Myasthenia Gravis Treatment Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Cholinesterase Inhibitors, Corticosteroids, Immunosuppressants, IVIg, and Monoclonal Antibodies); By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Regional Forecast, 2021-2028

The global myasthenia gravis treatment market size was valued at USD 1.15 billion in 2020 and is projected to grow from USD 1.22 billion in 2021 to USD 2.03 billion in 2028, exhibiting at a CAGR of 7.5% during the 2021-2028 period. Based on our analysis, the global market exhibited a slower growth of 4.6% in 2020 than the average year-on-year growth during 2017-2019. The global impact of COVID-19 has been unprecedented and staggering, with myasthenia gravis treatment witnessing a negative impact across all regions amid the pandemic. The sudden rise in CAGR is attributable to this market’s demand and growth rate, returning to pre-pandemic levels once the pandemic is over.

Myasthenia gravis (MG) is a rare autoimmune disease that causes skeletal muscle weakness and fatigue due to delayed communication between nerves and muscles caused by the antibodies.With the increasing aging population, the global prevalence of the condition in recent years has increased.The prevalence rate of the condition ranges from 11 to 50 per 100,000 population. For instance, according to a 2020 article published by Value in Health Journal, the prevalence rate in Australia is around 11.7, whereas the rate in Italy is 79.9. Similarly, it is estimated that there are more than 700,000 patients suffering from this disease globally and approximately 36,000 to 60,000 patients in the U.S.

Several organizations, governing bodies, and industries are focusing on increasing the awareness of the condition among general and patient populations. For instance, Myasthenia Gravis Foundation of America (MGFA) is promoting different ways to recognize June as an awareness month for the condition. The foundation runs a campaign to heighten public awareness wherein they offer a 23-page toolkit and educate the public about the condition and the available treatment options. This leads to an increase in the patient population requiring treatment for the condition.

To cater to the increasing demand of the population, the players in the market like Argenx, CSL Behring, F. Hoffmann-La Roche Ltd., and others are increasing their efforts to develop novel drugs and therapies for the condition. For instance, the drug Efgartigimod developed by Argenx is currently under review with the U.S. FDA to treat the condition.

COVID-19 IMPACT

Significant Decline in Patient Hospital Visit during the Pandemic, Impairing Market Growth

The outbreak of COVID-19 has had an overall negative impact on the market. Patients are usually on immunosuppressive medications that make their immune system weaker. Therefore, these patients are prone to infections, including COVID-19. Because of this, the patient footfall in hospitals and clinics reduced significantly in 2020 during the pandemic.

• National Organization for Rare Disorders (NORD) conducted a survey in the U.S. in 2020 to analyze the effect of the pandemic on treatment access among patients suffering from various rare diseases. According to the analysis:
  
  
  
  • More than 70% of the patients had their appointments canceled due to the unavailability of the physicians
  
  
  • Around 30% of the patients had challenges accessing medical care.
  
  
  
  

Meanwhile, the key manufacturers faced supply chain issues and hurdles for clinical trials during the COVID-19 pandemic. The companies projected a significant revenue from the novel therapies but witnessed a decline due to disruption in the myasthenia gravis treatment among the patients. For instance, Alexion Pharmaceuticals witnessed a 5% decrease to the 2020 revenue projection for the drug Soliris for this indication. All these factors mentioned above are anticipated to slower the myasthenia gravis treatment market growth.

LATEST TRENDS

Robust Efforts by Key Players Towards Novel Therapies to Provide Lucrative Market Growth 

There is a gradual shift of the patients towards novel therapies for this disorder because of the side effects of conventional therapies. Also, with the increasing prevalence and awareness of the condition, the diagnosis rate among the population is increasing. This is resulting in an increase in the number of patients requiring treatment. This, along with the current unmet needs of the patient population, results in rising demand for novel therapeutics.

These factors boost the efforts by the companies towards research and development of the drugs for the condition and their approval. For instance, in July 2021, Alexion Pharmaceutical, Inc. announced positive results for the phase III study of Ultomiris, a humanized monoclonal antibody for generalized myasthenia gravis, and based on the results, the company plans to make regulatory filings in the U.S., EU, and Japan in early 2022.

Additionally, several key players in the market are focusing on subcutaneous Ig (SCIg) therapy for the condition due to the increasing demand for home health care among the population. For instance, CSL Behring conducted trials on subcutaneous immunoglobulin (SCIg), an investigational immune therapy for administering the condition as an injection under the skin.

DRIVING FACTORS

Rising Prevalence of Myasthenia Gravis to Augment Demand for Treatment

Globally, the condition's prevalence has increased significantly over the last several decades. This increase can be due to the rising awareness and diagnosis rate of the condition among the population in emerging and developed countries. The improving reimbursement policies for the condition in the countries is also driving the market growth.

• Also, according to a survey conducted by The National Organization for Rare Disorders (NORD), the prevalence of this condition in the U.S.is approximately 14-40 per 100,000 individuals, which are roughly around 50,000 patients. Additionally, the prevalence of the condition in the U.K. is estimated to be 15 per 100,000 individuals, which has increased over time.

With the increasing diagnosis rate and favorable reimbursement policies for the condition, the demand for novel therapies is also increasing. This is increasing the efforts by the key players in the market to develop and gain approval for new drugs for the disease.

For instance, F. Hoffmann-La Roche Ltd has a drug in the pipeline for myasthenia gravis treatment under the trade name Enspyrng of which the filing is expected to be done in 2024. These factors are expected to drive the market during the forecast period.

Moreover, the population's age structure is also a factor that drives the market growth. According to the Eurostat report, more than one-fifth of Europe's population, i.e., 20.6%, was aged 65 and above in 2020. The population in Europe aged 80 years and above witnessed a significant increase from 5.9% to 14.6% from 2010 to 2020. According to the MDPI Journal of Clinical Medicine, the condition's incidence increases steadily with age. The highest incidence is found in the 60-89 years of age group. Thus, the prevalence of the condition is rising as the average life expectancy among the population increases.

• According to a 2020 epidemiology of myasthenia gravis article published by Value in Health Journal, a higher prevalence of the condition was reported among the elderly population compared to younger ages. For instance, the prevalence of the condition in the U.K. in the geriatric population was 46.3 per 100,000 compared to 12 per 100,000 in younger ages.

RESTRAINING FACTORS

High Cost of Treatment and Inadequate Reimbursement Policies in Emerging Countries to Hinder Market Growth

Specific aspects limit the market growth during the forecast period despite the increasing prevalence of the condition and the constant R&D focus; FDA approval for the drugs is the high cost of the myasthenia gravis treatment and the limited reimbursement policies.

• For instance, according to a 2018 study by NCBI (National Center for Biotechnology Information) in the U.S., the treatment costs of the disease are higher than many other chronic neurological diseases. According to the study, IVIg accounted for 85% of the total annual pharmacy costs in the U.S.

Moreover, the reimbursement policies in the developing regions are inadequate, leading to higher out-of-pocket expenses. This is a crucial factor determining the market's growth during the forecast period. For instance, according to a 2018 study of Urban Basic Medicine Insurance of China, the total expenses reimbursed for the myasthenia gravis treatment decreased drastically to 58.7% from 73.1%. This increased the out-of-pocket expenditure of the patients from 14.7% to 22.6%.

Various healthcare organizations and authorities are now focusing on introducing and improvising reimbursement policies to diagnose and treat the condition in emerging countries.

Thus, the above factors and lack of well-established healthcare infrastructure are some of the restraining factors that are comparatively limiting the growth of the market in emerging countries.

SEGMENTATION

By Drug Class Analysis

Comparatively High Cost of IVIg Enabled the Segment to Account for Dominant Share

Based on drug class, the global market is segmented into cholinesterase inhibitors, corticosteroids, Immunosuppressants, IVIg, and others.

The IVIg segment held a leading share in 2020. The domination is accredited to its rising adoption among the patient population. This is because of the lower preference owing to the side effects caused by the conventional therapies. Also, IVIG treatment provides safe and effective long-term therapy for patients who are unresponsive to conventional therapies. For instance, according to the 2018 report published by the Medical Services Advisory Committee of Australia, the adoption of IVIg treatment among patients increased by 12.6% from 2016 to 2018. Along with this, higher costs and advanced research and development of the key players in the introduction of new IVIg drugs for the condition is anticipated to contribute to the segment's growth during the forecast period.

On the other hand, the monoclonal antibodies segment is expected to grow significantly during the forecast period. The increasing prevalence of the disease among the population and the rising demand for targeted therapies for the condition are the factors that are anticipated to spur segmental growth between 2021 and 2028.

By Distribution Channel Analysis

Increasing Number of Hospital Admissions Enabled Hospital Pharmacies to Dominate Market in 2020

The hospital pharmacies segment held the dominating share in 2020. This is due to the rising rate of hospitalizations and physician visits. About 15-20% develop a myasthenia crisis during their treatment once in their treatment course because of the side effects of the drugs, which require hospitalization. Moreover, the well-established healthcare infrastructure in developed countries is also a factor that is spurring the growth of this segment.

On the other hand, the online pharmacies segment is anticipated to record the highest CAGR during the forecast period. Changing monitoring guidelines for online sales of prescription drugs in established nations, pooled with the existence of dominating e-pharmacy players in nations such as Germany, the U.K., and others, lead to a modification of patient inclination towards online pharmacies.

REGIONAL INSIGHTS

The market size in North America stood at USD 0.56 billion in 2020. The rising prevalence of the disease and the growing geriatric population in the region are the factors that contribute to the growth of the market during the projection period. Moreover, developed healthcare infrastructure and favorable reimbursement policies in the region are improving the diagnosis rate and treatment of the condition in both emerging and developed countries. These factors are anticipated to drive the market during the forecast period.

Europe held the second-largest share in the global market. This is due to the increased funding and establishments of various healthcare bodies to diagnose and treat rare diseases like myasthenia gravis. According to a 2019 article from a national journal in Europe, the European Joint Programme on Rare Diseases was established to develop effective treatments and improve diagnosis for rare conditions in associated EU member states. Similarly, according to the U.K. National Ig Database Annual Report 2019-2020, there were in total 733 patients, and the IVIg usage was 197 kg which is around 8% of total IVIg used in neurology. Additionally, the rising prevalence and diagnosis of the condition in the region are leading to an increase in the efforts by the key players to develop novel therapies for the condition. All these factors mentioned above are expected to drive the market during the forecast period.

Meanwhile, the Asia Pacific market is projected to register the highest CAGR during the forecast period. The fastest growing prevalence of the condition in the region, along with improving reimbursement policies for the treatment, is increasing the diagnosis rate of the condition as well as increasing the number of patients undergoing treatment. For instance, according to a 2020 article published by the Journal of the Formosan Medical Association, in Australia, among the top 10 indications for IVIg, myasthenia gravis accounted for around 8.1%. These factors are anticipated to spur the region's market growth during the forecast period.

Due to the emerging healthcare infrastructure and absence of satisfactory reimbursement guidelines, the Rest of theWorld is estimated to witness slower growth during the forecast period. However, rising awareness and demand of the treatment for the condition in regions like Latin America and the Middle East are the factors that are expected to drive the market growth between 2021 and 2028.

KEY INDUSTRY PLAYERS

Sturdy Portfolio of Key Players to Intensify Competition

The global market is combined with major players such as AstraZeneca, Bausch Health Companies Inc., Astellas Pharma Inc., Veloxis Pharmaceuticals, Inc, and F. Hoffmann-La Roche Ltd. Prime companies are incessantly concentrating on the introduction of innovative drug therapies and tactical procurement of other domestic companies to fortify their product portfolios. For example, in October 2020, Johnson & Johnson attained Momenta Pharmaceuticals with the aim to broaden its leadership in autoimmune disorders and other neurological conditions.

Many other players are focusing on expanding the use of their existing drugs for myasthenia gravis treatment. These drugs are currently used for the treatment of other autoimmune and neurological conditions. For instance, Prograf, an immunosuppressant drug by Astellas Pharmaceuticals used to prevent organ transplant rejection, is being investigated to treat this disorder. Similarly, Tirasemtiv, which is being developed by Cytokinetics for conditions with muscle weakness, is also being tested for this condition.

Moreover, there are several players in the market conducting clinical trials to investigate the potentiality of the drugs for the condition. For instance, UCB S.A. Pharmaceutical is conducting trials for its pipeline drug, Rozanolixizumab, to develop targeted therapy focusing on the patient population.

LIST OF KEY COMPANIES PROFILED:

• AstraZeneca (Cambridge, U.K.)


• Astellas Pharma Inc. (Tokyo, Japan)


• F. Hoffmann-La Roche Ltd. (Basel, Switzerland)


• Novartis AG (Basel, Switzerland)


• Veloxis Pharmaceuticals, Inc. (Horsholm, Denmark)


• Bausch Health Companies Inc. (Laval, Canada)

KEY INDUSTRY DEVELOPMENTS:

• March 2021-  Argenx announced FDA acceptance of BLA filing for Efgartigimod for generalized myasthenia gravis treatment.


• March 2021 - Horizon Therapeutics plc acquired Viela Bio, Inc. with the aim to strengthen the portfolio, pipeline and therapeutic focus on rare disease treatments.

REPORT COVERAGE

The myasthenia gravis treatment market research report provides a detailed analysis of the market. It focuses on key aspects such as leading and emerging companies, drug class, and distribution channel. Besides this, it offers insights into the market trends and highlights key industry developments. In addition to these factors, the report provides insights into several factors contributing to the market's growth over recent years.

Report Scope & Segmentation