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市場調査レポート
商品コード
1745765
ジヒドロオロチン酸デヒドロゲナーゼ(DHODH) 阻害剤:対象患者集団・競合情勢・市場予測 (~2034年)Dihydroorotate Dehydrogenase (DHODH) Inhibitor- Target Population, Competitive Landscape, and Market Forecast - 2034 |
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ジヒドロオロチン酸デヒドロゲナーゼ(DHODH) 阻害剤:対象患者集団・競合情勢・市場予測 (~2034年) |
出版日: 2025年06月01日
発行: DelveInsight
ページ情報: 英文 120 Pages
納期: 2~10営業日
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当レポートでは、米国、EU4カ国 (ドイツ、フランス、イタリア、スペイン)、英国、日本におけるジヒドロオロチン酸デヒドロゲナーゼ (DHODH) 阻害剤の市場を調査し、市場背景、市場動向、既存薬および新興薬の概要、競合情勢、市場シェア、患者数、市場規模の推移・予測、アンメットメディカルニーズ、市場アクセスと償還の動向などをまとめています。
DelveInsight's "Dihydroorotate Dehydrogenase (DHODH) inhibitor- Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the DHODH inhibitors, historical and competitive landscape as well as its market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The DHODH inhibitors' market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM DHODH inhibitors' market size from 2020 to 2034. The report also covers current DHODH inhibitors' treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
Dihydroorotate Dehydrogenase (DHODH) Inhibitors Overview
DHODH inhibitors are a class of drugs that block the DHODH enzyme, a key player in the de novo synthesis of pyrimidines-molecules essential for DNA and RNA production. This enzyme is located in the mitochondria and supports the rapid proliferation of cells by enabling nucleotide synthesis. By inhibiting DHODH, these drugs limit the availability of pyrimidines, leading to reduced DNA synthesis and cell cycle arrest, particularly affecting rapidly dividing cells.
These inhibitors are used primarily in diseases characterized by excessive immune activation or abnormal cell growth. In autoimmune conditions like rheumatoid arthritis and multiple sclerosis, they suppress the proliferation of overactive immune cells. In oncology, DHODH inhibitors are being studied for their potential to slow the growth of cancer cells, which heavily rely on nucleotide synthesis. Through this mechanism, DHODH inhibitors serve as a targeted approach to control pathological cell activity in various disorders.
Dihydroorotate Dehydrogenase (DHODH) Inhibitors Market Overview
In recent years, DHODH inhibitors have emerged as a promising therapeutic approach in the treatment of chronic inflammatory and autoimmune conditions such as multiple sclerosis, ulcerative colitis, rheumatoid arthritis, NHL, and others. Their ability to modulate immune responses by targeting de novo pyrimidine synthesis positions them as potential disease-modifying agents. Clinical data continues to support their utility across these indications, driving interest and investment in this drug class. As development progresses, DHODH inhibitors are increasingly viewed as valuable additions to the immunology pipeline.
The epidemiology chapter of DHODH inhibitors in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for DHODH inhibitors, total eligible patient pool in selected indications for DHODH inhibitors, and total treated cases in selected indications for DHODH inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the DHODH inhibitors report encloses a detailed analysis of approved DHODH inhibitors, late-stage (Phase III and Phase II) DHODH inhibitors. It also helps understand the clinical trial details of DHODH inhibitors, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.
Marketed Dihydroorotate Dehydrogenase (DHODH) Inhibitors
The approved landscape of DHODH inhibitors is limited to two agents: leflunomide and its active metabolite teriflunomide. Leflunomide, available in generic form, is primarily used in rheumatoid arthritis. Teriflunomide, marketed as AUBAGIO, is approved for the treatment of multiple sclerosis and became available as a generic in 2023. Beyond these, no other DHODH inhibitors have received regulatory approval. Several novel compounds are in clinical development for autoimmune diseases, cancer, and viral infections, indicating growing interest in this target.
Emerging Dihydroorotate Dehydrogenase (DHODH) Inhibitors
Vidofludimus Calcium (IMU-838): Immunic Therapeutics
Vidofludimus calcium is a small molecule investigational drug in development as an oral next-generation treatment option for patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. The selective immune modulator activates the neuroprotective transcription factor nuclear receptor-related 1 (Nurr1), which is associated with direct neuroprotective properties. Additionally, Vidofludimus calcium is a highly selective inhibitor of the enzyme DHODH, which is a key enzyme in the metabolism of overactive immune cells and virus-infected cells. This mechanism is associated with the anti-inflammatory and anti-viral effects of Vidofludimus calcium.
IMU-838, is currently in Phase III and Phase II clinical trials for the treatment of relapsing and progressive multiple sclerosis, respectively, and has shown therapeutic activity in Phase II clinical trials in patients suffering from relapsing-remitting multiple sclerosis, progressive multiple sclerosis, and moderate-to-severe ulcerative colitis.
JBZ-001: Jabez Bioscience
JBZ-001, an orally bioavailable small-molecule DHODH inhibitor, was designed to disrupt de novo pyrimidine nucleotide biosynthesis, a critical pathway for cancer cell proliferation. By targeting DHODH, the rate-limiting enzyme in this pathway, JBZ-001 demonstrated the potential to induce cytotoxic effects in tumor cells, offering a promising new approach to cancer treatment. The development of JBZ-001 marks a significant milestone in Jabez Biosciences' "bench-to-bedside" academic collaboration, with the compound receiving FDA approval for a commercial Investigational New Drug (IND) application in 2024. Currently in Phase I of the developmental process for the treatment of patients with advanced solid and hematological malignancies.
The global DHODH inhibitor market is poised for steady growth, fueled by the rising burden of autoimmune and inflammatory diseases, along with increasing interest in targeting metabolic pathways in oncology and Immunology. While only two agents-leflunomide and teriflunomide-are currently approved, a growing clinical pipeline featuring candidates from companies like Immunic Therapeutics, Jabez Bioscience, and others suggests expanded therapeutic potential beyond traditional autoimmune indications.
Key areas of development include multiple sclerosis, ulcerative colitis, rheumatoid arthritis, NHL, and even viral infections. As emerging DHODH inhibitors progress through clinical trials, the field is expected to evolve toward more selective and better-tolerated agents. Over the next few years, data from late-stage studies will clarify the clinical value of this class and potentially position DHODH inhibitors as a broader therapeutic platform across immunology and oncology.
This section focuses on the uptake rate of potential approved and emerging DHODH inhibitors expected to be launched in the market during 2025-2034.
Dihydroorotate Dehydrogenase (DHODH) Inhibitors Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. The presence of numerous drugs under different stages is expected to generate immense opportunity for DHODH inhibitors' market growth over the forecast period.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for DHODH inhibitor therapies.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on DHODH inhibitors' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Washington University and others.
Their opinion helps understand and validate current and emerging therapy treatment patterns or DHODH inhibitors' market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health Technology Assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.
In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Continuing Medical Education (CME) program, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Key Updates on Dihydroorotate Dehydrogenase (DHODH) Inhibitors
The abstract list is not exhaustive and will be provided in the final report.