Histone Deacetylase Inhibitors Market – By Type, By Treatment - Global Forecast 2025 – 2034

Report ID: GMI13266
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Published Date: March 2025
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Report Format: PDF

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Histone Deacetylase Inhibitors Market Size

The global histone deacetylase inhibitors market size was valued at around USD 1.3 billion in 2024 and is estimated to grow at 7.7% CAGR from 2025 to 2034. Histone deacetylase (HDAC) inhibitors are a key group of molecules that affect the gene expression by eliminating the acetyl groups from histones. These inhibitors are used for many purposes in oncology, neurology, cardiovascular disorders, and autoimmune disorders. HDAC inhibitors are usually administered prior to systemic chemotherapy in patients with advanced disease progression.
 

Histone Deacetylase Inhibitors Market

The increasing prevalence of cancers, particularly multiple myeloma and T-cell lymphomas worldwide, is a key driver of market growth. For example, as per Wiley, the global incidence of T-cell lymphoma is around 1.4%. HDAC inhibitors have shown high efficiency in the treatment of these diseases, facilitating market growth. Besides, HDAC inhibitors play a great role in lowering the mortality rate of cancer, enabling its acceptance as a novel treatment. For example, the World Health Organization (WHO) estimated that during 2022, there were around 20 million new cancer cases and 9.7 million deaths across the globe. The high volume of new cancer cases has drawn more attention to new treatments for boosting the growth of the HDAC inhibitor market.
 

Additionally, growing research and development investments by drug manufacturers to create new HDAC inhibitors with broader clinical uses, potential for combination treatment, and greater efficacy are supporting the market growth. For example, in March 2024, the U.S. Food and Drug Administration (FDA) approved Duvyzat (givinostat), an oral HDAC inhibitor by ITF Therapeutics, for the treatment of Duchenne Muscular Dystrophy (DMD) in patients aged six years and above. The initiatives undertaken by the pharmaceutical firms coupled with regulatory agency approval support is likely to drive the market growth.
 

Histone Deacetylase Inhibitors Market Trends

  • The HDAC inhibitors market shift from traditional applications in oncology to other clinical areas like neurology, autoimmune diseases, and inflammatory disorders is driving research and development (R&D) of new inhibitors that provide improved patient quality of life, patient survival rate, and treatment efficacy.
     
  • The incorporation of AI technologies has furthermore improved the efficacy of the drug discovery and development processes in the market for HDAC inhibitors. For instance, in June 2024, Italfarmaco entered into an agreement with Iktos to accelerate the design of non-oncology drugs with the help of AI for developing advanced HDAC inhibitors.
     
  • Further, regulatory agencies like the European Medicines Agency (EMA), the National Medical Products Administration (NMPA), and the U.S. FDA are providing valuable assistance to drug companies active in the market of HDAC inhibitors. Regulatory agencies are offering funding support, orphan drug designations, and accelerated approvals owing to the critical demand for new drugs against aggressive and uncommon cancers like multiple myelomas and T-cell lymphomas.
     

Histone Deacetylase Inhibitors Market Analysis

Histone Deacetylase Inhibitors Market, By Drug Class, 2021 – 2034 (USD Billion)
  • Hydroxamic acid derivatives have high zinc-binding capability owing to which they are used as one of the most potent classes of HDAC inhibitors. As a result, hydroxamic acid are substantially used in cancer treatments. For instance, as per the recent study published by American Chemical Society in August 2021, three hydroxamic acid-based HDAC inhibitors were approved to treat T-cell lymphoma and multiple myeloma.
     
  • Additionally, increasing number of cases of multiple myeloma and T-cell lymphoma is expected to propel the demand for hydroxamic acid-based HDAC inhibitors during the forecast period. For example, as per the National Institutes of Health (NIH), in 2022, 188,000 new cases and 121,000 deaths due to multiple myeloma were reported worldwide.
     
  • Furthermore, the effectiveness of hydroxamic acid derivatives in inhibiting chemotherapy resistance and tumor growth suppression also aids to their growing use in cancer treatments, propelling the growth of the segment.

     
Histone Deacetylase Inhibitors Market, By Application (2024)
  • The rise in solid tumors and hematologic cancers, such as lymphomas, is boosting the market for targeted therapies such as HDAC inhibitors. For instance, the MDPI Journal estimates that the number of newly diagnosed Hodgkins and Non-Hodgkins lymphomas globally will increase to approximately 107000 and 778000 respectively by 2040. The diseases have a high fatality rate, highlighting the need for efficient treatment in the form of HDAC inhibitors.
     
  • In addition, growing usage of combination therapies with HDAC inhibitors, chemotherapy, proteasome inhibitors, and immune checkpoint inhibitors is propelling the segment growth. The combination therapies significantly improve survival rate and therapeutic efficacy in cancer patients.
     

Based on distribution channel, the HDAC inhibitor market is segmented into hospital pharmacies, retail pharmacies, and e-commerce. The hospital pharmacies segment dominated the market with the largest revenue of USD 830.7 million in 2024.
 

  • Some of the approved HDAC inhibitors like Belinostat, Panobinostat, and Vorinostat demand continuous patient surveillance and stringent dosage regulation, necessitating hospital dispensing facilities.
     
  • Moreover, in-hospital administration requirements by regulatory agencies for HDAC inhibitor therapies with the potential of serious toxicity risks and side effects are propelling the revenue growth in hospital pharmacies segment.
     
  • Furthermore, majority of cancer treatments are inhibited across acute care facilities such as hospitals as they have well-built oncology units and infusion centers. This further promotes the revenue growth in hospital pharmacy segment.
     

 

U.S. Histone Deacetylase Inhibitors Market, 2021 – 2034 (USD Million)
  • The regulatory bodies in the U.S. such as the U.S. FDA are focusing on the research and launch of new histone deacetylase inhibitor treatments with orphan drug approvals, priority reviews, and fast-track designations, boosting the market growth. For example, abexinostat, a new oral HDAC inhibitor for the treatment of multiple cancer types by Pharmacyclics is featured in numerous clinical trials. The drug received fast-track approval by the FDA in September 2019.
     
  • Moreover, increasing prevalence of Alzheimer’s disease in the U.S. has surged the interest in HDAC inhibitors, owing to their potential neuroprotective effects. According to the 2024 fact sheet of Alzheimer’s Association, about 7 million patients in the U.S. are affected with Alzheimer’s disease, and by 2050, the affected patients are expected to rise to 13 million.
     
  • Also, the presence of numerous biotechnology and pharmaceutical companies, such as Bristol-Myers Squibb Company, Merck &Co., and Novartis, which participate in the development and sale of new histone deacetylase inhibitors is also propelling market growth in the U.S.
     

Europe: The histone deacetylase inhibitors market in UK is expected to experience significant and promising growth from 2025 to 2034.
 

  • The growing incidence of various cancer types in the UK due to factors such as aging population, genetic expressions, and unhealthy lifestyle is driving the demand for novel treatments such as HDAC inhibitors. For instance, according to Cancer Research UK, approximately 385,000 new cases of cancer are diagnosed in the UK every year, highlighting the need for effective novel treatments.
     
  • In addition, regulatory support by the Medicines and Healthcare products Regulatory Agency (MHRA) for the clinical use and approval of innovative HDAC inhibitor therapies, is driving market growth in the region.
     

Asia Pacific: Japan histone deacetylase inhibitors market is anticipated to witness lucrative growth between 2025 – 2034.
 

  • Japan is prone to a high incidence of adult T-cell lymphomas, a highly aggressive subtype of lymphoma, due to its large geriatric population and the high infection rate of human T-cell leukemia virus type 1 (HTLV-1). According to Wiley Online Library, Japan experience approximately 4000 new cases of HTLV-1 infections each year with over one million HTLV-1 infection patients in any given year. Furthermore, over 1000 deaths are reported each year due to adult T-cell lymphoma.
     
  • HDAC inhibitors are effective in the management and treatment of T-cell lymphomas due to their ability to target epigenetic modifications and regulate gene expression. HDAC inhibitors such as Tazemetostat and Romidepsin are approved in Japan and are effective in the management of this condition, thereby driving the market growth in the region.
     

Middle East and Africa: The histone deacetylase inhibitors market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.
 

  • Saudi Arabia has one of the fastest growing healthcare infrastructure due to various government initiatives and foreign investments. The establishment of dedicated cancer research centers and clinical trials aimed at developing innovative treatments for cancer is driving the market growth in the region.
     
  • Additionally, the increasing incidence of cancer in the country is driving the demand for innovative treatment options such HDAC inhibitors. For instance, according to the Saudi Health Council, approximately 28,100 new cases and 13,400 fatalities related to cancer were reported in 2022 in Saudi Arabia.
     

Histone Deacetylase Inhibitors Market Share

The market is concentrated, featuring 6 pharmaceutical firms having approved products. The top players in this market include Bristol-Myers Squibb Company, Merck & Co., and Novartis. These players collectively account for approximately 65% market share. These players are investing in the development of advanced treatments to enhance treatment efficiency. Moreover, strategic partnerships with research institutions and healthcare providers are critical for integrating modern technologies and expanding distribution, which will enable the companies to address the surge in demand for treatment options.
 

The market experiences a regulatory support and streamlines approval processes which further motivates to innovate and facilitates market entry. Additionally, emerging players such as ITF Therapeutics and Spectrum Pharmaceuticals are focussing on development of new treatments which aim to improve disease management. These innovations continue to promote market progression.
 

Histone Deacetylase Inhibitors Market Companies

Some of the eminent market participants operating in the histone deacetylase inhibitors industry include:

  • Bristol-Myers Squibb Company
  • Chipscreen Bioscience
  • ITF Therapeutics
  • Merck & Co.
  • Novartis
  • Spectrum Pharmaceuticals
  • Taizhou EOC Pharma
  • Merck& Co. is a major player in the market. It has developed Vorinostat (Zolinza), the first approved HDAC inhibitor by the U.S. FDA, for the treatment of cutaneous T-cell lymphoma (CTCL). The company has an extensive distribution network, ensuring that the treatments reach even remote areas, expanding their reach.
  • Novartis is a global company with a strong presence in the HDAC inhibitors market. Its Panobinostat (Farydak) HDAC inhibitor indicated for the treatment of multiple myelomas has significant market potential. The company utilizes its advanced R&D capabilities to advance innovations in HDAC inhibitors.
     

Histone Deacetylase Inhibitors Industry News:

  • In April 2024, Chipscreen Bioscience announced approval of its Chidamide (Epidaza), an oral histone deacetylase (HDAC) inhibitor in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) by the National Medical Products Administration (NMPA).
     
  • In April 2024, Taizhou EOC Pharma announced to receive NMPA approval for its innovative drug, Entinostat tablets. These tablets, used with an aromatase inhibitor, are for treating patients with locally advanced or metastatic breast cancer. The treatment is for those who are hormone receptor (HR) positive, human epidermal growth factor receptor-2 (HER-2) negative, and have already had endocrine therapy.
     
  • In March 2024, ITF Therapeutics announced the U.S. FDA approval of its givinostat (Duvyzat) for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years and older. The approval strengthened the company’s position in the HDAC inhibitor market and significantly expanded its portfolio.
     
  • In November 2019, Bristol Myers Squibb Company announced the acquisition of Celgene Corporation. Through the transaction, Bristol Myers Squibb Company acquired the Romidepsin HDAC inhibitor treatment from Celgene, which was expected to significantly boost its market presence.
     

The histone deacetylase inhibitors market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

Market, By Drug Class

  • Hydroxamic acid derivatives
  • Cyclic peptides
  • Benzamides

Market, By Application

  • Oncology
  • Neurology
  • Other applications

Market, By Distribution Channel

  • Hospital pharmacies
  • Retail pharmacies
  • E-commerce

The above information is provided for the following regions and countries:

  • North America 
    • U.S.
    • Canada
  • Europe 
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Netherlands
  • Asia Pacific 
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America 
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa 
    • South Africa
    • Saudi Arabia
    • UAE

 

Authors: Mariam Faizullabhoy, Gauri Wani
Frequently Asked Question(FAQ) :
How much is the U.S. histone deacetylase inhibitors market worth in 2024?
The U.S. histone deacetylase inhibitors industry was valued at USD 567.8 million in 2024 and is expected to reach USD 1.2 billion by 2034.
Who are the key players in the histone deacetylase inhibitors market?
How big is the histone deacetylase inhibitors market?
What is the revenue of the hospital pharmacies segment in the market?
Histone Deacetylase Inhibitors Market Scope
  • Histone Deacetylase Inhibitors Market Size
  • Histone Deacetylase Inhibitors Market Trends
  • Histone Deacetylase Inhibitors Market Analysis
  • Histone Deacetylase Inhibitors Market Share
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    Base Year: 2024

    Companies covered: 7

    Tables & Figures: 120

    Countries covered: 22

    Pages: 130

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