PharmaPoint: Multiple Sclerosis – Global Drug Forecast and Market Analysis to 2022

LONDON - March 11, 2013 - PRLog -- Established players are investing heavily to maintain their presence in the increasingly competitive

Multiple Sclerosis (MS) therapy market, states a new report by GlobalData.

The new report* shows that several market-leading disease-modifying therapies (DMT) are due to suffer patent expiries over the coming years, exposing therapy sales to significant brand erosion. Governments undergoing financial austerity measures are also likely to demand more cost-effective treatments, resulting in reimbursement challenges for new DMTs trying to gain market penetration, and the increased promotion of generic and biosimilar drug use. Therefore, the established players may well struggle to maintain their leads in the MS market following patent expiries to their key branded products, which will adversely impact on the future growth of the MS market.

The MS market has historically been dominated by four players: Bayer HealthCare, Biogen Idec, Teva, and Merck Serono. These companies have been the leading competitors globally since the 1990s, with the successful launch of Bayer’s Betaseron/Betaferon (interferon beta-1b) followed soon after by Biogen’s Avonex (interferon beta-1a), Teva’s Copaxone (glatiramer acetate) and Merck’s Rebif (interferon beta-1a). These established first-line DMTs have shaped the treatment paradigm and now generate the majority of global sales. However, the MS market has become increasingly competitive with the emergence of oral therapies, several pipeline products with notable efficacies, and looming biosimilars following the patent expiries of key branded products. Therefore, these top four companies are facing major challenges in maintaining their position in the MS marketplace, especially with the entry of new challengers onto the competitive landscape.

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In an attempt to gain market share, companies are seeking to expand the coverage of their existing products to enhance the treated patient population, and are targeting alternative disease subtypes where competition is less fierce. Biogen is investigating Tysabri (natalizumab) for the treatment of secondaryprogressive MS, while Novartis’ Gilenya (fingolimod) is being evaluated for primary-progressive MS. Another common strategy is to seek approval or brand extensions based on combination therapies. For example, Sanofi/Genzyme’s Aubagio (teriflunomide) and Teva’s/Active Biotech’s laquinimod (ABR- 215062) are already being tested as possible adjuvant therapies, which would allow these drugs to generate uptake even if more efficacious drugs are available.

Partnerships also allow companies to broaden pipeline portfolios and build experience in target markets. The recent collaborative agreement between Merck and Opexa Therapeutics for the development and commercialization of Tcelna (imilecleucel-T), a novel first-in-class MS vaccine, is of particular strategic importance. Roche/Genentech, with no previous involvement in the MS market, also entered an agreement with Biogen for the development of its late-stage pipeline product, ocrelizumab (RG1594), which will help maximize potential future sales for the drug. In addition, Teva’s acquisition of Taiyo Pharmaceutical Industry in 2011 will boost the company’s presence in Japan, representing an important opportunity for Teva to extend its MS franchise in future. GlobalData estimates that DMT sales for MS across the global markets (US, France, Germany, Italy, Spain, the UK, Japan, Canada, China, and India) will grow from around US$12.6 billion in 2012 to US$13.6 billion in 2022, with a Compound Annual Growth Rate (CAGR) of 0.7%.

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