【レポートの概要(一部)】
1. Report Overview
1.1 Contract Biotech API Manufacturing: World Market Review 2015
1.2 Benefits of this Report
1.2.1 How This Report Delivers
1.2.2 Main Questions Answered by This Analytical Report
1.3 Who is This Study For?
1.4 Methods of the Study
1.5 Frequently Asked Questions (FAQ)
1.6 Some Associated Reports
1.7 About Visiongain
2. Introduction to Biotech API Manufacturing Services
2.1 What are Biotech API Manufacturing Services?
2.1.1 Producing Biotech API: An Overview of the Manufacturing Process
2.1.2 Defining the Biotech API Manufacturing Market
2.1.3 Differing Expression Systems to Manufacture APIs
2.2 Challenges in Manufacturing Biotech API
2.3 Outsourcing: A Common Trend in Biotech API Manufacturing Services
2.4 Future Trends for the Biotech API Manufacturing Services Market
2.5 Glossary
3. Biotech API Manufacturing Services: World Market Outlook and Forecast 2015-2025
3.1 The Contract Biotech API Manufacturing Services Market Performance, 2014
3.1.1 Contract Biotech API Manufacturing Services: Forecast 2015-2025
3.2 Drivers and Restraints in the Biotech API Manufacturing Services Market
3.2.1 Important Drivers in the Biotech API Manufacturing Services Market for the Coming Decade
3.2.1.1 The Ageing Population is a Driver for Growth
3.2.1.2 The Patent Cliff Effect Will Stimulate Biologics and Biosimilar Development
3.2.1.3 Outsourcing as a Driver for Growth
3.2.1.4 Opportunities from the Long Pipeline Will Drive Growth
3.2.1.5 Increased Investment in Orphan Drugs from Companies
3.2.1.6 Emerging Markets Will Grow and Influence the Market
3.2.1.7 Technological Changes: Single-Use Technology Will Become Essential in the Next 10 Years
3.2.2 Restraints on Growth in the Biotech API Manufacturing Services Market
3.2.2.1 Pricing Pressures Will Limit Market Growth
3.2.2.2 Regulatory Restrictions Will Increase
3.2.2.3 Overcapacity Will Be Adverse to Market Growth for CMOs
3.2.2.4 Complexity of API Production is a Challenge
3.3 Outlook for the Outsourced Biotech API Services: Increased Demand
4. Biotech API Manufacturing Services Submarkets: World Market Outlook and Forecasts 2015-2025
4.1 Submarkets for the Biotech API Manufacturing Services Industry
4.1.1 The Mammalian Cell Culture Submarket
4.1.2 The Mammalian Cell Culture Submarket Forecast 2015-2025
4.1.3 ADCs and Next-Generation Antibodies Will Drive Growth 2015-2025
4.1.4 The Microbial Fermentation Submarket
4.1.5 The Microbial Fermentation Submarket Forecast 2015-2025
4.1.5.1 Increase in Demand for Insulin Will Drive Growth 2015-2025
4.1.6 Other APIs Expression Systems Are Still in Development
4.1.6.1 Plant-Made Pharmaceuticals
4.1.6.2 Yeast Cell Expression Systems
4.1.6.3 Insect Cell Expression Systems
4.1.6.4 Other Expression Systems Submarket Forecast 2015-2025
4.2 Chapter Summary: Positive Growth for the Market
5. Biotech API Manufacturing: Outlook for Leading Biological Drug Contract API Sectors, 2015-2025
5.1 Antibody Therapies: An Introduction to the Largest Contract API Biological Drug Sector
5.1.1 Contract API Monoclonal Antibody Manufacturing Forecast 2015-2025
5.1.2 Outlook: Outsourced Manufacturing for Monoclonal Antibody APIs Will Increase
5.2 Contract API Vaccine Manufacturing: A Promising Opportunity for CMOs
5.2.1 Contract API Vaccine Market: Outlook and Forecast 2015-2025
5.2.2 Challenges in Manufacturing Vaccines
5.3 Introduction to the Insulin Therapies Market and Outlook for the Contract API Insulin Therapies Market
5.3.1 Contract API Insulin Analogues Forecast 2015-2025
5.3.2 Insulin Analogues: In-House Production Restrains the Contract API Insulin Therapies Market Growth
5.3.3 Development Trends in the Contract API Insulin Market to 2025
5.4 Introduction to the Interferon Therapy Market and Outlook for the Contract API Interferon Therapy Market
5.4.1 Contract API Interferon Market Forecast 2015-2025
5.4.2 Unlikely to be Opportunities in the Contract API Interferon Market
5.5 Introduction to the Growth Hormone Market and Outlook for the Contract API Growth Hormone Manufacturing Market
5.5.1 Contract API Growth Hormone Market Forecast 2015 to 2025
5.5.2 Most Manufacturing is In-House for Growth Hormone Production
5.5.3 Long-Acting Therapies Provide Opportunity for Outsourcing
5.6 Chapter Summary: Outsourcing for Key Biological Products 2015-2025
6. Leading National Markets for Contract Biotech API Manufacturing Services, 2015-2025
6.1 Regional Breakdown of the World Biotech API Manufacturing Services Market
6.1.1 US and EU Dominate Growth for Leading National Submarkets 2015-2025
6.1.2 National Revenue Shares by 2025: Emerging Market Growth
6.2 Contract Biotech API Manufacturing in Europe 2015-2025
6.2.1 Strong Growth for the EU Revenue Forecasts 2015-2025
6.2.2 Forecasts for Switzerland and Leading EU National Revenues 2015-2025
6.2.2.1 Germany Leads the EU Biotech Market with Strong Growth
6.2.2.2 UK: Strong Research Sector Will Drive Market Growth
6.2.2.3 France: Strong Vaccine Development Industry
6.2.2.4 Switzerland: Headquarters for Leading Companies
6.2.2.5 Spain: Numerous Biotech Companies
6.2.2.6 Italy: Outlook and Forecast 2015-2025
6.2.3 US: A Market Leader in Biotech API Manufacturing
6.2.4 Japan: A Less Mature Contract Manufacturing Market
6.2.5 BRIC Market: Outlook and Forecasts for Emerging Markets 2015-2025
6.2.5.1 Emerging Nations May Develop a Presence in the Biologics Market
6.2.5.2 Increased Demand for Biosimilars and Biological Drugs 2015-2025
6.2.5.3 China is Poised for Growth: Forecast for 2015-2025
6.2.5.4 India Offers a Lower-Cost Advantage for Biotech API Manufacturing Services: Forecast 2015-2025
6.2.5.5 Brazilian and Russian Governments Promoting Domestic Biotech Development
6.2.5.6 Russian Biotech API Manufacturing Services Forecast: 2015-2025
6.2.5.7 Brazilian Biotech API Manufacturing Services Forecast: 2015-2025
6.2.6 South Korea: Market Forecast, 2015-2025
6.2.6.1 Leading CMOs Celltrion and Samsung BioLogics Drive the Market
6.2.7 Singapore: Market Forecast, 2015-2025
6.3 Summary of Chapter: Outlook for Leading National Submarkets, 2015-2025
7. Leading CMOs in the Biotech API Manufacturing Services Market, 2014
7.1 Four Companies Led the Market in 2014
7.2 Leading Companies by Capacity
7.2.1 Small-Scale Biopharmaceutical Manufacturing is a Common Trend
7.2.2 Barriers to Market Entry 2015-2025
7.2.2.1 The High Cost of Facilities: Acquisition as a Cheaper Alternative
7.3 FDA Opens Barriers for the Biosimilars Market
7.4 Boehringer Ingelheim BioXcellence
7.4.1 Strategic Outlook: Expanding into the Asian Market
7.5 Celltrion: Biologics Leader in Asia
7.5.1 Celltrion: Likely Target for Mergers and Acquisitions?
7.6 DSM Biologics: Strategically Increasing Capacity
7.7 Lonza Has the Largest Worldwide Cell Culture Capacity
7.7.1 Lonza: Biopharmaceutical Core Competency as a Strategy for Growth
7.8 Other Market Players of Interest in 2014
7.8.1 Samsung BioLogics: Focusing on Biosimilars
7.8.2 Cytovance Biologics: Plans to Expand
7.8.3 Fujifilm Diosynth Biotechnologies
7.8.3.1 Facility and Service Expansion for the Future
7.9 Leading Biopharma Companies Operate CMO Divisions
7.9.1 AbbVie Contract Manufacturing: Strength through Acquisition
7.9.2 GSK Biopharmaceuticals
7.9.3 Sandoz: Expertise in Biologics and Biosimilars
7.9.4 Rentschler Biotechnologie: Recent Expansions
7.10 Teva: A Future Player in the Biologics Market
7.11 Catalent Offers a New Platform through Partnership
7.12 Chapter Summary: Leading Companies, 2015-2025
8. Biotech API Manufacturing Services Market Industry Trends, 2015-2025: Qualitative Analysis
8.1 SWOT Analysis: Strengths and Weaknesses of the Biotech API Manufacturing Services Market, 2014
8.1.1 Biopharmaceutical Demand for Outsourcing is Increasing
8.1.2 A Fragmented Market with a Costly and Difficult Manufacturing Process
8.2 Opportunities for the Biotech API Manufacturing Services Market 2015-2025
8.3 Threats for the Biotech API Manufacturing Services Market 2015-2025
8.4 STEP Analysis of the Biotech API Manufacturing Services Market
8.4.1 Social Factors: Drug Pricing Pressures to Meet Demand for an Increasing Ageing Population
8.4.2 Technological Factors: Advances Will Drive Growth
8.4.2.1 Single-Use Technology: A Vital Trend for the Future
8.4.3 Economic Factors: The High Cost of Manufacturing Will Lead to Outsourcing
8.4.4 Political Factors: Regulatory Requirements Need to Be Met
8.5 Trends in Biological Drug Development 2015-2025
8.5.1 Biosimilars Will Be an Important Opportunity for CMOs
8.5.2 CMOs are Investing in Next-Generation Antibody Development
8.5.3 Orphan Drugs and Personalised Medicine: Trend for Smaller Batches
8.5.4 Outlook for Single-Use Technologies in Biotech API Manufacturing 2015-2025
8.5.4.1 Future Direction: Single-Use Systems Will be Essential
8.5.5 Outsourcing Trends for Biotech API Manufacturing 2015-2025
8.5.5.1 Biopharma Companies Continue to Invest in In-House Facilities
8.5.5.2 Offshoring Biotech API Manufacturing to Emerging Markets: Not a Trend for this Decade?
8.5.5.3 Overcapacity is a Risk for the Biotech CMO Industry
8.5.5.4 Future Trends: Strategic Partnering
8.5.5.5 Alternative Expression Methods
8.6 Regulations and Effects on the Biotech API Manufacturing Services Industry
8.6.1 Effect on the Emerging Biotech API Manufacturing Services Market 2015-2025
8.6.2 Regulations in Other Countries in the Biotech API Market
8.7 Chapter Summary: Industry Trends for Contract Biotech API Manufacturing to 2025
9. Research Interviews
9.1 Interview with Mr Steve Bagshaw, Chief Executive Officer, FUJIFILM Diosynth Biotechnologies
9.1.1 Novel Expression Platforms
9.1.2 Expanding Manufacturing Capacity
9.1.3 Acquisition of Kalon Biotherapeutics – Effects on Business?
9.1.4 Over-capacity – A Realistic Threat to API Manufacturing CMOS?
9.1.5 Future Opportunities for the API Manufacturing CMO Market
9.2 Interview with Mr Jon S. Gingrich, Manager, Business Development, Avid Bioservices Inc., California, USA
9.2.1 Avid Bioservices
9.2.2 The Influence of Biosimilars on the Current Biotech API Manufacturing Services Market for CMOs
9.2.3 Competition in the US Biotech API Manufacturing Services Market
9.2.4 The Challenges of API Manufacturing
9.2.5 Avid Bioservices Strategies for Growth in the Biotech API Manufacturing Services Market
10. Conclusions
10.1 The Contract Biotech API Manufacturing Services Market
10.2 Outlook for the Biotech API Manufacturing Services Market
10.2.1Mammalian Cell Culture is the Leading Expression Platform for Outsourced Biotech API Manufacturing
10.2.2 The US and EU Markets Lead for the Global Biotech API Manufacturing Services Market in 2014-2015
10.2.3 Single-Use Technology Will Become Indispensable for Success in the Market
10.3 Growth in the Market 2014-2025
10.3.1 The Future of the Biotech API Manufacturing Services Marketplace
【レポート販売概要】
■ タイトル:生物学的製剤API(原薬)製造サービスの世界市場■ 英文:Biological Drug API Manufacturing Services: World Industry and Market Predictions 2015-2025
■ 発行日:2015年7月
■ 調査会社:visiongain
■ 商品コード:VGAIN5072209
■ 調査対象地域:グローバル
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