|
Pharmaceutical Contract Manufacturing: Industry and Market Prospects 2010-2025Übersetzung: Pharmazeutische Lohnherstellung: Industrie und Marktaussichten 2010-2025
|
|||||||||||
| Preis** (Lieferformat): |
Versandkostenfrei ** WICHTIG: Alle Preise sind netto ausgewiesen. Abhängig von Versand- und Leistungsort ist hierauf noch USt. zu entrichten (Deutschland z.Z. 19%). Der korrekte Gesamtendpreis wird Ihnen mit der Angabe Ihrer Rechnungsadresse, USt-ID-Nr. etc. im Bestellverlauf ausgewiesen. Weitere Informationen zu den Bestandteilen des Kaufpreises finden Sie in unseren FAQs. |
|||||||||||
| Zahlen und Fakten zur Studie: |
Our report gives you the following benefits in particular: • You will receive hard data for the contract manufacturing sector – and much more – including our revenue predictions from 2010 to 2025 • You will receive analyses for the overall market and its main components, helping you to stay ahead • You will find out potential revenues in leading national markets (US, Japan, Germany, France, UK, Italy, Spain, India, China) from 2010 to 2025 • You will discover how the pharmaceutical contract manufacturing sector will change and adapt from 2010 to 2025 • You will find out how the sector can deliver improved services for APIs, finished dosage forms and other requirements • You will discover opportunities for established companies and new market entrants from 2010 to 2025, as well as their customers • You will discover the drivers, restraints, competition and opportunities influencing the sector • You will discover expert views from our survey, including full interview transcripts • You will find out where contract manufacturing is heading – technologically and commercially – from 2010 onwards. Our study gives you answers and trends, saving you time and aiding your decisions. 128 seiten | |||||||||||
| Inhalt der Studie: |
How will the contract manufacturing sector adapt to the needs of pharma from 2010 onwards? Our new report will show you trends and prospects there. How will the sector and its customers face challenge.....
How will the contract manufacturing sector adapt to the needs of pharma from 2010 onwards? Our new report will show you trends and prospects there. How will the sector and its customers face challenges and opportunities? We show commercial benefits for the pharma contract manufacturing sector and its customers, including revenue trends for 2010-2025. You can have that report today, staying ahead. Contract manufacturing is an expanding sector, with rising prominence. Which of its segments will grow fastest from 2010? What are the commercial trends to watch? How will companies perform? You will discover how the worldwide market for pharmaceutical contract manufacturing will perform from 2010 to 2025. Contract manufacturing services in emerging countries are increasingly prominent. That trend is accelerated by rising numbers of contract manufacturing organisations (CMOs) in those countries and the globalisation of pharma manufacturing. Our report shows how you can benefit, saving time and aiding your work. This report covers all the important considerations for those within the contract pharma manufacturing industry. We also provide an understanding of the sector for companies that are considering the outsourcing of production. This sector will expand and extend its capabilities from 2010 onwards. Pharma contract manufacturing has been changing, a trend that will continue. Cost-efficiencies and rapid time-to-market are crucial. There is rising competition and demand. Increasingly specialised requirements will appear – especially for biological products. Demand for APIs will particularly influence contract manufacturing from 2010 onwards. Our report shows you its technological and commercial potential, revealing opportunities and challenges. Analysis of the pharma contract manufacturing sector to meet your needs Our new report examines the contract manufacturing sector critically. We harness primary and secondary research to meet your needs. We provide revenue forecasts, market share analyses and other data. You will discover market strengths, weaknesses, opportunities and threats. We include many tables, figures and expert interviews, as shown in the contents listing with this message. Report Highlights Companies Listed Abbott Laboratories Accenture Actelion Pharmaceuticals Aditya Dispomed Products Advanced Biotech Products Advanced Medical Optics Advanced Micronic Devices Advantage Dental Laboratories Alps International Altana American Ortho-Tech Amgen Anaesthetics India Angiosyn Angiplast Anhui BBCA Biochemical Apothecaries Sundries Manufacturing Company Appasamy Associates Appasamy Ocular Devices Ashva Technologies Aurobindo Pharma Aurolab Avecia Axitec Baxter International BEBAC – Consultancy Services for Bioequivalence and Bioavailability Studies Bharat Enterprises Bilink International, Biogen Idec Biogenex Life Sciences Biotech Vision Care Bristol-Myers Squibb Cadila Pharmaceuticals Carbogen Amcis Catalent Pharma Solutions Celgene Celltrion Cephalon Cephas Medical Ceradyne India Ceramics Chembiotek Chifeng Arker Pharmaceutical Technology Chinese State Food and Drug Administration (SFDA) Chongqing Carelife Pharmaceutical Chongqing Daxin Pharmaceutical Clininvent Consultancy Services for Bioequivalence and Bioavailability Studies (BEBAC, Austria) Covance CSL Cyber Approach Dabur India Dahlgren India Damon Biotech Degania Medical Devices Dishman Group Divis Laboratories Dr. Reddy's Laboratories Dr. Sabharwal's Manufacturing Labs Dr. Sabharwal's Medicals Dr. Sabharwal's Wound Care Eastern Medikit Limited Eclipsys India Eli Lilly Emory University Encube Ethicals Enkay (India) Rubber Co. Epsilon Eye Care eReady Monitors Essilor Manufacturing European Medicines Agency (EMA/EMEA) Flexit Laboratories Food and Drug Administration (FDA, US) G K B Rx Lens Ganko Opticians GE Medical Systems (India) General Surgical Company Genetech Geneva Genzyme Corp George Philips Medical Engineering Gilead Sciences Gillette Diversified Operations Gkb Ophthalmics Gkb Rx Lens GlaxoSmithKline Glenmark Pharmaceuticals Gpc Medical Grandeur Exports Granules India Gst Corporation H.P. Industries Harmony Plastics Hero Exports Hetero Drugs Himedia Laboratories Hindustan Syringes & Medical Devices Hll Lifecare Hollister Medical India Hollister-Stier Laboratories Hospital Equipment Manufacturing Company (India) Hyperion Source Ig Dental Indica Chemical Industries Indo Webal Surgical Indo-German Surgical Corporation Indus Medicare Institute for OneWorld Health Intermarket India Private Limited Invitron IPCA Laboratories Iscon Surgicals Johnson & Johnson J.K. Ansell Jai Surgicals Jewel Consumer Care JJ Orthodontics Johari Digital Healthcare Johnson & Johnson Jubilant Organosys Jullundur Surgical Works Kanam Latex Industries Kanam Latex Industries Kdans Surgical Kemwell Khosla Surgical Industries Kiran Medical Systems Labotech Microscopes India Larsen & Toubro Laxmi Dental Export Laxmi Electronics Moulds & Precision Engg Lifeline Systems LM First Aid Products Lonza Group Lupin Pharmaceuticals M/S Orthopaedic Appliance Company M/S Osi Madhu Instruments Marck Biosciences Marian Personal & Hygiene Care Products Matrix Clinical Mcm Overseas Agencies Medico Electrodes International Medicure Instruments Meditec Devices Medsynaptic Medtech Products Merck & Co. MGRM Medicare Ministry of Science and Technology (India) Modern Orthodontics Mylan Pharmaceuticals Natco Pharma National Biotechnology Regulatory Authority (NBRA, India) National Health Service (NHS, UK) National Institutes of Health (NIH, US) National IP Strategy Formulation Office (NIPSO, China) Neuland Laboratories Nicholas Piramal Nipro Pharma Corporation Northeast General Pharmaceutical Factory Novartis Novella Clinical Novo Nordisk Orchid Chemicals and Pharmaceuticals Patheon Perigo Pfizer PharmaLinkFHI Polymed Therapeutics Quintiles Ranbaxy Laboratories Rhodia Group Roche Sandoz Sanofi-Aventis Schering-Plough Shadong XINHUA Pharm Shandong New Time Pharmaceutical Shanghai Sunve Pharmaceutical Shasun Pharma Solutions Solvay Pharmaceuticals State Food and Drug Administration (SFDA, China) Sun Pharmaceutical Industries Suven Life Sciences Takeda Tata Consulting Services The National Biotechnology Regulatory Authority (NBRA) UCB Verax Biomedical Vetter Pharma Fertigung Wockhardt World Trade Organisation (WTO) Wyeth Zhejiang Jiuzhou Pharmaceutical Zhejiang Medicine Zhejiang NHU Zhejiang Supor Pharmaceuticals Zyday Cadila [Studien Infos ausblenden] |
|||||||||||
|
1. Executive Summary 1.1 Contract Pharma Manufacturing 2010-2025 1.2 Aims, Scope and Format of the Report 1.3 Research & Analysis Methods 2. Introduction to Pharma Outsourcing of Manufacturing 2.1 Contract Pharma Described 2.1.1 Evolving Nature of Contract Research Organisations (CROs) and Contract Manufacturing Organisations (CMOs) 2.2 Contract Development and Manufacturing Organisations (CDMO) 2.3 Why Are Pharma Companies Interested in Contract Pharma? 2.3.1 Small/Mid-sized Pharma and Biotech Have a Flexible Attitude to Outsourcing 2.3.2 Lack of Capacity is Still a Major Reason to Outsource 2.3.3 Tactical vs. Strategic Use of Outsourcing 2.4 The Changing Nature of the Pharmaceutical Market is Affecting the CRM Market 2.4.1 The Rise of Generics 2.4.2 Pipelines are Becoming Expensive 2.4.3 The Decline of the Traditional Blockbuster 2.5 Biopharmaceutical Drug Discovery and Development by Contract Pharma Companies will Continue to Increase 2.6 Disadvantages of Outsourcing in the Pharmaceutical Industry Can be Overcome 3. Regulatory Aspects of Pharma Outsourcing for Manufacturing 3.1 Legal Liabilities and Regulatory Considerations in Outsourced Manufacturing 3.2 Summary of GMP Requirements 3.3 Compliance with FDA Provisions is Vital 3.4 EU Regulations and the Qualified Person Role 3.5 Q7A Guidance for Active Pharmaceutical Ingredient (API) and Excipient Production 3.6 Harmonisation of GMP Standards 3.7 EU API Makers for Good Manufacturing Practices Inspections 3.8 Enforcing cGMP Compliance for APIs in EU 3.9 EU Requirements for Outsourcing Services 3.10 Good Manufacturing Practice (GMP) Compliance 3.11 API Requirements Challenge Outsourcing Services from China 3.12 Summary: Globalisation Benefits Pharma Harmonisation 4. The Outsourcing Decision 4.1 Reasons to Outsource 4.1.1 Outsourcing as a Tactical Decision 4.1.2 Outsourcing as a Strategic Decision 4.2 Cost-Benefit Analysis of Outsourcing 4.3 Risks Associated with Outsourcing Incur Hidden Costs 4.3.1 Errors and Delays Can Cost Millions 4.3.2 Regulatory Compliance Must be Assured 4.3.3 IP and Other Sensitive Data May be at Risk 4.3.4 Management of Outsourcing Requires Continued Monitoring 4.4 Technology Transfer Considerations 4.5 The Virtual Company 4.5.1 'Virtuality' Helps Control Rising Costs 4.5.2 Strong Project and Operations Management is Vital 4.5.3 The Challenges of Virtual Companies are Relevant Across the Industry 4.6 Key Requirements for Successful Outsourcing 4.6.1 Trust and Accountability 4.7 Summary: Planning the Guiding Principle for Outsourcing 5. Pharma Contract Manufacturing Industry and Market 2010-2025 5.1 The World Contract Manufacturing Market in 2010 5.2 Growing Market for Contract Manufacturing Services 5.2.1 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2010-2016 5.2.2 Revenue Forecast for Total Pharma Contract Manufacturing Market, 2017-2025 5.3 Breakdown of the Pharma Contract Manufacturing Market 5.3.1 Revenue Forecast for API Market, 2010-2016 5.3.2 Revenue Forecast for API Market, 2017-2025 5.3.3 Revenue Forecast for Dosage Forms Market, 2010-2016 5.3.4 Revenue Forecast for Dosage Forms Market, 2017-2025 5.4 Leading National Markets for Pharma Contract Manufacturing, 2010-2025 5.4.1 The US Pharma Contract Manufacturing Market, 2010-2025 5.4.2 The Japanese Pharma Contract Manufacturing Market, 2010-2025 5.4.3 The Leading European Pharma Contract Manufacturing Markets, 2010-2025 5.4.4 Emerging Pharma Contract Manufacturing Markets 5.4.5 The Indian Pharma Contract Manufacturing Market, 2010-2025 5.4.6 The Chinese Pharma Contract Manufacturing Market, 2010-2025 5.5 Summary of the Chapter 6. Contract Manufacturing Sector to Provide Marked Benefits to Clients 6.1 Reasons for Outsourcing 6.2 Commercial Drivers of Outsourcing 6.3 Commercial Restraints for Outsourcing 6.4 API Manufacturers Closely Linked with Innovative Pharmaceutical Developers 6.5 Various Outsourcing Partners 6.6 Selecting an Appropriate CMO 6.7 Management of the Supply Chain for Cost-Efficient Contract Manufacturing 6.8 Mergers and Acquisitions for Pharmaceutical Manufacturing 6.8.1 Alliances with CMOs – a Growing Trend in the US 6.8.2 Patheon Forms Alliance with India's Kemwell 6.9 Interview with Manish Badonia, Cadila 6.9.1 Contract Manufacturing Outsourcing to Asia will Grow due to Cost Competitiveness 6.9.2 Alliance Formation for Moving up the Value Chain 6.9.3 Quality Control for Contract Pharma to Improve Further 6.10 Contract Pharma for Biotech Products 6.10.1 Failure in Early Efforts in Contract Biologic Manufacturing 6.10.2 Cost Benefits of Outsourced Manufacturing in Biotech Sector 6.10.3 The Future of Pharma Biotech Outsourcing 6.10.4 Custom Peptides are an Opportunity for APIs to Move up the Value Chain 6.10.5 One More Step for Outsourcing Contract Pharma Manufacturing to Asia 6.11 Western Companies Can Compete by Moving into Speciality API Manufacturing 6.12 Contract Pharma for Improved Process Tools 6.13 Chinese API Export Growing Rapidly 6.14 Outsourcing to Low-Cost Geographic Areas 6.15 Low Cost Services in India and China Drive Prices Down 6.16 Main Tendencies in Current Asian IP Law 6.17 Patent Protection Status in Indian Pharmaceutical Industry 6.18 Recommendation for Improvement of China's Intellectual Property Rights 6.19 Interview with Dr Zhang Zhicheng, National Intellectual Property (IP) Strategy Formulation Office, SIPO, China 6.19.1 International Framework: IP Protection for Contract Manufacturing 6.19.2 IP Holders Get the Profits 6.19.3 Changing IP Situation in the Developing Countries 6.19.4 Innovation-Oriented Industry Development in China 7. The Pharma Contract Manufacturing Sector in India 7.1 Contract Manufacturing in India 7.2 Drivers for Contract Manufacturing Outsourcing to India 7.3 Contract Manufacturing and Role of Indian Companies 7.3.1 Outsourcing for Generics 7.3.2 Sourcing Generics from Non-Competitors 7.3.3 Divis Laboratories’ Business Model 7.3.4 Granules India in Production of Generic Prescription Medicines and OTCs 7.3.5 Matrix Acquired by PharmaLinkFHI/Novella, a Global CRO 7.3.6 Neuland Focused on Anti-Bacterials 7.3.7 Natco Chose Chronic Diseases 7.4 Enforcing cGMP Compliance for APIs in EU 7.5 Expansion of Indian Biotechnology Sector 7.6 Interview with Dr Jagdish N Sheth, Business School, Emory University 7.6.1 India's Key Strength 7.6.2 India's Edge over China in Pharmaceutical Business 7.6.3 Need for Routine Inspection of Outsourcing Sites 7.6.4 Need for Creation of Economic Zone for Pharmaceutical Industry 7.6.5 India as an Emerging Market 7.6.6 Vertical Integration Recommended for India's Companies 7.6.7 India's Emergence as a Major Pharmaceutical Market 8. Contract Pharma for Specialised Areas 8.1 Value-Added Services and Contract Pharma 8.2 One-Stop Shop (CRO and CMO)? 8.3 Interview with Manish Badonia, Cadila 8.3.1 One-Stop Shop: CROs and CMOs 8.3.2 Value-Added Services in Global Settings 8.4 Interview with Wesley Wheeler, Patheon 8.4.1 Outsourcing for Analytical Testing Services 8.5 CMOs Venture into Development and Product Extensions 8.6 The Use of CROs in Drug Discovery and Development is Increasing in Pharma Industry 8.6.1 Contract Research for Drug Discovery at Suven Life Sciences 8.7 Interview with Dr Debra Sponholtz, Chembiotek 8.7.1 CROs Offer a Full Range of Services 8.8 Outsourcing Electronic Data Management 8.9 Outsourcing of Data Management in India 8.9.1 GlaxoSmithKline to Outsource Data Management 8.9.2 Wyeth (Pfizer): Outsourced Data Management 8.10 Planning Required for Regulatory Affairs Outsourcing 8.11 Outsourcing Bioequivalence Studies for Generic Drugs 8.12 Requesting a Waiver from a Bioequivalence Trial 8.13 Bioequivalence Studies for New Drug Applications 8.14 Interview with Helmut Schutz, BEBAC 8.14.1 When in Vivo Bioequivalent Studies are Waived for ANDA 8.14.2 Success of Outsourcing Dissolution Testing/ Bioequivalence Studies 8.14.3 Success of Off-Shoring in Vivo Bioequivalence Studies to India 8.15 Interview with Dr Daniel Abran, Sandoz 8.15.1 Waivers of in Vivo BE Studies (Biowaivers) for Abbreviated New Drug Applications 8.15.2 Comparative Clinical Trial Requirement for ANDA 8.16 Interview with Manish Badonia, Cadila 8.16.1 Prospects for Outsourcing Bioequivalence Studies 8.17 Outsourced Biostorage Becomes a Strategic Consideration 8.18 Contract Pharma for Lyophilisation 8.19 Contract Packaging Services 8.19.1 Contract Packaging is Not Just Boxes and Packs 8.19.2 Advantages Offered by Contract Packaging Organisations 9. Conclusions from this Study 9.1 Growth Rates will Vary According to Sector 9.2 Contract Pharma Manufacturing Encompasses Requirements in Biotechnology 9.3 Outsourcing for Value-Added Services 9.4 Concluding Remarks [Inhaltsverzeichnis ausblenden] |
||||||||||||
|
Table 2.1 Top 10 Pharma Biotech Products, 2009 Table 2.2 Top 10 Biotech Companies: Revenues and Market Shares, 2009 Table 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016 Table 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025 Table 5.3 API Market: World Revenue Forecast, 2010-2016 Table 5.4 API Market: World Revenue Forecast, 2017-2025 Table 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016 Table 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025 Table 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2016 Table 5.8 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2017-2025 Table 5.9 Pharma Contract Manufacturing (CM) National Market Forecasts, 2010-2015, 2020 & 2025 Table 6.1 Alliances for APIs in India, 2010 Table 6.2 Relationship Build-Up for Contract Manufacturing in India, 2010 Table 6.3 SWOT Analysis for Contract Manufacturing Services from Developing Countries, 2010 Table 6.4 Top US DMF Holders in India and China, 2007-2008 Table 7.1 FDA-Approved Manufacturing Sites in India, 2010 Table 9.1 Pharma Contract Manufacturing Market: World Revenue Forecast, 2010, 2012, 2015, 2018, 2020 & 2025 Figure 2.1 Examples of Contract Services During the Pharma Product Lifecycle, 2010 Figure 2.2 The Role of Contract Pharma Organisations in Drug Development, 2010 Figure 2.3 Comparison of R&D Costs and the Number of Approved NMEs, 2010 Figure 5.1 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2010-2016 Figure 5.2 Pharmaceutical Contract Manufacturing: World Revenue Forecast, 2017-2025 Figure 5.3 API Market: World Revenue Forecast, 2010-2016 Figure 5.4 API Market: World Revenue Forecast, 2017-2025 Figure 5.5 Finished Dosage Forms Market: World Revenue Forecast, 2010-2016 Figure 5.6 Finished Dosage Forms Market: World Revenue Forecast, 2017-2025 Figure 5.7 Pharma Contract Manufacturing Market: World Revenue Forecasts by Class, 2010-2025 Figure 5.8 US Pharma CM Market: Revenue Forecast, 2010-2025 Figure 5.9 Other Leading Pharma CM National Markets: Revenue Forecasts, 2010-2025 Figure 5.10 Pharma CM Revenue Shares in Leading National Markets, 2010 Figure 5.11 Pharma CM Revenue Shares in Leading National Markets, 2015 Figure 5.12 Pharma CM Revenue Shares in Leading National Markets, 2020 Figure 5.13 Pharma CM Revenue Shares in Leading National Markets, 2025 Figure 6.1 Top Ten Biotech Drugs: World Sales, 2009 Figure 7.1 Path up the Value Chain for Indian Pharma Companies, 2010 Figure 9.1 Pharma Contract Manufacturing Market: Revenue Trends, Overall and by Class, 2009-2025 [Tabellenverzeichnis ausblenden] |
||||||||||||
| Hinweis: | * Der Rechnungsbetrag für diese Studie wird in $ (Dollar) ausgewiesen. Kunden aus dem Inland bekommen von uns eine Rechnung in Euro, umgerechnet zum letztwöchigen Schlusskurs | |||||||||||
|
|
||||||||||||
