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Myelodysplastic Syndrome Market Report 2032: Epidemiology, Therapies, Latest FDA, EMA, PDMA Approvals by DelveInsight

In 2020, the incident population of Myelodysplastic Syndrome in the 7MM was 41,600, asserts DelveInsight.

LAS VEGAS, NEVADA, UNITED STATES, April 4, 2024 / -- DelveInsight’s “Myelodysplastic Syndrome Market Insights, Epidemiology, and Market Forecast-2032″ report offers an in-depth understanding of the Myelodysplastic Syndrome Market, historical and forecasted epidemiology as well as the Myelodysplastic Syndrome Market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

To Know in detail about the Myelodysplastic Syndrome Market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Myelodysplastic Syndrome Market Forecast

Some of the key facts of the Myelodysplastic Syndrome Market Report:

The Myelodysplastic Syndrome Market size is anticipated to grow with a significant CAGR during the study period (2019-2032).
On November 03, 2022, Active Biotech announced that an abstract containing preclinical data on tasquinimod, a small molecule immunomodulator, in myelodysplastic syndrome (MDS) had been accepted for presentation at the 64th American Society of Hematology (ASH 2022) Annual Meeting, which will be held in New Orleans, Louisiana, from December 10-13, 2022.
On October 31, 2022, Bristol-Myers Squibb announced that the COMMANDS study, a Phase III, open-label, randomized trial evaluating Reblozyl® (luspatercept-aamt), met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in RBC-TI with concurrent hemoglobin (Hb) increase in the first-line treatment of adult patients with very low-, low-, or intermediate-risk MDS).
On September 13, 2022, I-Mab announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with China’s National Medical Products Administration (NMPA) and has received approval from the CDE to begin a Phase III registrational trial evaluating lemzoparlimab (HR-MDS).
In April 2022, Jasper Therapeutics announced updated data from the Phase I Clinical Trial of JSP191 as a Targeted stem CellConditioning Agent in older patients with Myelodysplastic Syndrome or Acute Myeloid leukemia undergoing hematopoietic cell transplantation.
In February 2022, the FDA granted orphan drug designation to tamibarotene for the treatment of MDS. The company also initiated a pivotal trial in Newly diagnosed HR-MDS (SELECT-MDS-1 Trial) and mid clinical study in Newly diagnosed unfit AML (SELECT-AML-1 Trial).
As per DelveInsight, the Myelodysplastic Syndrome Market is expected to expand at a healthy growth rate during the forecast period (2023-2032), owing to the launch of new therapies in the market and the rise in the number of cases.
Key Myelodysplastic Syndrome Companies: Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, and others
Key Myelodysplastic Syndrome Therapies: Reblozyl, Inqovi, Roxadustat, Venclexta (Venetoclax) + Azacitidine, Magrolimab ± Azacitidine, SY-1425 + Azacitidine, Pevonedistat ± Azacitidine, Glasdegib + Azacitidine, and others
In 2020, the incident population of Myelodysplastic Syndrome in the 7MM was 41,586.
Epidemiology assessed for Myelodysplastic Syndrome showed that the US, in 2020, accounted for approximately 20,428 incident cases of Myelodysplastic Syndrome.
In the United States, in 2020, there were 240, 1,070, 3,654, 7,283, and 8,181 cases, in the age groups 0–49 years, 50–59 years, 60–69 years, 70–79 years, and 80+ years, respectively.
As per the estimates, in the United States, there were 6,741, 1,021, 2,043, 6,333, 3,064, and 1,226 cases of RAEB/MDS-EB, del(5q) MDS, MDS-RS/RARS, MDS-MLD/RCMD, MDS-SLD/RCUD, and MDS-U subtypes in 2020, respectively.
In 2020, there were 4,903, 2,043, 817, 2,043, 2,554, 1,839, 4,086, 2,860, 817, and 1,021 cases, for the mutation SF3B1, SRSF2, U2AF1, DNMT3A, RUNX1 TP53, TET2, ASXL1, ZRSR2, and IDH2 respectively, in the US.
In the US, based on the IPSS scoring, Low-risk Myelodysplastic Syndrome and High-risk Myelodysplastic Syndrome accounted for the highest and lowest cases, respectively, in 2020. On the other hand, based on the IPSS-R scoring, Low-risk Myelodysplastic Syndrome and Very high-risk Myelodysplastic Syndrome accounted for the highest and lowest cases, respectively, in 2020.
Among the EU-5 countries in 2020, Germany had the highest incident population of Myelodysplastic Syndrome patients with 4,515 cases, followed by France (4,371) and UK (3,302). In contrast, Spain had the lowest cases (2,010) in 2020.
As per the estimates, Japan accounted for 3,909 incident Myelodysplastic Syndrome cases in 2020.
The Myelodysplastic Syndrome Market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Myelodysplastic Syndrome pipeline products will significantly revolutionize the Myelodysplastic Syndrome Market dynamics.

Myelodysplastic Syndrome Overview

Myelodysplastic syndrome (MDS) is a diverse group of blood disorders characterized by abnormal development and ineffective production of blood cells in the bone marrow, stemming from clonal abnormalities in hematopoietic stem cells. In MDS, bone marrow cells fail to mature into functional blood cells and remain immature within the bone marrow. The condition encompasses various subtypes, ranging from mild to severe, with some cases posing a high risk of progressing to acute myelogenous leukemia (AML). The severity and subtype of MDS depend on factors such as the degree of blood cell deficiency and genetic alterations in bone marrow cells. MDS, along with aplastic anemia (AA) and paroxysmal nocturnal hemoglobinuria (PNH), belongs to the category of bone marrow failure disorders, where the marrow fails to produce sufficient quantities of healthy red blood cells, white blood cells, and platelets, or produces defective ones, resulting in inadequate blood supply to the body.

MDS can either occur spontaneously (de novo) or be induced by prior exposure to chemotherapy or other treatments, known as treatment-related MDS (t-MDS). The exact causes of de novo MDS are not fully elucidated but are thought to arise from an oncogenic process leading to somatic mutations. Advances in gene sequencing technology have provided valuable insights into the genetic mutations commonly associated with MDS. Researchers can now identify driver mutations in a significant portion (up to 80─90%) of MDS patients, with notable mutations including SF3B1, TET2, SRSF2, ASXL1, DNMT3A, RUNX1, U2AF1, TP53, and EZH2. For instance, the RUNX1 mutation is known to disrupt normal blood cell formation. More than 100 genes are recurrently mutated in MDS, encoding various components such as spliceosomes, chromatin remodelers, epigenetic regulators, and transcription factors, among others.

Myelodysplastic Syndrome Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2019 to 2032. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Myelodysplastic Syndrome Epidemiology Segmentation:

The Myelodysplastic Syndrome Market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
Total Myelodysplastic Syndrome Incident Population
Age-specific Incident Population of Myelodysplastic Syndrome
Subtype-specific Incident Population of Myelodysplastic Syndrome
Risk-specific Incident Population of Myelodysplastic Syndrome
Mutation-specific Incident Population of Myelodysplastic Syndrome

Download the report to understand which factors are driving Myelodysplastic Syndrome epidemiology trends @ Myelodysplastic Syndrome Epidemiology Forecast

Myelodysplastic Syndrome Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Myelodysplastic Syndrome Market or expected to get launched during the study period. The analysis covers Myelodysplastic Syndrome uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Myelodysplastic Syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Myelodysplastic Syndrome Therapies

Venclexta (Venetoclax) + Azacitidine
Magrolimab ± Azacitidine
SY-1425 + Azacitidine
Pevonedistat ± Azacitidine
Glasdegib + Azacitidine

Myelodysplastic Syndrome Key Companies

Bristol-Myers Squibb
Astex Pharmaceutical
Taiho Oncology
Gilead Sciences
Syros Pharmaceuticals
Geron Corporation
Karyopharm Therapeutics
Antengene Corporation
BerGenBio ASA
Jazz Pharmaceuticals
Aprea Therapeutics

Discover more about therapies set to grab major Myelodysplastic Syndrome market share @ Myelodysplastic Syndrome Treatment Landscape

Myelodysplastic Syndrome Treatment Market

The current treatment options available for patients with Myelodysplastic Syndrome (MDS) include allo-HSCT (allogeneic hematopoietic stem cell transplantation) and a range of non-intensive therapies. These non-intensive therapies encompass interventions such as iron chelation, growth factors, lenalidomide, and hypomethylating agents (HMA). While allo-HSCT stands as the sole curative treatment for MDS patients, other therapeutic approaches focus on enhancing quality of life and slowing disease progression.

Chemotherapeutic agents like azacitidine (Vidaza) or decitabine (Dacogen) are commonly prescribed as initial treatments, particularly for individuals with lower-risk forms of MDS. In certain cases, immunosuppressive medications such as ATG and cyclosporine may be utilized. Lenalidomide (Revlimid), an FDA-approved medication, is often the first-line therapy for patients with MDS and the del(5q) mutation. Additionally, Reblozyl, an erythroid maturation agent, is FDA-approved for the second-line treatment of MDS in patients who have previously received erythropoiesis-stimulating agents (ESA).

Beyond the current treatment options, the MDS pipeline shows promise with several potential medications in various stages of development. These include FibroGen's roxadustat, AbbVie's Venclexta in combination with azacitidine, Novartis's sabatolimab, and Syros Pharmaceuticals' SY-1425 combined with azacitidine, among others. The anticipated launch of these therapies has the potential to expand the MDS market in the future, especially considering the projected increase in the MDS patient population.

Myelodysplastic Syndrome Market Dynamics

The Myelodysplastic Syndrome (MDS) market is experiencing growth due to the availability of diverse treatment options, including curative, supportive, and symptomatic therapies, which are readily accessible along with their generic versions. Additionally, numerous studies have underscored the significance of multiple gene mutations such as RUNX1, TP53, TET2, DNMT3A, ASXL1, among others, in MDS. Emerging therapies like Syros Pharma's SY-1425 and BMS' Enasidenib are being developed as targeted treatments for patients with specific genetic mutations, such as RARA positivity and IDH-2 mutations, respectively. These targeted therapies represent a promising avenue for companies involved in MDS treatment development.

Nevertheless, several factors may impede the growth of the Myelodysplastic Syndrome market. Firstly, there is a lack of up-to-date evidence and analysis regarding the prescription patterns of drugs for MDS patients in EU5 countries, which could hinder market expansion. Moreover, MDS predominantly affects elderly individuals, and many of these patients may not be eligible for allogeneic hematopoietic stem cell transplantation (HSCT), the only current curative option. Additionally, some MDS patients receiving treatment with hypomethylating agents (HMA) may experience treatment failure, limiting their subsequent treatment options. Furthermore, upcoming therapies may face competition from established MDS treatments and numerous other therapies in the pipeline. The considerable cost associated with treating MDS may also pose a threat to the overall MDS market.

Scope of the Myelodysplastic Syndrome Market Report

Study Period: 2019–2032
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Myelodysplastic Syndrome Companies: Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, and others
Key Myelodysplastic Syndrome Therapies: Reblozyl, Inqovi, Roxadustat, Venclexta (Venetoclax) + Azacitidine, Magrolimab ± Azacitidine, SY-1425 + Azacitidine, Pevonedistat ± Azacitidine, Glasdegib + Azacitidine, and others
Myelodysplastic Syndrome Therapeutic Assessment: Myelodysplastic Syndrome Market current marketed and Myelodysplastic Syndrome Market emerging therapies
Myelodysplastic Syndrome Market Dynamics: Myelodysplastic Syndrome Market drivers and Myelodysplastic Syndrome Market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
Myelodysplastic Syndrome Unmet Needs, KOL’s views, Analyst’s views, Myelodysplastic Syndrome Market Access and Reimbursement

Table of Contents

1. Myelodysplastic Syndrome Market Report Introduction
2. Executive Summary for Myelodysplastic Syndrome Market
3. SWOT analysis of Myelodysplastic Syndrome Market
4. Myelodysplastic Syndrome Patient Share (%) Overview at a Glance
5. Myelodysplastic Syndrome Market Overview at a Glance
6. Myelodysplastic Syndrome Disease Background and Overview
7. Myelodysplastic Syndrome Epidemiology and Patient Population
8. Country-Specific Patient Population of Myelodysplastic Syndrome Market
9. Myelodysplastic Syndrome Current Treatment and Medical Practices
10. Myelodysplastic Syndrome Unmet Needs
11. Myelodysplastic Syndrome Emerging Therapies
12. Myelodysplastic Syndrome Market Outlook
13. Country-Wise Myelodysplastic Syndrome Market Analysis (2019–2032)
14. Myelodysplastic Syndrome Market Access and Reimbursement of Therapies
15. Myelodysplastic Syndrome Market Drivers
16. Myelodysplastic Syndrome Market Barriers
17. Myelodysplastic Syndrome Market Appendix
18. Myelodysplastic Syndrome Market Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight

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Myelodysplastic Syndrome Pipeline

"Myelodysplastic Syndrome Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Myelodysplastic Syndrome Market. A detailed picture of the Myelodysplastic Syndrome pipeline landscape is provided, which includes the disease overview and Myelodysplastic Syndrome treatment guidelines.

Myelodysplastic Syndrome Epidemiology

DelveInsight's 'Myelodysplastic Syndrome Epidemiology Forecast to 2032' report delivers an in-depth understanding of the disease, historical and forecasted Myelodysplastic Syndrome Market epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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