Biological Drug API Manufacturing Services World Industry and Market Predictions 2016-2026: Mammalian Cell Culture, Microbial Fermentation, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccine reviews the contract active pharmaceutical ingredient (API) manufacturing market for biologics. This study gives quantitative and qualitative analysis for that overall world market, as well as for countries and other submarkets, including the mammalian cell culture and microbial fermentation segments. This report assesses leading applications and significant developments within each, as well as drivers and restraints for them. Future trends that will affect the biotech API manufacturing services market are also examined. In addition, this study profiles leading contract manufacturing organisations (CMOs) in the outsourcing market and assesses their outlooks. Visiongain provides forecasts revenues for the period 2015 to 2026 for the biotech API manufacturing services market, as well as for therapeutic applications.
How this 238 page report delivers:
• Provides qualitative and quantitative analysis of the leading submarkets the period 2015-2026. Visiongain forecasts revenues and their growth for these submarkets: – Mammalian cell culture – Microbial fermentation – Other expression platforms
• Provides qualitative and quantitative analysis of the leading contract API biological drug applications for the period 2015-2026. Visiongain forecasts contract API drug revenues to 2026 for these individual segments: – Monoclonal antibody (mAb) therapies – Vaccines – Insulin therapies – Interferon therapies – Growth hormones
• Find forecasts of the leading therapeutic and national markets from 2015 to 2026: – The EU, including the five leading markets (UK, Germany, France, Italy and Spain). – The US – Japan – Switzerland – Emerging markets such as the BRIC (Brazil, Russia, India, and China) countries, South Korea and Singapore.
• Profiles leading global and national companies that offer biotech API manufacturing services to the pharmaceutical industry. For each company, current services offered, recent developments and outlooks are discussed. Leading CMOs profiled in this chapter are: – Boehringer Ingelheim BioXcellence – Celltrion – DSM Biologics – Lonza – Samsung BioLogics – Cytovance Biologics – Fujifilm Diosynth Biotechnologies – Operations of leading biopharma companies, such as AbbVie, GSK and Novartis.
• Discover the regulatory outlook for biotech API manufacturing in leading regional and national markets in 2016, as well as predicted developments for the period to 2026. • Read expert opinions from other authorities on the biotech API manufacturing industry. • Identify important drug development and technology trends that will affect CMOs, their clients and other market participants from 2016. The report also contains SWOT and STEP analysis of the industry and market. • Find profiles for leading CMOs offering biological drug API manufacturing services to pharmaceutical companies.
How This Report Delivers: Chapter Summary This updated study provides an overview of the subject along with qualitative and quantitative analyses of the biotech API manufacturing services market. This report contains expert opinions from industry participants. In more detail, the chapters of this report contain the following information:
Chapter 1 forms a report overview.
Chapter 2 defines the biotech API manufacturing services market and provides an introduction to that industry.
Chapter 3 quantitatively assesses the world market for biotech API manufacturing services revenues. The chapter provides an estimate for the size of the market in 2015 and forecasts revenues for the period 2015-2026. Visiongain discusses the main drivers and restraints on the market for a 10-year forecast period.
Chapter 4 provides qualitative and quantitative analysis of the leading submarkets the period 2015-2026. Visiongain forecasts revenues and their growth for these submarkets: • Mammalian cell culture • Microbial fermentation • Other expression platforms.
For the leading submarkets, we analyse commercial drivers and restraints, as well as forecasting revenues to 2026.
Chapter 5 provides qualitative and quantitative analysis of the leading contract API biological drug applications for the period 2015-2026. Visiongain forecasts contract API drug revenues to 2026 for these individual segments: • Monoclonal antibody (mAb) therapies • Vaccines • Insulin therapies • Interferon therapies • Growth hormones.
Chapter 6 forecasts the leading national submarkets for biotech API manufacturing services, for the period 2015-2026. That section also provides quantitative analysis. The chapter offers a regional breakdown of the market by market share, and also discusses developments and future expectations for each main national submarket. National submarkets forecasted in this chapter are these: • The EU, including the five leading markets (UK, Germany, France, Italy and Spain). • The US • Japan • Switzerland • Emerging markets such as the BRIC (Brazil, Russia, India, and China) countries, South Korea and Singapore.
Chapter 7 profiles leading global and national companies that offer biotech API manufacturing services to the pharmaceutical industry. For each company, current services offered, recent developments and outlooks are discussed. Leading CMOs profiled in this chapter are: • Boehringer Ingelheim BioXcellence • Celltrion • DSM Biologics • Lonza • Samsung BioLogics • Cytovance Biologics • Fujifilm Diosynth Biotechnologies • Operations of leading biopharma companies, such as AbbVie, GSK and Novartis.
Chapter 8 provides qualitative analysis of the biotech API manufacturing services market from 2015. That chapter identifies main strengths and weaknesses of the market, as well as opportunities and threats facing CMOs to 2026. Social, technological, economic and political (STEP) factors affecting market growth are also discussed. Industry trends and regulatory developments affecting the market are discussed.
Chapter 9 provides transcripts of interviews conducted by Visiongain with other authorities. For this report, Visiongain interviewed the following authorities on the CMO industry: • Steve Bagshaw, CEO, Fujifilm Diosynth Biotechnologies, UK. • Jon S. Gingrich, Manager of Business Development, Avid Bioservices Inc., US.
Chapter 10 summarises the report, highlighting conclusions from Visiongain’s research and analysis.
Visiongain is a trading partner with the US Federal Government CCR Ref number: KD4R6
1. Report Overview
1.1 Contract Biotech API Manufacturing: World Market Review 2016
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 Report 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 2016-2026
3.1 The Contract Biotech API Manufacturing Services Market Performance, 2016
3.1.1 Contract Biotech API Manufacturing Services: Forecast 2015-2026
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 2016-2026
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 2015-2026
4.1.3 ADCs and Next-Generation Antibodies Will Drive Growth 2015-2026
4.1.4 The Microbial Fermentation Submarket
4.1.5 The Microbial Fermentation Submarket Forecast 2015-2026
4.1.5.1 Increase in Demand for Insulin Will Drive Growth 2015-2026
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 2015-2026
4.2 Chapter Summary: Positive Growth for the Market
5. Biotech API Manufacturing: Outlook for Leading Biological Drug Contract API Sectors: 2015-2026
5.1 Antibody Therapies: An Introduction to the Largest Contract API Biological Drug Sector
5.1.1 Contract API Monoclonal Antibody Manufacturing Forecast 2015-2026
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 2015-2026
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 2015-2026
5.3.2 Insulin Analogues: In-House Production Restrains Contract API Insulin Therapies Market Growth
5.3.3 Development Trends in the Contract API Insulin Market to 2026
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 2015-2026
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 2026
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 2015-2026
6. Leading National Markets for Contract Biotech API Manufacturing Services 2015-2026
6.1 Regional Breakdown of the World Biotech API Manufacturing Services Market
6.1.1 US and EU Dominate Growth for Leading National Submarkets 2015-2026
6.1.2 National Revenue Shares by 2026: Emerging Market Growth
6.2 Contract Biotech API Manufacturing in EU Market 2015-2026
6.2.1 Strong Growth for the EU Revenue Forecasts 2015-2026
6.2.2 Forecasts for Switzerland and Leading EU National Revenues 2015-2026
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
6.2.2.4.1 Switzerland: Headquarters for Leading Companies
6.2.2.5 Spain: Numerous Biotech Companies
6.2.2.6 Italy: Outlook and Forecast 2015-2026
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- 2026
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 2015-2026
6.2.5.3 China is Poised for Growth: Forecast for 2015-2026
6.2.5.4 India Offers a Lower-Cost Advantage for Biotech API Manufacturing Services: Forecast 2015-2026
6.2.5.5 Brazilian and Russian Governments Promoting Domestic Biotech Development
6.2.5.6 Russian Biotech API Manufacturing Services Forecast: 2015-2026
6.2.5.7 Brazilian Biotech API Manufacturing Services Forecast: 2015-2026
6.2.6 South Korea: Market Forecast, 2015-2026
6.2.6.1 Leading CMOs Celltrion and Samsung BioLogics Drive the Market
6.2.7 Singapore: Market Forecast, 2015-2026
6.3 Summary of Chapter: Outlook for Leading National Submarkets 2015-2026
7. Leading CMOs in the Biotech API Manufacturing Services Market 2016
7.1 Four Companies Led the Market in 2015
7.2 Leading Companies by Capacity
7.2.1 Small-Scale Biopharmaceutical Manufacturing is a Common Trend
7.2.2 Barriers to Market Entry 2015-2026
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?
Table 10.1 Contract Biotech API Manufacturing Market: Revenue Forecasts ($bn) by Sector, 2016, 2018, 2020, 2022, 2024 and 2026
Table 10.2 Contract Biotech API Manufacturing Market: Revenue Forecasts ($bn) by Region, 2016, 2018, 2020, 2022, 2024 and 2026
3P Biopharmaceuticals
AbbVie
AbbVie Contract Manufacturing (part of AbbVie)
Adocia
Ajinomoto Omnichem
Ambrx
Amgen
Aptuit
arGEN-X N.V.
AstraZeneca
Avid Bioservices (part of Peregrine Pharmaceuticals)
Bachem
Banner Life Sciences (part of DPx Holdings)
BaroFold
Baxter International
Bayer
Biocad
Bioceuticals Arzneimittel (part of Stada)
Biocon
Biogen Idec
Bioplanta
Boehringer Ingelheim
Boehringer Ingelheim BioXcellence (part of Boehringer Ingelheim)
Bristol-Myers Squibb
Calico Life Sciences
Carbogen Amcis
Catalent
Celltrion
Cinfa
CMC Biologics
Cytovance Biologics
DPx Fine Chemicals (part of DPx Holdings)
DPx Holdings
DSM Biologics (was part of Royal DSM, now part of DPx Holdings)
DSM Sinochem Pharmaceuticals (part of DPx Holdings)
Eisai
Eli Lilly
EMD Millipore (part of Merck)
European Medicines Agency (EMA)
Ferring Pharmaceuticals
Food and Drug Administration (US FDA)
Fujifilm
Fujifilm Diosynth Biotechnologies (part of Fujifilm)
Gallus Biopharmaceuticals (part of DPx Holdings)
GE Healthcare
Genentech (part of Roche)
Genmab
Genzyme (part of Sanofi)
Gilead Sciences
GlyTech
Granules
GSK
GSK Biopharmaceuticals (part of GSK)
Hexal (part of Novartis)
Hospira
Hospira One2One (part of Hospira)
Infinity Pharmaceuticals
International Diabetes Federation
Ipsen
Kalon Biotherapeutics (part of Fujifilm)
Korea Food and Drug Administration (KFDA)
Kyowa Hakko Kirin
Laureate Biopharma (part of DPx Holdings)
Lek Pharmaceuticals (Sandoz)
Lonza
Medice
Merck & Co.
Merck Biomanufacturing Network
Merck KGaA
Merck Millipore
Merck Serono
Millennium Pharmaceuticals
Millhouse LLC
Ministry for Food and Drug Safety [Korea]
Ministry of Health [Brazil]
Mitsubishi Gas Chemical Company
Mylan
Neopharm
Nikon
Norbitec
Nordmark Arzneimittel
Novartis
Novasep
Novo Nordisk
Nuron Biotech
Nycomed
Open Monoclonal Technology (OMT)
Opko Health
Patheon (part of DPx Holdings)
Patheon Biologics(part of DPx Holdings)
Peregrine Pharmaceuticals
Perrigo
Pfizer
Pharmacyclics
Pharmstandard
Phyton Biotech
Piramal Healthcare
Precision Biologics
Prolor Biotech
Quintiles
Recepta Biopharma
Redwood Bioscience (part of Catalent)
Relthy Laboratórios (part of Catalent)
Rentschler Biotechnologie
Roche
Royal DSM (part of DPx Holdings)
SAFC (part of Sigma-Aldrich)
Samsung
Samsung Bioepis (part of Samsung)
Samsung BioLogics (part of Samsung)
Sandoz (part of Novartis)
Sanofi
Schering-Plough (part of Merck & Co.)
SCM Pharma
Seattle Genetics
ShangPharma
SICOR Biotech (part of Teva)
Stada Arzneimittel
Sunshine Biopharma
Takeda
TAPI (part of Teva)
Teva Pharmaceutical Industries
Tonghua Dongbao Pharmaceutical
Toyobo Biologics
Tufts Center for the Study of Drug Development (CSDD)
Vertex
Vida Pharma
World Health Organization (WHO)
WuXi PharmaTech
Xcellerex
Zhangjiang Biotech and Pharmaceutical Base Development (ZJ Base)
Zhejiang Jiang Yuan Tang Biotechnology
Zhuhai United Laboratories
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