【レポートの概要(一部)】
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, 2016-2026
2.6 Pharmaceutical Contract Manufacturing: Market Segmentation
3. Pharmaceutical Contract Manufacturing: World Market 2015-2026
3.1 Pharmaceutical Contract Manufacturing Market: Historical Performance 2012-2014
3.1.1 Contract Manufacturing is the Most Mature Pharma Outsourcing Sector
3.1.2 The Pharma Contract Manufacturing Market by Sector 2014
3.2 Pharma Contract Manufacturing: Overall Market Forecast 2015-2026
3.2.1 Changing Submarket Shares by Segment 2015-2026
3.2.2 Drivers for Growth in the Contract Manufacturing Market to 2026
3.2.3 Generics: A Driver or Restraint?
3.2.4 Other Contract Manufacturing Services Submarket: Outlook and Forecast 2014-2016
3.2.4.1 Increasing Demand for Formulation Development Services
4. The Contract API Manufacturing Services Submarket 2015-2026
4.1 The Contract API Manufacturing Submarket 2014
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 2014
4.2 The Contract API Manufacturing Submarket: Outlook and Forecast 2015-2026
4.2.1 Drivers for Growth in the API Submarket to 2026
4.2.2 The Potential for Microreactors in Commercial Manufacturing to 2026
4.2.3 How Will New EU Regulations Impact the API Manufacturing Submarket?
4.2.4 Contract API Manufacturing Submarket Restraint 2016-2026
4.2.4.1 Backwards Integration for Generics Manufacturers
4.3 The Contract Generic API Manufacturing Submarket 2015-2026
4.3.1 The Contract Generic API Manufacturing Submarket Forecast 2015-2026
4.3.2 The Contract Generic API Manufacturing Submarket Drivers and Restraints to 2026
4.3.2.1 The US Generic Drug User Fee Act and API Manufacturing
4.4 The Contract HPAPI Manufacturing Submarket 2015-2026
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 2015-2026
4.4.4 The Contract HPAPI Manufacturing Submarket Drivers and Restraints to 2026
5. The Contract FDF Manufacturing Services Submarket 2015-2026
5.1 The Contract FDF Manufacturing Submarket 2014
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 2015-2026
5.2.1 Complex Molecule Manufacturing Will Drive Growth to 2026
5.2.2 What Will Restrain Growth in FDF Outsourcing?
5.3 The Contract Solid Dosage Manufacturing Submarket 2015-2026
5.3.1 How Will Revenue for Solid Dosage Manufacturing Grow to 2026?
5.3.2 The Solid Dosage Manufacturing Submarket Drivers and Restraints 2016-2026
5.3.2.1 Will Product Reformulation Drive Growth to 2026?
5.4 The Contract Injectable Dosage Manufacturing Submarket 2015-2026
5.4.1 The Contract Injectable Dosage Manufacturing Submarket Forecast 2015-2026
5.4.1.1 Drug Shortages Offer Opportunity to CMOs in the Short-Term
5.4.2 Demand for Biopharma Manufacturing Will Drive Growth 2016-2026
5.4.2.1 Interest in Antibody-Drug Conjugate Development Is Growing
5.4.2.2 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 2015-2026
6.1 Leading National Markets for Pharmaceutical Contract Manufacturing 2014
6.1.1 Challenges in Assessing the Market: Supply versus Demand
6.1.2 Leading National Pharmaceutical Contract Manufacturing Markets: Revenue Forecasts 2015-2026
6.1.3 Pharmaceutical Manufacturing in the US: Regulatory Oversight 2014
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 2015-2026
6.3 Outlook for Pharmaceutical Contract Manufacturing in the EU
6.3.1 The EU is the Leading Destination for Pharmaceutical Contract Manufacturing
6.3.2 Regulatory Aspects of Pharma Manufacturing in the EU
6.3.2.1 The European Commission Amends Annex 16
6.3.2.2 The Falsified Medicine Directive: Controlling API Imports
6.3.3 Biopharma Manufacturing Demand Will Rise to 2026
6.3.4 The EU Contract Manufacturing Market Forecast 2015-2026
6.3.5 Germany: The Leading EU Destination for API and FDF Manufacturing
6.3.5.1 Demand for Contract Manufacturing in Germany: Revenue Forecast 2015-2026
6.3.6 CMOs Account for a Third of Manufacturing Sites in France
6.3.6.1 French Pharma Contract Manufacturing Market Forecast 2015-2026
6.3.7 Italy: Strong API Manufacturing Traditions
6.3.7.1 Revenue Forecast for the Italian Pharma Contract Manufacturing Market 2015-2026
6.3.8 Spain: How Will Demand for Manufacturing Services Grow to 2026?
6.3.9 UK: Pharmaceutical Contract Manufacturing Market Forecast 2015-2026
6.4 Pharma Contract Manufacturing in Japan to 2026
6.4.1 Pharmaceutical Manufacturing Regulations in Japan
6.4.1.1 The Pharmaceutical Affairs Law
6.4.2 Greater API Outsourcing to Drive Japanese Market Growth to 2026 In Spite of Currency Devaluation Weakening the Economy
7. Leading Emerging Markets for Pharmaceutical Contract Manufacturing 2015-2026
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 2015-2026
7.2 Chinese Demand for Pharma Contract Manufacturing Services 2015-2026
7.2.1 Improved Manufacturing Regulations in China
7.2.1.1 New Regulations for Excipients and Guidance for API Manufacturing 2012-2013
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 2015-2026
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 2015-2026
7.4 Brazil: Contract Manufacturing Outlook 2015-2026
7.4.1 Pharmaceutical Manufacturing Regulations in Brazil
7.4.1.1 New Guidelines and Regulations Proposed 2012-2013
7.4.2 Brazil Imports Most of its APIs
7.4.3 Brazil: Pharma Contract Manufacturing Market Forecast 2015-2026
7.5 The Russian Pharma Contract Manufacturing Market 2015-2026
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 2026?
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 2015-2026
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
8.3 Lonza: Potential to Lead in ADC Manufacturing
8.3.1 Lonza: Expanding its Capacities to Meet Customer Demand for Biologic Manufacturing
8.4 Evonik Degussa: Specialising in Small Molecules
8.4.1 Developments at Evonik Degussa
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?
8.7 Boehringer Ingelheim BioXcellence: Boehringer’s Biopharma Manufacturing Division
8.7.1 Adding New Services for Growth
8.8 Famar: A Possible Candidate for Acquisition
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
9. Pharmaceutical Contract Manufacturing Industry Trends: Qualitative Analysis from a CMO Perspective 2016-2026
9.1 Pharma Contract Manufacturing Market: Strengths and Weaknesses from a CMO Perspective 2016-2026
9.2 Pharma Contract Manufacturing Market: Opportunities and Threats from a CMO Perspective 2016-2026
9.3 Pharma Contract Manufacturing Market: STEP Analysis 2016-2026
9.3.1 Social Factors
9.3.2 New Technologies Will Drive Market Growth to 2026
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 2026
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 2016-2026
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 2016-2026
10.1 Pharma Contract Manufacturing Market: Strengths and Weaknesses from a Client Perspective 2016-2026
10.2 Pharma Contract Manufacturing Market: Opportunities and Threats from a Client Perspective 2016-2026
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 2016-2026
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 2026?
11. Research Interviews
11.1 Interview with Gordon Bates, SVP Business Unit Head, Chemical and Microbial Manufacturing, Lonza Pharma & Biotech
11.1.1 Lonza’s Pharmaceutical Contract Manufacturing Capabilities and Experience
11.1.2 Upcoming Trends in Drug Development that Will Affect the Pharmaceutical Contract Manufacturing Industry
11.1.3 The Potential of the Emerging Marketplace
11.1.4 Outlook on Qualities Needed For CMO Success
11.1.5 Industry Trends: Changes in the Next Ten Years
11.2 Interview with Dr Michael Quirmbach, VP, Global Sales and Marketing, CordenPharma International
11.2.1 The Range of CDMO Services Available at CordenPharma
11.2.2 CordenPharma’s Systematic Approach Navigates the Challenges of HPAPI Manufacturing
11.2.3 Future Trends in the Developed and Emerging Markets for Contract Manufacturing
11.2.4 Certain Manufacturing Sectors are Primed for Growth While Others Decline
11.2.5 Factors for CDMO Success in the Contract Manufacturing Market
12. Conclusions
12.1 The World Pharmaceutical Contract Manufacturing Market
12.2 Outlook for the Market to 2026
12.2.1 Rising Demand for High Value Services 2016-2026
12.2.2 Demand Will Be Highest Among Developed-Market Clients
12.3 Which New Technologies Will Stimulate Demand to 2026?
【レポート販売概要】
■ タイトル:医薬品製造委託の世界市場2016-2026■ 英文:Pharmaceutical Contract Manufacturing Market 2016-2026 : Discover Revenue Forecasts for Active Ingredient (API) and Finished Dose Formulation (FDF) Services
■ 発行日:2016年3月
■ 調査会社:visiongain
■ 商品コード:VGAIN6041532
■ 調査対象地域:グローバル
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