Abstract
Overview
Introduction
The 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
Report 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
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
- Opportunities
- 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
- Strict pricing controls
- 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
- Global opportunities and threats
- 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
- Assumptions and events
- 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
- Pricing and roll-out strategy: Humira's example leads the way, but
certain aspects may now be outdated
- 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
- Biologic DMARDs market data
- 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
