The current multiple sclerosis (MS) pipeline is strong and diverse with a total of 49 products in all stages and phases of clinical development. However, despite this increasing arsenal, diagnosing the disease still remains a challenge - even for experienced neurologists, says GlobalData, a leading data and analytics company.
Tissue biopsy is currently the only testing method, as no other tests are 100% specific in securing an MS diagnosis, and efforts to establish satisfactory biomarkers are proving to be difficult due to the pathophysiological and clinical complexities of the disease.
Environmental unmet needs include the lack of reliable biomarkers for MS, making early diagnosis of the disease and treatment selection a challenge, and the need for more cost-effective drugs, as DMTs have experienced substantial revenue accrual in recent years. Furthermore, the development of biomarkers for diagnosis, therapy selection, and prognosis represents a potentially lucrative opportunity that will increase as more DMTs enter the market. The availability of predictive tests would aid in early diagnosis of the disease and expand the window of opportunity for patients to receive efficacious therapy.
The MS market is expected to grow in sales from $19.8bn in 2018 to $32.9bn in 2028 in the seven major markets (*7MM) at a compound annual growth rate (CAGR) of 5.2%, due to the entry in the market of new pipeline agents. These candidates have a broad range of mechanisms of action (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.
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 therapy (DMT) options for patients with progressive MS subtypes, and these populations remain significantly underserved.
Alessio Brunello, Pharma Analyst at GlobalData, comments: “The majority of the late-stage candidates targeting RRMS are either ‘me-too’ products, such as second-generation S1P receptor modulators (Celgene’s ozanimod and Janssen’s ponesimod) or anti-CD20 mAbs (Novartis’ ofatumumab and TG Therapeutics’ ublituximab).”
While the last two decades have brought many important advances in the management of MS with the approval of 13 DMTs and numerous palliative treatment options, significant unmet needs still remain in the market. The MS therapeutics market is mature and becoming increasingly crowded for immunosuppressive agents. However, the overall fulfilment of unmet needs is low to medium. The aforementioned unmet needs drive the research for better MS therapies. There is a plethora of pipeline drugs that aim to address these unmet needs, but development progress has been challenging.
Brunello continues: “There are no curative therapies for MS, and most existing DMTs only have limited efficacy on slowing neurodegeneration and disease progression. There are also insufficient options for patients with progressive forms of MS.”
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 Biogen’s opicinumab and AbbVie’s elezanumab could address this need as they are promoting axonal regeneration and myelination.
Brunello adds: “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, Japan and the 5EU (UK, Germany, France, Italy and Spain)