Systemic Mastocytosis Treatment

Global Systemic Mastocytosis Treatment Market to Reach US$709.1 Million by 2030

The global market for Systemic Mastocytosis Treatment estimated at US$530.9 Million in the year 2024, is expected to reach US$709.1 Million by 2030, growing at a CAGR of 4.9% over the analysis period 2024-2030. AK-002 Treatment, one of the segments analyzed in the report, is expected to record a 4.4% CAGR and reach US$305.2 Million by the end of the analysis period. Growth in the BLU-285 Treatment segment is estimated at 5.4% CAGR over the analysis period.

The U.S. Market is Estimated at US$139.6 Million While China is Forecast to Grow at 4.9% CAGR

The Systemic Mastocytosis Treatment market in the U.S. is estimated at US$139.6 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$114.8 Million by the year 2030 trailing a CAGR of 4.9% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 4.6% and 4.2% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.1% CAGR.

Global Systemic Mastocytosis Treatment Market - Key Trends & Drivers Summarized

Why Is Systemic Mastocytosis Gaining Attention in Precision Medicine?

Systemic mastocytosis (SM) is a rare, hematologic neoplasm characterized by abnormal accumulation of mast cells in various organs such as the skin, bone marrow, liver, and spleen. The disease ranges from indolent forms to aggressive subtypes, with symptoms caused by both organ infiltration and mast cell mediator release (e.g., histamine, tryptase). The complex clinical presentation, often involving anaphylaxis, gastrointestinal dysfunction, and bone pain, makes early diagnosis and personalized treatment essential. Advances in molecular diagnostics—particularly the identification of KIT D816V mutations—have allowed for more accurate disease classification and prognosis. As a result, SM is now at the forefront of targeted therapy development in rare oncology, with a growing number of tailored treatment options being explored and approved.

How Are Targeted Therapies Changing the Systemic Mastocytosis Treatment Landscape?

The introduction of tyrosine kinase inhibitors (TKIs) targeting the KIT mutation has redefined treatment strategies. Avapritinib, a selective inhibitor approved for advanced SM, has shown significant clinical benefit in terms of symptom relief and disease burden reduction. Midostaurin, another KIT-targeted therapy, remains a key treatment for aggressive and advanced forms. Combination therapies and novel agents—such as anti-IgE antibodies and mast cell stabilizers—are being evaluated for managing mediator-related symptoms and co-existing allergic conditions. Additionally, research into immunomodulatory drugs and newer kinase inhibitors is ongoing to address drug-resistant or smoldering SM variants. Personalized dosing strategies, based on mutation load and disease subtype, are further improving therapeutic outcomes and tolerability.

Where Is Treatment Access and Disease Monitoring Improving for SM Patients?

Specialized hematology and rare disease centers are implementing comprehensive SM care programs that combine genomic testing, multidisciplinary care, and longitudinal patient monitoring. Disease-specific scoring tools are being integrated into EHRs to guide therapy selection and track progression. Patient advocacy networks are collaborating with pharmaceutical companies to facilitate compassionate use and expanded access to investigational therapies. Digital platforms are supporting remote symptom tracking and treatment response, especially in countries with limited access to specialists. Increasing awareness among allergists, dermatologists, and oncologists is helping reduce diagnostic latency, a key barrier to timely intervention. The establishment of global SM registries is also improving clinical insight and informing policy development. 

The Growth in the Systemic Mastocytosis Treatment Market Is Driven by Several Factors…

It is driven by the availability of mutation-specific targeted therapies, advances in molecular diagnostics, and the expansion of rare disease treatment infrastructure. The approval and commercialization of KIT-targeting TKIs have opened a new therapeutic era for patients with advanced SM. Growing inclusion of SM in rare cancer reimbursement programs and orphan drug pipelines is improving treatment accessibility. Development of companion diagnostics and biomarker-guided monitoring tools is enhancing treatment precision and patient outcomes. Increased research funding, international clinical collaborations, and heightened physician awareness are collectively sustaining momentum in the systemic mastocytosis treatment landscape.

SCOPE OF STUDY:

The report analyzes the Systemic Mastocytosis Treatment market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Type (AK-002 Treatment, BLU-285 Treatment, Brentuximab Vedotin Treatment, Crenolanib Besylate Treatment, Other Treatments); Administration Route (Oral Administration, Injectable Administration, Topical Administration)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 44 Featured) -

• AB Science SA
• AbbVie Inc.
• Allakos Inc.
• AstraZeneca
• Bayer AG
• Blueprint Medicines Corp.
• Bristol-Myers Squibb Company
• Cogent Biosciences Inc.
• Deciphera Pharmaceuticals
• Eli Lilly & Company
• Glenmark Pharmaceuticals Ltd.
• Hoffmann-La Roche Ltd.
• Intas Pharmaceuticals Ltd.
• Johnson & Johnson
• Mallinckrodt Pharmaceuticals
• Merck & Co. Inc.
• Mylan NV (now Viatris)
• Novartis AG
• Pfizer Inc.
• Sanofi Aventis
• Teva Pharmaceutical Industries Ltd.

AI INTEGRATIONS
We`re transforming market and competitive intelligence with validated expert content and AI tools.

Instead of following the general norm of querying LLMs and Industry-specific SLMs, we built repositories of content curated from domain experts worldwide including video transcripts, blogs, search engines research, and massive amounts of enterprise, product/service, and market data.

TARIFF IMPACT FACTOR
Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by increasing the Cost of Goods Sold (COGS), reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

Please note: Reports are sold as single-site single-user licenses. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks. The Publisher uses digital controls protecting against copying and printing is restricted to one full copy to be used at the same location.

The latest version of Adobe Acrobat Reader is required to view the report. Upon ordering an electronic version, the Publisher will provide a link to download the purchased report.

Prior to fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher. Show more