Myelodysplastic Syndromes (MDS) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Myelodysplastic Syndromes (MDS) Market Outlook

Thelansis’s “Myelodysplastic Syndromes (MDS) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Myelodysplastic Syndromes treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Myelodysplastic Syndromes (MDS) Overview

Myelodysplastic syndrome (MDS) comprises a group of myeloid hematological disorders distinguished by reduced blood cell counts, abnormalities in the bone marrow, and a significant risk of evolving into acute myeloid leukemia (AML). Clinical manifestations primarily result from low blood cell counts, predominantly anemia, leading to fatigue, shortness of breath, and potentially angina. Less frequently, MDS may manifest as thrombocytopenia, resulting in spontaneous bleeding or neutropenia, making individuals susceptible to bacterial or, in rarer cases, fungal infections. The underlying cause remains unknown in 80% of cases. In the remaining 20%, it may be attributed to acquired factors such as prior chemotherapy or radiation therapy, occupational exposure to benzene derivatives or ionizing radiation, or inherited factors, including gene mutations mainly involving DDX41, GATA2, RUNX, and telomerase genes, or DNA instability (notably seen in Fanconi anemia patients who are prone to developing MDS). MDS progresses into AML in approximately 30% of patients. The prognosis varies depending on several criteria evaluated using the IPSS-R and IPSS-M scoring systems. These criteria consider the number and significance of cytopenias, the percentage of blasts in the bone marrow, and cytogenetic abnormalities in the marrow. These scores categorize patients into lower-risk groups (primarily characterized by anemia and, less frequently, thrombocytopenia) and higher-risk groups (typically featuring severe cytopenias, including neutropenia). These categories are divided into five (IPSS-R) or six (IPSS-M) levels, ranging from very low risk (with a 2.8% risk of progressing to AML within four years) to very high risk (with a 42.8% risk of AML transformation within four years). The risk of developing MDS increases with age, with approximately 86% of newly diagnosed MDS patients in the United States being 60 years old on average (median age: 76 years). Management and treatment strategies are determined based on the prognostic score calculated using the revised International Prognostic Scoring System for Myelodysplastic Syndromes (IPSS-R).

• The incidence of MDS patients eligible for second-line therapy is estimated at 3 per 100,000 individuals, suggesting that approximately 9,500 people in the United States may be suitable candidates for second-line therapy for MDS annually.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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