LAS VEGAS, March 8, 2022 /PRNewswire/ -- There has been a mediocre success with the approval of novel agents in Myelodysplastic Syndrome (MDS), where the patients had to wait for more than 13 years after the last approval of lenalidomide (Revlimid), which is only approved for 5–10% (del 5q mutations only) of total MDS patients. Since then, only two companies (Celgene and Astex) could make up for the approval for this rare disease. In April 2020, the US FDA approved Reblozyl (Celgene Corporation) for the treatment of anemia failing an ESA in adult patients with very low- to intermediate-risk MDS with ring sideroblasts (MDS-RS). Reblozyl has already achieved more than satisfactory sales since its launch, and as per DelveInsight's analysis, we estimate this drug to be a blockbuster therapy at its peak year considering the fact that BMS and Acceleron Pharma have also planned to launch the drug in the first-line setting for MDS after a final data readout in the year by late 2022.
As far as emerging pipeline is concerned, most of the pharma companies are focused on developing their drugs for the newly diagnosed patient pool (first-line) since 30–40% first-line patient pool progresses to acute myeloid leukemia (AML). Since azacitidine/decitabine are the only Hypomythylating agents (HMAs) approved either for low or high-risk MDS, and even the current pipeline is devoid of any emerging HMAs, therefore we do not expect any of the emerging therapies to completely replace azacitidine. Instead based on the positive results of azacitidine as a combination treatment option with the emerging therapies, we can hope for the emergance of combination therapies for MDS.
DelveInsight's "Myelodysplastic Syndrome (MDS) Market" report provides a thorough comprehension of the Myelodysplastic Syndrome historical and forecasted epidemiology and the Myelodysplastic Syndrome market trends in the 7MM [the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan]. The Myelodysplastic Syndrome market report also proffers an analysis of the current Myelodysplastic Syndrome treatment algorithm/practice, market drivers, market barriers, and unmet medical needs.
Some of the necessary takeaways from the Myelodysplastic Syndrome Market Research Report
- Several key pharmaceutical companies, including 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, are developing novel products to improve the Myelodysplastic Syndrome treatment outlook.
- Companies such as Bristol Myers Squibb, Aprea Therapeutics, Geron Corporation, and others are developing therapies targeting specific mutations like TP53, IDH2, RARA, etc. This will provide more precise treatment for Myelodysplastic Syndrome patients not responding or having poor outcomes toward the current standard of treatment.
- Myelodysplastic Syndrome market to grow because of the increasing disease awareness programs, development of therapies for the second-line setting, robust pipeline activity, potential of upcoming therapies. However, the growth of the Myelodysplastic Syndrome market will be impeded by lack of MDS treatment pattern studies, underdiagnosis of disease, the high-cost burden for MDS treatment, and progression of patients toward AML.
- Few late stage therapies with Breakthrough therapy designations for MDS include: Abbvie's Venclexta (Venetoclax), Gilead Sciences' Magrolimab and Takeda's Pevonedistat. Venclexta is already approved for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and newly-diagnosed (AML), and we expect the company to get an edge while occupying more of the market share in blood cancer through MDS as well. Another rival geared up in the field is Gilead Sciences, investigating Magrolimab (anti-CD47 Monoclonal Antibody) in combination with azacitidine for treatment-naïve intermediate, high, and very high-risk MDS.
- During ASH 2021, Takeda's Pevonedistat plus azacitidine combination interim results did not appear to improve outcomes compared with azacitidine alone among patients with HR-MDS, CMML, or AML. Even after the dissapointing interim results, the company is looking forward to the full data set for further guidance.
- Apart from these therapies receiving breakthrough designations, another leading candidate, Sabatolimab (MBG453), by Novartis is a humanized anti-TIM-3 IgG4 antibody that is in the late phase of development for the treatment of MDS, AML, and other malignancies.
- Not just for the first-line segment, a handful of companies are also exploring their drug candidates for the second-line pool, such as Karyopharm Therapeutics/Antengene Corporation, Bristol Myers Squibb, and others.
- In an era where we have a bunch of chimeric antigen receptor therapies (CAR-T cells) being tried in almost every hematological cancer, there is just one company that is focused on working for MDS, Celyad Oncology, who are evaluating the next-generation NKG2D-based CAR-T candidate for the treatment of R/R AML/MDS
For further information on Market Impact by Therapies, visit: Myelodysplastic Syndrome Drugs Market Analysis
Myelodysplastic Syndrome (MDS) is a heterogeneous group of hematologic neoplasms classically described as a clonal disorder of hematopoietic stem cells leading to dysplasia and ineffective hematopoiesis in the bone marrow.
DelveInsight estimates that the total Myelodysplastic Syndrome incident population in the 7MM was 41,586 cases in 2020. Also, the disease is more common in men as compared to women.
The Myelodysplastic Syndrome Market Analysis Report provides historical as well as forecasted epidemiological analysis 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
Get a complete epidemiological segmentation breakdown @ Myelodysplastic Syndrome Epidemiological Analysis
Myelodysplastic Syndrome Treatment Market
The current Myelodysplastic Syndrome treatment landscape for patients comprises allo-HSCT, non-intensive therapies ranging from iron chelation and growth factors to lenalidomide and HMA. Allo-HSCT remains the only curative for this patient pool. Other approaches are non-curative, improving quality of life, and delaying disease progression.
For chemotherapy, drugs such as azacitidine (Vidaza) or decitabine (Dacogen) are often the first choice, especially for patients with lower-risk forms of Myelodysplastic Syndrome. Another option for some people might be medicines to suppress the immune system, such as ATG and cyclosporine. However, for Myelodysplastic Syndrome del(5q) patients, lenalidomide (Revlimid), which is FDA-approved for this indication, is often used as the first treatment. Another FDA-approved drug for supportive care for Myelodysplastic Syndrome is Reblozyl. It is an erythroid maturation agent indicated for second-line treatment of Myelodysplastic Syndrome in patients previously treated with ESA.
Other than these current therapies, the Myelodysplastic Syndrome pipeline is robust and possesses multiple potential drugs in the late, mid, and early stages of developments, yet to be launched. The emerging pipeline of MDS possesses several potential products developed in different stages of clinical development. The expected launch of potential therapies, namely FibroGen (roxadustat), AbbVie (Venclexta ± azacitidine), Novartis (sabatolimab), Syros Pharmaceuticals (SY-1425 + azacitidine), Gilead Sciences (magrolimab ± azacitidine), Geron Corporation (imetelstat), Takeda (pevonedistat ± azacitidine), Pfizer (glasdegib + azacitidine), Aprea Therapeutics (eprenetapopt), Jazz Pharmaceuticals (CPX-351), Karyopharm Therapeutics (eltanexor), BerGenBio (bemcentinib), Bristol Myers Squibb (enasidenib), Sanofi (fludarabine + busulfan ± clofarabine and Medac (treosulfan ± fludarabine) may increase Myelodysplastic Syndrome market size in the coming years, assisted by an increase in the MDS patient pool.
Myelodysplastic Syndrome Market Analysis
Myelodysplastic Syndrome market to growing due to the current MDS treatment options that include curative, supportive, and symptomatic treatments, which are easily and widely available in the market, and their generics. Moreover, various studies have highlighted the role of multiple gene mutations like RUNX1, TP53, TET2, DNMT3A, ASXL1, and others in MDS. The emerging therapies such as Syros Pharma's SY-1425 and BMS' Enasidenib are being developed as targeted therapies for RARA positive and IDH-2 mutated patients, respectively. The companies are developing therapies with targetable mutations that will open a new window of opportunity for companies developing MDS therapies.
However, the growth of the Myelodysplastic Syndrome market will be hampered by the lack of the latest evidence and analysis related to drug prescription pattern share for Myelodysplastic Syndrome patients in EU5 countries. Also, the disease affects old age people, and most of these patients are ineligible for HSCT, which is currently the only curative option. Some MDS patients undergoing treatment with HMA might fail the therapy, due to which they might not have many treatment options left. In addition to that, the upcoming therapies might face some competition from the approved and established therapies for MDS and the various upcoming therapies in the Myelodysplastic Syndrome pipeline. The high-cost burden for the overall Myelodysplastic Syndrome treatment might threaten the current MDS market.
Scope of the Myelodysplastic Syndrome Market Insight Report
- Geography Covered: The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
- Study Period: 3-year historical and 10-year forecasted analysis (2018-2030).
- Myelodysplastic Syndrome Markets Segmentation: By Geographies and By Myelodysplastic Syndrome Therapies (Historical and Forecasted, Current and Upcoming)
- Dominant Myelodysplastic Syndrome companies in the market: 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 several others.
- Analysis: Comparative and conjoint analysis of emerging therapies.
- Case Studies
- KOL's Views
- Analyst's View
Request for a Webex demo of the report @ Myelodysplastic Syndrome Therapeutics Market
Table of Contents
1 |
Myelodysplastic Syndrome Key Insights |
2 |
Myelodysplastic Syndrome Report Introduction |
3 |
MDS Market Overview at a Glance |
4 |
Executive Summary of Myelodysplastic Syndrome |
5 |
Myelodysplastic Syndrome Disease Background and Overview |
6 |
Myelodysplastic Syndrome Epidemiology and Patient Population |
7 |
Country Wise-Epidemiology of Myelodysplastic Syndrome |
7.1 |
The United States |
7.2 |
EU5 Countries |
7.2.1 |
Germany |
7.2.2 |
France |
7.2.3 |
Italy |
7.2.4 |
Spain |
7.2.5 |
The United Kingdom |
7.3 |
Japan |
8 |
Organizations contributing towards Myelodysplastic Syndrome |
9 |
Myelodysplastic Syndrome Case Reports |
10 |
MDS Patient Journey |
11 |
Myelodysplastic Syndrome Marketed Therapies |
12 |
Myelodysplastic Syndrome Emerging Therapies |
13 |
Myelodysplastic Syndrome 7MM Market Analysis |
13.1 |
The United States Myelodysplastic Syndrome Market Size |
13.2 |
EU-5 Myelodysplastic Syndrome Market Size |
13.2.1 |
Germany Market Size |
13.2.2 |
France Market Size |
13.2.3 |
Italy Market Size |
13.2.4 |
Spain Market Size |
13.2.5 |
The United Kingdom Market Size |
13.2.3 |
Japan Myelodysplastic Syndrome Market Size |
14 |
Myelodysplastic Syndrome Market Drivers |
15 |
Myelodysplastic Syndrome Market Barriers |
16 |
Myelodysplastic Syndrome SWOT Analysis |
17 |
Myelodysplastic Syndrome Unmet Needs |
18 |
Myelodysplastic Syndrome KOL Views |
19 |
Appendix |
20 |
DelveInsight Capabilities |
21 |
Disclaimer |
22 |
About DelveInsight |
Browse full report with detailed TOC with charts, figures, tables @ Myelodysplastic Syndrome Diagnostics Report
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