Commercial Insight Osteoarthritis and Rheumatoid Arthritis

A Datamonitor In-Depth Analysis Commercial Insight Osteoarthritis and Rheumatoid Arthritis New Growth In A Mature Market Published: Jul-03 Product Code: DMHC1891 Why buy this analysis? Target current and future growth areas through identification of the strongest product lifecycle and pricing strategies Learn from case studies analyzing details of the most successful drug launches in the arthritis market Plan future product positioning through utilization of event-based forecasts for all major arthritis drugs For over 93% of our clients, access to Datamonitor research saves them time Evaluate the effects of all major events affecting the arthritis market in the past 12 months Source: Datamonitor customer research www.datamonitor.com/healthcare

Commercial Insight: Osteoarthritis and Rheumatoid Arthritis - New Growth In A Mature Market DMHC1891 Introduction The market entrance of the COX-II inhibitors and biologic DMARDs has sparked renewed growth in the NSAID and DMARD classes in the arthritis market. This analysis focuses on the changing landscape of the commercial environment in the global arthritis market and investigates key strategies required to succeed. Analysis of company portfolio strategies and product positioning provides knowledge of how specific company strategies result in varying levels of commercial returns. Scope and coverage Detailed case studies featuring company portfolio, product development and launch strategies of leading global players in arthritis Global sales data for the major classes used in treating arthritis (NSAIDs, DMARDs, HA viscosupplements and steroids) along with event-based forecasts to 2011 for the top selling drugs in each class. Forecasts are linked to Datamonitor's Pharma Market Forecast methodologies SWOT analyses of key arthritis drugs are provided, along with 12-month event screens - providing detailed knowledge of events specific to each product Research methodology The data contained within this report was sourced from extensive secondary research. Sales data was obtained from IMS Health and company reports and validations were conducted with in-house sales and epidemiology data. Sales forecasts were generated through Datamonitor's in-house modeling methodologies and Pharma Market Forecast: Arthritis 2003. For more information... Contact Simon Wright, Business Unit Director tel: +44 20 7675 7844 fax: +44 20 7675 7016 email: hcinfo@datamonitor.com

www.datamonitor.com/healthcare Despite facing adversity in the past year, including continued negative publicity surrounding the cardiovascular side effect profile of Vioxx and the delayed launch of Arcoxia, Merck will remain a strong competitor for Pfizer/Pharmacia in the future and the COX-II inhibitor class will continue to flourish through 2011. The alleviation of Enbrel's supply shortage through the new manufacturing facility approved in early 2003 will enable Amgen to regain a significant portion of sales lost to Johnson & Johnson's Remicade, although Humira is presenting formidable competition for both drugs. Enbrel sales were $802m in 2002, representing growth of 5% from 2001 sales, while Remicade sales were $1,513m, representing year-on-year growth of 78%. Key findings and highlights Growth in ethical revenues vs. growth in arthritis revenues for major players in the arthritis market, The effects of Enbrel's supply shortage on Enbrel and Remicade sales, 1999-2002 Growth in Arthritis Revenues (%) 100 80 J&J Low ethical growth, high 60 arthritis growth High ethical growth, high arthritis growth 40 Pfizer/ Amgen 20 Pharmacia Aventis Novartis 0 Merck -20-10 0 10 20 30 40 50 Low ethical -20 High ethical growth, low Growth in Ethical Revenues (%) growth, low arthritis growth arthritis growth $1,600 $1,400 $1,200 $1,000 $800 $600 $400 $200 $0 Before During Enbrel supply Enbrel supply shortage shortage Enbrel Sales Remicade Sales Enbrel Growth Remicade Growth 1999 2000 2001 2002 300% 250% 200% 150% 100% 50% 0% Source: Datamonitor DATAMONITOR Source: Datamonitor DATAMONITOR Market Segmentation and Definition: Provides strategic scoping and focus Global Market Overview: Analysis of the global markets in the NSAID, DMARD, HA viscosupplement and steroid classes with current and forecasted sales to 2011, SWOT analyses, and 12-month event screens for the major drugs in each class Portfolio and Lifecycle Management: Strategic portfolio and lifecycle management analysis for major DMARDs and NSAIDs, including case studies Strategic Product Positioning: Analysis of physician and patient focused positioning strategies, and pricing and reimbursement analysis for major DMARDs and NSAIDs, including case studies Structure chapter by chapter...with the supply shortage in its past, Amgen's Enbrel is set to regain lost ground and once again be fierce competition for Remicade... Susan Altman, Arthritis Market Analyst

Commercial Insight: Osteoarthritis and Rheumatoid Arthritis - New Growth In A Mature Market DMHC1891 Summary of contents DRIVERS AND TRENDS The market entrance of the COX-II inhibitors to the NSAID class and of the biologic DMARDs to the DMARD class in recent years has served to rejuvenate both of these maturing markets: As both of these subsegments get increasingly crowded, which launch strategies will ensure success for new entrants? Which product lifecycle management strategies guarantee profits as competition increases? What strategies will enable traditional DMARDs and NSAIDs to survive? MARKET SEGMENTATION AND DEFINITION View the scope of the market covered in Datamonitor's analysis of the arthritis market and understand traits of gold standards in treatment. GLOBAL MARKET OVERVIEW Details the key characteristics, global sales, 12-month event screen and event-based forecasted sales for the major drugs in the NSAID, DMARD, HA viscosupplement and steroid classes: Sales coverage for all of the major classes in arthritis and key individual drugs Analysis of overall market, classes as a whole and individual drugs SWOT analysis of all key arthritis drugs Evaluation of future events expected to affect individual drugs, classes and the market as a whole PORTFOLIO AND LIFECYCLE MANAGEMENT Gain insight into strong and weak strategies for portfolio and lifecycle management to maximize sales of arthritis drugs: Comparative analysis of the positioning of the portfolios of all of the major players in arthritis with BCG/McKinsey matrix analyses Assessment of osteoarthritis and rheumatoid arthritis product lifecycles both now and in the future Evaluation of successful and unsuccessful arthritis drug launches Numerous case studies depicting possible strategies in both portfolio and product lifecycle management STRATEGIC PRODUCT POSITIONING Presents assessments of product positioning to both physicians and patients as well as pros and cons of various pricing strategies: Analysis of physician focused marketing strategies in osteoarthritis and rheumatoid arthritis with case studies to gauge success of various strategies Investigation and comparison of the strengths and weaknesses of patient focused product positioning and advocacy initiatives for all major players in arthritis Discussion of pricing strategies and the effects of recent changes to reimbursement policies across the globe with case studies and comparisons of pricing of arthritis drugs across the major global markets ACTION POINTS Despite facing adversity in the past year, including continued negative publicity surrounding the cardiovascular side effect profile of Vioxx and the delayed launch of key second-generation product Arcoxia, Merck will remain a strong competitor for Pfizer/Pharmacia in the future and the COX-II inhibitor class will continue to flourish through 2011. The alleviation of Enbrel's supply shortage through the FDA approval of a new manufacturing facility in early 2003 will enable Amgen to regain a significant portion of sales lost to J&J's Remicade although Humira is presenting formidable competition for both of these market leaders. Enbrel sales were $802m in 2002, representing growth of 5% from 2001 sales, while Remicade sales were $1,513m, representing year-on-year growth of 78%. APPENDIX Both IMS and company reported sales data for key arthritis drugs, classes and the overall market. Key fact tables for the top 10 arthritis drugs in each class including manufacturer, marketing partners and patent expiry data. DATASETS Table 1: Key parameters of the arthritis market to 2011 Table 2: Forecast key currently marketed products in arthritis, 2003-11 Table 3: Defining the gold standard: key clinical trial results for Celebrex Table 4: Defining the gold standard: key clinical trial results for Enbrel Table 5: Global sales in the arthritis market, $m, 1995-2002 Table 6: Global quarterly growth (%) and value ($m) in the arthritis market, Table 7: Global arthritis market forecast, 2003-11...Although Vioxx sales were slowed by negative publicity surrounding cardiovascular side effects, sales remain strong and will do so in the future... Susan Altman, Arthritis Market Analyst

www.datamonitor.com/healthcare Table 8: Global NSAID forecast by brand, 2003-11 Table 9: R&D included in the NSAID forecast, 2003-11 Table 10: Celebrex: key facts Table 11: Key Celebrex events, 2002-03 Table 12: Bextra: key facts Table 13: Key Bextra events, 2002-03 Table 14: Vioxx: key facts Table 15: Key Vioxx events, 2002-03 Table 16: Arcoxia: key facts Table 17: Key Arcoxia events, 2002-03 Table 18: Mobic: key facts Table 19: Key Mobic events, 2002-03 Table 20: Global DMARD forecast by leading brand, 2003-11 Table 21: R&D included in the DMARD class forecast, 2003-11 Table 22: Enbrel: key facts Table 23: Key Enbrel events, 2002-03 Table 24: Remicade: key facts Table 25: Key Remicade events, 2002-03 Table 26: Kineret: key facts Table 27: Key Kineret events, 2002-03 Table 28: Arava: key facts Table 29: Key Arava events, 2002-03 Table 30: Humira: key facts Table 31: Key Humira events, 2002-03 Table 32: Global sales in the HA viscosupplement class, $m, 1997-2002 Table 33: Global HA viscosupplement forecast by leading brand, 2003-11 Table 34: Synvisc: key facts Table 35: Key Synvisc events, 2002-03 Table 36: Hyalgan: key facts Table 37: Supartz: key facts Table 38: Class Attractiveness Index metrics and ranking system Table 39: Total, arthritis/osteoporosis and arthritis performance of the arthritis market leaders, 2002 Table 40: Growth in total, arthritis/osteoporosis and arthritis revenues for the arthritis market leaders, Table 41: Arthritis market leader portfolio composition, 2002 Table 42: Pfizer/Pharmacia GE/McKinsey Matrix Ratings Table 43: Pfizer/Pharmacia key marketed arthritis products, Table 44: Merck GE/McKinsey Matrix Ratings Table 45: Merck key marketed arthritis products, Table 46: Amgen GE/McKinsey Matrix Ratings Table 47: Amgen key marketed arthritis products, Table 48: Johnson & Johnson GE/McKinsey Matrix Ratings Table 49: Johnson & Johnson key marketed arthritis products, Table 50: Novartis GE/McKinsey Matrix Ratings Table 51: Novartis key marketed arthritis products, Table 52: Aventis GE/McKinsey Matrix Ratings Table 53: Aventis key marketed arthritis products, Table 54: Remicade vs. Enbrel worldwide sales, 1999-2002 Table 55: Sales of leading traditional NSAIDS, $m, 1995-2002 Table 56: Proportion (%) of initial presentation and initial treatment of OA, seven major markets, by specialty Table 57: Proportion of initial presentation and initial treatment of RA, seven major markets, by specialty Table 58: Enbrel vs. Remicade sales, 1999-2001 Table 59: Enbrel vs. Remicade sales post-supply constraints Table 60: COX-II inhibitor patient product positioning Table 61: Biologic DMARD patient product positioning Table 62: Selected market pricing data for osteoarthritis, 2003 Table 63: Annual cost of treatment for OA in representative markets, 2003 Table 64: Selected market pricing data for rheumatoid arthritis, Table 65: Annual cost of treatment for RA in representative markets, 2003 Table 66: Global sales in the arthritis market by drug class,, IMS reported Table 67: Global sales in the arthritis market by drug class,, company reported Table 68: NSAID fact file Table 69: Global sales of the leading branded NSAID drugs,, IMS reported Table 70: Global sales of the leading branded NSAID drugs,, company reported Table 71: DMARD fact file Table 72: Global sales of the leading branded DMARD drugs,, IMS reported Table 73: Global sales of the leading branded DMARD drugs,, company reported Table 74: HA viscosupplement fact file Table 75: Global sales of the leading branded HA...As the biologic DMARD market becomes increasingly crowded, differentiation in terms of efficacy and delivery will be key to success... Susan Altman, Arthritis Market Analyst

Commercial Insight: Osteoarthritis and Rheumatoid Arthritis - New Growth In A Mature Market Table 72: Global sales of the leading branded DMARD drugs,, IMS reported Table 73: Global sales of the leading branded DMARD drugs,, company reported Table 74: HA viscosupplement fact file Table 75: Global sales of the leading branded HA viscosupplements,, IMS reported Table 76: Global sales of the leading branded HA viscosupplements,, company reported Table 77: Global sales of the leading branded anti-rheumatic steroids, Figure 1: Effects of negative publicity of Vioxx's CV side-effect profile on the NSAID class Figure 2: The effects of Enbrel's supply shortage on Enbrel and Remicade sales, 1999-2002 Figure 3: Arthritis market 2003 and in the future, GE/McKinsey matrix Figure 4: Growth in the global arthritis market, 1996-2002 Figure 5: Global arthritis growth by class, by quarter, Figure 6: Global arthritis market forecast, 2003-11 Figure 7: NSAID class market growth by quarter for top 10 NSAIDs, Figure 8: Expanded view of slow growth NSAIDs in Figure 7 Figure 9: Company reported vs. IMS growth in the NSAID class, Figure 10: NSAID market concentration, 2003-11 Figure 11: SWOT matrix for Celebrex Figure 12: Global sales forecasts for Celebrex, 2003-11 Figure 13: SWOT matrix for Bextra Figure 14: Global sales forecasts for Bextra, 2003-11 Figure 15: SWOT matrix for Vioxx Figure 16: Global sales forecasts for Vioxx, 2003-11 Figure 17: SWOT matrix for Arcoxia Figure 18: Global sales forecasts for Arcoxia, 2003-11 Figure 19: SWOT matrix for Mobic Figure 20: Global sales forecasts for Mobic, 2003-11 Figure 21: DMARD class global market shares by value, 2002 Figure 22: Company reported vs. IMS growth in the DMARD class, Figure 23: DMARD market concentration, 2003-11 Figure 24: SWOT matrix for Enbrel Figure 25: Global sales forecasts for Enbrel, 2003-11 Figure 26: SWOT matrix for Remicade Figure 27: Global sales forecasts for Remicade, 2003-11 Figure 28: SWOT matrix for Kineret Figure 29: Global sales forecasts for Kineret, 2003-11 Figure 30: SWOT matrix for Arava Figure 31: Global sales forecasts for Arava, 2003-11 Figure 32: SWOT matrix for Humira Figure 33: Global sales forecasts for Humira, 2003-11 Figure 34: HA viscosupplement market concentration, 2003-11 Figure 35: Competitive attractiveness of the anti-arthritic market, 2002-11 Figure 36: Comparative attractiveness of the drug classes within the arthritis market, 2002-11 Figure 37: Growth in ethical revenues vs. growth in arthritis revenues for major players in the arthritis market, Figure 38: Arthritis market 2003, GE/McKinsey matrix Figure 39: Lifecycle of traditional NSAIDs vs. COX-II inhibitors, 2002 Figure 40: Effects of negative publicity of Vioxx's CV side-effect profile on the NSAID class Figure 41: Timeline of Remicade expanded indications, 1999-2003 Figure 42: Sales of leading traditional NSAIDs, 1995-2002 Figure 43: Summary of factors in the success of the launch of Celebrex Figure 44: The effects of Enbrel's supply shortage on Enbrel and Remicade sales, 1999-2002 Figure 45: Selected market pricing data for osteoarthritis, 2003 Figure 46: Annual cost of treatment for OA in representative markets, 2003 Figure 47: Annual cost of treatment for RA in representative markets, 2003 Figure 48: Datamonitor's Healthcare Consultancy Figure 49: Datamonitor Healthcare's Therapeutic Consulting capabilities For 91% of our clients, Datamonitor research helps their company to respond to competitive threats Source: Datamonitor Customer Research

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