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Recombinant Therapeutic Proteins: Delivering a $53 Billion Mature Market by 2010Published by: Datamonitor Published: May. 3, 2004 - 334 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 4 Scope 4 Datamonitor’s insight into the therapeutic recombinant proteins market in 2004 5 The recombinant protein market will continue to rely on blockbuster revenue, primarily derived from 16 brands. Between 2001 and 2003 blockbuster market share increased from 51.8% to 64.3% and is forecast to remain above 58% to 2010. Successful lifecycle management of these 16 core brands will be critical to continued market development 6 Hematology, diabetes and endocrinology and oncology will be the most valuable therapy areas for recombinant proteins over the forecast period. However; while the latter two therapy areas reflect strong opportunities for future investment, generating 44% of all pipeline products, novel products in hematology are few and far between 9 Erythropoietins, interferons and insulins will lead the market to 2010, accounting for 62% of sales in 2003 and 53% in 2010. However, the fastest-growing class will be fusion/protein inhibitors, with sales forecast to almost triple from 2004 to $6.1 billion in 2010, while their market share will double from 6% to 12%; 12 Despite 28 product approvals between 2004 and 2010, the rDNA protein pipeline value will not be more than $4.7 billion in 2010 and will not be sufficient to sustain current growth. The rDNA market will continue to be dependent on lifecycle management and market expansion strategies, employed to primarily support the growth of its blockbusters and protect key franchises from potential biogeneric threat and interplatform competition 14 CHAPTER 2 DYNAMICS OF THE RECOMBINANT THERAPEUTIC PROTEIN MARKET 23 Introduction 23 Securing sustainable growth: blending innovation and business development 23 Key recommendations to support innovation and business development 24 Historical development of the rDNA proteins business model 25 Phase 1: (1982-1991)-business generation 26 Phase 2: (1992-2001)-business expansion 28 Phase 3: (2002-today)-business maturation 29 Innovation evolution - from business generation to expansion and maturation 30 Return on innovation - current market formation 30 Waves of innovation - key market formation trends 36 Early innovation wave - business generation 40 Advanced innovation wave - business expansion 42 Early signs of business maturation 46 The new waves of innovation - sustaining growth to 2010 47 The anatomy of innovation, 2004-2010 51 Key preclinical development trends 52 Key early clinical development trends 59 Advanced stage pipeline development trends 64 Ready-to-market pipeline trends, 2004-2010 70 Business development trends 78 Market leaders will continue to rely on rDNA protein business 78 rDNA market’s core business will rely on 16 key brands 81 Biotech vs Pharma blockbuster revenue-market relies on biotech 84 Supporting the core business - focus on lifecycle management 86 Reformulation strategies - the role of inhalation and pegylation 86 Market expansion strategies 91 Factors impacting market growth - regulation, biogenerics, partnering, and competition 94 Changing regulatory frameworks - from CBER to CDER 94 The impact of biogenerics - key drivers and resistors 96 The role of alliance networks - higher returns or lower risk 100 Inter platform competition 102 CHAPTER 3 THE RDNA MARKET TO 2010: COMPANY, CLASS & THERAPY AREA DYNAMICS 111 The global rDNA market 111 Market size to 2010 111 Contribution of the rDNA proteins pipeline to market size 112 rDNA market segmentation to 2010 113 Market leaders - ten companies account for 84% of market 113 rDNA leading brands 116 rDNA class analysis - erythropoietins and interferons to dominate 118 Therapy area analysis - hematology, diabetes/endocrinology and oncology lead sales 147 CHAPTER 4 LEADING RDNA PLAYERS 158 Amgen 158 rDNA proteins and Amgen’s business model 158 Assessment of Amgen’s strategic position 160 Amgen’s rDNA proteins deals 166 Amgen’s rDNA proteins class focus 168 Amgen’s portfolio 169 Biogen-IDEC 190 rDNA proteins and Biogen-IDEC’s business model 190 Assessment of Biogen-IDEC’s strategic position 191 Biogen-IDEC’s rDNA protein class focus 194 Biogen-IDEC’s portfolio 195 Chiron 201 Chiron’s business model 201 Assessment of Chiron’s strategic position 203 Chiron’s rDNA proteins deals 205 Chiron’s rDNA protein class focus 207 Chiron’s portfolio 207 Genzyme 216 rDNA proteins and Genzyme’s business model 216 Assessment of Genzyme’s strategic position 217 Genzyme’s rDNA proteins alliances 219 Genzyme’s rDNA proteins class focus 220 Genzyme’s portfolio 221 Serono 233 rDNA proteins and Serono’s business model 233 Assessment of Serono’s strategic position 234 Serono’s rDNA proteins deals 236 Serono’s rDNA protein class focus 237 Serono’s portfolio 238 Aventis 249 rDNA proteins and Aventis’s business model 249 Assessment of Aventis’s strategic position 250 Aventis’s rDNA proteins deals 253 Aventis’s rDNA protein class focus 254 Aventis’s portfolio 255 Eli Lilly 265 rDNA proteins and Eli Lilly’s business model 265 Assessment of Eli Lilly’s strategic position 266 Eli Lilly’s rDNA proteins deals 268 Eli Lilly’s rDNA proteins class focus 269 Eli Lilly’s portfolio 269 Johnson & Johnson 279 rDNA proteins and Johnson & Johnson’s business model 279 Assessment of Johnson & Johnson’s strategic position 280 Johnson & Johnson’s rDNA proteins deals 282 Johnson & Johnson’s rDNA protein class focus 284 Novo Nordisk 292 rDNA proteins and Novo Nordisk’s business model 292 Assessment of Novo Nordisk’s strategic position 294 Novo Nordisk’s rDNA proteins alliances 296 Novo Nordisk’s rDNA proteins class focus 299 Novo Nordisk’s portfolio 300 Roche 314 rDNA proteins and Roche’s business model 314 Assessment of Roche’s strategic position 315 Roche’s rDNA proteins deals 317 Roche’s rDNA protein class focus 318 Roche’s portfolio 319 APPENDIX A 328 Contributing experts 328 Report methodology 328 APPENDIX B 329 About Datamonitor 329 About Datamonitor Healthcare 329 Datamonitor Healthcare’s research and analysis methodologies 330 Datamonitor Healthcare’s therapy area capabilities 330 About Disease analysis team 331 Key therapy team members 332 Disclaimer 334 AbstractIntroductionThe discovery and development of recombinant DNA technology formed the cornerstone of the modern medical biotechnology industry. With a market valued at almost $32 billion in 2003, the changing dynamics of the recombinant therapeutic proteins market will have a significant impact on numerous companies and therapy areas. This analysis seeks to identify and evaluate the key market dynamics to 2010. Scope Reviews the industry’s current R&D pipeline and recent business model evolution, and deal activity of leading biotech and pharmaceutical companies Phase-to-phase analysis calculates the return of the sector’s current pipeline of 104 recombinant products to 2010 Market segmentation and forecasting by leading players, key protein classes, top-selling brands and therapeutic foci reveal key revenue trends to 2010 Report Highlights Despite an increasing interest in protein inhibitors, fusion proteins and tissue growth factors, innovation-driven income will not be sufficient to drive market growth, as the sector’s drug pipeline, with 28 new approvals in the next six years, will account for just 9% of the market in 2010. The recombinant protein market will continue to rely on blockbuster revenue derived from 16 brands. Between 2001 and 2003 blockbuster market share increased from 51.8% to 64.3% and is forecast to remain above 58% to 2010. Successful lifecycle management of these 16 core brands will be critical to continued market development. Hematology, diabetes and endocrinology and oncology will be the most valuable therapy areas for recombinant proteins over the forecast period. However; while the latter two therapy areas reflect strong opportunities for future investment, generating 44% of all pipeline products, novel products in hematology are few and far between. Reasons to Purchase Examine the portfolios of 112 companies by probing Datamonitor’s interactive recombinant therapeutic proteins analysis and forecasting tool Identify therapy area and class-based market opportunities and target product development and lifecycle management strategies accordingly Assess current corporate strategies and evaluate partnering opportunities for new product development, reformulation or market expansion Get Full Details About This Report >> |
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