The European market for drugs and diagnostics against multiple sclerosis (MS) will nearly double over the next five years, yet the continent is underserved by the current supply of treatments and especially tools, a new report cautions.
Frost & Sullivan’s Analysis of the European Multiple Sclerosis Market projects that the size of that market will grow from about $3.2 billion as of 2010 to $5.8 billion by 2017, reflecting a compound annual growth rate of 7.2%. Europe’s nearly 550,000 cases reportedly account for more than 1 in 5 of the more than 2.5 million people worldwide with MS.
"The rising number of people suffering from MS is resulting in higher demand for therapeutics," notes Deepika Pramod Chopda, a Frost & Sullivan research analyst. "This, coupled with strong pipeline development, is pushing robust growth in the overall market." A key challenge to that growth, though, Chopda added, is a lack of diagnostic tools sensitive enough to record accurate findings as well as noncompliance with the often cumbersome treatment procedures associated with MS drugs.
Frost & Sullivan’s report comes two months after the EMA released a draft guidance on January 23 covering clinical and nonclinical requirements for developing interferon beta biosimilars; interferon beta drugs have been approved for treating MS since the 1990s. In the EU, as in the U.S., two interferon beta-1a drugs are available: Biogen Idec’s Avonex and Merck Serono’s Rebif. Additionally, there are two interferon beta-1b drugs, Betaseron (also called Betaferon) made by Bayer HealthCare and Novartis’ Extavia, a copy of Betaseron for which Novartis pays Bayer royalties. Noninterferon beta drugs for MS include Copaxone and Tysabri.
As Chopda noted in a January Frost & Sullivan report, all available MS drugs are licensed for relapsing-remitting cases, while Betaferon has been approved for secondary progressive MS as well. However, as of January, only one clinical trial had ever been carried out that proved any effect of this drug on secondary progressive MS. Worse, there is no drug for primary progressive MS. Avonex and Betaferon are used to treat patients with clinically isolated symptom (CIS), a possible indication of MS.
Scotland’s Scottish Medicines Consortium recently rejected Novartis’ Gileyna contending its benefit has yet to be proven against Tysabri, despite approvals in the U.S., EU, and Canada. The pipeline of potential new MS drugs include Aubagio™, for which Sanofi sought approval last month from the EU; and ibudilast (MN-166), MediciNova’s lead drug development candidate for progressive forms of multiple sclerosis among several neurological conditions.