IDH Market Size Will Witness Robust Growth with Emerging Therapies by 2034 | DelveInsight

LAS VEGAS, NV, UNITED STATES, December 10, 2024 /EINPresswire.com/ -- The IDH market is projected to experience rapid growth due to the expansion of indications for already approved therapies, increased R&D activities. Additionally, the competitive landscape is relatively sparse and the regulatory pathway for approval will likely involve extensive clinical trials to demonstrate safety and efficacy.

DelveInsight’s IDH Market Insights report includes a comprehensive understanding of current treatment practices, emerging IDH, market share of individual therapies, and current and forecasted IDH market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Takeaways from the IDH Market Report:

As per DelveInsight’s analysis, the IDH market is anticipated to grow at a significant CAGR by 2034.
Leading IDH companies such as Servier, Bayer, and others are developing novel IDH that can be available in the IDH market in the coming years.
Some of the key IDH in the pipeline include IDHIFA (enasidenib), and others.
Upon its approval in 2017, IDHIFA (enasidenib) became the first-in-class oral targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for treating patients with relapsed or refractory acute myeloid leukemia (AML) harboring an IDH2 mutation. This therapy addressed a critical unmet need, offering an effective option for this patient population. IDHIFA has demonstrated the ability to induce complete remission in some patients and reduce the need for red blood cell and platelet transfusions.
IDH inhibitors, including TIBSOVO (ivosidenib), IDHIFA (enasidenib mesylate), and REZLIDA (enasidenib mesylate), have gained approval from regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These therapies are used to treat various cancers, including AML, myelodysplastic syndromes, metastatic cholangiocarcinoma, and others.
The development of IDH inhibitors continues to expand, with several under clinical evaluation. For example, Servier’s vorasidenib is in advanced development and is expected to gain regulatory approval during the forecast period. In February 2024, both the FDA and EMA accepted regulatory submissions for vorasidenib for the treatment of IDH-mutant diffuse glioma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while European Commission approval is anticipated in the second half of 2024. Vorasidenib has also received Fast Track Designation (FTD) in February 2023 and Breakthrough Therapy Designation in August 2023 from the FDA.
IDH inhibitors target mutated IDH enzymes, reducing the production of the oncometabolite 2-hydroxyglutarate (2-HG), which is implicated in tumor growth. By lowering 2-HG levels, these therapies aim to slow or inhibit tumor progression, offering a promising approach to treating cancers with IDH mutations.
Research into IDH inhibitors continues to hold significant promise, with ongoing advancements expected to refine their therapeutic applications and improve outcomes for patients with IDH-mutant cancers.

Discover which therapies are expected to grab the IDH market share @ IDH Market Report

IDH Market Dynamics

The IDH market is shaped by a range of dynamics, driven by advancements in medical research and a growing understanding of complement system-related diseases. As research progresses, the pipeline for IDH inhibitors is expanding, with several candidates undergoing clinical trials, which is expected to significantly impact market growth.

IDH inhibitors are primarily used to treat specific types of cancer associated with mutations in isocitrate dehydrogenase (IDH) genes, including gliomas, acute myeloid leukemia (AML), chondrosarcomas, and intrahepatic cholangiocarcinomas. Before starting treatment, patients undergo genetic testing to identify mutations in the IDH1 or IDH2 genes. If a mutation is confirmed and the patient is deemed suitable for therapy, an appropriate IDH inhibitor is prescribed. For instance, ivosidenib is used to treat AML patients with IDH1 mutations, while enasidenib is indicated for those with IDH2 mutations.

These inhibitors work by targeting mutated IDH enzymes, reducing the production of the oncometabolite 2-hydroxyglutarate (2-HG), which is implicated in tumor growth. By lowering 2-HG levels, IDH inhibitors can potentially slow or inhibit tumor progression. Their effectiveness in preclinical studies and clinical trials has supported their development as targeted therapies, offering a promising treatment approach for cancers with IDH mutations.

Learn more about the FDA-approved IDH @ IDH Drugs

Key Marketed IDH and Companies

TIBSOVO (ivosidenib): Servier

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of patients with IDH1-mutated acute myeloid leukemia (AML), IDH1-mutated cholangiocarcinoma, and IDH1-mutated myelodysplastic syndromes, as identified through an FDA-approved diagnostic test.

As the first FDA-approved therapy for patients with relapsed or refractory (R/R) AML and an IDH1 mutation, TIBSOVO represents a significant milestone for the 6–10% of AML patients harboring this mutation. It offers a novel approach to treatment, distinct from traditional chemotherapy, and provides a critical option for patients who have long awaited new therapeutic strategies.

IDHIFA (enasidenib mesylate): Bristol Myers Squibb

IDHIFA is an isocitrate dehydrogenase-2 (IDH2) inhibitor that blocks specific enzymes promoting cancer cell growth. Patients eligible for IDHIFA treatment must have the IDH2 mutation detected in blood or bone marrow samples using the RealTime IDH2 Assay, a companion diagnostic tool. Approved by the FDA for use alongside this diagnostic, IDHIFA is designed to target IDH2-mutated AML. The drug's approval was granted to Celgene Corporation, while the RealTime IDH2 Assay was approved for Abbott Laboratories.

The prescribing information and patient Medication Guide for IDHIFA include a boxed warning for differentiation syndrome (DS), a severe and potentially life-threatening condition. Differentiation syndrome occurs when cancer cells release proteins into the bloodstream, triggering harmful systemic effects. Patients developing DS during IDHIFA treatment may require urgent medical intervention, including hospitalization, to manage the condition effectively. This boxed warning underscores the importance of monitoring and prompt management of DS during therapy.

Emerging Drugs in the IDH Inhibitors Market

Emerging Drugs

Vorasidenib: Servier

Vorasidenib, developed by Servier, is an innovative oral therapy designed as a selective and highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes. It is specifically targeted for the treatment of IDH-mutant diffuse glioma, a malignant and currently incurable brain tumor.

The drug was evaluated in the Phase III INDIGO clinical trial for patients with residual or recurrent IDH-mutant low-grade glioma. The trial achieved its primary endpoint of progression-free survival (PFS) and the key secondary endpoint of time to the next intervention (TTNI), demonstrating statistically significant and clinically meaningful improvements.

Servier has received FDA filing acceptance with priority review for a New Drug Application (NDA) for vorasidenib, and the European Medicines Agency (EMA) has granted accelerated assessment for its Marketing Authorization Application (MAA). Regulatory decisions are anticipated by August 20, 2024 (FDA) and in the second half of 2024 (European Commission).

If approved, vorasidenib will become the first targeted therapy for IDH-mutant diffuse glioma. It has shown robust penetration of the blood-brain barrier and offers promising advancements in treating this challenging disease, providing patients with improved progression-free survival and delayed time to subsequent interventions.

To know more about IDH clinical trials, visit @ IDH Treatment Drugs

IDH Overview

An IDH inhibitor is a type of drug or compound that targets and inhibits the activity of the isocitrate dehydrogenase (IDH) enzymes, which play a critical role in cellular metabolism. These enzymes catalyze the conversion of isocitrate to alpha-ketoglutarate (α-KG) in the citric acid cycle, a key process in energy production and metabolic regulation. Inhibiting IDH enzymes has therapeutic significance, particularly for treating certain cancers.

The isocitrate dehydrogenase (IDH) protein family includes three self-regulating enzymes: IDH1, IDH2, and IDH3. Both IDH1 and IDH2 are nicotinamide adenine dinucleotide phosphate (NADP)-dependent enzymes, catalyzing the oxidative decarboxylation of isocitrate to α-KG while producing NADPH. IDH1 functions in the cytosol and peroxisomes, while IDH2 operates in mitochondria. In contrast, IDH3 is NAD-dependent and catalyzes the same reaction in mitochondria, playing a distinct role in the citric acid cycle.

Mutations in IDH1 and IDH2 have been identified in various cancers, including gliomas, acute myeloid leukemia (AML), chondrosarcomas, and intrahepatic cholangiocarcinomas. These mutations result in the production of an oncometabolite, 2-hydroxyglutarate (2-HG), which disrupts normal cellular processes and contributes to tumor growth and progression.

Approved IDH inhibitors, such as TIBSOVO (ivosidenib) and IDHIFA (enasidenib), target mutated IDH enzymes to reduce 2-HG production, slowing tumor progression. These therapies have been approved by regulatory agencies like the U.S. FDA for treating AML with specific IDH mutations.

Ongoing research continues to explore the broader potential of IDH inhibitors, including their use in treating other cancers and improving patient outcomes. The discovery of these inhibitors has generated significant hope, particularly in addressing IDH1/2-mutant malignancies, by leveraging their ability to specifically target tumor-promoting metabolic pathways.

IDH Inhibitors Market Outlook

The market for IDH inhibitors is expected to experience significant growth in the coming years, driven by the increasing incidence of IDH-mutated cancers such as acute myeloid leukemia (AML) and cholangiocarcinoma, along with growing awareness of these targeted therapies.

The clinical adoption of IDH inhibitors, including ivosidenib and enasidenib, has steadily risen, especially for the treatment of AML with IDH mutations. As healthcare providers become more familiar with these therapies and their indications, their use is anticipated to expand further.

In February 2024, the FDA and EMA accepted vorasidenib regulatory submissions for the treatment of IDH-mutant diffuse glioma. Vorasidenib is a novel, selective, and highly brain-penetrant dual inhibitor of IDH1/2 enzymes, designed for the treatment of IDH-mutant diffuse glioma. If approved, it will become the first-in-class targeted therapy for patients with IDH-mutant gliomas and mark Servier’s sixth approval in the IDH-mutant cancer space.

Recently, Servier acquired Agios Pharmaceuticals for USD 2 billion plus royalties. This acquisition includes Agios’s oncology portfolio, development pipeline, and research programs, further enhancing Servier’s position in the IDH inhibitor market.

However, IDH inhibitors are only effective in patients with specific genetic mutations in the IDH gene, limiting the eligible patient population and resulting in a smaller market potential compared to other cancer therapies.

Several key players, including Servier, Bayer, and others, are actively developing IDH inhibitors for various indications, such as Grade 2 glioma, residual glioma, recurrent glioma, astrocytoma, and other solid tumors.

Overall, IDH inhibitors represent a promising new class of cancer therapies, with considerable potential for development. Ongoing studies and clinical advancements in the coming years will provide a deeper understanding of their role in cancer treatment.

Scope of the IDH Market Report
Study Period: 2020–2034
IDH Report Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key IDH Companies:
Key IDH:
IDH Therapeutic Assessment: IDH current marketed and emerging therapies
IDH Market Dynamics: Conjoint Analysis of Emerging IDH Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
IDH Unmet Needs, KOL’s views, Analyst’s views, IDH Market Access and Reimbursement

Discover more about IDH drugs in development @ IDH Clinical Trials

https://www.delveinsight.com/sample-request/isocitrate-dehydrogenase-idh-inhibitors-market?utm_source=einpresswire&utm_medium=pressrelease&utm_campaign=kpr

Table of Contents
1. IDH Market Key Insights
2. IDH Market Report Introduction
3. Executive Summary of IDH
4. Key Events
5. IDH Market Forecast Methodology
6. IDH Market Overview at a Glance in the 7MM
7. IDH: Background and Overview
8. IDH Target Patient Pool
9. IDH Marketed Drugs
10. IDH Emerging Drugs
11. Seven Major IDH Market Analysis
12. IDH Market Access and Reimbursement
13. SWOT Analysis
14. KOL Views
15. IDH Unmet Needs
16. Appendix
17. DelveInsight Capabilities
18. Disclaimer
19. About DelveInsight
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