Biological Drug API Manufacturing Services World Industry and Market Forecast to 2029
The biological drug API manufacturing market is estimated to grow at a CAGR of 9.5% in the first half of the forecast period. In 2018, Mammalian cell culture systems submarket represents the largest submarket within the biological drug API manufacturing industry.
How this 211-page report delivers:
- Biological Drug API Manufacturing Services market forecast to 2029
- Biological Drug API Manufacturing Services market forecast to 2029 by Expression Systems:
- Mammalian cell culture
- Microbial fermentation
- Other expression platforms
- Biological Drug API Manufacturing Services market forecast to 2029 by Therapeutic Area:
- Monoclonal antibody (mAb) therapies
- Vaccines
- Insulin therapies
- Interferon therapies
- Growth hormones
- Other Therapeutic Areas
- Biological Drug API Manufacturing Services market forecast to 2029 by Regional and National Market:
- North America: US, Canada
- Europe: Germany, France, the UK, Switzerland, Spain, Italy, Rest of Europe
- BRIC: Brazil, Russia, China, India
- Japan
- South Korea
- Singapore
- RoW
- Profiles leading companies that offer biotech API manufacturing services to the pharmaceutical industry. Leading CMOs profiled in this report are:
- Abbvie
- Boehringer Ingelheim BioXcellence
- Catalent
- Celltrion
- Cytovance Biologics
- Fujifilm Diosynth Biotechnologies
- GSK
- Lonza
- Patheon N.V.
- Rentschler Biopharma
- Samsung BioLogics
- Sandoz
- Teva
- Provides qualitative analysis: SWOT and STEP Analysis of the biological drug API manufacturing market.
- Key questions answered by this report:
- How is the biological drug API manufacturing services market evolving?
- What is driving and restraining the biological drug API manufacturing services market?
- What are the market shares of each main segment of the overall biological drug API manufacturing services market in 2018?
- How will each main biological drug API manufacturing services submarket grow over the forecast period and how much revenue will these submarkets account for in 2029?
- How will the market shares for biological drug API manufacturing services submarkets develop from 2019 to 2029?
- What will be the main drivers for the overall market from 2019 to 2029?
- How will political and regulatory forces influence the regional markets and submarkets?
- Will leading national biological drug API manufacturing services markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
- How will the market shares of the national markets change by 2029 and which countries will lead the market in 2029?
- Who are the leading companies and what are their prospects?
- What are the predictions for M&A activity, consolidation for existing players and the potential prospects for new market entrants?
- How will the industry evolve during the period 2019 to 2029, and which trends will be important?
Please Note: Prior to initiating fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.
The publisher is using a password system to access all reports. Single user (non-printable) and departmental licenses expires after 12 month period. In the case of departmental site license purchases, the publisher requires all email addresses for the licensed users prior to fulfillment.
- 1. Report Overview
- 1.1 Contract Biological Drug API Manufacturing: World Market Review 2018
- 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 Associated Reports
- 1.7 About Visiongain
- 2. Introduction to Biological Drug API Manufacturing Services
- 2.1 What are Biological Drug API Manufacturing Services?
- 2.1.1 Producing Biological drug API: An Overview of the Manufacturing Process
- 2.1.2 Defining the Biological Drug API Manufacturing Market
- 2.1.3 Differing Expression Systems to Manufacture APIs
- 2.2 Challenges in Manufacturing Biological drug API
- 2.3 Outsourcing: A Common Trend in Biological Drug API Manufacturing Services
- 2.4 Future Trends for the Biological Drug API Manufacturing Services Market
- 3. Biological Drug API Manufacturing Services: World Market Outlook and Forecast 2019-2029
- 3.1 The Contract Biological Drug API Manufacturing Services Market Performance, 2018
- 3.1.1 Contract Biological Drug API Manufacturing Services: Forecast 2018-2029
- 3.2 Drivers and Restraints in the Biological Drug API Manufacturing Services Market
- 3.2.1 Drivers in the Biological Drug API Manufacturing Market
- 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 Biological Drug 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 Biological drug API Services: Increased Demand
- 4. Biological Drug API Manufacturing Services Submarket by Expression Systems: World Market Outlook and Forecasts 2019-2029
- 4.1 Submarkets for the Biological Drug API Manufacturing Services Industry
- 4.1.1 The Mammalian Cell Culture Submarket
- 4.1.1.1 The Mammalian Cell Culture Submarket Forecast 2018-2029
- 4.1.1.2 ADCs and Next-Generation Antibodies Will Drive Growth 2018-2029
- 4.1.2 The Microbial Fermentation Submarket
- 4.1.2.1 The Microbial Fermentation Submarket Forecast 2018-2029
- 4.1.2.2 Increase in Demand for Insulin Will Drive Growth 2018-2029
- 4.1.3 Other APIs Expression Systems Are Still in Development
- 4.1.3.1 Plant-Made Pharmaceuticals
- 4.1.3.2 Yeast Cell Expression Systems
- 4.1.3.3 Insect Cell Expression Systems
- 4.1.3.4 Other Expression Systems Submarket Forecast 2018-2029
- 4.2 Chapter Summary: Positive Growth for the Market
- 5. Biological Drug API Manufacturing: Outlook for Leading Biological Drug Contract API Sectors: 2019-2029
- 5.1 Antibody Therapies: An Introduction to the Largest Contract API Biological Drug Sector
- 5.1.1 Contract API Monoclonal Antibody Manufacturing Forecast 2018-2029
- 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 2018-2029
- 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 2018-2029
- 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 2018 to 2029
- 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 2018-2029
- 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 2018 to 2029
- 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 2018-2029
- 6. Leading National Markets for Contract Biological Drug API Manufacturing Services Market Forecast to 2029
- 6.1 Regional Breakdown of the World Biological Drug API Manufacturing Services Market
- 6.1.1 North America and EU Dominate Growth for Leading National Submarkets 2018-2029
- 6.1.2 National Revenue Shares by 2029: Emerging Market Growth
- 6.2 Contract Biological Drug API Manufacturing in EU Market 2018-2029
- 6.2.1 Strong Growth for the EU Revenue Forecasts 2018-2029
- 6.2.2 Forecasts for Switzerland and Leading EU National Revenues 2018-2029
- 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 2018-2029
- 6.3 Contract Biological Drug API Manufacturing in North America Market 2018-2029
- 6.3.1 Forecasts for North America Leading National Revenues 2018-2029
- 6.3.2 US: A Market Leader in Biological Drug API Manufacturing
- 6.3.3 Canada: A Market Leader in Biological Drug API Manufacturing
- 6.3.4 Mexico: A Market Leader in Biological Drug API Manufacturing
- 6.4 BRIC Market: Contract Biological Drug API Manufacturing Services Market 2018-2029
- 6.4.1 Emerging Nations May Develop a Presence in the Biologics Market
- 6.4.2 Increased Demand for Biosimilars and Biological Drugs 2018-2029
- 6.4.3 China is Poised for Growth: Forecast for 2018-2029
- 6.4.4 India Offers a Lower-Cost Advantage for Biological Drug API Manufacturing Services: Forecast 2018-2029
- 6.4.5 Brazilian and Russian Governments Promoting Domestic Biotech Development
- 6.4.5.1 Russian Biological Drug API Manufacturing Services Forecast: 2018-2029
- 6.4.5.2 Brazilian Biological Drug API Manufacturing Services Forecast: 2018-2029
- 6.5 Forecasts for the Other Leading Nationals Revenues 2018-2029
- 6.5.1 Japan: A Less Mature Contract Manufacturing Market
- 6.5.2 Leading CMOs Celltrion and Samsung BioLogics Drive the Market in South Korea: Market Forecast, 2018-2029
- 6.5.3 Singapore: Market Forecast, 2018-2029
- 6.6 Summary of Chapter: Outlook for Leading National Submarkets 2018-2029
- 7. Leading CMOs in the Biological Drug API Manufacturing Services Market
- 7.1 Four Companies Led the Market in 2018
- 7.2 Leading Companies by Capacity
- 7.2.1 Small-Scale Biopharmaceutical Manufacturing is a Common Trend
- 7.2.2 Barriers to Market Entry 2018-2029
- 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: Following Partnerships and Joint Ventures Path
- 7.6 Patheon N.V.: Target for Mergers and Acquisitions
- 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 2018
- 7.9 Samsung BioLogics: Focusing on Biosimilars
- 7.9.1 Samsung BioLogics: Partnership Strategy for Future Expansion
- 7.10 Cytovance Biologics: Plans to Expand
- 7.11 Fujifilm Diosynth Biotechnologies
- 7.11.1 Facility and Service Expansion for the Future
- 7.12 Leading Biopharma Companies Operate CMO Divisions
- 7.13 AbbVie Contract Manufacturing: Strength through Acquisition
- 7.14 GSK Biopharmaceuticals
- 7.15 Sandoz: Expertise in Biologics and Biosimilars
- 7.16 Rentschler Biopharma: Recent Expansions
- 7.17 Teva: A Future Player in the Biologics Market
- 7.18 Catalent: Follows Acquisition and Investment Strategy for Expansion
- 8. Biological Drug API Manufacturing Services Market Industry Trends: Qualitative Analysis
- 8.1 SWOT Analysis: Strengths and Weaknesses of the Biological Drug API Manufacturing Services Market 2018
- 8.1.1 Strength: Biopharmaceutical Demand for Outsourcing is increasing
- 8.1.2 Weakness: A Fragmented Market with a Costly and Difficult Manufacturing Process
- 8.1.3 Opportunities for the Biological Drug API Manufacturing Services Market 2018-2029
- 8.1.4 Threats for the Biological Drug API Manufacturing Services Market 2018-2029
- 8.2 STEP Analysis of the Biological Drug API Manufacturing Services Market
- 8.2.1 Social Factors: Drug Pricing Pressures to Meet Demand for an Increasing Ageing Population
- 8.2.2 Technological Factors: Advances Will Drive Growth
- 8.2.2.1 Single-Use Technology: A Vital Trend for the Future
- 8.2.3 Economic Factors: The High Cost of Manufacturing Will Lead to Outsourcing
- 8.2.4 Political Factors: Regulatory Requirements Need to Be Met
- 8.3 Trends in Biological Drug Development 2018-2029
- 8.3.1 Biosimilars Will Be an Important Opportunity for CMOs
- 8.3.2 CMOs are investing in Next-Generation Antibody Development
- 8.3.3 Orphan Drugs and Personalised Medicine: Trend for Smaller Batches
- 8.3.4 Outlook for Single-Use Technologies in Biological Drug API Manufacturing 2018-2029
- 8.3.4.1 Future Direction: Single-Use Systems will be Essential
- 8.3.5 Outsourcing Trends for Biological Drug API Manufacturing 2018-2029
- 8.3.5.1 Biopharma Companies Continue to Invest in In-House Facilities
- 8.3.5.2 Off-shoring Biological Drug API Manufacturing to Emerging Markets: Not a Trend for this Decade?
- 8.3.5.3 Overcapacity is a Risk for the Biotech CMO Industry
- 8.3.5.4 Future Trends: Strategic Partnering
- 8.3.5.5 Alternative Expression Methods
- 8.4 Regulations and Effects on the Biological Drug API Manufacturing Services Industry
- 8.4.1 Effect on the Emerging Biological Drug API Manufacturing Services Market 2018-2029
- 8.4.2 Regulations in Other Countries in the Biological drug API Market
- 8.5 Chapter Summary: Industry Trends for Contract Biological Drug API Manufacturing to 2028
- 9. Conclusions
- 9.1 The Contract Biological Drug API Manufacturing Services Market
- 9.2 Outlook for the Biological Drug API Manufacturing Services Market
- 9.2.1 Mammalian Cell Culture is the Leading Expression Platform for Outsourced Biological Drug API Manufacturing
- 9.2.2 The US and EU Markets Lead for the Global Biological Drug API Manufacturing Services Market in 2017
- 9.2.3 Single-Use Technology Will Become Indispensable for Success in the Market
- 9.3 Growth in the Market 2018-2029
- 9.3.1 The Future of the Biological Drug API Manufacturing Services Marketplace
- Appendices
- Associated Reports
- Visiongain Report Sales Order Form
- About Visiongain
- Visiongain Report Evaluation Form
- List of Tables
- Table 2.1 Contract API Manufacturing: Revenues ($bn) and Market Share (%) by Sector, 2018
- Table 3.1 Contract Biological Drug API Manufacturing Services Market: Overall Revenue Forecast ($bn), AGR (%), CAGR (%), 2018-2029
- Table 4.1 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts by Expression Systems Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 4.2 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Mammalian Cell Culture Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 4.3 ADC Pipeline 2019
- Table 4.4 Recent ADC’s Investment
- Table 4.5 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Microbial Fermentation Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 4.6 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Other APIs Expression Systems Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.1 Top Ten Best-Selling Drugs in 2018: Revenue ($bn)
- Table 5.2 Contract API Biological Drug Revenue Forecasts ($bn), AGR (%), CAGR (%), by Therapeutic Area, 2018-2029
- Table 5.3 Monoclonal Antibody Types and Sources
- Table 5.4 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Monoclonal Antibodies Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.5 The Four Classes of Next- Generation Antibody Therapies
- Table 5.6 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Vaccines Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.7 Comparison between biomanufacturing platforms for Vaccine Production: VLP
- Table 5.8 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Insulin Analogues Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.9 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Interferon Therapies Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.10 Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Growth Hormones Submarket ($bn), AGR (%), CAGR (%), 2018-2029
- Table 5.11 Selected Long-Acting Growth Hormones in Development, 2018
- Table 6.1 Contract Biological Drug API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Region, 2018
- Table 6.2 Contract Biological Drug API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Submarket, 2018
- Table 6.3 Contract API Biological Drug Revenue Forecasts ($bn), AGR (%), CAGR (%), by Region, 2018-2029
- Table 6.4 Contract Biological Drug API Manufacturing Market: Leading Nationals Revenue Shares (%), 2018, 2024 & 2029
- Table 6.5 EU and Switzerland Contract Biological Drug API Manufacturing: Revenue Forecasts ($bn), GAGR (%), AGR (%), 2018-2029
- Table 6.6 EU and Switzerland Contract Biological Drug API Manufacturing: Revenues ($bn) and Shares (%) by Leading Country, 2018
- Table 6.7 Germany Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GAGR (%), AGR (%), 2018-2029
- Table 6.8 UK Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2018-2029
- Table 6.9 France Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2018-2029
- Table 6.10 Switzerland Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.11 Spain Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%),2018-2029
- Table 6.12 Italian Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.13 North America Contract Biological Drug API Manufacturing: Revenue Forecasts ($bn), GAGR (%), AGR (%), 2018-2029
- Table 6.14 US Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.15 Canada Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.16 Mexico Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.17 Contract Biological Drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.18 BRIC Markets: API Revenues ($bn) and Market Shares (%), 2018
- Table 6.19 Contract Biological Drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2018-2029
- Table 6.20 Chinese Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%),
Research Assistance
Download our eBook: How to Succeed Using Market Research
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
Download eBook