Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Epigenetics Diagnostics Market size was over USD 17.3 billion in 2024 and is estimated to reach USD 94.5 billion by the end of 2037, expanding at a CAGR of 15.2% during the forecast timeline, i.e., 2025-2037. In 2025, the industry size of epigenetics diagnostics is evaluated at USD 19.9 billion.
The epigenetics diagnostics market provides resolutions and amenities that include the study of alterations to DNA and connected proteins that modify gene expressions without fluctuating the genetic sequencing. As per the February 2024 Cell Metabolism article, epigenetic adjustments have a high-frequency connotation of more than 90% to 95% of individuals with pathology in epigenome-wide association studies (EWASs). Besides, the expansion of resourceful epigenetic biomarkers for disease predisposition will simplify a standard modification from unreceptive medicine to anticipatory medicine. Therefore, all these factors are highly responsible for the upliftment of the market globally.
The demand for the epigenetic diagnostics market depends heavily on the implementation of chemical analysis instruments. These instruments quantify and detect epigenetic modifications, which are essential markers for aiding neurological diseases. Therefore, in this regard, the export and import of such instruments are readily active across nations, signifying their importance for market expansion. As per the 2023 OEC report, the global trade valuation for chemical analysis instruments is USD 55.6 billion with the United States being the top exporter of USD 11.5 billion and China as the top importer for USD 8.1 billion. In addition, the product complexity is 1.6, and these instruments are positioned at 77 for the most traded products internationally.
International Chemical Analysis Instruments Export/Import
|
Countries |
Export |
Import |
|
Germany |
USD 8.6 billion |
USD 4.7 billion |
|
Japan |
USD 5.6 billion |
- |
|
China |
USD 4.1 billion |
USD 8.1 billion |
|
Singapore |
USD 4.0 billion |
USD 2 billion |
|
Netherlands |
- |
USD 2.1 billion |
|
United States |
USD 11.5 billion |
USD 7.8 billion |
Source: OEC 2023
Epigenetics Diagnostics Sector: Growth Drivers and Challenges
Growth Drivers
- Rising occurrence of cancer: The aspect of the rapidly aging population is resulting in the increased prevalence of cancer, which is highly driving the growth of the market. According to the February 2024 WHO report, approximately there were 20 million cases of cancer and 9.7 million deaths in 2022. Besides, it is projected that there will be 35 million new cases by 2050, which is a 77% increase from 2022. Therefore, to combat this, the implementation of histone modification, RNA regulation, and DNA methylation as part of epigenetics diagnostic research is uplifting market expansion.
- Enhancement in research and development: An increase in R&D activities in the public health industry, as well as the pharmaceutical industry, is also readily amplifying the epigenetics diagnostics market globally. For instance, in January 2025, researchers from the Leuven Centre for Human Genetics (CME) have developed the latest diagnostic method that can identify both genetic and epigenetic anamolies with one single analysis. This is a huge contribution towards the market to expand internationally, offering effective possibilities to ensure the diagnosis of rare developmental disorders. This will soon be transformed into a suitable standard clinical practice, thus a driving force for the market.
Challenges
- Complex interpretation of epigenetic data: Epigenetic data is usually critical and entails substantial proficiency to precisely understand. The requirement for progressive analytical methodologies and computational tools demands highly trained professionals. Besides, the extensive diversity of epigenetic modifications owing to the multidimensional nature of epigenetic data makes it problematic to separate imperative signals. Additionally, extracting applicable perceptions that can develop remedies and acumens for diagnosis, needs specialists with a robust background in biotechnology as well as cutting-edge statistical methods, thus restraining the market growth.
- High price of epigenetic technology: The growth of the market is subjected to face another challenge catering to the implementation of innovative technology that includes maintenance, installation, and operation costs. Even though epigenetic technology has gained increased attention in nations such as Europe and North America, it is quite expensive in a few emerging economies. For instance, the huge cost of confirmatory testing for coronary heart disease (CHD) is a major barrier when it comes to providing high-quality and accessible care for all patients, as stated in the April 2024 NLM article.
Epigenetics Diagnostics Market: Key Insights
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
15.2% |
|
Base Year Market Size (2024) |
USD 17.3 billion |
|
Forecast Year Market Size (2037) |
USD 94.5 billion |
|
Regional Scope |
|
Epigenetics Diagnostics Segmentation
Application (Oncology, Non-Oncology)
In epigenetics diagnostics market, oncology segment is set to dominate revenue share of over 76.8% by 2037. Epigenetic-based research into the Human papillomaviruses (HPVs) which leads to cervical cancers and subsections of anal, oral, vulval, and penile cancers has been enhanced by the rising cases of these conditions. As per the January 2024 NLM article, 2,001,140 latest tumor cases and 611,720 deaths occurred in the United States. In addition to the rising prevalence, commercialization and innovations of advanced drugs in the upcoming years are also expected to amplify the evolution of the segment.
Product (Reagents, Kits, Instrument, Enzymes, Services)
By 2037, reagents segment is anticipated to capture epigenetics diagnostics market share of over 37.7%. Histones and DNA modifiers are two main categories of reagents that include nucleic acid reagents, buffers, primers, electrophoresis reagents, and PCR reagents. In January 2021, Adeptrix Corp declared the conclusion of its Series A investment round with Bruker Corporation as a new marginal investor. This further accelerated the commercialization of BAMS bioanalytical reagents and launched custom BAMS assay development services for pharma, clinical, and food-science customers, thus boosting the segment’s growth.
Our in-depth analysis of the global market includes the following segments:
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Application |
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Product |
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Technology |
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Customize this ReportEpigenetics Diagnostics Industry - Regional Synopsis
North America Market Analysis
By 2037, North America epigenetics diagnostics market is set to capture over 43.5% revenue share. Factors including extensive investments from governments, biotechnology, and pharmaceutical organizations are driving the demand of the market in the region. Additionally, the region comprises vastly industrialized healthcare facilities and a vigorous research ecosystem, which endorses revolution in epigenetic diagnostic technology. Also, the rising prevalence of rare or chronic disorders and probable treatment strategies are strengthening the market within the region.
The market in the U.S. is rapidly growing with the potential for the availability of personalized treatment solutions and early cancer detection strategies. In addition, the involvement of administrative bodies plays a pivotal role in the market expansion in the country. For instance, in January 2025, the U.S. FDA approved fam-trastuzumab deruxtecan-nxki for metastatic HR-positive, HER2-low, or HER2-ultralow breast cancer. This has successfully progressed on one or more endocrine therapies in the metastatic situation. Therefore, such approvals by regulatory organizations positively support the growth of the market, thereby driving its demand.
The epigenetics diagnostics market in Canada is projected to strengthen based on government funding. For instance, in the October 2020 Government of Canada report, the parliament secretary declared an investment of over USD 20 million to support developments in stem cell and recovering medicine and support genomics research. This ensures market upliftment since genomics technologies can be increasingly utilized to unveil therapeutic and diagnostic possibilities. The investment comprised USD 4.3 million for stem cell network research and USD 16 million for Genome Canada to support 10 new genomics projects. Therefore, this has effectively contributed towards the market upliftment in the country.
APAC Market Statistics
The epigenetics diagnostics market in the Asia Pacific is predicted to determine the fastest growth in the market during the forecast timeline. Factors such as the enhancement of medical tourism and investments initiated by governments within the region are bolstering the market. Moreover, the region constitutes the maximum incidence of stomach and liver cancers with prostate cancer becoming one of the foremost male cancers in a few countries. As per the May 2023 NLM article, more than 60% of gastric cancer has been prevalent in East Asia owing to lifestyle, diet, race, and genetic alterations. Thereby, this ensures a huge demand for epigenetic diagnostic solutions to cater to the population.
The market in India is eventually expanding since there has been the identification of biomarkers for heart diseases along with the development of technology for clinical detection. According to a study conducted by Environmental Advances in July 2021, DNA methylation was utilized to detect epigenetic modifications residing in high and low air pollution zones in the country. The mean levels of individuals residing in high zones ranged between 22.0% to 1.041% and for low-risk zones, it was between 16.7% to 0.8%. The study further denoted the implementation of a point-of-care epigenomic assay for human bio-monitoring, thus driving market growth.
The epigenetics diagnostics market in China is experiencing more traction since it has emerged as an influential tool for cancer discovery and customized medicine. This is possible with effective research focusing on epigenetic biomarkers for initial cancer detection and evaluation through standard treatment solutions, as well as discovering the role of epigenetics based on the use of traditional medicine. As per an article published by NLM in December 2021, epigenetic alterations act as diagnostic biomarkers for malignant lung lesions. As per the study, the QCIGISH diagnostic model established 99.1% of sensitivity and 92.1% of specificity, thus accurate enough to treat the condition and boost market growth.
Companies Dominating the Epigenetics Diagnostics Landscape
- Abcam plc.
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- Roche Diagnostics
- Thermo Fisher Scientific, Inc.
- Novartis AG
- Element Biosciences, Inc.
- Dovetail Genomics LLC.
- Illumina, Inc.
- ValiRx Plc.
- Cardio Diagnostics Holdings, Inc
- Aimil Ltd
- Illumina, Inc.
- Sangamo Therapeutics
- Oxford Nanopore
- UK Biobank
The epigenetics diagnostics market is united due to the existence of chief market players focusing on developmental strategies such as new product launches, partnerships, collaborations, mergers & acquisitions, and service expansions. For instance, in October 2023, Cardio Diagnostics Holdings, Inc. entered into a Supply and Distribution Agreement with one of India’s premier organizations, Aimil Ltd. to unveil cardiovascular epigenetic technologies in India.
The first phase of the collaboration focused on pre-marketing and laying the foundation for an effective product introduction to Aimil’s widespread healthcare network. In addition, Cardio Diagnostics and Aimil intended to further expand the Supply and Distribution Agreement after a successful phase one, to ensure that customers in India have consistent and reliable access to Cardio Diagnostics’ groundbreaking diagnostic test. Therefore, such a collaboration is effective and suitable for the market expansion internationally.
Here's the list of some key players:
In the News
- In March 2025, Sangamo Therapeutics notified two neurology license contracts with blue-chip pharma companies, including a global epigenetic guideline and capsid delivery license agreement with Genentech in August 2024 to advance innovative genomic medicines for neurodegenerative illnesses and a capsid license treaty with Astellas in December 2024 to distribute genomic medicines for up to five neurological disease targets.
- In November 2024, Oxford Nanopore and UK Biobank created the world’s first epigenetic dataset pointing out the causes of cancer, dementia, and complex diseases. This initiative mapped out epigenetic modifications across 50,000 samples to advance early detection and treatment possibilities.
- In August 2024, Illumina, Inc. declared the U.S. Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) comprehensive test and its first two companion diagnostic (CDx) indications.
Author Credits: Radhika Pawar
- Report ID: 7407
- Published Date: Mar 27, 2025
- Report Format: PDF, PPT
