Disease Modification in Rheumatoid Arthritis - The Biologics Boom
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS, Arthritis and Pain pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the RA market - page 3
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 13
- The current treatment approach puts biologic therapy after different combinations of traditional DMARD treatments - page 13
- Current market definition includes the most common biologic and traditional DMARDs - page 14
- The Japanese market - page 15
- The market value is calculated using IMS diagnosis value - page 15
- Assumptions and caveats for diagnosis value estimates - page 17
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 20
- Global opportunities and threats - page 20
- Opportunities - page 20
- Global aging population - page 20
- Biologics move up the treatment algorithm - page 22
- Threats - page 25
- Can the market continue to sustain growth in expensive biologic products - page 25
- EU guidelines for biosimilar products due for finalization in 2006 - page 25
- Opportunities - page 20
- US: opportunities and threats - page 26
- Market overview - page 26
- Opportunities - page 28
- The number of over 65s is forecast to increase as the 'baby boom' generation reaches retirement - page 28
- Medicare reforms allow manufacturers pricing freedom - page 29
- Volume of drugs sold is likely to increase as seniors have increased access - page 30
- Offer of assistance to Medicare enrollees - page 31
- The Arthritis Prevention, Control and Cure Act of 2005 - page 32
- Threats - page 33
- The Medicare 'doughnut hole' - page 33
- Increased scrutiny of DTC advertising due to COX-2 withdrawals - page 34
- US bears the burden of the world's R&D - page 34
- Japan: opportunities and threats - page 35
- Market overview - page 35
- Opportunities - page 36
- Biologic uptake increasing, as Remicade and Enbrel pave the way but have not yet monopolized the market - page 36
- Rising population over the age of 65 - page 37
- Pricing process slows generic incursion - page 38
- Threats - page 38
- 134 deaths linked to Rheumatrex reported in Japan - page 38
- Biannual pricing restrictions - page 39
- High tuberculosis prevalence - page 39
- France: opportunities and threats - page 40
- Market overview - page 40
- Opportunities - page 42
- 'Accord Cadre' raises drug prices and accelerates time to market - page 42
- Enbrel uptake jumps in 2004 - page 42
- Threats - page 43
- Re-evaluation of treatment of long-term illnesses threatens reimbursement status - page 43
- Second wave of French drug price reductions - page 43
- Germany: opportunities and threats - page 45
- Market overview - page 45
- Opportunities - page 47
- 2004 jump in biologic sales - page 47
- Free pricing system - page 47
- Threats - page 47
- 2004 extension of reference pricing and rebates - page 47
- Generic erosion more rapid - page 48
- Italy: opportunities and threats - page 48
- Market overview - page 48
- Opportunities - page 50
- Abolition of the compulsory 50% discount to qualifying hospitals allows pharmaceutical companies greater negotiation on price - page 50
- Threats - page 51
- Pharma hit by Italian price cuts - page 51
- Use of generics on the increase - page 51
- Greater restrictions on marketing and promotion - page 52
- High pricing can disqualify products from reimbursement - page 53
- Spain: opportunities and threats - page 55
- Market overview - page 55
- Opportunities - page 57
- Metoject (methotrexate) uptake shows market for pre-filled syringes - page 57
- Regional differences provide localized opportunities - page 58
- Threats - page 59
- Strict pricing controls - page 59
- UK: opportunities and threats - page 60
- Market overview - page 60
- Opportunities - page 61
- Growing political interest in rheumatology - page 61
- Biologics uptake is one of best in Europe - page 61
- Threats - page 62
- NICE delays in assessment - page 62
- Pricing restrictions on profitable drugs in the UK - page 63
- Anakinra is rejected by NICE - page 64
- Summary of environmental issues affecting RA market size - page 65
- Global opportunities and threats - page 20
- CHAPTER 4 FORECAST ANALYSIS - page 66
- Assumptions and events - page 66
- Pipeline causes growth in market - page 66
- Lack of generic competition for biologics - page 67
- Why are biogenerics important? - page 68
- How will companies address the issues? - page 68
- When can the RA market expect generic entrants? - page 69
- Arava (leflunomide) patent expiry - page 69
- Remicade approval in JRA - page 71
- Humira approvals and indication expansions - page 72
- Approval for early RA in the EU and US - page 72
- Humira launches in Japan - page 73
- Humira approval in juvenile RA - page 74
- Approval in psoriatic arthritis - page 74
- Medicare Part D to be implemented in US in January 2006 - page 75
- About the Medicare Modernization Act - page 75
- Forecast impact of Medicare 2006 - page 77
- Positive effect on pharma won't last - page 81
- Remicade launch 10mg/kg dose for RA in Japan - page 82
- Enbrel uptake in Japan - page 83
- Forecasts - page 84
- Assumptions and events - page 66
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 85
- Introduction - page 85
- Case studies - page 85
- Pricing and roll-out strategy: Humira's example leads the way, but certain aspects may now be outdated - page 85
- Humira key facts - page 85
- Uptake comparison - page 86
- Pricing comparisons - page 87
- Pricing for pipeline RA products - page 91
- The Vioxx-effect - page 92
- Product differentiation - sequence of approval in RA indications and distribution channels - page 92
- RA indications - page 93
- Amgen/Wyeth's key focus is RA for Enbrel, but Centocor/S-P are expanding Remicade use in niche GI indications - page 100
- Distribution channel differences in the US - page 102
- Manufacturing deals - page 103
- Licensing deals benefit the large and small - page 104
- Spotlight on Genentech - page 104
- Pricing and roll-out strategy: Humira's example leads the way, but certain aspects may now be outdated - page 85
- APPENDIX A - MAJOR BRAND KEY FACTS - page 106
- Biologic DMARDs market data - page 106
- Enbrel (etanercept) - page 106
- Remicade (infliximab) - page 108
- Kineret (anakinra) - page 110
- Humira (adalimumab) - page 111
- Traditional DMARD market data - page 113
- Arava (leflunomide) - page 113
- Neoral (cyclosporine) - page 114
- Plaquenil (hydroxychloroquinine) - page 115
- Salazopyrin (sulphasalazine) - page 116
- Ledertrexate (methotrexate) - page 117
- Marketed vs. pipeline analysis - page 118
- Company factors - page 118
- Product factors - page 120
- Biologic DMARDs market data - page 106
- APPENDIX B - FORECAST DATA TABLES - page 122
- US - page 122
- Japan - page 123
- France - page 124
- Germany - page 125
- Italy - page 126
- Spain - page 127
- UK - page 128
- M5EU - page 129
- Global - page 131
- APPENDIX C - page 133
- Bibliography - page 133
- Report methodology - page 137
- Definitions - page 137
- Standard units - page 137
- Japanese market data - page 137
- Derivation of sales forecasts and pricing trends - page 137
- Regional launch dates for new products - page 138
- Generic erosion and pricing assumptions - page 138
- Contributing experts - page 139
- About Datamonitor - page 141
- About Datamonitor Healthcare - page 141
- Datamonitor Healthcare's therapy area capabilities - page 142
- About the CNS, Arthritis and Pain analysis team - page 142
- Disclaimer - page 145
- List of Tables
- Table 1: Increase in population over 65, 000s, 1990-2001 - page 21
- Table 2: Italian total brand sales for Arava, Enbrel and Remicade, H2 2003 and H2 2004 - page 51
- Table 3: Late-phase DMARDs in the pipeline, 2005 - page 66
- Table 4: Forecast impact of Arava patent expiry in the US, five major EU and Japan ($000s), 2004-14 - page 71
- Table 5: US formulary prices for key RA treatments - page 80
- Table 6: Formulary price comparisons, US, UK, France, Germany and Italy, 2004-05 - page 88
- Table 7: Enbrel: key facts - page 106
- Table 8: Key Enbrel events, 2004-05 - page 107
- Table 9: Remicade: key facts - page 108
- Table 10: Key Remicade events, 2004-05 - page 109
- Table 11: Kineret: key facts - page 110
- Table 12: Key Kineret events, 2004-05 - page 111
- Table 13: Humira: key facts - page 111
- Table 14: Key Humira events, 2004-05 - page 112
- Table 15: Arava: key facts - page 113
- Table 16: Key Arava events, 2004-05 - page 114
- Table 17: Neoral: key facts - page 114
- Table 18: Plaquenil: key facts - page 115
- Table 19: Salazopyrin: key facts - page 116
- Table 20: Ledertrexate: key facts - page 117
- Table 21: Company factors and score definition - page 118
- Table 22: Marketed treatments company scores - page 119
- Table 23: Product factors and score definitions - page 120
- Table 24: Marketed treatments product scores - page 121
- Table 25: US RA indication specific forecast, $m, 2004-2014 - page 122
- Table 26: Japan RA indication specific forecast, $m, 2004-2014 - page 123
- Table 27: France RA indication specific forecast, $m, 2004-2014 - page 124
- Table 28: Germany RA indication specific forecast, $m, 2004-2014 - page 125
- Table 29: Italy RA indication specific forecast, $m, 2004-2014 - page 126
- Table 30: Spain RA indication specific forecast, $m, 2004-2014 - page 127
- Table 31: UK RA indication specific forecast, $m, 2004-2014 - page 128
- Table 32: Five major EU countries RA indication specific forecast, $m, 2004-2014 - page 129
- Table 33: Global RA indication specific forecast, $m, 2004-2014 - page 131
- List of Figures
- Figure 1: Treatment algorithm for RA - page 13
- Figure 2: Percentage of total sales of US biologics attributable to each diagnosis, 2004 - page 18
- Figure 3: Estimated percentage of total sales for EU biologics attributable to each diagnosis, 2004 - page 19
- Figure 4: Life expectancy in the seven major markets, 1990-2001 - page 21
- Figure 5: Methotrexate in RA, RX-Days, 2002-04 - page 22
- Figure 6: Use of biologics and methotrexate by age, US and Germany retail data, 2002-04 - page 24
- Figure 7: Market and pipeline sales growth, 2004-14 - page 25
- Figure 8: US traditional vs. biologic sales for RA indication ($m), 2001-04 - page 26
- Figure 9: US top DMARD brand sales in RA only, 2004 - page 27
- Figure 10: Comparative uptake of biologics in the US, 2001-04 - page 28
- Figure 11: The over 65 US population (m), 1900-2040 - page 29
- Figure 12: Enbrel Medicare help page, 2005 - page 32
- Figure 13: Japan traditional vs. biologic sales for RA indication ($m), 2001-04 - page 35
- Figure 14: Japan top DMARD brand sales in RA, 2004 - page 36
- Figure 15: Japan over 65 population (m), 1950-2050 - page 37
- Figure 16: France traditional vs. biologic sales for RA indication ($m), 2001-04 - page 40
- Figure 17: France top DMARD brand sales for RA indication, 2004 - page 41
- Figure 18: Comparative biologic uptake, 2001-04 - page 42
- Figure 19: German traditional vs. biologic sales for RA indication ($m), 2001-04 - page 45
- Figure 20: German top DMARD brand sales for RA indication, 2004 - page 46
- Figure 21: Comparative biologic uptake, 2001-04 - page 46
- Figure 22: Italy traditional vs. biologic sales for RA indication ($m), 2001-04 - page 49
- Figure 23: Italy top DMARD brand sales for RA indication, 2004 - page 49
- Figure 24: Comparative biologic uptake in Italy, 2001-04 - page 50
- Figure 25: Spain traditional vs. biologic sales for RA indication ($m), 2001-04 - page 55
- Figure 26: Spain top DMARD brand sales for RA indication, 2004 - page 56
- Figure 27: Spanish uptake of biologic products in RA, 2001-04 - page 57
- Figure 28: Metoject convenience marketing message - page 58
- Figure 29: UK traditional vs. biologic sales for RA indication ($m), 2001-04 - page 60
- Figure 30: UK top DMARD brand sales for the RA indication, 2004 - page 61
- Figure 31: UK uptake of biologics in RA, 2001-04 - page 62
- Figure 32: Summary of environmental issues affecting RA market - page 65
- Figure 33: Company and product scores for key currently marketed and pipeline products for RA - page 67
- Figure 34: Comparison of RX-Days by indication for Enbrel and Humira, US, 2004 - page 73
- Figure 35: Calculation of available Medicare revenues - page 78
- Figure 36: Effect of a 10% price cut in 2011 on Datamonitor US forecasts for key biologic brands, 2001-14 - page 82
- Figure 37: Comparative uptake of biologics in RA across the five major EU countries ($m), 2001-04 - page 87
- Figure 38: Average traditional dollars per SU, by year and country - page 90
- Figure 39: Comparative $ per SU, dose adjusted, 2004 - page 91
- Figure 40: Enbrel RA approvals and impacts, US, Q3 1998 to Q4 2004 - page 94
- Figure 41: Remicade RA approvals and impacts, US, Q3 1998 to Q4 2004 - page 95
- Figure 42: Molecules that are co-prescribed with marketed biologics for the RA indication, RX, %, 2004 - page 96
- Figure 43: Humira RA approvals and impacts, US, Q4 2002 to Q4 2004 - page 97
- Figure 44: Enbrel, Remicade and Humira total brand sales, US, Q1 1999-Q4 2004 - page 98
- Figure 45: Currently marketed biologic treatment forecasts, US, 2001-14 - page 98
- Figure 46: Enbrel RA approvals, five major EU countries, Q3 1998-Q4 2004 - page 99
- Figure 47: Remicade RA approvals, five major EU countries, Q3 1998-Q4 2004 - page 100
- Figure 48: Enbrel's patient focused website - page 101
- Figure 49: Remicade's more diverse website - page 102
- Figure 50: Distribution channels in the US for biologic products (all indications) - page 103
- Figure 51: Genentech licensing deals with RA market players - page 105
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