Biological Drug API Manufacturing Services World Industry and Market Forecast to 2029

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?
Visiongain’s study is intended for anyone requiring commercial analyses for the biological drug API manufacturing market. You find data, trends and predictions.

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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 (%),

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