Personalized Medicine Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (Early Detection/Screening, Indication, Treatment Selection, Monitoring), By Indication (Oncology, Neurology, Diabetes, Autoimmune Diseases, Cardiology, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 15.99 Billion
CAGR (2026-2031)	6.51%
Fastest Growing Segment	Oncology
Largest Market	North America
Market Size (2031)	USD 23.34 Billion

Market Overview

The Global Personalized Medicine Biomarkers Market will grow from USD 15.99 Billion in 2025 to USD 23.34 Billion by 2031 at a 6.51% CAGR. Personalized medicine biomarkers are distinct biological molecules, such as genes, proteins, or genetic variations, utilized to identify patient subsets likely to benefit from specific therapeutic interventions or to predict potential adverse reactions. The market is primarily propelled by rapid advancements in genomic sequencing technologies and a fundamental shift in healthcare toward targeted therapies that improve treatment efficacy while minimizing toxicity. This transition is further supported by the increasing prevalence of chronic diseases like cancer and the growing integration of companion diagnostics into drug development pipelines. According to the Personalized Medicine Coalition, in 2024, the U.S. Food and Drug Administration approved 18 new personalized medicines, representing approximately 38 percent of all newly approved therapeutic molecular entities, highlighting the sector's expanding influence on modern healthcare.

Despite this robust growth trajectory, the market faces a significant impediment regarding the complex reimbursement landscape for diagnostic tests. Payers often struggle to assign value to biomarker testing, leading to inconsistent coverage policies that can limit patient access to these critical diagnostic tools. Furthermore, the high cost associated with developing and validating novel biomarkers creates a substantial financial barrier for smaller biotechnology firms. Consequently, while scientific innovation continues to accelerate, the misalignment between regulatory approval and reimbursement mechanisms remains a critical challenge that could slow the broader commercial adoption of personalized medicine solutions globally.

Key Market Drivers

Rapid advancements in next-generation sequencing and genomic technologies serve as a primary catalyst for the market, enabling the high-throughput identification of genetic mutations and expression patterns. These technical improvements allow researchers to analyze vast datasets of genetic information, facilitating the discovery of novel biomarkers that are essential for developing precision therapies. The ability to process genomic data at scale is exemplified by large initiatives that rely on robust sequencing infrastructure to map disease susceptibility and identify therapeutic targets. According to UK Biobank, November 2023, in the 'UK Biobank releases world’s largest genetic dataset' announcement, the organization successfully made whole genome sequencing data from 500,000 participants accessible to approved researchers, providing a comprehensive resource for correlating genetic markers with health outcomes. Such accessible genomic data accelerates the validation of biomarkers, directly reducing the timeline for translating genetic insights into clinical diagnostic tools.

Simultaneously, the market is heavily influenced by the escalating global prevalence of cancer and chronic diseases, which necessitates the adoption of targeted treatment regimens to improve patient survival rates. As the burden of complex pathologies grows, healthcare systems are increasingly relying on biomarkers to stratify patients and select appropriate therapeutic interventions. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, it is projected that there will be 2,001,140 new cancer cases in the United States alone in 2024, underscoring the critical need for precise diagnostic modalities. This rising disease incidence compels pharmaceutical companies to prioritize biomarker-driven drug development to ensure efficacy. Highlighting this strategic shift, according to AstraZeneca, February 2024, in the 'Annual Report and Form 20-F Information 2023', approximately 90 percent of the company’s clinical pipeline consisted of targeted therapies, reflecting the industry-wide commitment to personalized medicine solutions.

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Key Market Challenges

The complex reimbursement landscape for diagnostic tests operates as a severe constraint on the growth of the Global Personalized Medicine Biomarkers Market. Payers and insurers frequently struggle to apply consistent value assessment frameworks to these advanced diagnostics, resulting in unpredictable coverage decisions and high denial rates. This uncertainty creates a challenging environment for healthcare providers who may hesitate to order essential biomarker tests due to administrative hurdles and potential financial liability. As a result, the commercial viability of novel biomarkers is compromised, and the uptake of linked targeted therapies is significantly delayed.

This coverage misalignment directly hampers market penetration by severing the link between diagnostic availability and patient access. Without reliable reimbursement pathways, the adoption of personalized medicine remains suboptimal, limiting revenue opportunities for developers. According to the Personalized Medicine Coalition, in 2024, personalized medicines reached only 36 percent of potentially eligible advanced non-small cell lung cancer patients, underscoring the profound impact of these access barriers. Such data illustrates that despite scientific breakthroughs, the market's trajectory is heavily suppressed by the inability of reimbursement models to keep pace with clinical innovation.

Key Market Trends

The widespread adoption of liquid biopsy is shifting the market from static tissue sampling to dynamic, non-invasive monitoring. This technology detects circulating tumor DNA to identify resistance mechanisms in real time, allowing clinicians to adjust treatments without the risks of repeat biopsies. Commercial traction is accelerating as providers increasingly rely on blood-based testing for therapy selection and recurrence tracking. According to Guardant Health, May 2024, in the 'First Quarter 2024 Financial Results' press release, the company reported a 20 percent increase in clinical test volume year-over-year to 46,900 tests, illustrating the growing dependence on liquid biopsy for precision management.

Simultaneously, the implementation of artificial intelligence is reshaping biomarker discovery by integrating multi-modal datasets. Computational tools analyze interactions between genomic and clinical data to identify predictive signatures that traditional methods overlook, thereby increasing clinical trial success rates. This data-driven approach creates extensive libraries that fuel algorithmic diagnostics and personalized care strategies. According to Tempus AI, May 2024, in the 'Form S-1 Registration Statement' filed with the U.S. Securities and Exchange Commission, the organization disclosed that its multimodal database grew to include over 200 petabytes of data, demonstrating the massive scale of digital infrastructure now supporting biomarker development.

Segmental Insights

The Oncology segment currently represents the fastest-growing category in the Global Personalized Medicine Biomarkers Market, driven by the increasing global prevalence of cancer and the urgent demand for targeted therapies. This growth is largely fueled by the adoption of precision medicine, where biomarkers play a crucial role in developing companion diagnostics. The consistent approval of these diagnostic methods by regulatory entities such as the US FDA further validates the sector's expansion, as they are essential for identifying patients suitable for specific treatments. Consequently, oncology remains a primary focus for biomarker development to ensure effective and individualized patient care.

Regional Insights

North America leads the Global Personalized Medicine Biomarkers Market, supported by an advanced healthcare ecosystem and the concentration of major biotechnology companies. The region benefits from substantial investment in research and development, enabling the rapid translation of genomic discoveries into clinical applications. Furthermore, the U.S. Food and Drug Administration (FDA) actively fosters industry growth through established regulatory frameworks for companion diagnostics and targeted therapies. This supportive environment, combined with the high adoption of precision medicine to manage the rising prevalence of chronic diseases like cancer, secures North America’s position as the primary market globally.

Recent Developments

• In October 2025, Tempus AI, Inc. announced a multi-year collaboration with Whitehawk Therapeutics to advance biomarker-driven research in oncology. The partnership leverages Tempus’s extensive multimodal real-world dataset to support the development of the therapeutic company’s pipeline of antibody-drug conjugates. By utilizing artificial intelligence and large-scale data analysis, the collaboration aims to validate novel targets and identify predictive biomarkers that can guide the application of these targeted treatments. This strategic alliance highlights the growing importance of data-driven approaches in precision medicine, focusing on delivering optimal therapeutics to patients with high-potential cancer indications through enhanced biological insights and efficient drug development.
• In August 2025, Agilent Technologies Inc. received approval from the U.S. Food and Drug Administration for its MMR IHC Panel pharmDx as a companion diagnostic for colorectal cancer. This diagnostic test identifies patients with mismatch repair deficient solid tumors who may benefit from treatment with specific immunotherapy regimens, such as nivolumab. The approval provided oncologists with a standardized tool to detect critical biomarkers, facilitating precise treatment decisions. By accurately assessing mismatch repair status, the test supports the delivery of personalized cancer care and enhances the ability to match patients with effective therapeutic options, marking a significant advancement in precision oncology.
• In August 2024, Illumina, Inc. announced that the U.S. Food and Drug Administration approved its TruSight Oncology Comprehensive test along with two companion diagnostic indications. This approval marked a significant milestone as the first distributable comprehensive genomic profiling in vitro diagnostic kit with pan-cancer companion diagnostic claims. The test was designed to interrogate over 500 genes to profile solid tumors, increasing the likelihood of identifying immuno-oncology biomarkers or clinically actionable insights. It specifically identifies patients with solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions and non-small cell lung cancer patients with RET fusion-positive tumors for targeted therapy.
• In February 2024, Roche announced an exclusive collaboration agreement with PathAI to expand digital pathology capabilities within the companion diagnostics sector. Under this partnership, PathAI agreed to work solely with Roche Tissue Diagnostics to develop artificial intelligence-enabled algorithms designed to support the development of companion diagnostics for biopharmaceutical partners. These algorithms were planned to be deployed using Roche’s navify Digital Pathology platform, ensuring seamless integration into clinical laboratory workflows. The collaboration aimed to accelerate the delivery of AI-driven diagnostic solutions that assist clinicians in characterizing biomarkers and identifying patients eligible for targeted therapies, ultimately advancing the adoption of personalized medicine.

Key Market Players

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

By Application	By Indication	By Region
Early Detection/Screening Indication Treatment Selection Monitoring	Oncology Neurology Diabetes Autoimmune Diseases Cardiology Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Personalized Medicine Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Personalized Medicine Biomarkers Market, By Application:

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

• Personalized Medicine Biomarkers Market, By Indication:

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

• Personalized Medicine Biomarkers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE