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Emerging Markets as Opportunities, Rather than Threats
Emerging Markets as Opportunities, Rather than Threats
IS YOUR EMPLOYER ALREADY PRESENT IN EMERGING MARKETS
IS YOUR EMPLOYER ALREADY PRESENT IN EMERGING MARKETS
WHERE DO YOU SEE MOST OPPORTUNITIES FOR YOUR COMPANY
WHERE DO YOU SEE MOST OPPORTUNITIES FOR YOUR COMPANY
BACKDROP
BACKDROP
AGENDA
AGENDA
MARKET FOR DOSE: India
MARKET FOR DOSE: India
MARKET FOR DOSE: India
MARKET FOR DOSE: India
MARKETS FOR API: India ~1200 Indian Import Registrations filed since
MARKETS FOR API: India ~1200 Indian Import Registrations filed since
MARKET FOR API: India
MARKET FOR API: India
R&D AND MANUFACTURING BASE: India
R&D AND MANUFACTURING BASE: India
R&D AND MANUFACTURING BASE: India
R&D AND MANUFACTURING BASE: India
MARKETS FOR DOSE: China
MARKETS FOR DOSE: China
MARKETS FOR DOSE: China
MARKETS FOR DOSE: China
MARKETS FOR API: China
MARKETS FOR API: China
R&D AND MANUFACTURING BASE: China
R&D AND MANUFACTURING BASE: China
R&D AND MANUFACTURING BASE: China
R&D AND MANUFACTURING BASE: China
MARKETS FOR DOSE: Russia
MARKETS FOR DOSE: Russia
MARKETS FOR DOSE: Russia
MARKETS FOR DOSE: Russia
MARKETS FOR API: Russia
MARKETS FOR API: Russia
R&D AND MANUFACTURING BASE: Russia
R&D AND MANUFACTURING BASE: Russia
R&D AND MANUFACTURING BASE: Russia
R&D AND MANUFACTURING BASE: Russia
MARKETS FOR DOSE: Brazil
MARKETS FOR DOSE: Brazil
MARKETS FOR DOSE: Brazil
MARKETS FOR DOSE: Brazil
MARKETS FOR API: Brazil
MARKETS FOR API: Brazil
R&D AND MANUFACTURING BASE: Brazil
R&D AND MANUFACTURING BASE: Brazil
R&D AND MANUFACTURING BASE: Brazil
R&D AND MANUFACTURING BASE: Brazil
MARKETS FOR DOSE: Japan
MARKETS FOR DOSE: Japan
MARKETS FOR DOES: Japan
MARKETS FOR DOES: Japan
MARKETS FOR API: Japan ~2000 JDMFs filed since Feb 2005
MARKETS FOR API: Japan ~2000 JDMFs filed since Feb 2005
MARKETS FOR API: Japan
MARKETS FOR API: Japan
MAIN OPPORTUNITIES FOR REGULATED MARKET PLAYERS
MAIN OPPORTUNITIES FOR REGULATED MARKET PLAYERS
THANK YOU
THANK YOU

Презентация: «Emerging Markets as Opportunities, Rather than Threats». Автор: Thomas J. Vaichus. Файл: «Emerging Markets as Opportunities, Rather than Threats.ppt». Размер zip-архива: 233 КБ.

Emerging Markets as Opportunities, Rather than Threats

содержание презентации «Emerging Markets as Opportunities, Rather than Threats.ppt»
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1 Emerging Markets as Opportunities, Rather than Threats

Emerging Markets as Opportunities, Rather than Threats

KATE KUHRT DCAT Week MARCH 12, 2008

2 IS YOUR EMPLOYER ALREADY PRESENT IN EMERGING MARKETS

IS YOUR EMPLOYER ALREADY PRESENT IN EMERGING MARKETS

Yes No, but we are considering entering emerging markets. No. We are not considering entering emerging markets at this time.

3 WHERE DO YOU SEE MOST OPPORTUNITIES FOR YOUR COMPANY

WHERE DO YOU SEE MOST OPPORTUNITIES FOR YOUR COMPANY

India China Japan North America South America Eastern Europe Western Europe Russia Other regions

4 BACKDROP

BACKDROP

Growth Expectations for 2008 US and EU5: 4-5% Japan: 1-2% BRIC: 12-13% Brand pharma Innovation slump Blockbusters losing patent protection Generics Increasing competition, especially from India Low cost API coming from India, China Margin pressures in U.S., UK, Germany Drop in small molecule opportunities post-2011

5 AGENDA

AGENDA

Players Big Pharma Generics based in regulated markets API manufacturers based in regulated markets Areas of opportunity: Dose and API sales R&D and Manufacturing base

6 MARKET FOR DOSE: India

MARKET FOR DOSE: India

Big Pharma Has been there for years: J&J, Wyeth, Pfizer, AZ, Glaxo, Lilly, Abbott, others Generics Baxter: Leader in IV solutions market in India Mylan: Matrix acquisition motivated only by access to API? Teva: Perennial rumors about a major Indian acquisition

7 MARKET FOR DOSE: India

MARKET FOR DOSE: India

Pros Double-digit pharma market growth Economic boom Growing middle-class Increasing prevalence of Western diseases 2005 product patents

Cons Challenges to product patents Novartis’s Glivec Potential for compulsory licensing Roche’s Tarceva Many people still lack access to pharmaceuticals Poor infrastructure Large number of backward integrated local generic drug companies Dose imports from China Low prices Restrictive import duty on finished dose products Need marketing presence

8 MARKETS FOR API: India ~1200 Indian Import Registrations filed since

MARKETS FOR API: India ~1200 Indian Import Registrations filed since

Feb 2003

EU/US based companies with most IIRs DSM BASF Schering-Plough Sanofi Novartis Pfizer Bayer E.ON Glaxo

Products with most Euro/US IIRs Amoxicillin Clavulanate Potassium Pancreatin Beta Carotene Lactulose

Source: Newport Horizon

9 MARKET FOR API: India

MARKET FOR API: India

Pros Not self-sufficient in all products Fermentation Steroids Prostaglandins Polypeptides Demand for Intermediates Costs rising in China and India Opportunities in high-quality API for export dose

Cons Abundance of locally manufactured API Many local facilities FDA approved Extensive importing from China Local API manufacturers enjoy cost advantage Restrictive duty on API imports

10 R&D AND MANUFACTURING BASE: India

R&D AND MANUFACTURING BASE: India

Big Pharma Many have R&D and manufacturing sites in India: Novo Nordisk, Merck, Pfizer, others Generics Sandoz: a number of units Teva: small API/intermediates plant and R&D facility Apotex: manufacturing and R&D facilities Mylan: Matrix acquisition API Manufacturers Trifarma: Alchymars ICM Albany Molecular: FineKem, Ariane Orgachem

11 R&D AND MANUFACTURING BASE: India

R&D AND MANUFACTURING BASE: India

Pros Scientific talent Significant cost saving opportunities Proven abilities in IT arena Product patents introduced in 2005 100% Foreign Direct Investment permitted Huge treatment-na?ve patient population A number of sites with experience with submitting data to FDA Large English-speaking population

Cons Costs increasing IP Issues Long-distance management Infrastructure FDA-approval doesn’t necessarily mean consistent quality and cGMP compliance

12 MARKETS FOR DOSE: China

MARKETS FOR DOSE: China

Big Pharma Has been there for years: Abbott, AstraZeneca, Boehringer Ingelheim, Eli Lilly, J&J, Novartis, others Generics Baxter Actavis: Actavis (Foshan) Pharmaceutical Co., Ltd. Stada: Health Vision Enterprise, Stada Pharmaceuticals (Beijing) Sandoz: Guangdong Sandoz Pharmaceutical Company Teva: Tianjin Hualida Biotechnology Pharmaceutical (Sicor), Kunming Baker Norton (Ivax)

13 MARKETS FOR DOSE: China

MARKETS FOR DOSE: China

Cons Size of the country Fragmented market Many people still lack access to medicines Many government regulations that can slow down registration Competition from local players Must partner with local companies to get access to distribution channels Many Chinese companies active in individual provinces only Not all drugs currently sold in China Generics may need to conduct clinical trials

Pros Expected to be the 5th largest pharma market by 2010 Growing middle class Increasing life expectancy Increasing awareness of diseases and treatments Increasing prevalence of Western diseases Demand for cardiovascular, dermatological, oncology, pediatric drugs

14 MARKETS FOR API: China

MARKETS FOR API: China

Pros Rising costs in China Demand for difficult to manufacture APIs “nibs” Demand for high-quality API from dedicated facilities Newer cephalosporins

Cons China has manpower, intellect and raw materials to manufacture most products locally Heavy focus on cost Importing from low-cost countries High-value of Euro

15 R&D AND MANUFACTURING BASE: China

R&D AND MANUFACTURING BASE: China

Big Pharma AstraZeneca, Novo Nordisk, Glaxo, BMS, Schering, Novartis, others Generics Perrigo: Zibo Xinhua-Perrigo Pharmaceutical Company Watson: R&D and manufacturing in Changzhou City Sandoz: Guangdong Sandoz Pharmaceutical Company Teva: Hualida Biotech Baxter: at least four manufacturing facilities API Manufacturers DSM: R&D, manufacturing Esteve: Zhejiang Huayi Pharmaceutical Lonza: R&D, manufacturing Hovione: Zhejiang Hisyn

16 R&D AND MANUFACTURING BASE: China

R&D AND MANUFACTURING BASE: China

Pros Talented pool of scientists, engineers Lower cost base Base for selling into other emerging markets Improving intellectual property protection Infrastructure Government support for R&D Large treatment-na?ve population

Cons Increasing prices Need for handholding and close monitoring FDA-approval doesn’t necessarily mean consistent quality Risk of technology theft Environmental issues Language barriers

17 MARKETS FOR DOSE: Russia

MARKETS FOR DOSE: Russia

Big Pharma/Small Innovators Roche, Sanofi-Aventis, Novartis, Nycomed, Pfizer, Menarini, Servier Generics Lek, Gedeon, Krka – for decades Stada, Pliva, Polpharma, Actavis

18 MARKETS FOR DOSE: Russia

MARKETS FOR DOSE: Russia

Pros Growing middle class Demand for treatments for chronic diseases No alternative therapies Obligatory health insurance Few local dose companies with cGMP experience Market dominated by imports

Cons Size of the country Poor infrastructure Fragmented distribution network IP enforcement Counterfeiting Controlled pricing Gov’t debt to pharma cos Red tape Protectionist measures by government

19 MARKETS FOR API: Russia

MARKETS FOR API: Russia

Pros Almost all API is imported Little local production Little local expertise outside of supplements Local products w/ inconsistent quality Large number of local dose companies

Cons A lot of the API is coming from India, China Many local dose companies buy from offshore distributors Suspect quality Red tape

20 R&D AND MANUFACTURING BASE: Russia

R&D AND MANUFACTURING BASE: Russia

Innovators: Servier: dose plant near Moscow Nycomed, Glaxo, Pfizer? Generics: Stada: Nizhpharm, Makiz group (Makiz, Skopinpharm and Biodyne Pharmaceuticals) Actavis: ZiO Zdorovje Krka: Production facility in near Moscow Polpharma/Gedeon: Akrihin

21 R&D AND MANUFACTURING BASE: Russia

R&D AND MANUFACTURING BASE: Russia

Pros Low-cost production Platform for launching into CIS, E Europe Biotech and immunology experience Large clinical trial population Physicians eager to participate in trials Low cost of clinical trials

Cons Erosion of formerly strong scientific base Poor enforcement of IP rights Counterfeiting Limited number of sites with GMP experience Red tape Economic and political risks Language barriers

22 MARKETS FOR DOSE: Brazil

MARKETS FOR DOSE: Brazil

Big Pharma Abbott, Boehringer Ingelheim, BMS, Pfizer, others Generics Sandoz: only foreign generic co in top five Apotex: exiting the Brazilian market Teva: future plans?

23 MARKETS FOR DOSE: Brazil

MARKETS FOR DOSE: Brazil

Pros Largest population in Latin America Rapid market growth Ageing population Gov’t efforts to improve health care Gov’t efforts to increase generics’ uptake Opportunities with high-value specialty products

Cons Price controls Frequent, abrupt changes of rules Lack of transparency Views toward IP Efavirenz CL Generic market highly concentrated Top four players: 80% Domestic players dominate Fierce competition Need local manufacturing to be viable

24 MARKETS FOR API: Brazil

MARKETS FOR API: Brazil

Pros Most of API is imported Low import taxes Dose companies becoming more quality minded Regulatory environment becoming tougher Dose exports into neighboring countries Opportunities in High-quality hormones Controlled substances

Cons Currently most API imports from India and China Still heavy focus on cost rather than quality Strong Euro

25 R&D AND MANUFACTURING BASE: Brazil

R&D AND MANUFACTURING BASE: Brazil

Big Pharma Manufacturing base: Novartis, Roche, GSK, Janssen, Eli Lilly, Abbott Ongoing clinical trials: BMS, Pfizer, Roche Generics Sandoz: upgrading its manufacturing plant in Sao Paulo Apotex: looking to sell the plant in Sao Paulo API Manufacturers Italfarmaco ACS Dobfar DSM

26 R&D AND MANUFACTURING BASE: Brazil

R&D AND MANUFACTURING BASE: Brazil

Pros Biotech legislation Biodiversity and phytotherapeutics Platform for exporting into rest of Latin America Large treatment-na?ve population Seasonal diseases 6-months out-of-synch with North America/Europe

Cons Historically not strong in R&D Frequent, abrupt changes of rules Slow administrative processes Weak local API industry Language barrier

27 MARKETS FOR DOSE: Japan

MARKETS FOR DOSE: Japan

Big Pharma Abbott, AstraZeneca, Boehringer Ingelheim, others Generics Mylan: Merck Kgaa Sandoz: Hexal Hospira: agreement with Taiyo Teva: aggressive plans for 2008

28 MARKETS FOR DOES: Japan

MARKETS FOR DOES: Japan

Pros World’s second largest pharma market Ageing population All manufacturing can be done outside Japan Government aims to increase the market share of generics Incentives New Rx form Increasing use of OTC drugs

Cons Slow approval process Price cuts/reduced reimbursement Slow overall growth of market Low image of generics Generics must provide every dosage/formulation Requirement for a nationwide distribution network Difficult for foreign companies to do it alone Underdeveloped framework for patent challenges

29 MARKETS FOR API: Japan ~2000 JDMFs filed since Feb 2005

MARKETS FOR API: Japan ~2000 JDMFs filed since Feb 2005

EU/US based companies with most JDMFs Sanofi-Aventis Cambrex Schering-Plough Novartis DSM Pfizer BASF Merck & Co Erregierre FIS

Products with most Euro/US JDMFs Heparin Mesalamine Terbinafine Omeprazole Itraconazole

Source: Newport Horizon

30 MARKETS FOR API: Japan

MARKETS FOR API: Japan

Pros Most dose companies do not make their own API Introduction of JDMFs New DMF and accreditation system discouraging certain players from less regulated markets Harmonization of rules CTD can be used as the basis for a DMF

Cons Different standards Relatively small volumes JDMF system still new Reliance on agents and well-established relationships Language barrier Many Japanese generics buying from India, China, South Korea Competition from Japanese fine chemical companies

31 MAIN OPPORTUNITIES FOR REGULATED MARKET PLAYERS

MAIN OPPORTUNITIES FOR REGULATED MARKET PLAYERS

?

?

Pharma: Dose

Generics: Dose

API Sales

R&D

Manufacturing

India

China

Russia

Brazil

Japan

32 THANK YOU

THANK YOU

Kate Kuhrt Director, Generics and API Intelligence Thomson Reuters 215 Commercial Street Portland, Maine 04101 USA + 1 (207) 871-9700 x26 kate.kuhrt@thomsonreuters.com

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