Personalized Medicine Biomarkers Market Size to Hit USD 79.26 Bn by 2034

According to Nova One Advisor, the global personalized medicine biomarkers market size was exhibited at USD 21.95 billion in 2024 and is projected to hit around USD 79.26 billion by 2034, growing at a CAGR of 13.7% during the forecast period 2024 to 2034.

Personalized Medicine Biomarkers Market Size 2024 To 2034

Personalized Medicine Biomarkers Market Key Takeaways:

• The North America personalized medicine biomarkers market dominated the global market and accounted for 52.0% of revenue share in 2024

• The treatment selection segment dominated the market with the largest market share of 50.2% in 2024.

• Early detection/screening is expected to grow at a significant CAGR of 15.8% over the forecast period.

• Oncology dominated the market with the largest share of 36.0% in 2024, driven by the increasing prevalence of cancer worldwide.

• The diabetes segment is the fastest-growing segment and is expected to grow at a CAGR of 17.4% over the forecast period.

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The growth of the personalized medicine biomarkers market can be attributed to the increasing prevalence of chronic diseases across the globe and the increasing demand for personalized treatment regimes. The increasing emphasis on personalized medicine, which seeks personalized healthcare based on individual characteristics, is further driving the market growth. The increasing emphasis on patient-centric healthcare models is boosting market growth.

The personalized medicine biomarkers market is driven by the growing need for precision medicine in cardiology, oncology, and other therapeutic areas and the increasing prevalence of chronic diseases. The demand for biomarkers that can accurately monitor and detect cancer in children has increased, as diagnostic tools improve. There is an increased focus on understanding patients' unique biological profiles, as healthcare systems move towards more individualized approaches.

In addition, technological advancements play an important role in the personalized medicine biomarkers market. The rising innovations such as molecular imaging, bioinformatics, and next-generation sequencing (NGS) have revolutionized the validation processes and biomarker discovery. These advanced technologies allow for more accurate and early diagnosis and enable the identification of specific biomarkers associated with various cancers.

For example, leading to the discovery of novel genetic mutations that can serve as potential biomarkers, NGS facilitates the comprehensive analysis of cancer genomes. These technological innovations contribute to the development of targeted therapies and enhance the precision of diagnostics, further enhancing the market growth.

Major Trends in the Personalized Medicine Biomarkers Market 

• The rising additional advantages provided by biomarkers, which involve the capability to reduce treatment costs, improve patient survival, and detect health conditions in their early stages contributed to propel the market growth. 

• Healthcare providers can improve overall patient satisfaction and outcomes, by tailoring medical interventions to individual patients expected to enhance the market growth during the forecast period.

• The increasing use of personalized medicine biomarkers as a major tool for patient matching and screening the right patient with accurate therapy is driving the demand for this equipment. 

• The increasing prevalence of unhealthy lifestyle habits, such as physical inactivity, poor dietary choices, and smoking among others are further anticipated to boost the growth of the personalized medicine biomarkers market. 

• Clinical studies continuously use biomarkers to improve patient results and their application and rising advances in proteomics and genomics are further anticipated to enhance the market growth.

U.S. Personalized Medicine Biomarkers Market Size and Growth 2024 to 2034

The U.S. Personalized Medicine Biomarkers Market size is exhibited at USD 9.68 billion in 2024 and is projected to be worth around USD 40.90 billion by 2034, growing at a CAGR of 15.5% from 2024 to 2034.

U.S. Personalized Medicine Biomarkers Market Size 2024 To 2034

The North America personalized medicine biomarkers market dominated the global market and accounted for 52.0% of revenue share in 2024. The market growth in the region is attributed to the rising funding for biomarkers helped by the presence of key market players operating in the region, high disposable income, and technological advancements. In addition, to maintain dominance over the market, various major players are focusing on developing novel products in the region. 

Personalized Medicine Biomarkers Market Share, By Regional 2024 (%)

For instance, in February 2022, to categorize patients with microsatellite instability-high solid tumors, Foundation One CDx was approved by the FDA approval as a companion diagnostic for Keytruda. 

U.S. Personalized Medicine Biomarkers Market Trends

The U.S. personalized medicine biomarkers market held a significant share of North America market in 2024, driven by advancements in genomics and increased demand for targeted therapies. Rising investments in research, regulatory support for companion diagnostics, and a growing emphasis on precision medicine in oncology and chronic disease management are further propelling market expansion in this sector.

Europe Personalized Medicine Biomarkers Market Trends

The Europe personalized medicine biomarkers market driven by advancements in personalized medicine and intensive research efforts in oncology. Innovations such as next-generation sequencing and proteomics are improving biomarker discovery and diagnostic accuracy, enabling more tailored treatment approaches. European research institutions are increasingly focused on identifying novel biomarkers specific to cancers and other chronic disorders, fostering innovation in personalized medicine. According to the European Society of Cardiology, approximately 45% of individuals over the age of 65 are affected by cardiovascular diseases (CVDs), highlighting the significant health challenges faced by this demographic. In 2022, nearly 4 million people in Europe died from CVDs. This combination of technological advancements and dedicated research initiatives is significantly propelling the growth of the personalized medicine biomarkers market across the region, enhancing the potential for targeted therapies and improved patient outcomes.

The UK personalized medicine biomarkers market is expected to show significant growth driven by increasing research and development investments and enhanced funding for innovative projects. This financial support is facilitating the discovery of novel biomarkers and advancing precision medicine initiatives, leading to improved diagnostics and targeted therapies, ultimately enhancing patient outcomes across the region.

The Germany personalized medicine biomarkers market is experiencing significant growth, largely due to the rising prevalence of chronic disorders such as cancer, diabetes, and cardiovascular diseases. This increasing burden on healthcare systems is driving demand for targeted diagnostics and tailored therapies, fostering advancements in personalized medicine and enhancing patient care in the region.

Asia Pacific Personalized Medicine Biomarkers Market Trends

The Asia Pacific personalized medicine biomarkers market is expected to grow at the fastest CAGR over the forecast period. The growth of the market in the region is owing to growing healthcare reforms in the region aided by improved healthcare infrastructure, a growing population, and an increase in the number of companies entering the market. The Asia Pacific region has a large population and high cancer prevalence. 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.

The China personalized medicine biomarkers market is growing at a lucrative rate. 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 9.0 billion by 2030, aims to provide better healthcare provisions mainly for oncology.

Latin America Personalized Medicine Biomarkers Market Trends

The Latin America personalized medicine biomarkers market exhibits high growth potential for the personalized medicine biomarkers market. Driven by improvements in healthcare infrastructure and strong government support. Many countries in the region are investing in modernizing their healthcare systems, which enhances access to advanced diagnostic tools and personalized treatment options. Government initiatives aimed at promoting research and development in personalized medicine are further accelerating market expansion. Additionally, as awareness of the benefits of tailored therapies increases among healthcare providers and patients, demand for biomarkers that facilitate precision medicine is on the rise. These factors collectively contribute to the positive trajectory of the personalized medicine biomarkers market in Latin America.

Middle East and Africa Personalized Medicine Biomarkers Market Trends

The MEA personalized medicine biomarkers market growth driven by the increasing prevalence of chronic disorders, such as diabetes, cardiovascular diseases, and cancer. As healthcare systems in the region focus on improving diagnosis and treatment through personalized medicine, the demand for innovative biomarkers is rising, enhancing patient outcomes.

The Saudi Arabia personalized medicine biomarkers market growth is driving the market, largely supported by government funding aimed at enhancing healthcare innovation. Increased investment in research initiatives and the establishment of advanced healthcare facilities are fostering the development of novel biomarkers, which are essential for improving personalized treatment strategies and patient care in the region.

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Personalized Medicine Biomarkers Market Report Scope 

Report Attribute

Details

The market size value in 2025

USD 24.96 billion

The revenue forecast in 2034

USD 79.26 billion

Growth rate

CAGR of 13.7% from 2024 to 2034

Actual data

2019 - 2023

Forecast period

2024 - 2034

Quantitative units

Revenue in USD billion/million, and CAGR from 2024 to 2034

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Application, Indication, Region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; Mexico; Germany; France; UK; Italy; Spain; Denmark; Sweden; Norway; Japan; China; India; Australia; South Korea; Thailand; Brazil; Argentina; South Africa; Saudi Arabia; UAE; Kuwait

Key companies profiled

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.

Customization scope

Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope.

Precision medicine: Promising future as AI, biomarkers and technology bolster the field

It has been over a decade since Emily Whitehead was declared cancer-free after the first successful, experimental CAR T-cell treatment, a moment which marked a huge development in precision medicine. Since then, the landscape has focused on CAR-T therapies with six of these now approved. One of the newest movements in the field is with CRISPR therapies, further progressing the ability of precision medicine to provide long-term effective treatments for rare and complex diseases.

According to nova one advisor , cell therapies remain the leading drug type by clinical trial count. However, there has been a notable increase in gene therapies in the past few years.

Only 39 gene therapies were marketed by the end of H1 2023. Despite this, the market is expected to grow drastically over the next decade, with nova one advisor predicting that gene therapies will generate nearly $55bn in sales by 2029. At the same time, the cell therapy market is also expected to surge, with a predicted forecast of over $53bn by 2029, up from nearly $4bn in 2022, according to nova one advisor .

Precision medicine trials have always been oncology-focused due to the mechanism of action (MoA) of most candidates, targeting and killing T-cells. The field continues to favour oncology however, other indications, especially rare diseases, are now being investigated to see how they can utilise precision medicine.

Oncology remains the main target for both cell and gene therapies

Better use of biomarkers will further develop the field

One of the biggest advancements in precision medicine is the use of biomarkers. Biomarker diagnostic tools have advanced greatly in recent years, with oncology remaining a key area for biomarker-driven therapy. Consequently, biomarkers will be used to target subpopulations across cancer types, for example, the identification of specific mutations in tumour cells.

The development of new diagnostics and discovery of new biomarkers will advance the precision medicine space as physicians will be better placed to identify targeted treatments for more indications.

Further research into biomarkers and more advanced diagnostic tools will be required to drive the development of next-generation precision medicine. Sethi believes that this can be a way to utilise AI in precision medicine to identify both clinical trial populations and patient populations post-approval.

One advancement is the invention of digital biomarkers, moving away from the traditional blood biomarker model. NeuraLight, a startup developing an AI-driven platform that measures eye movements to diagnose neurological diseases.

Personalized Medicine Biomarkers Market Segment Insights

By Application Types

The treatment selection segment dominated the market with the largest market share of 50.2% in 2024. Personalized medicine biomarkers help choose the most suitable patients for early phase clinical trials, based on the molecular characteristics of the tumor. The segment provides data related to the action mechanism of a particular medicine. The probability of tackling the condition increases, with an enhanced selection of treatment which drives the demand for personalized medicine biomarkers. In addition, the major focus of cancer drug development programs has preferred from the production of non-specific cytotoxic chemotherapies to the production of targeted therapies as a result of the identification of special mutations that effectively perform the projection for a given drug.

The Early detection/screening is expected to grow at a significant CAGR of 15.8% over the forecast period. The segment growth is driven by the increasing need to offer early treatment. The probability of survival is dependent on the course of treatment, for patients who display the biomarker linked to a therapy's response. In addition, KRAS is a biomarker for anti-EGFR monoclonal antibody therapy resistance and a frequently mutated oncogene in colorectal cancer. Furthermore, the rising development of novel technologies to aid in the early treatment of several diseases is further driving the market growth.

By Indication Types

The Oncology dominated the market with the largest share of 36.0% in 2024. The oncology segment growth is attributed to the rising prevalence of cancer globally. Personalized medicine, which tailors’ treatment based on molecular profiles and individual genetics, minimizes adverse effects and enhances the efficacy of cancer therapies. In addition, the demand for biomarkers that can predict patient responses to immunotherapies and targeted therapies is improving overall patient outcomes in oncology and facilitating earlier detection, thus driving segment growth in the market.

Personalized Medicine Biomarkers Market Share, By Indication 2024 (%)

• For instance, cancer cases are projected to rise to 29.5 million by 2040, necessitating more precise therapeutic and diagnostic approaches, according to the World Health Organization. 

• For instance, there were 18,741,966 cancer cases globally in 2022 according to GLOBOCAN. The 9,175,141 cases were recorded in women, while 9,566,825 cases were reported in men. 

The diabetes segment is the fastest-growing segment and is expected to grow at a CAGR of 17.4% over the forecast period. The diabetes segment is witnessing significant growth across the market for personalized medicine biomarkers market, enhanced by the increasing global prevalence of diabetes. In addition, personalized medicine plays an important role in diabetes management by optimizing therapeutic strategies and identifying patients at risk for complications. The demand for personalized medicine biomarkers that can predict insulin sensitivity, glycemic control, and other metabolic responses is rising, improving patient outcomes in diabetes care and fostering advancements in targeted therapies. 

• For instance, the global number of individuals living with diabetes is at the forefront and is anticipated to rise by 46% from 2020 to 2045, while the world’s population is expected to grow by just 20%, according to the IDF Diabetes Atlas.

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Personalized Medicine Biomarkers Market Top Companies

• Laboratory Corporation of America Holding

• Quest Diagnostics Incorporated

Agilent Technologies, Inc.

Genome Medical, Inc.

• Coriel Life Sciences

Thermo Fisher Scientific Inc.

NeoGenomics Laboratories

FOUNDATION MEDICINE, INC.

• Illumina, Inc.

Guardant Health

Recent Developments

In October 2024, myeloMATCH, a unique portfolio of biomarker-driven precision medicine clinical trials was launched by the U.S. National Institutes of Health. This biomarker will test new treatments for patients with myeloid cancers. 

In July 2024, PandaOmics Box, an AI-powered hardware platform was launched by Insilico for personalized medicine research and on-premises drug discovery. 

In July 2024, a company focused on proprietary AI and network biology platform solutions to transform patient care, Scipher Medicine launched a new approach to develop biomarkers following the publication of the novel, patent-pending framework PRoBeNet (Predictive Response Biomarkers using Network medicine).

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the personalized medicine biomarkers market

By Application

• Early Detection/Screening

• Diagnosis

• Treatment Selection

• Monitoring

By Indication

• Oncology

o By Type

o Breast Cancer

o Lung Cancer

o Colon Cancer

o Others

o By Circulating Biomarkers

o Circulating Tumor Cells(CTCs)

o Circulating Cell-free DNA(cfDNA)

o Extracellular Vesicles (EVs)

o Other Circulating Biomarkers

Neurology

• Diabetes

• Autoimmune Diseases

• Cardiology

• Others

By Regional

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East and Africa (MEA)

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