Myasthenia Gravis Treatment Market

Market Overview

The global myasthenia gravis treatment market size was valued at USD 2.11 billion in 2023. It is estimated to reach USD 4.99 billion by 2032, growing at a CAGR of 10.05% during the forecast period (2024–2032). The global myasthenia gravis treatment market is primarily driven by the growing patient pool suffering from this disease. Better diagnostic methods, aging populations, and increased awareness boost market growth. The regulatory bodies' approval of novel drugs and treatment therapies targeting the treatment of myasthenia gravis is also anticipated to augment the market expansion. Moreover, ongoing clinical trials and research and development initiatives are expected to create market expansion opportunities.

Highlights

• Ocular MG dominates the type segment
• Autologous hematopoietic stem cell transplantation (HSCT) dominates the treatment segment 
• Hospitals dominate the end-user segment 
• North America is the highest shareholder in the global market

Market Overview

Myasthenia gravis is a chronic autoimmune neuromuscular condition marked by weakness and rapid exhaustion of voluntary muscles. This occurs when there is a breakdown in the transmission of signals between neurons and muscles. This condition has the potential to influence individuals across all age groups, although it is more prevalent among women under 40 and men over 60.

Symptoms of this illness include muscular weakness in the arms and legs, double vision, verbal communication, chewing, and swallowing challenges. The management of myasthenia gravis commonly entails a multifaceted approach that includes administering medicines, lifestyle modifications, and sometimes surgery. Healthcare practitioners must closely monitor the effectiveness of treatment, make any adjustments to drugs, and monitor for potential adverse effects or consequences.

Market Dynamics

Global Myasthenia Gravis Treatment Market Drivers

Growing Patient Population

Myasthenia Gravis is becoming more common worldwide. According to a study published in the Lancet, the global prevalence of myasthenia gravis is predicted to exceed 700,000 individuals. The high occurrence of this disease can be ascribed to several variables, including improved diagnostic techniques, aging demographics, and increased awareness.

Based on the World Population Prospects statistics, the 2019 Revision, it is estimated that by 2050, roughly 16% of the population will be aged 65 or older, in contrast to approximately 9% in 2019. This implies that the proportion of elderly individuals will rise from one in eleven to one in six. Consequently, this can result in an increasing number of patients, fueling the need for treatment alternatives.

Regulatory Support 

The presence of supportive regulatory regulations and streamlined approval procedures for orphan medications and therapies that specifically address rare diseases such as Myasthenia Gravis encourage pharmaceutical companies to allocate resources towards the advancement of treatments for this ailment, thereby stimulating market expansion. For instance, in June 2023, the US Food and Drug Administration (FDA) approved rozanolixizumab (Rystiggo), a drug manufactured by UCB, for the treatment of adults with generalized myasthenia gravis (gMG) testing positive for the anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody.

Furthermore, in October 2023, UCB Pharma's investigational medicine, zilucoplan, received approval from the FDA and European Commission (EC) as a complement C5 inhibitor for treating persons with myasthenia gravis (MG). Zilbrysq is an authorized subcutaneously administered medication for persons diagnosed with generalized myasthenia gravis (MG) who have tested positive for acetylcholine receptor antibodies (AChR-Ab+). This drug expands the therapeutic options accessible to patients with the condition.

Global Myasthenia Gravis Treatment Market Restraint

Limited Awareness

Myasthenia gravis is an uncommon autoimmune condition. Due to its relative rareness, healthcare providers may lack awareness of its symptoms or mistakenly diagnose it as other neuromuscular disorders. Insufficient knowledge about a condition can delay identification, allowing the patient's symptoms to deteriorate, potentially leading to serious illness and a decline in their overall well-being.

MG may be underdiagnosed in certain instances because of the variety of symptoms and insufficient awareness. Patients may ascribe their symptoms to the process of aging, stress, or other medical disorders, and healthcare providers may not contemplate myasthenia gravis as a potential diagnosis. This can lead to missed chances for early intervention and appropriate treatment, enabling the disease to advance without being controlled. These issues together hinder the growth of the market.

Global Myasthenia Gravis Treatment Market Opportunities

Growth in R&D and Clinical Trials

Pharmaceutical businesses, academic institutions, and research organizations are allotting resources to research and development (R&D) and clinical trials to create novel medications, treatments, and treatment methods for Myasthenia Gravis. An example is using a modified form of CAR-T, an advanced immunotherapy for blood cancer, to potentially address myasthenia gravis, as shown by evidence from a small clinical trial. The research published in the Lancet Neurology in June 2023 had financial support from a small business grant provided by the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health. Cartesian Therapeutics, located in Gaithersburg, Maryland, sponsored the study.

Furthermore, in February 2024, researchers will begin a phase 3 trial to assess the effectiveness of a completely human monoclonal antibody as a potential treatment for patients with general myasthenia gravis. According to the researchers, the study will provide crucial assistance for healthcare providers to manage MG, which varies in intensity over time. The FLEX trial aims to investigate the efficacy of batoclimab in meeting the various requirements of patients at different stages of the disease. This includes alleviating symptoms during flares, preventing severe worsening of myasthenic symptoms, and sustaining remission.

Regional Analysis

Based on region, the global myasthenia gravis treatment market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global myasthenia gravis treatment market shareholder and is expected to expand substantially during the forecast period. The myasthenia gravis treatment market is predominantly driven by North America, primarily due to the region's significant prevalence of MG cases. The estimated prevalence of myasthenia gravis in the United States is 14 to 20 incidents per 100,000 people, which corresponds to around 36,000 to 60,000 cases in the country. Moreover, there has been an increase in research and development of novel treatment options for myasthenia gravis, and it is expected that favorable outcomes from this research would stimulate market expansion in the region. For instance, in November 2023, Kyverna Therapeutics, Inc. (Kyverna) reported the publication of a Letter to the Editor of The Lancet Neurology. The letter, authored by a team of German investigators, described the first instance of treatment using KYV-101.

Furthermore, the treatment was administered to a 33-year-old patient with severe, treatment-refractory, anti-acetylcholine receptor auto-antibody positive, generalized myasthenia gravis (MG). Importantly, this treatment was provided to the patient individually outside of a clinical trial setting. During the two months after treatment, the patient did not exhibit any negative effects associated with chimeric antigen receptor (CAR) T-cell therapy, such as cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). During this time, the patient saw enhanced muscular power and decreased tiredness, accompanied by eradicating B cells and a 70% decrease in harmful anti-acetylcholine receptor autoantibodies. This case report presents convincing evidence for the efficacy of anti-CD19 CAR T-cell therapy in achieving profound B cell depletion, leading to remission and symptom improvement in patients with severe myasthenia gravis who have not responded to conventional treatments.

The Asia-Pacific region exhibits significant growth prospects. The expansion of healthcare infrastructure and the growing awareness among individuals drive the adoption of MG treatment. In addition, there has been a notable increase in research and development efforts undertaken by various institutes, organizations, and prominent companies. For instance, researchers in Vietnam discovered that the administration of propofol and sevoflurane, without the use of muscle relaxants, was both safe and effective in maintaining anesthesia for individuals with mild symptoms of myasthenia gravis who were undergoing thymus excision surgery. Dysfunction of this gland may lead to the generation of antibodies that cause myasthenia gravis.

Moreover, some patients may experience a severe worsening of MG symptoms, which can rapidly escalate to a life-threatening condition due to the administration of muscle relaxants commonly used before surgery. Further investigation is required to ascertain propofol and sevoflurane's comparative safety and efficacy in individuals with more advanced stages of the disease. Therefore, these factors contribute to the growth of the regional market.

Segmental Analysis

The global myasthenia gravis treatment market is bifurcated into type, treatment, and end-user.

Based on type, the global myasthenia gravis treatment market is segmented into ocular MG, congenital MG, and transient neonatal MG. 

The ocular MG segment is anticipated to capture the largest market share. Ocular myasthenia gravis (OMG) is a variant of myasthenia gravis (MG), a neurological condition characterized by weakening and exhaustion of voluntary muscles. Contrary to generalized myasthenia gravis, which impacts many muscle groups in the entire body, ocular myasthenia gravis mainly targets the muscles responsible for controlling eye movement and eyelid function. The management of ocular MG is individualized but often involves using cholinesterase inhibitors as a first-line treatment. A study conducted in Japan discovered that corticosteroids and other immunosuppressants, which are drugs that affect the immune system, can alleviate symptoms of ocular MG either when used alone or in conjunction with cholinesterase inhibitors.

Based on treatment, the global myasthenia gravis treatment market is segmented into medication, surgery, autologous hematopoietic stem cell transplantation (HSCT), plasmapheresis and intravenous immunoglobulin, and others. 

The autologous hematopoietic stem cell transplantation (HSCT) segment owns the highest market share. Autologous hematopoietic stem cell transplantation (HSCT) is a medical technique in which a patient's stem cells are collected, usually from bone marrow or peripheral blood. These stem cells are subjected to intense chemotherapy to eradicate dysfunctional immune cells. Subsequently, the collected stem cells are reintroduced into the patient's body, facilitating the regeneration of a fresh immune system that ideally lacks the autoimmune reaction responsible for the condition. Autologous hematopoietic stem cell transplantation (HSCT) aims to reinstate the patient's hematopoiesis and immune system functionality, which may have been impaired due to certain conditions such as myasthenia gravis.

Based on end-users, the global myasthenia gravis treatment market is bifurcated into hospitals, clinics, academic research institutes, and others. 

The hospital segment dominates the global market. Patients with myasthenia gravis often require hospital treatment when they undergo severe exacerbations or crises. The treatment of myasthenia gravis necessitates a collaborative approach involving various medical specialists such as neurologists, pulmonologists, intensivists, surgeons, nurses, and allied health professionals. This comprehensive care is customized to meet the specific requirements of each patient and is expected to contribute to the growth of the hospital segment.

Recent Developments

• February 2024- Johnson & Johnson released its primary findings from the crucial Phase 3 VIVACITY trial of nipocalimab in adults with generalized myasthenia gravis (gMG). The Phase 3 VIVACITY research in gMG demonstrated that nipocalimab successfully achieved the primary endpoint by significantly reducing the MG-ADLa score compared to placebo (PBO) for 22 to 24 weeks.
• December 2023- Kyverna Therapeutics' autologous, totally human CD19 chimeric antigen receptor (CAR) T-cell therapy KYV-101 was granted fast-track status by the US Food and Drug Administration (FDA) for the treatment of myasthenia gravis.