The Autoimmune Outlook to 2013

Competitive landscape, pipeline analysis and growth opportunities

Publication Date	April 2009
Publisher	Business Insights
Product Type	Report
Pages	208
ISBN Number	not applicable
Product Code	RBI00293

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Summary

The Autoimmune Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

Autoimmune disorders have been one of the most prominent growth segments in the pharma industry over the last decade. A growing patient population and high levels of unmet need are the main drivers of market growth, and novel biologics are increasingly helping to fulfill patient need, with their high cost helping to drive market sales. Study findings have also shown that the early use of anti-TNF drugs can help to halt/reverse disease progression. This has further expanded patient populations and prompted the use of these drugs in early-stage treatment. 'The Autoimmune Market Outlook to 2013' is a report published by Business Insights that provides comprehensive coverage of major markets within the global autoimmune area, incorporating a detailed epidemiological analysis of key indications and the main factors impacting their prevalence. Current leading brands of treatment within each indication are analysed and eight of the market's leading players are profiled. With coverage of over 95% of the total market for autoimmune products, this report reviews the factors and underlying trends that are shaping the market and identifies the most promising areas of potential growth. Forecasts for currently marketed and key pipeline products over the 2009-13 period are also provided.

Key Findings

The global autoimmune market generated sales of $31.9bn in 2007, an increase of 14.4% over 2006 sales. The market is forecast to grow at a CAGR of 8.1% to reach a total value of $51.0bn in 2013.
Immunosuppressant drugs dominate the automimnune market, with four products from this class accounting for 40.3% of total market sales. The highest selling immunosuppressant drug was J&J/Schering-Plough's Remicade, with 42.1% of total sales in this class.
Pfizer's Celebrex dominated the COX-II market with a share of 81.3% in 2007. Celebrex maintained blockbuster status despite the earlier withdrawals of major blockbuster COX-II inhibitors such as Vioxx and Bextra.
Roche's Actemra is expected to be launched in the US during Q1 2010, in view of the FDA's request for additional data and Roche's risk mitigation strategy. Actemra is forecast to generate sales of $680m in 2013.
Amgen is the global autoimmune market leader, having accrued a market share of 11.2% ($3.6bn) in 2007. This was driven almost entirely by Enbrel ($3.5bn) which had a sales increase of 12.2%.
Novartis' developmental MS drug 'fingolimod' (FTY-720) is one of the strongest competitors to Biogen Idec's MS franchise due to its potency and convenience of once daily oral dosing.

Use this report to:

Assess patient potential, treatment trends and sales patterns of major autoimmune indications over the period 2009-13, with this report's coverage of osteoarthritis, rheumatoid arthritis, crohn's disease, systemic lupus erythematosus, ulcerative colitis and multiple sclerosis markets across Japan, France, Germany, Italy, Spain, the UK and the US.
Discover the market dynamics of the autoimmune area and understand the impact of recent events by assessing key market trends, growth drivers and the latest issues affecting product development.
Compare the market performance and strategic positioning of major pharma companies' autoimmune portfolios with this report's evaluation of the franchises and market shares of Amgen, Abbott, J&J, Pfizer, Novartis, Wyeth, Roche and Astellas. Evaluate the autoimmune pipeline compounds of leading companies with this report's detailed analysis of clinically
Evaluate the autoimmune pipeline compounds of leading companies with this report's detailed analysis of clinically differentiated pipeline products by indication, and sales forecasts for key R&D pipeline products to 2013. sclerosis markets across Japan, France, Germany, Italy, Spain, the UK and the US.

Explore issues including

Reduced commercial opportunity for Coxibs. The commercial opportunity for the COX-II inhibitor class has been substantially reduced due to cardiovascular safety concerns. The US withdrawals of Vioxx and Bextra, in addition to the non-approvals of Arcoxia and Prexige, are likely to restrict the growth prospects of this class in the near future.
Impact of high value biologic treatments. Orencia, for use in DMARD failures, has yet to significantly affect the growth of existing agents. BMS's Orencia and Roche's Actemra target rheumatoid arthritis patients refractory to anti-TNFs, a population estimated to be between 20-40% of moderate/severe RA patients.
Cost of MS treatments. Research has shown that the cost of being diagnosed with MS in the UK is nearly 17,000 per person. The research also found that among 2,000 people surveyed from across the UK, half stated that they had to leave work due to MS, which increased the potential cost to over 25,000 per person when lost employment productivity is added.
Importance of arthritis disease management. Although several novel artrhitis treatments have been launched in recent years, it is possible for many patients to acheive effective disease control from the better use of existing medications.

Discover...

What will be the major growth indications in the autoimmune market over 2007-13?
Which companies were the winners and losers in this market in 2007?
How have major launches from companies such as Amgen, Roche, Abbott and J&J performed?
Which companies will become key players in the autoimmune market over 2007-13?
Which products will be affected by generic competitors over the period 2007-13?
Which pipeline products will be the growth drivers of the future?
Which indications have the highest levels of market potential over the period 2007-13?
What will be the competitive landscape in osteoarthritis, rheumatoid arthritis, crohn's disease, lupus, ulcerative colitis and multiple sclerosis in 2013?

Content

The Autoimmune Market Outlook to 2013
Executive Summary
Epidemiology of autoimmune diseases
Global market analysis
Pipeline analysis
Competitive landscape
Chapter 1 Scope and methodology
- Scope
- Key autoimmune indications covered in this report:
- Methodology
Chapter 2 Epidemiology of autoimmune
- diseases
- Summary
- Introduction
- Osteoarthritis
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
- Rheumatoid arthritis
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
- Crohn's disease
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
- Systemic lupus erythematosus
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
- Ulcerative colitis
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
- Multiple sclerosis
- Overview
- Diagnosis, treatment and management
- Epidemiology
- Forecast epidemiology
Chapter 3 Global market analysis
- Summary
- Introduction
- Market analysis by country
- Trends in generics usage and licensing
- Market analysis by drug class
- Leading brands dynamics
- Key events in the autoimmune market
- Enbrel growth slowing as it faces stiff competition from Humira
- RoActemra receives positive opinion in Europe for the treatment of
- RA
- NICE admits previous guidance around sequential use of anti-TNF
- therapies in RA is unfair
- Study shows prohibitive cost of MS treatment
- Mayo Clinic collaborates to advance Crohn's treatment
- Arthritis research shows better disease management is more
- important than the use of drugs
- CellCept's off-label use in lupus continues to increase
- Immunosuppressants
- Competitive dynamics of immunosuppressants
- Leading brands of immunosuppressants
- Key brands analysis
- Clinical developments
- Immunosuppressants sales forecasts to 2013
- Specific anti-rheumatic agents
- Competitive dynamics of specific anti-rheumatic agents
- Leading brands of specific anti-rheumatic agents
- Key brands analysis
- Specific anti-rheumatic agents sales forecasts to 2013
- Non-steroidal plain anti-rheumatics
- Competitive dynamics of non-steroidal plain anti-rheumatics
- Leading brands of non-steroidal plain anti-rheumatics
- Key brands analysis
- Non-steroidal plain anti-rheumatics sales forecasts to 2013
- Topical anti-rheumatics
- Competitive dynamics of topical anti-rheumatics
- Leading brands of topical anti-rheumatics
- Topical anti-rheumatic sales forecasts to 2013
- Coxibs
- Competitive dynamics of coxibs
- Leading brands of coxibs
- Key brands analysis
- Coxibs sales forecasts to 2013
- Non-steroidal (combinational) anti-rheumatics
- Competitive dynamics of non-steroidal (combinational) anti-rheumatics
- Leading brands of non-steroidal (combinational) anti-rheumatics
- Non-steroidal (combinational) anti-rheumatics sales forecasts to 2013
- Anti-rheumatic corticosteroids
- Competitive dynamics of anti-rheumatic corticosteroids
- Leading brands of anti-rheumatic corticosteroids
- Anti-rheumatic corticosteroids sales forecasts to 2013
- Total autoimmune sales forecasts to 2013
Chapter 4 Pipeline analysis
- Summary
- Introduction
- Key trends in R&D
- Biologics
- Combination drugs
- Aggressive medical therapy becoming the standard of care
- TNF inhibitors has a strong presence in autoimmune market
- Efforts to develop fully human monoclonal antibodies
- The autoimmune pipeline
- Leading drugs in development
- Profiles of key pipeline products
- Phase III compounds
- Licofelone (ML3000) Merckle GmbH
- Ocrelizumab (R-1594) Genentech, Biogen IDEC, Chugai and
- Roche
- LymphoStat-B (belimumab) Human Genome Sciences (HGS) and
- GSK
- Ofatumumab (HuMax-CD20) Genmab and GSK
- Fingolimod (FTY-720) Novartis/Mitsubishi Tanabe Pharma
- Fampridine-SR Acorda
- Campath (alemtuzumab) Genzyme and Bayer Schering Pharma
- Recently approved/marketed drugs
- Cimzia (certolizumab pegol) UCB
- Golimumab (CNTO-148) Centocor/Schering-Plough
- Actemra (tocilizumab) Roche/Chugai
- Tysabri (natalizumab) Elan/Biogen Idec
- Mesavance (mesalamine) Shire
- Pipeline forecasts
- Factors affecting forecasts
- Autoimmune pipeline forecast
Chapter 5 Competitive landscape
- Summary
- Introduction
- Sales performance of leading players
- Detailed analysis of leading autoimmune players
- Amgen
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Abbott
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Johnson and Johnson
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Pfizer
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Novartis
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Wyeth
- Overview
- Wyeth and Pfizer
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Roche
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
- Astellas
- Overview
- Sales focus by drug class
- Marketed product portfolio
- R&D pipeline analysis
- Strategic and growth analysis
- Drivers of growth
- Resistors of growth
Chapter 6 Appendix
- IMS Data
- Immunosuppressive agents
- L4A: Immunosuppressive agents
- Musculo-skeletal system
- M1: Anti-inflammatory and anti-rheumatic products
- M2: Topical anti-rheumatics
- Licensing status as per IMS Health
- Original brand
- Other brand
- Licensed brand
- Not-coded product
- Unbranded/ generic product
- Glossary
- Index
List of Figures
- Figure 3.1: Worldwide autoimmune market share by geography, 2007
- Figure 3.2: Sales of types of autoimmune brands, 2007
- Figure 4.3: Prevailing treatment approach for arthritis (OA and RA)
- Figure 4.4: The autoimmune pipeline by indication and stage of development, 2007 116
- Figure 4.5: Leading recently launched products and late-stage R&D in the autoimmune disorders market, 2008
- Figure 5.6: Competitive dynamics of the leading players in the global autoimmune market, 2007
- Figure 5.7: Amgen's autoimmune sales by drug class, 2007
- Figure 5.8: Abbott's autoimmune sales by drug class, 2007
- Figure 5.9: J&J's autoimmune sales by drug class, 2007
- Figure 5.10: Pfizer's autoimmune sales by drug class, 2007
- Figure 5.11: Novartis' autoimmune sales by drug class, 2007
- Figure 5.12: Wyeth's autoimmune sales by drug class, 2007
- Figure 5.13: Roche's autoimmune sales by drug class, 2007
- Figure 5.14: Astellas autoimmune sales by drug class, 2007
- Table 2.1: Estimated prevalence of autoimmune diseases across seven major markets, 2007
- Table 2.2: Estimated prevalence of OA across seven major markets, 2007
- Table 2.3: Forecast epidemiology of OA across seven major markets, 200713
- Table 2.4: Estimated prevalence of RA across seven major markets, 2007
- Table 2.5: Forecast epidemiology of RA across seven major markets, 200713
- Table 2.6: Estimated prevalence of CD across seven major markets, 2007
- Table 2.7: Forecast epidemiology of CD across seven major markets, 200713
- Table 2.8: Estimated prevalence of lupus across seven major markets, 2007
- Table 2.9: Forecast epidemiology of lupus across seven major markets, 200713
- Table 2.10: Estimated prevalence of UC across seven major markets, 2007
- Table 2.11: Forecast epidemiology of UC across seven major markets, 200713
- Table 2.12: Estimated prevalence of MS across seven major markets, 2007
- Table 2.13: Forecast epidemiology of MS across seven major markets, 200713
- Table 3.14: Worldwide autoimmune sales by countries, 2007
- Table 3.15: Breakdown of the global autoimmune market by drug class, 2007
- Table 3.16: Leading brands in the global autoimmune market, 2007
- Table 3.17: Leading immunosuppressant brands in the global autoimmune market, 200607
- Table 3.18: Remicade launch status in major markets
- Table 3.19: Immunosuppressants sales forecast, 200713
- Table 3.20: Leading specific anti-rheumatic brands in the global autoimmune market, 200607
- Table 3.21: Enbrel launch status in major markets
- Table 3.22: Specific anti-rheumatic agents sales forecast, 200713
- Table 3.23: Leading non-steroidal plain anti-rheumatic brands in the global autoimmune market,
200607
- Table 3.24: Non-steroidal plain anti-rheumatics sales forecast, 200713
- Table 3.25: Leading topical anti-rheumatic brands in the global autoimmune market, 200607
- Table 3.26: Topical anti-rheumatic sales forecast, 200713
- Table 3.27: Leading coxib brands in the global autoimmune market, 200607
- Table 3.28: Coxibs sales forecast, 200713
- Table 3.29: Leading non-steroidal (combinational) anti-rheumatic brands in the global autoimmune market, 200607
- Table 3.30: Non-steroidal (combinational) anti-rheumatics sales forecast, 200713
- Table 3.31: Leading anti-rheumatic corticosteroid brands in the global autoimmune market, 2006 07
- Table 3.32: Anti-rheumatic corticosteroids sales forecast, 200713
- Table 3.33: Therapeutic sales forecasts by drug class, 200713
- Table 4.34: An overview of Licofelone
- Table 4.35: An overview of Ocrelizumab
- Table 4.36: An overview of LymphoStat-B
- Table 4.37: An overview of Ofatumumab
- Table 4.38: An overview of FTY-720
- Table 4.39: An overview of Fampridine-SR
- Table 4.40: Fampridine-SR Phase III data
- Table 4.41: An overview of Campath
- Table 4.42: An overview of Cimzia
- Table 4.43: An overview of Golimumab
- Table 4.44: An overview of Actemra
- Table 4.45: An overview of Tysabri
- Table 4.46: An overview of Mesavance
- Table 4.47: Autoimmune pipeline sales forecasts, 200713
- Table 5.48: Leading players in the global autoimmune market, 200713 ($m)
- Table 5.49: Amgen's autoimmune product portfolio, 200607
- Table 5.50: Amgen's autoimmune R&D product pipeline, 2008
- Table 5.51: Abbott's autoimmune product portfolio, 200607
- Table 5.52: Abbott's autoimmune R&D product pipeline, 2008
- Table 5.53: J&J's autoimmune product portfolio, 200607
- Table 5.54: J&J's autoimmune R&D product pipeline, 2008
- Table 5.55: Pfizer's autoimmune product portfolio, 200607
- Table 5.56: Pfizer's autoimmune R&D product pipeline, 2008
- Table 5.57: Novartis' autoimmune product portfolio, 200607
- Table 5.58: Novartis' autoimmune R&D product pipeline, 2008
- Table 5.59: Wyeth's autoimmune product portfolio, 200607
- Table 5.60: Wyeth's autoimmune R&D product pipeline, 2008
- Table 5.61: Roche's autoimmune product portfolio, 200607
- Table 5.62: Roche's autoimmune R&D product pipeline, 2008
- Table 5.63: Astellas's autoimmune product portfolio, 200607
- Table 5.64: Astellas's autoimmune R&D product pipeline, 2008