EPIGENETICS DRUGS AND DIAGNOSTIC TECHNOLOGIES MARKET ANALYSIS

The global epigenetics drugs & diagnostic technologies market is estimated to be valued at US$ 11.2 billion in 2023 and is expected to exhibit a CAGR of 18.8 % during the forecast period (2023-2030).

Analysts’ views on the global epigenetics drugs & diagnostic technologies market:

The increasing prevalence of chronic diseases, new product launches, and strategies like mergers, acquisitions, and collaborations are expected to drive the global epigenetics drugs & diagnostic technologies market growth over the forecast period. For instance, according to data published by World Cancer Research Fund International, on March 23, 2022, cancer was considered as the leading cause of death worldwide, with an estimated 18.1 million cancer cases around the world in 2020. Out of these, 9.3 million cases were reported in men and 8.8 million in women. Breast and lung cancer were the most common cancer types worldwide, contributing to 12.5% and 12.2% of the total number of new cases diagnosed in 2020. Colorectal cancer was the third most common cancer with 1.9 million new cases in 2020, contributing 10.7% of new cases. Such increasing prevalence of these diseases increases the need of epigenetic drugs, which ultimately boosts the growth of global epigenetics drugs & diagnostic technologies market.

Figure 1. Global Epigenetics Drugs & Diagnostic Technologies Market Share (%), By Type, 2023

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Global Epigenetics Drugs & Diagnostic Technologies Market - Drivers

Increasing research and development activities in epigenetics

Increasing research and development in the field of epigenetics is expected to drive the global epigenetics drugs & diagnostic technologies market growth over the forecast period. For instance, according to article published in a journal, Clinical and Translational Medicine on October 3 2022, Scientist at Garvan Institute of Medical Research, an Australia-based biomedical research institute discovered new epigenetic biomarkers to predict more aggressive forms of prostate cancer. The bank of biopsies maintained for the last 20 years at Garvan and St Vincent's Hospital, allowed the researchers to analyze samples from 185 men who had their prostate removed due to a prostate cancer diagnosis in the 1990s and 2000s. The team then tracked the number of men who survived, and those who died from the disease, some more than 15 years later. The researchers looked at these genomes and identified changes on their DNA, known as DNA methylation. The methylation process can turn a gene's activity up or down without altering its DNA sequence like a mutation does.

Of those regions, 18 genes were further studied, with one standing out as a key biomarker, the CACNA2D4 gene, which is involved with calcium channel regulation. This epigenome analysis showed difference in men having lethal and non-lethal forms of prostrate cancer and these biomarkers also improved existing clinical tools for prognosis.

Increasing launch new technologies and products in epigenetics

Increasing launch of new technologies and products in epigenetics is expected to drive the global epigenetics drugs & diagnostic technologies market growth. For instance, on April 14, 2023, Biomodal, a U.K.-based life-sciences technology and analytics company, launched its new duet multiomics solution, which it says reveals the combinatorial power of genetic and epigenetic information from a single low volume sample. Duet multiomics solution +modC helps to unlock the full potential of liquid biopsies by breaking down significant barriers in the biomarker discovery research, which relies on gaining accurate, comprehensive genetic, and epigenetic data from our valuable samples. The duet multiomics solution empowers applications across many fields of disease research, delivering greater biological insights into cancer, neurodegenerative disease, aging, cell biology, and population genetics. Using cell-free DNA via liquid biopsy, duet multiomics can simultaneously detect powerful genetic and methylation biomarkers in an individual’s blood to provide unique disease insights.

Figure 2. Global Epigenetics Drugs & Diagnostic Technologies Market Share (%), By Region, 2023

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Global Epigenetics Drugs & Diagnostic Technologies Market - Regional Analysis

Among region, North America is estimated to hold a dominant position in the global epigenetics drugs & diagnostic technologies market over the forecast period, owing to increasing launches of technologies. For instance, according to an article published in Journal of Cell Biology on April 9, 2021, researchers at UC San Francisco and the Whitehead Institute, a U.S.-based non-profit research institute, described a novel CRISPR-based tool called “CRISPRoff,” which allows scientists to switch off almost any gene in human cells without making a single edit to the genetic code. The researchers also showed that once a gene is switched off, it remains inert in the cell’s descendants for hundreds of generations, unless it is switched back on with a complementary tool called CRISPRon, also described in the paper.

Global Epigenetics Drugs & Diagnostic Technologies Market - Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, the U.A.E., Egypt, and others, faced problems regarding the transportation of drugs from one place to another.

However, the COVID-19 pandemic had a positive impact on the global epigenetics drugs & diagnostic technologies market, due to increased demand of epigenetics for COVID-19 treatment. For instance, according to an article published by Global Medical Genetics on October 19, 2021, epigenetic modifications not only play an important role during the maintenance of genome and cellular homoeostasis but also for the etiopathophysiology of the virus infection. Methylation of ACE2 was changed to depend on host and age of the host during the viral infection. Hypomethylation of inflammatory genes, hypermethylation of IFN-related genes, and perturbations to the epigenetic clock and epigenetic inferred mortality risk were the major epigenetic alterations of severe COVID-19 cases. Studies showed that SARS-CoV-2 alters host epigenome in various ways. Genetic and epigenetic alterations in ACE2, TMPRSS2, IFN-related genes, and FURIN genes were an important determinant of SARS-CoV-2 cell entry of host and severity of the disease. In this point of view, reversible nature of epigenetic modifications holds promise for future studies that may block the infection activity of the virus.

Global Epigenetics Drugs & Diagnostic Technologies Market Segmentation:

The global epigenetics drugs & diagnostic technologies market report is segmented into type and region.

Based on type, the global epigenetics drugs & diagnostic technologies market is segmented into epigenetic drugs and epigenetics diagnostic technologies. Out of which, the epigenetic drugs segment is expected to dominate the market due to increasing launched of new products in DNMT Inhibitors.

Based on region, the global epigenetics drugs & diagnostic technologies market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Among these, North America segment is expected to dominate the market over the forecast period due to increasing research and development for newer epigenetic technologies in this region.

Among all segmentation, the type segment has the highest potential due to increasing fundings for launches of technologies. For instance, on January 31, 2020, Dana-Farber Cancer Institute, a U.S.-based adult and pediatric cancer treatment and research center announced the approval of the drug tazemetostat to treat epithelioid sarcomas. The U.S. Food and Drug Administration’s approval of tazemetostat, specifically for patients with advanced or metastatic epithelioid sarcoma who are not eligible for curative surgery, is the first approval of an epigenetic drug for a solid tumor. Tazemetostat targets an enzyme within the cancer cells that is overly active because a gene that usually controls it is gone. This type of indirect targeting is unusual: Most targeted drugs inhibit enzymes that are overactive because of a mutated gene or because the cell contains too many copies of the gene. Tazemetostat is an “epigenetic” drug because it alters the way these enzymes read the DNA instructions for cell division.

Global Epigenetics Drugs & Diagnostic Technologies Market Cross Sectional Analysis:

Increasing research and development activities in Europe are expected to drive growth of the type segment in the region. For instance, according to an article published by Journal of the American Chemical Society on August 31, 2022, research team from University of Freiburg, a Germany-based research institute, succeeded in characterizing the chemical changes in proteins that are typical for epigenetic modifications using nanopore analysis. Due to their special properties, they allow the structure of molecules to be analyzed within fractions of a second: As they are cylindrically arranged proteins, nanopores form tiny channels only a few millionths of a millimeter (nanometer) in diameter that can be embedded in biomembranes. In the study researchers were able to distinguish H4 fragments with or without acetylation as well as fragments with one two or three acetylation. Moreover, they succeeded in demonstrating that the nanopore they used was also sensitive to the site of acetylation. They were able to show through experiments that nanopore analytics allows us to distinguish molecules not only by their size, but also by their shape.

Global Epigenetics Drugs & Diagnostic Technologies Market: Key Developments

On October 20, 2021, Sygnature Discovery Ltd., a U.K.-based integrated Drug Discovery Clinical Research Organization announced a joint research agreement with Epigeneron, Inc., a Japan-based drug discovery and detection of gene mutation company. The collaboration is for Epigeneron’s proprietary technology, called ‘locus-specific ChIP’, to identify drug targets that regulate the expression of disease-related genes. By conducting drug discovery research for new drug candidate molecules on the novel drug targets identified by this technology, the company will contribute to the discovery of ‘novel drugs’ originating from Japan.

On February 23, 2022, Element Biosciences, a U.S.-based multi-disciplinary startup focused on innovating genetic analysis tools for the research and diagnostic markets, announced a partnership with Dovetail Genomics LLC, a U.S.-based biotechnology company demonstrating the value and performance of Dovetail’s proximity ligation-based Next-generation Sequencing (NGS) library prep solutions on Element’s AVITI System. The aim of the partnership with Dovetail Genomics is to deliver seamless compatibility between the AVITI System and Dovetail’s library preparation kits. Their proximity ligation technology couples well with Element Biosciences’s improvements in sequencing accuracy, lower optical duplication rate, and consistency of data, across a range of applications

On February 22, 2022,  Zenith Epigenetics, a Canada-based clinical-stage biotechnology company, announced dosing of first cancer patient with a combination of ZEN-3694 + Bristol Myers Squibb’s Immune Checkpoint Inhibitor OPDIVO and YERVOY, in a National Cancer Institute (NCI), a U.S.-based government  cancer research institute sponsored trial in solid tumor cancer. The trial will be conducted by NCI funded investigators and will evaluate the safety and activity of this combination in patients with solid tumors that have become resistant to other therapies. This Phase 1/1b clinical trial will also evaluate a triple combination of ZEN-3694 + OPDIVO + YERVOY (an inhibitor of another immune checkpoints, CTLA4). Upon determination of a dosing regimen of the aforementioned double and triple combination, the trial will be expanded to ovarian cancer patients who have progressed on platinum-based chemotherapy. This collaboration supplements our ongoing company sponsored Phase 2b trials in prostate cancer and breast cancer by significantly broadening the evaluation and development of ZEN-3694 into multiple other tumor types.

On January 25, 2022, Active Motif Inc., a Germany-based biotechnology company, announced the acquisition of Amaryllis Nucleics, a U.S.-based cancer diagnostics and pharmaceutical development company, and their proprietary RNASeq workflow. Amaryllis Nucleics provides Active Motif with a streamlined, low-cost library preparation method to perform high-efficiency RNA sequencing using their intellectual property associated with 3’ Digital Gene Expression. The technology utilizes a novel synthesis chemistry that is twice as fast from RNA to library prep compared to other methods, is less expensive, and shows greater than 99% strand-specificity. Amaryllis’ service business as well as their 3’ DGE RNA Library Prep Kit will be integrated into the Active Motif portfolio.

Global Epigenetics Drugs & Diagnostic Technologies Market: Market Trends

 Launch of newer epigenetics technologies

Launch of newer epigenetics technologies can drive growth of market. For instance, on February 24, 2021, Twist Bioscience, a U.S.-based semiconductor-based synthetic DNA manufacturing company announced the launch of Twist NGS Methylation Detection System, a robust, end-to-end sample preparation and target enrichment solution for identifying methylated regions in the human genome. In partnership with New England Biolabs, a U.S. based recombinant and native enzyme reagents supplier, it has developed a state-of-the-art system, to identify and accurately evaluate methylation patterns that enable our customers to create better tests and/or conduct research more efficiently. In addition, the superior results produced through this system provide incentive for customers using SNP microarray technology to switch to using Twist products plus sequencing.Acquisition strategy by key market players

Strategies like acquisitions by key market players can drive the market growth. For instance, on October 27, 2020, Exact Sciences, a U.S.-based biotechnology research company, and Thrive Earlier Detection Corp., a U.S.-based healthcare company, announced they have entered into a definitive agreement under which Exact Sciences will acquire Thrive Earlier Detection Corp  for cash and stock consideration of up to US$ 2.15 billion. Combining Thrive Earlier Detection Corp’s pioneering early-stage screening test, CancerSEEK, with Exact Sciences' scientific platform, clinical organization, and commercial infrastructure can establish exact sciences as a leading competitor in blood-based, multi-cancer screening.

Global Epigenetics Drugs & Diagnostic Technologies Market: Restraints

High cost of the epigenetic technique

The high cost of epigenetic technique is expected to hamper the global epigenetics drugs & diagnostic technologies market growth. For instance, according to an article published by Journal of Current Oncology Reports on January 26, 2022, cost of ConfirmMDx, tumor based molecular assay for localized prostate cancer is US$ 200 per individual core and slightly over. The total 1-year cost of repeated prostate cancer biopsies to the health plan was found to be nearly US$ 2,864,142. Such high costs can impact negatively on growth of market.

To counterbalance this restraint, reimbursement policies should be introduced by government.

Lack of infrastructure for epigenetics study

Lack of Infrastructure for epigenetics study is expected to hamper the global epigenetics drugs & diagnostic technologies market growth. For instance, according to an article published in Journal Biomedicines on September 18, 2021, existing preclinical and clinical studies are providing evidence that epigenetic mechanisms, such as DNA methylation and histone modifications, play crucial roles in several metabolic diseases. Since epigenetics applied to metabolic diseases is a relatively new field of investigation, a significant limitation is the current preclinical models which make it difficult to study the interplay between diet and epigenetic changes. The animal models used in study, diet used in animal study, ability of animal system to represent only specific aspect of disease rather than the whole spectrum, set of conditions that we use to measure response, the parameters that are considered and the technically difficult invasive procedures to get biopsies are also few limitations.

To counterbalance this restrain, accurate animal models should be used for epigenetics study.

Global Epigenetics Drugs & Diagnostic Technologies Market - Key Players

The major players operating in the global epigenetics drugs & diagnostic technologies market include Regenacy Pharmaceuticals, Inc., Astex Pharmaceuticals, 4SC AG, CellCentric Ltd., Celleron Therapeutics Ltd., Bristol-Myers Squibb Company, Oryzon Genomics S.A., ChromaMedicine, Inc., Epizyme, Inc., and EpiGentek Group Inc.

*Definition: Epigenetics is the study of chemical modifications of specific genes of an organism. Epigenetic drugs are used to reverse abnormal gene expression which leads to different types of diseases such as cancer, heart disease, diabetes, and mental illnesses. The increasing prevalence of cancer, increasing research and development for new drug molecule, and rising investments in the biotechnology industry are increasing the need for epigenetics.