and
2015 is oncology as
drugs worth $10 b are
set to lose patent
protection by 2015

6%
4%

CNS

Oncology

Bubble size represents market value

Rheumatology

Declining

Declining

Stable

Intense
competition,
promotion of branded
drugs
and
new
innovative formulations
such as
inhalable
insulin are all likely to
deter the growth of
generics.

2%

Cardiovascular

Relatively
lesser
number of drugs are
subjected to generic
exposure during the
forecast period and
hence the decline in
growth.

Respiratory

Diabetes

Dermatology Genitourinary

Others

Source: Frost & Sullivan analysis.
Key Market Drivers and Challenges
Key Drivers
Patent expiry of key
blockbuster drugs
worth $150 billion.

Access to emerging
markets and niche
therapeutic segments

New provisions
introduced by
governments

Price control measures
introduced by
governments

Changing population
demographics and
lifestyle patterns

Intense price
competition due to
imports from low-cost
markets
Increasingly
stringent
regulations to
safeguard quality

Key Challenges

Source: Frost & Sullivan analysis
Mergers & Acquisitions Outlook
Generic Pharmaceutical Market: Number of Deals and Amount Spent on Mergers & Acquisitions (Global), 2000 - 2009
30.00

90
80
70

20.00

60
50

15.00
40
10.00

30

Number of Deals

Total Value of Deals ($ Billion)

25.00

20
5.00
10
0.00

0
2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

Year
Total Value of Deals

Number of Deals
Note: All figures are rounded; Source: Frost & Sullivan analysis.

The number of deals and the total expenditure on mergers and acquisitions have been increasing steadily over the years
since 2000. There was a peak in M&A activity in 2005 and 2008. The trend is likely to continue with all the key generic
participants increasing their dependence on strategic alliances to conquer market shares.
Source: Thomson Reuters and Frost & Sullivan analysis.
Competitive Landscape Analysis
Generic Pharmaceutical Market: Ranking of Top Five Companies by Market Share (Global)

Rank

Company

 The top three companies namely Teva, Sandoz and
Mylan registered significant growth rates of 16, 14
and 11% respectively in 2010 - 2011.

1

 Most of the big companies prefer mergers and
acquisitions to organic growth as a faster means to
consolidate and expand their market shares.

2
3

 The top five generic pharmaceutical companies
accounted for 40% of the share in the global generic
pharmaceutical market.

Mylan

4
5
Source: Frost and Sullivan analysis
U.S. Generic Pharmaceutical Market

 World’s
largest
generic
pharmaceutical
market
represents 45% of global share.

 More
than
500
industry
participants
–
top
five
companies constitute 50% sales

 Highly saturated – highest
levels of generic penetration

 Most attractive hub for lowcost destinations like India,
China – increased pricing
pressure

 Predominantly
unbranded
generics (INN prescribing)

Market Overview
 Characterized by high levels of
generic prescribing, strong IP
legislations, retailers purchasing
on price
 Blockbuster drugs worth over
$67 billion to lose patent
protection

 Aggressive patent challenges
and Paragraph IV filings
 Mergers and acquisitions most sought-after trend in the
U.S.
Key Blockbuster Drugs Losing Patent Protection – U.S.
Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (United States), 2010-2017

2010

2011

2012

2013

2014

2015

2016

Atorvastatin

Clopidogrel

Candesartan
Cilexetil

Duloxetine

Aripiprazole

Epoetin alfa
(Procrit/ Eprex)

Adalimumab

Docetaxel

Goserelin

Enoxaparin

Filgrastim

Celecoxib

Imatinib
mesylate

Ezetimibe

-

Latanoprost

Epoetin beta

Insulin
lispro

Darbepoetin
alfa

Pregfilgrastim

Lopinavir
with
Ritonavir

-

Levofloxacin

Escitalopram
Oxalate

Interferon
beta – 1a
(Avonex

Esomeprazole
Magnesium

Rituximab

Olmesartan
Medoxomil

-

Interferon
beta – 1a

Glatiramer

Trastuzumab

-

-

Donepezil

Fluticasone
propionate with
Salmeterol
Xinofoate

Gemcitabine

Olanzapine

Etanercept

(Rebif)

acetate

2017
Oseltamivir

Source: Frost and Sullivan analysis

11
Key Blockbuster Drugs Losing Patent Protection – U.S.
(continued)
Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (United States), 2010-2017

2010

2011

2012

2013

2014

2015

2016

2017

Losartan

Pioglitazone

Irbesartan

Rabeprazol
e

Infliximab

-

-

-

Pantoprazole

Quetiapine

Montelukast

Risedronate

Raloxifene

-

-

-

-

Peginterferon
alfa 2a

Simvastatin
with

Telmisartan

-

-

-

-

Ezetimibe

-

-

Rosiglitazone

TacrolimU.S
.

Tiotropium

-

-

-

-

-

Rosuvastatin

Oxaliplatin

-

-

-

-

-

-

Sildenafil

-

-

-

-

-

-

-

Tolterodine

-

-

-

-

-

-

-

Valsartan

-

-

-

-

-

Source: Frost and Sullivan analysis

12
Regulatory Impact Analysis – U.S.

Regulatory Environment in the U.S Generic Pharmaceutical Market
Hatch-Waxman Act

Gregg-Schumer Act

Pricing & Reimbursement

• “Generic companies could
obtain market authorisation
by proving bioequivalence
of generics to brands

• “Single 30-month stay”
granted
to
branded
company
for
patent
infringement suit

• Safe Harbour Provision:
experimental
use
of
patented drugs permitted by
generic companies

• Stay to run concurrently
with FDA’s consideration
of application

• 180-day market exclusivity
for
first-to-file
generic
applicant
• 30-month stay for patents
listed in Orange Book

• No significant
generic entry

delay

in

• Allows generic companies
to
file
counterclaims
against innovators

• Generic drug price ranges
from
90%
of
brand
equivalent with just 1
competitor 5% with 16-20
competitors
• Medicare Prescription Drug,
Improvement
and
Modernization Act (MMA)
2003
• Medicare reimburses drugs
based on weighted average
prices
• Competitive
practiced

bidding

is

Source: Frost and Sullivan analysis
13
Europe Generic Pharmaceutical Market
 Mature markets (Germany, the
UK) to present sluggish growth
between 5 – 6%

 Top five countries – Germany,
the United Kingdom, France, Italy
and Spain represent 50% volume
share and 18% value share
globally.

 Italy and Spain are expected to
register higher growth rates
between 18 – 20%

 As per EGA, generic drugs
generate savings of €30 billion.

 Eastern Europe to contribute
maximum growth

Market Overview
 Germany and the UK are highly
penetrated generic markets

 Europe primarily dominated by
branded generics except the UK

 Represent 64% and 60% of
volume share respectively in
Europe.

 Calcium
antagonists,
antiulcerants and platelet inhibitors
to face high generic competition

 Germany is the largest generic
market in Europe accounting for
27% sales

 Highly fragmented market with
county-specific regulations
Source : Frost & Sullivan analysis.

M74E-52

14
Key Blockbuster Drugs Losing Patent Protection – Europe
Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (Europe), 2010-2017

Drug

France

Germany

Italy

Spain

U.K.

Anastrozole

2010

2010

2010

2010

2010

Aripiprazole

2011

2011

2011

2011

2011

Atorvastatin

2011

2011

2011

2011

2011

Candesartan Cilexetil

2012

2012

2012

2012

2012

Celecoxib

2014

2014

2014

2014

2014

Clopidogrel

2013

2013

2013

2013

2013

Darbepoetin alfa

2014

2014

2014

2014

2014

Docetaxil

2010

2010

2010

2010

2010

Donepezil

2012

2012

2012

2012

2012

15
Key Blockbuster Drugs Losing Patent Protection – Europe
(continued)
Drug

France

Germany

Italy

Spain

U.K.

Duloxetine

2012

2012

2012

2012

2012

Escitalopram Oxalate

2014

2014

2014

2014

2014

Esomeprazole
Magnesium

2010

2010

2010

2010

2010

Etanercept

2014

2014

2014

2014

2014

Ezetimibe

2017

2017

2014

2017

2017

Fluticasone propionate
with Salmeterol xinofoate

2013

2013

2013

2013

Invalidated

Glatiramer acetate

2015

2015

2015

2015

2015

Imatinib mesylate

2016

2016

2016

2016

2016

Infliximab

2014

2014

2014

2014

2014

16
Key Blockbuster Drugs Losing Patent Protection – Europe
(continued)
Drug

France

Germany

Italy

Spain

U.K.

Insulin glargine

2014

2014

2014

2014

2014

Insulin lispro

2010

2010

2010

2010

2010

Interferon beta 1a (Rebif)

2013

2013

2013

2013

2013

Irbesartan

2013

2013

2013

2012

2013

Levofloxacin

2011

2011

2011

2012

2011

Lopinavir with Ritonavir

2016

2016

2016

2016

2016

Montelukast

2012

2012

2012

2012

2012

Mycophenolate mofetil

2010

2010

2010

Expired (2007)

2010

Olanzapine

2011

2011

2016

2011

2011

17
Key Blockbuster Drugs Losing Patent Protection – Europe
(continued)
Drug

France

Germany

Italy

Spain

U.K.

Olmesartan medoxomil

2017

2017

2017

2017

2017

Oseltamivir

2017

2016

2017

2017

2016

Oxaliplatin

2013

2013

2013

2013

2013

Pegfilgrastim

2017

2017

2017

2017

2017

Peginterferon alfa-2a

2013

2013

2013

2013

2013

Pioglitazone

2011

2011

2011

2011

2011

Quetiapine

N.M

2012

2012

2012

2012

Rabeprazole

Expired
(2007)

2012

2012

2012

2012

Risedronate

2010

2010

2010

2013

2010

18
Key Blockbuster Drugs Losing Patent Protection – Europe
(continued)
Drug

France

Germany

Italy

Spain

U.K.

Rituximab

2013

2013

2013

2013

2013

Rosiglitazone

2013

2013

2013

2013

2013

Rosuvastatin

2017

Not mentioned

2012

Not mentioned

2017

Sildenafil

2013

2013

2013

2013

2013

Telmisartan

2013

2017

2017

2013

2017

Tiotropium

2016

2015

2014

2015

2012

Tolterodine

2012

2012

2012

2012

2012

Trastuzumab

2012

2012

2012

2012

2012

Valsartan

2011

2011

2011

2011

2011

Zoledronic acid

2012

2012

2012

2012

2012

19
Regulatory Impact Analysis - Europe
Regulatory Environment in the European Generic Pharmaceutical Market
Data Exclusivity

• Uniform level of data
protection
of
originator products for
10 years
• Permits to access data
of
a
generic
application but the
generic
version
cannot be launched
until the completion of
the ten-year period

8+2+1 Formula

European Bolar Clause
European Bolar Clause

• Originator companies
are granted 8-year
data exclusivity and 2
years
market
exclusivity

• Permits initiation of
generic R&D activity
prior
to
patent
expiry of brands

• Additional one year
exclusivity
awarded
for
new
product
indications and those
shifting
from
“prescription only” to
OTC
• Generics can enter the
market only after the
10th or 11th year

• Withdrawal
of
brands
before
generic entry cannot
stop
generic
companies
from
using
them
as
reference products

Sunset Clause

• Allows cancellation
of
marketing
authorization
for
products
not
in
market for 3 years
• Legal challenges by
patent owners can
prevent
generic
companies
from
applying
registrations
more
than 3 – 4 years in
advance of patent
expiry

Source: Frost & Sullivan analysis.

20
Regulatory Policies of Key Generic Markets in Europe Comparative Analysis
Generic Pharmaceutical Market: Impact of Regulatory Policies (Europe)

Policies

Germany

United
Kingdom

France

Spain

Italy

Reference pricing

Patient co-payment

Generic prescribing

Generic substitution

Time delay in market
access

High

Low

Source: Frost & Sullivan analysis.

21
Indian Generic Pharmaceutical Market
 Branded generics dominate the
Indian pharma market (98%)
valued at over $12.00 billion

 Highly fragmented market with
more than 22,000 registered
units

 World leader in exporting
generics to foreign countries;
exports growing at 22%

 Companies such as Sun,
Lupin, Aurobindo, Dr.Reddy’s
Laboratories, Cipla and Ranbaxy
have been aggressive in DMF
and ANDA filings with an
granted approval rates of 35%

 Anti-infectives and GI constitute
30% revenue share

Market Overview
 India produces 20 – 22% of
world’s generic drugs including
nearly 60,000 generic brands
covering 60 key therapeutic
areas
 Ranks
third
in
API
manufacturing accounting for
6.5% of world API production

 Top ten players account for
37% market share in India
Consolidation in the form of
strategic
alliances
between
Indian and foreign companies is
on the rise
 Extremely promising future for
generics in India
Source: Frost and Sullivan analysis
Export of Indian Generics to the U.S.
Total Pharmaceutical Market: Breakdown by
Domestic Sales and Export Sales (India)

 Steep rise in export of Indian generics to
the U.S. over the last five years

 Currently generic drugs from India
represent 18% of generic drugs in the U.S.

Export
52 %

Domestic

 India has more than 75 U.S. FDA approved
plants and tops the world in DMF and ANDA
filings in the U.S.

48 %
 Indian generic firms directly compete with
multinational generic companies leading to
Intensified price competition in the U.S.

 It is estimated that India is likely to capture
at least 30% of replacement generic
equivalents in the U.S. by 2018

Source: Frost and Sullivan analysis
Regulatory Impact Analysis - India
Pharmaceutical Policy

Drug Policy 1996
Pharmaceutical Policy 2002
National Pharmaceuticas Policy 2006

Quality Control

Price Control

On Prices

GMP/cGMP

Drug and Cosmetic Act 1940
Schedule M
Schedule Y

On Margin

Bulk Drugs

Formulations

IPR Protection

Essential Commodities Act 1955
Drug (Price Control) Order 1995

Amended Patents

Patents Amendment Act 2005

Source: Frost and Sullivan analysis
Regulatory Impact Analysis – India (continued)

Regulatory Environment in the Indian Generic Pharmaceutical Market
Pricing & Reimbursement

• The revised policy of the
National
Pharmaceutical
Policy
Authority,
has
capped margins on generic
drugs
at
15%
for
wholesalers and 35% for
retailers
• Price controlled drugs
Category I: Essential drugs
Category II: All drugs not in
Category I
• Drugs exempted from price
control required to meet
specific criteria

Patent Protection/ IP Rights

Quality Control

• Patents Amendment Act
2005 (TRIPS Agreement)
strictly prohibited reverse
engineering of drugs

• The Drug and Cosmetics Act
(D&C)
1940
regulates
import,
manufacture,
distribution and sales

• Covers two types of
generic drugs – off patent
generics and generics of
drugs patented before
1995

• Schedule M – requirements
for factory premises, plant,
materials,
plant
and
equipment

• Introduced
compulsory
licensing for exports

• Schedule Y – legislative
requirements for clinical
trials

• Mainly encourages foreign
companies to trade in
India

• Increasing
regulatory
compliance in India boosts
confidence of MNCs
Source: Frost and Sullivan analysis
25
Future Trends and Directions – Vision 2025
Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed
markets to emerging markets.

Consolidation is expected to remain the key factor for growth and sustenance of generic
companies.

Large generic companies are likely to increase their investments in R&D activities

Key Trends

Technology
Development of Transgenic technologies
Stem cell technologies
Cloning technologies

Generic consumption is likely to be favoured in a big way by the government, payers,
policy-makers and physicians.

Increasing focus on higher value biological therapies, biosimilars,
controlled release products, sterile formulations and niche therapeutic segments.
Source: Frost and Sullivan analysis
Strategic Recommendations for Success
Strategy is a style of thinking, a conscious and deliberate process, an intensive implementation system, the science
of insuring future success – Pete Johnson
Differentiated Approach

Explore New Avenues

Big multinational generic
firms require to focus on
 Products with
technologically
challenging formulations.
 Products which require
significant regulatory
support.
 Products with limited
availability of APIs.

 Analyze prospects for
market globalization
- Strategic alliances
between multinational
generic firms and
domestic participants with
locally restricted
operations.

Medium-sized generic firms
require to focus on
 Products with relatively
higher profit margins.
 Appropriate time of entry
into the right market.

 Strengthen distribution.

Instill Competitive Capabilities

 Invest in R&D.
 Improve product line.
 Defend company’s
position in the market.
 Strike a balance
between supply and
demand side.

 Pioneer new and better
technologies.

Plan Ahead for the Future

 Research customer
needs, preferences,
expectations.
 Monitor new
technological
developments to face
the change.
 Target therapeutic
areas with high levels
of unmet clinical
needs.

Source: Frost and Sullivan analysis
Related Market Research Reports


Global Pharmaceutical Contract Manufacturing Market



Global Next Generation Biosimilars Market



Global Contract Research Outsourcing Market

28
Questions
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30
Contact Information

State your need, we would be happy to serve you…
AISWARIYA CHIDAMBARAM
Senior Research Analyst – Life Sciences

Frost & Sullivan (I) Pvt. Ltd.
ASV HANSA
No.53, Greams Road
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www.frost.com

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31

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Global Generic Pharmaceutical Market - Qualitative and Quantitative Analysis

  • 1. Global Generic Pharmaceutical Market – Qualitative and Quantitative Analysis Aiswariya Chidambaram Senior Research Analyst - Life Sciences Pharma Tech, Ahmedabad 12-11-2013
  • 2. Focus Points Generics Lead the Way Ahead Global Generic Pharmaceutical Market – Patent Cliff Key Therapeutic Areas Overview Key Therapeutic Areas Growth Analysis Key Market Drivers and Challenges Mergers & Acquisitions Outlook Focus Points Competitive Landscape Analysis U.S. Generic Pharmaceutical Market Overview & Regulatory Analysis European Generic Pharmaceutical Market Overview & Regulatory Analysis Indian Generic Pharmaceutical Market Overview & Regulatory Analysis Future Trends and Directions – Vision 2025 Strategic Recommendations 2
  • 3. Generics Lead the Way Ahead The global generic pharmaceutical market worth over $150 billion in 2013, growing at CAGR (2013 – 2018) of 8.4% U.S world’s largest generics market (45%). India and China - huge generic markets in production volume. Over the next five years Emerging markets 15 % to 20% growth. Matured markets – 6% to 10% growth. The top eight global markets comprise 80% of the total generic sales. Blockbuster drugs ($150 billion) to lose patents between 2010 and 2017. The top ten global generic companies account for 47% market share. Source: Frost and Sullivan
  • 4. Global Generic Pharmaceutical Market – Patent Cliff Total Pharmaceutical Market: Sales Value of Drugs Losing Patent Protection (Global), 2007 - 2017  Generic companies have been proactive in filing for marketing rights and exclusivity well ahead of patent expiry. 42.11 45  Ranbaxy was the first filer of ANDA for generic Lipitor in November 2011 while Watson Pharma was to sell authorised generic version in the U.S. Sales ($ Billion) 40 33.43 35 30 25 20 33.18 27.79 24.33 16.95 15.21 15 7.08 10 8.13 7.96 2.96 5 0  Teva was awarded with 180 days exclusivity to sell generic Losartan while Hi Tech Pharmacal successfully challenged J&J’s Levaquin (oral solution). 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 Year  The U.S. patent for AstraZeneca’s Crestor was challenged by Apotex, Mylan and Sandoz.
  • 5. Key Therapeutic Areas Overview Generic Pharmaceutical Market: Percent Revenue Contribution by Therapeutic Segments (Global) 16.1% 35.1% 21.7% 0.2% 6.4% 3.4% CNS Cardiovascular Dermatology 8.3% Genitourinary/Hormonal Drugs 4.5% 4.3% Respiratory Rheumatology Diabetes Oncology Others Note: All figures are rounded;. Source: Frost & Sullivan Others include Gastro-intestinal, HIV, Immunology and so on.  Cardiovascular and CNS are the two largest market segments, constituting nearly 38% of the global generic pharmaceutical market together.  However, therapeutic segments such as Respiratory, CNS and Oncology are likely to witness significantly high growth rates, attracting the attention of market participants.  On the contrary, segments such as Diabetes and Genitourinary/ hormonal drugs are expected to decline by the 2017.
  • 6. Key Therapeutic Areas – Growth Analysis 20% 14% The patent expiry of several key antipsychotics and anti-depressants contribute to the rapid growth of CNS drugs market between 2010 and 2017. Development/ Fast Growing 12% C A G R Fast Growing 10% 8% The reason behind such enormous growth is the massive number of patent expiries. Almost half of the global asthma and COPD market drugs are set to lose patent protection by 2016. Development/ Fast Growing Fast Growing Growing Growing One of the promising segments for generic participants to venture between 2010 and 2015 is oncology as drugs worth $10 b are set to lose patent protection by 2015 6% 4% CNS Oncology Bubble size represents market value Rheumatology Declining Declining Stable Intense competition, promotion of branded drugs and new innovative formulations such as inhalable insulin are all likely to deter the growth of generics. 2% Cardiovascular Relatively lesser number of drugs are subjected to generic exposure during the forecast period and hence the decline in growth. Respiratory Diabetes Dermatology Genitourinary Others Source: Frost & Sullivan analysis.
  • 7. Key Market Drivers and Challenges Key Drivers Patent expiry of key blockbuster drugs worth $150 billion. Access to emerging markets and niche therapeutic segments New provisions introduced by governments Price control measures introduced by governments Changing population demographics and lifestyle patterns Intense price competition due to imports from low-cost markets Increasingly stringent regulations to safeguard quality Key Challenges Source: Frost & Sullivan analysis
  • 8. Mergers & Acquisitions Outlook Generic Pharmaceutical Market: Number of Deals and Amount Spent on Mergers & Acquisitions (Global), 2000 - 2009 30.00 90 80 70 20.00 60 50 15.00 40 10.00 30 Number of Deals Total Value of Deals ($ Billion) 25.00 20 5.00 10 0.00 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Year Total Value of Deals Number of Deals Note: All figures are rounded; Source: Frost & Sullivan analysis. The number of deals and the total expenditure on mergers and acquisitions have been increasing steadily over the years since 2000. There was a peak in M&A activity in 2005 and 2008. The trend is likely to continue with all the key generic participants increasing their dependence on strategic alliances to conquer market shares. Source: Thomson Reuters and Frost & Sullivan analysis.
  • 9. Competitive Landscape Analysis Generic Pharmaceutical Market: Ranking of Top Five Companies by Market Share (Global) Rank Company  The top three companies namely Teva, Sandoz and Mylan registered significant growth rates of 16, 14 and 11% respectively in 2010 - 2011. 1  Most of the big companies prefer mergers and acquisitions to organic growth as a faster means to consolidate and expand their market shares. 2 3  The top five generic pharmaceutical companies accounted for 40% of the share in the global generic pharmaceutical market. Mylan 4 5 Source: Frost and Sullivan analysis
  • 10. U.S. Generic Pharmaceutical Market  World’s largest generic pharmaceutical market represents 45% of global share.  More than 500 industry participants – top five companies constitute 50% sales  Highly saturated – highest levels of generic penetration  Most attractive hub for lowcost destinations like India, China – increased pricing pressure  Predominantly unbranded generics (INN prescribing) Market Overview  Characterized by high levels of generic prescribing, strong IP legislations, retailers purchasing on price  Blockbuster drugs worth over $67 billion to lose patent protection  Aggressive patent challenges and Paragraph IV filings  Mergers and acquisitions most sought-after trend in the U.S.
  • 11. Key Blockbuster Drugs Losing Patent Protection – U.S. Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (United States), 2010-2017 2010 2011 2012 2013 2014 2015 2016 Atorvastatin Clopidogrel Candesartan Cilexetil Duloxetine Aripiprazole Epoetin alfa (Procrit/ Eprex) Adalimumab Docetaxel Goserelin Enoxaparin Filgrastim Celecoxib Imatinib mesylate Ezetimibe - Latanoprost Epoetin beta Insulin lispro Darbepoetin alfa Pregfilgrastim Lopinavir with Ritonavir - Levofloxacin Escitalopram Oxalate Interferon beta – 1a (Avonex Esomeprazole Magnesium Rituximab Olmesartan Medoxomil - Interferon beta – 1a Glatiramer Trastuzumab - - Donepezil Fluticasone propionate with Salmeterol Xinofoate Gemcitabine Olanzapine Etanercept (Rebif) acetate 2017 Oseltamivir Source: Frost and Sullivan analysis 11
  • 12. Key Blockbuster Drugs Losing Patent Protection – U.S. (continued) Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (United States), 2010-2017 2010 2011 2012 2013 2014 2015 2016 2017 Losartan Pioglitazone Irbesartan Rabeprazol e Infliximab - - - Pantoprazole Quetiapine Montelukast Risedronate Raloxifene - - - - Peginterferon alfa 2a Simvastatin with Telmisartan - - - - Ezetimibe - - Rosiglitazone TacrolimU.S . Tiotropium - - - - - Rosuvastatin Oxaliplatin - - - - - - Sildenafil - - - - - - - Tolterodine - - - - - - - Valsartan - - - - - Source: Frost and Sullivan analysis 12
  • 13. Regulatory Impact Analysis – U.S. Regulatory Environment in the U.S Generic Pharmaceutical Market Hatch-Waxman Act Gregg-Schumer Act Pricing & Reimbursement • “Generic companies could obtain market authorisation by proving bioequivalence of generics to brands • “Single 30-month stay” granted to branded company for patent infringement suit • Safe Harbour Provision: experimental use of patented drugs permitted by generic companies • Stay to run concurrently with FDA’s consideration of application • 180-day market exclusivity for first-to-file generic applicant • 30-month stay for patents listed in Orange Book • No significant generic entry delay in • Allows generic companies to file counterclaims against innovators • Generic drug price ranges from 90% of brand equivalent with just 1 competitor 5% with 16-20 competitors • Medicare Prescription Drug, Improvement and Modernization Act (MMA) 2003 • Medicare reimburses drugs based on weighted average prices • Competitive practiced bidding is Source: Frost and Sullivan analysis 13
  • 14. Europe Generic Pharmaceutical Market  Mature markets (Germany, the UK) to present sluggish growth between 5 – 6%  Top five countries – Germany, the United Kingdom, France, Italy and Spain represent 50% volume share and 18% value share globally.  Italy and Spain are expected to register higher growth rates between 18 – 20%  As per EGA, generic drugs generate savings of €30 billion.  Eastern Europe to contribute maximum growth Market Overview  Germany and the UK are highly penetrated generic markets  Europe primarily dominated by branded generics except the UK  Represent 64% and 60% of volume share respectively in Europe.  Calcium antagonists, antiulcerants and platelet inhibitors to face high generic competition  Germany is the largest generic market in Europe accounting for 27% sales  Highly fragmented market with county-specific regulations Source : Frost & Sullivan analysis. M74E-52 14
  • 15. Key Blockbuster Drugs Losing Patent Protection – Europe Pharmaceutical Market: Key Blockbuster Drugs Losing Patent Protection (Europe), 2010-2017 Drug France Germany Italy Spain U.K. Anastrozole 2010 2010 2010 2010 2010 Aripiprazole 2011 2011 2011 2011 2011 Atorvastatin 2011 2011 2011 2011 2011 Candesartan Cilexetil 2012 2012 2012 2012 2012 Celecoxib 2014 2014 2014 2014 2014 Clopidogrel 2013 2013 2013 2013 2013 Darbepoetin alfa 2014 2014 2014 2014 2014 Docetaxil 2010 2010 2010 2010 2010 Donepezil 2012 2012 2012 2012 2012 15
  • 16. Key Blockbuster Drugs Losing Patent Protection – Europe (continued) Drug France Germany Italy Spain U.K. Duloxetine 2012 2012 2012 2012 2012 Escitalopram Oxalate 2014 2014 2014 2014 2014 Esomeprazole Magnesium 2010 2010 2010 2010 2010 Etanercept 2014 2014 2014 2014 2014 Ezetimibe 2017 2017 2014 2017 2017 Fluticasone propionate with Salmeterol xinofoate 2013 2013 2013 2013 Invalidated Glatiramer acetate 2015 2015 2015 2015 2015 Imatinib mesylate 2016 2016 2016 2016 2016 Infliximab 2014 2014 2014 2014 2014 16
  • 17. Key Blockbuster Drugs Losing Patent Protection – Europe (continued) Drug France Germany Italy Spain U.K. Insulin glargine 2014 2014 2014 2014 2014 Insulin lispro 2010 2010 2010 2010 2010 Interferon beta 1a (Rebif) 2013 2013 2013 2013 2013 Irbesartan 2013 2013 2013 2012 2013 Levofloxacin 2011 2011 2011 2012 2011 Lopinavir with Ritonavir 2016 2016 2016 2016 2016 Montelukast 2012 2012 2012 2012 2012 Mycophenolate mofetil 2010 2010 2010 Expired (2007) 2010 Olanzapine 2011 2011 2016 2011 2011 17
  • 18. Key Blockbuster Drugs Losing Patent Protection – Europe (continued) Drug France Germany Italy Spain U.K. Olmesartan medoxomil 2017 2017 2017 2017 2017 Oseltamivir 2017 2016 2017 2017 2016 Oxaliplatin 2013 2013 2013 2013 2013 Pegfilgrastim 2017 2017 2017 2017 2017 Peginterferon alfa-2a 2013 2013 2013 2013 2013 Pioglitazone 2011 2011 2011 2011 2011 Quetiapine N.M 2012 2012 2012 2012 Rabeprazole Expired (2007) 2012 2012 2012 2012 Risedronate 2010 2010 2010 2013 2010 18
  • 19. Key Blockbuster Drugs Losing Patent Protection – Europe (continued) Drug France Germany Italy Spain U.K. Rituximab 2013 2013 2013 2013 2013 Rosiglitazone 2013 2013 2013 2013 2013 Rosuvastatin 2017 Not mentioned 2012 Not mentioned 2017 Sildenafil 2013 2013 2013 2013 2013 Telmisartan 2013 2017 2017 2013 2017 Tiotropium 2016 2015 2014 2015 2012 Tolterodine 2012 2012 2012 2012 2012 Trastuzumab 2012 2012 2012 2012 2012 Valsartan 2011 2011 2011 2011 2011 Zoledronic acid 2012 2012 2012 2012 2012 19
  • 20. Regulatory Impact Analysis - Europe Regulatory Environment in the European Generic Pharmaceutical Market Data Exclusivity • Uniform level of data protection of originator products for 10 years • Permits to access data of a generic application but the generic version cannot be launched until the completion of the ten-year period 8+2+1 Formula European Bolar Clause European Bolar Clause • Originator companies are granted 8-year data exclusivity and 2 years market exclusivity • Permits initiation of generic R&D activity prior to patent expiry of brands • Additional one year exclusivity awarded for new product indications and those shifting from “prescription only” to OTC • Generics can enter the market only after the 10th or 11th year • Withdrawal of brands before generic entry cannot stop generic companies from using them as reference products Sunset Clause • Allows cancellation of marketing authorization for products not in market for 3 years • Legal challenges by patent owners can prevent generic companies from applying registrations more than 3 – 4 years in advance of patent expiry Source: Frost & Sullivan analysis. 20
  • 21. Regulatory Policies of Key Generic Markets in Europe Comparative Analysis Generic Pharmaceutical Market: Impact of Regulatory Policies (Europe) Policies Germany United Kingdom France Spain Italy Reference pricing Patient co-payment Generic prescribing Generic substitution Time delay in market access High Low Source: Frost & Sullivan analysis. 21
  • 22. Indian Generic Pharmaceutical Market  Branded generics dominate the Indian pharma market (98%) valued at over $12.00 billion  Highly fragmented market with more than 22,000 registered units  World leader in exporting generics to foreign countries; exports growing at 22%  Companies such as Sun, Lupin, Aurobindo, Dr.Reddy’s Laboratories, Cipla and Ranbaxy have been aggressive in DMF and ANDA filings with an granted approval rates of 35%  Anti-infectives and GI constitute 30% revenue share Market Overview  India produces 20 – 22% of world’s generic drugs including nearly 60,000 generic brands covering 60 key therapeutic areas  Ranks third in API manufacturing accounting for 6.5% of world API production  Top ten players account for 37% market share in India Consolidation in the form of strategic alliances between Indian and foreign companies is on the rise  Extremely promising future for generics in India Source: Frost and Sullivan analysis
  • 23. Export of Indian Generics to the U.S. Total Pharmaceutical Market: Breakdown by Domestic Sales and Export Sales (India)  Steep rise in export of Indian generics to the U.S. over the last five years  Currently generic drugs from India represent 18% of generic drugs in the U.S. Export 52 % Domestic  India has more than 75 U.S. FDA approved plants and tops the world in DMF and ANDA filings in the U.S. 48 %  Indian generic firms directly compete with multinational generic companies leading to Intensified price competition in the U.S.  It is estimated that India is likely to capture at least 30% of replacement generic equivalents in the U.S. by 2018 Source: Frost and Sullivan analysis
  • 24. Regulatory Impact Analysis - India Pharmaceutical Policy Drug Policy 1996 Pharmaceutical Policy 2002 National Pharmaceuticas Policy 2006 Quality Control Price Control On Prices GMP/cGMP Drug and Cosmetic Act 1940 Schedule M Schedule Y On Margin Bulk Drugs Formulations IPR Protection Essential Commodities Act 1955 Drug (Price Control) Order 1995 Amended Patents Patents Amendment Act 2005 Source: Frost and Sullivan analysis
  • 25. Regulatory Impact Analysis – India (continued) Regulatory Environment in the Indian Generic Pharmaceutical Market Pricing & Reimbursement • The revised policy of the National Pharmaceutical Policy Authority, has capped margins on generic drugs at 15% for wholesalers and 35% for retailers • Price controlled drugs Category I: Essential drugs Category II: All drugs not in Category I • Drugs exempted from price control required to meet specific criteria Patent Protection/ IP Rights Quality Control • Patents Amendment Act 2005 (TRIPS Agreement) strictly prohibited reverse engineering of drugs • The Drug and Cosmetics Act (D&C) 1940 regulates import, manufacture, distribution and sales • Covers two types of generic drugs – off patent generics and generics of drugs patented before 1995 • Schedule M – requirements for factory premises, plant, materials, plant and equipment • Introduced compulsory licensing for exports • Schedule Y – legislative requirements for clinical trials • Mainly encourages foreign companies to trade in India • Increasing regulatory compliance in India boosts confidence of MNCs Source: Frost and Sullivan analysis 25
  • 26. Future Trends and Directions – Vision 2025 Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed markets to emerging markets. Consolidation is expected to remain the key factor for growth and sustenance of generic companies. Large generic companies are likely to increase their investments in R&D activities Key Trends Technology Development of Transgenic technologies Stem cell technologies Cloning technologies Generic consumption is likely to be favoured in a big way by the government, payers, policy-makers and physicians. Increasing focus on higher value biological therapies, biosimilars, controlled release products, sterile formulations and niche therapeutic segments. Source: Frost and Sullivan analysis
  • 27. Strategic Recommendations for Success Strategy is a style of thinking, a conscious and deliberate process, an intensive implementation system, the science of insuring future success – Pete Johnson Differentiated Approach Explore New Avenues Big multinational generic firms require to focus on  Products with technologically challenging formulations.  Products which require significant regulatory support.  Products with limited availability of APIs.  Analyze prospects for market globalization - Strategic alliances between multinational generic firms and domestic participants with locally restricted operations. Medium-sized generic firms require to focus on  Products with relatively higher profit margins.  Appropriate time of entry into the right market.  Strengthen distribution. Instill Competitive Capabilities  Invest in R&D.  Improve product line.  Defend company’s position in the market.  Strike a balance between supply and demand side.  Pioneer new and better technologies. Plan Ahead for the Future  Research customer needs, preferences, expectations.  Monitor new technological developments to face the change.  Target therapeutic areas with high levels of unmet clinical needs. Source: Frost and Sullivan analysis
  • 28. Related Market Research Reports  Global Pharmaceutical Contract Manufacturing Market  Global Next Generation Biosimilars Market  Global Contract Research Outsourcing Market 28
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