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【英文タイトル】Pharmaceutical Contract Manufacturing: World Industry and Market Outlook 2015-2025

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【レポートの概要(一部)】

1. Report Overview
1.1 Pharma Contract Manufacturing: World Market Overview
1.2 Why You Should Read This Report
1.3 How This Report Delivers
1.4 Main Questions Answered by This Analysis
1.5 Who is This Study For?
1.6 Research and Analysis Methods
1.7 Frequently Asked Questions (FAQs)
1.8 Some Associated Reports
1.9 About Visiongain

2. Pharma Contract Manufacturing
2.1 An Introduction to Pharma Contract Manufacturing
2.1.1 Why Outsource in the Pharma Industry?
2.1.2 Services Offered by CMOs
2.1.3 Tactical and Strategic Manufacturing Outsourcing
2.1.4 Trends in Contract Manufacturing 2015-2025

3. The Pharma Contract Manufacturing Market: Outlook and Forecast 2015-2025
3.1 The Pharma Contract Manufacturing: Market Performance 2012-2013
3.1.1 Contract Manufacturing Is the Most Mature Pharma Outsourcing Sector
3.1.2 The Pharma Contract Manufacturing Market by Sector 2013
3.2 Pharma Contract Manufacturing: Overall Market Forecast 2015-2025
3.2.1 What Will Drive Growth for Contract Manufacturers 2015-2025?
3.2.2 Will Generics Drive or Restrain Market Growth?
3.2.3 Outlook and Revenue Forecast for Other Contract Manufacturing Services 2015-2025
3.2.3.1 Rising Demand for Formulation Development Services
3.3 Clinical and Commercial Manufacturing Services
3.3.1 Clinical-Stage Manufacturing: Submarket Forecast 2015-2025
3.3.2 Commercial-Stage Manufacturing: Submarket Forecast 2015-2025
3.4 Leading Contract Manufacturing Organisations (CMOs)
3.4.1 Catalent Pharma Solutions: The Market Leader
3.4.1.1 Expanding in Clinical and Biopharma Manufacturing
3.4.2 Lonza: An Expert in Biopharma Manufacturing
3.4.2.1 Lonza and Advanced Biopharma Manufacturing
3.4.3 Evonik Degussa: A Small Molecule Specialist
3.4.3.1 Growth in HPAPI Manufacturing
3.4.4 Royal DSM
3.4.4.1 Adding Biopharma Capacity
3.4.5 Teva API: The World’s Largest API Manufacturer
3.4.5.1 Will Teva Expand in Emerging Markets?
3.4.6 Patheon
3.4.6.1 Patheon Is Adding New Formulation Development Services
3.4.7 Boehringer BioXcellence: Boehringer’s Biopharma Manufacturing Division
3.4.7.1 Adding New Services for Growth
3.4.8 Famar
3.4.9 Fareva
3.4.10 Vetter Pharma: Aseptic Filling for Biologics and Small Molecules
3.4.10.1 Vetter Offers its Clients New Services

4. The Contract API Manufacturing Submarket: Outlook 2015-2025
4.1 The Contract API Manufacturing Submarket 2013
4.1.1 The API Manufacturing Submarket by Sector 2013
4.2 The Contract API Manufacturing Submarket Outlook 2014-2025
4.2.1 The Contract API Manufacturing Submarket Forecast 2015-2025
4.2.2 What Will Drive Submarket Growth to 2025?
4.2.2.1 The Potential for Microreactors in Commercial Manufacturing to 2025
4.2.3 How Will New EU Regulations Impact the API Manufacturing Submarket?
4.2.4 Contract API Manufacturing Submarket Restraints 2015-2025
4.2.4.1 Backwards Integration for Generics Manufacturers
4.3 The Contract Generic API Manufacturing Submarket 2015-2025
4.3.1 The Contract Generic API Manufacturing Submarket Forecast 2015-2025
4.3.2 The Contract Generic API Manufacturing Submarket Drivers and Restraints to 2025
4.3.2.1 The US Generic Drug User Fee Act and API Manufacturing
4.4 The Contract HPAPI Manufacturing Submarket 2015-2025
4.4.1 Challenges and Opportunities in High Containment Manufacturing
4.4.2 Many Companies Are Investing in HPAPI Manufacturing Facilities
4.4.3 The Contract HPAPI Manufacturing Submarket Forecast 2015-2025
4.4.4 Submarket Drivers and Restraints 2015-2025

5. The Contract FDF Manufacturing Submarket Outlook 2015-2025
5.1 The Contract FDF Manufacturing Submarket 2013
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 2015-2025
5.2.1 Complex Molecule Manufacturing Will Drive Growth to 2025
5.2.2 What Will Restrain Growth in FDF Outsourcing?
5.3 The Contract Solid Dosage Manufacturing Submarket 2015-2025
5.3.1 How Will Revenues for Solid Dosage Manufacturing Grow 2015-2025?
5.3.2 Submarket Drivers and Restraints 2015-2025
5.3.2.1 Will Product Reformulation Drive Growth to 2025?
5.4 The Contract Injectable Dosage Manufacturing Submarket 2015-2025
5.4.1 The Contract Injectable Dosage Manufacturing Submarket Forecast 2015-2025
5.4.1.1 Drug Shortages Offer an Opportunity for CMOs in the Short Term
5.4.2 Demand for Biopharma Manufacturing Will Drive Growth 2015-2025
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. Pharma Contract Manufacturing: Leading Developed National Markets 2015-2025
6.1 Leading National Markets for Pharma Contract Manufacturing 2013
6.1.1 Challenges in Assessing the Market: Supply vs. Demand
6.1.2 Leading National Pharma Contract Manufacturing Markets: Revenue Forecasts 2015-2025
6.2 The US Is the Leading National Market in Terms of Demand
6.2.1 Pharma Manufacturing in the US: Regulatory Oversight 2013
6.2.1.1 Controlling Foreign Manufacturing Sites
6.2.1.2 What Impact Will the GDUFA 2012 Have on Foreign Manufacturing?
6.2.1.3 Outsourcing and US Manufacturing Regulations
6.2.2 Increased Demand for Domestic API Manufacturing?
6.2.3 The US Contract Manufacturing Submarket Forecast 2015-2025
6.3 Outlook for Pharma Contract Manufacturing in the EU
6.3.1 The EU is the Leading Destination for Pharma Contract Manufacturing
6.3.2 Regulatory Aspects to 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 2025
6.3.4 The EU Contract Manufacturing Submarket Forecast 2015-2025
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 2015-2025
6.3.6 CMOs Account for a Third of Manufacturing Sites in France
6.3.6.1 French Pharma Contract Manufacturing Submarket Forecast 2015-2025
6.3.7 Italy: Strong API Manufacturing Traditions
6.3.7.1 Revenue Forecast for the Italian Pharma Contract Manufacturing Submarket 2015-2025
6.3.8 Spain: How Will Demand for Manufacturing Services Grow to 2025?
6.3.9 The UK: Pharma Contract Manufacturing Submarket Forecast 2015-2025
6.4 Pharma Contract Manufacturing in Japan 2015-2025
6.4.1 Pharma Manufacturing Regulations in Japan
6.4.1.1 The Pharmaceutical Affairs Law
6.4.2 Greater API Outsourcing to Drive Japanese Submarket Growth to 2025

7. Pharma Contract Manufacturing: Leading Emerging National Markets 2015-2025
7.1 Pharma Contract Manufacturing in Developing Countries
7.1.1 Outsourcing to Emerging National Markets from Developed Markets
7.1.1.1 Demand for Services in India and China
7.1.2 Domestic Demand for Pharma Contract Manufacturing Services
7.1.3 Pharma Contract Manufacturing: Leading Emerging National Market Forecasts 2015-2025
7.2 Chinese Demand for Pharma Contract Manufacturing Services 2015-2025
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 Submarket Forecast 2015-2025
7.3 India: CMOs with Growing Formulation Experience
7.3.1 Regulatory Outlook for Indian Pharma Manufacturing
7.3.1.1 Ensuring Compliance with New Rules in the EU
7.3.2 Domestic Manufacturing Dominates the Indian Pharma Market
7.3.3 Demand for Contract Manufacturing in India: Submarket Forecast 2015-2025
7.4 Brazil: Contract Manufacturing Outlook 2013-2025
7.4.1 Pharma 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 Submarket Forecast 2015-2025
7.5 The Russian Pharma Contract Manufacturing Submarket 2015-2025
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 2015-2025?
7.6 South Korea
7.6.1 South Korea: Strict GMP Regulations
7.6.2 South Korea: Pharma Contract Manufacturing Submarket Forecast 2015-2025

8. Pharma Contract Manufacturing Industry Trends: CMO Perspective 2015-2025
8.1 Pharma Contract Manufacturing Market: Strengths and Weaknesses for CMOs 2013-2014
8.2 Pharma Contract Manufacturing Market: Opportunities and Threats for CMOs 2015-2025
8.3 Pharma Contract Manufacturing Market: STEP Analysis 2015-2025
8.3.1 Social Factors
8.3.2 New Technologies Will Drive Market Growth to 2025
8.3.2.1 Single-Use Technologies in Biopharma Manufacturing
8.3.2.2 Green Technology in Contract Manufacturing
8.3.2.3 Drug Delivery Trends and CMOs
8.3.2.4 Biologics Are Causing Increased Demand for Lyophilisation
8.3.2.5 Improving Solubility and Stability for Small Molecules
8.3.2.6 Spray Drying as an Alternative to Lyophilisation
8.3.2.7 Hot-Melt Extrusion
8.3.3 Economic Pressures
8.3.3.1 Developed-Market CMOs Face Competition from Emerging Markets
8.3.4 Political Issues
8.3.4.1 How Will Regulatory Developments Affect CMOs?
8.4 Trends in Drug Development Affecting CMOs to 2025
8.4.1 Orphan Drug Development: Smaller Manufacturing Capacities
8.4.2 Complex Biologics: Interest in ADCs is Rising
8.4.3 How Will Biosimilar Market Growth Affect CMOs?
8.4.4 The Future of Small Molecule Outsourcing
8.5 How Will CMOs Expand in the Coming 10 Years?
8.5.1 CMO Consolidation Will Increase
8.5.2 There Will be More Manufacturing Facilities Available for Acquisition
8.6 Developments in the Manufacturing Process 2015-2025
8.6.1 Quality by Design (QbD)
8.6.2 A Move Towards Continuous Manufacturing?

9. Pharma Contract Manufacturing Industry Trends: Client Perspective 2015-2025
9.1 Pharma Contract Manufacturing: Client Perspective Industry Strengths and Weaknesses 2013-2014
9.2 Pharma Contract Manufacturing: Client Perspective Industry Opportunities and Threats 2015-2025
9.3 Important Aspects of the Outsourcing Decision
9.3.1 What Factors Will Influence CMO Selection?
9.3.2 CMO-Pharma Partnering Models
9.3.3 Strategic Partnering
9.3.4 Selecting a Local CMO vs. Offshoring
9.3.5 CMOs in Emerging Markets
9.3.6 Communication
9.3.7 Ensuring Protection in Intellectual Property and Tech Transfer
9.3.8 Regulatory Compliance is a Key Deciding Factor for Pharma Clients
9.3.8.1 Regulatory Bodies and Outsourcing
9.3.8.2 Quality Agreement
9.3.8.3 Global Harmonisation Will Improve Compliance
9.4 Trends in Outsourcing Partnerships 2015-2025
9.4.1 Big Pharma and Outsourced Manufacturing
9.4.2 Small and Virtual Pharma Companies
9.4.3 How Will Biotech Funding Affect the Pharma Contract Manufacturing Industry to 2025?

10. Research Interviews from Our Industry Survey
10.1 Dr Cynthia Wooge, Global Strategic Marketing Manager, SAFC
10.1.1 SAFC
10.1.2 Are ADCs Limited to Oncology?
10.1.3 The Challenges of ADCs Manufacturing
10.1.4 What Solution Does SAFC Offer for ADCs Manufacturing?
10.1.5 Advancement in Conjugation Technology
10.2 Mr. Peter Soelkner, Managing Director of Vetter Pharma International GmbH
10.2.1 Vetter
10.2.2 Singapore, a Global Biomedical Sciences Hub
10.2.3 Market Outlook for APAC Region
10.2.4 Challenges to Be Addressed in the APAC Region

11. Conclusions of the Study
11.1 The World Pharma Contract Manufacturing Market
11.2 Outlook for the Market to 2025
11.2.1 Rising Demand for High Value Services 2015-2025
11.2.2 Demand Will be Highest Among Developed Market Clients
11.3 Which New Technologies Will Stimulate Demand to 2025?


【レポート販売概要】

■ タイトル:医薬品製造受託(CMO)サービスの世界市場
■ 英文:Pharmaceutical Contract Manufacturing: World Industry and Market Outlook 2015-2025
■ 発行日:2015年2月
■ 調査会社:visiongain
■ 商品コード:VGAIN502207
■ 調査対象地域:グローバル
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