Hdac (Histone Deacetylase) Inhibitors Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, UK, Germany, China - Size and Forecast 2024-2028

HDAC Inhibitors Market Size 2024-2028 

The HDAC (histone deacetylase) inhibitors market size is forecast to increase by USD 194.1 million at a CAGR of 8.09% between 2023 and 2028. The market is experiencing significant growth due to several key factors. Firstly, the high target affinity and specificity of HDAC inhibitors make them effective therapeutic agents, particularly in the treatment of various cancers and neurological disorders. Secondly, the growing geriatric population represents a substantial market opportunity, as age-related diseases such as Alzheimer's and Parkinson's are major indications for HDAC inhibitors. However, the high costs associated with the development and production of these drugs pose a significant challenge to market growth. Despite this, the potential benefits in addressing unmet medical needs and improving patient outcomes are driving research and development efforts in this field.

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Histone Deacetylase (HDAC) inhibitors have gained significant attention in the pharmaceutical industry due to their potential therapeutic applications in various diseases. These inhibitors have shown promise in the treatment of lysosomal storage disorders and neurodegenerative disorders, including cachexia, by modifying the expression of specific genes. Additionally, they exhibit anti-inflammatory and anti-apoptotic properties, making them potential candidates for neurological disorders such as multiple sclerosis. The global HDAC inhibitors market is expected to grow steadily due to the increasing prevalence of neurological disorders and the development of new reimbursement policies. The key players in this market are focusing on the development of HDAC inhibitors for various indications.

Furthermore, active players contribute to the market growth through research and development. The reimbursement scenario for HDAC inhibitors is a significant factor influencing market growth. Personal disposable income and the availability of effective treatments also play a role in the market's expansion. Overall, the market is poised for growth due to the potential therapeutic benefits and the increasing focus on research and development in this area.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018- 2022 for the following segments.

• Route Of Administration
  • Oral HDAC inhibitors
  • Parenteral HDAC inhibitors
• Distribution Channel
  • Hospital pharmacies
  • Retail pharmacies
  • Online pharmacies
  • Others
• Geography
  • North America
    • Canada
    • US
  • Europe
    • Germany
    • UK
  • Asia
  • Rest of World (ROW)

By Route Of Administration Insights

The oral HDAC inhibitors segment is estimated to witness significant growth during the forecast period. The strong pipeline of oral HDAC inhibitors is the major factor driving the growth of the segment. This type of HDAC inhibitor is taken orally or through the mouth. Currently, more than ten HDAC inhibitors, which can be administered through oral RoA, are in the pipeline. The presence of such a strong pipeline will aid in the launch of new drugs for administration via the oral route during the forecast period, which will increase the product portfolio of the oral HDAC inhibitors segment.

Furthermore, the oral route is the easiest way to administer a drug. However, the cost of these drugs is very high. Therefore, to overcome the high-cost challenge of these drugs, many companies and government or non-government organizations are providing financial assistance through patient assistance programs.

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The oral HDAC inhibitors segment was valued at USD 243.20  million in 2018 and showed a gradual increase during the forecast period.

Regional Insights

North America is estimated to contribute 33% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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Regulatory authorities are closely monitoring the development of these drugs due to their potential to address unmet medical needs in cancer therapy. Epidemiology analysis indicates a growing prevalence of T-cell lymphoma and myeloma, increasing the demand for effective treatments. Azacitadine and Belinostat are other HDAC inhibitors used in the treatment of myelodysplastic syndromes and peripheral T-cell lymphoma, respectively. Celeron Therapeutics is also an active player in this market, developing novel HDAC inhibitors.

Furthermore, the reimbursement scenario for HDAC inhibitors varies across regions, influenced by personal disposable income and healthcare policies. Syndax, for instance, has secured approval for entinostat in combination with exemestane for the treatment of advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women in the US. These developments underscore the potential growth opportunities in the market.

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

HDAC (Histone Deacetylase) Inhibitors Market Driver

The high target affinity and specificity is the key drivers of the market. The enzyme, Histone Deacetylase (HDAC), plays a crucial role in epigenetic regulation by removing the acetyl group from N-acetyl lysine amino acids on histone and non-histone proteins. HDAC inhibitors have gained significant attention in the pharmaceutical industry due to their potential applications in various therapeutic areas, including cancer, haematological malignancies, lysosomal storage disorders, neurodegenerative disorders, cachexia, and neurological disorders such as multiple sclerosis. Companies are leading the HDAC inhibitors market with their innovative pipelines. For instance, RND-001, a Class II HDAC inhibitor is in the clinical stage for the treatment of haematological malignancies.

Similarly, Class I HDAC inhibitor, RG7112, developed by Merck KGaA, is under investigation for the treatment of solid tumors, including breast cancer. Moreover, HDAC inhibitors exhibit anti-inflammatory and anti-apoptotic properties, making them suitable for neurological disorders. For instance, Medivir AB's MIV-711, a Class I HDAC inhibitor, is under investigation for the treatment of multiple sclerosis. In addition, HBI-8000, a pan-HDAC inhibitor, is in the clinical stage for the treatment of various cancers. Despite the promising therapeutic potential of HDAC inhibitors, reimbursement policies and pricing remain significant challenges. The high cost of these therapies may limit their accessibility to patients, especially in emerging markets such as the Middle East & Africa and the GCC.

However, with ongoing research and development efforts, the HDAC inhibitors market is expected to witness significant growth in the oncology and neurology segments. Key players in the HDAC inhibitors market include TCI Chemicals, InvivoGen, Abcam plc, and Mirati Therapeutics. The pipeline analysis by the American Cancer Society indicates that several HDAC inhibitors are in various stages of clinical development for various cancer indications. For instance, Class III HDAC inhibitor, MK-8628, developed by Merck KGaA, is in the clinical stage for the treatment of breast cancer. Similarly, Class IV HDAC inhibitor, SAR425838, is in the preclinical stage for the treatment of hematology diseases.

HDAC (Histone Deacetylase) Inhibitors Market Trends

The growing geriatric population is the upcoming trend in the market. The enzyme, Histone Deacetylase (HDAC), plays a crucial role in epigenetic regulation by removing the acetyl group from N-acetyl lysine amino acids on histone and non-histone proteins. HDAC inhibitors have gained significant attention in oncology and neurology due to their potential applications in cancer, haematological malignancies, neurodegenerative disorders, cachexia, and inflammatory diseases. Companies like AMO Pharmaceuticals, Ranedis Pharmaceuticals, and Cetya Therapeutics are developing HDAC inhibitors for various indications. For instance, RND-001 from Ranedis Pharmaceuticals is under development for lysosomal storage disorders, while Mirati Therapeutics' MK-8628 is being studied for multiple myeloma and solid tumors. HDAC inhibitors exhibit anti-inflammatory and anti-apoptotic properties, making them potential therapeutic options for neurological disorders such as multiple sclerosis and central nervous system diseases.

Furthermore, reimbursement policies and pricing remain key challenges for HDAC inhibitor market growth. Merck KGaA, Medivir AB, and Abcam plc are some of the other major players in the HDAC inhibitor market. The pipeline analysis indicates that Class I, II, III, and IV HDAC inhibitors are under development for various indications in oncology, neurology, haematology diseases, and other therapeutic areas. According to the American Cancer Society, breast cancer is the most common cancer among women, making it a significant focus area for HDAC inhibitor development. HBI-8000 is an example of a Class I HDAC inhibitor under investigation for breast cancer treatment.

HDAC (Histone Deacetylase) Inhibitors Market Challenge

The high costs associated with treatment is a key challenge affecting the market growth. The market encompasses a range of enzyme inhibitors that target N-acetyl lysine amino groups on histone and non-histone proteins, playing a crucial role in epigenetic regulation. These inhibitors exhibit potential applications in various therapeutic areas, including cancer, haematological malignancies, lysosomal storage disorders, neurodegenerative disorders, cachexia, and neurological disorders such as multiple sclerosis. Companies like AMO PHARMA, Ranedis Pharmaceuticals, and Medivir AB are developing HDAC inhibitors for oncology and neurology indications. For instance, RND-001 from Ranedis Pharmaceuticals is under development for the treatment of cancer and neurological disorders. HDAC inhibitors exhibit anti-inflammatory and anti-apoptotic properties, making them attractive candidates for the treatment of neurological disorders.

Furthermore, the market is expected to grow significantly due to the increasing prevalence of cancer and neurological disorders. However, high treatment costs remain a significant challenge, with belinostat (BELEODAQ) priced at approximately USD 1,976.75 per unit. Reimbursement policies and affordability are major concerns, especially in developing and underdeveloped countries. The pipeline analysis of HDAC inhibitors includes various phases of clinical trials for haematology diseases, breast cancer, and multiple sclerosis. According to the American Cancer Society, the cost of cancer care is projected to reach nearly USD174 billion by 2020. HDAC inhibitors target Class I, II, III, and IV HDACs, offering potential therapeutic benefits in various indications across oncology and neurology.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Acrotech Biopharma Inc. - The company offers beleodaq histone deacetylase inhibitor which is used to treat patients with peripheral T cell lymphoma.

The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• AstraZeneca Plc
• Bio Techne Corp.
• BioVision Inc.
• Bristol Myers Squibb Co.
• Celleron Therapeutics Ltd.
• Cetya Therapeutics Inc.
• Curis Inc.
• Huya Bioscience International LLC
• InvivoGen Corp.
• Italfarmaco Holding SPA
• Medivir AB
• Merck and Co. Inc.
• Novartis AG
• Shenzhen Chipscreen Biotechnology Co. Ltd.
• Syndax Pharmaceuticals, Inc
• Tokyo Chemical Industry Co. Ltd.
• Valerio Therapeutics
• Viracta Therapeutics Inc.
• Xynomic Pharmaceuticals Nanjing Co. Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Research Analyst Overview

Histone Deacetylase (HDAC) inhibitors are a class of enzyme inhibitors that target the removal of the acetyl group from N-acetyl lysine amino acids on histone proteins, thereby altering the epigenetic regulation of genes. These inhibitors have gained significant attention in the medical field due to their potential applications in various therapeutic areas, including cancer, haematological malignancies, lysosomal storage disorders, neurodegenerative disorders, cachexia, and neurological disorders such as multiple sclerosis. Class I, II, III, and IV HDACs have distinct roles in the central nervous system and other tissues. Pharmaceutical companies are developing HDAC inhibitors for oncology and neurology indications.

Furthermore, reimbursement policies and regulatory approvals are crucial factors influencing the market growth. Merck KGaA and Huya Bioscience International are some of the key players with approved HDAC inhibitors for cancer treatment. The American Cancer Society reports that breast cancer is the most common cancer and a significant cause of cancer deaths worldwide. The market for HDAC inhibitors is expected to grow in the Middle East & Africa and GCC regions due to the increasing prevalence of cancer and neurological disorders.

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What are the Key Data Covered in this Market Research and Growth Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies

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