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