Summary

Personalized Medicine Biomarkers Market Growth & Trends

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.

Personalized Medicine Biomarkers Market Report Highlights

• 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.

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation and Scope
1.2. Segment Definitions
1.2.1. Indication
1.2.2. Application
1.2.3. Regional Scope
1.2.4. Estimates and forecasts timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.4.5. Details of primary research
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Application outlook
2.2.2. Indication outlook
2.3. Regional outlook
2.4. Competitive Insights
Chapter 3. Personalized Medicine Biomarkers Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Increasing prevalence of chronic diseases
3.2.1.2. Rising awareness and importance of predicting prognosis and selection of dose
3.2.1.3. Need to provide early diagnosis and treatment
3.2.2. Market Restraint Analysis
3.2.2.1. Regulatory & reimbursement hurdles
3.3. Personalized Medicine Biomarkers Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.1.1. Bargaining power of suppliers
3.3.1.2. Bargaining power of buyers
3.3.1.3. Threat of substitutes
3.3.1.4. Threat of new entrants
3.3.1.5. Competitive rivalry
3.3.2. PESTEL Analysis
3.3.2.1. Political landscape
3.3.2.2. Economic landscape
3.3.2.3. Social landscape
3.3.2.4. Technological landscape
3.3.2.5. Environmental landscape
3.3.2.6. Legal landscape
Chapter 4. Personalized Medicine Biomarkers Market: Application Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Personalized Medicine Biomarkers Market: Indication Movement Analysis
4.3. Personalized Medicine Biomarkers Market by Indication Outlook (USD Million)
4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
4.5. Early Detection/Screening
4.5.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
4.6. Diagnosis
4.6.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
4.7. Treatment Selection
4.7.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
4.8. Monitoring
4.8.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
Chapter 5. Personalized Medicine Biomarkers Market: Indication Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Personalized Medicine Biomarkers Market: Biomarker Movement Analysis
5.3. Personalized Medicine Biomarkers Market by Biomarker Outlook (USD Million)
5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
5.5. Oncology
5.5.1. By Type Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.1.1. Breast Cancer
5.5.1.1.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.1.2. Lung Cancer
5.5.1.2.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.1.3. Colon Cancer
5.5.1.3.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.1.4. Others
5.5.1.4.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.2. By Circulating Biomarkers Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.2.1. Circulating Tumor Cells
5.5.2.1.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.2.2. Circulating Cell-free DNA
5.5.2.2.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.2.3. Extracellular Vesicles
5.5.2.3.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.5.2.4. Other Circulating Biomarkers
5.5.2.4.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.6. Neurology
5.6.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.7. Diabetes
5.7.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.8. Autoimmune Diseases
5.8.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.9. Cardiology
5.9.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
5.10. Others
5.10.1. Market Estimates And Forecast, 2018 - 2030 (USD Million)
Chapter 6. Personalized Medicine Biomarkers Market: Regional Estimates & Trend Analysis
6.1. Regional Dashboard
6.2. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
6.3. North America
6.3.1. U.S.
6.3.1.1. Key country dynamics
6.3.1.2. Regulatory framework/ reimbursement structure
6.3.1.3. Competitive scenario
6.3.1.4. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
6.3.2. Canada
6.3.2.1. Key country dynamics
6.3.2.2. Regulatory framework/ reimbursement structure
6.3.2.3. Competitive scenario
6.3.2.4. Canada market estimates and forecasts 2018 to 2030 (USD Million)
6.3.3. Mexico
6.3.3.1. Key country dynamics
6.3.3.2. Regulatory framework/ reimbursement structure
6.3.3.3. Competitive scenario
6.3.3.4. Mexico market estimates and forecasts 2018 to 2030 (USD Million)
6.4. Europe
6.4.1. UK
6.4.1.1. Key country dynamics
6.4.1.2. Regulatory framework/ reimbursement structure
6.4.1.3. Competitive scenario
6.4.1.4. UK market estimates and forecasts 2018 to 2030 (USD Million)
6.4.2. Germany
6.4.2.1. Key country dynamics
6.4.2.2. Regulatory framework/ reimbursement structure
6.4.2.3. Competitive scenario
6.4.2.4. Germany market estimates and forecasts 2018 to 2030 (USD Million)
6.4.3. France
6.4.3.1. Key country dynamics
6.4.3.2. Regulatory framework/ reimbursement structure
6.4.3.3. Competitive scenario
6.4.3.4. France market estimates and forecasts 2018 to 2030 (USD Million)
6.4.4. Italy
6.4.4.1. Key country dynamics
6.4.4.2. Regulatory framework/ reimbursement structure
6.4.4.3. Competitive scenario
6.4.4.4. Italy market estimates and forecasts 2018 to 2030 (USD Million)
6.4.5. Spain
6.4.5.1. Key country dynamics
6.4.5.2. Regulatory framework/ reimbursement structure
6.4.5.3. Competitive scenario
6.4.5.4. Spain market estimates and forecasts 2018 to 2030 (USD Million)
6.4.6. Norway
6.4.6.1. Key country dynamics
6.4.6.2. Regulatory framework/ reimbursement structure
6.4.6.3. Competitive scenario
6.4.6.4. Norway market estimates and forecasts 2018 to 2030 (USD Million)
6.4.7. Sweden
6.4.7.1. Key country dynamics
6.4.7.2. Regulatory framework/ reimbursement structure
6.4.7.3. Competitive scenario
6.4.7.4. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
6.4.8. Denmark
6.4.8.1. Key country dynamics
6.4.8.2. Regulatory framework/ reimbursement structure
6.4.8.3. Competitive scenario
6.4.8.4. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
6.5. Asia Pacific
6.5.1. Japan
6.5.1.1. Key country dynamics
6.5.1.2. Regulatory framework/ reimbursement structure
6.5.1.3. Competitive scenario
6.5.1.4. Japan market estimates and forecasts 2018 to 2030 (USD Million)
6.5.2. China
6.5.2.1. Key country dynamics
6.5.2.2. Regulatory framework/ reimbursement structure
6.5.2.3. Competitive scenario
6.5.2.4. China market estimates and forecasts 2018 to 2030 (USD Million)
6.5.3. India
6.5.3.1. Key country dynamics
6.5.3.2. Regulatory framework/ reimbursement structure
6.5.3.3. Competitive scenario
6.5.3.4. India market estimates and forecasts 2018 to 2030 (USD Million)
6.5.4. Australia
6.5.4.1. Key country dynamics
6.5.4.2. Regulatory framework/ reimbursement structure
6.5.4.3. Competitive scenario
6.5.4.4. Australia market estimates and forecasts 2018 to 2030 (USD Million)
6.5.5. South Korea
6.5.5.1. Key country dynamics
6.5.5.2. Regulatory framework/ reimbursement structure
6.5.5.3. Competitive scenario
6.5.5.4. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
6.5.6. Thailand
6.5.6.1. Key country dynamics
6.5.6.2. Regulatory framework/ reimbursement structure
6.5.6.3. Competitive scenario
6.5.6.4. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
6.6. Latin America
6.6.1. Brazil
6.6.1.1. Key country dynamics
6.6.1.2. Regulatory framework/ reimbursement structure
6.6.1.3. Competitive scenario
6.6.1.4. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
6.6.2. Argentina
6.6.2.1. Key country dynamics
6.6.2.2. Regulatory framework/ reimbursement structure
6.6.2.3. Competitive scenario
6.6.2.4. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
6.7. MEA
6.7.1. South Africa
6.7.1.1. Key country dynamics
6.7.1.2. Regulatory framework/ reimbursement structure
6.7.1.3. Competitive scenario
6.7.1.4. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
6.7.2. Saudi Arabia
6.7.2.1. Key country dynamics
6.7.2.2. Regulatory framework/ reimbursement structure
6.7.2.3. Competitive scenario
6.7.2.4. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
6.7.3. UAE
6.7.3.1. Key country dynamics
6.7.3.2. Regulatory framework/ reimbursement structure
6.7.3.3. Competitive scenario
6.7.3.4. UAE market estimates and forecasts 2018 to 2030 (USD Million)
6.7.4. Kuwait
6.7.4.1. Key country dynamics
6.7.4.2. Regulatory framework/ reimbursement structure
6.7.4.3. Competitive scenario
6.7.4.4. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.2. Recent Developments & Impact Analysis by Key Market Participants
7.3. Company Market Share Analysis, 2024
7.4. Company overview
7.4.1. Laboratory Corporation of America Holding
7.4.1.1. Company Overview
7.4.1.2. Financial performance
7.4.1.3. Product benchmarking
7.4.1.4. Strategic initiatives
7.4.2. Quest Diagnostics Incorporated
7.4.2.1. Company Overview
7.4.2.2. Financial performance
7.4.2.3. Product benchmarking
7.4.2.4. Strategic initiatives
7.4.3. Agilent Technologies, Inc
7.4.3.1. Company Overview
7.4.3.2. Financial performance
7.4.3.3. Product benchmarking
7.4.3.4. Strategic initiatives
7.4.4. Genome Medical, Inc
7.4.4.1. Company Overview
7.4.4.2. Financial performance
7.4.4.3. Product benchmarking
7.4.4.4. Strategic initiatives
7.4.5. Thermo Fisher Scientific, Inc
7.4.5.1. Company Overview
7.4.5.2. Financial performance
7.4.5.3. Product benchmarking
7.4.5.4. Strategic initiatives
7.4.6. Coriell Life Sciences
7.4.6.1. Company Overview
7.4.6.2. Financial performance
7.4.6.3. Product benchmarking
7.4.6.4. Strategic initiatives
7.4.7. NeoGenomics Laboratories
7.4.7.1. Company Overview
7.4.7.2. Financial performance
7.4.7.3. Product benchmarking
7.4.7.4. Strategic initiatives
7.4.8. FOUNDATION MEDICINE, INC
7.4.8.1. Company Overview
7.4.8.2. Financial performance
7.4.8.3. Product benchmarking
7.4.8.4. Strategic initiatives
7.4.9. Illumina, Inc
7.4.9.1. Company Overview
7.4.9.2. Financial performance
7.4.9.3. Product benchmarking
7.4.9.4. Strategic initiatives
7.4.10. Guardant Health
7.4.10.1. Company Overview
7.4.10.2. Financial performance
7.4.10.3. Product benchmarking
7.4.10.4. Strategic initiatives