Myasthenia Gravis – Opportunity Analysis and Forecasts to 2028
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Myasthenia gravis (MG) is a rare chronic autoimmune and neuromuscular disorder. Most patients experience weakness of the muscles around the eye, which can cause drooping of the eyelids and blurred vision. In other types of MG, weakness can extend to other muscles and cause respiratory difficulties that require immediate attention to ensure the survival of the patient. Most cases of MG affect the eyes, and subtypes of MG are defined according to the severity of muscular weakness and patients’ response to pharmacotherapy. Patients who are non-refractory respond to first-line treatment options and find these drugs provide sufficient management of the disease. Refractory patients on the other hand have difficulty with first-line therapies and require more aggressive treatment strategies to mitigate symptoms. Ocular or Class I MG affects only the muscles around the eye. The level of weakness can be mild, moderate or pronounced. Generalized or Class II-V MG can include weakness of ocular muscles in addition to other muscles around the body.
The subtypes of MG included in this report are: Non-refractory Ocular MG, Non-refractory Class II-V MG, Refractory Ocular MG and Refractory Class II-V MG
The most prevalent form of MG is non-refractory class II-V MG. Across the 7MM there are few approved therapies for MG.
Patients are first treated with Mestinon (pyridostigmine bromide). The autoimmune component of the disease is generally treated with immunosuppressants such as azathioprine and cyclosporine. These drugs are not effective for all patients, may be carcinogenic or teratogenic and can take several months to exhibit therapeutic effects. Steroids such as prednisone are commonly used for all types of MG, but side effects include potential blindness, hypertension and diabetes and so there is significant unmet needs for MG pharmacotherapy for safe, effective and affordable therapies. Soliris (eculizumab) was the first biologic approved for MG and while its use has been successful, the annual cost of therapy is $678,392. This substantially restricts access, leaving many refractory patients with uncontrolled myasthenia, significantly reducing their quality of life.
GlobalData estimates that drug sales for MG in 2018 were approximately $836.5M across the seven major markets (US, France, Germany, Italy, Spain, UK, Japan) covered in this report. Over the 10-year forecast period, the market is expected to grow to $1.9B at a CAGR of 8.7%. This growth will be driven by the launch of eight late-stage pipeline products. The two highest selling drugs are expected to be Ra Pharma’s zilucoplan and Alexion’s ravulizumab, which address some of the clinical unmet needs in the market.
Key Questions Answered in This Report
What were the key MG treatments in 2018?
When will the late stage pipeline products launch in each of the 7MM?
How will the late-stage pipeline agents affect drug sales in the 7MM?
Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?
Scope
Overview of MG, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
Annualized MG therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (non-refractory ocular MG, non-refractory class II-V MG, refractory ocular MG and refractory class II-V MG) forecast from 2018 to 2028.
Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the MG therapeutics market
Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for MG therapy. The most promising candidates in Phase II-b and Phase III stages of development are profiled.
Analysis of the current and future market competition in the global MG therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Key Highlights
The MG market is expected to grow at a CAGR of 8.7% from 2018 to 2028, reaching a global value of $1.9 billion.
There are currently only two approved therapies in the US and 5EU (France, Germany, Italy, Spain and UK) and these are Mestinon and Soliris. Mestinon is not effective in many patients with MG caused by immunological dysfunction. Soliris is priced at $678,392 in the US and is unaffordable for most healthcare systems. Three drugs are approved for MG in Japan. Mestinon, Soliris and tacrolimus which is an immunosuppressant approved for specific cases of refractory MG. The major unmet needs are reducing costs of therapy and medicines with an improved side effect profile as steroids which are commonly used are associated with undesirable outcomes if used on a chronic basis.
Other unmet needs include updating treatment guidelines and identifying biomarkers which may guide treatment regimens for refractory patients, reducing the potential cost of therapy also.
KOLs were impressed by the diversity of the MG pipeline and favored complement inhibition as a mechanism of action. Biologics and immunosuppressants were viewed as the most promising with the novel mechanisms of action utilized by monoclonal antibodies ARGX-113 and rozanolixizumab being seen as a viable strategy for refractory patients.
Clinical trial data is lacking for MG and drug developers are focusing more on testing pipeline therapeutics vigorously in both healthy participants and patients with specific types of MG.
Dosing arrangements are expected to be challenging as weight-based dosing is used for intravenous agents, which also require patients to be in a clinical setting to receive treatment. This is an unmet need of MG pharmacotherapy which will be addressed by three pipeline agents. The distinguishing factor of zilucoplan, the top-selling pipeline agent, is that the subcutaneous route of administration and efficacy will allow patients to have greater control over their treatment regimen.
High patient share is attainable for efficacious products released in the 7MM, regardless of whether launch is early in the forecast window or in later years.
High costs of therapy associated with biologics are expected to remain an unmet need throughout the forecast window and beyond.
Reasons to Buy
The report will enable you to:
Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
Develop business strategies by understanding the trends shaping and driving the global MG therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MG therapeutics market in the future.
Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
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