The global personalized medicine biomarkers market size is estimated to reach USD 47.16 billion by 2030, registering a CAGR of 13.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. The growth is attributed to the rising awareness, importance of predicting prognosis, and selection of dose. Moreover, personalized medicine biomarkers serve as an essential tool for the selection of patients and providing the right treatment to the right patient further propelling the demand for personalized medicine biomarkers.
Biomarkers are unique analytes that can be utilized to improve diagnosis forecast treatment outcomes and direct treatment decisions. They are crucial to personalized medicine. The increased usage of biomarkers to enhance patient outcomes is popular in clinical trials, and its use in clinical practice is expanding quickly. The development of personalized medicines using biomarkers is expected to create effective and safe therapies for every patient. This is a major relief for patients at advanced stages of chronic diseases like cancer, which further drives the market growth. For instance, in August 2022, VENTANA MMR RxDx Panel, an FDA approved first IHC-based assay used for the identification of patients with advanced cancer that is Pembrolizumab treatment eligible.
Early detection/screening biomarkers predict the outcome of disease in patient population prior to therapy. It can also help enrich clinical trials by helping choose patients more likely to respond to treatment. For instance, Oncotype Dx is a diagnostic test developed by Genomic Health, Inc. This test examines 21 genes and helps predict the likelihood of reoccurrence of breast cancer in a patient after initial treatment. In April 2022, updated ASCO guidelines recommended the usage of the Oncotype DX test for breast cancer patients at early stages to guide treatment decisions.
Moreover, biomarkers are used for their predictive and prognostic utility that helps predict the occurrence of a health condition. For instance, the prostate-specific antigen is used to predict the survival of patients with prostate cancer. CRP is used to predict disease-free survival in breast cancer and as a risk factor in cardiovascular disorders. Serum LDH helps predict survival in case of metastatic brain tumors. Similarly, CA125 helps predict metastatic diseases in patients with uterine carcinoma.
Furthermore, key players operating in the personalized medicine biomarkers industry are focusing on expanding and launching products that can be used for a wide range of applications. For instance, in October 2021, Agilent Technologies Inc. received FDA approval for Agilent Ki-67 IHC MIB-1 pharmDx (Dako Omnis), for the identification of patients with a high risk of breast cancer recurrence.
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Based on application, the early detection/screening segment is expected to grow at the fastest CAGR owing to the need to provide early treatment to patients.
By indication, the oncology segment held the largest market share in 2024, owing to the rising prevalence of cancer and the wide availability of FDA-approved personalized biomarkers tests for cancer
North America held the largest market share attributable to the presence of improved healthcare infrastructure, rising prevalence of target diseases, and increasing government funding for innovation in biomarkers.
Grand View Research has segmented the global personalized medicine biomarkers market on the basis of application, indication, and region:
Personalized Medicine Biomarkers Application Outlook (Revenue, USD Million, 2018 - 2030)
Early Detection/Screening
Diagnosis
Treatment Selection
Monitoring
Personalized Medicine Biomarkers Indication Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
By Type
Breast Cancer
Lung Cancer
Colon Cancer
Others
By Circulating Biomarkers
Circulating Tumor Cells(CTCs)
Circulating Cell-free DNA(cfDNA)
Extracellular Vesicles (EVs)
Other Circulating Biomarkers
Neurology
Diabetes
Autoimmune Diseases
Cardiology
Others
Personalized Medicine Biomarkers Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Sweden
Norway
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
Middle East and Africa (MEA)
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players in the Personalized Medicine Biomarkers Market
Laboratory Corporation of America Holding
Quest Diagnostics Incorporated
Agilent Technologies, Inc.
Genome Medical, Inc.
Coriell Life Sciences.
Thermo Fisher Scientific Inc.
NeoGenomics Laboratories
FOUNDATION MEDICINE, INC.
Illumina, Inc.
Guardant Health
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