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Commercial Insight: Disease Modification in Rheumatoid Arthritis - The Biologics BoomPublished by: Datamonitor Published: Dec. 21, 2005 - 145 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 Objective of the analysis 3 Datamonitor insight into the RA market 3 CHAPTER 2 MARKET DEFINITION AND OVERVIEW 13 The current treatment approach puts biologic therapy after different combinations of traditional DMARD treatments 13 Current market definition includes the most common biologic and traditional DMARDs 14 The Japanese market 15 The market value is calculated using IMS diagnosis value 15 Assumptions and caveats for diagnosis value estimates 17 CHAPTER 3 COUNTRY MARKET ASSESSMENTS 20 Global opportunities and threats 20 Opportunities 20 Global aging population 20 Biologics move up the treatment algorithm 22 Threats 25 Can the market continue to sustain growth in expensive biologic products 25 EU guidelines for biosimilar products due for finalization in 2006 25 US: opportunities and threats 26 Market overview 26 Opportunities 28 The number of over 65s is forecast to increase as the ‘baby boom’ generation reaches retirement 28 Medicare reforms allow manufacturers pricing freedom 29 Volume of drugs sold is likely to increase as seniors have increased access 30 Offer of assistance to Medicare enrollees 31 The Arthritis Prevention, Control and Cure Act of 2005 32 Threats 33 The Medicare ‘doughnut hole’ 33 Increased scrutiny of DTC advertising due to COX-2 withdrawals 34 US bears the burden of the world’s R&D 34 Japan: opportunities and threats 35 Market overview 35 Opportunities 36 Biologic uptake increasing, as Remicade and Enbrel pave the way but have not yet monopolized the market 36 Rising population over the age of 65 37 Pricing process slows generic incursion 38 Threats 38 134 deaths linked to Rheumatrex reported in Japan 38 Biannual pricing restrictions 39 High tuberculosis prevalence 39 France: opportunities and threats 40 Market overview 40 Opportunities 42 ‘Accord Cadre’ raises drug prices and accelerates time to market 42 Enbrel uptake jumps in 2004 42 Threats 43 Re-evaluation of treatment of long-term illnesses threatens reimbursement status 43 Second wave of French drug price reductions 43 Germany: opportunities and threats 45 Market overview 45 Opportunities 47 2004 jump in biologic sales 47 Free pricing system 47 Threats 47 2004 extension of reference pricing and rebates 47 Generic erosion more rapid 48 Italy: opportunities and threats 48 Market overview 48 Opportunities 50 Abolition of the compulsory 50% discount to qualifying hospitals allows pharmaceutical companies greater negotiation on price 50 Threats 51 Pharma hit by Italian price cuts 51 Use of generics on the increase 51 Greater restrictions on marketing and promotion 52 High pricing can disqualify products from reimbursement 53 Spain: opportunities and threats 55 Market overview 55 Opportunities 57 Metoject (methotrexate) uptake shows market for pre-filled syringes 57 Regional differences provide localized opportunities 58 Threats 59 Strict pricing controls 59 UK: opportunities and threats 60 Market overview 60 Opportunities 61 Growing political interest in rheumatology 61 Biologics uptake is one of best in Europe 61 Threats 62 NICE delays in assessment 62 Pricing restrictions on profitable drugs in the UK 63 Anakinra is rejected by NICE 64 Summary of environmental issues affecting RA market size 65 CHAPTER 4 FORECAST ANALYSIS 66 Assumptions and events 66 Pipeline causes growth in market 66 Lack of generic competition for biologics 67 Why are biogenerics important? 68 How will companies address the issues? 68 When can the RA market expect generic entrants? 69 Arava (leflunomide) patent expiry 69 Remicade approval in JRA 71 Humira approvals and indication expansions 72 Approval for early RA in the EU and US 72 Humira launches in Japan 73 Humira approval in juvenile RA 74 Approval in psoriatic arthritis 74 Medicare Part D to be implemented in US in January 2006 75 About the Medicare Modernization Act 75 Forecast impact of Medicare 2006 77 Positive effect on pharma won’t last 81 Remicade launch 10mg/kg dose for RA in Japan 82 Enbrel uptake in Japan 83 Forecasts 84 CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 85 Introduction 85 Case studies 85 Pricing and roll-out strategy: Humira’s example leads the way, but certain aspects may now be outdated 85 Humira key facts 85 Uptake comparison 86 Pricing comparisons 87 Pricing for pipeline RA products 91 The Vioxx-effect 92 Product differentiation - sequence of approval in RA indications and distribution channels 92 RA indications 93 Amgen/Wyeth’s key focus is RA for Enbrel, but Centocor/S-P are expanding Remicade use in niche GI indications 100 Distribution channel differences in the US 102 Manufacturing deals 103 Licensing deals benefit the large and small 104 APPENDIX A - MAJOR BRAND KEY FACTS 106 Biologic DMARDs market data 106 Enbrel (etanercept) 106 Remicade (infliximab) 108 Kineret (anakinra) 110 Humira (adalimumab) 111 Traditional DMARD market data 113 Arava (leflunomide) 113 Neoral (cyclosporine) 114 Plaquenil (hydroxychloroquinine) 115 Salazopyrin (sulphasalazine) 116 Ledertrexate (methotrexate) 117 Marketed vs. pipeline analysis 118 Company factors 118 Product factors 120 APPENDIX B - FORECAST DATA TABLES 122 US 122 Japan 123 France 124 Germany 125 Italy 126 Spain 127 UK 128 M5EU 129 Global 131 APPENDIX C 133 Bibliography 133 Report methodology 137 Definitions 137 Standard units 137 Japanese market data 137 Derivation of sales forecasts and pricing trends 137 Regional launch dates for new products 138 Generic erosion and pricing assumptions 138 Contributing experts 139 About Datamonitor 141 About Datamonitor Healthcare 141 Datamonitor Healthcare’s therapy area capabilities 142 About the CNS, Arthritis and Pain analysis team 142 Disclaimer 145 AbstractIntroductionThe global Rheumatoid Arthritis (RA) market has experienced extraordinary growth over the last decade. This market valued at $4.14 billion in 2004, shows no hint of decline. The explosion in new disease modifying drugs since the late 1990's has resulted in a competitive and rapidly evolving market. However, the recent events in the COX-2 market will continue to impact all arthritis drugs. Scope Detailed analysis of traditional and biologic DMARDs, with sales and volume forecasts to 2014 for the RA indication alone Assessment of current and future opportunities and threats in the RA market across the seven major pharmaceutical markets Consideration of key events that may affect revenues in each of the seven major pharmaceutical markets are applied and discussed Lifecycle management case studies show how previously successful strategies should be applied in today's market Highlights The key indications required by a new disease-modifying treatment include improvement in physical function, reducing signs and symptoms and inhibiting structural progression. Additional indications in the treatment of early RA and juvenile idiopathic arthritis would allow a new product to compete with the now well-established TNF inhibitors. The launch of new treatments at a premium cost appears to confer a superior treatment, as exemplified by Abbott's launch of Humira. The variation in key product pricing across different countries for a year of treatment shows that careful selection of launch price is needed to make the product competitive and also ensure good returns. Japan, as the last market forecast to launch most of the biologics, lags behind and is predicted to show slower uptake of these products. However, the recent launch of Enbrel and forecast launch of Humira in this market is expected to push the biologic class above traditional DMARDs by 2010 in this region. Reasons to Purchase Assess the impact of events such as Medicare changes, patent expiries and sub-indication approvals on the RA sales of key brand name products Quantify the future size of the market, in terms of volume and value, for the RA indication in each of the seven major markets Gain insight into opinion leaders thoughts on the challenges facing the RA market Get Full Details About This Report >> |
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