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The Systemic Mastocytosis Treatment Market size is forecast to increase by USD 157.1 million, at a CAGR of 6.2% between 2023 and 2028. The market is witnessing significant growth due to the increasing aging population and advancements in diagnostic technologies for systemic mastocytosis. Immunomodulatory drugs, such as oral administration of prescription drugs like cromolyn sodium and sodium cromoglicate, are gaining popularity in the treatment of systemic mastocytosis. Clinical trials are underway to develop new drugs, including JAK inhibitors and monoclonal antibodies, to address the unmet medical needs of patients with this condition. The high cost associated with this treatment poses a challenge to patient compliance and accessibility. Hospital pharmacies play a crucial role in ensuring the availability and affordability of these prescription drugs to patients. Ensuring patient compliance through personalized medicine approaches, such as tailored dosing and administration schedules, is essential to improve treatment outcomes and reduce healthcare costs.
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The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.
The AK-002 segment is estimated to witness significant growth during the forecast period. The market encompasses various therapeutic interventions, with a focus on targeting the underlying genetic mutations that contribute to the disease. A key emerging player in this market is AK-002 (lirentelimab), a monoclonal antibody therapy that specifically binds to CD117, a cell surface receptor integral to mast cell growth and activation. This receptor, or c-Kit, is overactivated in systemic mastocytosis, leading to the proliferation and accumulation of mast cells, resulting in debilitating symptoms such as skin lesions, gastrointestinal issues, and anaphylactic reactions.
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The AK-002 segment was valued at USD 119.50 million in 2018. AK-002's mechanism of action involves inhibiting CD117, thereby reducing the abnormal proliferation and activation of mast cells. This targeted approach aims to alleviate symptoms and improve the quality of life for patients. Diagnosis typically involves a combination of blood tests, genetic testing, bone marrow biopsy, and imaging tests. Treatment options also include medications such as cromolyn sodium and ketotifen, which help prevent mast cell degranulation and reduce symptoms.
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North America is estimated to contribute 42% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. The market in North America is experiencing notable growth due to several factors, including an aging population, increasing healthcare expenditure, and a rising prevalence of related conditions. According to the Population Reference Bureau (PRB), the number of people aged 65 and older in the United States is projected to increase from 57.8 million in 2022 to 82 million by 2050, representing a 47% increase and a larger proportion of the total population. This demographic shift is expected to fuel demand, as older adults are more susceptible to various health conditions, including systemic mastocytosis. Diagnosis involves a combination of blood tests, genetic mutation analysis, bone marrow biopsy, and imaging tests. Treatment options include medications such as Cromolyn Sodium and Ketotifen, which help prevent mast cell degranulation and reduce symptoms. The market is expected to grow significantly in the coming years, driven by the increasing prevalence and the availability of effective treatment options.
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
A. Menarini Industrie Farmaceutiche Riunite Srl - The company offers ELZONRIS medicine through its subsidiary Stemline Therapeutics, which is involved in the development of systemic mastocytosis therapies.
Technavio provides the ranking index for the top 20 companies along with insights on the market positioning of:
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Market structure |
Fragmented |
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YoY growth 2023-2024 |
5.9 |
Systemic mastocytosis (ISM) is a rare disorder characterized by the proliferation and activation of mast cells in various organs, leading to symptoms such as skin lesions, itching, abdominal pain, and diarrhea. The epidemiology of ISM is not well established, but it is believed to affect approximately 1 in 100,000 people. Diagnosis of ISM involves a combination of clinical evaluation, medical diagnostic methods including blood tests, genetic mutation analysis, bone marrow biopsy, and medical imaging tests. The treatment market for ISM focuses on supportive care and symptom management. Antihistamines and other medications are used to manage symptoms such as itching and abdominal pain. Healthcare professionals are actively involved in clinical studies and drug development for ISM, exploring the use of immunomodulatory drugs and emerging treatments. The treatment algorithm for ISM is constantly evolving, with ongoing research into the disease definition, pathophysiology, and diagnostic methods. The ultimate goal is to develop effective and safe treatments for this rare condition. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
The growth of aging population is notably driving the market growth. It is a rare disorder characterized by the overproduction and abnormal functioning of mast cells, which are essential components of the immune system. This condition can manifest in various symptoms, including itching, skin lesions, and abdominal pain. The epidemiology of systemic mastocytosis is influenced by the aging population, as the number of older adults is increasing rapidly worldwide.
According to the World Health Organization (WHO), the proportion of the global population aged 60 years and above is projected to nearly double by 2050. In particular, this demographic shift is significant in Asian countries and North American nations, where the geriatric population is expected to quadruple by the end of this decade. As a result, the demand for effective treatments is anticipated to grow, driving the expansion of the market. Thus, such factors are driving the growth of the market during the forecast period.
Advancements in diagnostic technologies for systemic mastocytosis treatment are the key trend in the market. It is a rare disorder characterized by the overproduction and abnormal functioning of mast cells, leading to various symptoms such as itching, skin lesions, and abdominal pain. The epidemiology is not well understood, with an estimated prevalence of approximately 1 in 100,000 people. Diagnostic advancements have significantly impacted the management of this complex condition. Genetic testing plays a crucial role in identifying the underlying mutations, particularly in the KIT gene, which is responsible for the overproduction of mast cells.
The detection of specific mutations, including KIT D816V, facilitates personalized treatment approaches and aids in disease monitoring and prognostication. Recent diagnostic innovations have expanded the identification of mutational profiles beyond KIT D816V, providing a more comprehensive genomic understanding. This knowledge is essential in guiding the development of targeted therapies and refining prognostic assessments. Thus, such trends will shape the growth of the market during the forecast period.
The high cost associated with systemic mastocytosis treatment is the major challenge that affects the growth of the market. It is a rare disorder characterized by the abnormal proliferation of mast cells, resulting in various symptoms including itching, skin lesions, and abdominal pain. The epidemiology is complex, with an estimated prevalence of approximately 1 in 100,000 individuals. The diagnosis of this condition involves extensive diagnostic testing, including genetic and molecular diagnostic, which can be costly. The treatment process is individualized and often requires specialized care, leading to substantial expenses.
Novel therapeutic modalities, such as tyrosine kinase inhibitors (TKIs) and monoclonal antibodies, offer promising solutions but come with high price tags. For instance, midostaurin, a TKI used at a standard dose of 100 mg twice daily, has an annual cost of approximately USD 192,000. The high-cost burden associated with managing systemic mastocytosis presents a significant challenge for both patients and healthcare systems. Hence, the above factors will impede the growth of the market during the forecast period
The market forecasting report includes the adoption lifecycle of the market research and growth, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.
Customer Landscape
Systemic mastocytosis is a rare disorder characterized by the proliferation of mast cells in various organs, leading to a range of symptoms including skin lesions, itching, abdominal pain, and diarrhea. The epidemiology is not well understood, but it is estimated to affect fewer than 1 in 100,000 people. Diagnosis involves a combination of clinical symptoms, and diagnostic tests such as blood tests, bone marrow biopsy, and imaging tests. Genetic mutations in the KIT and D816V genes are commonly associated with the condition. Current treatment practices for systemic mastocytosis focus on symptom management and supportive care. Antihistamines and other medications such as cromolyn sodium and ketotifen are commonly used for symptomatic treatment. Targeted therapies, including immunomodulatory drugs and biomarker analysis, are emerging as potential treatments for systemic mastocytosis (ISM). Diagnostic technologies such as genetic testing and biomarker analysis are playing an increasingly important role in diagnosis and treatment.
Clinical studies and drug development are ongoing to explore new treatment options, including pipeline drugs and personalized medicine. The market is expected to grow due to the increasing number of diagnosed cases and the development of new treatments. Healthcare professionals are working to improve patient compliance and optimize treatment algorithms through the use of prescription drugs, oral administration, and hospital pharmacies. The pathophysiology involves the release of inflammatory mediators from mast cells, which leads to symptoms. Understanding the disease definition and diagnosis methods is crucial for effective treatment, and conventional therapies and marketed drugs continue to play a role in managing the condition. Bone marrow transplants are a potentially curative option for some patients.
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Market Scope |
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Report Coverage |
Details |
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Page number |
209 |
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Base year |
2023 |
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Historic period |
2018 - 2022 |
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Forecast period |
2024-2028 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 6.2% |
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Market Growth 2024-2028 |
USD 157.1 million |
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Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
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Performing market contribution |
North America at 42% |
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Key countries |
US, China, Germany, UK, France, Spain, Canada, Japan, South Korea, and India |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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Key companies profiled |
A. Menarini Industrie Farmaceutiche Riunite Srl, AB Science SA, AdvaCare Pharma, BDR Pharmaceuticals Internationals Pvt. Ltd, Blueprint Medicines Corp., Dr Reddys Laboratories Ltd., F. Hoffmann La Roche Ltd., Glenmark Pharmaceuticals Ltd., Intas Pharmaceuticals Ltd., Lupin Ltd., NOVA PHARMA LLC, Novartis AG, Ono Pharmaceutical Co. Ltd., Pfizer Inc., Sanofi SA, Sun Pharmaceutical Industries Ltd., Takeda Pharmaceutical Co. Ltd., and Zydus Lifesciences Ltd. |
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Market dynamics |
Parent market analysis, market growth inducers and obstacles, fast-growing and slow-growing segment analysis, AI impact on market trends, COVID-19 impact and recovery analysis and future consumer dynamics, market condition analysis for the market forecast period |
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Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
1 Executive Summary
2 Technavio Analysis
3 Market Landscape
4 Market Sizing
5 Historic Market Size
6 Qualitative Analysis
7 Five Forces Analysis
8 Market Segmentation by Type
9 Market Segmentation by Route of Administration
10 Customer Landscape
11 Geographic Landscape
12 Drivers, Challenges, and Opportunity/Restraints
13 Competitive Landscape
14 Competitive Analysis
15 Appendix
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