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TMO Overview - Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, progressive autoimmune disorder characterized by inflammatory attacks by the body's immune system on the central nervous system. For reasons that are not well understood, immune T cells erroneously destroy the myelin sheath that insulates and protects the brain's nerve fibers. AVOS predicts that the growth in the MS market in the coming years will result from marginal increases in diagnosis rates and patient compliance. These changes will increase the population suffering from multiple sclerosis and undergoing treatment from 303,887 individuals in 2008 to 343,670 individuals in 2014. Despite this growth in diagnosis rates and patient compliance, AVOS expects the overall prevalence rate for individuals suffering from multiple sclerosis to remain stagnant at 0.13% of the total U.S. population. AVOS projects that the U.S. MS market will increase from $3.9 billion in 2008 to nearly $5.9 billion in 2014, driven largely by growing physician acceptance of Tysabri and a modest revenue contribution from late-stage oral products in the out-years of our forecast.

AVOS Life Sciences' TMO Multiple Sclerosis report addresses each key aspect of a rigorous, disease-based market analysis:

Market Size & Expected Growth	In-depth epidemiological analysis and modeling Detailed review of current and projected treatment landscape at a class level
Treatment Cascade	Consideration of the treatment algorithms for primary indication Impact of manipulating treatment cascade through promotional and other initiatives
Drug Class Characteristics	Fundamentals: safety, efficacy, side effects, onset of action, duration, etc. Developer strengths and weaknesses (technology, marketing, sales, etc.)
Competitive Landscape	Comprehensive competitve pipeline overview at a drug level In-depth review of all major competing treatment mechanisms and drug classes
Pricing & Reimbursement Landscape	Where appropriate, price elaticity calculations based on payer and provider interviews Evaluation of reimbursement landscape for indication and similar projects
Class Position Effects	Detailed research and analysis for first-in-class products Scenario analysis of entrants into markets with existing products
Projected Market Share Shifts	Sophisticated uptake models (historical view, firm and product attributes) Predictions for shifts resulting from the use of several marketing levers

Key findings in AVOS's TMO Multiple Sclerosis report include:

• Cautious optimism marks Tysabri's return: Biogen Idec's Tysabri was voluntarily pulled from the market in early 2005 when it was discovered that three patients in clinical trials had developed the neurological disease PML, eventually resulting in two patient deaths. Tysabri made an unexpected comeback in 2006, returning to the market after reexamination of trial participants and clinical data revealed no further cases of PML. The FDA allowed Tysabri to re-launch on the basis that the drug's benefits outweighed the risk of developing PML. To date, 26,000 patients worldwide have...
• Oral therapies will alter the MS treatment paradigm: A plethora of pharmaceutical and biotech companies are developing the next disruptive therapy in the treatment of MS - an oral medication to improve the administration burden on the patient. We estimate the first oral medication for MS to reach the market will...
• Changes in physician attitudes: The Tysabri events had the earth-shaking effect of changing physician attitudes toward managing MS. Physicians today are much more cautious in their prescribing habits than what has been observed historically. Neurologists are increasingly...
• Market shifts will be slow despite new treatment options: Conservative physician attitudes will make the shift towards new, innovative therapies slow and gradual. The "A-B-C" drugs will...
• Moderate market growth: The growth in the MS market over the next five years will stem from marginal increases in the diagnosis rate and patient compliance. Market entry of a new drug entity may...

The AVOS TMO Multiple Sclerosis report details the uptake prospects for key Phase III products using a multi-attribute scoring system to rate product characteristics against the gold standard. That analysis, combined with physician sentiment from our panel of neurologists, makes this a must-read for decision makers in R&D, strategy, business development, and marketing.