Sections
| Title | Starting Page | Number of Pages |
|---|
| Table of Contents | 6 | 3 |
| List of Tables | 8 | 1 |
| List of Figures | 8 | 1 |
| Introduction | 9 | 2 |
| Global Market Overview | 11 | 15 |
| Biobetter Therapies Already on the Market | 11 | 1 |
| Erythropoietins | 12 | 2 |
| Granulocyte-colony Stimulating Factors | 14 | 1 |
| | 15 | 1 |
| Insulin and Insulin Analogs | 16 | 3 |
| Monoclonal Antibodies | 19 | 1 |
| | 20 | 1 |
| Promising Drug Classes for Biobetter Therapies | 21 | 1 |
| Human Growth Hormone | 21 | 2 |
| Comparison of Biosimilars and Biobetters | 23 | 3 |
| Technology Analysis | 26 | 4 |
| Introduction | 26 | 1 |
| Host Cell | 26 | 1 |
| Glycosylation | 27 | 1 |
| PEGylation | 28 | 1 |
| Polysialylation | 28 | 1 |
| Fusion Protein | 28 | 1 |
| PASylation | 28 | 1 |
| HESylation | 29 | 1 |
| Challenges and Opportunities | 30 | 2 |
| Opportunities | 30 | 1 |
| Biobetter Therapies Gain Substantial Market Shares upon Launch | 30 | 1 |
| Higher Success Rates in the Development of Biobetter Therapies | 30 | 1 |
| Challenges | 30 | 1 |
| Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs | 30 | 1 |
| Growing Debts and the Slowing of the Economy will Drive Governmental Bodies and Healthcare Providers to Restrict the Use of Expensive Biobetter Therapies | 31 | 1 |
| Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies | 31 | 1 |
| Pipeline Analysis | 32 | 13 |
| Introduction3 | 32 | 1 |
| Human Growth Hormone | 32 | 2 |
| Erythropoietin | 34 | 1 |
| Granulocyte-colony Stimulating Factor | 35 | 1 |
| | 36 | 2 |
| Insulin and Insulin Analogs | 38 | 2 |
| Monoclonal Antibodies | 40 | 2 |
| Promising Drugs | 42 | 1 |
| LB03002 - HGH | 42 | 1 |
| Overview | 42 | 1 |
| Clinical Study Details | 42 | 1 |
| Safety and Efficacy | 42 | 1 |
| Degludec - Insulin Analog | 42 | 1 |
| Overview | 42 | 1 |
| Clinical Study Details | 42 | 1 |
| Safety and Efficacy | 43 | 1 |
| Theracim - Monoclonal Antibody | 43 | 1 |
| Overview | 43 | 1 |
| Clinical Study Details | 43 | 1 |
| Safety and Efficacy | 43 | 1 |
| Pertuzumab - Monoclonal Antibody | 43 | 1 |
| Overview | 43 | 1 |
| Clinical Study Details | 43 | 1 |
| Safety and Efficacy | 44 | 1 |
| RG7159 - Monoclonal Antibody | 44 | 1 |
| Overview | 44 | 1 |
| Clinical Study Details | 44 | 1 |
| Safety and Efficacy | 44 | 1 |
| The US Regulatory Environment and Approval Pathways | 45 | 2 |
| Introduction | 45 | 1 |
| Biobetter Therapies | 45 | 1 |
| Biosimilar Therapies | 46 | 1 |
| The EU Regulatory Environment and Approval Pathways | 47 | 2 |
| Introduction | 47 | 1 |
| Biobetter Therapies | 47 | 1 |
| Biosimilar Therapies | 47 | 2 |
| Japan Regulatory Environment and Approval Pathways | 49 | 2 |
| Biobetter Therapies | 49 | 1 |
| Biosimilar Therapies | 50 | 1 |
| Australia Regulatory Environment and Approval Pathways | 51 | 1 |
| Biobetter Therapies | 51 | 1 |
| Biosimilar Therapies | 51 | 1 |
| China Regulatory Environment and Approval Pathways | 52 | 1 |
| Biobetter Therapies | 52 | 1 |
| Biosimilar Therapies | 52 | 1 |
| India Regulatory Environment and Approval Pathways | 53 | 1 |
| Biobetter Therapies | 53 | 1 |
| Biosimilar Therapies | 53 | 1 |
| Biobetter Companies | 54 | 8 |
| Key Players | 54 | 1 |
| Amgen | 54 | 1 |
| Overview | 54 | 1 |
| Product Portfolio | 54 | 1 |
| SWOT Analysis | 55 | 1 |
| Merck | 56 | 1 |
| Overview | 56 | 1 |
| Product Portfolio | 56 | 1 |
| SWOT Analysis | 56 | 1 |
| Roche | 57 | 1 |
| Overview | 57 | 1 |
| Product Portfolio | 57 | 1 |
| SWOT Analysis | 58 | 1 |
| Novo Nordisk | 59 | 1 |
| Overview | 59 | 1 |
| Product Portfolio | 59 | 1 |
| SWOT Analysis | 59 | 1 |
| Sanofi-Aventis | 60 | 1 |
| Overview | 60 | 1 |
| Product Portfolio | 60 | 1 |
| SWOT Analysis | 61 | 1 |
| Strategic Consolidations | 62 | 14 |
| Deals Analysis | 62 | 1 |
| Mergers and Acquisitions | 62 | 1 |
| Overview | 62 | 1 |
| Human Genome Sciences Rejects Acquisition Offer from GlaxoSmithKline | 62 | 1 |
| Amylin Pharmaceuticals Rejects Unsolicited Bid for the Acquisition of all of its Outstanding Shares by Bristol-Myers Squibb | 62 | 1 |
| Dainippon Sumitomo Pharma Agrees to Acquire Boston Biomedical Inc. | 62 | 1 |
| Amgen Completes the Acquisition of Micromet | 62 | 1 |
| Celgene Corporation Completes the Acquisition of Avila Therapeutics, Inc. | 62 | 1 |
| Serum Institute of India Limited Denies Rumors that it is Planning to Divest its 14% Stake in Xenetic Biosciences | 63 | 1 |
| Bristol-Myers Squibb Completes the Acquisition of Inhibitex through its Wholly Owned Subsidiary Inta Acquisition Corporation | 63 | 1 |
| Zydus Cadila Healthcare Limited Acquires Biochem Pharmaceutical Industries | 63 | 1 |
| Gilead Sciences, through its Wholly Owned Subsidiary, Royal Merger Sub II, Completed the Acquisition of Pharmasset | 63 | 1 |
| Merck, through its Wholly Owned Subsidiary Monarch Transaction Corp., Completes the Acquisition of all Outstanding Shares of Common Stock in Inspire Pharmaceuticals | 64 | 1 |
| Biotie Therapies Corp. Terminates the Acquisition of Newron Pharmaceuticals | 64 | 1 |
| Teva Pharmaceutical Industries Limited Invests an Additional $19m in CureTech | 64 | 1 |
| Pfizer, through its Wholly Owned Subsidiary Eclipse Acquisition Corp., Completes the Acquisition of all the Outstanding Shares of Icagen | 64 | 1 |
| Takeda Pharmaceutical Company Limited Completes the Acquisition of Nycomed International Management GmbH | 65 | 1 |
| Teva Pharmaceutical Industries Limited Completes the Acquisition of all the Outstanding Shares of Cephalon | 65 | 1 |
| Forest Laboratories, Inc., through its Indirect Wholly Owned Subsidiary Magnolia Acquisition Corp., Completes Acquisition of Clinical Data, Inc. | 65 | 1 |
| Astellas Pharma, Inc., Completes the Acquisition of Remaining 83% Equity Interest in Perseid Therapeutics LLC | 65 | 1 |
| Amgen Completes the Acquisition of BioVex Group | 66 | 1 |
| Amarin Corporation Plans Sale of its Stake | 66 | 1 |
| Novartis AG Completes the Acquisition of the Remaining 23% stake in Alcon | 66 | 1 |
| Eli Lilly and Company Completes the Acquisition of all Outstanding shares of Avid Radiopharmaceuticals | 66 | 1 |
| Pfizer, through its Wholly Owned Subsidiary Parker Tennessee Corp., Completes the Acquisition of all Outstanding Shares of Common Stock of King Pharmaceuticals | 67 | 1 |
| Johnson &Johnson, through its Newly Formed Indirect Wholly Owned Subsidiary JJC, Completes the Acquisition of Outstanding Shares of Crucell N.V. | 67 | 1 |
| Bristol-Myers Squibb Company, through its Wholly Owned Subsidiary Zeus Acquisition Corporation, Completes the Acquisition of all Outstanding Shares of ZymoGenetics Inc. | 67 | 1 |
| Sanofi-Aventis Completes the Acquisition of all Outstanding Shares of Genzyme Corporation | 68 | 1 |
| Celgene Corp. Completes the Acquisition of Abraxis BioScience | 68 | 1 |
| Astellas Pharma Inc., through its Indirect Subsidiary Ruby Acquisition, Inc., Acquires all Outstanding Shares of OSI Pharmaceuticals Inc. | 68 | 1 |
| Licensing Agreements | 69 | 1 |
| Overview | 69 | 1 |
| ThromboGenics NV Enters into a Licensing Agreement with Alcon | 69 | 1 |
| Nuron Biotech Enters into a Licensing Agreement with Akshaya Bio for Hepatitis Vaccines | 69 | 1 |
| Xenon Pharmaceuticals Enters into Licensing Agreement with Genentech | 69 | 1 |
| Metamark Genetics, Inc. Enters into a Licensing Agreement with Janssen Biotech | 69 | 1 |
| MacroGenics, Inc. Enters into an Option for a License Agreement with Les Laboratoires Servier | 70 | 1 |
| Biogen Idec Inc. Receives Approval from Federal Antitrust Regulators for an Exclusive Worldwide Licensing Agreement with Portola Pharmaceuticals, Inc. | 70 | 1 |
| Bristol-Myers Squibb Company Enters into a Global Licensing Agreement with Innate Pharma SA | 70 | 1 |
| Glenmark Pharmaceuticals S.A. Receives Approval from Hart-Scott-Rodino Antitrust Improvements Act for the Development and Commercialization of GBR 500 with Sanofi | 71 | 1 |
| Zealand Pharma A/S Enters into a Licensing and Collaboration Agreement with Boehringer Ingelheim GmbH | 71 | 1 |
| Hanwha Chemical Corporation Enters into a Worldwide Licensing Agreement with Merck Sharp &Dohme Research Ltd | 71 | 1 |
| Vertex Pharmaceuticals Incorporated Enters into a Worldwide Licensing Agreement with Alios BioPharma | 71 | 1 |
| Aveo Pharmaceuticals, a Biopharmaceutical Company, Enters into an Exclusive Licensing Agreement with Centocor Ortho Biotech | 72 | 1 |
| Allergan, Inc. Enters into a Licensing Agreement with Molecular Partners AG | 72 | 1 |
| Human Genome Sciences Enters into a Licensing Agreement with FivePrime Therapeutics | 72 | 1 |
| Xoma Ltd., a US Biopharmaceutical company, Enters into a Licensing Agreement with Les Laboratoires Servier | 73 | 1 |
| Astellas Pharma Inc. Enters into a Worldwide Licensing Agreement with Aveo Pharmaceutical, to Develop and Commercialize Tivozanib outside Asia | 73 | 1 |
| Avila Therapeutics, Inc. Enters into an Exclusive Worldwide Licensing Agreement with Sanofi-Aventis | 73 | 1 |
| Lpath Enters into an Exclusive Option Worldwide Licensing Agreement with Pfizer Inc. to Develop and Commercialize iSONEP | 74 | 1 |
| f-star Biotechnologische Forschungs- und Entwicklungsges.m.b.H, Enters into Collaboration and Licensing Agreement with Boehringer Ingelheim GmbH | 74 | 1 |
| Sanofi-aventis Exercises its Option Licensing Agreement with Alopexx Pharmaceuticals, LLC for F598 Antibody | 74 | 1 |
| Synosia Therapeutics AG Enters into a New Strategic Partnership with UCB Group | 75 | 1 |
| Biobetters Therapeutics Market to 2018 - Appendix | 76 | 7 |
| Abbreviations | 76 | 2 |
| Sources | 78 | 1 |
| Research Methodology | 78 | 5 |
| Coverage | 79 | 1 |
| Secondary Research | 79 | 1 |
| Primary Research | 79 | 1 |
| Forecasts | 80 | 1 |
| Epidemiology-based Forecasting | 80 | 2 |
| Expert Panel Validation | 82 | 1 |
| Contact Us | 82 | 1 |
| Disclaimer | 82 | 1 |
