Competition in Multiple Sclerosis market set to increase with launch of new pipeline drugs and entry of new generics

The Multiple Sclerosis (MS) therapeutics market has entered an exciting phase, with an upsurge of available treatment options and several promising late-stage pipeline products offering diverse mechanisms of action (MOAs). The launch of 12 new therapies will drive growth in the MS space, provide more options for patients, and stimulate further competition, says GlobalData, a leading data and analytics company.

The MS pipeline features 299 drugs across all stages of development, 65% of these drugs are in preclinical stage of development; which is dominated by small molecules and monoclonal antibodies.

According to GlobalData’s latest report, ‘Dynamic Market Forecast: Multiple Sclerosis’ 12 late-stage drug products will launch in the seven major markets (7MM*) during, or shortly after, the forecast period from 2016 to 2026.

The MS market is expected to grow in sales from $19,063M in 2016 to $25,566M in 2026 with a compound annual growth rate (CAGR) of 3%, due to the entry in the market of new pipeline agents. These candidates have a broad range of MOAs, including anti-CD20 antibodies, three second generation S1P receptor modulators, an anti-LINGO-1 antibody, a tyrosine kinase inhibitor, and antioxidants.

Alessio Brunello, Pharma Analyst at GlobalData, comments, “The potential launch of three S1P receptor inhibitors (siponimod, ozanimod and ponesimod) will increase competition in the MS market and these new drugs will take patient share from the approved treatment Novartis’ Gilenya. However, the patent of Gilenya is expected to expire in 2019 and the entry of generics in the market will affect the new pipeline drugs, as during the trials, they did not show significant advantages compared to Gilenya.

“While physicians may be persuaded that there may be some advantages of the newer generation, the pipeline developers may find it difficult to persuade payers, or insurance companies to use their drug over fingolimod generics, especially in the US, where branded drug prices are high.”

The current MS market is highly competitive, with 13 available treatment options, most of which are immunomodulatory agents. The majority of approved treatments address the inflammatory and systemic origins of the disease, but few possess neuroprotective effects and, as such, have an insufficient impact on the underlying neurologic deterioration caused by MS.

Two additional monoclonal antibodies, from Novartis (ofatumumab) and TG Therapeutics (ublituximab) are expected to launch in the forecast period despite physicians being satisfied with Roche’s/Genentech’s Ocrevus (ocrelizumab). Key Opinion Leaders (KOLs) explained that it is possible that there may be some advantages to ofatumumab but nothing that would have a huge impact over the ocrelizumab market.

Brunello concludes, “The MS market is heading towards earlier and more aggressive therapies, with studies in the US questioning whether people with MS who are recently diagnosed should already go on with one of the monoclonal antibody therapies.

“If the results strongly indicate that there is an advantage to starting aggressive therapy earlier, monoclonal antibodies, particularly ocrelizumab and perhaps cladribine, will become first-line treatment for most patients and this will be a big paradigm shift in the treatment algorithm.”

* 7MM: US, France, Germany, Italy, Spain, UK and Japan

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