Biopharmaceuticals: Market Research Report
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
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
A. Recombinant Protein
B. Monoclonal Antibodies (mAbs)
C. Insulin
D. Vaccines
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW
Biologics: Taking over the Conventional Drugs Market
Current and Future Analysis
Competition
Intensifying Consolidation Activity
Recent M&A Activity in the Biologics Industry: 2014 &
2015: A YEAR OF PATENT EXPIRIES FOR BIOLOGICS
Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
Market Drivers
Growing Aging Population
Market Restraints
Affordability
Complex Supply Chain
Quality and Regulatory Issues
2014-15: A LAUNCH-DRIVEN PERIOD FOR BIOPHARMACEUTICALS
Recently Approved Biopharmaceuticals: 2013, 2014 &
R&D Funding Crucial
2. SEGMENT ANALYSIS
Monoclonal Antibodies – The Most Viable Biopharmaceutical Segment
Approved Monoclonal Antibodies for Therapeutic Use: 1986
Opportunity Indicators
Cancer Incidence
Rheumatoid Arthritis Prevalence
Insulin – Segment with High Potential
Competitive Landscape
List of Different Insulin Brands of the Three Major Players by Type
Comparative Analysis of New Insulin Basal Analogs
Opportunity Indicator
Diabetes Prevalence & Incidence
Recombinant Therapeutic Proteins
Anemia in CKD and Cancer Patients: Opportunity for EPO Therapy
Blood Growth Factors: Improving Circulation & Mobility in Peripheral Artery Disease Patients
Wound Management Market and Cellular Growth Factors
Multiple Sclerosis Drugs Market: Competition Set to Intensify
Interferon-based Drugs for HCV Treatment: An Insight
Vaccine Market Dynamics
Growth Drivers in a Capsule
Pediatric Vaccines: A Lucrative Segment
Hepatitis B Combination Vaccines to Propel Market Growth
Conjugated and Protein-based Vaccines to Take over Polysaccharide Vaccines for Infectious Diseases
DNA Vaccines: Engineering Growth
3. BIOPHARMACEUTICALS IN THE PIPELINE
Insulin Products in Development
List of Newly Approved and Pipeline Insulin Products:
4. MARKET TRENDS
Disposable Systems Favored for Manufacturing
Innovations in Single-use Systems
Increasing Appeal of Biosimilars
Supply Chain Management Crucial for Clinical Trials
Plant-based Production Scores over Mammalian Cell Culture Systems
Safety & Efficacy Issues Concerning Erythropoietin Stimulating Agents (ESAs)
hMSC-based Therapies to Drive Need for Growth Factors
Stem Cell Therapies Gain Popularity
Development of Cost Effective Methods – Need of the Hour
M&A Activity to Maintain Momentum
Key Factors Determining Long-Term Success
Innovations
Peptide against Skin Cancer
Monoclonal Antibodies to Treat Ebola
5. BIOPHARMACEUTICALS – AN OVERVIEW
Regulatory Environment for Biopharmaceuticals’ Manufacture & Storage
Glossary of Terms
Evolution of Biopharmaceuticals
Biopharmaceutical Manufacturing
Bioprocess Membrane Technology
Disposable Manufacturing with Single-Use Systems
Major Concerns Related to the Production of Biopharmaceuticals
Future of Biopharmaceutical Manufacturing
Marketing Approval for Biopharmaceuticals
Techniques to Characterize Biopharmaceuticals
Biopharmaceuticals – Types and Therapeutic Applications
Insulin
Monoclonal Antibodies
Recombinant Proteins
Cytokines
Interferon
Colony Stimulating Factors (CSF)
Erythropoietin (EPO)
Clotting Factors
Vaccines
Types of Vaccines
Live, Attenuated Vaccines
Combination Vaccines
Killed or Inactivated Vaccines
DNA & Recombinant DNA Vaccines
Toxoids
Subunit Vaccines
6. PRODUCT LAUNCHES/APPROVALS
Mexican Health Authority, COFEPRIS, Approves Biocon’s Insulin Glargine
Shantha Biotechnics Delivers 400,000 doses of Shan5 Vaccine
Amyris to Launch µPharm platform for Biotherapeutics Production
FDA Approves IMBRUVICA for New Indication
FDA Approves Cosentyx by Novartis
Hospira Submits BLA for the Biosimilar Retacrit
Celestial Biolabs to Launch Antibiotic for Diabetes
MHRA Validates RedHill Biopharma’s Bekinda MAA
Zydus Cadila Launches Adalimumab Biosimilar
EPIRUS Launches Infimab
KYTHERA Biopharmaceuticals Submits NDS for ATX
FDA Accepts New Drug Application of KYTHERA’s ATX
FDA Approves sNDA for Lymphoseek by Navidea
Hospira’s Biosimilar Inflectra Launched in Central and Eastern Europe
7. RECENT INDUSTRY ACTIVITY
Sun Pharmaceuticals Integrates Ranbaxy
Baxter Acquires SuppreMol GmbH
Baxalta to Separate from Baxter and Change Headquarters
Matinas BioPharma Holdings Acquires Aquarius BioTechnologies
3SBIO ACQUIRES SIRTON PHARMACEUTICALS SPA
Pfizer to Acquire Hospira
Roche to Acquire Trophos
Novartis Completes Transaction with GSK
Johnson & Johnson Forms Ebola Vaccine Development Consortia
Boehringer Ingelheim and Sanofi Enter Strategic Manufacturing Agreement
OnCore Biopharma and Tekmira Enter Merger Agreement
Regado Biosciences and Tobira Enter Merger Agreement
WuXi PharmaTech Acquires NextCODE Health
Adaptive Biotechnologies to Acquire Sequenta
Cardio3 BioSciences Acquires OnCyte
FUJIFILM Diosynth Biotechnologies Acquires Kalon Biotherapeutics
Prima BioMed Completes Acquisition of Immutep
BioMarin Pharmaceutical Acquires ProSensa Holding
Ricerca Biosciences Acquired by Investment Group Main Market Partners
GE Healthcare Life Sciences to Open Biopharmaceutical Laboratory in Turkey
Johnson & Johnson Acquires Alios BioPharma
PDL Biopharma Acquires Part of Cerdelga Royalties
DPx Holdings B. V. Acquires Gallus BioPharmaceuticals
Sunshine Biopharma Forms Canadian Subsidiary
Albany Molecular Research Inc. (AMRI) Acquires OSO Biopharmaceuticals
Pall Corporation Acquires New Biopharmaceutical Production Technologies
Actavis Plc. Acquires Forest Laboratories
Roche to Acquire InterMune
CSL Acquires Influenza Vaccines Business of Novartis
8. FOCUS ON SELECT GLOBAL PLAYERS
AbbVie, Inc. (US)
Anavex Life Sciences Corp. (US)
Baxter International, Inc. (US)
Bayer HealthCare Pharmaceuticals, Inc. (US)
Biocon (India)
Eli Lilly (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Genentech (US)
GlaxoSmithKline (UK)
Janssen Biotech, Inc. (US)
Kemwell Biopharma (India)
Novartis (Switzerland)
Sandoz
Pfizer, Inc. (US)
Sun Pharmaceutical Industries Ltd. (India)
Sanofi S. A. (France)
9. GLOBAL MARKET PERSPECTIVE
Biopharmaceuticals Market by Product Segment
III. MARKET
1. THE UNITED STATES
A. Market Analysis
United States: The Largest Biopharmaceutical Market Globally
A R&D Driven Industry
Impending Patent Expiries
Biosimilars and the Implications of the BPCI Act
Segment Analysis
Monoclonal Antibodies
Opportunity Indicators
Rheumatoid Arthritis Incidence
Recombinant Proteins
Erythropoietin (EPO) Market: Amgen Continues to Dominate
Interferon Market: An Insight
Colony Stimulating Factors (CSF) Market: An Overview
Vaccines Industry in the US
Federal Research & Grants
National Cancer Institute
National Institutes of Health (NIH)
Pediatric Vaccines Market Witnesses Rapid Growth
Opportunity Indicator
Select Market Trends
Manufacturers Shift Focus to Small Bioreactors
Biosimilar Developers Face Higher Litigation Risks
Varying Biosimilar Prescription Rules across the Country
Regulatory Scenario
Combination Products Pose Challenges to Manufacturers
FDA Efforts to Mitigate Concerns
FDA Announces New Labeling Guidelines for Biologics and Prescription Drugs
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
2. CANADA
A. Market Analysis
Lucrative Partnership Opportunities for Global Players
Mabs Lead, Insulin Exhibits Faster Growth
Strategic Corporate Developments
B. Market Analytics
3. JAPAN
A. Market Analysis
Erythropoietin Market
Leading EPO Drugs in Japan
HCV Infection: Combination Therapy Dominates
Diabetes Prevalence: Opportunity Indicator for the Insulin Market
B. Market Analytics
4. EUROPE
A. Market Analysis
Funding Challenges Faced by Biopharmaceutical Startups
Healthcare Agencies Looking to Embrace Biosimilars to Cut Healthcare Costs
Biosimilars Currently Licensed in Europe
Regulatory Scenario
Erythropoietin Market
Leading EPO Drugs in Europe
B. Market Analytics
4A. FRANCE
A. Market Analysis
Sanofi S. A. – A Key Player
B. Market Analytics
4B. GERMANY
A. Market Analysis
Strategic Corporate Development
B. Market Analytics
4C. ITALY
Market Analysis
4D. THE UNITED KINGDOM
A. Market Analysis
Strategic Corporate Development
Glaxosmithkline – A Key Player
B. Market Analytics
4E. SPAIN
Market Analysis
4F. RUSSIA
A. Market Analysis
Russia Sets Eyes on Emerging as a Notable Pharmaceutical Market
Encouraging Local Manufacturing
Challenges - Need for Extensive R&D
B. Market Analytics
4G. REST OF EUROPE
A. Market Analysis
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
5. ASIA-PACIFIC
A. Market Analysis
Regional Biopharma Players Gain Strength by Innovation and Partnerships
Asia Set to Emerge as Preferred Outsourcing Destination for Biopharma Manufacturing
Availability of Scientific Talent – Major Advantage for India
Primary Challenges for Asian CMOs
China – An Untapped Market for Antitumor mAbs
List of Anti-Cancer Monoclonal antibodies Approved by China Food & Drug Administration
Chinese Erythropoietin Market
Injectable Interferons: The Only Treatment for HCV Patients
Hepatitis B Market: Smaller Role of Interferons
G-CSF Market: Competitive Landscape
Interleukins Market
Cell Therapies Gaining Ground in Korea
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
6. REST OF WORLD
A. Market Analysis
Lack of Access Impedes Market in Developing Economies
Interferons Widely Used in HCV Therapeutics in Brazil
Product Launches
B. Market Analytics
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)
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
A. Recombinant Protein
B. Monoclonal Antibodies (mAbs)
C. Insulin
D. Vaccines
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW
Biologics: Taking over the Conventional Drugs Market
Table 1. Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart)
Table 2. Percentage Share of Pipeline Drugs for Biologics vs. Small Molecules (2014) (includes corresponding Graph/Chart)
Current and Future Analysis
Competition
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)
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)
Intensifying Consolidation Activity
Recent M&A Activity in the Biologics Industry: 2014 &
2015: A YEAR OF PATENT EXPIRIES FOR BIOLOGICS
Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
Market Drivers
Growing Aging Population
Table 5. Global Population Statistics for the 65+ Age Group: 2013 (includes corresponding Graph/Chart)
Table 6. Life Expectancy by Select Countries: 2013 (includes corresponding Graph/Chart)
Market Restraints
Affordability
Complex Supply Chain
Quality and Regulatory Issues
2014-15: A LAUNCH-DRIVEN PERIOD FOR BIOPHARMACEUTICALS
Recently Approved Biopharmaceuticals: 2013, 2014 &
R&D Funding Crucial
Table 7. Global Biopharmaceutical R&D Expenditure: 2010- 2015E (includes corresponding Graph/Chart)
2. SEGMENT ANALYSIS
Monoclonal Antibodies – The Most Viable Biopharmaceutical Segment
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)
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)
Approved Monoclonal Antibodies for Therapeutic Use: 1986
Opportunity Indicators
Cancer Incidence
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)
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)
Rheumatoid Arthritis Prevalence
Table 12. Projections of Rheumatoid Arthritis Prevalence in the US in Millions (2010-2030) (includes corresponding Graph/Chart)
Table 13. Prevalence of Treated Rheumatoid Arthritis in South Africa (Rate per 1000 Beneficiaries): 2008-2013 (includes corresponding Graph/Chart)
Insulin – Segment with High Potential
Competitive Landscape
List of Different Insulin Brands of the Three Major Players by Type
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)
Comparative Analysis of New Insulin Basal Analogs
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)
Opportunity Indicator
Diabetes Prevalence & Incidence
Table 16. Global Diabetes Mellitus Prevalence by Geographic Region (2014E & 2035P): Prevalence (in Millions) and Percentage Share (includes corresponding Graph/Chart)
Table 17. Percentage Increase in DM Incidence among Ages 20-79 Worldwide by Geographic Region: 2013-2035 (includes corresponding Graph/Chart)
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)
Recombinant Therapeutic Proteins
Anemia in CKD and Cancer Patients: Opportunity for EPO Therapy
Blood Growth Factors: Improving Circulation & Mobility in Peripheral Artery Disease Patients
Wound Management Market and Cellular Growth Factors
Multiple Sclerosis Drugs Market: Competition Set to Intensify
Interferon-based Drugs for HCV Treatment: An Insight
Vaccine Market Dynamics
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)
Growth Drivers in a Capsule
Pediatric Vaccines: A Lucrative Segment
Table 20. Number of Reported Cases for Vaccine-Preventable Diseases Globally: 2009-2013 (includes corresponding Graph/Chart)
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)
Hepatitis B Combination Vaccines to Propel Market Growth
Conjugated and Protein-based Vaccines to Take over Polysaccharide Vaccines for Infectious Diseases
DNA Vaccines: Engineering Growth
3. BIOPHARMACEUTICALS IN THE PIPELINE
Table 22. Biopharmaceutical Products’ Pipeline by Therapeutic Category (2015) (includes corresponding Graph/Chart)
Table 23. No. of Pipeline Biopharmaceuticals for Cancer by Site (2015) (includes corresponding Graph/Chart)
Table 24. No. of Pipeline Biopharmaceuticals for HIV/AIDS Treatment by Type of Therapy (2015) (includes corresponding Graph/Chart)
Insulin Products in Development
List of Newly Approved and Pipeline Insulin Products:
4. MARKET TRENDS
Disposable Systems Favored for Manufacturing
Innovations in Single-use Systems
Increasing Appeal of Biosimilars
Table 25. Global Biosimilars Market Size Estimates and Forecasts: 2012-2018F (includes corresponding Graph/Chart)
Supply Chain Management Crucial for Clinical Trials
Plant-based Production Scores over Mammalian Cell Culture Systems
Safety & Efficacy Issues Concerning Erythropoietin Stimulating Agents (ESAs)
hMSC-based Therapies to Drive Need for Growth Factors
Stem Cell Therapies Gain Popularity
Development of Cost Effective Methods – Need of the Hour
M&A Activity to Maintain Momentum
Key Factors Determining Long-Term Success
Innovations
Peptide against Skin Cancer
Monoclonal Antibodies to Treat Ebola
5. BIOPHARMACEUTICALS – AN OVERVIEW
Regulatory Environment for Biopharmaceuticals’ Manufacture & Storage
Glossary of Terms
Evolution of Biopharmaceuticals
Biopharmaceutical Manufacturing
Bioprocess Membrane Technology
Disposable Manufacturing with Single-Use Systems
Major Concerns Related to the Production of Biopharmaceuticals
Future of Biopharmaceutical Manufacturing
Marketing Approval for Biopharmaceuticals
Techniques to Characterize Biopharmaceuticals
Biopharmaceuticals – Types and Therapeutic Applications
Insulin
Monoclonal Antibodies
Recombinant Proteins
Cytokines
Interferon
Colony Stimulating Factors (CSF)
Erythropoietin (EPO)
Clotting Factors
Vaccines
Types of Vaccines
Live, Attenuated Vaccines
Combination Vaccines
Killed or Inactivated Vaccines
DNA & Recombinant DNA Vaccines
Toxoids
Subunit Vaccines
6. PRODUCT LAUNCHES/APPROVALS
Mexican Health Authority, COFEPRIS, Approves Biocon’s Insulin Glargine
Shantha Biotechnics Delivers 400,000 doses of Shan5 Vaccine
Amyris to Launch µPharm platform for Biotherapeutics Production
FDA Approves IMBRUVICA for New Indication
FDA Approves Cosentyx by Novartis
Hospira Submits BLA for the Biosimilar Retacrit
Celestial Biolabs to Launch Antibiotic for Diabetes
MHRA Validates RedHill Biopharma’s Bekinda MAA
Zydus Cadila Launches Adalimumab Biosimilar
EPIRUS Launches Infimab
KYTHERA Biopharmaceuticals Submits NDS for ATX
FDA Accepts New Drug Application of KYTHERA’s ATX
FDA Approves sNDA for Lymphoseek by Navidea
Hospira’s Biosimilar Inflectra Launched in Central and Eastern Europe
7. RECENT INDUSTRY ACTIVITY
Sun Pharmaceuticals Integrates Ranbaxy
Baxter Acquires SuppreMol GmbH
Baxalta to Separate from Baxter and Change Headquarters
Matinas BioPharma Holdings Acquires Aquarius BioTechnologies
3SBIO ACQUIRES SIRTON PHARMACEUTICALS SPA
Pfizer to Acquire Hospira
Roche to Acquire Trophos
Novartis Completes Transaction with GSK
Johnson & Johnson Forms Ebola Vaccine Development Consortia
Boehringer Ingelheim and Sanofi Enter Strategic Manufacturing Agreement
OnCore Biopharma and Tekmira Enter Merger Agreement
Regado Biosciences and Tobira Enter Merger Agreement
WuXi PharmaTech Acquires NextCODE Health
Adaptive Biotechnologies to Acquire Sequenta
Cardio3 BioSciences Acquires OnCyte
FUJIFILM Diosynth Biotechnologies Acquires Kalon Biotherapeutics
Prima BioMed Completes Acquisition of Immutep
BioMarin Pharmaceutical Acquires ProSensa Holding
Ricerca Biosciences Acquired by Investment Group Main Market Partners
GE Healthcare Life Sciences to Open Biopharmaceutical Laboratory in Turkey
Johnson & Johnson Acquires Alios BioPharma
PDL Biopharma Acquires Part of Cerdelga Royalties
DPx Holdings B. V. Acquires Gallus BioPharmaceuticals
Sunshine Biopharma Forms Canadian Subsidiary
Albany Molecular Research Inc. (AMRI) Acquires OSO Biopharmaceuticals
Pall Corporation Acquires New Biopharmaceutical Production Technologies
Actavis Plc. Acquires Forest Laboratories
Roche to Acquire InterMune
CSL Acquires Influenza Vaccines Business of Novartis
8. FOCUS ON SELECT GLOBAL PLAYERS
AbbVie, Inc. (US)
Anavex Life Sciences Corp. (US)
Baxter International, Inc. (US)
Bayer HealthCare Pharmaceuticals, Inc. (US)
Biocon (India)
Eli Lilly (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Genentech (US)
GlaxoSmithKline (UK)
Janssen Biotech, Inc. (US)
Kemwell Biopharma (India)
Novartis (Switzerland)
Sandoz
Pfizer, Inc. (US)
Sun Pharmaceutical Industries Ltd. (India)
Sanofi S. A. (France)
9. GLOBAL MARKET PERSPECTIVE
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)
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)
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)
Biopharmaceuticals Market by Product Segment
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
III. MARKET
1. THE UNITED STATES
A. Market Analysis
United States: The Largest Biopharmaceutical Market Globally
Table 41. No. of Biologics Approved by the Center for Biologics Evaluation and Research (CBER): 2003-2013 (includes corresponding Graph/Chart)
A R&D Driven Industry
Impending Patent Expiries
Table 42. Leading US Biopharmaceuticals by Revenue (in US$ Billion) and Year of Patent Expiry (includes corresponding Graph/Chart)
Biosimilars and the Implications of the BPCI Act
Segment Analysis
Monoclonal Antibodies
Opportunity Indicators
Rheumatoid Arthritis Incidence
Table 43. Rheumatoid Arthritis Prevalence in the US in Millions (2010-2030) (includes corresponding Graph/Chart)
Table 44. The US Cancer Incidence by Gender (2014): No. of Reported New Cases for Men and Women (includes corresponding Graph/Chart)
Table 45. The US Cancer Incidence by Affected Site (2014): Number of New Cancer Cases (includes corresponding Graph/Chart)
Recombinant Proteins
Erythropoietin (EPO) Market: Amgen Continues to Dominate
Interferon Market: An Insight
Colony Stimulating Factors (CSF) Market: An Overview
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)
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)
Vaccines Industry in the US
Federal Research & Grants
National Cancer Institute
National Institutes of Health (NIH)
Pediatric Vaccines Market Witnesses Rapid Growth
Opportunity Indicator
Table 48. Number of Reported Cases for Vaccine-Preventable Diseases in American Regions (includes corresponding Graph/Chart)
Table 49. Routine Immunization Coverage in the US (2011-2013): Percentage of Live Births/New Borns/Infants/Children Vaccinated (includes corresponding Graph/Chart)
Select Market Trends
Manufacturers Shift Focus to Small Bioreactors
Biosimilar Developers Face Higher Litigation Risks
Varying Biosimilar Prescription Rules across the Country
Regulatory Scenario
Combination Products Pose Challenges to Manufacturers
FDA Efforts to Mitigate Concerns
FDA Announces New Labeling Guidelines for Biologics and Prescription Drugs
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
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)
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)
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)
2. CANADA
A. Market Analysis
Lucrative Partnership Opportunities for Global Players
Mabs Lead, Insulin Exhibits Faster Growth
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)
Strategic Corporate Developments
B. Market Analytics
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)
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)
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)
3. JAPAN
A. Market Analysis
Erythropoietin Market
Leading EPO Drugs in Japan
HCV Infection: Combination Therapy Dominates
Diabetes Prevalence: Opportunity Indicator for the Insulin Market
Table 57. Prevalence of Diabetes Mellitus in Japan (2013): Number of People with DM (in thousands) by Age Group (includes corresponding Graph/Chart)
B. Market Analytics
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)
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)
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)
4. EUROPE
A. Market Analysis
Funding Challenges Faced by Biopharmaceutical Startups
Healthcare Agencies Looking to Embrace Biosimilars to Cut Healthcare Costs
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)
Table 62. Biosimilar Penetration in Select EU Countries (2013)
Biosimilars Currently Licensed in Europe
Regulatory Scenario
Erythropoietin Market
Leading EPO Drugs in Europe
B. Market Analytics
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)
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)
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)
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)
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)
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)
4A. FRANCE
A. Market Analysis
Sanofi S. A. – A Key Player
B. Market Analytics
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)
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)
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)
4B. GERMANY
A. Market Analysis
Strategic Corporate Development
B. Market Analytics
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)
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)
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)
4C. ITALY
Market Analysis
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)
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)
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)
4D. THE UNITED KINGDOM
A. Market Analysis
Strategic Corporate Development
Glaxosmithkline – A Key Player
B. Market Analytics
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)
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)
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)
4E. SPAIN
Market Analysis
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)
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)
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)
4F. RUSSIA
A. Market Analysis
Russia Sets Eyes on Emerging as a Notable Pharmaceutical Market
Encouraging Local Manufacturing
Challenges - Need for Extensive R&D
B. Market Analytics
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)
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)
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)
4G. REST OF EUROPE
A. Market Analysis
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
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)
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)
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)
5. ASIA-PACIFIC
A. Market Analysis
Regional Biopharma Players Gain Strength by Innovation and Partnerships
Asia Set to Emerge as Preferred Outsourcing Destination for Biopharma Manufacturing
Availability of Scientific Talent – Major Advantage for India
Primary Challenges for Asian CMOs
China – An Untapped Market for Antitumor mAbs
List of Anti-Cancer Monoclonal antibodies Approved by China Food & Drug Administration
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)
Chinese Erythropoietin Market
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)
Injectable Interferons: The Only Treatment for HCV Patients
Table 92. Interferon Market in China (2014): Percentage Share Breakdown of Value Sales by Type of Interferon (includes corresponding Graph/Chart)
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)
Hepatitis B Market: Smaller Role of Interferons
G-CSF Market: Competitive Landscape
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)
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)
Interleukins Market
Table 96. Interleukins Market in China (2014): Percentage Share Breakdown of Value Sales by Type - Interleukin-11 and Interleukin-2 (includes corresponding Graph/Chart)
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)
Cell Therapies Gaining Ground in Korea
Product Launches
Strategic Corporate Developments
Select Key Players
B. Market Analytics
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)
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)
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)
6. REST OF WORLD
A. Market Analysis
Lack of Access Impedes Market in Developing Economies
Interferons Widely Used in HCV Therapeutics in Brazil
Product Launches
B. Market Analytics
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)
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)
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)
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)