Abstract
In a market believed to approach 5 million people in the leading pharma markets, the market for rheumatic anti-inflammatory drugs is both profitable and set to increase due to new launches. The annual revenue to Q3 2006, from the main prescription anti-inflammatory drugs worldwide, including non steroidal anti-inflammatories (NSAIDs), anti-rheumatic corticosteroid combinations and specific anti-rheumatics was in the order of $16bn worldwide. This market cannot be ignored. A life-long disease with no cure, the disease has been targeted greatly by pharma companies with the launch of novel targeted biologic therapies. However this has meant that the market for severe RA has become crowded - but is it saturated?
Historically management of RA has relied on symptomatic treatment with a variety of anti-inflammatories, toxic immunosuppressants and corticosteroids. None of these treatments, however, had the ability to prevent underlying disease progression. The advent of a series of new biological monoclonal antibodies to treat RA has changed this situation dramatically. There is now a real possibility of actually modifying the progression of chronic disease, decreasing disability levels and enabling more normal lifestyles for RA patients.
These new monoclonal antibodies specifically target the early pathways of inflammation preventing damage and abrogating the onset of the vicious cycle of inflammation and tissue destruction. The first new biological drugs for RA are already on the market and have met with outstanding clinical success. There are now several important regulatory issues concerning the older biological drugs as patents are expiring and the biosimilar race by generic companies gets underway. There is also a strong pipeline of new drugs in development which could make exciting and important breakthroughs.
Questions however remain, that this new report will answer for you, such as: Will the current monoclonal blockbuster used to treat RA continue to grow? How dark is the future for coxibs and as a drug class are they doomed? What are the hottest research drugs in the pipeline? Will the manufacture and marketing of biosimilars overcome regulatory hurdles?
The main treatment categories discussed in the report include:
- nonsteroidal anti-inflammatories (NSAIDs, COX inhibitors known as coxibs)
- corticosteroids
- viscosupplements (for joints) - Synvisc and Suvenyl
- new biologicals (anti-TNF), Kineret ( anti IL-1Ra )
- MabThera/Rituxan (anti-CD 20), Orencia (anti-IL-2 and IL-4)
With new expensive biological drugs targeted at the US, Europe and Japan, generating revenues of $9450m in the last 12 months, visiongain believe that the growth of the disease within developing nations will see cheaper alternatives increase revenue also.
With global market analysis and forecast right through to 2012, the report tackles a SWOT breakdown affecting the use of NSAIDs and biologicals. Targeted immunology relating to RA and sets out the targets for future research. This is taken up in the pipelines chapter which deals with the pipeline. These two chapters have been designed to allow the reader to get a good summary of what is opening up in the future treatment for RA. Visiongain sees a continuing shift towards biological treatment of RA and the treatment options are expanding. Biologicals provide greater opportunity to modulate disease progression and alleviate the chronic cycle of inflammation and pathology. Leading biological companies have strong pipelines and time will determine the future potential of the next generation of anti-inflammatory drugs. In the meantime, the use of traditional mainstay drugs will continue until newer agents have a proven record of safety and efficacy. The early signs with the novel therapies look very promising.
- Exclusive information of market shares and revenues till 2012 for all of the major drugs have been forecast -
Included in this report:
This report includes an up-to-date, analysis of RA including the current market and possible future developments. The following important issues are covered in detail:
- An introduction of the concepts behind AI disease
- Discussion of the immunology of RA and key issues in inflammation
- World prevalence rates and aetiological considerations
- A market analysis of the leading anti-inflammatories for RA, 2005-2006
- A market forecast for the global RA prescription market, 2007-2012
- Summaries of forecasts for the leading biological monoclonal antibodies for RA
- SWOT analyses
- An appraisal of pipeline biologicals for RA
Methodology
The information contained in this report is from primary industry sources. This includes one-on-one interviews with companies, with governmental bodies and academic institutions. Analysis has also been drawn from company reports, whether annual financial returns or white papers. The author of this report has dealt with over 50+ companies and industry contacts to assist on the production of this report.
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Table of Contents
1. Executive Summary
- 1.1 Aims of the Report
- 1.2 Summary and Contents
2. Immunity
- 2.1 Innate and Acquired Immune Systems
- 2.1.1 Innate Immunity
- 2.1.2 Acquired Immunity
- 2.2 Autoimmune Disease
- 2.2.1 Antigens
- 2.2.2 Autoantibodies
- 2.2.3 Inflammation and Central Matrix Destruction
- 2.3 The Regulators of Inflammation
- 2.3.1 Cytokine Storms
- 2.3.2 Chemoattractant Chemokines
- 2.4 Spectrum of Autoimmune Disease
- 2.4.1 Organ Specific AI Disease
- 2.4.2 Non Organ Specific AI Disease
3. The Anti-inflammatory Market
- 3.1 Prescription Anti-inflammatory Drugs- Significant Economic Impact
- 3.2 World Arthritis market
- 3.3 The Anti-arthritis Market by Country
- 3.3.1 North America
- 3.3.2 Europe
- 3.3.2 Asia by Country
- 3.3.3 India
- 3.3.4 Latin America by Country
- 3.3 Anti-inflammatory Drugs have Multiple Indications
- 3.4 The Key Players
- 3.5 Growth of the Immunomodulator Market
- 3.6 Diseases with Biggest Impact on the Pharmaceutical Market
4. Rheumatoid Arthritis (RA)
- 4.1 What is RA?
- 4.2 Aetiology of RA
- 4.2.1 Genetic Predisposition
- 4.2.2 Infectious Agents
- 4.2.3 Rheumatoid Factor (RF)
- 4.2.4 Pro-inflammatory Chemokines and Cytokines
- 4.2.5 Smoking
- 4.3 Diagnosis, Differential Diagnosis , Biomarkers and Theranostics
- 4.3.1 Diagnosis
- 4.3.2 Differential Diagnosis
- 4.3.3 Biomarkers
- 4.3.4 Theranostics/Therapeutic Diagnostics in RA
- 4.4 Symptoms and Prognosis of RA
- 4.5 World Incidence, Prevalence and Impact of RA
- 4.5.1 World Incidence and Prevalence of RA
- 4.5.2 Impact of RA
- 4.5.3 Time Trends in RA Up or Down?
5. Treatment of RA
- 5.1 NSAIDs
- 5.2 Glucocorticoids and Bridge Therapy
- 5.3 DMARDS
- 5.3.1 Methotrexate
- 5.3.2 Hydroxychloroquine
- 5.3.3 Other DMARDs
- 5.4 Biological DMARDs
- 5.4.1 TNF-? Antagonists
- 5.4.2 Kineret (anakinra) Therapy
- 5.4.3 MabThera/ Rituxan (Rituximab) Therapy
- 5.4.4 Orencia (abatacept) Therapy
- 5.4.6 Hyaluronic Acid Supplements and Osteoarthritis
6. Juvenile Arthritis a Special Market Area
- 6.1 Nomenclature and Definitions
- 6.2 Diagnosis
- 6.3 Prevalence
- 6.4 Symptoms and Signs
- 6.5 Treatment
7. Global Market Forecast
- 7.1 Increased Revenue Predicted for Global Arthritis Market
- 7.1.1 Corticosteroids
- 7.1.2 Methotrexate
- 7.1.3 Other Anti-rheumatics
- 7.1.4 Leading Brand Treatments for RA during 2006
- 7.2 Leading TNF-? Biologicals
- 7.2.1 Enbrel
- 7.2.2 Remicade
- 7.2.3. Humira
- 7.2.4 Conclusions
- 7.3 New RA Biologicals - Actemra, Kineret, Orencia and MabThera
- 7.3.1 Actemra
- 7.3.2 Orencia
- 7.3.3. MabThera
- 7.4 NSAIDs- The COX Inhibitors (coxibs)
- 7.4.1 The COX-2 Inhibitor Market during 2005-2006
- 7.4.2 COX Inhibitor Market 2007-2012
- 7.4.3 Celebrex (Celecoxib, Pfizer)
- 7.4.4 Mobic (Meloxicam, Boehringer Ingelheim)
- 7.4.5 Voltaren (Diclofenac, Novartis)
- 7.4.6 Arthrotec (Diclofenac/Misoprostol, Pfizer)
- 7.4.7 Arcoxia (Etoricoxib, Merck & Co)
- 7.4.8 Lorcam (Lornoxicam, Taisho Pharmaceutical)
- 7.4.9 Conclusions on the Future of COX-2 Inhibitor Market
- 7.5 Hyaluronic Acid Viscosupplementation
- 7.5.1 Hyaluronic Supplements, 2005-2006
- 7.5.2 Suvenyl 2007-20012
- 7.5.3 Worldwide Revenues for Synvisc 2007-2012
8 SWOT Analyses
- 8.1 NSAIDs- Coxibs
- 8.2 Coxib Strengths
- 8.2.1. Oral Formulations
- 8.2.2 Fast Acting
- 8.2.3 Broad Spectrum
- 8.2.4 Inexpensive
- 8.3 Coxib Weaknesses
- 8.3.1 Adverse Side Effect Profile
- 8.3.2 Broad Spectrum No Underlying DMARD Activity with Daily Regimen
- 8.3.3 Potential for Dependency
- 8.3.4 Patent Expiry
- 8.4 Coxib Opportunities
- 8.4.1 Combination Products
- 8.4.2 New Drug Development
- 8.5 Coxib Threats
- 8.5.1 Biological Competition
- 8.5.2 New Coxibs?
- 8.6 The Biologicals
- 8.7 Strengths of Biologicals
- 8.7.1 Specific, Effective DMARDs
- 8.7.2 Favourable Patent Issues
- 8.8. Weaknesses of Biologicals
- 8.8.1 Side Effects
- 8.8.2 Expense
- 8.8.3 Parenteral Route of Administration
- 8.9 Opportunities for Biologicals
- 8.9.1 Multiple Target Pathways - Discovery Channels
- 8.9.2 Novel Formulations
- 8.10 Threats for Biologicals
- 8.10.1 Competition from Other Biologicals
- 8.10.2 Research and Development
- 8.10.3 New Product Introductions
- 8.10.4 Biosimilars
- 8.10.4.1 History
- 8.10.4.2 Geography
- 8.10.4.3 US and Europe
- 8.10.4.4 Conclusion
9. Pipeline
- 9.1 Products in Phase III Clinical Trial
- 9.2 New Products
- 9.2.1 Apadenoson (Adenosine Therapeutics)
- 9.2.2 Belatacept (BMS)
- 9.2.3 Rituximab (Genentech)
- 9.2.4 Ofatumumab (GSK, Genmab)
- 9.2.5 Belimumab (Cambridge Antibody Technology)
- 9.2.4 CPH82 (Reumacon, Meda)
- 9.2.5 AMG 162 (Amgen)
- 9.2.6 Golimumab (Schering-Plough)
- 9.2.6 Icatibant (Aventis, Jerini)
- 9.2.9 Coxib 406381 (GSK)
- 9.2.10 Conclusion
10. Conclusion
List of Tables
- 2.1 Pro-inflammatory and Anti-inflammatory Cytokines
- 2.2 Spectrum of Autoimmune Disease
- 3.1 World Sales of Leading Prescription Anti-inflammatories in 2006
- 3.2 Leading Brands for the Treatment of Arthritis to Q3 2006
- 5.1 Leading Brand COX Inhibitors for the Treatment of RA Worldwide ($m)
- 5.2 World Sales of Leading Systemic Corticosteroids/Corticosteroid Combinations, 2005
- 5.3 Steroids Commonly in Use for Treatment of Arthritis in the UK
- 5.3 Non-Biological DMARDS Used to Treat RA
- 6.1 Different Classifications for Juvenile Arthritis
- 6.2 Existing and Potential Biological for Potential Use in Juvenile Arthritis
- 7.1 Enbrel World Revenues and Annual Growth Rate, 2007-2012
- 7.2 Remicade World Revenues and Annual Growth Rate, 2007-2012
- 7.3 Forecast for Humira World Revenues and Annual Growth Rate, 2007-2012
- 8.1 SWOT Analysis of the COX- Inhibitors
- 8.1 SWOT Analysis of the Biologicals
- 9.1 Anti-rheumatics in the Pipeline
List of Figures
- 3.1 Global Anti-arthritis Market
- 3.2 Global Anti-arthritis Market Share
- 3.3 Global Anti-arthritis Market by Drug Category
- 3.4 North American Arthritis Market
- 3.5 North American Arthritis Market by Drug Class
- 3.6 The European Arthritis Market by Country
- 3.7 European Arthritis Market by Drug Category
- 3.8 Asian Arthritis Market by Country
- 3.9 Latin American Arthritis Drug Market by Country
- 3.10 Market Shares of the 6 leading RA Drugs
- 4.1 Prevalence of Arthritis in Different Countries
- 7.1 Revenue from the Leading Brand Arthritis Treatments in 2006
- 7.2 Global Sales of TNF-? Biologicals for the Treatment of Arthritis 2005/2006
- 7.3 Forecast for the TNF-? Biological Market, 2007-2012
- 7.4 Forecast for Individual TNF-? Products, 2007-2012
- 7.5 Revenue Forecast for Enbrel, 2007-2012
- 7.6 Annual Growth Rate for Enbrel, 2007-2012
- 7.7 Revenue Forecast for Remicade, 2007-2012
- 7.8 Annual Growth Rate for Remicade, 2007-2012
- 7.9 Revenue Forecast for Humira, 2007-2012
- 7.10 Annual Growth Rate for Humira, 2007-2012
- 7.11 World Sales of COX-2 Inhibitors in 2005
- 7.12 World Sales of COX-2 Inhibitors in 2006
- 7.13 Global Sales of Leading COX Inhibitors 2005/2006
- 7.14 Worldwide COX 2 Inhibitor Market 2007-2012
- 7.15 World Sales of Leading Brand COX Inhibitors, 2007-2012
- 7.16 Leading Brand COX Inhibitors, 2007-2012
- 7.17 Growth in the Sales of Viscosupplements during 2005-2006
- 7.18 Global Sales Forecast for Synvisc and Suvenyl 2007-2012
Organisations Listed
- Abbott
- Adenosine Therapeutics
- Amgen
- Axis Shield
- Biogen Idec
- Boehringer Ingelheim
- Bristol Myers Squib
- Cambridge Antibody Technology
- Chugai Pharmaceutical
- Conpharm
- Daiichi Sanyo
- Genentech
- Genesis Genmag
- Genzyme
- Glaxo Smith Kline
- Jerini
- Johnson & Johnson
- Lupin
- Meda
- Mylan
- Nippon Roussel
- Novartis
- Par Actavis
- Pharma
- Pharmacia
- Pfizer
- Roche
- Sanofi-Aventis
- Sanofi-Synthelabo
- Schering Plough
- Shire
- Sovereign
- Tanabe
- Teva
- UCB
- Upjohn
- Watson
- Wyeth
