Epigenetics Diagnostic Market Size, Share & Trends Analysis Report By Technology, By Product (Reagents, Kits, Instruments), By Application (Oncology, Non-oncology), By Region, And Segment Forecasts, 2019 - 2026

Industry Insights

The global epigenetics diagnostic market size was valued at USD 5.5 billion in 2018 and is estimated to register a CAGR of 18.8% over the forecast period. Increasing prevalence of cancer and other chronic diseases and the growing geriatric population are some of the key factors expected to drive the market.

The presence of organizations such as the International Human Epigenome Consortium (IHEC), the National Cancer Institute (NCI), and the National Institute of Health (NIH) is expected to fuel the market growth. These organizations promote funding and support R&D and product development exercises pertaining to the field of epigenetics. The NIH funds epigenetics research through the Common fund epigenomics program, which actively supports new epigenetic research worldwide. 

Growing need to understand the epigenetic modifications at the molecular level and development of therapeutic solutions is anticipated to motivate these organizations to fund research and development programs. In addition, endeavors such as the Epidemiology and Genomics Research Program (EGRP) in the NCI's Division of Cancer grants research initiatives owing to novel epigenetic research that serves as a driving force of the market.

According to the NIH, the estimated number of cancer deaths in the U.S. is 171.2 per 100,000 men and women per year. Incidence rate, mortality and survival statistics, information on cancer symptoms, risk factors, early detection, and early treatment are the key factors for its high prevalence. The International Cancer Genome Consortium (ICGC) is focusing on obtaining the genomic description, epigenomic changes, and transcriptomic changes in different types of tumors.

The Encyclopedia of DNA Elements (ENCODE) project was launched by the U.S. National Human Genome Research Institute with an objective to identify all the human genome sequence functional elements. The International Human Epigenome Consortium (IHEC), built by the NIH is also involved in the development of epigenomic data generation and analysis, which can be made useful for epigenomic researchers. Majorly, epigenetics research is focusing on the identification of treatment options for various types of tumors.

Product Insights

The reagents segment dominated the epigenetics diagnostic market in 2018. Histone and DNA modifiers are the major types of reagents used for epigenetics. Epigenetic reagents are segmented into antibodies, PCR reagents, histones, primers, electrophoresis reagents, nucleic acid analysis reagents, and buffers. PyroMark Q24 is one of the advanced reagents featuring advanced pyrosequencing chemistry to provide even better real-time sequence-based detection and quantification than before.

Existence of a number of technology platforms facilitates analysis at the gene, protein, or cellular levels, which leads to innovation in epigenetic reagents. The polymerase chain reaction (PCR) established a platform for genomic. Gene regulation is impacted by epigenetic factors such as chromatin structure, DNA methylation, and non-coding RNAs. The life sciences and analytical tools market is mostly driven by the widespread use of reagents.

The kits product segment is likely to emerge as the fastest-growing segment over the forecast period. The ready-to-use kits are manufactured by many biotechnology companies for the detection of epigenetic modifications. Kits available in the market range from kits for nucleic acid purification, analysis of DNA methylation status, and detection of histone modifications by various enzymes to kits for chromatin immunoprecipitation. Epigenetic diagnostic kits are used for the diagnosis of disorders due to epigenetic modifications in the early stages and during treatment to check the efficacy of therapeutics. They work on the basis of immunoprecipitation by the involvement of modification-specific monoclonal antibodies.

Technology Insights

DNA methylation emerged as the largest segment in 2018. It is the covalent addition of a methyl group in the cytosine ring, which leads to inhibition of transcription. Sensitive bisulphite modification, followed by PCR, is performed called Methylation Sensitive PCR (MSP).

Real-time PCR for methylation detection, methyl light, and quantitative analysis of methylated alleles are the variations of MSP. Currently, quantitative methods such as allele-specific bisulphite sequencing, southern-based method, bisulphite pyrosequencing, and bisulphite PCR, followed by MALDI-TOF MS are also useful for DNA methylation. Advancement of technologies is increasingly enabling the assessment of locus-specific DNA methylation on a genome-wide scale.

Histone Acetylation is expected to witness the fastest growth over the forecast period owing to their enhanced efficacy, which could be attributed to the introduction of novel mechanisms. Histone acetylation is the enzymatic incorporation of an acetyl group to lysine residues. Histone acetylation is involved in the control of cellular processes such as gene silencing, chromatin transcription and dynamics, the progression of the cell cycle, differentiation, apoptosis, DNA replication, neuronal repression, nuclear import, and DNA repair. The enzymes involved in histone acetylation are Histone Acetyl Transferases (HATs) and the enzymes involved in deacetylation are histone deacetylases (HDACs).

Application Insights

Oncology dominated the overall market in 2018 accounting for 69.6% share of the overall revenue. Increasing prevalence of cancer worldwide, along with increasing deaths due to cancer, is expected to be a high-impact rendering driver in the market. Moreover, this segment is expected to gain a major revenue share over the forecast period owing to the introduction of new products and potential future commercialization of products currently in the pipeline.

Hypermethylation and epigenetic silencing are known as epimutations, occurring due to epigenetic changes. Epimutations have been known to be involved in the etiology of cancers. Extensive R&D is carried out for detecting epimutations, specifically related to the silencing of tumor suppressor genes and activation of oncogenes. Unlike regular mutations, epimutations are reversible in nature.

Non-oncology is estimated to be the fastest-growing segment owing to rigorous R&D initiatives undertaken by private institutions and biopharmaceutical companies for the identification of epigenetic markers related to these disorders. Epigenetic modifications have been proved to be the base of many non-oncology disorders, such as metabolic disorders, neurodegenerative disorders, and infectious diseases. Extensive research is undertaken by private institutions and biopharmaceutical companies for the detection of biomarkers for drug development.

Regional Insights

North America emerged as the dominant regional market in 2018. Prominent drivers in the market are the presence of advanced technological facilities, successful initiatives, constantly increasing geriatric population, improved healthcare facilities, government funding for ongoing research activities on epigenetics, diligent research, and accurate diagnostic procedures.

In addition, the Common Fund-supported programs in the U.S. are expected to boost the epigenetic research activities covering a diversified range of diseases including oncology and non-oncology diseases, such as cardiovascular, metabolic, and inflammatory.

Asia Pacific is estimated to witness the fastest growth over the forecast period owing to rising disposable income, high unmet clinical needs of patients, rising awareness about early diagnosis, and availability of effective treatment in emerging countries, such as India and China. Asia Pacific is in limelight due to increasing cases of various types of cancers.

Increasing cases of oncology as well as chronic diseases due to growth in the geriatric population are expected to further enhance the market growth. R&D initiatives related to the analysis of epigenetic base in various diseases are increasing in this region. EpiGen Research Consortium based in U.K. has extended its research facility in Singapore for research on chronic diseases, such as diabetes and obesity.

Epigenetics Diagnostic Market Share Insights

Key players in this industry are Roche Diagnostics; Thermo Fisher Scientific, Inc.; Eisai Co. Ltd.; and Novartis AG. Major players are focusing on expanding their businesses in developing regions to increase their market share.

In addition, they are adopting strategies such as mergers and acquisitions and development of new products. For instance, in March 2015, Illumina, Inc. collaborated with Merck Serono to develop a universal next-sequencing-based oncology diagnostic.

Report Scope

Segments Covered in the Report:

This report forecasts revenue and volume growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2026. For the purpose of this study, Grand View Research has segmented the global epigenetics diagnostic market report on the basis of product, technology, application, and region:

• Product Outlook (Revenue, USD Million, 2014 - 2026)

  • Reagents

  • Kits

    • ChIP Sequencing Kit

    • Whole Genomic Amplification Kit

    • Bisulfite Conversion Kit

    • RNA Sequencing Kit

    • Others

  • Instruments

  • Enzymes

  • Services

• Technology Outlook (Revenue, USD Million, 2014 - 2026)

  • DNA Methylation

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

  • Histone Methylation

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

  • Histone Acetylation

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

  • Large non-coding RNA

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

  • MicroRNA Modification

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

  • Chromatin structures

    • Reagents

    • Kits

    • Instruments

    • Enzymes

    • Services

• Application Outlook (Revenue, USD Million, 2014 - 2026)

  • Oncology

    • Solid Tumors

    • Liquid Tumors

  • Non-oncology

    • Inflammatory Diseases

    • Metabolic Diseases

    • Infectious Diseases

    • Cardiovascular Diseases

    • Others

• Regional Outlook (Revenue, USD Million, 2014 - 2026)

  • North America

    • The U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Spain

    • France

    • Italy

    • Russia

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Singapore

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • United Arab Emirates

    • Saudi Arabia