Myelodysplastic Syndrome (MDS) Treatment Market Size, Competitive Landscape and Market Forecast - 2029

Global Myelodysplastic Syndrome (MDS) Treatment Market is segmented By Treatment Type (Stem Cell Transplant, Immune Treatments, Chemotherapy (Hypomethylating Agents (Azacitidine (Vidaza), Decitabine (Dacogen)), Immunomodulatory Drugs (Lenalidomide (Revlimid), Others), Anti-anemics (Luspatercept-AAMT (REBLOZYL®), Others), Others (Cytarabine (Cytosar-U), Daunorubicin (Cerubidine), Idarubicin (Idamycin), INQOVI® (ASTX727))), Growth factors, Others), By End-User (Hospitals, Specialty Clinics, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2022-2029

 

Market Overview

The Global Myelodysplastic Syndrome (MDS) Treatment Market is expected to grow at a high CAGR of 8.9% during the forecasting period (2022-2029).

Myelodysplastic Syndrome (MDS), also referred to as a “bone marrow failure disorder” is a type of bone marrow disorder, in which the bone marrow does not produce enough healthy blood cells. These disorders are characterized by ineffective hematopoiesis, including abnormalities in proliferation, differ­entiation, and apoptosis. This syndrome usually affects the geriatric population and more often in older men than women. MD syndrome is characterized by specific chromosomal mutations in the Janus Kinase gene, that include deletion of q arm in one or more chromosomes and complete the deletion of chromosome 5 or 7 and an extra copy of chromosome 8. MDS is diagnosed through several techniques including blood count, peripheral blood smear test, microscopic exams, cytochemistry, flow cytometry, immunotherapy, cytogenetics, FISH, and PCR. The MDS International Foundation is a nonprofit health organization that provides psychological support as well as funding to patients for treatment of the disorder.

Market Dynamics

The global myelodysplastic syndrome (MDS) treatment market growth is driven by several factors such as the rising geriatric population, growing awareness, the emergence of novel therapeutics, government initiatives to provide target-specific treatments, and favorable reimbursement policies.

Myelodysplastic syndrome is one of the most common malignant hematological diseases that occur at a rate of 4.8 cases for every 100,000 people. About 60,000 people in the U.S. live with MDS, and over 13,000 new cases are reported annually as per American Cancer Society data. The new cases diagnosed each year are increasing as the average age of the population increases. Patients may present with clinical manifestations such as anaemia, thrombocytopenia, and neutropenia.

The MDS treatment market is expected to grow significantly during the forecast period, owing to the increasing pipeline drugs, drug approvals, and R&D investments in the development of novel drugs for myelodysplastic syndrome. For instance, in July 2020, the U.S. Food and Drug Administration approved Inqovi (decitabine and cedazuridine) tablets for the treatment of adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML). This is an important advancement in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy.

Also, in 2018, Lupin received approval for its Decitabine for injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Otsuka Pharmaceutical Co. Ltd's Dacogen for Injection, 50 mg/vial, single-dose vial.

However, the side effects associated with chemotherapy medications and the high cost of therapeutics are expected to hamper the growth of the myelodysplastic syndrome treatment market.

Segment Analysis

Based on treatment type, the myelodysplastic syndrome (MDS) market is classified into chemotherapy, stem cell transplant, immune treatments, growth factors, and other treatments. Among these, the stem cell transplant (SCT) segment is expected to grow significantly over the forecast period. Stem cell transplantation offers a potentially beneficial therapy for patients with myelodysplastic syndromes. There are two major types of SCT, one is an allogeneic stem cell transplant and the other is an autologous stem cell transplant. For an allogeneic stem cell transplant, after the bone marrow is destroyed, the patient receives blood-forming stem cells from another person, the donor. This is the type of transplant typically used for MDS. In an autologous stem cell transplant, the patients get back their stem cells (which were removed before treatment). This type of transplant is not typically used for patients with MDS because the patient's bone marrow contains abnormal stem cells.

The chemotherapy segment is further segmented based on drug class such as hypomethylating agents, immunomodulatory drugs, and anti-anemics

MDS drugs are divided into the following therapeutic classes: hypomethylating agents, immunomodulatory drugs, and anti-anemics. Among these, immunomodulatory drugs accounted for the largest market share in 2019, due to the growing adoption of therapeutics and lack of generic competition. Currently, Revlimid (lenalidomide) is the only one approved for the treatment of low-risk MDS and myelodysplastic syndrome with isolated del(5q). Lenalidomide is considered an immunomodulatory agent. This means it can enhance the activity of immune cells and reduce inflammation. This slows the growth of abnormal bone marrow cells. In addition, it improves the way certain white blood cells work and is thought to slow the growth of new blood vessels that feed the MDS cells. Lenalidomide (Revlimid®) is approved for treating MDS patients with isolated del(5q) MDS subtyped who are transfusion-dependent (still need blood transfusions) and have a low or intermediate-1 risk IPSS (International Prognostic Scoring System) score. Research studies are currently looking at how well lenalidomide works for patients with other MDS subtypes.

Hypomethylating agents such as Celgene's Vidaza and Otsuka's Dacogen are used as first-line treatments for patients with high-risk myelodysplastic syndrome. This segment is forecast to witness a steep fall in market share due to patent expirations of both the aforementioned drugs, which has led to the launch of several generics in the market.

In recent years, demand for hypomethylating agents has been at a high due to the approval and adoption of Vidaza and Dacogen. A strong pipeline including Aranesp is expected to boost the market growth in the near future. Easy availability and access to novel treatments in major countries provide strong commercial opportunities to the market. Azacitidine is in a class of medicines called hypomethylating agents. Drugs in this class help prevent the growth of abnormal bone marrow stem cells. Azacitidine was the first medicine approved by the U.S. Food and Drug Administration (FDA) specifically to treat MDS. It is approved to treat both low- and high-risk patients with all subtypes of MDS. Decitabine is in a class of medicines called hypomethylating agents. Drugs in this class help prevent the growth of abnormal bone marrow stem cells. Decitabine, like azacitidine, is approved by the U.S. Food and Drug Administration (FDA) specifically to treat MDS. It is approved to treat both low- and high-risk patients with all subtypes of MDS.

The anticipated launch of Celgene's luspatercept and Amgen's Aranesp in 2019 are projected to significantly fuel the anti-anemics drug segment. Both are under investigation in late-stage clinical trials for the treatment of the myelodysplastic syndrome. Recent study outcomes have demonstrated that they successfully increased RBC count in the blood, thus reducing the need for frequent blood transfusions. Luspatercept-aamt is the first erythroid maturation agent (EMA) approved by the US Food and Drug Administration and European Union for the treatment of anemia in adult patients with myelodysplastic syndromes (MDS) who have been failed an erythropoiesis-stimulating agent (ESA) or are unlikely to respond to an ESA, and are requiring transfusions of 2 or more red blood cell (RBC) units over 8 weeks.

The U.S. Food and Drug Administration (FDA) has approved four drugs to treat MDS:

• Azacitidine (Vidaza) for both low- and high-risk patients with all subtypes of MDS
• Decitabine (Dacogen) for both low- and high-risk patients with all subtypes of MDS
• Lenalidomide (Revlimid) for transfusion-dependent MDS patients with isolated del(5q) and with a low or intermediate-1 risk IPSS score
• Luspatercept-aamt (REBLOZYL) for adult MDS patients with ring sideroblasts (MDS-RS) or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T), who have been failed an erythropoiesis-stimulating agent (ESA) or are unlikely to respond to an ESA, and are requiring transfusions of 2 or more red blood cell (RBC) units over 8 weeks.
• INQOVI (previously known as ASTX727) for adult patients with MDS or CMML who are intermediate-1, intermediate-2, and high-risk IPSS groups including previously treated and untreated, de novo and secondary MDS including patients with refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts and CMML.

 

Geographical Analysis

North America region is dominating the global myelodysplastic syndrome treatment market accounted for the largest market share in 2019, owing to rising prevalence, high R&D investments in the development of novel drugs, and the presence of advanced healthcare infrastructure. It is one of the most common malignant hematological diseases that affects five out of every 100,000 people in the U.S. annually. An estimated 60,000 people in the U.S. live with MDS, and approximately 10,000-15,000 new cases are reported each year.

In December 2019, Bristol-Myers Squibb and Acceleron Pharma announced that the FDA Advisory Committee would review Reblozyl (luspatercept-aamt) for use in patients with myelodysplastic syndrome.

Asia-Pacific is expected to experience lucrative growth in the global myelodysplastic syndrome treatment market due to the developing healthcare infrastructure, rapidly improving economic conditions, and a promising regulatory environment for new treatment. In September 2019, Astellas Pharma Inc. and FibroGen, Inc announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved Evrenzo® (generic name: roxadustat) for the treatment of anemia associated with chronic kidney disease (CKD) in dialysis patients. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe and Phase 2/3 development in China for anemia associated with myelodysplastic syndromes.

 

Competitive Landscape

The myelodysplastic syndrome (MDS) treatment market is moderately competitive and consists of several major players.   Some of the key players which are contributing to the growth of the market include AbbVie, Otsuka America Pharmaceutical Inc., Accord Healthcare Ltd., Novartis, Bristol-Myers Squibb, Takeda Pharmaceutical Company Limited, Onconova Therapeutics, Celgene Corporation, Sandoz, Inc., Dr. Reddy's Laboratories, Inc., among others.

The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the myelodysplastic syndrome (MDS) treatment market globally. For instance,

• In July 2020, Takeda Pharmaceutical Company announced the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS).
• In March 2020, Gilead Sciences, Inc. and Forty-Seven, Inc. have entered into a definitive agreement pursuant to which Gilead will acquire Forty Seven for $95.50 per share in cash. Through the addition of Forty Seven’s investigational lead product candidate, magrolimab. Magrolimab is a monoclonal antibody in clinical development for the treatment of several cancers for which new, transformative medicines are urgently needed, including myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), and diffuse large B-cell lymphoma (DLBCL).
• In June 2019, Celgene Corporation and Acceleron Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene’s Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions.

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