Therapeutic Antibodies: Capitalizing on the Fully Human Wave

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope

Datamonitor' s Insight into the Therapeutic Antibodies market in 2003

The market will triple in value over the next five years from $5.4 billion in 2002 to $16.7 billion in 2008. Although the growth will rely on the rise of humanized and fully human antibodies, chimeric products, led by Remicade and Rituxan, will continue to dominate market share in 2008.

Oncology will continue to be the leading therapy area both in terms of commercial success and pipeline development. However, while the pipeline for autoimmune is currently half the size of that for oncology, commercial products for this therapy area will show the highest revenue growth and achieve almost equal returns with oncology in 2008.

The Ab market is heavily reliant on a few key drugs for the majority of market value, with five products accounting for 95% of the market in 2002. Five Ab blockbusters will still account for 68% of the market in 2008, with all but two of the 16 Ab products forecast to generate sales over $200m marketed to some extent by a top 20 pharma company.

Technology providers, emerging drug developers and fully integrated players are driving the Ab biotech sector towards integration and market expansion. Success will require strategies targeting lower development times, well-protected patents, higher molecular engineering sophistication, cost efficient manufacturing and improved drug delivery

CHAPTER 2 KEY DYNAMICS OF THE THERAPEUTIC ANTIBODY MARKET

• Introduction
• Historical development of the antibody-oriented biotech business model
• Blending innovation and integration for success
• Company evolution – the current antibody development model
• The evolution of innovation – fulfilling unmet need
• Reducing development time – optimising target selection
• Development platform evolution – humanized and fully human therapies take over
• Advancing antibody engineering – beyond the traditional molecule
• Single or multiple platform – focused expertise versus risk diversification
• Antibody manufacturing – innovation meets economics
• Drug delivery
• Business model evolution- optimizing commercial potential
• From service provision to full integration
• Virtual pharma – alliance networking is key to growth

CHAPTER 3 MARKET ANALYSIS

• Introduction
• Segmentation of technology platforms
• Commercial market size and growth
• The current marketed portfolio
• Future monoclonal antibody market potential
• Antibody development programs
• Current marketed and pipeline technology distribution
• Current marketed and pipeline therapy area distribution
• The relationship between therapy area and technology

CHAPTER 4 COMPANY ANALYSIS

• Introduction
• Company dynamics
• Current position
• Forecast position in 2008
• Technology focus
• Therapeutic focus
• Financial positioning
• Abbott
• Monoclonal antibodies and Abbott' s business model
• Assessment of Abbott' s strategic position
• Abbott' s antibody alliances
• Abbott' s technological focus
• Abbott' s portfolio
• Abgenix
• Abgenix' s antibody business model
• Assessment of Abgenix' s strategic position
• Abgenix' s antibody alliances
• Abgenix' s technology
• Abgenix' s portfolio
• Antisoma
• Antisoma' s antibody business model
• Assessment of Antisoma' s strategic position
• Antisoma' s alliance network
• Antisoma' s technology
• Antisoma' s portfolio
• Biogen-IDEC
• Monoclonal antibodies and Biogen' s business model
• Assessment of Biogen-IDEC' s strategic position
• Biogen-IDEC' s antibody alliances
• Biogen-IDEC' s antibody technology
• Biogen-IDEC' s antibody products
• Cambridge Antibody Technology
• Monoclonal antibodies and CAT' s business model
• Assessment of CAT' s strategic position
• CAT' s antibody alliances
• CAT' s technology
• CAT' s portfolio
• Celltech
• Monoclonal antibodies and Celltech' s business model
• Assessment of Celltech' s strategic position
• Celltech' s alliance network
• Celltech' s technology
• Celltech' s antibody portfolio
• Genentech
• Monoclonal antibodies and Genentech' s business model
• Assessment of Genentech' s strategic position
• Genentech' s antibody alliances
• Genentech' s technology
• Genentech' s portfolio
• Genmab
• Monoclonal antibodies and Genmab' s business model
• Assessment of Genmab' s strategic position
• Genmab' s antibody alliances
• Genmab' s technology
• Genmab' s portfolio
• ImClone Systems
• Monoclonal antibodies and ImClone' s business model
• Assessment of ImClone' s strategic position
• Strengths
• Weaknesses
• ImClone' s alliance network
• ImClone' s Technology
• Therapeutic focus
• ImClone' s portfolio
• Immunomedics
• Monoclonal antibodies and Immunomedics'  business model
• Assessment of Immunomedics'  strategic position
• Immunomedics' s antibody alliances
• Immunomedics'  technology
• Immunomedics'  portfolio
• Johnson & Johnson
• Monoclonal antibodies and Johnson & Johnson' s business model
• Assessment of Johnson & Johnson' s strategic position
• Johnson & Johnson' s antibody alliances
• Johnson & Johnson' s technology
• Johnson & Johnson' s portfolio
• Medarex
• Medarex' s antibody business model
• Assessment of Medarex' s strategic position
• Medarex' s antibody alliances
• Medarex' s technology
• Medarex' s portfolio
• MedImmune
• Monoclonal antibodies and MedImmune' s business model
• Assessment of MedImmune' s strategic position
• MedImmune' s antibody alliances
• MedImmune' s antibody technology focus
• MedImmune' s portfolio
• Protein Design Labs
• Monoclonal antibodies and PDL' s business model
• Assessment of PDL' s strategic position
• PDL' s antibody alliances
• PDL' s technology
• PDL' s portfolio
• Seattle Genetics
• Monoclonal antibodies and Seattle Genetics'  business model
• Assessment of Seattle Genetics'  strategic position
• Seattle Genetics'  antibody alliance network
• Seattle Genetics'  technology
• Seattle Genetics'  portfolio

CHAPTER 5 APPENDIX A: VIRTUAL DIALOGUE WITH ANTIBODY OPINION LEADERS

• Key messages
• Innovation – realizing antibody potential
• Success rates and development time
• Optimising antibody development
• Manufacturing evolution
• Integration and growth – guiding commercial success

CHAPTER 6 APPENDIX B

• Acknowledgments
• Report methodology
• Exchange rates
• About Datamonitor
• About Datamonitor Healthcare
• Datamonitor Healthcare' s research and analysis methodologies
• Datamonitor Healthcare' s therapy area capabilities
• Datamonitor' s Competitive Intelligence Business Unit

List of Tables

Table 1: Marketed antibodies 2003

Table 2: Sales and growth of antibodies by technology, 2002

Table 3: Sales and growth of antibodies by therapy area, 2002

Table 4: Forecast antibody market in 2008

Table 5: Sales and growth of antibodies by technology, 2008

Table 6: Sales and growth of antibodies by therapy area, 2008

Table 7: Antibody related sales in 2001 and 2002

Table 8: Forecast antibody sales in 2008

Table 9: Sales of Abbott' s marketed antibody products, 2001–02

Table 10: Abbott' s antibody pipeline, 2003

Table 11: Abbott' s forecast antibody sales, 2003–08

Table 12: Key products in Abgenix' s pipeline, 2003

Table 13: ABX-EGF' s clinical trials, 2003

Table 14: Antisoma' s antibody pipeline, 2003

Table 15: Antisoma' s forecast antibody sales

Table 16: Sales of Biogen-IDEC' s marketed antibody products, 2001–02

Table 17: Biogen-IDEC' s antibody pipeline, 2003

Table 18: Biogen-IDEC' s forecast antibody sales, 2003–08

Table 19: Sales of CAT' s marketed antibody products, 2001–02

Table 20: CAT' s antibody pipeline

Table 21: CAT' s forecast antibody sales, 2003–08

Table 22: Celltech' s key pipeline antibodies, 2003

Table 23: Datamonitor and analyst consensus forecasts for sales of CDP 870, 2005–08

Table 24: Sales of Genentech' s marketed antibody products 2001–02

Table 25: Genentech' s antibody pipeline, 2003

Table 26: Genentech' s forecast antibody sales

Table 27: Genmab' s antibody pipeline, 2003

Table 28: Genmab' s forecast antibody sales

Table 29: ImClone' s key pipeline therapeutics, 2003

Table 30: ImClone' s forecast antibody sales

Table 31: Immunomedics'  antibody pipeline, 2003

Table 32: Immunomedics' s forecast antibody sales, 2003–08

Table 33: Sales of Johnson & Johnson' s marketed antibody products, 2001–02

Table 34: Johnson & Johnson' s forecast antibody sales

Table 35: Key products in Medarex' s pipeline, 2003

Table 36: Forecast sales for Phase III developmental drugs in ovarian cancer, 2003–08

Table 37: Medarex' s forecast antibody sales

Table 38: MedImmune' s alliance network, 2003

Table 39: MedImmune' s marketed antibody portfolio

Table 40: MedImmune' s key pipeline antibodies, 2003

Table 41: Forecast sales for MedImmune' s antibody products, 2003–08

Table 42: Sales of PDL' s marketed products, 2001–02

Table 43: PDL' s antibody pipeline, 2003

Table 44: Seattle Genetics'  key pipeline products, 2003

Table 45: Exchange rates, 2002

List of Figures

Figure 1: The structure of Datamonitor' s analysis of the therapeutic antibody market

Figure 2: Technological exposure of the AB clinical pipeline, 2003

Figure 3: New product approval trajectories in terms of technological exposure

Figure 4: Therapeutic focus of antibody development, 2003

Figure 5: Contribution of blockbuster Abs to the sector' s total ethical revenues, 2002 and 2008

Figure 6: The Ab sector' s move from tech provision to full integration

Figure 7: Evolution of the antibody-oriented business model

Figure 8: Key strategic factors that will affect the antibody sector

Figure 9: Five critical steps to develop a commercially attractive Ab production engine

Figure 10: Commercial and developmental therapeutic focus of the therapeutic antibody market

Figure 11: New antibody approvals according to therapeutic focus, 2003-08

Figure 12: The evolution of antibody engineering technologies

Figure 13: Technological exposure of the antibody-based pipeline, 2003

Figure 14: New product approval trajectories in terms of technological exposure

Figure 15: The Ab sector' s move from tech provision to full integration

Figure 16: Technology exposure in 2003

Figure 17: Therapy area exposure in 2003

Figure 18: Technology exposure in 2008

Figure 19: Therapy area exposure in 2008

Figure 20: The marketed and pipeline antibody market by phase, 2003

Figure 21: Technology exposure across whole market, 2003

Figure 22: Technology exposure across development phases, 2003

Figure 23: Programs by technology type, 2003

Figure 24: Therapy area exposure across whole market, 2003

Figure 25: Therapy area exposure across development phases, 2003

Figure 26: Programs by therapy area, 2003

Figure 27: Technology exposure of key antibody companies

Figure 28: Therapy area exposure of key antibody companies

Figure 29: Revenues of Biotech companies with antibody exposure, 2002

Figure 30: Cost ratios of companies with antibody exposure, 2002

Figure 31: Net profit margin of companies with antibody exposure, 2002

Figure 32: Turnover of cash for companies with antibody exposure, 2002

Figure 33: Abbott' s monoclonal antibody exposure, FY2002

Figure 34: Abbott' s strategic position within monoclonal antibodies

Figure 35: Abbott' s antibody alliances, 2003

Figure 36: Abbott' s technology exposure, 2003

Figure 37: Abbott' s therapeutic exposure, 2003

Figure 38: Abgenix' s strategic position

Figure 39: Abgenix' s antibody alliances, 2003

Figure 40: Abgenix' s technology exposure, 2003

Figure 41: Abgenix' s therapeutic exposure, 2003

Figure 42: Antisoma' s strategic position

Figure 43: Medarex' s antibody alliances, 2003

Figure 44: Antisoma' s technology exposure

Figure 45: Development stage of Antisoma' s oncology portfolio, 2003

Figure 46: Biogen-IDEC' s monoclonal antibody exposure, FY2002

Figure 47: Biogen-IDEC' s strategic position within monoclonal antibodies

Figure 48: Biogen-IDEC' s antibody alliances, 2003

Figure 49: Biogen-IDEC' s technology exposure, 2003

Figure 50: Biogen-IDEC' s therapeutic exposure, 2003

Figure 51: CAT' s strategic position within monoclonal antibodies

Figure 52: CAT' s antibody alliances, 2003

Figure 53: CAT' s technology exposure, 2003

Figure 54: CAT' s therapeutic exposure, 2003

Figure 55: Assessment of Celltech' s strategic position

Figure 56: Celltech' s alliance network

Figure 57: Celltech' s technology exposure

Figure 58: Celltech' s therapeutic focus

Figure 59: Genentech' s monoclonal antibody exposure, FY2002

Figure 60: Genentech' s strategic position within monoclonal antibodies

Figure 61: Genentech' s antibody alliances

Figure 62: Genentech' s technology exposure, 2003

Figure 63: Genentech' s therapeutic exposure, 2003

Figure 64: Genmab' s strategic position within monoclonal antibodies

Figure 65: Genmab' s antibody alliances, 2003

Figure 66: Genmab' s technology exposure, 2003

Figure 67: Genmab' s therapeutic exposure, 2003

Figure 68: ImClone' s strategic position

Figure 69: ImClone' s alliance network

Figure 70: ImClone' s technology exposure

Figure 71: ImClone' s therapeutic focus

Figure 72: Immunomedics'  strategic position within monoclonal antibodies

Figure 73: Immunomedics' s antibody alliances, 2003

Figure 74: Immunomedics'  technology exposure, 2003

Figure 75: Immunomedics'  therapeutic exposure, 2003

Figure 76: Johnson & Johnson' s monoclonal antibody exposure, FY2002

Figure 77: Johnson & Johnson' s strategic position within monoclonal antibodies

Figure 78: Johnson & Johnson' s antibody alliances, 2003

Figure 79: Johnson & Johnson' s technology exposure, 2003

Figure 80: Johnson & Johnson' s therapeutic exposure, 2003

Figure 81: Medarex' s strategic position

Figure 82: Medarex' s antibody alliances, 2003

Figure 83: Medarex' s technology exposure, 2003

Figure 84: Therapeutic focus of Medarex' s antibody portfolio, 2003

Figure 85: Contribution of MedImmune' s antibodies to ethical sales, 2002–08

Figure 86: MedImmune' s strategic position

Figure 87: MedImmune' s technology exposure, 2003

Figure 88: MedImmune' s therapeutic focus, 2003

Figure 89: PDL' s strategic position within monoclonal antibodies

Figure 90: PDL' s antibody alliances, 2003

Figure 91: PDL' s technology exposure, 2003

Figure 92: PDL therapeutic exposure, 2003

Figure 93: Seattle Genetics'  strategic position

Figure 94: Seattle Genetics'  alliance network

Figure 95: Seattle Genetics'  technology exposure, 2003

Figure 96: Development stage of Seattle Genetics'  oncology portfolio, 2003