Report: Monoclonal Antibody Therapies: Evolving into a $30 billion market TOC

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report
Key findings: The monoclonal antibodies market is expected to almost triple in value over the next six years from $10.3 billion in 2004 to $30.3 billion, growing at a CAGR of 19.8%. Oncology products will continue to dominate the market in terms of commercial value and pipeline development. However, sales of arthritis, immune and inflammatory disorders (AIID) products are forecast to grow strongly and account for 40.1% of the market value in 2010.; The development focus of the industry is moving away from murine and chimeric antibodies, to humanized and, in particular, fully human technologies. The market is expected to continue to evolve as antibody engineering capabilities advance further, including more efficient manufacturing and alternative delivery methods, broadening the commercial viability of antibodies treatments in a wider range of diseases.; Roche and Genentech dominate the monoclonal market, with a combined market share of 44.9% in 2004, although this is forecast to slip to 35.7% in 2010. Datamonitor identified just 17 companies with direct sales of monoclonal antibodies in 2004, but this figure is expected to more than double to 36 in 2010, as new products and companies flood the market; The intellectual property (IP) situation surrounding monoclonal antibodies remains complex, although resolution of patent disputes and cross-licensing agreements are starting to simplify the IP landscape. In stark contrast to small molecule drugs, antibodies currently face no prospect of generic competition. Datamonitor expects this to extend the lifecycle of antibody therapies, thereby massively increasing their profitability.

CHAPTER 2 KEY DYNAMICS IN THE MONOCLONAL ANTIBODIES MARKET

Introduction
Drivers and resistors to the growth of the monoclonal antibody market: Technology focus - evolving from murine to fully human; Development of portfolio and pipeline - fully human antibodies to take over; Conjugated antibodies - untapped potential; Class of antibody - crucial to induction of effector functions; Narrowing therapeutic focus - road to success; Infectious and niche diseases - opportunity to expand market; Development time - faster than conventional drugs; Manufacturing issues - efficiency and reliability supersede under-capacity as the primary manufacturing concern; Mammalian cell culture - disadvantages persist, but still the most widely-used system; In-house production or out-sourcing; Contract manufacturing; Novel approaches - transgenic animals and plant systems; Intellectual property - cross-licensing settlements limit legal costs and extract maximum value in the rapidly-changing IP landscape; Patent issues; Biosimilar antibodies - likely to rely on compulsory licensing; Target selection - exploiting proteomics and genomics
Antibody engineering evolution: Drug delivery - improving patient convenience; Delivery devices; Route of administration; Intracellular delivery of antibodies - expanding targets accessible; Reformulation - improving the pharmacological profile; Bispecific monoclonal antibodies - harnessing the immune system; Recombinant polyclonal antibodies - a human-like immune response; Symphogen; Therapeutic Human Polyclonals; New techniques for antibody discovery and validation; Ribosome display; Target-independent discovery; Cross-species antibodies for target validation; Hybridoma-free generation; In silico antibody modeling and analysis
Company strategy: Business model evolution - biotech moves upstream; Technology developers and providers; Early-stage antibody drug developers; Late-stage antibody drug developers; Fully integrated players; Alternative growth strategies - the impact of big pharma; Alliance networks; Key drivers of partnerships - creating synergies and lowering risk; Early-stage research and development alliances; Later-stage development alliances; Mergers & Acquisitions; Development and commercialization strategies

CHAPTER 3 MARKET ANALYSIS

Introduction to the monoclonal antibody market
Market evaluation, 2004-10: Monoclonal antibody market value, 2004; Technology focus of monoclonal antibody market, 2004; Therapeutic focus of monoclonal antibody market, 2004; Monoclonal antibody market potential to 2010; Technology focus of monoclonal antibody market, 2005-10; Therapeutic focus of monoclonal antibody market, 2005-10
Portfolio and pipeline analysis: Monoclonal antibodies marketed portfolio, 2004; Technology focus; Therapeutic focus; Launch pattern of marketed monoclonal antibodies, 1986-2004; Monoclonal antibody pipeline; Key late-stage pipeline monoclonal antibodies; Forecasted launch trajectory for monoclonal antibodies, 2005-10; Key growth drivers, 2005-10
R&D development programs: Technology focus, 2005; Therapeutic focus, 2005

CHAPTER 4 ANTIBODY ENGINEERING TECHNOLOGIES

Introduction
Murine
Chimeric
Humanized
Fully human: Transgenic mice; Phage display
Fragments
Conjugated
Technology profiles - Humanized Technologies: Protein Design Labs SMART Humanization Technology; SMART Humanization technology; Partnerships; Product portfolio and pipeline; XOMAs Human Engineering Technology; Human Engineering; Partnerships; Product portfolio and pipeline; Aeres Biomedicals Humanization Technology; Aeres Biomedicals humanization technology; Partnerships; Product portfolio and pipeline
Technology profiles - Fully Human Technologies: Medarexs UltiMAb Technology; UltiMAb Human Antibody Development System; Partnerships; Product portfolio and pipeline; Abgenixs XenoMouse and XenoMax; XenoMouse and XenoMax; Partnerships; Product portfolio and pipeline; Cambridge Antibody Technologys Phage Display and Ribosome Display Technologies; Phage Display technology; Ribosome Display technology; Partnerships; Product portfolio and pipeline; Dyaxs Phage Display Discovery Tool; Phage Display Discovery Tool; Partnerships; Product portfolio and pipeline
Technology profiles - Antibody Fragment Technologies: Enzons Single Chain Antibody Technology; Single-Chain Antibody (SCA) technology; Partnerships; Product portfolio and pipeline; Domantis Domain Antibodies; Domain Antibodies; Partnerships; Product portfolio and pipeline
Technology profiles - Conjugated Antibody Technologies: Immunogens Tumor-Activated Prodrug (TAP) technology; Tumor-Activated Prodrug (TAP) Technology; Partnerships; Product portfolio and pipeline; Seattle Genetics Antibody-drug Conjugate (ADC) and Antibody-Directed Enzyme Prodrug Therapy (ADEPT) Technologies; Antibody-drug conjugate (ADC) technology; Antibody-Directed Enzyme Prodrug Therapy (ADEPT); Overview; Partnerships; Product portfolio and pipeline

CHAPTER 5 COMPANY ANALYSIS

Key players in mAb market, 2004: Current position
Benchmarking key players future performance to 2010
Analysis of key players by technology focus
Analysis of key players by therapeutic focus: Oncology antibodies - current and future market leaders; AIID (arthritis, immune and inflammatory disorders) antibodies - current and future market leaders; Other therapeutic markets - niche products growing in importance; Infectious disease; Ophthalmology; CNS; Cardiovascular; Respiratory
Company profiles
Abbott Laboratories: Introduction to Abbott; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
Alexion: Introduction to Alexion; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
Biogen Idec: Introduction to Biogen Idec; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; Rituxan (rituximab); Zevalin (ibritumomab tiuxetan); Tysabri (natalizumab); R&D compounds; Sales forecasts and forecast revenue growth
Cambridge Antibody Technology: Introduction to Cambridge Antibody Technology; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth; Key licensed products
Genentech: Introduction to Genentech; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Strengths; Weaknesses; Opportunities; Threats; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; Rituxan (rituximab); Herceptin (trastuzumab); Avastin (bevacizumab); Xolair (omalizumab); Raptiva (efalizumab); R&D compounds; Lucentis (ranibizumab); Rituxan (rituximab); Sales forecasts and forecast revenue growth
Genmab: Introduction to Genmab; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
ImClone Systems: Introduction to ImClone Systems; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
Medarex: Introduction to Medarex; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
MedImmune: Introduction to MedImmune; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth
UCB: Introduction to UCB; Strategy; Growth strategy in the monoclonal antibody market; Financial position; SWOT analysis; Alliance network; Technology focus; Monoclonal antibody portfolio and pipeline analysis; Marketed portfolio; R&D compounds; Sales forecasts and forecast revenue growth

CHAPTER 6 APPENDIX : SUPPORTING DATA

Financial data: Exchange rates; Methodology for therapy area forecasting

List of Tables

Table 1: Key effector functions of antibody classes
Table 2: Sales of monoclonal antibodies by technology, 2004
Table 3: Sales of monoclonal antibodies by therapy area, 2004
Table 4: Forecast sales of the monoclonal antibodies market by technology, 2005-10
Table 5: Forecast sales of the monoclonal antibodies market by therapy area in terms of sales, 2005-10
Table 6: Marketed monoclonal antibodies, 2004
Table 7: Launch year of marketed monoclonal antibody, 1986-2004
Table 8: Top 10 late-stage pipeline monoclonal antibodies in terms of value, 2005
Table 9: Launch trajectory of monoclonal antibodies in development, 2005-10
Table 10: Products developed using PDLs SMART Humanization technology
Table 11: Products developed using Xomas Human Engineering
Table 12: Products developed using Aeres Biomedicals antibody humanization technology
Table 13: Products developed using Medarexs UltiMAb technology
Table 14: Products developed using Abgenixs Xenomouse and Xenomax technologies
Table 15: Products developed using CATs Phage Display technology
Table 16: Products developed using Dyaxs Phage Display Discovery Tool technology
Table 17: Products developed using Enzons SCA technology
Table 18: Products developed using Domantiss Domain Antibodies technology
Table 19: Products developed using ImmunoGens TAP technology
Table 20: Products developed using Seattle Genetics ADC technology
Table 21: Monoclonal antibody revenues for leading companies, 2002-04
Table 22: Forecast monoclonal antibody revenues for leading companies, 2004-10
Table 23: Leading companies sales of monoclonal antibodies for oncology indications, 2003-10
Table 24: Leading companies sales of monoclonal antibodies for AIID indications, 2003-10
Table 25: Leading companies sales of monoclonal antibodies for infectious disease indications, 2003-10
Table 26: Leading companies sales of monoclonal antibodies for ophthalmic indications, 2003-10
Table 27: Leading companies sales of monoclonal antibodies for CNS indications, 2003-10
Table 28: Leading companies sales of monoclonal antibodies for cardiovascular indications, 2003-10
Table 29: Leading companies sales of monoclonal antibodies for respiratory indications, 2003-10
Table 30: Breakdown of Abbotts monoclonal antibody sales by therapy area, 2003-04
Table 31: Abbotts marketed monoclonal antibody products
Table 32: Abbotts monoclonal antibody pipeline, 2005
Table 33: Forecast sales for Abbotts monoclonal antibody portfolio, 2005-10
Table 34: Alexions monoclonal antibody pipeline, 2005
Table 35: Forecast sales for Alexions monoclonal antibodies, 2005-10
Table 36: Breakdown of Biogen Idecs monoclonal antibody revenues by therapy area, 2003-04
Table 37: Biogen Idecs marketed monoclonal antibody products
Table 38: Biogen Idecs monoclonal antibody pipeline, 2005
Table 39: Forecast revenues for Biogen Idecs monoclonal antibody portfolio, 2005-10
Table 40: Breakdown of CATs monoclonal antibody sales by therapy area, 2003-04
Table 41: CATs marketed monoclonal antibody products
Table 42: CATs monoclonal antibody pipeline, 2005
Table 43: Forecast revenues for CATs monoclonal antibodies, 2004-10
Table 44: Genentechs collaboration focus
Table 45: Genentechs monoclonal antibody sales by therapy area, 2003-04
Table 46: Genentechs marketed monoclonal antibody products
Table 47: Genentechs monoclonal antibody pipeline, 2005
Table 48: Forecast sales for Genentechs monoclonal antibody portfolio, 2004-10
Table 49: Genmabs monoclonal antibody pipeline, 2005
Table 50: Forecast sales for Genmabs monoclonal antibodies, 2005-10
Table 51: Breakdown of ImClones monoclonal antibody sales by therapy area, 2003-04
Table 52: ImClones marketed monoclonal antibody products
Table 53: BOND trial summary results
Table 54: ImClones monoclonal antibody pipeline, 2005
Table 55: Forecast revenues for ImClones monoclonal antibody portfolio, 2004-10
Table 56: Medarexs monoclonal antibody pipeline, 2005
Table 57: Forecast revenues for Medarexs monoclonal antibody, 2005-10
Table 58: Breakdown of MedImmunes monoclonal antibody revenue by therapy area, 2003-04
Table 59: MedImmunes marketed monoclonal antibody products
Table 60: MedImmunes monoclonal antibody pipeline, 2005
Table 61: Forecast revenues for MedImmunes monoclonal antibody portfolio, 2004-10
Table 62: UCBs monoclonal antibody pipeline, 2005
Table 63: Forecast sales for UCBs monoclonal antibody portfolio, 2004-10
Table 64: Exchange rates, 2004

List of Figures

Figure 1: Monoclonal antibody market absolute ethical sales forecast by therapy area, 2002-10
Figure 2: Technological exposure of antibody development programs, 2005
Figure 3: By 2010, the market dominance of the leading few companies will be diluted, as increasing numbers of new products and new players enter the marketplace
Figure 4: Launch trajectory of marketed monoclonal antibodies by technology, 1986-2010
Figure 5: Positioning of antibody companies by stage of development of business model
Figure 6: Technology exposure of monoclonal antibody market, 2003-04
Figure 7: Therapy area exposure of monoclonal antibody market, 2003-04
Figure 8: Evolution in technology of the monoclonal antibody market in terms of sales, 2004-10
Figure 9: Evolution in therapy area of the monoclonal antibody market, 2004-10
Figure 10: Monoclonal antibody market technology split by sales, in comparison with the number of marketed monoclonal antibodies in 2004
Figure 11: Monoclonal antibody market therapy area split by sales, in comparison with the number of marketed monoclonal antibodies in 2004
Figure 12: Growth drivers of the monoclonal antibody market, 2005-10
Figure 13: Stage of development of antibody development programs, 2005
Figure 14: Technological exposure of antibody development programs, 2005
Figure 15: Therapeutic exposure of antibody development programs, 2005
Figure 16: The structure of an antibody
Figure 17: Types of antibodies
Figure 18: Schematic illustration of antibody fragments
Figure 19: PDLs partnerships for its SMART humanization technology
Figure 20: Xomas partnerships for its Human Engineering technology
Figure 21: Aeres Biomedicals partnerships for its antibody humanization technology
Figure 22: Medarexs partnerships for its UltiMAb technology
Figure 23: Abgenixs partnerships for its XenoMouse and XenoMax technologies
Figure 24: CATs partnerships for its Phage Display technology
Figure 25: Dyaxs partnerships for its Phage Display Discovery Tool technology
Figure 26: Enzons partnerships for its SCA technology
Figure 27: Domantiss partnerships for its Domain Antibodies technology
Figure 28: ImmunoGens partnerships for its TAP technology
Figure 29: Seattle Genetics partnerships for its ADC and ADEPT technologies
Figure 30: Leading companies global market shares of antibody product sales, 2004
Figure 31: Leading companies forecast global market shares of antibody product sales, 2010
Figure 32: Technology exposure of key antibody companies
Figure 33: Market shares of companies involved in the oncology mAbs market, 2004-10
Figure 34: Market shares of companies involved in the AIID mAbs market, 2004-10
Figure 35: Assessment of Abbotts strategic position, 2004
Figure 36: Abbotts monoclonal antibody alliances
Figure 37: Abbotts technology exposure
Figure 38: Abbotts ethical sales breakdown, 2004
Figure 39: Abbotts therapeutic focus
Figure 40: Assessment of Alexions strategic position, 2004
Figure 41: Alexions monoclonal antibody alliances
Figure 42: Alexions technology exposure
Figure 43: Alexions therapeutic focus
Figure 44: Proportion of Biogen Idecs revenues derived from monoclonal antibodies, 2004-2010
Figure 45: Assessment of Biogen Idecs strategic position, 2004
Figure 46: Biogen Idecs monoclonal antibody alliances
Figure 47: Technology focus of Biogen Idecs antibody portfolio and pipeline
Figure 48: Therapeutic focus of Biogen Idecs antibody portfolio
Figure 49: Assessment of CATs strategic position, 2004
Figure 50: CATs monoclonal antibody alliances
Figure 51: CATs technology exposure
Figure 52: CATs business development for monoclonal antibody products by therapy area
Figure 53: Assessment of Genentechs strategic position, 2004
Figure 54: Genentechs monoclonal antibody alliances
Figure 55: Genentechs technology focus, 2004
Figure 56: Genentechs antibody sales breakdown, 2004
Figure 57: Genentechs business development for monoclonal antibody products by therapy area
Figure 58: Assessment of Genmabs strategic position, 2004
Figure 59: Genmabs monoclonal antibody alliances
Figure 60: Genmabs technology focus
Figure 61: Genmabs therapeutic focus
Figure 62: Assessment of ImClones strategic position, 2004
Figure 63: ImClone Systems monoclonal antibody alliances
Figure 64: ImClones technology exposure
Figure 65: ImClones therapeutic focus
Figure 66: Assessment of Medarexs strategic position, 2004
Figure 67: Medarexs monoclonal antibody alliances
Figure 68: Medarexs technology exposure
Figure 69: Medarexs therapeutic focus
Figure 70: Assessment of MedImmunes strategic position, 2004
Figure 71: MedImmunes monoclonal antibody alliances
Figure 72: MedImmunes technology exposure
Figure 73: MedImmunes therapeutic focus
Figure 74: UCBs monoclonal antibody exposure, 2010
Figure 75: Assessment of UCBs strategic position, 2004
Figure 76: UCBs monoclonal antibody alliances
Figure 77: UCBs technology exposure
Figure 78: UCBs therapeutic focus