Juvenile Arthritis Foundation

Global Arthritis Market Review 2008 (World Top Ten RA Drugs)

This knol discusses the current trends in the global arthritis market, leading companies and top ten global brands/drugs. The market is highly fragmented with generics dominating the market by number of prescriptions. Generic companies rarely provide breakdown of sales by different products and one has to rely mainly on commercial reports. The over the counter and generics brands are high volume, fast selling, low marketing and low profitability segment of the market. The global market for arthritis drugs was worth $35 billion in 2008 out of which TNF Inhibitors accounted for sale of $18 billion. NSAIDs branded, OTC and generics generated sales of $10 billion, COXIBs at $3.7 billion and DMARDs $3 billion in 2008. Enbrel with sales of $7.4 billion was the market leader followed by Remicade with sales of $6.5 billion and Humira at $4.5 billion. Enbrel, Remicade and Humira all showed annual gains of over $1 billion.

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Introduction, Methods and Data Collection, Discussion (Para 1, 2), References are common in all Global Market Reseach Knols, please read:

• Global Pharmaceutical Market Review & World Top Ten/Twenty Drugs 2008

Introduction

Rheumatoid arthritis or arthritis is a chronic autoimmune disease with chronic inflammation of the joints and surrounding tissues (ligaments, tendons, muscles) and other organs. The joint inflammation is probably triggered by shock, infection or obesity and causes swelling, pain, stiffness and redness of the joint and difficulties of movement. Chronic inflammation often leads to progressive destruction of cartilage, ligaments and bones and deformity of the joints. Several other conditions like Osteoarthritis and autoimmune disorders like Psoriasis, Juvenile Arthritis, Psoriatic Arthritis, and Ankylosing spondylitis, Ulcerative Colitis, Crohn's Disease, Sjogren's syndrome and Felty's Syndrome are related.

Thousands of branded drugs are used to treat arthritis and related diseases. Corticosteroids and Nonsteroidal anti-inflammatory drugs, often referred to as NSAIDS are used to reduce or control pain and swelling. Analgesic drugs both opioids and non opioids to reduce pain, antacids and proton pump inhibitors to protect from NSAIDs induced gastrointestinal toxicity. The newer COX II inhibitors were developed to provide enhanced GI tract protection. Disease Modifying Anti Rheumatic Drugs (DMARDs) are used to reduce disease progression. Biologics and monoclonal antibodies (TNF inhibitors and IL1 inhibitors) are used to control, stop and reverse disease progression.

Bayer introduction of Aspirin in 1899 started the modern pharmaceutical industry. Acetyl Salicylic Acid (Aspirin) is the most widely used drug today both by volume, number of patients and by production. Bayer sales of Aspirin were near $1 billion during the past two years and the company paid $1 billion a few years go to get its trademark back in USA. Tylenol and Panadol brands of acetaminophen were introduced in 1955. The leading ibuprofen brands are Advil, Motrin and Brufen.

NSAIDs are assumed to be well tolerated and are widely used by millions for pain relief, antipyretic action and as an initial therapy for common inflammation. They range from over the counter aspirin, acetaminophen and ibuprofen to a whole host of prescription brands. These pharmaceutical agents constitute one of the most widely used class of drugs, with more than 70 million prescriptions and more than 30 billion over-the counter tablets sold annually to 15 million patients in the United States. (FDA estimates).

NSAID was the first drug class with several blockbuster drugs which initiated the era of industrial R&D of new drugs. There are as many as 70 marketed and approved NSAID molecules, out of which only 4-5 molecules are used widely. As many as 10 marketed drugs were banned due to links with serious adverse events. NSAIDs drug class can be blamed for increasing regulations, regulatory oversight and the need to show safety and efficacy of new drugs by long term trials in thousands of patients. The cost of bringing a new drug to market is in the range of $1-2 billion and it takes 7-12 years from discovery to market and even longer to recover the cost of development.

Steroids are associated with weight gain, water retention and puffed rounded face. In the USA, NSAID induced ulcers and GI bleeding is linked to deaths of 16000 patients every year. Thus there is a medical need to develop new safe and effective analgesic and anti-inflammatory agents. Discovery of the CycloOxygenase II (COX I and II) in 1990 and its role in inflammation, and that of COX I in GI protection, selective COX II inhibitors were developed to provide pain relief without GI toxicity. However the COX II has cardioprotective role in and prevents clot formation. COX-2 selective agents (Vioxx, Celebrex, and Bextra) are associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

The first two selective COX II inhibitors Celecoxib (Celebrex) by Pfizer and Rofecoxib (Vioxx) Merck were approved in USA and Europe in 1999 and the third Valdecoxib (Bextra) Pfizer in 2001. Parecoxib (Dynastat) is the prodrug of valdecoxib for injections in Europe marketed by Pfizer in Europe. Two newer COX II inhibitors Etoricoxib (Arcoxia) Merck and Lumiracoxib (Prexige) Novartis are approved in 47 and 16 countries mainly in Europe and FDA asked for additional long term safety data for approval. The association of COX II inhibitors with higher cardiovascular risk (stroke, heart attack) led to the withdrawal of Vioxx in 2004, Bextra in 2005 and Prexige in 2007 leaving only Celebrex and Arcoxia in the market and only Celebrex in the USA. Development of newer COX II inhibitor projects was terminated due to the class cardiotoxicity of all COX II inhibitors. Preliminary results from a long-term clinical trial (up to three years) suggest that long term use of a non-selective NSAID, Voltaren and naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo. There is some evidence of activity of COX II inhibitors in some cancer types which express high level of COX II. FDA and the European Medicines Agency EMEA published review of all COX II inhibitors and their role in increasing the risk of heart attack and stroke.

Marketing and sales data for top ten global medicinal brands in any therapeutic area is considered highly confidential in the market intelligence and data mining companies. These companies together generated total income of $7 billion in 2008 and issue hundreds of market research reports costing thousands of dollars each. In several instances the sales figures for a particular medicinal brand differed by over $1 billion when compared to the company annual sales data. In other cases these reports failed to predict the comeback of vaccines and rise of monoclonal antibodies and biologics. There is no reliable method to predict sales for high growth recently introduced products or sales loss due to patent expiry or labeling restrictions or black box warnings.

Methods and Data Collection

(Common in all Global Market ---Review knols)

Results and Discussion

(Para 1 and 2 Common in all Global Market ---Review knols)

The total global sales of COX II inhibitors were $8 billion in 2003, USA accounted for $6 billion and sales of celecoxib and rofecoxib were $1.9 and $2.5 billion respectively. In the first half of 2004, global sales of COX II inhibitors were celecoxib $1.5 billion, rofecoxib $1.3 billion, valdecoxib $545 million and etoricoxib $92 million. Worldwide 80-100 million patients each had used celecoxib and rofecoxib respectively and 40 million in USA. When medicines are used on such a large scale in millions of patients for long term, very rare latent delayed serious adverse reactions appear. Risk-benefit profile for a drug and the societal need and desire for new drugs should determine the regulatory approval, as no drug is fully safe.

Since most of the steroids, analgesics, NSAIDs, antiulcer and DMARDs are generic or OTC and sell on their own with little or minimum marketing, companies rarely report or list annual sales of these products. The other difficulty is in knowing the % of these drugs used in RA patients. Analgesics like Aspirin and Tylenol are used for a variety of conditions like headache and cardioprotective Aspirin. DMARDs drugs (Neoral, cyclosporine) are mainly used in transplant and methotrexate and Rituxan in cancer. It is difficult to come up with exact figures for national and global market for arthritis and related conditions.

The global market for arthritis drugs was worth $32 billion in 2008 out of which TNF Inhibitors accounted for sale of $18 billion and COX II inhibitors $3.7 billion. NSAIDs branded, OTC and generics generated sales of $10 billion and DMARDs $3 billion in 2008. It is difficult to get an idea of the global NSAIDs, DMARDs and Steroid market and its use in rheumatic and related conditions as companies fail to report high volume, low priced OTC and Generic brands. In such cases there is no alternative to commercial reports. Bayer, J&J and Novartis still recorded sales of over $1 billion for their OTC/Generic brands of Aspirin, Tylenol, Advil, Motrinand Voltaren. In DMARDs class, Cell Ceptand Neoral reported sales are mainly for transplant use and only a small portion 5-10% accounts for use in arthritis patients. Enbrel with sales of $7.4 billion was the market leader followed by Remicade with sales of $6.5 billion and Humira at $4.1 billion. Enbrel, Remicade and Humira all showed annual gains of over $1 billion. Biologics have have become the main treatment option for RA patients by providing 50-60% response rate to delay the progression of the disease. The cost of biologic treatment is $20000 per year as compared to $300 pa for NSAIDs and older DMARDs. Several biologic drugs like Orencia, Amevive, Kineret failed in the market mainly due to their lack of add on effect to TNF blockers. Initial sales forecasts were $3 billion for Orencia, $500 million each for Amevive and Kineret. Amgen sold the marketing rights to Kineret to Biovitrum in 2008. Cimzia was the new RA treatment approved by FDA in 2008. Actemra and Stelara are most likely to be approved by FDA in 2009.

Comments and suggestions for improved forecasts are invited from pharmaceutical and biotechnology executives and marketing professionals or Wall Street analysts. Reliable sales data from Japan and Europe is required for some of these listed products.

Acknowledgements

Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrative support.

From Google images

Table 1 Global Arthritis Market 2006-2008 ($ billion)

2006 2007 2008 P

Global Arthritis Market 26.5 33

Leading arthritis categories P Projected

NSAIDs Non Steroidal Anti Inflammatory Drugs includes generic and OTC (IMS data)

Aspirin sales were $1 billion in 2008

DMARDs Disease Modifying Anti Rheumatic Drugs

(Methotrexate, Auronofin, CellCept, Leflunomide, Cyclosporin, Azathioprine)

Coxibs Selective COx II inhibitors Celecoxib + Arcoxib

*IMS Top Line Industry Data 2008; Ernst & Young 2008 Beyond Borders, Datamonitor

**Maggon K. R&D Paradigm Shift & billion dollar biologics. In Shayne C. Gad Ed. Handbook of Pharmaceutical Biotechnology. John Wiley, New York. May 2007 + Knols

Table 2. Global TNF Inhibitors & Biologics Arthritis Market 2008

Sales data for 2008 is based on actual 1-3Q2008 data as reported by companies and adding 4th quarter projections based on sales growth of current 3Q2008 and change between 3 and 4 Q 2007. Exchange rates are average of the period 1-3Q2008 as reported and used by companies.

This projected data P has been updated and replaced by actual A results as companies start reporting in 2009.

All listed brands were first approved in USA followed by European approvals 1-2 years later.

Sales data for 12 approved and marketed monoclonal antibodies with low sales (

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