Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 3 | 4 |
| List of Tables | 5 | 1 |
| List of Figures | 6 | 1 |
| Contract Manufacturing Organizations to 2018 - Introduction | 7 | 1 |
| GBI Research Guide | 7 | 1 |
| Contract Manufacturing Organizations to 2018 - Industry Overview | 8 | 13 |
| Current Status of Pharmaceutical Industry | 8 | 1 |
| Cost Optimization Steps for the Pharmaceutical Companies | 8 | 1 |
| Reduction in Physical Assets | 9 | 1 |
| Downsizing Manufacturing | 9 | 1 |
| Reduction in R&D Spending | 10 | 2 |
| What CMOs are and Reasons for Outsourcing to Them | 12 | 1 |
| Different Types of CMOs and the Range of Services Provided by Them | 12 | 1 |
| Tier 1 CMOs | 13 | 1 |
| Tier 2 CMOs | 13 | 1 |
| Tier 3 CMOs | 13 | 1 |
| How Does Outsourcing to CMOs Take Place? | 14 | 1 |
| Defining the Key Objectives of Outsourcing | 15 | 1 |
| CMO Selection and Validation | 15 | 1 |
| Decision Making | 16 | 1 |
| Key Outsourcing Models | 16 | 1 |
| Mixed Outsourcing Model Leveraging the Best In-house and Outsourced Capabilities Simultaneously | 16 | 1 |
| Full Service Model Complete Manufacturing Process Outsourcing, Leading to Easier Process Management and Cost Benefits. | 16 | 1 |
| Sale Leaseback Model Innovative Outsourcing Model, Leading to Increased Liquidity and Flexibility | 17 | 1 |
| Key Benefits of Outsourcing | 18 | 1 |
| Cost Advantage in Terms of Low-cost Labor, Cheaper Raw Materials and Cheaper Export Options | 18 | 1 |
| Flexibility in Terms of Production Volume | 19 | 1 |
| Risk Mitigation against Usage of Obsolete Technology and Variable Economic Conditions | 19 | 1 |
| Increased Efficiency Due to Increased Working Capital | 19 | 1 |
| Increased Focus on Core Competencies | 19 | 1 |
| Access to Latest Technology through Collaborations with Specialized CMOs | 19 | 1 |
| Faster Time to Market, thereby Boosting the Profitability and Lifecycle of a Drug | 20 | 1 |
| Contract Manufacturing Organizations to 2018 - Market Characterization | 21 | 2 |
| Market Forecasts | 21 | 2 |
| Contract Manufacturing Organizations to 2018 - Geographical Landscape | 23 | 9 |
| Introduction | 23 | 1 |
| Established Markets | 24 | 1 |
| The US CMO Market | 24 | 1 |
| The Eastern European CMO Market | 25 | 2 |
| Emerging Markets | 27 | 1 |
| The Indian CMO Market | 27 | 1 |
| Challenges and Key Concerns for the Indian CMO Market | 28 | 1 |
| The Chinese CMO Market | 29 | 1 |
| Challenges and Key Concerns for the Chinese CMO Market | 30 | 2 |
| Contract Manufacturing Organizations to 2018 - Market Drivers and Restraints | 32 | 14 |
| Global CMO Market Drivers | 33 | 1 |
| Availability of Low-cost Skilled Manpower | 33 | 1 |
| Increasing Government Sanctions are Favoring CMOs | 34 | 1 |
| Regulatory Changes in India | 34 | 1 |
| Regulatory Changes in China | 35 | 1 |
| Increased Consumption of Generics | 35 | 5 |
| Better Intellectual Property Rights Protection | 40 | 1 |
| Increasing Uptake of Biologics and Entry of Biosimilars into Market | 41 | 1 |
| Global CMO Market Restraints | 42 | 1 |
| Capacity Utilization Issues Affecting the Profitability of CMOs | 42 | 1 |
| Reduced Number of New Drug Approvals | 42 | 3 |
| Complex Cost Structures in Outsourcing | 45 | 1 |
| Contracting Costs Arise During the Process of CMO Selection, Negotiation and Agreement Finalization Process | 45 | 1 |
| Transition Costs are Associated with Knowledge Transfer Processes, Training and Employee Relocation | 45 | 1 |
| Interaction Costs are Associated with Continuous Coordination and Communication Management between the Client and the CMO | 45 | 1 |
| Contract Manufacturing Organizations to 2018 - Regulatory Framework | 46 | 9 |
| Overview | 46 | 1 |
| FDA Guidelines | 46 | 1 |
| Organization and Personnel | 46 | 1 |
| Building and Facilities | 47 | 1 |
| Process Equipment | 47 | 1 |
| Control of Raw Materials | 47 | 1 |
| Production and Process Controls | 47 | 1 |
| Packaging and Labeling | 47 | 1 |
| Holding and Distribution | 48 | 1 |
| Key Changes in FDA Guidelines | 48 | 1 |
| Exemption of Phase I Investigational Drugs from CGMP Requirements | 48 | 1 |
| Amendment of cGMP regulations for Aseptic Processing and Finished Pharmaceuticals | 48 | 1 |
| EMA Guidelines | 49 | 1 |
| Quality Management | 50 | 1 |
| Production Activities | 51 | 1 |
| Buildings and Facilities | 51 | 1 |
| Process Equipment | 52 | 1 |
| Materials Management | 52 | 1 |
| Packaging and Labeling | 52 | 1 |
| Key Changes in EMA Guidelines | 53 | 1 |
| PIC/S | 53 | 2 |
| Contract Manufacturing Organizations to 2018 - Key Aspects of the Upstream and Downstream Processing CMO Industry | 55 | 3 |
| Comparison of Upstream Processing and Downstream Processing | 55 | 1 |
| CMO Market Size for Upstream Processing | 56 | 1 |
| CMO Market Size for Downstream Processing | 57 | 1 |
| Contract Manufacturing Organizations to 2018 - Key CMO Participants | 58 | 14 |
| Catalent Pharma Solutions, Inc. | 58 | 2 |
| Lonza Group AG | 60 | 2 |
| Royal DSM N.V. | 62 | 2 |
| Piramal Healthcare Ltd. | 64 | 1 |
| Jubilant Life Sciences | 65 | 2 |
| Evonik Industries AG | 67 | 1 |
| Patheon Inc. | 68 | 1 |
| Fareva Holding | 69 | 1 |
| Cambrex | 70 | 1 |
| Boehringer Ingelheim | 71 | 1 |
| Contract Manufacturing Organizations to 2018 - Strategic Consolidations within the Global CMO Market | 72 | 8 |
| Mergers and Acquisitions | 72 | 1 |
| Summary of Mergers and Acquisitions | 72 | 1 |
| Piramal Healthcare Acquires 76% Stake in Oxygen Bio Research | 72 | 1 |
| Co-development Deals | 73 | 1 |
| Summary of Co-development Deals | 74 | 1 |
| Cambrex Enters Into Co-Development Agreement with Tillotts Pharma in 2011 | 74 | 1 |
| Nuevolution Enters Into Co-Development Agreement with Boehringer Ingelheim in 2011 | 74 | 1 |
| Elan Corporation Enters Into Co-Development Agreement with Boehringer Ingelheim in 2011 | 74 | 1 |
| Eli Lilly Enters Into Co-Development Agreement with Boehringer Ingelheim in 2011 | 74 | 1 |
| Athera Biotechnologies Enters Into Co-Development Agreement with Lonza in 2011 | 75 | 1 |
| Licensing Deals | 76 | 1 |
| Summary of Licensing Deals | 77 | 1 |
| Boehringer Ingelheim Enters Into Licensing Agreement with Gilead Sciences for BI 224436 in 2011 | 77 | 1 |
| Boehringer Ingelheim Enters Into Licensing Agreement with ProBioGen in 2011 | 77 | 1 |
| Zealand Pharma Enters Into Licensing and Collaboration Agreement with Boehringer Ingelheim in 2011 | 78 | 1 |
| Depomed Enters Into Licensing Agreement with Boehringer Ingelheim in 2011 | 78 | 1 |
| Catalent Pharma Solutions Enters Into Licensing Agreement with Sanwa Kagaku Kenkyusho in 2011 | 78 | 1 |
| Catalent Pharma Enters Into Licensing Agreement with Pantec in 2011 | 79 | 1 |
| Oxford BioTherapeutics Enters Into Licensing Agreement with Lonza in 2011 | 79 | 1 |
| Lonza Enters Into License Agreement with ORGANOBALANCE in 2011 | 79 | 1 |
| KaloBios Pharmaceuticals Enters Into Licensing Agreement with BioWa and Lonza in 2011 | 79 | 1 |
| Contract Manufacturing Organizations to 2018 - Appendix | 80 | 5 |
| Market Definitions | 80 | 1 |
| Abbreviations | 80 | 1 |
| Research Methodology | 81 | 3 |
| Coverage | 82 | 1 |
| Secondary Research | 82 | 1 |
| Primary Research | 82 | 1 |
| Expert Panel Validation | 83 | 1 |
| Contact Us | 83 | 1 |
| Disclaimer | 83 | 1 |
| Sources | 83 | 2 |
