PERSONALIZED MEDICINE BIOMARKERS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Personalized Medicine Biomarkers Market Size and Trends

Global personalized medicine biomarkers market is estimated to be valued at USD Bn 24.70 Bn in 2024 and is expected to reach USD Bn 68.11 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 15.6% from 2024 to 2031.

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The personalized medicine biomarkers industry is expected to witness significant growth during the forecast period. This can be attributed to rising prevalence of chronic diseases, growing application of biomarkers in drug discovery and development, increasing focus on targeted therapies, and technological advancements in the field of personalized medicine. Widespread adoption of personalized healthcare approach is also expected to boost demand for personalized medicine biomarkers during the forecast period.

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Insights By Type - Growing Genomic Knowledge Drives Genetic Biomarkers Segment Growth

Based on type, genetic biomarkers segment is expected to hold the largest market share of 52.8% in 2024, due to advancements in genomic technologies like next-generation sequencing. These technologies enable high-throughput analysis of biomarkers such as mutation and gene fusions, providing crucial insights into disease risk, diagnosis, and treatment response. The increasing availability of genetic data, including from the Human Genome Project and databases like ClinVar, supports precision medicine. Non-invasive methods like liquid biopsies also aid real-time monitoring, advancing personalized treatment decisions.

Insights By Application - Rising Cancer Burden Fuels Oncology Segment Growth

Based on application, oncology segment is expected to hold a market share of 42.12% in 2024, due to the rising global cancer burden. Cancer remains a top cause of death, with an increasing incidence driven by lifestyle and environmental factors. Personalized medicine, utilizing biomarkers such as EGFR, Epidermal Growth Factor Receptor mutations and HER2, and Human Epidermal Growth Factor Receptor 2 expression, helps optimize cancer treatment. Biomarker-driven clinical trials are advancing targeted therapies with improved efficacy. 

Insights By End User - Advancing Precision Diagnostics Boosts Hospital Segment

Based on end user, hospitals segment is expected to dominate the market with 51% in 2024, as these are key providers of diagnostic testing and patient management. These are at the forefront of adopting advanced technologies, including biomarker profiling for personalized care. Hospitals incorporate genomic and precision oncology departments to enhance clinical decision-making. By using electronic medical records and biomarker detection platforms, hospitals gain insights into disease heterogeneity and treatment responses.

Regional Insights

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Dominating Region: North America

North America dominates the global personalized medicine biomarker industry with an estimated share of 37.2% in 2024 due to treatment advancements. In September 2024, AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) showed significantly greater progression-free survival benefits in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had TROP2-QCS biomarker-positive tumors, compared to the overall trial population.

Fastest-Growing Region: Asia Pacific

Asia Pacific region is experiencing the fastest growth, driven by rising healthcare expenditure and funding, an expanding patient pool, and an increasing focus on specialized diagnostics in key countries like China and India. For instance, according to the NIH, National Institute of Health, in May 2021, the Chinese Personalized Medicine Initiative, which is expected to receive USD Bn 9.0 billion in funding by 2030, aims to improve healthcare provisions, particularly in oncology.

Personalized Medicine Biomarkers Market Outlook for Key Countries

Genomics and Biotechnology Advancements in the U.S.

The U.S. is driving the personalized medicine biomarkers industry growth, fueled by significant investments in genomics and biotechnology, alongside a robust regulatory framework supporting companion diagnostics. Advancements in next-generation sequencing and liquid biopsy technologies are enhancing biomarker identification, making personalized treatment more effective and accessible.

Government Initiatives and Technological Advancements in China

China's personalized medicine biomarkers industry growth is propelled by government initiatives aimed at upgrading the healthcare infrastructure., Investments in precision medicine are enhancing access to personalized treatments, supported by significant funding for research and development in biomarker discovery. The focus on chronic disease management further drives demand for innovative diagnostic solutions.

Expertise in Personalized Healthcare Solutions in Japan

Japan benefits from its strong technical expertise and focus on personalized healthcare, particularly due to its aging population. The market is expected to grow as healthcare providers increasingly adopt advanced diagnostic technologies, including genomic testing and proteomics, to improve treatment outcomes. This commitment to precision medicine ensures a robust market for biomarkers.

Cost-Effective Solutions and Untapped Potential in India

India is emerging as a key player in the personalized medicine biomarkers market, driven by its cost-effective skilled workforce and large untapped patient base. The market is projected to expand rapidly as awareness about targeted therapies increases among healthcare providers. Government initiatives to enhance healthcare access also supports the growing demand for personalized medicine solutions.

Strong Research Networks and Pharmaceutical Leadership in Germany

Germany personalized medicine biomarkers industry is bolstered by advanced research networks and its pharmaceutical leadership within Europe. With significant investments in biomarker research, the country is positioned as a key player in the landscape of personalized medicine. Innovations in molecular diagnostics are enhancing the accuracy of biomarker discovery, fostering growth in this sector.

Market Concentration and Competitive Landscape

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Top Strategies Followed by Global Personalized Medicine Biomarkers Market Players

• Established players in the global personalized medicine biomarkers market focus heavily on research and development to drive innovation. Companies like Thermo Fisher Scientific, Roche, and Illumina invest over 10% of annual revenues into R&D. This allows them to continuously enhance genomic profiling platforms, next-generation sequencing technologies, and bioinformatics solutions. Large firms also form strategic partnerships with emerging biotechs and contract research organizations.
• Mid-sized market players employ cost-effective strategies to target price-sensitive customer segments. They develop affordable assays and diagnostic kits for various cancer and infectious disease indications. Companies collaborate with academic medical centers and contract manufacturing firms to optimize production processes.
• Small biotech companies focus on niche diseases and novel biomarkers, addressing unmet needs and enabling early detection. They use open innovation, partner with research hospitals, and leverage AI and cloud computing to analyze molecular data, allowing them to compete in crowded markets with limited funding.

Emerging Startups in the Global Personalized Medicine Biomarkers Market

• Several startups are advancing personalized medicine through innovative technologies. Companies like Anthropic and Deep Genomics use AI and machine learning to accelerate biomarker discovery from large genomic datasets, helping identify biomarkers for patient stratification and therapeutic monitoring.
• If successful, AI could transform biomarker research and reduce development costs. Rising environmental concerns are driving startups like PBC Biotech, which uses plant-based materials for bioassays, and Cielo, which employs a microfluidics platform that reduces reagent use.
• These eco-friendly technologies help reduce plastic waste. Niche startups like Karius focus on infectious disease biomarkers for immunosuppressed patients, while Perimeter Medical is developing an optical molecular imaging platform for tumor margin assessment during breast cancer surgery, addressing unique clinical needs overlooked by larger companies.

Personalized Medicine Biomarkers Industry News

• In August 2024, Paige, a digital pathology platform, launched OmniScreen, an AI-driven biomarker module that analyzes over 505 genes and identifies 1,228 molecular biomarkers from standard H&E-stained digital pathology slides
• In August 2024, Illumina, Inc., a biotechnology company, announced U.S. FDA (Food and Drug Administration) approval for its TruSight Oncology Comprehensive test, which profiles over 500 genes to identify immuno-oncology and clinically actionable biomarkers, supporting targeted therapies and clinical trial participation
• On June 1, 2024, Sapience Therapeutics, a biotechnology company, presented positive clinical and biomarker data from its Phase 2 ST101 study in glioblastoma (GBM) at the ASCO 2024 Annual Meeting. The data showed durable responses across three patient cohorts, including both recurrent and newly diagnosed GBM cases.
• In February 2022, the U.S. FDA, Food and Drug Administration approved FoundationOne CDx as a companion diagnostic for Keytruda, enabling the identification of patients with microsatellite instability-high solid tumors

Key Takeaways from Analyst

• Global personalized medicine biomarkers market is set for strong growth, driven by rising cancer prevalence and increased adoption of personalized medicine. Demand for non-invasive diagnostics and research funding further supports market expansion. However, stringent regulations and high costs for biomarker discovery pose challenges. North America leads in revenue due to high healthcare spending and active R&D, while Asia Pacific is expected to grow rapidly, spurred by healthcare awareness and infrastructure improvements. Key strategies for market players include biomarker collaborations, diagnostic kit development, and geographic expansion, particularly in emerging markets, to capture opportunities and maintain a competitive edge.

Market Report Scope

Market Dynamics

Market Driver - Rising prevalence of chronic diseases requiring personalized treatment

The rising prevalence of chronic and life-threatening diseases, such as cancer and cardiovascular disorders, is driving global demand for personalized medicine. For instance, as per a Centers for Disease Control and Prevention report in February 2024, about 129 million U.S. individuals have at least one chronic illness, increasing the demand for predictive biomarkers in treatment. The National Cancer Institute estimates that in 2024, around 9,620 children aged 0-14 will be diagnosed with cancer, with 1,040 expected fatalities.

Market Challenge - High costs associated with personalized medicine development

One of the major challenges faced by the global personalized medicine biomarkers market is the high costs with the development of personalized medicines. Developing biomarkers and companion diagnostics require huge investments in R&D. Clinical validation of biomarkers is a lengthy and expensive process requiring large clinical trials. Manufacturing of precision therapies involves high capital investments due to stringent regulatory standards. Additionally, the testing and analysis of biomarkers is technically complex and cost intensive which increases the overall cost of personalized therapies.

Market Opportunity - Growing demand for targeted therapies in oncology

The oncology segment presents a significant opportunity for the personalized medicine biomarkers market, driven by rising cancer cases and the need for targeted therapies. Biomarkers enable the identification of gene mutations, allowing for tailored drug treatments that improve outcomes and minimize side effects. Growing investments and advancements in genomic and proteomic technologies are further expanding biomarker discovery, enhancing personalized cancer care options. For instance, in October 2024, SandboxAQ partnered with Sanofi, pharmaceutical companies, to utilize large quantitative models for biomarker discovery, aiming to enhance trust in clinical development.

Key Stakeholders of Market

What does growth in personalized medicine biomarkers market mean for different stakeholders?

Personalized medicine biomarkers industry has multiple players with varied designations and offers multiple opportunities based on their scope of operations.

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Market Segmentation

•  Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Genetic Biomarkers
  • Protein Biomarkers
  • Metabolite Biomarkers
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
• • Oncology
  • Neurology
  • Diabetes
  • Autoimmune Diseases
  • Cardiology
  • Others
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
• • Hospitals
  • Diagnostic Laboratories
  • Research Institutions
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Roche Diagnostics
  • Illumina, Inc.
  • Thermo Fisher Scientific Inc.
  • QIAGEN N.V.
  • Agilent Technologies, Inc.
  • Bio-Rad Laboratories, Inc.
  • Siemens Healthineers
  • Abbott Laboratories
  • Merck KGaA
  • Genomic Health, Inc.
  • Myriad Genetics, Inc.
  • Foundation Medicine, Inc.
  • Exact Sciences Corporation
  • Guardant Health, Inc.
  • Luminex Corporation