Lower Risk Myelodysplastic Syndromes Market Set for Strong Growth to USD 7,052.79 Million by 2031, Led by North America's 43.5% Market Share | DataM Intelligence

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

Market growth is driven by the rising incidence of lower-risk MDS cases, particularly among aging populations, and increasing adoption of targeted therapies like lenalidomide and hypomethylating agents. Advancements in novel treatments such as luspatercept, expanding clinical pipelines from key players like Bristol-Myers Squibb and Novartis, growing R&D investments, and favorable regulatory approvals are further accelerating market expansion.
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United States: Key Industry Developments
✅ December 2025: Novartis received FDA accelerated approval for imetelstat (Rytelo) in lower-risk MDS patients with transfusion-dependent anemia, marking a novel telomerase inhibitor therapy after positive phase 3 results showed sustained transfusion independence.​

✅ October 2025: The FDA expanded label for luspatercept (Reblozyl) to include lower-risk MDS with ring sideroblasts, enhancing treatment options based on updated trial data demonstrating improved hemoglobin response rates.​

✅ August 2025: Bristol Myers Squibb announced phase 2 trial advancements for CC-90009 in lower-risk MDS, focusing on targeted apoptosis induction with promising early efficacy in anemia management.​

Asia Pacific / Japan: Key Industry Developments
✅ November 2025: Japan's PMDA approved generic azacitidine formulations for lower-risk MDS, improving access and affordability amid rising geriatric patient needs and national health policy support.​

✅ September 2025: Ono Pharmaceutical initiated a phase 3 trial for OPB-111077 in lower-risk MDS, targeting STAT3 inhibition to address ineffective hematopoiesis, with enrollment boosted by regional cancer registry expansions.​

✅ July 2025: Australia's TGA granted provisional approval for luspatercept in lower-risk MDS transfusion-dependent cases, aligning with Asia-Pacific harmonization efforts and increasing therapy adoption in high-incidence areas.

Key Merges and Acquistions:
✅ Major pharmaceutical firms expanded their portfolios in the Lower Risk Myelodysplastic Syndromes Market through strategic acquisitions of innovative therapy developers, enhancing treatment pipelines and clinical capabilities.​

✅ Leading biotech companies pursued targeted mergers to integrate novel hypomethylating agents and immunomodulatory platforms, strengthening their positions in personalized MDS therapeutics.​

✅ Global players collaborated on asset purchases and licensing deals for emerging lower-risk MDS candidates, driving R&D acceleration and market penetration in supportive care solutions.​​

Market Segmentation Analysis:
-Treatment Type
Hypomethylating agents (HMAs) like azacitidine lead with 28% share in 2024, favored for delaying progression to AML and improving survival in lower-risk MDS patients needing transfusion support. Lenalidomide captures 25%, targeting del(5q) subtype for red blood cell independence with oral convenience. Chemotherapy and supportive care split the rest at 25% and 22%, used for symptom management but limited by toxicity.​

-Route of Administration
Parenteral routes dominate at 60%, driven by IV/subcutaneous HMAs like azacitidine for reliable dosing in clinical oversight. Oral formulations hold 40%, gaining from lenalidomide's adherence benefits in outpatient lower-risk cases.​

-Age Group
Adults over 65 command 70% share, reflecting MDS incidence in elderly with comorbidities requiring tailored low-intensity therapies. Adults 18-64 take 25%, often fitter for oral agents; pediatrics under 5% due to rarity.​

-Distribution Channel
Hospital pharmacies lead with 50%, essential for supervised infusions in specialized hematology settings. Retail pharmacies follow at 30% for oral prescriptions; online at 20% via growing telehealth access.​

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Why is the Lower Risk Myelodysplastic Syndromes Market Growing?
The rapid expansion of the Lower Risk Myelodysplastic Syndromes (LR-MDS) market in 2026 stems from innovative therapies addressing unmet needs in anemia management and transfusion dependence.​

-Surging Demand for Anemia Treatments
Luspatercept's approval has transformed care for LR-MDS patients with anemia, reducing transfusion burdens and improving quality of life. Lenalidomide remains a cornerstone for del(5q) subtypes, sustaining demand through proven transfusion independence.​

-Robust Drug Pipeline
Pharma investments fuel next-generation therapies like oral hypomethylating agents and targeted immunomodulators, enhancing efficacy and tolerability. Late-stage trials for anti-anemics promise broader options beyond generics post-patent expiry.​

-Aging Population Impact
Rising MDS incidence among elderly demographics drives higher diagnosis rates and treatment needs globally. Emerging markets like Asia-Pacific amplify growth via expanding healthcare access.​

-AI and Precision Advances
AI diagnostics enable earlier detection and personalized regimens, optimizing outcomes in LR-MDS. Regulatory nods from FDA bolster clinical adoption and commercialization.​

Regional Insights:
-North America leads the Lower Risk Myelodysplastic Syndromes Market with the highest share at 43.5%, driven by advanced healthcare infrastructure, high R&D investments in novel therapies, and favorable regulatory approvals that accelerate access to treatments like luspatercept and imetelstat. The U.S. dominates within this region, supported by robust clinical trial networks and reimbursement policies.​

-Europe follows as the second-largest market, capturing around 28% share through established universal healthcare systems and EMA-aligned approvals for key drugs, with strong contributions from Germany, the UK, and France.​

-Asia Pacific ranks third with approximately 18% market share, fueled by rapid population aging, expanding healthcare access in China and Japan, and a projected CAGR of 7.7%, though it lags due to uneven infrastructure.​

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Key Players:
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 | Keros Therapeutics

Key Highlights (Top 5 Key Players) for Lower Risk Myelodysplastic Syndromes Market:
-Johnson & Johnson Services, Inc. develops and markets therapies targeting anemia and transfusion dependence in lower-risk MDS patients, advancing clinical programs for improved erythroid maturation.

-Amgen Inc. focuses on biologics that enhance red blood cell production, offering treatments superior to traditional erythropoiesis-stimulating agents for managing cytopenias.

-Bristol-Myers Squibb Company provides Reblozyl (luspatercept), an FDA-approved erythroid maturation agent that reduces transfusion burden in lower-risk MDS with ring sideroblasts.

-Novartis AG advances hypomethylating agents and supportive therapies to address bone marrow dysfunction and lower anemia risks in early-stage MDS populations.

-Pfizer Inc. develops oral and targeted immunomodulatory drugs aimed at delaying progression and improving quality of life for patients with lower-risk disease profiles.

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