The personalized medicine biomarkers market size is estimated to be USD 11,985.2 million in 2022 and is expected to witness a CAGR of 15.86% during the forecast period 2023-2033. Technological advances in the development of biomarkers and rise in usage of diagnostics to determine the effect of a biomarker are projected to drive the market growth in near future. Furthermore, increase in chronic disease prevalence, rising demand for personalised medicine, and technical developments in the diagnosis and detection of chronic diseases are other factors supporting the market growth. However, high price of personalized medicine and lack of awareness are predicted to limit market growth are expected to restrain the market growth.

Technological advances in the development of biomarkers is expected to propel the market growth during the forecast period. As the need for individualised therapy increases significantly, technological advances in the discovery of biomarkers are increasing quickly. As reimbursement regulations have a direct effect on the growth and improvement of diagnostic and prognostic instruments, this can push manufacturers to invest in new technologies.

Rise in usage of diagnostics to determine the effect of a biomarker is predicted to fuel the market growth during the projected period. The FDA’s Center for Devices and Radiological Health (CDRH) approved numerous applications for in vitro diagnostic testing in 2021 that support personalized treatment approaches. The tests manual concentrated on the selection of treatments to improve drug efficacy and safety through new approvals and broader indications. For instance, in May 2020, FoundationOne CDx received approval to diagnose MET exon 14 skipping mutations in order to guide treatment choices for non-small cell lung cancer using Tabrecta. Additionally, in September 2021, Therascreen KRAS RGQ PCR Kit received approval for use in making decisions on Lumakras for the treatment of non-small cell lung cancer.

Segmentation

By Indication

The market is categorized into neurology, oncology, cardiology, diabetes, autoimmune diseases, and others. In 2022, the oncology segment accounted for the highest revenue share due to the growing use of biomarker-based testing for early detection and treatment selection in personalized medicine. The selection of proper treatment options frequently improves patient health. For instance, the Oncotype DX test may evaluate the activity of 21 different genes to forecast whether chemotherapy will be appropriate in cases of breast cancer. Personalized medicine biomarkers present great opportunities in this area of medicine due to their important function in assisting physicians in selecting the best course of action. EpiSwitch Explorer is an array kit that may be used for biomarker identification and is an essential part in the development of customized medicine. In March 2021, Oxford BioDynamics signed a reseller and supply agreement with Agilent Technologies, Inc.

By Application

The market is categorized into diagnosis, early detection/screening, monitoring, and treatment selection. In the global market, the treatment selection segment accounted for the largest revenue share in 2022 owing to the fact that personalized medicine biomarkers assist in selecting the best individuals for early-phase clinical trials based on the molecular characteristics of the tumor. They also offer details on a particular medicine’s mechanism of action. The identification of specific mutations that effectively perform the prediction for a given drug in a molecularly defined patient group has led to a shift in the focus of oncology drug development programmes away from the development of non-specific cytotoxic chemotherapies and toward the development of molecularly targeted therapeutics. The early detection/screening segment is anticipated to have profitable growth during the projection period. The requirement for early treatment can be attributed to the segment’s expansion. The course of therapy affects the probability of survival for patients who exhibit the biomarker connected to a therapy’s response. For instance, the HER2/neu protein expression is a predictive biomarker of breast cancer.

Regional Markets

In 2022, North America region accounted for the highest revenue in the personalized medicine biomarkers market and is expected to maintain its dominance during the forecast period. This is attributed to rising funding for biomarkers. Technology improvements, high discretionary income, and the existence of significant market players operating in the area all contribute to this. The U.S. held the highest share of personalised medicine in the area due to rising private and public initiatives and strong public knowledge of chronic diseases and treatments. In order to maintain their market supremacy, major players are also focusing on creating new products. To identify patients with solid tumours with high levels of microsatellite instability, FoundationOne CDx, a companion diagnostic for Keytruda, was authorised by the FDA in February 2022. Asia Pacific is anticipated to experience the fastest growth over the forecast period. The region’s expanding healthcare reforms are to accountable for the market’s expansion. A larger population, improved healthcare facilities, and more companies entering the market all contribute to this

Competitor Insights

Some of the key players operating in the personalized medicine biomarkers market are NeoGenomics Laboratories, Quest Diagnostics Incorporated, FOUNDATION MEDICINE, INC, Thermo Fisher Scientific Inc., Illumina, Inc., Laboratory Corporation of America Holding, Coriell Life Sciences., Agilent Technologies, Inc., Genome Medical, Inc., and Guardant Health.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, in June 2022, GRAIL and AstraZeneca established a strategic alliance to develop additional diagnostic tests that would enable the management of early-stage cancer.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including indication and application from 2022 to 2033.

Report Scope:

Segmentation: Personalized Medicine Biomarkers Market Report 2022 – 2033

Indication (Revenue, USD Million), 2022 – 2033

• Neurology
• Oncology
• Cardiology
• Diabetes
• Autoimmune Diseases
• Others

Application (Revenue, USD Million), 2022 – 2033

• Diagnosis
• Early Detection/Screening
• Monitoring
• Treatment Selection

By Region (Revenue, USD Million), 2022 – 2033

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA