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 (MOA). The MS market is expected to grow in sales from $19.8bn in 2018 to $32.9bn in 2028 with a compound annual growth rate (CAGR) of 5.2%, due to the launch of 11 new pipeline agents providing more options for patients and stimulating further competition, says GlobalData, a leading data and analytics company.

The 11 new pipeline agents have a broad range of MOA, including anti-CD20 antibodies, three second generation S1P receptor modulators, an anti-LINGO-1 antibody, a tyrosine kinase inhibitor, a Repulsive Guidance Molecule A (RGMA) Inhibitor and antioxidants.

According to GlobalData’s latest report, ‘Multiple Sclerosis – Global Drug Forecast and Market Analysis to 2028’, a further 14 late-stage drug products will launch in the seven major markets (7MM*) during, or shortly after, the forecast period from 2018 to 2028.

The MS pipeline is strong and diverse with a total of 49 products in all stages and phases of clinical development, of which 24 are early-stage and 25 are in the late-stage pipeline. Progressive MS is a significant focus for product development, with seven of the late-stage products targeting this patient group as an initial indication. There is currently a distinct lack of disease modifying therapies (DMT) options for patients with progressive MS subtypes, and these populations remain significantly underserved.

Alessio Brunello, Senior Pharma Analyst at GlobalData, comments: “The launch of Mayzent in March 2019 and the potential launch of two other receptor inhibitors – ozanimod and ponesimod – will increase competition in the MS market and these new drugs will take patient share from the approved treatment – Novartis’ Gilenya. Gilenya’s market share would have been undermined by generic erosion following US patent expiries in 2019, but Novartis gains temporary injunction from generic competition of the US Gilenya patent, which means that the patent will now expire in December 2027; however, there could still be generic entry in 2022 based on other litigation.

“While physicians might 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 14 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 pipeline drugs namely opicinumab and elezanumab could address this need as they are promoting axonal regeneration and myelination.

Brunello adds: “Remyelination strategies could prove revolutionary for MS, as they address a key pathophysiological aspect of the disease that is thought to contribute to the accrual of permanent disability.”

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.”

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