Global Biopharmaceuticals Industry

Nov 26, 2015, 17:19 ET from ReportBuyer

LONDON, Nov. 26, 2015 /PRNewswire/ -- This report analyzes the worldwide markets for Biopharmaceuticals in US$ Million by the following Segments: Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2014 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 514 companies including many key and niche players such as -

AbbVie, Inc.
Anavex Life Sciences Corp.
Baxter International, Inc.
Bayer HealthCare Pharmaceuticals, Inc.
Biocon

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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1 Disclaimers.............. I-2 Data Interpretation & Reporting Level I-2 Quantitative Techniques & Analytics I-3 Product Definitions and Scope of Study I-3 A. Recombinant Protein..............I-3 B. Monoclonal Antibodies (mAbs) I-3 C. Insulin.............. I-4 D. Vaccines.............. I-4

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW.............. II-1 Biologics: Taking over the Conventional Drugs Market II-1 Table 1: Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart).............. II-1

Table 2: Percentage Share of Pipeline Drugs for Biologics vs. Small Molecules (2014) (includes corresponding Graph/Chart) II-2 Current and Future Analysis..............II-2 Competition.............. II-2 Table 3: Leading Players in the Global Biopharmaceuticals Market (2014E): Percentage Market Share Breakdown of Value Sales for AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Roche, Sanofi, and Others (includes corresponding Graph/Chart) II-3

Table 4: Leading Brands in the Global Biopharmaceuticals Market (2014E): Percentage Market Share Breakdown of Revenues for Avastin, Enbrel, Herceptin, Humira, Lantus, Lucentis, Neulasta, Novolog/NovoRapid, Remicade, Rituxan, and Others (includes corresponding Graph/Chart) II-4 Intensifying Consolidation Activity II-4 Recent M&A Activity in the Biologics Industry: 2014 & 2015 II-5 2015: A year of Patent Expiries for Biologics II-5 Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe.............. II-5 Market Drivers.............. II-6 Growing Aging Population..............II-7 Table 5: Global Population Statistics for the 65+ Age Group: 2013 (includes corresponding Graph/Chart) II-8

Table 6: Life Expectancy by Select Countries: 2013 (includes corresponding Graph/Chart)..............II-9 Market Restraints.............. II-9 Affordability.............. II-10 Complex Supply Chain..............II-10 Quality and Regulatory Issues II-10 2014-15: A Launch-Driven Period for Biopharmaceuticals II-10 Recently Approved Biopharmaceuticals: 2013, 2014 & 2015 II-11 R&D Funding Crucial.............. II-13 Table 7: Global Biopharmaceutical R&D Expenditure: 2010- 2015E (includes corresponding Graph/Chart) II-13

2. SEGMENT ANALYSIS.............. II-14 Monoclonal Antibodies - The Most Viable Biopharmaceutical Segment II-14 Table 8: Global Monoclonal Antibody Market by Leading Player (2014E) - Percentage Share of Value Sales for AbbVie, Amgen, Johnson & Johnson, Novartis, Pfizer, Roche, and Others (includes corresponding Graph/Chart) II-15

Table 9: Global Monoclonal Antibody Market by Leading Brand (2014E) - Percentage Share of Value Sales for Avastin, Enbrel, Herceptin, Humira, Remicade, Rituxan, and Others (includes corresponding Graph/Chart) II-15 Approved Monoclonal Antibodies for Therapeutic Use: 1986-2014 II-16 Opportunity Indicators..............II-17 Cancer Incidence..............II-17 Table 10: World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported in Thousands for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart).............. II-17

Table 11: World Cancer Mortality by Geographic Region and Gender (2012): Number of Cancer-Related Deaths in Thousands for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart).............. II-18 Rheumatoid Arthritis Prevalence II-18 Table 12: Projections of Rheumatoid Arthritis Prevalence in the US in Millions (2010-2030) (includes corresponding Graph/Chart).............. II-19

Table 13: Prevalence of Treated Rheumatoid Arthritis in South Africa (Rate per 1000 Beneficiaries): 2008-2013 (includes corresponding Graph/Chart) II-19 Insulin - Segment with High Potential II-19 Competitive Landscape..............II-20 List of Different Insulin Brands of the Three Major Players by Type.............. II-20 Table 14: Global Insulin Market by Brand (2014E): Percentage Share of Value sales for Apidra, Humalog, Humulin, Insuman, Lantus, Levimir, NovoMix, NovoRapid, and Others (includes corresponding Graph/Chart)..............II-20 Comparative Analysis of New Insulin Basal Analogs II-21 Table 15: Global Basal Insulin Market by Brand (2016-2020E): Percentage Market Share Breakdown of Revenues for Basalgar, Lantus, Levemir, Peg Lispro, Toujeo, and Tresiba (includes corresponding Graph/Chart)..............II-22 Opportunity Indicator..............II-23 Diabetes Prevalence & Incidence II-23 Table 16: Global Diabetes Mellitus Prevalence by Geographic Region (2014E & 2035P): Prevalence (in Millions) and Percentage Share (includes corresponding Graph/Chart) II-23

Table 17: Percentage Increase in DM Incidence among Ages 20-79 Worldwide by Geographic Region: 2013-2035 (includes corresponding Graph/Chart)..............II-24

Table 18: Top Ten Countries Worldwide with the Highest Number of People (in the Age Group 20-79 Years) with DM (in Millions): 2014E & 2035P (includes corresponding Graph/Chart).............. II-25 Recombinant Therapeutic Proteins II-25 Anemia in CKD and Cancer Patients: Opportunity for EPO Therapy II-27 Blood Growth Factors: Improving Circulation & Mobility in Peripheral Artery Disease Patients II-27 Wound Management Market and Cellular Growth Factors II-27 Multiple Sclerosis Drugs Market: Competition Set to Intensify II-28 Interferon-based Drugs for HCV Treatment: An Insight II-29 Vaccine Market Dynamics..............II-30 Table 19: Global Vaccines Market by Leading Player (2014) - Percentage Share of Value Sales for GSK, Merck, Novartis Flu Vaccines, Pfizer, Sanofi, SP-MSD & Others (includes corresponding Graph/Chart)..............II-31 Growth Drivers in a Capsule..............II-31 Pediatric Vaccines: A Lucrative Segment II-31 Table 20: Number of Reported Cases for Vaccine-Preventable Diseases Globally: 2009-2013 (includes corresponding Graph/Chart).............. II-32

Table 21: Global Pediatric Vaccines Market by Leading Players (2013): Percentage Market Share Breakdown of Dollar Sales for GlaxoSmithKline, Novartis, Sanofi-Pasteur, Merck, and Others (includes corresponding Graph/Chart) II-33 Hepatitis B Combination Vaccines to Propel Market Growth II-33 Conjugated and Protein-based Vaccines to Take over Polysaccharide Vaccines for Infectious Diseases II-33 DNA Vaccines: Engineering Growth II-34

3. BIOPHARMACEUTICALS IN THE PIPELINE II-36 Table 22: Biopharmaceutical Products' Pipeline by Therapeutic Category (2015) (includes corresponding Graph/Chart) II-36 Table 23: No. of Pipeline Biopharmaceuticals for Cancer by Site (2015) (includes corresponding Graph/Chart) II-37

Table 24: No. of Pipeline Biopharmaceuticals for HIV/AIDS Treatment by Type of Therapy (2015) (includes corresponding Graph/Chart).............. II-37 Insulin Products in Development..............II-37 List of Newly Approved and Pipeline Insulin Products: 2015 II-38

4. MARKET TRENDS.............. II-39 Disposable Systems Favored for Manufacturing II-39 Innovations in Single-use Systems II-39 Increasing Appeal of Biosimilars II-40 Table 25: Global Biosimilars Market Size Estimates and Forecasts: 2012-2018F (includes corresponding Graph/Chart) II-40 Supply Chain Management Crucial for Clinical Trials II-41 Plant-based Production Scores over Mammalian Cell Culture Systems II-41 Safety & Efficacy Issues Concerning Erythropoietin Stimulating Agents (ESAs).............. II-41 hMSC-based Therapies to Drive Need for Growth Factors II-41 Stem Cell Therapies Gain Popularity II-42 Development of Cost Effective Methods - Need of the Hour II-42 M&A Activity to Maintain Momentum II-43 Key Factors Determining Long-Term Success II-43 Innovations.............. II-44 Peptide against Skin Cancer..............II-44 Monoclonal Antibodies to Treat Ebola II-45

5. BIOPHARMACEUTICALS - AN OVERVIEW..............II-46 Regulatory Environment for Biopharmaceuticals' Manufacture & Storage.............. II-46 Glossary of Terms.............. II-46 Evolution of Biopharmaceuticals..............II-47 Biopharmaceutical Manufacturing..............II-47 Bioprocess Membrane Technology..............II-48 Disposable Manufacturing with Single-Use Systems II-48 Major Concerns Related to the Production of Biopharmaceuticals II-48 Future of Biopharmaceutical Manufacturing II-49 Marketing Approval for Biopharmaceuticals II-49 Techniques to Characterize Biopharmaceuticals II-49 Biopharmaceuticals - Types and Therapeutic Applications II-50 Insulin.............. II-50 Monoclonal Antibodies..............II-50 Recombinant Proteins..............II-51 Cytokines.............. II-51 Interferon.............. II-52 Colony Stimulating Factors (CSF) II-52 Erythropoietin (EPO)..............II-52 Clotting Factors..............II-52 Vaccines.............. II-53 Types of Vaccines.............. II-53 Live, Attenuated Vaccines..............II-53 Combination Vaccines..............II-54 Killed or Inactivated Vaccines II-54 DNA & Recombinant DNA Vaccines II-55 Toxoids.............. II-56 Subunit Vaccines.............. II-56

6. PRODUCT LAUNCHES/APPROVALS..............II-57 Mexican Health Authority, COFEPRIS, Approves Biocon's Insulin Glargine.............. II-57 Shantha Biotechnics Delivers 400,000 doses of Shan5 Vaccine II-57 Amyris to Launch µPharm platform for Biotherapeutics Production II-57 FDA Approves IMBRUVICA for New Indication II-57 FDA Approves Cosentyx™ by Novartis II-57 Hospira Submits BLA for the Biosimilar Retacrit II-57 Celestial Biolabs to Launch Antibiotic for Diabetes II-57 MHRA Validates RedHill Biopharma's Bekinda MAA II-58 Zydus Cadila Launches Adalimumab Biosimilar II-58 EPIRUS Launches Infimab..............II-58 KYTHERA Biopharmaceuticals Submits NDS for ATX-101 II-58 FDA Accepts New Drug Application of KYTHERA's ATX-101 II-58 FDA Approves sNDA for Lymphoseek by Navidea II-58 Hospira's Biosimilar Inflectra Launched in Central and Eastern Europe.............. II-58

7. RECENT INDUSTRY ACTIVITY..............II-59 Sun Pharmaceuticals Integrates Ranbaxy II-59 Baxter Acquires SuppreMol GmbH II-59 Baxalta to Separate from Baxter and Change Headquarters II-59 Matinas BioPharma Holdings Acquires Aquarius BioTechnologies II-59 3SBio Acquires Sirton Pharmaceuticals SpA II-59 Pfizer to Acquire Hospira..............II-59 Roche to Acquire Trophos..............II-60 Novartis Completes Transaction with GSK II-60 Johnson & Johnson Forms Ebola Vaccine Development Consortia II-60 Boehringer Ingelheim and Sanofi Enter Strategic Manufacturing Agreement.............. II-60 OnCore Biopharma and Tekmira Enter Merger Agreement II-60 Regado Biosciences and Tobira Enter Merger Agreement II-60 WuXi PharmaTech Acquires NextCODE Health II-61 Adaptive Biotechnologies to Acquire Sequenta II-61 Cardio3 BioSciences Acquires OnCyte II-61 FUJIFILM Diosynth Biotechnologies Acquires Kalon Biotherapeutics II-61 Prima BioMed Completes Acquisition of Immutep II-61 BioMarin Pharmaceutical Acquires ProSensa Holding II-61 Ricerca Biosciences Acquired by Investment Group Main Market Partners.............. II-61 GE Healthcare Life Sciences to Open Biopharmaceutical Laboratory in Turkey..............II-62 Johnson & Johnson Acquires Alios BioPharma II-62 PDL Biopharma Acquires Part of Cerdelga Royalties II-62 DPx Holdings B.V. Acquires Gallus BioPharmaceuticals II-62 Sunshine Biopharma Forms Canadian Subsidiary II-62 Albany Molecular Research Inc. (AMRI) Acquires OSO Biopharmaceuticals.............. II-62 Pall Corporation Acquires New Biopharmaceutical Production Technologies.............. II-62 Actavis Plc. Acquires Forest Laboratories II-63 Roche to Acquire InterMune..............II-63 CSL Acquires Influenza Vaccines Business of Novartis II-63

8. FOCUS ON SELECT GLOBAL PLAYERS..............II-64 AbbVie, Inc. (US).............. II-64 Anavex Life Sciences Corp. (US)..............II-64 Baxter International, Inc. (US)..............II-64 Bayer HealthCare Pharmaceuticals, Inc. (US) II-65 Biocon (India).............. II-65 Eli Lilly (US).............. II-65 F. Hoffmann-La Roche Ltd. (Switzerland) II-66 Genentech (US).............. II-66 GlaxoSmithKline (UK)..............II-66 Janssen Biotech, Inc. (US)..............II-67 Kemwell Biopharma (India)..............II-67 Novartis (Switzerland)..............II-67 Sandoz.............. II-68 Pfizer, Inc. (US).............. II-68 Sun Pharmaceutical Industries Ltd. (India) II-69 Sanofi S.A. (France)..............II-69

9. GLOBAL MARKET PERSPECTIVE..............II-71 Table 26: World Recent Past, Current & Future Analysis for Biopharmaceuticals by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) II-71

Table 27: World Historic Review for Biopharmaceuticals by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) II-72

Table 28: World 14-Year Perspective for Biopharmaceuticals by Geographic Region - Percentage Breakdown of Value Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart).............. II-73 Biopharmaceuticals Market by Product Segment II-74 Table 29: World Recent Past, Current & Future Analysis for Recombinant Protein by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) II-74

Table 30: World Historic Review for Recombinant Protein by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) II-75

Table 31: World 14-Year Perspective for Recombinant Protein by Geographic Region - Percentage Breakdown of Value Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart).............. II-76

Table 32: World Recent Past, Current & Future Analysis for Monoclonal Antibodies (mAbs) by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. II-77

Table 33: World Historic Review for Monoclonal Antibodies (mAbs) by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) II-78

Table 34: World 14-Year Perspective for Monoclonal Antibodies (mAbs) by Geographic Region - Percentage Breakdown of Value Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............II-79

Table 35: World Recent Past, Current & Future Analysis for Insulin by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) II-80

Table 36: World Historic Review for Insulin by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)..............II-81

Table 37: World 14-Year Perspective for Insulin by Geographic Region - Percentage Breakdown of Value Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) II-82

Table 38: World Recent Past, Current & Future Analysis for Vaccines by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart) II-83

Table 39: World Historic Review for Vaccines by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)..............II-84

Table 40: World 14-Year Perspective for Vaccines by Geographic Region - Percentage Breakdown of Value Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) II-85

III. MARKET

1. THE UNITED STATES.............. III-1 A.Market Analysis.............. III-1 United States: The Largest Biopharmaceutical Market Globally III-1 Table 41: No. of Biologics Approved by the Center for Biologics Evaluation and Research (CBER): 2003-2013 (includes corresponding Graph/Chart) III-1 A R&D Driven Industry..............III-2 Impending Patent Expiries..............III-2 Table 42: Leading US Biopharmaceuticals by Revenue (in US$ Billion) and Year of Patent Expiry (includes corresponding Graph/Chart).............. III-3 Biosimilars and the Implications of the BPCI Act III-3 Segment Analysis..............III-4 Monoclonal Antibodies..............III-4 Opportunity Indicators..............III-4 Rheumatoid Arthritis Incidence III-4 Table 43: Rheumatoid Arthritis Prevalence in the US in Millions (2010-2030) (includes corresponding Graph/Chart) III-4

Table 44: The US Cancer Incidence by Gender (2014): No. of Reported New Cases for Men and Women (includes corresponding Graph/Chart)..............III-5

Table 45: The US Cancer Incidence by Affected Site (2014): Number of New Cancer Cases (includes corresponding Graph/Chart)..............III-5 Recombinant Proteins..............III-5 Erythropoietin (EPO) Market: Amgen Continues to Dominate III-6 Interferon Market: An Insight III-6 Colony Stimulating Factors (CSF) Market: An Overview III-7 Table 46: The US Short Acting Granulocyte Colony Stimulating Factors (G-CSFs) Market (2014 & 2020): Percentage Share Breakdown of Volume Sales for HSP Nivestim, Neupogen, Sandoz EP2006, and TEVA Granix (includes corresponding Graph/Chart) III-7

Table 47: The US Long Acting Granulocyte Colony Stimulating Factors (G-CSFs) Market (2014 & 2020): Percentage Share Breakdown of Volume Sales for HSP peg-Filgrastim, Neulasta, Sandoz LA-EP2006, and TEVA Balugrastim (includes corresponding Graph/Chart) III-8 Vaccines Industry in the US III-8 Federal Research & Grants..............III-9 National Cancer Institute..............III-9 National Institutes of Health (NIH) III-9 Pediatric Vaccines Market Witnesses Rapid Growth III-9 Opportunity Indicator..............III-10 Table 48: Number of Reported Cases for Vaccine-Preventable Diseases in American Regions (includes corresponding Graph/Chart).............. III-10

Table 49: Routine Immunization Coverage in the US (2011-2013): Percentage of Live Births/New Borns/Infants/Children Vaccinated (includes corresponding Graph/Chart).............. III-11 Select Market Trends..............III-11 Manufacturers Shift Focus to Small Bioreactors III-11 Biosimilar Developers Face Higher Litigation Risks III-12 Varying Biosimilar Prescription Rules across the Country III-12 Regulatory Scenario..............III-13 Combination Products Pose Challenges to Manufacturers III-13 FDA Efforts to Mitigate Concerns III-13 FDA Announces New Labeling Guidelines for Biologics and Prescription Drugs..............III-13 Product Launches..............III-14 Strategic Corporate Developments III-15 Select Key Players..............III-17 B.Market Analytics..............III-20 Table 50: The US Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-20

Table 51: The US Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-21

Table 52: The US 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-22

2. CANADA.............. III-23 A.Market Analysis.............. III-23 Lucrative Partnership Opportunities for Global Players III-23 Mabs Lead, Insulin Exhibits Faster Growth III-23 Table 53: Prevalence of Diabetes Mellitus in Canada (2013 & 2035): Number of People with DM (in Thousands) in the 20-79 Age Group (includes corresponding Graph/Chart) III-24 Strategic Corporate Developments III-24 B.Market Analytics..............III-25 Table 54: Canadian Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-25

Table 55: Canadian Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-26

Table 56: Canadian 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-27

3. JAPAN.............. III-28 A.Market Analysis.............. III-28 Erythropoietin Market..............III-28 Leading EPO Drugs in Japan..............III-28 HCV Infection: Combination Therapy Dominates III-28 Diabetes Prevalence: Opportunity Indicator for the Insulin Market.............. III-29 Table 57: Prevalence of Diabetes Mellitus in Japan (2013): Number of People with DM (in thousands) by Age Group (includes corresponding Graph/Chart) III-29 B.Market Analytics..............III-30 Table 58: Japanese Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-30

Table 59: Japanese Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-31

Table 60: Japanese 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-32

4. EUROPE.............. III-33 A.Market Analysis.............. III-33 Funding Challenges Faced by Biopharmaceutical Startups III-33 Healthcare Agencies Looking to Embrace Biosimilars to Cut Healthcare Costs..............III-33 Table 61: European Biosimilar Market by Leading Player (2014): Percentage Market Share of Value Sales for Hospira, Sandoz, Teva, and Others (includes corresponding Graph/Chart).............. III-34

Table 62: Biosimilar Penetration in Select EU Countries (2013).............. III-34 Biosimilars Currently Licensed in Europe III-35 Regulatory Scenario..............III-35 Erythropoietin Market..............III-35 Leading EPO Drugs in Europe III-35 B.Market Analytics..............III-36 Table 63: European Recent Past, Current & Future Analysis for Biopharmaceuticals by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-36

Table 64: European Historic Review for Biopharmaceuticals by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-37

Table 65: European 14-Year Perspective for Biopharmaceuticals by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-38

Table 66: European Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-39

Table 67: European Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-40

Table 68: European 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-41

4a. FRANCE.............. III-42 A.Market Analysis.............. III-42 Sanofi S.A. - A Key Player..............III-42 B.Market Analytics..............III-43 Table 69: French Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-43

Table 70: French Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-44

Table 71: French 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-45

4b. GERMANY.............. III-46 A.Market Analysis.............. III-46 Strategic Corporate Development III-46 B.Market Analytics..............III-47 Table 72: German Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-47

Table 73: German Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-48

Table 74: German 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-49

4c. ITALY.............. III-50 Market Analysis.............. III-50 Table 75: Italian Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-50

Table 76: Italian Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-51

Table 77: Italian 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-52

4d. THE UNITED KINGDOM..............III-53 A.Market Analysis.............. III-53 Strategic Corporate Development III-53 Glaxosmithkline - A Key Player III-53 B.Market Analytics..............III-54 Table 78: The UK Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-54

Table 79: The UK Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-55

Table 80: The UK 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-56

4e. SPAIN.............. III-57 Market Analysis.............. III-57 Table 81: Spanish Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-57

Table 82: Spanish Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-58

Table 83: Spanish 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-59

4f. RUSSIA.............. III-60 A.Market Analysis.............. III-60 Russia Sets Eyes on Emerging as a Notable Pharmaceutical Market III-60 Encouraging Local Manufacturing III-60 Challenges - Need for Extensive R&D III-61 B.Market Analytics..............III-62 Table 84: Russian Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart).............. III-62

Table 85: Russian Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart) III-63

Table 86: Russian 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)..............III-64

4g. REST OF EUROPE.............. III-65 A.Market Analysis.............. III-65 Product Launches..............III-65 Strategic Corporate Developments III-65 Select Key Players..............III-66 B.Market Analytics..............III-68 Table 87: Rest of European Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-68

Table 88: Rest of European Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-69

Table 89: Rest of European 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-70

5. ASIA-PACIFIC.............. III-71 A.Market Analysis.............. III-71 Regional Biopharma Players Gain Strength by Innovation and Partnerships.............. III-71 Asia Set to Emerge as Preferred Outsourcing Destination for Biopharma Manufacturing..............III-71 Availability of Scientific Talent - Major Advantage for India III-72 Primary Challenges for Asian CMOs III-72 China - An Untapped Market for Antitumor mAbs III-73 List of Anti-Cancer Monoclonal antibodies Approved by China Food & Drug Administration III-73 Table 90: Chinese Biopharmaceuticals Market by Segment (2014): Percentage Share Breakdown of Value Sales for EPO, G-CSF, Insulin, Interferon, Interleukin, mAb, Nerve Growth Factors, and Others (includes corresponding Graph/Chart) III-74 Chinese Erythropoietin Market..............III-74 Table 91: Leading Players in the Chinese EPO Market (2014): Percentage Share Breakdown of Value Sales for 3SBio, Beijing Sihuan, Harbin Pharma, Nanjin Huaxin Pharma, and Others (includes corresponding Graph/Chart) III-75 Injectable Interferons: The Only Treatment for HCV Patients III-75 Table 92: Interferon Market in China (2014): Percentage Share Breakdown of Value Sales by Type of Interferon (includes corresponding Graph/Chart) III-76

Table 93: Leading Players in the Chinese Interferons Market (2014): Percentage Share Breakdown of Value Sales for Hualida Bio, Huaxin Bio, Merck, Roche, Sinovac, Tri-Prime Gene, and Others (includes corresponding Graph/Chart) III-76 Hepatitis B Market: Smaller Role of Interferons III-77 G-CSF Market: Competitive Landscape III-77 Table 94: G-CSF Market in China by Agent (2014): Percentage Share Breakdown of Revenues for Filgrastim, Lenograstim, Molgramostim, Nartograstim, and Others (includes corresponding Graph/Chart)..............III-77

Table 95: Leading Manufacturers in the Chinese G-CSF Market (2014): Percentage Share Breakdown of Revenues for Hangzhou Jiuyuan, Jiangsu Wuzhong Pharma, Qilu Pharma, Roche, Xiamen Amoytop Bio, Xiehe Fajio Qilin, and Others (includes corresponding Graph/Chart)..............III-78 Interleukins Market..............III-78 Table 96: Interleukins Market in China (2014): Percentage Share Breakdown of Value Sales by Type - Interleukin-11 and Interleukin-2 (includes corresponding Graph/Chart) III-78

Table 97: Leading Players in the Chinese Interleukins Market (2014): Percentage Share Breakdown of Value Sales for E China Pharm, Four Rings, QG Pharm, Qilu Pharm, SL Pharm, and Others (includes corresponding Graph/Chart) III-79 Cell Therapies Gaining Ground in Korea III-79 Product Launches..............III-79 Strategic Corporate Developments III-80 Select Key Players..............III-81 B.Market Analytics..............III-82 Table 98: Asia-Pacific Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-82

Table 99: Asia-Pacific Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-83

Table 100: Asia-Pacific 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-84

6. REST OF WORLD.............. III-85 A.Market Analysis.............. III-85 Lack of Access Impedes Market in Developing Economies III-85 Interferons Widely Used in HCV Therapeutics in Brazil III-85 Product Launches..............III-86 B.Market Analytics..............III-87 Table 101: Rest of World Recent Past, Current & Future Analysis for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)..............III-87

Table 102: Rest of World Historic Review for Biopharmaceuticals by Segment - Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart).............. III-88

Table 103: Rest of World 14-Year Perspective for Biopharmaceuticals by Segment - Percentage Breakdown of Value Sales for Recombinant Protein, Monoclonal Antibodies (mAbs), Insulin, and Vaccines Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart) III-89

IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 514 (including Divisions/Subsidiaries - 525)

The United States (300) Canada (14) Japan (5) Europe (137) - France (21) - Germany (21) - The United Kingdom (12) - Italy (5) - Spain (3) - Rest of Europe (75) Asia-Pacific (Excluding Japan) (60) Middle East (9)
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