Recombinant Therapeutic Proteins: Delivering a $53 Billion Mature Market by 2010

SUMMARY

The discovery and development of recombinant DNA technology formed thecornerstone of the modern medical biotechnology industry. With a market valuedat almost $32 billion in 2003, the changing dynamics of the recombinanttherapeutic proteins market will have a significant impact on numerous companiesand therapy areas. This analysis seeks to identify and evaluate the key marketdynamics to 2010.

Scope of this report

• Reviews the industry's current R&D pipeline and recent business modelevolution, and deal activity of leading biotech and pharmaceutical companies
• Phase-to-phase analysis calculates the return of the sector's currentpipeline of 104 recombinant products to 2010
• Market segmentation and forecasting by leading players, key proteinclasses, top-selling brands and therapeutic foci reveal key revenue trendsto 2010

Research and analysis highlights

Despite an increasing interest in protein inhibitors, fusion proteins andtissue growth factors, innovation-driven income will not be sufficient to drivemarket growth, as the sector's drug pipeline, with 28 new approvals in the nextsix years, will account for just 9% of the market in 2010.

The recombinant protein market will continue to rely on blockbuster revenuederived from 16 brands. Between 2001 and 2003 blockbuster market share increasedfrom 51.8% to 64.3% and is forecast to remain above 58% to 2010. Successfullifecycle management of these 16 core brands will be critical to continuedmarket development.

Hematology, diabetes and endocrinology and oncology will be the most valuabletherapy areas for recombinant proteins over the forecast period. However; whilethe latter two therapy areas reflect strong opportunities for future investment,generating 44% of all pipeline products, novel products in hematology are fewand far between.

Key reasons to read this report

• Examine the portfolios of 112 companies by probing Datamonitor'sinteractive recombinant therapeutic proteins analysis and forecasting tool
• Identify therapy area and class-based market opportunities and targetproduct development and lifecycle management strategies accordingly
• Assess current corporate strategies and evaluate partnering opportunitiesfor new product development, reformulation or market expansion

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

Scope

Datamonitor's insight into the therapeutic recombinant proteins market in2004

The recombinant protein market will continue to rely on blockbusterrevenue, primarily derived from 16 brands. Between 2001 and 2003 blockbustermarket share increased from 51.8% to 64.3% and is forecast to remain above58% to 2010. Successful lifecycle management of these 16 core brands will becritical to continued market development

Hematology, diabetes and endocrinology and oncology will be the mostvaluable therapy areas for recombinant proteins over the forecast period.However; while the latter two therapy areas reflect strong opportunities forfuture investment, generating 44% of all pipeline products, novel productsin hematology are few and far between

Erythropoietins, interferons and insulins will lead the market to 2010,accounting for 62% of sales in 2003 and 53% in 2010. However, thefastest-growing class will be fusion/protein inhibitors, with sales forecastto almost triple from 2004 to $6.1 billion in 2010, while their market sharewill double from 6% to 12%;

Despite 28 product approvals between 2004 and 2010, the rDNA proteinpipeline value will not be more than $4.7 billion in 2010 and will not besufficient to sustain current growth. The rDNA market will continue to bedependent on lifecycle management and market expansion strategies, employedto primarily support the growth of its blockbusters and protect keyfranchises from potential biogeneric threat and interplatform competition

CHAPTER 2 DYNAMICS OF THE RECOMBINANT THERAPEUTIC PROTEIN MARKET

Introduction

Securing sustainable growth: blending innovation and business development

Key recommendations to support innovation and business development

Historical development of the rDNA proteins business model

Phase 1: (1982-1991)-business generation

Phase 2: (1992-2001)-business expansion

Phase 3: (2002-today)-business maturation

Innovation evolution - from business generation to expansion andmaturation

Return on innovation - current market formation

Waves of innovation - key market formation trends

Early innovation wave - business generation

Advanced innovation wave - business expansion

Early signs of business maturation

The new waves of innovation - sustaining growth to 2010

The anatomy of innovation, 2004-2010

Key preclinical development trends

Key early clinical development trends

Advanced stage pipeline development trends

Ready-to-market pipeline trends, 2004-2010

Business development trends

Market leaders will continue to rely on rDNA protein business

rDNA market's core business will rely on 16 key brands

Biotech vs Pharma blockbuster revenue-market relies on biotech

Supporting the core business - focus on lifecycle management

Reformulation strategies - the role of inhalation and pegylation

Market expansion strategies

Factors impacting market growth - regulation, biogenerics, partnering, andcompetition

Changing regulatory frameworks - from CBER to CDER

The impact of biogenerics - key drivers and resistors

The role of alliance networks - higher returns or lower risk

Inter platform competition

CHAPTER 3 THE RDNA MARKET TO 2010: COMPANY, CLASS & THERAPY AREADYNAMICS

The global rDNA market

Market size to 2010

Contribution of the rDNA proteins pipeline to market size

rDNA market segmentation to 2010

Market leaders - ten companies account for 84% of market

rDNA leading brands

rDNA class analysis - erythropoietins and interferons to dominate

Therapy area analysis - hematology, diabetes/endocrinology and oncologylead sales

CHAPTER 4 LEADING RDNA PLAYERS

Amgen

rDNA proteins and Amgen's business model

Assessment of Amgen's strategic position

Amgen's rDNA proteins deals

Amgen's rDNA proteins class focus

Amgen's portfolio

Biogen-IDEC

rDNA proteins and Biogen-IDEC's business model

Assessment of Biogen-IDEC's strategic position

Biogen-IDEC's rDNA protein class focus

Biogen-IDEC's portfolio

Chiron

Chiron's business model

Assessment of Chiron's strategic position

Chiron's rDNA proteins deals

Chiron's rDNA protein class focus

Chiron's portfolio

rDNA proteins and Genzyme's business model

Assessment of Genzyme's strategic position

Genzyme's rDNA proteins alliances

Genzyme's rDNA proteins class focus

Genzyme's portfolio

Serono

rDNA proteins and Serono's business model

Assessment of Serono's strategic position

Serono's rDNA proteins deals

Serono's rDNA protein class focus

Serono's portfolio

Aventis

rDNA proteins and Aventis's business model

Assessment of Aventis's strategic position

Aventis's rDNA proteins deals

Aventis's rDNA protein class focus

Aventis's portfolio

Eli Lilly

rDNA proteins and Eli Lilly's business model

Assessment of Eli Lilly's strategic position

Eli Lilly's rDNA proteins deals

Eli Lilly's rDNA proteins class focus

Eli Lilly's portfolio

Johnson & Johnson

rDNA proteins and Johnson & Johnson's business model

Assessment of Johnson & Johnson's strategic position

Johnson & Johnson's rDNA proteins deals

Johnson & Johnson's rDNA protein class focus

Novo Nordisk

rDNA proteins and Novo Nordisk's business model

Assessment of Novo Nordisk's strategic position

Novo Nordisk's rDNA proteins alliances

Novo Nordisk's rDNA proteins class focus

Novo Nordisk's portfolio

rDNA proteins and Roche's business model

Assessment of Roche's strategic position

Roche's rDNA proteins deals

Roche's rDNA protein class focus

Roche's portfolio

Contributing experts

Report methodology

About Datamonitor

About Datamonitor Healthcare

Datamonitor Healthcare's research and analysis methodologies

Datamonitor Healthcare's therapy area capabilities

About Disease analysis team

Key therapy team members

Disclaimer

List of Tables

Table 1: The rDNA proteins market according to protein class focus,2001-03

Table 2: The rDNA proteins market according to therapeutic focus, 2001-03

Table 3: Phase II derived sales, according to protein class andtherapeutic foci, 2007-2010

Table 4: Phase III income according to protein class and therapeutic foci,2004-2010

Table 5: Revenues generated by products awaiting for approval according toprotein class and therapeutic foci, 2004-2010

Table 6: rDNA protein sales according to protein class, 2003-10

Table 7: The erythropoietin portfolio sales forecasts, 2003-10

Table 8: The interferon portfolio sales forecasts, 2003-10

Table 9: The insulin portfolio sales forecasts, 2003-10

Table 10: The fusion/protein inhibitor portfolio sales forecasts, 2003-10

Table 11: The interleukin portfolio sales forecasts, 2003-10

Table 12: Hormonal therapies portfolio sales forecasts, 2003-10

Table 13: Colony-stimulating factors portfolio sales forecasts, 2003-10

Table 14: Blood factors portfolio sales forecasts, 2003-10

Table 15: Growth factors portfolio sales forecasts, 2003-10

Table 16: Enzymes portfolio sales forecasts, 2003-10

Table 17: Plasminogen activators portfolio sales forecasts, 2003-10

Table 18: rDNA protein sales by therapy area, 2003-10

Table 19: Sales of Amgen's marketed rDNA proteins, 2001-03

Table 20: Amgen's rDNA proteins pipeline, 2004

Table 21: Amgen's forecast rDNA protein sales, 2003-10

Table 22: Sales of Biogen-IDEC's marketed rDNA proteins, 2001-03

Table 23: Biogen(IDEC's rDNA proteins pipeline, 2004

Table 24: Biogen-IDEC's rDNA protein sales, 2004-10

Table 25: Sales of Chiron's marketed rDNA proteins, 2001-03

Table 26: Sales performance of Betaseron's RRMS competitors, 2000-03

Table 27: Chiron's rDNA protein pipeline, 2004

Table 28: Chiron's forecast rDNA protein sales, 2004-10

Table 29: Sales of Genzyme's marketed rDNA proteins, 2001-03

Table 30: Genzyme's rDNA proteins pipeline, 2004

Table 31: Genzyme's forecast rDNA protein sales, 2004-10

Table 32: Sales of Serono's marketed rDNA proteins, 2001-03

Table 33: Serono's rDNA proteins pipeline, 2004

Table 34: Serono's forecast rDNA protein sales, 2004-10

Table 35: Sales of Aventis's marketed rDNA proteins, 2001-03

Table 36: Aventis's rDNA proteins pipeline, 2004

Table 37: Aventis's forecast rDNA protein sales, 2003-10

Table 38: Sales of Eli Lilly's marketed rDNA proteins, 2001-03

Table 39: Eli Lilly's rDNA proteins pipeline, 2004

Table 40: Eli Lilly's forecast rDNA protein sales, 2003-10

Table 41: Sales of Johnson & Johnson's marketed rDNA proteins, 2001-03

Table 42: Johnson & Johnson's forecast rDNA protein sales, 2003-10

Table 43: Sales of Novo Nordisk's marketed rDNA proteins, 2002-03

Table 44: Novo Nordisk's rDNA proteins pipeline, 2004

Table 45: Novo Nordisk's forecast rDNA protein sales, 2004-10

Table 46: Sales of Roche's marketed rDNA proteins, 2001-03

Table 47: Roche's rDNA proteins pipeline, 2004

Table 48: Roche's forecast rDNA protein sales, 2004-10

List of Figures

Figure 1: The structure of Datamonitor's analysis of the therapeuticrecombinant proteins market, 2004

Figure 2: The rDNA proteins market growth, 2001-03

Figure 3: The rDNA proteins market growth, 2004-10

Figure 4: Blockbuster approval rates, 1982-2002

Figure 5: Recombinant products revenue distribution according totherapeutic focus, 2001-03

Figure 6: Therapeutic focus of rDNA product pipeline, 2004

Figure 7: Recombinant products' revenue distribution according totherapeutic focus, 2004-10

Figure 8: Recombinant products' revenue distribution according to proteinclass focus, 2001-03

Figure 9: Recombinant products' revenue distribution according to proteinclass focus, 2004-10

Figure 10: Pipeline contribution to total market size, 2001-2010

Figure 11: Key strategic factors that will shape the rDNA proteins sectorto 2010

Figure 12: The evolution of the rDNA protein sector, 1982-2003

Figure 13: The rDNA proteins market according to protein class focus,2001-03

Figure 14: The rDNA proteins market according to therapeutic focus,2001-03

Figure 15: The development of the current rDNA proteins market, 1982-2003

Figure 16: rDNA product approval trends according to protein class,1982-1991

Figure 17: rDNA product approval trends according to protein class,1992-2001

Figure 18: rDNA product approval trends according to protein class

Figure 19: The therapeutic recombinant protein pipeline distributionaccording to protein class and therapeutic foci, 2004

Figure 20: Product approval trends, according to therapy area 2004-2010

Figure 21: Return on innovation, according to protein class focus,2004-2010

Figure 22: Preclinical rDNA pipeline dynamics according to protein classand therapeutic foci, 2004

Figure 23: Key players within the preclinical phase of development, 2004

Figure 24: Preclinical development partnering trends, 2004

Figure 25: Phase I pipeline dynamics according to protein class andtherapeutic foci, 2004

Figure 26: Phase I key players, 2004

Figure 27: Phase I partnering trends, 2004

Figure 28: Phase II pipeline dynamics according to class and therapeuticfoci, 2004

Figure 29: Distribution of Phase II derived revenues according to proteinclass and therapeutic foci, 2010

Figure 30: Phase II key players, 2004

Figure 31: Phase II partnering trends, 2004

Figure 32: Phase III income distribution according to protein class andtherapeutic foci, 2010

Figure 33: Distribution of registration phase sales according to proteinclass and therapeutic foci, 2010

Figure 34: Ready-to-market pipeline dynamics according to class andtherapeutic foci, 2004

Figure 35: Key players with ready-to-market products 2004

Figure 36: Partnering trends involving ready-to-market drugs, 2004

Figure 37: The contribution of the top 10 players' rDNA revenues to totalethical sales, 2003-10

Figure 38: Dependence of the top 10 players' ethical sales on their rDNAproteins income, 2003, 2007 and 2010

Figure 39: The contribution of rDNA protein core and non-core businessesto total market size, 2010

Figure 40: Blockbuster approval rates, 1982-2002

Figure 41: Blockbuster sales trends, 2001-2010

Figure 42: Biotech versus Pharma driven blockbuster revenues, 2001-2010

Figure 43: The contribution of pharma and biotech blockbusters to corebusiness value 2001-2010

Figure 44: New product approval trajectories in terms of technologicalexposure

Figure 45: Global rDNA market value, 2001-10

Figure 46: Sales contribution of global rDNA portfolio, 2003-10

Figure 47: Contribution of top 10 rDNA players to market size, 2003-10

Figure 48: rDNA revenues of top 10 leading players, 2003-10

Figure 49: Contribution of the top 10 rDNA proteins players to marketsize, 2003 and 2010

Figure 50: Leading rDNA products, 2003-10

Figure 51: Leading rDNA products' contribution to market size, 2003-10

Figure 52: rDNA revenues by class, 2003-10

Figure 53: rDNA class contribution to market size, 2003-10

Figure 54: Erythropoietin revenue trends, 2003-10

Figure 55: Interferon revenue trends, 2003-10

Figure 56: Interferons' therapeutic focus, 2003-10

Figure 57: Insulin revenue trends, 2003-10

Figure 58: Fusion protein inhibitor revenue trends, 2003-10

Figure 59: Fusion protein inhibitors' therapeutic focus, 2003-10

Figure 60: Interleukin revenue trends, 2003-10

Figure 61: Interleukins' focus by therapy area, 2003-10

Figure 62: Hormonal therapies revenue trends, 2003-10

Figure 63: Hormonal therapies by therapy area, 2003-10

Figure 64: CSF revenue trends, 2003-10

Figure 65: Blood factors portfolio sales forecasts, 2003-10

Figure 66: Growth factors portfolio sales forecasts, 2003-10

Figure 67: Enzymes portfolio sales forecasts, 2003-10

Figure 68: Plasminogen activators portfolio sales forecasts, 2003-10

Figure 69: The contribution of therapy areas to rDNA market growth,2003-10

Figure 70: Hematology rDNA protein sales forecasts, 2003-10

Figure 71: Leading rDNA classes in hematology, 2003-10

Figure 72: Evaluation of hematology products in the rDNA market, 2003-10

Figure 73: Leading rDNA classes in diabetes and endocrinology, 2003-10

Figure 74: Leading rDNA classes in infectious diseases, 2003-10

Figure 75: Leading rDNA classes in infectious diseases, 2003-10

Figure 76: Evaluation of oncology products in the rDNA market, 2003-10

Figure 77: Leading rDNA classes in oncology, 2003-10

Figure 78: Leading rDNA classes in AIID, 2003-10

Figure 79: Leading rDNA classes in AIID, 2003-10

Figure 80: Amgen's strategic position within rDNA proteins, 2004

Figure 81: Amgen's rDNA proteins alliances/deals, 1999-2004

Figure 82: Amgen's rDNA proteins class focus, 2004

Figure 83: Amgen's therapeutic exposure, 2004

Figure 84: Amgen's rDNA protein sales, 2001-03

Figure 85: Amgen's forecast rDNA protein sales, 2003-10

Figure 86: Biogen-IDEC's strategic position within rDNA proteins, 2004

Figure 87: Biogen-IDEC's rDNA protein class focus, 2004

Figure 88: Biogen-IDEC's therapeutic exposure, 2004

Figure 89: Biogen-IDEC's rDNA protein sales, 2004-10

Figure 90: Chiron's rDNA protein exposure, 2001-03

Figure 91: Chiron's strategic position within rDNA proteins, 2004

Figure 92: Chiron's rDNA proteins alliances/deals, 2004

Figure 93: Chiron's rDNA protein class focus exposure, 2004

Figure 94: Chiron's therapeutic exposure, 2004

Figure 95: Market share of the leading MS brands, 2002 and 2003

Figure 96: Chiron's forecast rDNA protein sales, 2003-10

Figure 97: Genzyme's rDNA protein exposure, 2001 and 2003

Figure 98: Genzyme's strategic position within rDNA proteins, 2004

Figure 99: Genzyme's rDNA proteins alliances, 2004

Figure 100: Genzyme's rDNA proteins class focus, 2004

Figure 101: Genzyme's therapeutic exposure, 2004

Figure 102: Genzyme's sales from its marketed rDNA proteins, 2001-03

Figure 103: Genzyme's forecast rDNA protein sales, 2003-10

Figure 104: Serono's rDNA protein exposure, 2001 and 2003

Figure 105: Serono's strategic position within rDNA proteins, 2004

Figure 106: Serono's rDNA proteins alliances/deals, 2004

Figure 107: Serono's rDNA protein class focus, 2004

Figure 108: Serono's therapeutic exposure, 2003

Figure 109: Serono's forecast rDNA protein sales, 2003-10

Figure 110: Aventis's rDNA protein exposure, 2001-03

Figure 111: Aventis's strategic position within rDNA proteins, 2004

Figure 112: Aventis's rDNA proteins alliances/deals, 2004

Figure 113: Aventis's rDNA protein class focus, 2004

Figure 114: Aventis's therapeutic exposure, 2004

Figure 115: Aventis's forecast rDNA protein sales, 2004-10

Figure 116: Eli Lilly's rDNA protein exposure, 2001-03

Figure 117: Eli Lilly's strategic position within recombinant proteins

Figure 118: Eli Lilly's rDNA alliances/deals, 1999-2003

Figure 119: Eli Lilly's rDNA protein class focus, 2004

Figure 120: Eli Lilly's therapeutic exposure, 2004

Figure 121: Eli Lilly's forecast rDNA protein sales, 2003-10

Figure 122: Aventis's rDNA protein exposure, 2001 and 2003

Figure 123: Johnson & Johnson's strategic position within rDNAproteins, 2004

Figure 124: Johnson & Johnson's rDNA proteins alliances/deals, 2004

Figure 125: Johnson & Johnson's rDNA protein class focus, 2004

Figure 126: Johnson & Johnson's therapeutic exposure, 2004

Figure 127: Johnson & Johnson's forecast rDNA protein sales, 2003-10

Figure 128: Novo Nordisk's rDNA protein exposure, 2001 and 2003

Figure 129: Novo Nordisk's strategic position within rDNA proteins, 2004

Figure 130: Novo Nordisk's rDNA proteins alliances, 2004

Figure 131: Novo Nordisk's technology exposure, 2004

Figure 132: Novo Nordisk's sales of rDNA proteins by class, 2003

Figure 133: Novo Nordisk's therapeutic exposure, 2004

Figure 134: Novo Nordisk's forecast rDNA protein sales, 2004-10

Figure 135: Roche's rDNA protein exposure, 2001 and 2003

Figure 136: Roche's strategic position within rDNA proteins, 2004

Figure 137: Roche's rDNA proteins alliances/deals, 2004

Figure 138: Roche's rDNA proteins class focus, 2004

Figure 139: Roche's therapeutic exposure, 2004

Figure 140: Roche's forecast rDNA protein sales, 2003-10