SUPERGENERICS BIOSIMILARS Biosimilars (Continued) TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS,

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THE STUDY... 1 SCOPE OF REPORT... 2 MARKET ANALYSES AND FORECASTS... 2 METHODOLOGY... 2 INTENDED AUDIENCE... 3 INFORMATION SOURCES... 3 ANALYST CREDENTIALS... 3 RELATED REPORTS... 3 BCC ONLINE SERVICES... 4 DISCLAIMER... 4 CHAPTER TWO: SUMMARY... 5 SUMMARY... 5 MARKET SIZE AND EVOLUTION... 6 SUMMARY TABLE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 7 SUMMARY FIGURE MAJOR GENERICS MARKETS, THROUGH 2016 ($ BILLIONS)... 7 CHAPTER THREE: OVERVIEW... 8 OVERVIEW... 8 OVERVIEW (CONTINUED)... 9 TABLE 1 GLOBAL PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS) RECENT HISTORY OF THE GENERICS SECTOR ROCHE-BOLAR Roche-Bolar (Continued) GENERICS LOBBY ICH CHAPTER FOUR: THE NEW GENERICS ERA THE PATENT CLIFF TABLE 2 FIRST PATENT EXPIRIES, TYPES OF GENERICS SIMPLE GENERICS Factors Influencing the Success or Failure of Generics Adequate Market Size Patent-Expired Therapies Older Products Still Used Long-Term Use Straightforward Production Technology Drugs Used in Primary Care... 20

2 SUPERGENERICS BIOSIMILARS Biosimilars (Continued) TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS, Special Challenges Special Challenges (Continued) The Biosimilar Market Some Biosimilar Developments and Introductions EPO G-CSF Interferons HGH Monoclonal Antibodies Monoclonal (Continued) MAJOR GENERIC ISSUES REGULATORY ENVIRONMENT U.S TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS U.S. (Continued) European Union EU Marketing Authorization Systems The Centralized Procedure Decentralized and Mutual Recognition Procedures Mutual-Recognition Procedure Types of Applications Applications Under Article 10 (Generic Products) Japan Approval (Shonin) of Pharmaceuticals REGULATION OF BIOSIMILARS EU Provisions Evolving Situation in the U.S Hatch-Waxman and Bolar Defensive Strategies by Big Pharma AUTHORIZED GENERICS User Fees A Mood Swing Toward Generics The Situation in Europe PATENTS AND IP SUPPLEMENTARY PROTECTION CERTIFICATES Supplementary Protection Certificates (Continued)... 47

3 CHAPTER FIVE: THE GLOBAL PHARMACEUTICAL AND GENERICS MARKET GLOBAL GENERICS MARKET MAIN NATIONAL GENERICS MARKETS TABLE 5 WORLD PHARMA AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS) TABLE 6 CURRENT AND FORECAST NATIONAL GENERICS MARKETS, THROUGH 2016 ($ BILLIONS) MARKET OPPORTUNITIES BY PRODUCT CLASS LEADING GENERIC MOLECULES TABLE 7 WIDELY PRESCRIBED GENERIC MOLECULES IN THE U.S. AND EUROPE TABLE 7 (CONTINUED) Anti-infectives Anti-infectives (Continued) TABLE 8 LEADING ANTI-INFECTIVE PRODUCTS SALES ESTIMATES WITH YEAR OF PATENT EXPIRY, 2010 ($ BILLIONS) CNS Therapies TABLE 9 CNS MARKET BY MAJOR INDICATIONS, 2010 ($ BILLIONS) FIGURE 1 CNS MARKET SHARES BY MAJOR INDICATIONS, 2010 (%) Antidepressants Antipsychotics TABLE 10 LEADING CNS PRODUCT SALES ESTIMATES, 2010 ($ BILLIONS) Anxiolytics Sleep Disorders Epilepsy Parkinson s Disease Migraine Cardiovascular Products TABLE 11 LEADING CARDIOVASCULAR PRODUCT SALES, 2009 ($ BILLIONS) Anti-arthritis Products Steroids NSAIDs COX- II Inhibitors DMARDs TABLE 12 LEADING ANTI-ARTHRITIS PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS) Respiratory Products Asthma COPD... 66

4 Allergic Rhinitis Allergic (Continued) TABLE 13 LEADING RESPIRATORY PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS) Drugs Used to Treat Asthma and COPD Bronchodilators Inhaled Bronchodilators Anticholinergics Oral Bronchodilators Leukotriene Antagonists Steroids FIGURE 2 USAGE OF MAIN PRODUCT CATEGORIES BASED REVENUES (%) FIGURE 2 (CONTINUED) Anticancer Products Cytotoxic Drugs Hormonal Therapy Biologic Response Modifiers Antiangiogenesis Drugs Monoclonal Antibodies TABLE 14 LEADING ANTICANCER PRODUCT SALES ESTIMATES, 2009 ($ BILLIONS) Monoclonal Antibodies (Continued) CHAPTER SIX: THE AMERICAN MARKET THE U.S. MARKET VITAL STATISTICS HEALTH AND HEALTHCARE Health and Healthcare (Continued) THE U.S. PHARMACEUTICAL MARKET THE GENERICS MARKET: SIZE AND GROWTH Biosimilars Generic Prices Carve-Outs Generics Industry FIGURE 3 U.S. PHARMACEUTICAL MARKET SHARES BASED ON DOLLAR SALES AND PERCENTAGE SHARE OF PRESCRIPTIONS BY TYPE, 2010 (%) FIGURE 3 (CONTINUED) The Future TABLE 15 U.S. PHARMACEUTICAL AND GENERICS MARKETS, THROUGH 2016 ($ BILLIONS) CANADA VITAL STATISTICS HEALTH AND HEALTHCARE... 85

5 THE PHARMACEUTICAL MARKET GENERICS Generic Prices Future Market Growth How Generics are Supplied TABLE 16 GENERICS MARKET IN CANADA, THROUGH 2016 ($ BILLIONS) LATIN AMERICA BRAZIL Vital Statistics Health and Healthcare Pharmaceutical Market Generics Market M&A Activity Background Background (Continued) PróGenéricos TABLE 17 PHARMACEUTICAL AND GENERICS MARKET IN BRAZIL, THROUGH 2016 ($ BILLIONS) MEXICO Vital Statistics Health and Healthcare Pharmaceutical Market Market Resistors Generic Sector Generic Industry Regulatory Issues AMEGI Forecasts TABLE 18 PHARMACEUTICAL AND GENERICS MARKET IN MEXICO, THROUGH 2016 ($ BILLIONS) CHAPTER SEVEN: THE EUROPEAN MARKET TABLE 19 PHARMACEUTICAL PRICES IN EUROPE AND U.S., ($) FRANCE VITAL STATISTICS HEALTH AND HEALTHCARE Healthcare Provision FIGURE 4 TOTAL EXPENDITURES ON HEALTH IN MAJOR EUROPEAN MARKETS AND THE U.S. AS A PERCENTAGE OF GDP, 2007 (%) PHARMACEUTICAL MARKET GENERIC SECTOR

6 TABLE 20 PHARMACEUTICAL AND GENERICS MARKET IN FRANCE, THROUGH 2016 ($ BILLIONS) GERMANY VITAL STATISTICS HEALTH AND HEALTHCARE Provision of Healthcare PHARMACEUTICAL MARKET Price Controls GENERICS SECTOR TABLE 21 PHARMACEUTICAL AND GENERICS MARKET IN GERMANY, THROUGH 2016 ($ BILLIONS) ITALY VITAL STATISTICS HEALTH AND HEALTHCARE Healthcare System PHARMACEUTICAL MARKET Implications for Research TABLE 22 SELECTED PRIORITY AREAS IN ITALY S NATIONAL HEALTH PLAN GENERICS SECTOR Generics Sector (Continued) TABLE 23 PHARMACEUTICAL AND GENERICS MARKET IN ITALY, THROUGH 2016 ($ BILLIONS) SPAIN VITAL STATISTICS HEALTH AND HEALTHCARE Healthcare Provision Pharmaceutical Services PHARMACEUTICAL MARKET GENERICS SECTOR Generics Industry TABLE 24 LEADING GENERICS COMPANIES IN SPAIN, 2010 ($ MILLIONS) TABLE 25 PHARMACEUTICAL AND GENERICS MARKET IN SPAIN, THROUGH 2016 ($ BILLIONS) UNITED KINGDOM VITAL STATISTICS HEALTH AND HEALTHCARE Healthcare Provision Private Sector Involvement Pharmaceuticals THE PHARMACEUTICAL MARKET GENERICS SECTOR

7 TABLE 26 PHARMACEUTICAL AND GENERICS MARKET IN THE UNITED KINGDOM, THROUGH 2016 ($ BILLIONS) RUSSIA VITAL STATISTICS HEALTH AND HEALTHCARE Healthcare Delivery PHARMACEUTICAL MARKET Pharma GENERICS SECTOR TABLE 27 PHARMACEUTICAL AND GENERICS MARKET IN RUSSIA, THROUGH 2016 ($ BILLIONS) CHAPTER EIGHT: THE ASIAN REGION JAPAN VITAL STATISTICS HEALTH AND HEALTHCARE PHARMACEUTICAL MARKET TABLE 28 TOP 5 JAPANESE PHARMA COMPANIES, 2008 (%) GENERICS SECTOR Foreign Presence Market Resistance Generics Industry TABLE 29 JAPANESE PHARMACEUTICAL AND GENERICS MARKET, ($ BILLIONS) INDIA VITAL STATISTICS HEALTH AND HEALTHCARE Growing Affluence Changing Medical Needs Regulatory Changes PHARMACEUTICAL MARKET Demographic Factors Pharma Industry Patent Reform GENERICS INDUSTRY TABLE 30 LEADING PHARMA COMPANIES IN INDIA, 2010 ($ MILLIONS) TABLE 31 PHARMACEUTICAL AND GENERICS MARKET IN INDIA, THROUGH 2016 ($ BILLIONS) CHINA VITAL STATISTICS HEALTH AND HEALTHCARE Health and Healthcare (Continued) PHARMACEUTICAL MARKET Domestic Industry Foreign Company Involvement

8 Importance of R&D Challenges Market Trends Regulatory Changes Generic Exports Domestic Generics Market Local Dominance FIGURE 5 GENERICS MARKET THERAPEUTIC CATEGORIES 2008 (%) TABLE 32 PHARMACEUTICAL AND GENERICS MARKET, CHINA, THROUGH 2016 ($ BILLIONS) CHAPTER NINE: PROFILES OF THE TOP TEN GENERICS COMPANIES TABLE 33 LEADING GENERICS MANUFACTURERS, 2010 ($ BILLIONS/%) TRENDS STRUCTURE OF THE GENERICS INDUSTRY PROFILES OF TOP 10 GENERICS COMPANIES ACTAVIS Actavis (Continued) APOTEX INC DR. REDDY S LABORATORIES, LTD Acquisitions Financials HOSPIRA, INC Biogenerics Financials MYLAN INC Mylan Inc. (Continued) Financials Looking Ahead PAR PHARMACEUTICAL, INC Generics Financials RANBAXY LABORATORIES, LTD History Acquisition by Daiichi Sankyo Financials Looking Ahead SANDOZ INTERNATIONAL GMBH Products TEVA PHARMACEUTICAL INDUSTRIES, LTD Teva Pharmaceutical Industries, Ltd. (Continued) Financials WATSON PHARMACEUTICALS, INC

9 Products Financials Looking Ahead CHAPTER TEN: PROFILES OF OTHER INTERNATIONAL GENERICS COMPANIES PROFILES ALAPIS GROUP AMNEAL PHARMACEUTICALS, LLC Amneal Pharmaceuticals Co. India Pvt., Ltd ASPEN PHARMACARE HOLDINGS, LTD Financial Results AUROBINDO PHARMA, LTD Products Financials Looking Ahead BERLIN-CHEMIE AG BIOCON Biocon U.S Biocon U.S. (Continued) Biocon U.S. (Continued) BIOGARAN FRANCE CIPLA, LTD COBALT EGIS PHARMACEUTICALS, PLC APIs Pharmaceutical R&D GEDEON RICHTER, PLC GENEPHARM GROUP KRKA, D.D., NOVO MESTO Products Financials Looking Ahead KV PHARMACEUTICAL CO LUPIN, LTD Lupin, Ltd. (Continued) MITSUBISHI TANABE PHARMA CORP Tanabe Seiyaku Hanbai Co., Ltd NICHI-IKO PHARMACEUTICAL CO., LTD Products Financials Looking Ahead NIPPON CHEMIPHAR CO., LTD Financials Looking Ahead

10 NOVARTIS INTERNATIONAL AG Looking Ahead ORION CORP Products Generics Financials Looking Ahead PFIZER INC U.S. Basic Patent Expiry TABLE 34 PFIZER S U.S. PATENT EXPIRIES, THROUGH Financials PLIVA D.D ROXANE LABORATORIES, INC SANOFI-AVENTIS Looking Ahead SAWAI PHARMACEUTICAL Products Financials Looking Ahead STADA ARZNEIMITTEL Generics Biosimilars Financials Looking Ahead STRIDES ARCOLAB, LTD Product Range Looking Ahead WOCKHARDT, LTD Financials Looking Ahead ZYDUS CADILA Zydus U.S. Corporate Office Zydus U.S. (Continued)