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LUPIN LIMITED IN JAPAN
REPORT BY:
VIJAY GAUR
NINAD SATAM
DR. SWAPNALI PATIL
HETANG DESAI
Broadly, the
presentation is
about…
Pharmaceutical sector in Japan:
Evolution, market shares, Mergers &
Acquisitions, Policy, distribution,
Regulations & Performance.
Pestle, Porter’s 5 Forces, SWOT, BCG
matrix, 4 P’s
Concluding Observations
INTRODUCTION
• At the turn of the century, the financial situation in Japan surrounding
health insurance had become strained due to increasing medical costs
shouldered by the government owing to the aging population, advances in
medical technology and the development of new medical equipment.
• The Ministry of Health, Labour and Welfare (MHLW) had to respond with
measures designed to help curb the cost of medicine shouldered by patients,
medical institutions and insurers, which stimulated the market for generic
drugs.
• In fiscal 2003, the sales share of generic drugs in the pharmaceutical
market increased 5.2%, or 0.4 percentage points, in terms of value and 16.4%,
or 4.2 percentage points, in terms of sales volume. This upward trend was to
continue.
• These measures by MHLW saw a reorganization of the pharmaceutical
industry particularly in the drug wholesale trade and generic market.
• It resulted in mergers and restructuring of major domestic pharmaceutical
manufacturers which were almost nonexistent in the past but had become
commonplace now.
• The other new business model which emerged for pharmaceutical firms
was to outsource business to bio-venture companies, a move that
attracted much attention.
Generic Drugs Market Share
Japanese Market % Value
(Drug price basis)
% Quantity basis
1999 4.70 10.80
2002 4.80 12.20
2003 5.20 16.40
2004 5.47 17.00
Market Shares of Generic Drugs in Main Countries (2002)
U.S. Germany U.K France Japan
Quantity (%) 52 50 52 12 12
Value(%) 9 29 17 3 5
FY (Billion Yen)
Cardio-
vascular
Drugs
Other
Metabolic
Drugs
Gastro-
intestinal
Drugs
CNS
Drugs
Anti- biotic
Preparations
Blood and
Body Fluid
Drugs
Allergy
Medication
Biologica
l Drugs
Dermat
Drugs
Chemo-
therapy
1980
Value
Produced
361.7 254.7 183.6 271.8 814.3 82.5 33.8 114.4 121.9 29.5
% Total 12.1 8.6 6.2 9.1 27.3 2.8 1.1 3.8 4.1 1
rank 2 4 6 3 1 11 15 8 7 17
1985
Value
Produced
506.2 185.1 272.2 289.4 690.5 120.9 19 153.4 156.9 59
% Total 15 5.5 8 8.6 20.4 3.6 0.6 4.5 4.6
Rank 2 5 4 3 1 10 20 9 7 16
1988
Value
Produced
383.8 225.5 365.5 406.9 702.5 151.2 25.8 162 214.7 103.3
% Total 15.9 5.2 8.5 9.4 16.3 3.5 0.6 3.8 5 2.4
Rank 2 5 4 3 1 11 20 10 6 14
1989
Value
Produced
757.9 256.7 421.2 442.1 724.5 175.9 24.3 159.8 227.1 118.9
% Total 16.2 5.5 9 9.5 15.5 3.8 0.5 3.4 4.9 2.5
Rank 1 5 4 3 2 9 21 10 6 13
1990
Value
Produced
814.8 274.7 424 429.4 624.1 177.9 24.4 171.7 228.1 162.1
% Total 17.3 5.8 9 9.1 13.2 3.8 0.5 3.6 4.8 3.4
Rank 1 5 4 3 2 9 22 10 7 13
THERAPY BREAKDOWN
FY (Billion Yen)
Cardio-
vascular
Drugs
Other
Metabolic
Drugs
Gastro-
intestinal
Drugs
CNS
Drugs
Anti biotic
Preparations
Blood and
Body Fluid
Drugs
Allergy
Medication
Biological
Drugs
Dermat
Drugs
Chemo-
therapy
1995
Value
Produced
1045.7 415 457.4 442.5 451.5 263 183.1 233.2 218.2 179.7
% Total 19.1 7.9 8.7 8.4 8.6 5 3.5 4.4 4.2 3.4
Rank 1 5 2 4 3 6 9 7 8 10
2000
Value
Produced
1113.5 435.5 445.3 389.4 373.9 343 185.3 250.7 240 159
% Total 20.7 7.1 8.3 7.2 7 6.4 3.4 4.7 4.5 3
Rank 1 3 2 4 5 6 9 7 8 11
2001
Value
Produced
1234.8 484.3 477.5 428 410.4 301.3 247.8 255.4 236.6 167.4
% Total 21.6 8.5 8.3 7.5 7.2 5.3 4.3 4.5 4.1 2.9
Rank 1 2 3 4 5 6 8 7 9 10
2002
Value
Produced
1226.1 519.9 477.1 459.5 369.8 295.7 218.5 254.7 230.8 186.6
% Total 21.4 9.1 8.3 8 6.5 5.2 3.8 4.4 4 3.3
Rank 1 2 3 4 5 6 9 7 8 10
2003
Value
Produced
1299.8 528.8 488.4 474.6 386.9 312 245.1 237.2 223 194.1
% Total 22.4 9.1 8.4 8.2 6.7 5.4 4.2 4.1 3.8 3.3
Rank 1 2 3 4 5 6 7 8 9 10
• The growth of cardiovascular medicines was supported by
antihypertensive drugs, vasodilators and lipid-lowering agents.
Antihypertensive drugs in fiscal 2003 totaled ¥439.7 billion, an
increase of 8.5%, retaining the top position in terms of drugs
classified by effect.
• The reason for the strong growth was the rapid expansion of the
Angiotensin II receptor inhibitor.
• Cardiovascular medicines that attained steady growth included
Blopress (Candesartan) from Takeda Pharmaceutical, Nu-Lotan
(Losartan) by Banyu Pharmaceutical, and Diovan (Valsartan) from
Novartis Pharma.
• In addition, contributing to this increase was the release of Micardis
(Telmisartan) by Nippon Boehringer Ingelheim in December 2002,
and the release of Olmetec (Olmesartan) by Sankyo–Sanwa Kagaku
Kenkyusho and Kowa–Nikken Chemicals in May 2003.
• Lipid-lowering agents in 2002 stagnated at ¥269.5 billion, down
6.4%, but bounced back vigorously in 2003 to ¥302.7 billion, up
12.3%.
• Sales of the HMG-CoA reductase inhibitor increased.
• Mevalotin (Pravastatin) of Sankyo and Lipovas (Lovastatin) of Banyu
which were top ranked drugs were reclassified as generic drugs in
July 2003 which resulted in minus growth in the CVS agents as a
whole in 2004
• Lipitor (Atorvastatin) of Pfizer and Astellas, a second-generation
cardiovascular agent, exhibited strong growth. Livaro (Pitavastatin)
was introduced by Kowa and Sankyo in September 2003.
• Competition in the cardiovascular agent market was expected to
further intensify with the launch of Crestor (Rosuvastatin) by
AstraZeneca and Shionogi in March 2005.
• The market for agents affecting the central nervous system
gradually expanded, although the respective market share did not
change much.
Four top-ranking products showed rapid growth :
• Psychoneurotic agent Zyprexa (Olanzapine) from Eli Lilly Japan
• Risperdal (Risperidone) from Janssen Pharmaceutical
• Seroquel (Quetiapine) from Astellas
• Depas (Etizolam) from Mitsubishi Pharma
%Sales Shares of Japanese Companies
FISCAL YEAR TOP 5 TOP 10 TOP 30 TOP 50 TOP 100
NUMBER OF
COMPANIES
1990 21.3 34.1 58.5 71.5 84.5 1,567
1991 20 33.5 59 71.4 84.4 1,738
1992 25.4 43.2 74 89.2 100 95
1993 18.8 31.6 56.1 69.2 83.5 1,856
1994 18.3 30.9 55.7 68.9 83.8 1,788
1995 19.3 31.4 56.3 69.6 84.2 1,691
1996 22.2 34.6 59.2 72.2 85.3 1,596
1997 23.6 36 62.9 75.9 87.4 1,562
1998 20.3 32.2 60.1 73 85.8 1,627
1999 23.6 36.5 65.6 78.8 90.7 1,427
2000 26.7 40.6 68 80.6 92.3 1,396
2001 27.4 41.5 69.3 81.5 92.2 1,391
2002 28.3 42.3 69.7 82 92.8 1,347
2003 28.6 42.5 70.8 82.3 92.7 1,342
• The number of pharmaceutical companies operating in the
Japanese market had been increasing due to the entry of foreign
pharmaceutical companies and non-pharmaceutical firms
diversifying their product portfolios but around the year 2000 the
number had decreased.
• There were several reasons for this, the first being the slower
growth of the domestic drug market. In addition, some
pharmaceutical companies tried to expand through mergers and
restructuring, while others simply withdrew from the market due to
the time lag between research and commercialization, as well as
the increased costs for development.
• As a result, the number of pharmaceutical companies peaked at
1,646 in 1993, but then decreased to 1,062 in 2003.
Broadly classified, there were three groups of
pharmaceutical companies:
• Those that mainly produced and sold prescription drugs
(474 firms)
• Those that mainly produced and sold over-the-counter
drugs (416)
• Those that produced and sold drugs other than
prescription and over-the-counter drugs (172).
• Within the first group, 71 mainly produced and sold
generic drugs. The trend toward oligopoly in the
pharmaceutical market strengthened, with the top 10
firms accounting for 42.5% of sales in fiscal 2003
Top 20 Drug Companies by Sales
-
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000 Sales 2004 (Million Yen)
Mergers & Acquisitions
Various types of mergers and reorganizations were seen during the period. These included
• Mergers between Japanese and foreign-affiliated drug companies,
• Japanese-only drug companies which we the most common, or
• Foreign-only companies.
Mergers and reorganizations in the Japanese pharmaceutical industry during the period include:
Period Company 1 Company 2 New Entity
October 2002 Chugai Pharmaceutical Nihon Roche New Chugai
October 2002 Daiichi Pharmaceutical Suntory Pharma Daiichi Suntory Pharma
October 2003 Taisho pharmaceutical Toyama Chemical Taisho Toyama
Pharmaceutical
February 2003 Dynabott Hokuriku Seiyaku Abbott Japan
August 2003 Pfizer Pharmacia Pfizer
Other examples of Japanese-foreign mergers included:
• Nippon Boehringer Ingelheim in July 1997,
• Novartis Pharma in April 1997,
• Wyeth Lederle (currently Wyeth) in December 1998,
• AstraZeneca, Aventis Pharma and Sanofi- Synthelabo in January 2000, and Glaxo
Smith Kline in January 2001.
• Japanese-only mergers started appearing around 2004.
• Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical merged on April 1, 2005
to create Astellas Pharma.
• Dainippon Pharmaceutical and Sumitomo Pharmaceuticals were to merge as
Dainippon Sumitomo Pharma,
• Daiichi Pharmaceutical and Sankyo were to jointly form the holding company
Daiichi Sankyo, both in October 2005.
New moves by top-ranking Japanese pharmaceutical companies began to open up a
new stage of mergers and reorganizations, with some observers expecting more
activity among major domestic drug companies, following the example of Takeda
Pharmaceutical.
Foreign-Affiliated Companies
• Almost all large pharmaceutical companies in the world had
entered the Japanese market. There were few barriers for
innovators to entering this market, but experience had shown that
it can take a long time for foreign companies to establish
themselves.
The major routes to enter the market:
• Establish a joint venture with a Japanese pharmaceutical company
• Conclude a sales tie-up or also called as co-promotion deals
After doing business in Japan and learning about the market, however,
many foreign companies ended up selling their own products directly.
Furthermore, foreign companies had already realized increased growth
through mergers and reorganizations.
By the end of 2004, 3 foreign-affiliated companies were listed among
the top 10 pharmaceutical companies: Pfizer was second, Chugai fifth
and Novartis Pharma eighth.
Mergers and reorganizations of foreign-affiliated pharmaceutical companies
can be broadly divided into two types.
• The merger of Japanese subsidiaries of foreign companies resulting from
mergers and restructuring of parent companies in their home countries.
• This was mostly seen, and examples include AstraZeneca (established by
the merger of Astra Japan and Zeneca Pharma in January 2000), Glaxo
Smith Kline (established by the merger of Glaxo Welcome and Smith Kline
Beecham in January 2001) and Pfizer (established by the merger of Pfizer
and Pharmacia).
• The other was to combine management between a foreign-affiliated
pharmaceutical company and a Japanese pharmaceutical company.
• This includes Abbott Japan (established by the merger of Dynabott and
Hokuriku Seiyaku in February 2002) and Chugai (established by the merger
of Chugai Pharmaceutical and Nippon Roche in October 2002).
Spin-off & Consolidation
Company Name Action
Kyorin
Pharmaceutical
Closed Nogi plant in March 2006
Sankyo Yasugawa & Tanashi plants closed
Shinogi & Co. Concentrate on production at Settsu & Kanegasaki plants and shut down the rest
Tanabe Seiyaku Separated Onada Plant as Tanabe Seiyaku. Yamaguchi Co Ltd.
Takeda Chemical
Industries
Closed Shonan plant in March 2006 & concentrated production at Hikari & Osaka
plants
Chugai
Pharmaceutical
Closed down 3 plants and concentrated production at Utsunomiya & Fujieda
plants. Later spun off the production division as a separate entity
Mitsubishi
Pharma
Separated Yoshitimu & Ashikaga plants as MP- Technopharma in April 2005
Meija Seika
Closed Yodogawa drug preparation plant and consolidated production at
Odawara plant
Mochida
Pharmaceutical
Seperated Otawara plant as Mochida Seiyaku Kojo in April 2005.
Re-organisation of Generic MFG
Company Name Period Action
Towa
Pharmaceutical
Oct-03
Acquired all shares of J-Dolph Pharmaceutical & converted it into a wholly-
owned subsidiary
Nipro Apr-04
Accepted the allocation of new shares to a third party issued by Takeshima
Seiyaku & converted the latter into a subsidiary. Nipro's shareholding ratio rose
to 65.5%
Sawai
Pharmaceuticals
Nov-04
Entered in a business tieup with Zensei Pharmaceutical Industries. Acquired
167,000 shares (19.9%) issued & outstanding
Nichi-iko
Pharmaceutical
Jan-05 Absorbs Nippon Galen
Apr-05
Concluded a comprehensive business tieup agreement & business transfer
agreement covering drugs with Maruko Pharmaceuticals. Acquired Maruko
Pharmaceuticals & converted into its subsidairy
Teikoku Medix Oct-05
Teikoku Medix & Ohta Pharmaceutical merged and the new entity was Teikoku
Medix Co Ltd.
Drug Wholesalers
• The introduction of the price quotation system escalated
competition among drug wholesalers and profitability worsened.
• Wholesalers were forced into mergers or business tie-ups with the
purpose of lowering their costs by developing economies of scale,
which helped them to strengthen sales and create more bargaining
power with manufacturers.
• As a result, member companies of the Japan Pharmaceutical
Wholesalers Association (JPWA) decreased from 440 in 1986 to 142
in fiscal 2005, a drop of 298
• Mergers and reorganizations accelerated from around 1999,
resulting in four main groups: Mediceo Holdings, Suzuken group,
Alfresa group and Kyoso Mirai group
JPWA Membership
0
50
100
150
200
250
300
350
400
450
500
1986 1990 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Wholesaler Turnover & Subsidiaries
Company Name Major Subsidiaries
Mediceo HD
Senshu Yakuhim, Ushioda Sangokudo Yakuhin, Chiyaku, Kuraya Sanseido, Yamahiro Kuraya,
Heiseiyakuhin, Izutsu-Yakuhin, Everlth, Atol
Suzuken Suzuken Okinawa Yakuhin,Suzuken Iwate, Nakano Yakyhin, Astis
Alfresa HD Alfresa Pip Tokyo, Daiwa Yakuhin, Kowa-yakulin, Odashima, Alfresanikkensangyo, Ando
Toho
Pharmaceuticals
Sanus, Honma Toho, Tokai Toho, Yamagachi Toho, Ogawa Toho, Yakushin, Gogo Toho
-
500,000
1,000,000
1,500,000
2,000,000
Mediceo HD Suzuken Alfresa HD Toho Pharmaceuticals
Sales (Million Yen)
Drug distribution is roughly divided into four main channels:
• Prescription drugs flow from manufacturers to hospitals via
wholesalers.
• Some over-the-counter drugs flow from manufacturers to
consumers via drugstores and other retailers.
• Other over-the-counter drugs move from manufacturers to
consumers via wholesalers and then drugstores/retailers.
• Medicines sold door-to-door move from manufacturers to
consumers via sales companies specializing in this kind of sales.
About 70% of prescription drugs is sold to medical institutions via
primary wholesalers, and the rest is sold by small/midsized or
secondary wholesalers that have no direct transactions with either
large or second-tier manufacturers.
Distribution Models
Drug manufacturers (including
importer-distributors
Primary Wholesalers
Secondary
Wholesalers
Cash & carry Wholesalers
Patient & Consumers
Manufacturersthatproducedrugs
solddoortodoor
OTCdrugmanufacturersthatsell
theirproductsdirectly
Ethicaldrugmanufacturersthatsell
theirproductsdirectly
Hospitals&
Clinics
Hospitals
Insurance
dispensaries
Dispensaries&
DrugStores
OTC
Drugs
Ethical
Drugs
Prescriptions
Injections &
Dispensing
Dispensing
Selling
Selling
Policy environment for Generic Drugs
Date Major Policy to encourage use of generic drugs
April 2002
Incentives introduced for doctors and pharmacists
Introduction of additional fees for prescriptions with
generic drugs
Introduction of generics information fees and generic
drug dispensing fees
April 2003 Introduction of comprehensive payment system*1 for DPCs
April 2006 Review of prescription forms
October 2007 Government set target in numerical terms for the share of
generics (former indicator*2) of 30% or more by March
2013.
Policy Changes
• An incentive to use lower-cost generic drugs was included in the April
2002 revisions to the health insurance system, under the section covering
dispensing fees and medical service fees.
• It was decided that if a generic drug were included in a prescription
obtained from a pharmacy that is not part of a hospital, two points may be
added to the medical service fee and two points to the dispensing fee.
• In addition, 10 points may be added if information about the drug is
furnished to the patient.
• In June of the same year, the Ministry of Health, Labour and Welfare sent
a notice to government-operated hospitals and sanatoriums encouraging
them to use generic drugs more. Three months later, the ministry
introduced a fixed-rate payment for geriatric care.
• In April 2003, salaried workers’ burden of medical fees was raised to 30%,
resulting in higher medical costs for patients at medical institutions.
• Thus, the business climate became more favorable for generic drugs.
• Moreover, patent rights expired on such big-market
drugs as Gaster of Yamanouchi, Mevalotin of Sankyo
and Lipovas of Banyu.
• In April 2003, the comprehensive evaluation system
known as diagnosis-procedure combination (DPC) was
introduced, stimulating the proliferation and increased
consumption of generic drugs at medical institutions.
• The new environment had become a boon to major
generic drug firms, such as Towa Pharmaceutical, Sawai
Pharmaceuticals, Taiyo Yakuhin and Nichi-iko, while
other generic drug companies began to actively seek
mergers and restructuring to expand their shares.
• The revised Pharmaceutical Law enacted in April 2005
replaced the old “approval for manufacture” regulation
with “approval for manufacture and wholesale.”
• Previously, only partial outsourcing of a manufacturing
process was permitted, but the revised law allows
complete outsourcing.
• As a result, the market for drug manufacturing services
expanded. In Addition, some major pharmaceutical
companies spinned off manufacturing operations into
separate companies.
Generic Drugs Registration
• The total time from new generic drug application to approval was generally 12 months
• New generic drugs were approved in February and August, because the National Health
Insurance drug price list was updated twice a year, in June and December.
• The application review time was 9 months, and MHLW approval procedures and Good
Manufacturing Practice (GMP) inspections were conducted during the remaining 3 months.
Application
12 months
First Inquiry
Answer
Preparing
Inquiry
Answer
GMP
inspection
5 months 1.5 months 2.5 months 2 months
Approval
Approval judgment
period of MHLW
Applicant
time
Process of Screening
Applicant Pharmaceuticals & Medical Devices Agency
Interview
Inquiry by PMDA & confirmation
Presentation by Applicant
Applicant Screening Specialist
Investigation Specialist
Factory
GMP
Inspection
Screening &
investigation
of reliability
Report about
screening
Report about screening
Result of screening (notification
of results)
External Specialist
Consultation
(Screening
Experts) Discussion of main problems
Document review
External Specialists
Screening
Experts
Result of
GMP
investigation
(notification
of Result)
Interview
by
screening
committe
e
Applicant
Applicant
Side expert
Screening
expert
External expert
• Explanation (presentation) by Applicant
• Study of main problem
• Proceedings entrusted to department
manager in charge of screening
• Two interviews possible
Screening
expert
External expert
Consultation among
screening experts
(ongoing, following
interview)
Ministry of Health, Labour & Welfare Pharmaceutical Affairs Council
Approval Request for Advice
Designation &
consultation
Advice
Summing up main problem
PESTLE ANALYSIS
POLITICAL
• Early 2000’s was a time of turmoil in the Political system of Japan
• Prime Minister Obuchi suffered a stroke in April 2000 and was replaced by Yoishiro
Mori.
• After the Liberal Party left the coalition in April 2000, Prime Minister Mori
welcomed a Liberal Party splinter group, the New Conservative Party, into the
ruling coalition which lasted for 1 year.
• On 24 April 2001, riding a wave of grassroots desire for change, maverick politician
Junichiro Koizumi defeated former Prime Minister and other party stalwarts on a
platform of economic and political reform.
• on 8 August 2005, Prime Minister called for a snap election to the lower house, as
threatened, after LDP stalwarts and opposition DPJ parliamentarians defeated his
proposal for a large-scale reform and privatization of Japan Post, which besides
being Japan's state-owned postal monopoly was the world's largest financial
institution, with nearly 331 trillion yen of assets.
• The ruling LDP started losing hold since 2006. No prime minister except Koizumi
had good public support.
• On 26 September 2006, new LDP President Shinzo Abe was elected by a special
session of the Diet to succeed Junichiro Koizumi as Prime Minister.
Economy
• Average duration of the Japanese business cycles was around
50 months, which was relatively short in comparison with
other developed countries where an average cycle lasted for 6
years.
• Average duration of the recessions in Japan was around 17
months, which was longer than in other developed countries
whose recessions lasted only 12 months on average.
• The total amount of trade between Japan and India had been
rising since 2002, reaching approximately US$6.8 billion in
2005.
• However, this figure was not commensurate with the two
countries economic power and potential.
The trade share and its relative importance between
Japan and India were diminishing:
• Japan ranked 10th among India’s export destinations
(share of 2.5%) and 10th among import sources (2.8%),
• India ranked 26th among Japan’s export destinations
(0.6%) and 28th among import sources (0.6%).
• As for other comparable major economies in 2005, the
trade value between Japan and China was US$189.4
billion and between India and the US, US$20 billion
indicated a substantial potential for further expansion
of trade between Japan and India.
• India’s exports of software to Japan had grown dramatically in years, marking a
60% increase in the year 2004 alone.
• At the same time, there had been no changes in the traditional structure in which
major exports were comprised of commodities such as gems, marine products and
iron ore, making diversification of the trade structure a challenge.
• Manufactured goods such as automobile components still constituted a large
proportion of India’s imports from Japan.
• Japan and India were studying the sectors in which India had expanded its trade
volume with other countries, and considerations were drawn for increasing the
trade value in IT, textiles and fiber products and pharmaceutical products.
• A study conducted by Japan Bank for International Cooperation (JBIC) revealed
that India ranked third after China and Thailand, as a promising country in which to
expand business in the medium term, and second after China in the long term.
• Thus the expectations were high for the future.
Social
– Japan is ranked as the 10th most populated country in the world (the U.S.
Census Bureau, 2005). However, according to some other sources, it is not
10th, rather 11th in the world.
– Total population in Japan is 126.4 million. Shintoism and Buddhism are two
major religions while the major language is Japanese which is spoken by
around 99% of the country’s population.
– Japan faces a number of social challenges. Ageing population and sinking birth
rate are two of the biggest challenges Japan faces today.
– The life expectancy for men is 81 years, while 87 years for women. Many
sources forecast that the Japanese population is likely to fall below 100 million
in 2048 and about 87 million by 2060.
– This will severely impact on Japan and it will lose out to regional powers,
particularly China.
– Therefore, many Japanese politicians are now highlighting an ‘integrated’
immigration policy to draw vital foreign workers to Japan to reduce the skill-
gaps created by shrinking birth rate and ageing population.
• Many people in Japan prefer Japanese companies to
foreign ones. This makes trading difficult for foreign
companies. Indeed, this is one of the main reasons as to
why many foreign companies failed in Japan.
• For instance, after operating 9 years, Tesco (British retail
giant) had to close its operations in Japan in 2012 (BBC,
2012). Likewise, Wendy’s, Pret A Manger’s, and many
other global companies failed in Japan.
• However, it is also true that some foreign companies did
very well in Japan as well. Therefore, it is extremely
important for foreign companies to carry out a detailed
environmental scanning before entering into Japan.
Technology
• Japan is one of the most technologically advanced countries in world. The
Japanese are well-known as extremely creative in searching out and
learning to use modern technologies. Japan has been pushing
technological innovation and creativity in such a way that many countries
will struggle to emulate.
• Japan’s innovation can be found in a variety of fields. For example,
automation systems are widely used in Japan, particularly in hospitals,
airports, and restaurants. Likewise, Japan is well ahead of many other
advanced countries in robotic development. Indeed, it has more than half
of the industrial robots in the world.
• The contactless payment system has been in Japan for a long time; indeed,
long before many countries even thought about it. Japan has also done
tremendously well in areas such as space research and development,
chemicals, optics, rail transport, and semi-conductors. These
developments offer great opportunities for both Japanese and foreign
individuals and companies.
– Lupin began making incremental changes in its Japanese
facilities tweaking the system for greater efficiency,
ensuring better economies of scale, and renegotiating
prices with large independent wholesalers (oroshi) and
regional (hansha) players.
– For instance, at Kyowa’s factories, instead of producing the
full quota of drugs for a month (200-odd), it decided to
produce less per month but for three months continuously.
– This brought down operational costs significantly because
it reduced the time taken for cleaning between
changeover for drugs.
– “Without creating any dissonance in the company, we
were able to raise margins from 33% to 42% in the first
year,” says Kamal K. Sharma, managing director, Lupin.
Legal
• Legal environment is the last element to discuss in the PESTEL
analysis of Japan.
• People can work in Japan as employees, dispatched workers,
independent contractors, and directors.
• All employees enjoy employment rights and benefits such as
maximum work hours, work breaks, holidays, and maternity
leave.
• Companies need to register employees for mandatory
pension insurance, health insurance, unemployment
insurance, and workers’ accident compensation insurance.
• All of these apply to employment relationships regardless of
the citizenship of employees (Ohta, 2015).
Environment
• Japan is a relatively clean and environmentally responsible
nation. However, it faces some environmental challenges today. For
example, waste management is one of the biggest environmental
issues in Japan. Trash produced by the modern society, industrial
activities, and agriculture contribute to the production of a great
deal of waste. Japan is indeed under pressure to minimise waste
and control environmental pollution.
• Japan is one of the countries, most affected by calamities and
natural disasters. Tsunamis, floods, earthquakes, mudslides,
cyclones, and volcanic eruptions hit Japan from time-to-time. These
disasters cost Japan billions of dollars for reforms and rebuilding. In
fact, Japan is a less popular tourist destination because of natural
disasters, high-cost, and language barriers.
PORTER’S 5 FORCES
1.Competition/
Industry Rivalry
is high
1.Threat of
new
entrants
1.Bargainin
g power of
the buyers
1.Threat of
substitutes
1.Bargainin
g power of
the
suppliers
1. BP high - API Cos - Difficult to manufacture
products.
2. BP low – API suppliers – Simple to
manufacture or commoditized.
3. Hence, BPOS is medium.
1. TOS medium: because one generic can be
substituted by another.
2. However, there are limited number of generic
players in Japan.
1. Entry barriers for Japan are high considering
the regulatory approval timelines for generic
entry in their market along with consumer’s
preference for branded innovator products.
2. TONE is low for the short term. Registrations
can go on for a 2 year period by which new
strategies can be developed to counter comp
1. Generics – Cost Effectiveness
2. Significant savings for buyers
3. Therefore BPOB is low since the government is
pushing for generics.
Competitive Rivalry
• Ranbaxy (now wholly owned by Daiichi Sankyo) was one of the first to enter the
country in 2002 by acquiring a 50% stake in Nihon Pharmaceutical Industry (a
subsidiary of Nippon Chemifar). But it was unable to make much headway, and
after its acquisition by Daiichi, it ended the tieup in 2009.
• Ahmedabad-based Torrent Pharmaceuticals opened a fully-owned subsidiary in
Yokohama in April 2006, only to exit two years later.
• Dr. Reddy’s too announced its entry into Japan in 2011 by signing a joint venture
with Tokyo-based Fujifilm to deliver APIs and formulations.
• Similarly, Ahmedabad-based Zydus Cadila has been in Japan since 2007 after it
acquired Nippon Universal Pharma. But Japan barely accounts for 1% of the total
business of Zydus Cadila and Dr. Reddy’s.
• Those who track international pharma describe Japan as a fortress, where the top
10 firms, including Takeda, Astellas, Daiichi Sankyo, Eisai (all Japanese), Pfizer,
Roche, Merck, and Novartis (foreign), account for 44.7% of the total market.
• Most foreign firms partner a local player because the Japanese prefer buying drugs
made by Japanese companies; the big Japanese firms also control the trade.
SWOT ANALYSIS
LUPIN LTD.
44%
21%
15%
20%
Therapeutic Mix
Cephalosporins
Anti-TB
Cardiovasculars
Others
53%
22%
25%
Gross Sales (Geography Break-
down)
Domestic
Exports - Advanced
Markets
Exports - Emerging
Markets
23 22
77 78
0
50
100
2005-06 2006-07
SalesContribution%
Global Sales (Market Break-
down)
Advanced Markets Emerging Markets
 Lupin was one of the top-
5 Indian Pharmaceutical
Companies operating in
50 countries
 It earned revenues of
around Rs. 20 Bn and
profit of Rs. 3 Bn
 Lupin had six
manufacturing facilities
all located in India
 It had a debt equity ratio
of 0.61
 Lupin’s promoters held
slightly more than 50% of
its share capital
1827.2
3020.6
0
1000
2000
3000
2005-06 2006-07
InRs.Million
Net Profit
Net Profit
Strength
1. World leader in Anti-TB drugs &
Cephalosporin.
2. Considerable presence in market of
Asthma, Pediatric Diabetes and CNS
3. Presence in US & European market
4. Manufacturer of API & vertical
integration in most areas
5. R&D focus and strong pipeline
Weakness
1. High dependence on the US market.
2. Operates in low growth segments
such as CNS and Respiratory.
Opportunity
1. Increased generic awareness in
Japanese pharma market.
2. Strong leadership with cultural know
how in the Japanese market
3. 3 year relationship with Kyowa for API
supply.
Threat
1. Indian generic players who are trying
to enter Japan.
2. Regulatory hurdles
3. Japanese obsession with the quality
of medicines.
Kyowa Pharmaceutical
 Established in 1954 and involved in the development, manufacture,
sale and import of generic drugs
 Business strategy- to become the market leader in generic psychiatry
drugs
 Out of 1379 psychiatric hospitals in japan, 1258 prescribed Kyowa’s
products
 Kyowa spent around 8% of its FY 2006-07 sales on R&D
 63% of sales were achieved through small distributors and the rest
through wholesalers
 83% of revenue was from own-product sales and the remaining were
from merchandize sales, where Kyowa acted merely as a trader for
both domestic and overseas manufacturers
2% 1.90% 1.90% 2%
0%
1%
2%
FY2005 FY2006 FY2007 FY2008E
Market Share in Japan (% of total)
Market Share (% of total)
33.60%
15.10%13.60%
37.70%
Segments by Sales
Psychia
tric
Cardiov
ascular
Respira
tory
Others
0
2000
4000
6000
8000
InJPYMillions
Sales
50
Strength
1. Market leader in generic psychiatry drugs
2. Presence in cardiovascular, Respiratory and
other category.
3. Good hospital coverage (1258/1379)
4. Good products demand
5. 8% R&D spend
6. Good distribution network
7. 83% of revenue was from domestic sale
Weakness
1. Low cash reserves and negative balance
sheet
2. Complete dependence Domestic market.
3. Formulators (dependency for API)
4. High Operational costs
5. Less focus on Respiratory
Opportunity
1. Increased generic awareness and policy
changes in Japanese pharma market.
2. Increased cash flow and streamlining
operations can lead to a turn around.
Threat
1. Highly regulated market.
2. Lagging incase of no cash infusion.
3. Maintaining Market leadership
BCG MATRIX
BCG Matrix
Psychiatry
CVS Drugs
Gastrointestinal drugs
Anti TB drugs
Anti-biotic drugs
Hypnotic & sedative
Hypertension drugs
Relative Market Share
MarketGrowthRate
CashUsage
High Low
Low
Star Question Mark
Cow Dog
Cash Generation
10% 0.1%1.0%
PRODUCT PLACE PROMOTION PRICE
4P of
marketing
Product
Price
Place
Promotion
• Diverse price
range
• Regulatory
controlled
• Competitive
• Co promotions
• Skilled Field force
• Doctor promotion
• Pharmacy stores
• Website, Press
release
• Distributor
• Semi
distributor
• Institutions
• Psychotropics (Risperidone,
carbamazepine )
• Sedatives & Hypnotics
(Alprazolam)
• Hyper tensives (Amlodipine,
Nicardipine) & Vasodialators
• Peptic Ulcer agents (Lansoprazole,
Domperidone) .
• Addressing the need gap.
Current Scenario
• Even as the company faces another price cut in Japan, Lupin looks
to rationalize costs, shift manufacturing units and looks at non-
Japanese markets to continue growth.
• The company bought a portfolio of 21 generic brands from the
Osaka-based company paying $150 million two years ago. It is also
looking at in-licensing deals to distribute specialty and complex
drugs in central nervous system and neurology segments.
• Lupin in-licensed and launched Bipresso, a speciality brand from
Astellas for the treatment of bipolar depression last year. The drug
is a top-selling one for Lupin in Japan.
• 2 years after Kyowa takeover, Lupin acquired I’rom Pharmaceuticals
to complement their portfolio and include injections and a wider
hospital base.
• Lupin’s 1st biosimiliar Etanercept was developed with Nichi-iko and
was commercialized in Japan.
Way Forward
• The company is focusing on non-Japanese Asia-Pacific markets such as
Australia and South East Asia to compensate for the dip in Japanese
growth.
• In 2017-2018, Asia Pacific (APAC) as a block, excluding Japan, contributed
7 percent to Lupin sales whereas Japan along contributed 11%
• In Australia, Lupin turned around its loss-making business, which is now
growing by 28 percent, outperforming the market. The company expects
its Australian business to maintain the growth trajectory. Australian
pharmaceutical market was valued at $13 billion in 2017 with generics
accounting for over 30 percent of the sales volume.
• Lupin now plans to strengthen its presence in the Philippines and expand
in Malaysia, Thailand and Myanmar through more launches. It is also
exploring ways to enter China.
• The plan is to generate $100 million sales from non-Japanese APAC
markets.
Lupin In Japan- International Marketing

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Lupin In Japan- International Marketing

  • 1. LUPIN LIMITED IN JAPAN REPORT BY: VIJAY GAUR NINAD SATAM DR. SWAPNALI PATIL HETANG DESAI
  • 2. Broadly, the presentation is about… Pharmaceutical sector in Japan: Evolution, market shares, Mergers & Acquisitions, Policy, distribution, Regulations & Performance. Pestle, Porter’s 5 Forces, SWOT, BCG matrix, 4 P’s Concluding Observations
  • 4. • At the turn of the century, the financial situation in Japan surrounding health insurance had become strained due to increasing medical costs shouldered by the government owing to the aging population, advances in medical technology and the development of new medical equipment. • The Ministry of Health, Labour and Welfare (MHLW) had to respond with measures designed to help curb the cost of medicine shouldered by patients, medical institutions and insurers, which stimulated the market for generic drugs. • In fiscal 2003, the sales share of generic drugs in the pharmaceutical market increased 5.2%, or 0.4 percentage points, in terms of value and 16.4%, or 4.2 percentage points, in terms of sales volume. This upward trend was to continue.
  • 5. • These measures by MHLW saw a reorganization of the pharmaceutical industry particularly in the drug wholesale trade and generic market. • It resulted in mergers and restructuring of major domestic pharmaceutical manufacturers which were almost nonexistent in the past but had become commonplace now. • The other new business model which emerged for pharmaceutical firms was to outsource business to bio-venture companies, a move that attracted much attention.
  • 6. Generic Drugs Market Share Japanese Market % Value (Drug price basis) % Quantity basis 1999 4.70 10.80 2002 4.80 12.20 2003 5.20 16.40 2004 5.47 17.00 Market Shares of Generic Drugs in Main Countries (2002) U.S. Germany U.K France Japan Quantity (%) 52 50 52 12 12 Value(%) 9 29 17 3 5
  • 7. FY (Billion Yen) Cardio- vascular Drugs Other Metabolic Drugs Gastro- intestinal Drugs CNS Drugs Anti- biotic Preparations Blood and Body Fluid Drugs Allergy Medication Biologica l Drugs Dermat Drugs Chemo- therapy 1980 Value Produced 361.7 254.7 183.6 271.8 814.3 82.5 33.8 114.4 121.9 29.5 % Total 12.1 8.6 6.2 9.1 27.3 2.8 1.1 3.8 4.1 1 rank 2 4 6 3 1 11 15 8 7 17 1985 Value Produced 506.2 185.1 272.2 289.4 690.5 120.9 19 153.4 156.9 59 % Total 15 5.5 8 8.6 20.4 3.6 0.6 4.5 4.6 Rank 2 5 4 3 1 10 20 9 7 16 1988 Value Produced 383.8 225.5 365.5 406.9 702.5 151.2 25.8 162 214.7 103.3 % Total 15.9 5.2 8.5 9.4 16.3 3.5 0.6 3.8 5 2.4 Rank 2 5 4 3 1 11 20 10 6 14 1989 Value Produced 757.9 256.7 421.2 442.1 724.5 175.9 24.3 159.8 227.1 118.9 % Total 16.2 5.5 9 9.5 15.5 3.8 0.5 3.4 4.9 2.5 Rank 1 5 4 3 2 9 21 10 6 13 1990 Value Produced 814.8 274.7 424 429.4 624.1 177.9 24.4 171.7 228.1 162.1 % Total 17.3 5.8 9 9.1 13.2 3.8 0.5 3.6 4.8 3.4 Rank 1 5 4 3 2 9 22 10 7 13 THERAPY BREAKDOWN
  • 8. FY (Billion Yen) Cardio- vascular Drugs Other Metabolic Drugs Gastro- intestinal Drugs CNS Drugs Anti biotic Preparations Blood and Body Fluid Drugs Allergy Medication Biological Drugs Dermat Drugs Chemo- therapy 1995 Value Produced 1045.7 415 457.4 442.5 451.5 263 183.1 233.2 218.2 179.7 % Total 19.1 7.9 8.7 8.4 8.6 5 3.5 4.4 4.2 3.4 Rank 1 5 2 4 3 6 9 7 8 10 2000 Value Produced 1113.5 435.5 445.3 389.4 373.9 343 185.3 250.7 240 159 % Total 20.7 7.1 8.3 7.2 7 6.4 3.4 4.7 4.5 3 Rank 1 3 2 4 5 6 9 7 8 11 2001 Value Produced 1234.8 484.3 477.5 428 410.4 301.3 247.8 255.4 236.6 167.4 % Total 21.6 8.5 8.3 7.5 7.2 5.3 4.3 4.5 4.1 2.9 Rank 1 2 3 4 5 6 8 7 9 10 2002 Value Produced 1226.1 519.9 477.1 459.5 369.8 295.7 218.5 254.7 230.8 186.6 % Total 21.4 9.1 8.3 8 6.5 5.2 3.8 4.4 4 3.3 Rank 1 2 3 4 5 6 9 7 8 10 2003 Value Produced 1299.8 528.8 488.4 474.6 386.9 312 245.1 237.2 223 194.1 % Total 22.4 9.1 8.4 8.2 6.7 5.4 4.2 4.1 3.8 3.3 Rank 1 2 3 4 5 6 7 8 9 10
  • 9. • The growth of cardiovascular medicines was supported by antihypertensive drugs, vasodilators and lipid-lowering agents. Antihypertensive drugs in fiscal 2003 totaled ¥439.7 billion, an increase of 8.5%, retaining the top position in terms of drugs classified by effect. • The reason for the strong growth was the rapid expansion of the Angiotensin II receptor inhibitor. • Cardiovascular medicines that attained steady growth included Blopress (Candesartan) from Takeda Pharmaceutical, Nu-Lotan (Losartan) by Banyu Pharmaceutical, and Diovan (Valsartan) from Novartis Pharma. • In addition, contributing to this increase was the release of Micardis (Telmisartan) by Nippon Boehringer Ingelheim in December 2002, and the release of Olmetec (Olmesartan) by Sankyo–Sanwa Kagaku Kenkyusho and Kowa–Nikken Chemicals in May 2003.
  • 10. • Lipid-lowering agents in 2002 stagnated at ¥269.5 billion, down 6.4%, but bounced back vigorously in 2003 to ¥302.7 billion, up 12.3%. • Sales of the HMG-CoA reductase inhibitor increased. • Mevalotin (Pravastatin) of Sankyo and Lipovas (Lovastatin) of Banyu which were top ranked drugs were reclassified as generic drugs in July 2003 which resulted in minus growth in the CVS agents as a whole in 2004 • Lipitor (Atorvastatin) of Pfizer and Astellas, a second-generation cardiovascular agent, exhibited strong growth. Livaro (Pitavastatin) was introduced by Kowa and Sankyo in September 2003. • Competition in the cardiovascular agent market was expected to further intensify with the launch of Crestor (Rosuvastatin) by AstraZeneca and Shionogi in March 2005.
  • 11. • The market for agents affecting the central nervous system gradually expanded, although the respective market share did not change much. Four top-ranking products showed rapid growth : • Psychoneurotic agent Zyprexa (Olanzapine) from Eli Lilly Japan • Risperdal (Risperidone) from Janssen Pharmaceutical • Seroquel (Quetiapine) from Astellas • Depas (Etizolam) from Mitsubishi Pharma
  • 12. %Sales Shares of Japanese Companies FISCAL YEAR TOP 5 TOP 10 TOP 30 TOP 50 TOP 100 NUMBER OF COMPANIES 1990 21.3 34.1 58.5 71.5 84.5 1,567 1991 20 33.5 59 71.4 84.4 1,738 1992 25.4 43.2 74 89.2 100 95 1993 18.8 31.6 56.1 69.2 83.5 1,856 1994 18.3 30.9 55.7 68.9 83.8 1,788 1995 19.3 31.4 56.3 69.6 84.2 1,691 1996 22.2 34.6 59.2 72.2 85.3 1,596 1997 23.6 36 62.9 75.9 87.4 1,562 1998 20.3 32.2 60.1 73 85.8 1,627 1999 23.6 36.5 65.6 78.8 90.7 1,427 2000 26.7 40.6 68 80.6 92.3 1,396 2001 27.4 41.5 69.3 81.5 92.2 1,391 2002 28.3 42.3 69.7 82 92.8 1,347 2003 28.6 42.5 70.8 82.3 92.7 1,342
  • 13. • The number of pharmaceutical companies operating in the Japanese market had been increasing due to the entry of foreign pharmaceutical companies and non-pharmaceutical firms diversifying their product portfolios but around the year 2000 the number had decreased. • There were several reasons for this, the first being the slower growth of the domestic drug market. In addition, some pharmaceutical companies tried to expand through mergers and restructuring, while others simply withdrew from the market due to the time lag between research and commercialization, as well as the increased costs for development. • As a result, the number of pharmaceutical companies peaked at 1,646 in 1993, but then decreased to 1,062 in 2003.
  • 14. Broadly classified, there were three groups of pharmaceutical companies: • Those that mainly produced and sold prescription drugs (474 firms) • Those that mainly produced and sold over-the-counter drugs (416) • Those that produced and sold drugs other than prescription and over-the-counter drugs (172). • Within the first group, 71 mainly produced and sold generic drugs. The trend toward oligopoly in the pharmaceutical market strengthened, with the top 10 firms accounting for 42.5% of sales in fiscal 2003
  • 15. Top 20 Drug Companies by Sales - 100,000 200,000 300,000 400,000 500,000 600,000 700,000 800,000 Sales 2004 (Million Yen)
  • 16. Mergers & Acquisitions Various types of mergers and reorganizations were seen during the period. These included • Mergers between Japanese and foreign-affiliated drug companies, • Japanese-only drug companies which we the most common, or • Foreign-only companies. Mergers and reorganizations in the Japanese pharmaceutical industry during the period include: Period Company 1 Company 2 New Entity October 2002 Chugai Pharmaceutical Nihon Roche New Chugai October 2002 Daiichi Pharmaceutical Suntory Pharma Daiichi Suntory Pharma October 2003 Taisho pharmaceutical Toyama Chemical Taisho Toyama Pharmaceutical February 2003 Dynabott Hokuriku Seiyaku Abbott Japan August 2003 Pfizer Pharmacia Pfizer
  • 17. Other examples of Japanese-foreign mergers included: • Nippon Boehringer Ingelheim in July 1997, • Novartis Pharma in April 1997, • Wyeth Lederle (currently Wyeth) in December 1998, • AstraZeneca, Aventis Pharma and Sanofi- Synthelabo in January 2000, and Glaxo Smith Kline in January 2001. • Japanese-only mergers started appearing around 2004. • Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical merged on April 1, 2005 to create Astellas Pharma. • Dainippon Pharmaceutical and Sumitomo Pharmaceuticals were to merge as Dainippon Sumitomo Pharma, • Daiichi Pharmaceutical and Sankyo were to jointly form the holding company Daiichi Sankyo, both in October 2005. New moves by top-ranking Japanese pharmaceutical companies began to open up a new stage of mergers and reorganizations, with some observers expecting more activity among major domestic drug companies, following the example of Takeda Pharmaceutical.
  • 18. Foreign-Affiliated Companies • Almost all large pharmaceutical companies in the world had entered the Japanese market. There were few barriers for innovators to entering this market, but experience had shown that it can take a long time for foreign companies to establish themselves. The major routes to enter the market: • Establish a joint venture with a Japanese pharmaceutical company • Conclude a sales tie-up or also called as co-promotion deals After doing business in Japan and learning about the market, however, many foreign companies ended up selling their own products directly. Furthermore, foreign companies had already realized increased growth through mergers and reorganizations. By the end of 2004, 3 foreign-affiliated companies were listed among the top 10 pharmaceutical companies: Pfizer was second, Chugai fifth and Novartis Pharma eighth.
  • 19. Mergers and reorganizations of foreign-affiliated pharmaceutical companies can be broadly divided into two types. • The merger of Japanese subsidiaries of foreign companies resulting from mergers and restructuring of parent companies in their home countries. • This was mostly seen, and examples include AstraZeneca (established by the merger of Astra Japan and Zeneca Pharma in January 2000), Glaxo Smith Kline (established by the merger of Glaxo Welcome and Smith Kline Beecham in January 2001) and Pfizer (established by the merger of Pfizer and Pharmacia). • The other was to combine management between a foreign-affiliated pharmaceutical company and a Japanese pharmaceutical company. • This includes Abbott Japan (established by the merger of Dynabott and Hokuriku Seiyaku in February 2002) and Chugai (established by the merger of Chugai Pharmaceutical and Nippon Roche in October 2002).
  • 20. Spin-off & Consolidation Company Name Action Kyorin Pharmaceutical Closed Nogi plant in March 2006 Sankyo Yasugawa & Tanashi plants closed Shinogi & Co. Concentrate on production at Settsu & Kanegasaki plants and shut down the rest Tanabe Seiyaku Separated Onada Plant as Tanabe Seiyaku. Yamaguchi Co Ltd. Takeda Chemical Industries Closed Shonan plant in March 2006 & concentrated production at Hikari & Osaka plants Chugai Pharmaceutical Closed down 3 plants and concentrated production at Utsunomiya & Fujieda plants. Later spun off the production division as a separate entity Mitsubishi Pharma Separated Yoshitimu & Ashikaga plants as MP- Technopharma in April 2005 Meija Seika Closed Yodogawa drug preparation plant and consolidated production at Odawara plant Mochida Pharmaceutical Seperated Otawara plant as Mochida Seiyaku Kojo in April 2005.
  • 21. Re-organisation of Generic MFG Company Name Period Action Towa Pharmaceutical Oct-03 Acquired all shares of J-Dolph Pharmaceutical & converted it into a wholly- owned subsidiary Nipro Apr-04 Accepted the allocation of new shares to a third party issued by Takeshima Seiyaku & converted the latter into a subsidiary. Nipro's shareholding ratio rose to 65.5% Sawai Pharmaceuticals Nov-04 Entered in a business tieup with Zensei Pharmaceutical Industries. Acquired 167,000 shares (19.9%) issued & outstanding Nichi-iko Pharmaceutical Jan-05 Absorbs Nippon Galen Apr-05 Concluded a comprehensive business tieup agreement & business transfer agreement covering drugs with Maruko Pharmaceuticals. Acquired Maruko Pharmaceuticals & converted into its subsidairy Teikoku Medix Oct-05 Teikoku Medix & Ohta Pharmaceutical merged and the new entity was Teikoku Medix Co Ltd.
  • 22. Drug Wholesalers • The introduction of the price quotation system escalated competition among drug wholesalers and profitability worsened. • Wholesalers were forced into mergers or business tie-ups with the purpose of lowering their costs by developing economies of scale, which helped them to strengthen sales and create more bargaining power with manufacturers. • As a result, member companies of the Japan Pharmaceutical Wholesalers Association (JPWA) decreased from 440 in 1986 to 142 in fiscal 2005, a drop of 298 • Mergers and reorganizations accelerated from around 1999, resulting in four main groups: Mediceo Holdings, Suzuken group, Alfresa group and Kyoso Mirai group
  • 23. JPWA Membership 0 50 100 150 200 250 300 350 400 450 500 1986 1990 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
  • 24. Wholesaler Turnover & Subsidiaries Company Name Major Subsidiaries Mediceo HD Senshu Yakuhim, Ushioda Sangokudo Yakuhin, Chiyaku, Kuraya Sanseido, Yamahiro Kuraya, Heiseiyakuhin, Izutsu-Yakuhin, Everlth, Atol Suzuken Suzuken Okinawa Yakuhin,Suzuken Iwate, Nakano Yakyhin, Astis Alfresa HD Alfresa Pip Tokyo, Daiwa Yakuhin, Kowa-yakulin, Odashima, Alfresanikkensangyo, Ando Toho Pharmaceuticals Sanus, Honma Toho, Tokai Toho, Yamagachi Toho, Ogawa Toho, Yakushin, Gogo Toho - 500,000 1,000,000 1,500,000 2,000,000 Mediceo HD Suzuken Alfresa HD Toho Pharmaceuticals Sales (Million Yen)
  • 25. Drug distribution is roughly divided into four main channels: • Prescription drugs flow from manufacturers to hospitals via wholesalers. • Some over-the-counter drugs flow from manufacturers to consumers via drugstores and other retailers. • Other over-the-counter drugs move from manufacturers to consumers via wholesalers and then drugstores/retailers. • Medicines sold door-to-door move from manufacturers to consumers via sales companies specializing in this kind of sales. About 70% of prescription drugs is sold to medical institutions via primary wholesalers, and the rest is sold by small/midsized or secondary wholesalers that have no direct transactions with either large or second-tier manufacturers.
  • 26. Distribution Models Drug manufacturers (including importer-distributors Primary Wholesalers Secondary Wholesalers Cash & carry Wholesalers Patient & Consumers Manufacturersthatproducedrugs solddoortodoor OTCdrugmanufacturersthatsell theirproductsdirectly Ethicaldrugmanufacturersthatsell theirproductsdirectly Hospitals& Clinics Hospitals Insurance dispensaries Dispensaries& DrugStores OTC Drugs Ethical Drugs Prescriptions Injections & Dispensing Dispensing Selling Selling
  • 27. Policy environment for Generic Drugs Date Major Policy to encourage use of generic drugs April 2002 Incentives introduced for doctors and pharmacists Introduction of additional fees for prescriptions with generic drugs Introduction of generics information fees and generic drug dispensing fees April 2003 Introduction of comprehensive payment system*1 for DPCs April 2006 Review of prescription forms October 2007 Government set target in numerical terms for the share of generics (former indicator*2) of 30% or more by March 2013.
  • 28. Policy Changes • An incentive to use lower-cost generic drugs was included in the April 2002 revisions to the health insurance system, under the section covering dispensing fees and medical service fees. • It was decided that if a generic drug were included in a prescription obtained from a pharmacy that is not part of a hospital, two points may be added to the medical service fee and two points to the dispensing fee. • In addition, 10 points may be added if information about the drug is furnished to the patient. • In June of the same year, the Ministry of Health, Labour and Welfare sent a notice to government-operated hospitals and sanatoriums encouraging them to use generic drugs more. Three months later, the ministry introduced a fixed-rate payment for geriatric care. • In April 2003, salaried workers’ burden of medical fees was raised to 30%, resulting in higher medical costs for patients at medical institutions. • Thus, the business climate became more favorable for generic drugs.
  • 29. • Moreover, patent rights expired on such big-market drugs as Gaster of Yamanouchi, Mevalotin of Sankyo and Lipovas of Banyu. • In April 2003, the comprehensive evaluation system known as diagnosis-procedure combination (DPC) was introduced, stimulating the proliferation and increased consumption of generic drugs at medical institutions. • The new environment had become a boon to major generic drug firms, such as Towa Pharmaceutical, Sawai Pharmaceuticals, Taiyo Yakuhin and Nichi-iko, while other generic drug companies began to actively seek mergers and restructuring to expand their shares.
  • 30. • The revised Pharmaceutical Law enacted in April 2005 replaced the old “approval for manufacture” regulation with “approval for manufacture and wholesale.” • Previously, only partial outsourcing of a manufacturing process was permitted, but the revised law allows complete outsourcing. • As a result, the market for drug manufacturing services expanded. In Addition, some major pharmaceutical companies spinned off manufacturing operations into separate companies.
  • 31. Generic Drugs Registration • The total time from new generic drug application to approval was generally 12 months • New generic drugs were approved in February and August, because the National Health Insurance drug price list was updated twice a year, in June and December. • The application review time was 9 months, and MHLW approval procedures and Good Manufacturing Practice (GMP) inspections were conducted during the remaining 3 months. Application 12 months First Inquiry Answer Preparing Inquiry Answer GMP inspection 5 months 1.5 months 2.5 months 2 months Approval Approval judgment period of MHLW Applicant time
  • 32. Process of Screening Applicant Pharmaceuticals & Medical Devices Agency Interview Inquiry by PMDA & confirmation Presentation by Applicant Applicant Screening Specialist Investigation Specialist Factory GMP Inspection Screening & investigation of reliability Report about screening Report about screening Result of screening (notification of results) External Specialist Consultation (Screening Experts) Discussion of main problems Document review External Specialists Screening Experts Result of GMP investigation (notification of Result) Interview by screening committe e Applicant Applicant Side expert Screening expert External expert • Explanation (presentation) by Applicant • Study of main problem • Proceedings entrusted to department manager in charge of screening • Two interviews possible Screening expert External expert Consultation among screening experts (ongoing, following interview) Ministry of Health, Labour & Welfare Pharmaceutical Affairs Council Approval Request for Advice Designation & consultation Advice Summing up main problem
  • 34. POLITICAL • Early 2000’s was a time of turmoil in the Political system of Japan • Prime Minister Obuchi suffered a stroke in April 2000 and was replaced by Yoishiro Mori. • After the Liberal Party left the coalition in April 2000, Prime Minister Mori welcomed a Liberal Party splinter group, the New Conservative Party, into the ruling coalition which lasted for 1 year. • On 24 April 2001, riding a wave of grassroots desire for change, maverick politician Junichiro Koizumi defeated former Prime Minister and other party stalwarts on a platform of economic and political reform. • on 8 August 2005, Prime Minister called for a snap election to the lower house, as threatened, after LDP stalwarts and opposition DPJ parliamentarians defeated his proposal for a large-scale reform and privatization of Japan Post, which besides being Japan's state-owned postal monopoly was the world's largest financial institution, with nearly 331 trillion yen of assets. • The ruling LDP started losing hold since 2006. No prime minister except Koizumi had good public support. • On 26 September 2006, new LDP President Shinzo Abe was elected by a special session of the Diet to succeed Junichiro Koizumi as Prime Minister.
  • 35. Economy • Average duration of the Japanese business cycles was around 50 months, which was relatively short in comparison with other developed countries where an average cycle lasted for 6 years. • Average duration of the recessions in Japan was around 17 months, which was longer than in other developed countries whose recessions lasted only 12 months on average. • The total amount of trade between Japan and India had been rising since 2002, reaching approximately US$6.8 billion in 2005. • However, this figure was not commensurate with the two countries economic power and potential.
  • 36. The trade share and its relative importance between Japan and India were diminishing: • Japan ranked 10th among India’s export destinations (share of 2.5%) and 10th among import sources (2.8%), • India ranked 26th among Japan’s export destinations (0.6%) and 28th among import sources (0.6%). • As for other comparable major economies in 2005, the trade value between Japan and China was US$189.4 billion and between India and the US, US$20 billion indicated a substantial potential for further expansion of trade between Japan and India.
  • 37. • India’s exports of software to Japan had grown dramatically in years, marking a 60% increase in the year 2004 alone. • At the same time, there had been no changes in the traditional structure in which major exports were comprised of commodities such as gems, marine products and iron ore, making diversification of the trade structure a challenge. • Manufactured goods such as automobile components still constituted a large proportion of India’s imports from Japan. • Japan and India were studying the sectors in which India had expanded its trade volume with other countries, and considerations were drawn for increasing the trade value in IT, textiles and fiber products and pharmaceutical products. • A study conducted by Japan Bank for International Cooperation (JBIC) revealed that India ranked third after China and Thailand, as a promising country in which to expand business in the medium term, and second after China in the long term. • Thus the expectations were high for the future.
  • 38. Social – Japan is ranked as the 10th most populated country in the world (the U.S. Census Bureau, 2005). However, according to some other sources, it is not 10th, rather 11th in the world. – Total population in Japan is 126.4 million. Shintoism and Buddhism are two major religions while the major language is Japanese which is spoken by around 99% of the country’s population. – Japan faces a number of social challenges. Ageing population and sinking birth rate are two of the biggest challenges Japan faces today. – The life expectancy for men is 81 years, while 87 years for women. Many sources forecast that the Japanese population is likely to fall below 100 million in 2048 and about 87 million by 2060. – This will severely impact on Japan and it will lose out to regional powers, particularly China. – Therefore, many Japanese politicians are now highlighting an ‘integrated’ immigration policy to draw vital foreign workers to Japan to reduce the skill- gaps created by shrinking birth rate and ageing population.
  • 39. • Many people in Japan prefer Japanese companies to foreign ones. This makes trading difficult for foreign companies. Indeed, this is one of the main reasons as to why many foreign companies failed in Japan. • For instance, after operating 9 years, Tesco (British retail giant) had to close its operations in Japan in 2012 (BBC, 2012). Likewise, Wendy’s, Pret A Manger’s, and many other global companies failed in Japan. • However, it is also true that some foreign companies did very well in Japan as well. Therefore, it is extremely important for foreign companies to carry out a detailed environmental scanning before entering into Japan.
  • 40. Technology • Japan is one of the most technologically advanced countries in world. The Japanese are well-known as extremely creative in searching out and learning to use modern technologies. Japan has been pushing technological innovation and creativity in such a way that many countries will struggle to emulate. • Japan’s innovation can be found in a variety of fields. For example, automation systems are widely used in Japan, particularly in hospitals, airports, and restaurants. Likewise, Japan is well ahead of many other advanced countries in robotic development. Indeed, it has more than half of the industrial robots in the world. • The contactless payment system has been in Japan for a long time; indeed, long before many countries even thought about it. Japan has also done tremendously well in areas such as space research and development, chemicals, optics, rail transport, and semi-conductors. These developments offer great opportunities for both Japanese and foreign individuals and companies.
  • 41. – Lupin began making incremental changes in its Japanese facilities tweaking the system for greater efficiency, ensuring better economies of scale, and renegotiating prices with large independent wholesalers (oroshi) and regional (hansha) players. – For instance, at Kyowa’s factories, instead of producing the full quota of drugs for a month (200-odd), it decided to produce less per month but for three months continuously. – This brought down operational costs significantly because it reduced the time taken for cleaning between changeover for drugs. – “Without creating any dissonance in the company, we were able to raise margins from 33% to 42% in the first year,” says Kamal K. Sharma, managing director, Lupin.
  • 42. Legal • Legal environment is the last element to discuss in the PESTEL analysis of Japan. • People can work in Japan as employees, dispatched workers, independent contractors, and directors. • All employees enjoy employment rights and benefits such as maximum work hours, work breaks, holidays, and maternity leave. • Companies need to register employees for mandatory pension insurance, health insurance, unemployment insurance, and workers’ accident compensation insurance. • All of these apply to employment relationships regardless of the citizenship of employees (Ohta, 2015).
  • 43. Environment • Japan is a relatively clean and environmentally responsible nation. However, it faces some environmental challenges today. For example, waste management is one of the biggest environmental issues in Japan. Trash produced by the modern society, industrial activities, and agriculture contribute to the production of a great deal of waste. Japan is indeed under pressure to minimise waste and control environmental pollution. • Japan is one of the countries, most affected by calamities and natural disasters. Tsunamis, floods, earthquakes, mudslides, cyclones, and volcanic eruptions hit Japan from time-to-time. These disasters cost Japan billions of dollars for reforms and rebuilding. In fact, Japan is a less popular tourist destination because of natural disasters, high-cost, and language barriers.
  • 45. 1.Competition/ Industry Rivalry is high 1.Threat of new entrants 1.Bargainin g power of the buyers 1.Threat of substitutes 1.Bargainin g power of the suppliers 1. BP high - API Cos - Difficult to manufacture products. 2. BP low – API suppliers – Simple to manufacture or commoditized. 3. Hence, BPOS is medium. 1. TOS medium: because one generic can be substituted by another. 2. However, there are limited number of generic players in Japan. 1. Entry barriers for Japan are high considering the regulatory approval timelines for generic entry in their market along with consumer’s preference for branded innovator products. 2. TONE is low for the short term. Registrations can go on for a 2 year period by which new strategies can be developed to counter comp 1. Generics – Cost Effectiveness 2. Significant savings for buyers 3. Therefore BPOB is low since the government is pushing for generics.
  • 46. Competitive Rivalry • Ranbaxy (now wholly owned by Daiichi Sankyo) was one of the first to enter the country in 2002 by acquiring a 50% stake in Nihon Pharmaceutical Industry (a subsidiary of Nippon Chemifar). But it was unable to make much headway, and after its acquisition by Daiichi, it ended the tieup in 2009. • Ahmedabad-based Torrent Pharmaceuticals opened a fully-owned subsidiary in Yokohama in April 2006, only to exit two years later. • Dr. Reddy’s too announced its entry into Japan in 2011 by signing a joint venture with Tokyo-based Fujifilm to deliver APIs and formulations. • Similarly, Ahmedabad-based Zydus Cadila has been in Japan since 2007 after it acquired Nippon Universal Pharma. But Japan barely accounts for 1% of the total business of Zydus Cadila and Dr. Reddy’s. • Those who track international pharma describe Japan as a fortress, where the top 10 firms, including Takeda, Astellas, Daiichi Sankyo, Eisai (all Japanese), Pfizer, Roche, Merck, and Novartis (foreign), account for 44.7% of the total market. • Most foreign firms partner a local player because the Japanese prefer buying drugs made by Japanese companies; the big Japanese firms also control the trade.
  • 48. LUPIN LTD. 44% 21% 15% 20% Therapeutic Mix Cephalosporins Anti-TB Cardiovasculars Others 53% 22% 25% Gross Sales (Geography Break- down) Domestic Exports - Advanced Markets Exports - Emerging Markets 23 22 77 78 0 50 100 2005-06 2006-07 SalesContribution% Global Sales (Market Break- down) Advanced Markets Emerging Markets  Lupin was one of the top- 5 Indian Pharmaceutical Companies operating in 50 countries  It earned revenues of around Rs. 20 Bn and profit of Rs. 3 Bn  Lupin had six manufacturing facilities all located in India  It had a debt equity ratio of 0.61  Lupin’s promoters held slightly more than 50% of its share capital 1827.2 3020.6 0 1000 2000 3000 2005-06 2006-07 InRs.Million Net Profit Net Profit
  • 49. Strength 1. World leader in Anti-TB drugs & Cephalosporin. 2. Considerable presence in market of Asthma, Pediatric Diabetes and CNS 3. Presence in US & European market 4. Manufacturer of API & vertical integration in most areas 5. R&D focus and strong pipeline Weakness 1. High dependence on the US market. 2. Operates in low growth segments such as CNS and Respiratory. Opportunity 1. Increased generic awareness in Japanese pharma market. 2. Strong leadership with cultural know how in the Japanese market 3. 3 year relationship with Kyowa for API supply. Threat 1. Indian generic players who are trying to enter Japan. 2. Regulatory hurdles 3. Japanese obsession with the quality of medicines.
  • 50. Kyowa Pharmaceutical  Established in 1954 and involved in the development, manufacture, sale and import of generic drugs  Business strategy- to become the market leader in generic psychiatry drugs  Out of 1379 psychiatric hospitals in japan, 1258 prescribed Kyowa’s products  Kyowa spent around 8% of its FY 2006-07 sales on R&D  63% of sales were achieved through small distributors and the rest through wholesalers  83% of revenue was from own-product sales and the remaining were from merchandize sales, where Kyowa acted merely as a trader for both domestic and overseas manufacturers 2% 1.90% 1.90% 2% 0% 1% 2% FY2005 FY2006 FY2007 FY2008E Market Share in Japan (% of total) Market Share (% of total) 33.60% 15.10%13.60% 37.70% Segments by Sales Psychia tric Cardiov ascular Respira tory Others 0 2000 4000 6000 8000 InJPYMillions Sales 50
  • 51. Strength 1. Market leader in generic psychiatry drugs 2. Presence in cardiovascular, Respiratory and other category. 3. Good hospital coverage (1258/1379) 4. Good products demand 5. 8% R&D spend 6. Good distribution network 7. 83% of revenue was from domestic sale Weakness 1. Low cash reserves and negative balance sheet 2. Complete dependence Domestic market. 3. Formulators (dependency for API) 4. High Operational costs 5. Less focus on Respiratory Opportunity 1. Increased generic awareness and policy changes in Japanese pharma market. 2. Increased cash flow and streamlining operations can lead to a turn around. Threat 1. Highly regulated market. 2. Lagging incase of no cash infusion. 3. Maintaining Market leadership
  • 53. BCG Matrix Psychiatry CVS Drugs Gastrointestinal drugs Anti TB drugs Anti-biotic drugs Hypnotic & sedative Hypertension drugs Relative Market Share MarketGrowthRate CashUsage High Low Low Star Question Mark Cow Dog Cash Generation 10% 0.1%1.0%
  • 55. 4P of marketing Product Price Place Promotion • Diverse price range • Regulatory controlled • Competitive • Co promotions • Skilled Field force • Doctor promotion • Pharmacy stores • Website, Press release • Distributor • Semi distributor • Institutions • Psychotropics (Risperidone, carbamazepine ) • Sedatives & Hypnotics (Alprazolam) • Hyper tensives (Amlodipine, Nicardipine) & Vasodialators • Peptic Ulcer agents (Lansoprazole, Domperidone) . • Addressing the need gap.
  • 56. Current Scenario • Even as the company faces another price cut in Japan, Lupin looks to rationalize costs, shift manufacturing units and looks at non- Japanese markets to continue growth. • The company bought a portfolio of 21 generic brands from the Osaka-based company paying $150 million two years ago. It is also looking at in-licensing deals to distribute specialty and complex drugs in central nervous system and neurology segments. • Lupin in-licensed and launched Bipresso, a speciality brand from Astellas for the treatment of bipolar depression last year. The drug is a top-selling one for Lupin in Japan. • 2 years after Kyowa takeover, Lupin acquired I’rom Pharmaceuticals to complement their portfolio and include injections and a wider hospital base. • Lupin’s 1st biosimiliar Etanercept was developed with Nichi-iko and was commercialized in Japan.
  • 57. Way Forward • The company is focusing on non-Japanese Asia-Pacific markets such as Australia and South East Asia to compensate for the dip in Japanese growth. • In 2017-2018, Asia Pacific (APAC) as a block, excluding Japan, contributed 7 percent to Lupin sales whereas Japan along contributed 11% • In Australia, Lupin turned around its loss-making business, which is now growing by 28 percent, outperforming the market. The company expects its Australian business to maintain the growth trajectory. Australian pharmaceutical market was valued at $13 billion in 2017 with generics accounting for over 30 percent of the sales volume. • Lupin now plans to strengthen its presence in the Philippines and expand in Malaysia, Thailand and Myanmar through more launches. It is also exploring ways to enter China. • The plan is to generate $100 million sales from non-Japanese APAC markets.

Editor's Notes

  1. Source: Japan Generic Pharmaceutical Manufacturers Association
  2. In Billion yen %
  3. Source: Yano Research Institute from data released by each company