Biomarker Test Market Analysis

Global Biomarker Tests Market Overview

Biomarker Tests Market Size was valued at USD 1.96.5 billion in 2022. The biomarker tests industry is projected to grow from USD 209.076 Billion in 2023 to USD 3.9 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 4.2% during the forecast period (2023 - 2032). Growth in the business is predicted to be fueled by an increase in cancer prevalence, rising investments in biomarker research and substantial advancements due to continuing research are the key market drivers enhancing the market growth.

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

One of the main factors propelling the market's expansion is the rising demand for biomarkers in diagnosis, the awareness of biomarkers among researchers, and the strong demand among pharmaceutical and biopharmaceutical businesses for outsourcing biomarker testing services. The majority of research was carried out for COVID-19 during the epidemic. Diagnostic markets are experiencing rising demand. Today's market demands early diagnosis with precise and in-line outcomes, as opposed to conventional diagnostic equipment' concentration on delivering accurate and consistent results. Accurate results in the initial phases of diseases, particularly in the case of cancer, present considerable problems. Diagnostic biomarkers are technologies that require little to no invasiveness. The market expectations are being met by biomarkers when combined with important imaging and data administration technologies, but drawbacks exist.

Imaging technology uses biomarkers to produce clear images of cancer tumors and other issues while removing the possibility of radiation exposure through imaging via CT and MRI scans. The necessity for a secure and efficient therapy for all the novel viral types is developing; hence, clinical research on COVID-19 treatments is still being done. In clinical investigations, the need for biomarkers is expanding. These different categories of disease-specific biomarkers enable quicker and more precise disease detection. In 2018, the FDA approved 40.0% of personalized medications based on biomarkers, increasing demand for developing and validating biomarker assays. Increasingly, many people need companion diagnostics like immunohistochemistry kits for testing biomarkers in cancer diseases. As a result, clinical drug trials take less time, and developing new medicines moves along more quickly. Since they may detect changes in a cell's genetic makeup, biomarker testing services are often used to develop cancer medications. These benefits of biomarkers are anticipated to boost the market's expansion throughout the anticipated period.

The US Patent and Trademark Office has granted Cleo Diagnostics a patent for its novel ovarian cancer biomarker. The Proteins and Compositions of the CXCL10 Binding This patent covers Cleo's exclusive biomarkers and antibody compositions, which are key components of the business's blood test for ovarian cancer. This patent portfolio concentrates on methods for identifying an illness, such as cancer, and binding proteins for CXCL10, a chemokine ligand with a CXC motif. This comprises the assessment of the CXCL10 level in a subject.

In July 2023, Quest Diagnostics introduced a prostate cancer biomarker test designed to improve the accuracy of biopsy grading. Accurate tissue interpretation and grading are critical components in the diagnosis and care of patients diagnosed with prostate cancer. However, there is a possibility that appearance and reality do not correspond in terms of biology. This year, however, Australian researchers claimed to have created a panel that could "transform clinical practice" through the identification of biomarkers that characterize the biology of prostate cancer.

In September 2023, Oxford BioDynamics, Plc, a biotechnology firm specializing in the development of precision medicine tests utilizing the EpiSwitch® 3D genomics platform, declared the clinical laboratory validation of its EpiSwitch Prostate Screening (PSE) blood test. This development grants men who are at risk of developing prostate cancer prompt access to the exceedingly precise PSE test. The PSE test combines the PSA score with five epigenetic biomarkers to ascertain the presence or absence of prostate cancer. Patients who receive active monitoring and reassessment at a later time are not routinely referred for a destructive and invasive biopsy based on PSE results indicating a low risk of cancer. Therapy would almost certainly necessitate an appointment with a urologist.

In July 2023, LucentAD, a diagnostic tool utilized in the assessment of individuals exhibiting cognitive symptoms that align with the initial indications of Alzheimer's disease (AD), was introduced by Quanterix Corporation. This organization utilizes ultrasensitive biomarker detection to propel scientific progress and pioneering diagnostics. The LucentAD test, when utilized in conjunction with other diagnostic techniques, enables physicians to efficiently and promptly ascertain whether a patient exhibits amyloid pathology that is characteristic of Alzheimer's disease.

Biomarker Tests Market Trends

• Expanding Diagnostic Uses of Biomarkers to drive market growth

Biomarkers are widely utilized in personalized medicine, companion diagnostics, disease risk assessment, and medication development. Over the forecast period of 2019–2030, one of the key drivers anticipated to propel market growth is the increasing utilization of biomarkers in disease diagnostics. biomarkers technologies are important in personalized medicine because they may be used for many purposes, including diagnosis, prognosis, and tailored treatments for many different illness conditions. Due to several restrictions in diagnosing and treating conventional diseases, personalized medicine has gained recognition. One of the main factors driving the need for biomarkers, and hence the market's growth, is the increasing desire for customized treatment.

For Instance, Selzentry treats patients with the Trofile test. Pfizer created a chemokine receptor antagonist called Selzentry (Maraviroc) to treat HIV, which had a quick response. Another element boosting market expansion is the growing investment made in companion diagnostics by several major industrial companies. Therefore, Effective medicines for the treatment of several diseases, including cancer, cardiovascular disorders, immunological diseases, and neurological diseases, are being developed with the help of research that has recently enhanced the biomarker tests market CAGR across the globe years.

For instance, the National Institutes of Health awarded Boston University researchers USD 4.6 million in funding in October 2022 to develop novel lung cancer biomarkers. Technology developments in the creation of biomarker-based diagnostics are also a component in the industry's growth, another factor driving the growth of the biomarker tests revenue.

Biomarker Tests Market Segment Insights

Biomarker Tests Device Application Insights

Based on application, the biomarker tests segmentation includes cancer, cardiovascular, infectious diseases, central nervous systems, and others. In 2022, the cancer segment produced around 36.60% of the overall revenue, and it is estimated that it will maintain its dominance throughout the projected time. The biomarker tests market is growing due to the rising need for rapid and accurate diagnostic tools and the rise in cancer occurrence ly. According to estimates from the  Cancer Observatory, there were around 10 million cancer deaths and 19.3 million new cancer cases in the same year. In middle- and low-income countries, about 70% of all cancer-related fatalities occur, making cancer the second most prevalent cause of death ly.

The cardiovascular segment holds the second-largest revenue share for disease management to employ biomarkers to identify cancer, determine prognosis, track therapy response, and look for the emergence of drug resistance. Moreover, it is projected that the industry would be driven by a rise in the need for tailored medications and expanding partnerships between pharmaceutical and diagnostic businesses, which saw the greatest growth rate of XX% of biomarker tests revenue.

October 2021 DarwinHealth and Prelude Therapeutics have collaborated scientifically on creating new biomarkers for several cancer candidates. In 2022, the sector for cardiovascular illnesses had the second-largest revenue share.

June 2021 Tempus expanded its multi-year partnership with Janssen to support AI/ML and practical data in advancing the research and discovery of cancer treatments. Identifying individuals who could benefit from therapy was the aim of the biomarker collaboration, which would help in the early identification of illness and enhance patient outcomes. The category of customized medications is expected to grow at the fastest pace throughout the predicted years. According to a new study published today in Circulation, the premier journal of the American Heart Association, patients with Type 2 diabetes and renal disease may be able to forecast their risk of developing progressive cardiac and kidney disease using a straightforward blood test. Medical experts frequently measure biomarkers to detect, identify, or treat certain diseases. According to earlier studies, some biomarker concentrations may be able to predict the initiation and progression of cardiovascular events in Type 2 diabetics as well as the development of chronic renal disease. To determine the effects of canagliflozin on amounts of the four biomarkers at the beginning of the study, the researchers examined biomarker data from the blood samples of 2,627 participants in the Canagliflozin and Renal Events in Diabetes alongside Established Nephropathy Clinical Evaluation (CREDENCE) trial.

Biomarker Tests End User Insights

Based on End Users, the biomarker tests industry has been segmented into Pharma & Biotech Companies, Diagnostic Tools Companies, Healthcare It/ Big Data Companies, and Clinical Laboratories. The Diagnostics Tools Companies segment is expected to have the highest end-user share. Some of the key elements anticipated to propel the growth of the diagnostics and research laboratories segment during the forecast period include investments made by major market players in the development of novel biomarkers for diagnostic and therapeutic uses, as well as significant grants provided by public and private organizations for drug discovery and development. For instance, Empire Genomics, LLC provides researchers and doctors with grants totaling US$250,000 for creating and validating novel cancer biomarkers.

Additionally, the pharma & biotech companies category is projected to expand due to the rising use of customized medicine for chronic illnesses, high pharmacogenomics penetration, and rising awareness of personalized medicine among healthcare professionals, pharma & biotech companies held the largest segment share in 2022.

The third fastest-growing segment in the biomarker tests industry is clinical laboratories. Significant R&D efforts by top players, increasing use of biomarkers in drug development, and ongoing strategic partnerships in biomarkers discovery have contributed to the segment's rise. For instance, InterVenn Biosciences worked with the Worldwide Innovative Network (WIN) Consortium and the Foundation for the National Institutes of Health's Biomarker Consortium in June 2022.

Figure 2 Biomarker Tests Market, by End-User, 2022 & 2030 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Biomarker Tests Regional Insights

By Region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. North America held the largest market share with 45.80% because of the high prevalence of diseases, growing consumer knowledge of biomarkers, encouraging government programs, technical breakthroughs, and improvements in the healthcare system. A significant element anticipated to fuel the region's growth is the presence of prominent firms in this area and the many organic and inorganic projects they have undertaken. For Instance, Akoya Biosciences, Inc. declared the release of PhenoCode signature panels for high-throughput spatial biomarker identification in November 2022.

Further, the major countries studied in the market report are The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3 Biomarker Tests Market SHARE BY REGION 2022 (%)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe biomarker tests account for the second-largest market share due to the entry of  players in the region, along with the regional and national agencies emphasizing providing advanced tests and developed healthcare infrastructure to the patients to the patients driving the demand for biomarker-based tests in these regions. . Further, the UK biomarker tests held the largest market share, and the Germany biomarker tests were the fastest-growing market.

The Asia Pacific Biomarker Tests Market is expected to grow at the highest CAGR from 2022 to 2030. This is due to regional expansion is anticipated to be supported by elements including a rise in financing for the discovery of biomarkers, a high cancer prevalence, expanding research activities, and affordable clinical trials in emerging countries. Further, the China biomarker tests held the largest market share, and the India biomarker tests were the fastest-growing market in Asia.

For instance, the American Cancer Society predicts that in 2022, 1,918,030 new cancer cases will be recorded. The need for biomarkers is anticipated to rise in the nation since they have several uses in detecting and treating cancer. Furthermore, there is a demand for efficient and precise biomarkers due to the rising prevalence of chronic illnesses in the United States.

Biomarker Tests Key Market Players & Competitive Insights

Major market players spend a lot of money on research and development to expand their product offerings, which will spur further growth in biomarker tests. With significant market developments like introducing new products, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations, market participants are also undertaking various strategic initiatives to expand their footprint. To grow and thrive in a market that is ever more competitive and growing, competitors in the biomarker testing industry must provide affordable products.

One of the most common business methods firms use in the biomarker tests industry to benefit clients and expand the market sector is manufacturing locally to reduce operating costs. In recent years, biomarker tests industry has provided medicine with some of the most significant benefits. The biomarker tests major players such as Hoffmann-La Roche AG, Novartis AG, Pfizer Inc., GlaxoSmithKline plc, and others working on expanding the market demand by investing in research and development activities.

Hoffmann-La Roche AG is a multinational pharmaceutical company based in Basel, Switzerland. Roche's business is divided into two main segments Pharmaceuticals and Diagnostics. The Pharmaceuticals division is responsible for developing, manufacturing, and marketing innovative drugs in oncology, neuroscience, immunology, infectious diseases, ophthalmology, and respiratory diseases. For Instance, In April 2021, Using Elecsys technology, F. Hoffmann La Roche Ltd. unveiled a set of five new applications for its cardiac biomarkers. These biomarkers have successfully supported the therapy of cardiovascular disease.

Also, QIAGEN N.V. is a biotech company based in the Netherlands that provides sample and assay technologies for molecular diagnostics, applied testing, and academic and pharmaceutical research.   QIAGEN's products are used in various applications, including genetic testing, forensics, food safety testing, and infectious disease research. In May 2021, The debut of QIAGEN N.V.'s FDA-approved tissue companion diagnostic to detect the KRAS G12C mutation in NSCLC tumors will enable them to broaden their lung cancer precision medicine portfolio.

Key Companies in the biomarker tests includes

• Hoffmann-La Roche AG


• Novartis AG


• Pfizer Inc.


• GlaxoSmithKline plc


• GE Healthcare


• Medtronic plc


• Quest Diagnostics, among others

Biomarker Tests Industry Developments

February 2022 The "Neurofilament as a Fluid Biomarker of Neurodegeneration in Familial Frontotemporal Degeneration (FTD)" project, which the Foundation recently launched for the National Institutes of Health (FNIH) Biomarkers Consortium, will determine the most effective blood tests for measuring a protein that is essential for the early detection of rare neurodegenerative diseases.

February 2022 The OncoDEEP kit was introduced by the genomic and pharmaceutical business OncoDNA. With the use of the kit, laboratories with NGS capabilities may do thorough biomarker testing, offer powerful data analysis, and assist oncologists in providing the most efficient and individualized cancer therapies.

Biomarker Tests Market Segmentation

Biomarker Tests Device Type Outlook

• Cancer


• Cardiovascular


• Infectious Diseases


• Central Nervous Systems


• Others

Biomarker Tests End User Outlook

• Pharma & Biotech Companies


• Diagnostic Tooln Companies


• Healthcare It/ Big Data Companies


• Clinical Laboratories

Biomarker Tests Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America