Personalized Medicine Biomarkers Market Size, Share & Trends Analysis Report By Application (Early Detection, Diagnostics), By Indication (Oncology, Neurology), By Test Location, By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

According to Nova one advisor, the global Personalized Medicine Biomarkers market size is evaluated at USD 12.76 billion in 2022 and is expected to hit around USD 43.19 billion by 2030, growing at a CAGR of 15.59% from 2022 to 2030. 

Key Takeaways:

  • By Application, the U.S. Personalized Medicine Biomarkers market was valued at USD 4.9 Billion in 2021 and expected to witness growth at a CAGR of 14.11% from 2022 to 2030.
  • Early detection/screening segment is expected to grow at the fastest CAGR owing to the need to provide early treatment to patients
  • Oncology segment held the largest market share in 2021 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

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.

Report Scope of the Personalized Medicine Biomarkers Market

Report Coverage


Market Size

USD 43.19 Billion by 2030

Growth Rate

CAGR of 15.59% from 2022 to 2030

Largest Market

North America

Fastest Growing Market

Asia Pacific

Base Year


Forecast Period

2022 to 2030

Segments Covered

Application, indication and Region,

Companies Mentioned

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


Application Insights

Treatment selection segment held the largest share in 2021. Based on the molecular characteristics of the tumor, personalized medicine biomarkers help choose the most suitable patients for early-phase clinical trials. They also provide information regarding action mechanism of a particular medicine. The focus of oncology drug development programs has shifted from the creation of non-specific cytotoxic chemotherapies to the creation of molecularly targeted therapeutics as a result of the identification of particular mutations that efficiently perform the prediction for a given drug in a molecularly defined patient group. Moreover, with an enhanced selection of treatment, the probability to tackle the condition increases.

Early detection/screening segment is expected to show lucrative growth over the forecast period. The growth of the segment can be attributed to the need to provide early treatment. For patients who display the biomarker linked to a therapy's response, the probability of survival is dependent on the course of treatment. For instance, the expression of the HER2/neu protein is a prognostic biomarker of breast cancer. Moreover,KRAS is a frequently mutated oncogene in colorectal cancer and a biomarker for anti-EGFR monoclonal antibody therapy resistance. Moreover, the development of novel technologies to help in the early detection of various conditions further propels the growth of the market.

Indication Insights

Oncology segment dominated the market in 2021, attributable to increased adoption of personalized medicine biomarker-based tests for early detection and treatment selection. The selection of appropriate treatment alternatives regularly benefit patient health. For instance, the Oncotype DX test can evaluate the activity of 21 different genes to predict the applicability of chemotherapy for breast cancer cases. Hence, major opportunities exist for personalized medicine biomarkers in the personalized medicine segment owing to their significant role in helping physicians decide the appropriate treatment.

In March 2021, Oxford BioDynamics signed a resale and supply agreement with Agilent Technologies, Inc. for EpiSwitch Explorer, an array kit that can be used for biomarker discovery and acts as a critical component in personalized medicine development. Moreover, the non-invasive method provided by cfDNA for diagnosing recurrence or progression, streamlining prognosis, and finding emerging genomic anomalies remain a major promise. Furthermore, it can also find patients linked to drug resistance and provides ability to track tumors with molecular profiles in real-time at various time points.

Autoimmune diseases segment is anticipated to grow at a lucrative CAGR over the forecast period owing to the increased prevalence of autoimmune diseases among the global population. The growing awareness about benefits of early treatment among physicians also remains a promising driver of growth. According to the United States Autoimmune Association, in 2021, there is an existence of approximately 100 types of autoimmune diseases, affecting 4-5% of total world’s population.

Moreover, the inability to detect the onset of autoimmune disease in a patient is hampered by the lack of a single highly specific diagnostic test that can confirm the presence of a specific autoimmune disorder. This further increases the demand to provide diagnosis and monitoring of autoimmune diseases using minimally invasive methods that could be used to identify disease development and provide appropriate treatment.

Regional Insights

North America dominated the overall market in 2021 which can be attributed to increased funding for biomarkers. This is further aided by technological advancements, high disposable income, and the presence of key market players operating in the region. The U.S. held the largest share of personalized medicine in the region owing to increased private and public initiatives and high awareness among the population about chronic diseases and treatments.

Moreover, key players are focusing on developing novel products to maintain their dominance over the market. For instance, in February 2022, FoundationOne CDx was approved by the FDA approval as a companion diagnostic for Keytruda to categorize patients with microsatellite instability-high solid tumors.

Asia Pacific is estimated to showcase the fastest growth over the forecast period. The growth of the market in the region is due to the growing healthcare reforms in the region. This is further aided by improved healthcare infrastructure, a growing population, and an increase in the number of companies entering the market. The Asia Pacific region is home to a large population and a high cancer prevalence.

According to Global Cancer Statistics 2020, an estimated one-half of all cases and around 58.3% of cancer deaths occurred in Asia in 2020. Thus, the usage of screening tests for cancer has increased in the past few years owing to growing government initiatives, such as free screening for breast cancer and increased collaborations for the distribution and supply of these tests.

Moreover, the presence of government funding and initiatives in the region further fuels regional growth. For instance, The Chinese Personal Medicine Initiative which is expected to be funded with USD 9 billion by 2030, aims to provide better healthcare provisions mainly for oncology.

Some of the prominent players in the Personalized Medicine Biomarkers Market include:

  • Laboratory Corporation of America Holding
  • Quest Diagnostics Incorporated
  • Agilent Technologies, Inc.
  • Genome Medical, Inc.
  • Coriell Life Sciences.
  • Thermo Fisher Scientific Inc.
  • NeoGenomics Laboratories
  • Illumina, Inc.
  • Guardant Health

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Personalized Medicine Biomarkers market

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

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Key Benefits for Stakeholders

  • This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Personalized Medicine Biomarkers industry analysis from 2022 to 2030 to identify the prevailing Personalized Medicine Biomarkers industry opportunity.
  • The market research is offered along with information related to key drivers, restraints, and opportunities.
  • Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
  • In-depth analysis of the global Personalized Medicine Biomarkers industry segmentation assists to determine the prevailing market opportunities.
  • Major countries in each region are mapped according to their revenue contribution to the global market.
  • Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
  • The report includes the analysis of the regional as well as global Personalized Medicine Biomarkers industry trends, key players, market segments, application areas, and market growth strategies.

Report Detail

  • Report Code:7571
  • No. of Pages:150+
  • Format:PDF/PPT/Excel

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