Global Lower Risk Myelodysplastic Syndromes (MDS) Market - 2024-2031

Overview

The Global Lower-Risk Myelodysplastic Syndromes (MDS) Market reached US$ 3,362.85 million in 2023 and is expected to reach US$ 7,052.79 million by 2031, growing at a CAGR of 9.7% during the forecast period 2024-2031.

Myelodysplastic syndromes (MDS) are heterogeneous groups of conditions resulting from hematopoietic stem cell disorders and characterized by decreased production of blood cells, and cytopenia ultimately leading to acute myeloid leukemia, especially in high-risk and very high-risk patients. According to the Revised International Prognostic Scoring System (IPSS-R), if the prognosis score is less than 3, then MDS is categorized as low-risk MDS.

Market Dynamics: Drivers

Rising product development activities and approval of novel therapies

The market for low-risk myelodysplastic syndromes (MDS) is driven by rising research and development activities for novel therapies and subsequent approval of these therapies for clinical use. These novel therapies are aimed at majorly treating the life-threatening symptoms of MDS such as anemia, and cytopenias. The chances of novel therapies receiving fast-track designations and approvals by regulatory bodies are higher if the therapy seems promising as compared to the existing ones.

For instance, in June 2024, the U.S. Food and Drug Administration (FDA) approved RYTELO (imetelstat) for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia. RYTELO developed by Greon is a novel therapy for lower-risk MDS patients which acts as a oligonucleotide telomerase inhibitor. The FDA approval of RYTELO is based on results from the IMerge Phase 3 clinical trial and the drug is currently available for U.S. patients.

Moreover, in August 2024, the U.S. Food and Drug Administration (FDA) approved Reblozyl (luspatercept-aamt) as the first-line treatment of anemia in adults with lower-risk myelodysplastic syndromes (MDS) who require frequent transfusions. Reblozyl was developed by Bristol Myers Squibb through a global collaboration with Merck. Reblozyl acts as an erythroid maturation agent thereby increasing erythropoiesis.

In addition, several other novel drugs are currently in the different phases clinical pipeline, which have the potential to enter the market and revolutionize the treatment of low-risk MDS. For instance, Keros Therapeutics is conducting phase 2 clinical trials for Elritercept (KER-050), an activin receptor type IIA-Fc fusion protein being developed to treat low blood cell counts, cytopenias in low-risk MDS patients, and myelofibrosis patients. The drug received fast-track designation by the U.S. Food and Drug Administration (FDA) in March 2014.

Moreover, the rising prevalence of myelodysplastic syndromes and, the development of novel diagnostic techniques will help to identify the proper target population and subsequently improve the treatment rate.

Restraints

The market for lower-risk myelodysplastic syndromes (MDS) is restrained by factors such as the heterogeneity of patients and their clinical presentations, and the high cost of treatment. Patients with Lower-risk MDS often present with different symptoms which vary from person to person. This requires a tailoring treatment regimen for individual patient requirements. This may be challenging to make effective clinical decisions.

Market Segment Analysis

The global lower-risk myelodysplastic syndromes market is segmented based on treatment type, route of administration, age group, distribution channel, and region.

The erythropoiesis-stimulating agents (ESAs) in the treatment type segment accounted for approximately 65.4% of the global lower-risk myelodysplastic syndromes (MDS) market

The current mainstay treatment for low-risk myelodysplastic syndromes (MDS) is to control anemia and cytopenias - the two major life-threatening manifestations. In these patients, progressive anemia is a severe complication that needs to be addressed by frequent blood cell transfusions. However, this may put the patient at risk of iron overload and severe transfusion reactions, which can hinder the quality of life of the patient.

Hence to decrease the dependency on transfusions, erythropoiesis-stimulating agents are recommended as first-line agents in many patients suffering from anemia. According to the American Society of Hematology, ESA therapy is the preferred choice of treatment for the management of patients who are transfusion-dependent. Overall 20% to 40% of patients respond to ESA therapy if given for a duration of 18- to 24-months.

The approved agents include epoetin alfa and darbepoetin alfa, manufactured under the brand names Epogen, Procrit, and Aranesp. These agents act by the same mechanism as endogenous erythropoietin.

However, ESAs may get replaced as first-line agents by a novel therapy called luspatercept that was recently approved by the U.S. FDA. But, considering the long-term existence of ESAs in the market, their wide adoption, and affordability, puts them as mainstay therapeutic options with a significant market share in the forecast period.

Market Geographical Analysis

North America is expected to dominate the market with a share of 43.5% in the global lower-risk myelodysplastic syndromes (MDS) market

North America's dominance in the global lower-risk myelodysplastic syndromes (MDS) market is contributed by factors such as advanced healthcare infrastructure, availability of advanced therapeutic options, high-level R&D activities involving novel therapies discovery, product development efforts by manufacturers, and favorable regulatory scenarios.

Moreover, the manufacturers having a strong portfolio, have established a strong market position in the region. These manufacturers generate the majority of their product revenue from North America, especially from the U.S.

The development activities by manufacturers and support provided by the regulatory bodies to encourage innovations are one of the major contributors to the availability of advanced therapies in the United States. This favorable scenario also benefits the patient population, as they receive first-hand access to these advanced therapies.

For instance, the drug luspatercept (Reblozyl) an erythroid maturation agent is being considered to be superior to the first-line treatment option i.e., erythropoiesis-stimulating agents are first approved and marketed in the U.S.

Market Segmentation

By Treatment Type

Erythropoiesis-Stimulating Agents (ESAs)

Epoetin Alfa

Darbepoetin Alfa

Red Blood Cell Transfusion

Erythroid Maturation Agents

Demethylating Agents

Azacitidine

Decitabine

Immunosuppressive Agents

Antithymocyte Globulin

Cyclosporine

Others

Immunomodulatory Agents (Lenalidomide)

Telomerase Inhibitors

Others

By Route of Administration

Oral

Parenteral

Subcutaneous

Intravenous

Others

By Age Group

Adults

Geriatrics

By Distribution Channel

Hospital Pharmacies

Specialty Pharmacies

By Region

North America

The U.S.

Canada

Mexico

Europe

Germany

U.K.

France

Spain

Italy

Rest of Europe

South America

Brazil

Argentina

Rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major players in the lower-risk myelodysplastic syndromes (MDS) market include Johnson & Johnson Services, Inc., Amgen Inc., Bristol-Myers Squibb Company, Pfizer Inc., Sanofi-Aventis U.S. LLC., AbbVie Inc., Novartis AG, Otsuka Pharmaceutical Co., Ltd, Geron. and Keros Therapeutics among others.

Why Purchase the Report?

To visualize the global lower-risk myelodysplastic syndromes (MDS) market segmentation based on treatment type, route of administration, age group, distribution channel, and region as well as understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development

Excel data sheet with numerous data points of lower risk myelodysplastic syndromes (MDS) market-level with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping available as Excel consisting of key products of all the major players.

The global lower-risk myelodysplastic syndromes (MDS) market report would provide approximately 70 tables, 64 figures, and 187 Pages.

Target Audience 2024

Manufacturers/ Buyers

Industry Investors/Investment Bankers

Research Professionals

Emerging Companies