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Emerging Markets as Opportunities, Rather than Threats
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Emerging Markets as Opportunities, Rather than Threats

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1Emerging Markets as Opportunities, 16handholding and close monitoring
Rather than Threats. KATE KUHRT DCAT Week FDA-approval doesn’t necessarily mean
MARCH 12, 2008. consistent quality Risk of technology
2IS YOUR EMPLOYER ALREADY PRESENT IN theft Environmental issues Language
EMERGING MARKETS? Yes No, but we are barriers.
considering entering emerging markets. No. 17MARKETS FOR DOSE: Russia. Big
We are not considering entering emerging Pharma/Small Innovators Roche,
markets at this time. Sanofi-Aventis, Novartis, Nycomed, Pfizer,
3WHERE DO YOU SEE MOST OPPORTUNITIES Menarini, Servier Generics Lek, Gedeon,
FOR YOUR COMPANY? India China Japan North Krka – for decades Stada, Pliva,
America South America Eastern Europe Polpharma, Actavis.
Western Europe Russia Other regions. 18MARKETS FOR DOSE: Russia. Pros Growing
4BACKDROP. Growth Expectations for 2008 middle class Demand for treatments for
US and EU5: 4-5% Japan: 1-2% BRIC: 12-13% chronic diseases No alternative therapies
Brand pharma Innovation slump Blockbusters Obligatory health insurance Few local dose
losing patent protection Generics companies with cGMP experience Market
Increasing competition, especially from dominated by imports. Cons Size of the
India Low cost API coming from India, country Poor infrastructure Fragmented
China Margin pressures in U.S., UK, distribution network IP enforcement
Germany Drop in small molecule Counterfeiting Controlled pricing Gov’t
opportunities post-2011. debt to pharma cos Red tape Protectionist
5AGENDA. Players Big Pharma Generics measures by government.
based in regulated markets API 19MARKETS FOR API: Russia. Pros Almost
manufacturers based in regulated markets all API is imported Little local
Areas of opportunity: Dose and API sales production Little local expertise outside
R&D and Manufacturing base. of supplements Local products w/
6MARKET FOR DOSE: India. Big Pharma Has inconsistent quality Large number of local
been there for years: J&J, Wyeth, dose companies. Cons A lot of the API is
Pfizer, AZ, Glaxo, Lilly, Abbott, others coming from India, China Many local dose
Generics Baxter: Leader in IV solutions companies buy from offshore distributors
market in India Mylan: Matrix acquisition Suspect quality Red tape.
motivated only by access to API? Teva: 20R&D AND MANUFACTURING BASE:
Perennial rumors about a major Indian Russia. Innovators: Servier: dose plant
acquisition. near Moscow Nycomed, Glaxo, Pfizer?
7MARKET FOR DOSE: India. Pros Generics: Stada: Nizhpharm, Makiz group
Double-digit pharma market growth Economic (Makiz, Skopinpharm and Biodyne
boom Growing middle-class Increasing Pharmaceuticals) Actavis: ZiO Zdorovje
prevalence of Western diseases 2005 Krka: Production facility in near Moscow
product patents. Cons Challenges to Polpharma/Gedeon: Akrihin.
product patents Novartis’s Glivec 21R&D AND MANUFACTURING BASE:
Potential for compulsory licensing Roche’s Russia. Pros Low-cost production Platform
Tarceva Many people still lack access to for launching into CIS, E Europe Biotech
pharmaceuticals Poor infrastructure Large and immunology experience Large clinical
number of backward integrated local trial population Physicians eager to
generic drug companies Dose imports from participate in trials Low cost of clinical
China Low prices Restrictive import duty trials. Cons Erosion of formerly strong
on finished dose products Need marketing scientific base Poor enforcement of IP
presence. rights Counterfeiting Limited number of
8MARKETS FOR API: India ~1200 Indian sites with GMP experience Red tape
Import Registrations filed since Feb 2003. Economic and political risks Language
EU/US based companies with most IIRs DSM barriers.
BASF Schering-Plough Sanofi Novartis 22MARKETS FOR DOSE: Brazil. Big Pharma
Pfizer Bayer E.ON Glaxo. Products with Abbott, Boehringer Ingelheim, BMS, Pfizer,
most Euro/US IIRs Amoxicillin Clavulanate others Generics Sandoz: only foreign
Potassium Pancreatin Beta Carotene generic co in top five Apotex: exiting the
Lactulose. Source: Newport Horizon. Brazilian market Teva: future plans?
9MARKET FOR API: India. Pros Not 23MARKETS FOR DOSE: Brazil. Pros Largest
self-sufficient in all products population in Latin America Rapid market
Fermentation Steroids Prostaglandins growth Ageing population Gov’t efforts to
Polypeptides Demand for Intermediates improve health care Gov’t efforts to
Costs rising in China and India increase generics’ uptake Opportunities
Opportunities in high-quality API for with high-value specialty products. Cons
export dose. Cons Abundance of locally Price controls Frequent, abrupt changes of
manufactured API Many local facilities FDA rules Lack of transparency Views toward IP
approved Extensive importing from China Efavirenz CL Generic market highly
Local API manufacturers enjoy cost concentrated Top four players: 80%
advantage Restrictive duty on API imports. Domestic players dominate Fierce
10R&D AND MANUFACTURING BASE: India. competition Need local manufacturing to be
Big Pharma Many have R&D and viable.
manufacturing sites in India: Novo 24MARKETS FOR API: Brazil. Pros Most of
Nordisk, Merck, Pfizer, others Generics API is imported Low import taxes Dose
Sandoz: a number of units Teva: small companies becoming more quality minded
API/intermediates plant and R&D Regulatory environment becoming tougher
facility Apotex: manufacturing and R&D Dose exports into neighboring countries
facilities Mylan: Matrix acquisition API Opportunities in High-quality hormones
Manufacturers Trifarma: Alchymars ICM Controlled substances. Cons Currently most
Albany Molecular: FineKem, Ariane API imports from India and China Still
Orgachem. heavy focus on cost rather than quality
11R&D AND MANUFACTURING BASE: India. Strong Euro.
Pros Scientific talent Significant cost 25R&D AND MANUFACTURING BASE:
saving opportunities Proven abilities in Brazil. Big Pharma Manufacturing base:
IT arena Product patents introduced in Novartis, Roche, GSK, Janssen, Eli Lilly,
2005 100% Foreign Direct Investment Abbott Ongoing clinical trials: BMS,
permitted Huge treatment-na?ve patient Pfizer, Roche Generics Sandoz: upgrading
population A number of sites with its manufacturing plant in Sao Paulo
experience with submitting data to FDA Apotex: looking to sell the plant in Sao
Large English-speaking population. Cons Paulo API Manufacturers Italfarmaco ACS
Costs increasing IP Issues Long-distance Dobfar DSM.
management Infrastructure FDA-approval 26R&D AND MANUFACTURING BASE:
doesn’t necessarily mean consistent Brazil. Pros Biotech legislation
quality and cGMP compliance. Biodiversity and phytotherapeutics
12MARKETS FOR DOSE: China. Big Pharma Platform for exporting into rest of Latin
Has been there for years: Abbott, America Large treatment-na?ve population
AstraZeneca, Boehringer Ingelheim, Eli Seasonal diseases 6-months out-of-synch
Lilly, J&J, Novartis, others Generics with North America/Europe. Cons
Baxter Actavis: Actavis (Foshan) Historically not strong in R&D
Pharmaceutical Co., Ltd. Stada: Health Frequent, abrupt changes of rules Slow
Vision Enterprise, Stada Pharmaceuticals administrative processes Weak local API
(Beijing) Sandoz: Guangdong Sandoz industry Language barrier.
Pharmaceutical Company Teva: Tianjin 27MARKETS FOR DOSE: Japan. Big Pharma
Hualida Biotechnology Pharmaceutical Abbott, AstraZeneca, Boehringer Ingelheim,
(Sicor), Kunming Baker Norton (Ivax). others Generics Mylan: Merck Kgaa Sandoz:
13MARKETS FOR DOSE: China. Cons Size of Hexal Hospira: agreement with Taiyo Teva:
the country Fragmented market Many people aggressive plans for 2008.
still lack access to medicines Many 28MARKETS FOR DOES: Japan. Pros World’s
government regulations that can slow down second largest pharma market Ageing
registration Competition from local population All manufacturing can be done
players Must partner with local companies outside Japan Government aims to increase
to get access to distribution channels the market share of generics Incentives
Many Chinese companies active in New Rx form Increasing use of OTC drugs.
individual provinces only Not all drugs Cons Slow approval process Price
currently sold in China Generics may need cuts/reduced reimbursement Slow overall
to conduct clinical trials. Pros Expected growth of market Low image of generics
to be the 5th largest pharma market by Generics must provide every
2010 Growing middle class Increasing life dosage/formulation Requirement for a
expectancy Increasing awareness of nationwide distribution network Difficult
diseases and treatments Increasing for foreign companies to do it alone
prevalence of Western diseases Demand for Underdeveloped framework for patent
cardiovascular, dermatological, oncology, challenges.
pediatric drugs. 29MARKETS FOR API: Japan ~2000 JDMFs
14MARKETS FOR API: China. Pros Rising filed since Feb 2005. EU/US based
costs in China Demand for difficult to companies with most JDMFs Sanofi-Aventis
manufacture APIs “nibs” Demand for Cambrex Schering-Plough Novartis DSM
high-quality API from dedicated facilities Pfizer BASF Merck & Co Erregierre FIS.
Newer cephalosporins. Cons China has Products with most Euro/US JDMFs Heparin
manpower, intellect and raw materials to Mesalamine Terbinafine Omeprazole
manufacture most products locally Heavy Itraconazole. Source: Newport Horizon.
focus on cost Importing from low-cost 30MARKETS FOR API: Japan. Pros Most dose
countries High-value of Euro. companies do not make their own API
15R&D AND MANUFACTURING BASE: China. Introduction of JDMFs New DMF and
Big Pharma AstraZeneca, Novo Nordisk, accreditation system discouraging certain
Glaxo, BMS, Schering, Novartis, others players from less regulated markets
Generics Perrigo: Zibo Xinhua-Perrigo Harmonization of rules CTD can be used as
Pharmaceutical Company Watson: R&D and the basis for a DMF. Cons Different
manufacturing in Changzhou City Sandoz: standards Relatively small volumes JDMF
Guangdong Sandoz Pharmaceutical Company system still new Reliance on agents and
Teva: Hualida Biotech Baxter: at least well-established relationships Language
four manufacturing facilities API barrier Many Japanese generics buying from
Manufacturers DSM: R&D, manufacturing India, China, South Korea Competition from
Esteve: Zhejiang Huayi Pharmaceutical Japanese fine chemical companies.
Lonza: R&D, manufacturing Hovione: 31MAIN OPPORTUNITIES FOR REGULATED
Zhejiang Hisyn. MARKET PLAYERS. ? ? Pharma: Dose.
16R&D AND MANUFACTURING BASE: China. Generics: Dose. API Sales. R&D.
Pros Talented pool of scientists, Manufacturing. India. China. Russia.
engineers Lower cost base Base for selling Brazil. Japan.
into other emerging markets Improving 32THANK YOU! Kate Kuhrt Director,
intellectual property protection Generics and API Intelligence Thomson
Infrastructure Government support for Reuters 215 Commercial Street Portland,
R&D Large treatment-na?ve population. Maine 04101 USA + 1 (207) 871-9700 x26
Cons Increasing prices Need for kate.kuhrt@thomsonreuters.com.
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Emerging Markets as Opportunities, Rather than Threats

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