The pharmaceutical contract manufacturing market is expected to grow at a CAGR of 5.7% in the first half of the forecast period. The API Manufacturing submarket held 67% of the market in 2018. Visiongain estimated that the pharmaceutical contract manufacturing market will reach $138bn in 2024.
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Report Scope
• Global Pharmaceutical Contract Manufacturing Market forecasts from 2019-2029
• Submarket forecasts at world level, from 2019-2029: • Active pharmaceutical ingredients (APIs), with sub forecasts for generic APIs, high potency active pharma ingredients (HPAPIs) and other products • Finished dosage formulations (FDFs), with sub forecasts for solid dose forms, injectable dosages and other dosage types • Other applications of outsourced production – other related services
• Revenue forecasts from 2019-2029, for these regional and national markets: • The US • Canada • Japan • EU5: Germany, France, the UK, Italy and Spain • BRIC: Brazil, Russia, India, China • South Korea • Turkey • Mexico • Others
• Assessment of selected leading companies that hold major market shares in the pharmaceutical contract manufacturing industry
• Qualitative Analysis from a CMO Perspective
• Qualitative Analysis from a Client Perspective
• Key questions answered by this report: • What is the current size of the total global pharmaceutical contract manufacturing market? • How much will this market be worth from 2018 to 2029? • How is the pharmaceutical contract manufacturing market evolving? • What is driving and restraining the pharmaceutical contract manufacturing market? • What are the market shares of each segment of the overall pharmaceutical contract manufacturing market currently and how will these change to 2029? • What are the main submarkets and how much revenue will each pharmaceutical contract manufacturing submarket account for over the next 10 years to 2029 and why? • How will the market shares for each pharmaceutical contract manufacturing submarket develop from 2018 to 2029? • Who are the leading players and what are their prospects over the forecast period? • How will the industry evolve to 2029? • What are the largest national markets for pharmaceutical contract manufacturing? What is the current status and how will it develop over the next ten years? What are their forecasts for 2019-2029? • Who are the most prominent companies, and what are their activities and outlooks? • What are the main trends that will affect the pharmaceutical contract manufacturing market between 2018 and 2029?
Visiongain’s study is intended for anyone requiring commercial analyses for the pharmaceutical contract manufacturing market. You find data, trends and predictions.
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1. Report Overview 1.1 Global Pharmaceutical Contract Manufacturing Market Segmentation 1.2 Global Pharmaceutical Contract Manufacturing Market Overview 1.3 Why You Should Read This Report 1.4 How This Report Delivers 1.5 Key Questions Answered by This Analytical Report 1.6 Who is This Report For? 1.7 Methodology 1.8 Frequently Asked Questions (FAQ) 1.9 Associated Visiongain Reports 1.10 About Visiongain
2. Introduction to Pharmaceutical Contract Manufacturing 2.1 What is Pharmaceutical Contract Manufacturing? 2.2 The Benefits of Outsourcing in the Pharmaceutical Market 2.3 Pharmaceutical Contract Manufacturing Services 2.4 Strategy and Tactics: The Importance of Outsourcing Wisely 2.5 Trends in Contract Manufacturing, 2018-2029 2.6 Pharmaceutical Contract Manufacturing: Market Segmentation
3. Pharmaceutical Contract Manufacturing: World Market 2019-2029 3.1 Pharmaceutical Contract Manufacturing Market: 3.1.1 Contract Manufacturing is the Most Mature Pharma Outsourcing Sector 3.1.2 The Pharma Contract Manufacturing Market by Sector 2018 3.2 Pharma Contract Manufacturing: Overall Market Forecast 2019-2029 3.2.1 Changing Market Shares by Segment 2018-2029 3.2.2 Drivers for Growth in the Contract Manufacturing Market to 2029 3.2.3 Generics: A Driver or Restraint? 3.2.4 Other Contract Manufacturing Services Market: Outlook and Forecast, 2019-2029 3.2.4.1 Increasing Demand for Formulation Development Services 4. The Contract API Manufacturing Services Submarket 2019-2029 4.1 The Contract API Manufacturing Submarket 4.1.1 Chemical APIs Will Experience Resurgence after the Shift of Focus to Biological APIs 4.1.2 The API Manufacturing Submarket by Sector, 2018 4.2 The Contract API Manufacturing Submarket: Outlook and Forecast 2019-2029 4.2.1 Drivers for Growth in the API Submarket to 2029 4.2.2 The Potential for Microreactors in Commercial Manufacturing to 2029 4.2.3 How Will New EU Regulations Impact the API Manufacturing Submarket? 4.2.4 Contract API Manufacturing Submarket Restraint 2019-2029 4.2.4.1 Backwards Integration for Generics Manufacturers 4.3 The Contract Generic API Manufacturing Submarket 2019-2029 4.3.1 The Contract Generic API Manufacturing Submarket Forecast 2019-2029 4.3.2 The Contract Generic API Manufacturing Submarket Drivers and Restraints to 2029 4.3.2.1 The US Generic Drug User Fee Act and API Manufacturing 4.4 The Contract HPAPI Manufacturing Submarket 2015-2028 4.4.1 Challenges and Opportunities in High Containment Manufacturing 4.4.2 Company Investment into HPAPI Manufacturing Facilities: Growth Increases in the HPAPI Manufacturing Sector 4.4.3 The Contract HPAPI Manufacturing Submarket Forecast 2018-2029 4.4.4 The Contract HPAPI Manufacturing Submarket Drivers and Restraints to 2029
5. The Contract FDF Manufacturing Services Submarket 2019-2029 5.1 The Contract FDF Manufacturing Submarket, 2018 5.1.1 Solid Dosage Manufacturing Leads the Market 5.1.2 CMOs Report High Demand for Softgel Formulations 5.2 The Contract FDF Manufacturing Submarket Forecast 2019-2029 5.2.1 Complex Molecule Manufacturing Will Drive Growth to 2029 5.2.2 What Will Restrain Growth in FDF Outsourcing? 5.3 The Contract Solid Dosage Manufacturing Submarket 2019-2029 5.3.1 How Will Revenue for Solid Dosage Manufacturing Grow to 2029? 5.3.2 The Solid Dosage Manufacturing Submarket Drivers and Restraints 2019-2029 5.3.2.1 Will Product Reformulation Drive Growth to 2029? 5.4 The Contract Injectable Dosage Manufacturing Submarket 2019-2029 5.4.1 The Contract Injectable Dosage Manufacturing Submarket Forecast 2019-2029 5.4.1.1 Drug Shortages Offer Opportunity to CMOs in the Short-Term 5.4.2 Demand for Biopharma Manufacturing Will Drive Growth 2019-2029 5.4.2.1 Interest in Antibody-Drug Conjugate Development Is Growing 5.4.2.3 Challenges in Manufacturing Antibody-Drug Conjugates 5.4.3 Lyophilisation and Aseptic Filling Demand Will Rise 5.4.3.1 Will Spray Drying Replace Lyophilisation in FDF Manufacturing?
6. Leading National Markets for Pharmaceutical Contract Manufacturing 2019-2029 6.1 Leading National Markets for Pharmaceutical Contract Manufacturing, 2018 6.1.1 Challenges in Assessing the Market: Supply versus Demand 6.1.2 Leading National Pharmaceutical Contract Manufacturing Markets: Revenue Forecasts 2019-2029 6.1.3 Pharmaceutical Manufacturing in the US: Regulatory Oversight, 2018 6.1.4 Controlling Foreign Manufacturing Sites 6.1.5 What Impact Will the GDUFA 2012 Have on Foreign Manufacturing? 6.1.6 Outsourcing and US Manufacturing Regulations 6.1.7 Increased Demand for Domestic API Manufacturing? 6.2 The US Contract Manufacturing Market Forecast 2019-2029 6.3 Canada Contract Manufacturing Market Forecast 2019-2029 6.4 Outlook for Pharmaceutical Contract Manufacturing in the EU 6.4.1 The EU is the Leading Destination for Pharmaceutical Contract Manufacturing 6.4.2 Regulatory Aspects of Pharma Manufacturing in the EU 6.4.2.1 The European Commission Amends Annex 16 6.4.2.2 The Falsified Medicine Directive: Controlling API Imports 6.4.3 Biopharma Manufacturing Demand Will Rise 6.4.4 The EU Contract Manufacturing Market Forecast 2019-2029 6.4.5 Germany: The Leading EU Destination for API and FDF Manufacturing 6.4.5.1 Demand for Contract Manufacturing in Germany: Revenue Forecast 2019-2029 6.4.6 CMOs Account for a Third of Manufacturing Sites in France 6.4.6.1 French Pharma Contract Manufacturing Market Forecast 2019-2029 6.4.7 Italy: Strong API Manufacturing Traditions 6.4.7.1 Revenue Forecast for the Italian Pharma Contract Manufacturing Market 2019-2029 6.4.8 Spain: How Will Demand for Manufacturing Services Grow? 6.4.9 UK: Pharmaceutical Contract Manufacturing Market Forecast 2019-2029 6.5 Pharma Contract Manufacturing in Japan to 2029 6.5.1 Pharmaceutical Manufacturing Regulations in Japan 6.5.1.1 The Pharmaceutical Affairs Law 6.5.2 Greater API Outsourcing to Drive Japanese Market Growth to 2028 In Spite of Currency Devaluation Weakening the Economy
7. Leading Emerging Markets for Pharmaceutical Contract Manufacturing Market 2019-2029 7.1 Pharmaceutical Contract Manufacturing in Developing Countries 7.1.1 Outsourcing to Emerging National Markets from Developed Markets 7.1.1.1 Demand Will Increase for Services in India and China 7.1.2 Domestic Demand for Pharmaceutical Contract Manufacturing Services 7.1.3 Pharmaceutical Contract Manufacturing: Leading Emerging National Market Forecasts 2019-2029 7.2 Chinese Demand for Pharma Contract Manufacturing Services 2019-2029 7.2.1 Improved Manufacturing Regulations in China 7.2.1.1 Regulations for Excipients and Guidance for API Manufacturing 7.2.1.2 What Are the Consequences to Stricter Manufacturing Regulations in China? 7.2.2 Chinese CMOs Are Investing in Biopharma Manufacturing 7.2.3 China Pharma Contract Manufacturing Market Forecast 2019-2029 7.3 India: CMOs with Strong Infrastructure and Growing Expertise 7.3.1 Regulatory Outlook for Indian Pharma Manufacturing 7.3.1.1 Stricter Quality Standards to Ensure Compliance with EU Rules 7.3.2 Domestic Manufacturing Dominates the Indian Pharma Market 7.3.3 Demand for Contract Manufacturing in India: Market Forecast 2019-2029 7.4 Brazil: Contract Manufacturing Outlook 2019-2029 7.4.1 Pharmaceutical Manufacturing Regulations in Brazil 7.4.1.1 Guidelines and Regulations Proposed 7.4.2 Brazil Imports Most of its APIs 7.4.3 Brazil: Pharma Contract Manufacturing Market Forecast 2019-2029 7.5 The Russian Pharma Contract Manufacturing Market 2019-2029 7.5.1 Pharma Manufacturing Regulations in Russia 7.5.1.1 Compliance with GMP in Russia 7.5.2 How Will Demand for Contract Manufacturing Grow in Russia to 2029? 7.6 South Korea: Government Supported Growth 7.6.1 South Korea: Strict GMP Regulations 7.6.2 South Korea: Pharma Contract Manufacturing Market Forecast 2019-2029 7.7 Turkey: Domestic Market to offer Huge Growth Opportunities 7.7.1 Turkey: An Important Hub for Global Pharma Companies 7.7.2 Drug Approvals Delaying Growth of the Turkey Pharma Market 7.7.3 Turkey: Pharma Contract Manufacturing Market Forecast 2019-2029 7.8 Mexico: Emerging Market Power 7.8.1 Healthcare – A Top Priority in Mexico 7.8.2 Strategic Management of High Expectations 7.8.3 Mexico: Pharma Contract Manufacturing Market Forecast 2019-2029
8. Leading Companies in the Pharmaceutical Contract Manufacturing Market 8.1 Leading CMOs in the Pharmaceutical Contract Manufacturing Market 8.2 Catalent: Leading CMO 8.2.1 Multiple Expansions and Increased Focus on Biologic Manufacturing 8.2.2 Recent Developments 8.3 Lonza: Potential to Lead in ADC Manufacturing 8.3.1 Lonza: Expanding its Capacities to Meet Customer Demand for Biologic Manufacturing 8.3.2 Recent Developments 8.4 Evonik Degussa: Specialising in Small Molecules 8.4.1 Recent Developments 8.5 DPx Holdings - DSM and Patheon: Recent Merger Has Strengthened Their Position 8.5.1 Increasing Capacity Tactically and Expanding Worldwide 8.6 Teva: The World’s Largest API Manufacturer 8.6.1 Will Teva Expand into Emerging Markets? 8.6.2 Recent Developments 8.7 Boehringer Ingelheim BioXcellence: Boehringer’s Biopharma Manufacturing Division 8.7.1 Recent Developments 8.7.2 Adding New Services for Growth 8.8 Famar: A Possible Candidate for Acquisition 8.8.1 Recent Developments 8.9 Fareva: A Strategic Shift from Acquisition to Increase in Capacity 8.10 Vetter Pharma: Specialists in Aseptic Filling, Lyophilisation and Siliconisation 8.10.1 Vetter’s Growth: Increasing in Capacity and Market Expansion 8.11 Mylan: A World Leader in Generics Manufacturing 8.11.1 Recent Developments
9. Pharmaceutical Contract Manufacturing Industry Trends: Qualitative Analysis from a CMO Perspective 2019-2029 9.1 Pharma Contract Manufacturing Market: Strengths and Weaknesses from a CMO Perspective 2019-2029 9.2 Pharma Contract Manufacturing Market: Opportunities and Threats from a CMO Perspective 2019-2029 9.3 Pharma Contract Manufacturing Market: STEP Analysis 2019-2029 9.3.1 Social Factors 9.3.2 New Technologies Will Drive Market Growth to 2029 9.3.2.1 Advantages of Single-Use Technologies in Biopharma Manufacturing 9.3.2.2 Green Technology in Contract Manufacturing 9.3.2.3 Drug Delivery Trends and CMOs 9.3.2.4 Biologics Are Causing Increased Demand for Lyophilisation 9.3.2.5 Improving Solubility and Stability for Small Molecules 9.3.2.6 Spray Drying as an Advantageous Alternative to Lyophilisation 9.3.2.7 Hot-Melt Extrusion: A Niche Opportunity 9.3.3 Economic Pressures 9.3.3.1 Developed-Market CMOs Facing Competition from Emerging Markets 9.3.4 Political Issues 9.3.4.1 How Will Regulatory Developments Affect CMOs? 9.4 Trends in Drug Development Affecting CMOs to 2028 9.4.1 Orphan Drug Development: Smaller Manufacturing Capacities 9.4.2 Complex Biologics: Interest in ADCs is increasing 9.4.3 How Will Biosimilar Market Growth Affect CMOs? 9.4.4 The Future of Small Molecule Outsourcing 9.5 How Will CMOs Expand in the Coming 10 Years? 9.5.1 CMO Consolidation Will Increase 9.5.2 There Will Be More Manufacturing Facilities Available for Acquisition 9.6 Developments in the Manufacturing Process 9.6.1 Rising Interest from Companies in Quality by Design (QbD) 9.6.2 A Move Towards Continuous Manufacturing
10. Pharmaceutical Contract Manufacturing Trends: Qualitative Analysis of the Pharmaceutical Contract Manufacturing Market from a Client Perspective 2019-2029 10.1 Pharma Contract Manufacturing Market: Strengths and Weaknesses from a Client Perspective 2019-2029 10.2 Pharma Contract Manufacturing Market: Opportunities and Threats from a Client Perspective 2019-2029 10.3 Important Aspects of the Outsourcing Decision 10.3.1 What Factors Will Influence CMO Selection? 10.3.2 CMO - Pharma Partnering Models 10.3.3 Strategic Partnering 10.3.4 Selecting a Local CMO vs. Offshoring 10.3.5 CMOs in Emerging Markets 10.3.6 Good Communication is Vital for Success 10.3.7 Ensuring Protection in Intellectual Property and Tech Transfer 10.3.8 Regulatory Compliance is a Key Deciding Factor for Pharma Clients 10.3.8.1 Regulatory Bodies and Outsourcing 10.3.8.2 Quality Agreement 10.3.8.3 Global Harmonisation Will Improve Compliance 10.4 Trends in Outsourcing Partnerships 2019-2029 10.4.1 Big Pharma and Outsourced Manufacturing 10.4.2 Small and Virtual Pharma Companies 10.4.3 How Will Biotech Funding Impact the Pharma Contract Manufacturing Industry to 2029?
11. Conclusions 11.1 The World Pharmaceutical Contract Manufacturing Market 11.2 Outlook for the Market to 2029 11.2.1 Rising Demand for High Value Services 2018-2029 11.2.2 Demand Will Be Highest Among Developed-Market Clients 11.3 Which New Technologies Will Stimulate Demand to 2029?
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AbbVie Actavis ADC Biotechnology Aegerion Pharmaceuticals Aenova Group Aesica Pharma Agensys Agila Specialties Ajinomoto Althea Inc Alexion Pharmaceuticals Almac Group Althea Technologies AMRI (Albany Molecular Research Inc) API Corporation (APIC) Aspen Pharmacare Astellas AstraZeneca Banner Life Sciences Banner Pharmacaps Baring Private Equity Asia Bausch & Lomb Bayer Healthcare Ben Venue Laboratories Bend Research Biogen Idec BioIndustry Association (BIA) Biotest Blackstone Group Boehringer Ingelheim Boehringer Ingelheim BioXcellence Bristol-Myers Squibb Company Bushu Pharmaceuticals Cambrex Cambridge Major Laboratories Catalent Pharma Solutions Cedarburg Hauser Cell Therapy Catapult Celldex Therapeutics Celltrion Cenexi Chemisch-Pharmazeutisches Laboratorium Ravensburg Chemtrix China FDA (CFDA) Cipla Cook Pharmica CordenPharma CTC Bio Daito Pharmaceutical Delpharm Dishman Pharmaceuticals DPx Fine Chemicals DPx Holdings B.V. Dr. Reddy’s Laboratories DSP (DSM Sinochem Pharmaceuticals) Eisai Eli Lilly Esteve Quimica Euticals Evonik Degussa Famar Fareva FUJIFILM Diosynth Biotechnologies, Gallus Biopharmaceutical, LLC. G-CON GEA Pharma-Systems Genentech GlaxoSmithKline (GSK) Granules India Haupt Pharma Hexal Hospira Hospira One2One ImmunoGen Immunomedics Indian Pharmaceutical Alliance Innovent Biologics IRIX Pharmaceuticals Janssen JK Pharmaceutical Johnson & Johnson Knowledge Transfer Network (KTN) Lonza Lupin Marinopoulos Group Matrix Laboratories Medice Medichem Merck & Co. Micron Technologies Millennium Mitsui & Co Momenta Pharmaceuticals Mylan Neuland Laboratories NICE Insight NPS Pharmaceuticals Nycomed Orchid Chemicals & Pharmaceuticals Oxford Biomedica Patheon Patheon Biologics Pfizer Pharmapak Technologies Piramal Pharma Solutions Progenics Quintiles Recepta Biopharma Recipharm Redwood Bioscience Rentschler Biotechnologie Roche Royal DSM SAFC SafeBridge Samsung Bioepis Samsung BioLogics Sandoz Sanofi Seattle Genetics Shandong Xinhua ShangPharma Shire Siegfried AG Sigmar Italia SMS Pharmaceuticals Solvias AG Speedel Stada Stem CentRx Stevenage Bioscience Catalyst Takeda Temmler Group Teva API Thermo Fisher Scientific UMN Pharma UNIGEN Valeant Pharmaceuticals Valerion Therapeutics, LLC. Vetter Pharma-Fertigung GmbH Vivante GMP Solutions West Pharmaceutical Services WuXi PharmaTech Zhangjiang Biotech & Pharmaceutical Base Company Zhejiang Jiang Yuan Tang Biotechnology
List or Organizations Mentioned in the Report Agência Nacional de Vigilância Sanitária (ANVISA) Asociación Española de Fabricantes de Productos de Química Fina (AFAQUIM) Associação Brasileira da Indústria Farmoquímica e de Insumos Farmacêuticos (ABIQUIFI) Association of British Pharmaceutical Industry (ABPI) Central Drugs Standard Control Organization (CDSCO) Department of Health and Family Welfare Development and Reform Commission (NDRC) European Commission European Medicines Agency (EMA) Food and Drug Administration (US FDA) Indian Drug Manufacturer’s Association (IDMA) International Society of Pharmaceutical Engineering (IPSE) Korea Food and Drug Administration (KFDA) Korea Pharmaceutical Manufacturer’s Association (KPMA) Medicines and Healthcare Products Regulatory Agency (MHRA) Medicines Manufacturing Industry Partnership (MMIP) Ministry of Health (MOH) Ministry of Health, Labor and Welfare (MHLW) Ministry of Industry and Information Technology (MIIT) Pharmaceutical and Medical Devices Agency (PMDA) World Health Organization (WHO)
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