Systemic Mastocytosis Treatment Market | Acumen Research and Consulting

Systemic Mastocytosis Treatment Market Highlights

• The global systemic mastocytosis treatment market is projected to reach USD 482.3 million by 2032, with a CAGR of 5.1% from 2024 to 2032
• According to National Organization for Rare Disorders, Rare Disease Day is a patient-led international awareness campaign that highlights the challenges of the 300
• million individuals impacted by rare diseases worldwide
• In 2023, the North American systemic mastocytosis treatment market held a value of approximately USD 127.3 million
• According to National Organization for Rare Disorders, over 25 million Americans and their families are living with a rare disease and 50% of those affected are
• children. 90% of all rare diseases have no FDA approved therapy
• The Asia-Pacific region is expected to grow at a CAGR of over 5.9% from 2024 to 2032
• Among product type, AK-002 segment holds 45% of share in 2023
• Rising adoption of biologics, including monoclonal antibodies, in treatment regimens is the systemic mastocytosis treatment market trend that fuels the industry demand

Systemic mastocytosis is a rare illness in which mast cells accumulate in numerous organs, causing symptoms such as itching, stomach pain, and anaphylaxis. There is no definitive cure, therefore treatment focuses mostly on symptom management. Antihistamines, corticosteroids, and mast cell stabilizers can help reduce symptoms like allergies and inflammation. In severe situations, chemotherapy or targeted medicines such as imatinib may be used to inhibit mast cell proliferation. The treatment approach is adapted to the individual's symptoms and the severity of the ailment.

Global Systemic Mastocytosis Treatment Market Dynamics

Market Drivers

• Increasing prevalence of rare diseases, including systemic mastocytosis
• Advancements in targeted therapies and personalized medicine
• Growing awareness and improved diagnostic techniques

Market Restraints

• High cost of treatment and limited insurance coverage
• Lack of curative therapies and complex disease management
• Limited availability of specialists and treatment centers

Market Opportunities

• Research and development of novel drugs and biologics
• Expanding healthcare infrastructure in emerging markets
• Collaborations and partnerships for drug development and clinical trials

Systemic Mastocytosis Treatment Market Report Coverage

Systemic Mastocytosis Treatment Market Insights

With increased knowledge and diagnostic technologies, more cases of systemic mastocytosis are being detected, creating an increasing demand for effective therapies. Mastocytosis, for example, is considered a rare disease, with an incidence and prevalence previously estimated to be 0.89 per 100.000 and 9.59 per 100.000, respectively; however, recent improvements in diagnostic methods may have resulted in an increased incidence and prevalence. The 25-year limited-duration prevalence as of January 1, 2022 was 28, 44 per 100,000. This tendency is boosting the market, as patients look for long-term management solutions to improve their quality of life.

The emergence of targeted medicines, such as tyrosine kinase inhibitors, provides more effective and personalized therapy choices for systemic mastocytosis. According to the National Institute of Health (NIH), advances in molecular knowledge, such as the identification of the S/A/R profile and the development of new targeted medicines, have altered the landscape of this disease, particularly for advanced forms of systemic mastocytosis. Precision and customized medicine techniques will improve patient management and quality of life in mast cell neoplasms. These innovations not only improve patient outcomes, but they also drive market growth by attracting investment in R&D.

Treatments for systemic mastocytosis, particularly targeted medicines, are often costly and may not be fully reimbursed by insurance. This financial burden restricts patients' access to innovative treatments, impeding market growth.

Continued investment in R&D is paving the way for novel medicines and biologics that tackle the underlying causes of systemic mastocytosis. For example, the National Institutes of Health estimates that the International Consensus Classification and the World Health Organization revised the diagnostic criteria and classification of SM as a result of clinical experience and developments in molecular diagnosis. Somatic mutations in the KIT gene, most often KIT D816V, are found in 90% of patients with SM. Small-molecule kinase inhibitors that target KIT-downstream and KIT-independent pathways have recently been approved for the treatment of advanced systemic mastocytosis. These improvements in molecular diagnostics and targeted therapies are driving the development of novel medications for systemic mastocytosis, providing opportunities for pharmaceutical companies in the projection year.

Systemic Mastocytosis Treatment Market Segmentation

The worldwide market for systemic mastocytosis treatment is split based on product type, route of administration, application, and geography.

Systemic Mastocytosis Treatment Market By Product Type

• AK-002
• BLU-285
• Cromolyn Sodium
• Crenolanib Besylate
• Brentuximab Vedotin
• Others

According to the systemic mastocytosis treatment industry analysis, AK-002 (lirentelimab) has the highest market share. This supremacy is attributable to its specific method of action against mast cells, which provides good symptom control and better patient outcomes. Furthermore, the rising prevalence of systemic mastocytosis has increased demand for AK-002, bolstering the drug's market leadership.

Systemic Mastocytosis Treatment Market By Route of Administration

• Oral
• Injectables
• Topical

According to the systemic mastocytosis treatment industry analysis, injectables are gaining popularity because of their quick and effective action in treating symptoms and suppressing mast cell growth. Patients with severe or refractory illnesses choose injectable therapies such as biologics and chemotherapeutic drugs. Oral drugs, such as antihistamines and tyrosine kinase inhibitors, are frequently used for milder cases but take longer to take effect. Topical treatments, while effective for symptom alleviation, play a minor role in compared to injectables and oral medications.

Systemic Mastocytosis Treatment Market By Application

• Clinic
• Homecare
• Hospital
• Other

According to the systemic mastocytosis treatment market forecast, hospitals dominate because they provide specialized treatment, advanced diagnostic equipment, and provide complex therapies such as injectables and chemotherapy. Hospitals offer extensive care for severe instances, including anaphylactic responses. Clinics follow, managing routine monitoring and less intensive treatments. Homecare and other venues play minor roles, mostly assisting with continued medication administration and symptom control for stable patients.

Systemic Mastocytosis Treatment Market Regional Outlook

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• India
• Japan
• China
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of LATAM

The Middle East & Africa

• South Africa
• GCC Countries
• Rest of the Middle East & Africa (ME&A)

Systemic Mastocytosis Treatment Market Regional Analysis

For several reasons, North America dominates the systemic mastocytosis treatment market. The region also benefits from major investment in R&D, resulting in the availability of novel medicines. For example, according to CRS Reports, President Biden's FY2023 budget request contains about $204.9 billion for R&D, which is $45.3 billion (28%) more than the FY2021 predicted level of $159.6 billion. In constant FY2023 dollars (estimated), the FY2023 R&D proposal is $41.8 billion (26%) higher than the FY2022 projection. The Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and the National Science Foundation (NSF) all received funding in accordance with the request. Furthermore, favorable regulatory frameworks and insurance coverage contribute to market growth by improving patient access to new treatments.

The Asia-Pacific region's systemic mastocytosis therapy market is expanding rapidly, owing to rising healthcare spending and improved medical infrastructure. Rising awareness of rare diseases and increased availability to diagnostic techniques all contribute to higher diagnosis rates. Furthermore, increased investment from pharmaceutical companies and favorable government efforts create a dynamic market environment with significant development potential. According to the India Brand Equity Foundation, in the Interim Budget 2024-25, the government set aside Rs. 1,000 crore (US$ 120 million) for the marketing of bulk drug parks in FY25, a major increase over the previous year.

Systemic Mastocytosis Treatment Market Players

Some of the top systemic mastocytosis treatment companies offered in our report Medscape, AbbVie Inc, Blueprint Medicines Corp, Bristol-Myers Squibb Company, Stemline Therapeutics Inc, AB Science SA, Deciphera Pharmaceuticals LLC, Novartis AG, Mylan NV, and Arog Pharmaceuticals, Inc.