Blood Based Biomarkers Market By Biomarker Type (Proteomic, Genomic, cfDNA/RNA, Metabolomic, Exosomal); By Application (Oncology, Cardiology, Neurology, Infectious Diseases, Autoimmune Disorders); By End User (Hospitals & Clinics, Diagnostic Laboratories, Academic & Research, Biopharma & Biotech); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Blood Based Biomarkers Market will witness a robust CAGR of 13.2% , valued at $28.6 billion in 2024 , and projected to reach around $60.6 billion by 2030 , confirms Strategic Market Research.

 

Blood-based biomarkers are no longer niche tools reserved for oncology trials. They’ve evolved into essential diagnostic and monitoring assets across chronic disease management, neurology, cardiology, and even early Alzheimer’s detection. In 2024, this market sits at the intersection of rising diagnostic demand, aging demographics, and explosive progress in liquid biopsy and multi-omics platforms.

 

A few years ago, the focus was mostly on protein biomarkers and metabolic signatures. Now, the space is shifting toward high-throughput technologies that can detect circulating tumor DNA ( ctDNA ), exosomal RNA, and methylation patterns — all from a single blood draw. That’s not just innovation for innovation’s sake. It’s enabling earlier detection, reducing patient burden, and trimming diagnostic costs across care settings.

 

What’s driving this momentum? For one, payers and regulators are increasingly open to non-invasive testing — especially when paired with real-world evidence. Simultaneously, major pharma is investing in companion diagnostics to improve trial efficiency and reduce late-stage failures. In short, the economics are aligning with the science.

 

Key stakeholders in this market include IVD manufacturers , molecular diagnostics firms , biopharma sponsors , hospital systems , and research networks . Governments are also stepping in — not just through funding, but also with regulatory fast-tracks for early cancer detection technologies. Investors, meanwhile, are chasing platform-based diagnostics and liquid biopsy companies with scalable IP and multi-condition utility.

 

Of course, clinical validation and reimbursement remain bottlenecks. But with initiatives like the U.S. Cancer Moonshot, Horizon Europe’s health cluster, and the rise of AI-enabled biomarker discovery, the direction is clear — blood will remain the gold standard substrate for systemic insights.

 

“What used to take a tissue sample, weeks of processing, and uncertain interpretation now takes one tube of blood and a same-week result,” notes a senior oncologist from Massachusetts General Hospital. “That’s a sea change — and we’re just scratching the surface.”

 

Comprehensive Market Snapshot

• The Global Blood Based Biomarkers Market will witness a robust CAGR of 13.2%, valued at USD 28.6 billion in 2024, and is projected to reach around USD 60.6 billion by 2030, driven by rising adoption of minimally invasive diagnostics, precision medicine initiatives, and expanding oncology and chronic disease testing applications.

• The USA Blood Based Biomarkers Market will register a healthy 12.3% CAGR, expanding from USD 8.9 billion in 2024 to approximately USD 17.8 billion by 2030. The United States accounts for 31% of the global market, supported by advanced healthcare infrastructure, strong biomarker-based drug development activity, and high diagnostic testing volumes.

• The Europe Blood Based Biomarkers Market is expected to grow at a 10.6% CAGR, expanding from USD 7.4 billion in 2024 to around USD 13.6 billion by 2030. Europe holds a 26% market share, driven by increasing adoption of personalized medicine, favorable regulatory frameworks, and growing investments in translational research.

• The Asia-Pacific Blood Based Biomarkers Market will grow at a strong 14.0% CAGR, expanding from USD 5.7 billion in 2024 to nearly USD 12.6 billion by 2030. APAC represents 20% of the global market, supported by rapidly expanding diagnostic infrastructure, rising healthcare expenditure, and increasing prevalence of cancer and metabolic disorders across emerging economies.

 

Market Segmentation Insights

By Biomarker Type

• Proteomic Biomarkers held the largest market share of approximately 34% in 2024, reflecting their broad clinical validation, cost efficiency, and routine use across oncology, cardiology, and inflammatory disease testing, with an estimated market value of around USD 9.72 billion.

• Cell-free DNA (cfDNA) and RNA Biomarkers accounted for approximately 26% of the market in 2024, valued at around USD 7.44 billion, driven by strong adoption in cancer diagnostics, treatment monitoring, and minimal residual disease (MRD) detection.

• Genomic Biomarkers represented about 18% of the global market in 2024, corresponding to an estimated value of approximately USD 5.15 billion, supported by expanding use in hereditary disease risk profiling and precision oncology programs.

• Metabolomic Biomarkers captured roughly 12% share in 2024, translating to an estimated market value of around USD 3.43 billion, driven by applications in metabolic disorders, cardiovascular risk assessment, and drug response monitoring.

• Exosome-based Biomarkers accounted for approximately 10% of the market in 2024, valued at around USD 2.86 billion, and are projected to grow at a notable CAGR during 2024–2030, supported by increasing relevance in neurodegenerative disease diagnostics and their superior stability in circulation.

 

By Application

• Oncology represented the highest application share of approximately 47% in 2024, reflecting widespread use in lung, breast, colorectal, and prostate cancer diagnostics, with an estimated market value of around USD 13.44 billion.

• Cardiology accounted for about 18% of the market in 2024, translating to an estimated value of approximately USD 5.15 billion, supported by rising adoption of biomarkers for early risk stratification and disease monitoring.

• Infectious Diseases held nearly 14% share in 2024, valued at around USD 4.00 billion, driven by demand for rapid, minimally invasive diagnostic tools and post-infection monitoring.

• Neurology captured approximately 13% of the market in 2024, corresponding to an estimated value of about USD 3.72 billion, and is expected to grow at the fastest CAGR during 2024–2030, fueled by unmet needs in Alzheimer’s and Parkinson’s disease diagnostics.

• Autoimmune Disorders represented roughly 8% of total revenue in 2024, with an estimated market value of around USD 2.29 billion, supported by increasing use of biomarker panels for disease activity tracking and treatment response assessment.

 

By End User

• Diagnostic Laboratories dominated end-user adoption with approximately 38% market share in 2024, reflecting high testing volumes through centralized reference labs and expanding decentralized testing models, equivalent to around USD 10.87 billion.

• Hospitals and Clinics accounted for about 27% of the market in 2024, translating to an estimated value of approximately USD 7.72 billion, supported by inpatient diagnostics and integration into routine clinical workflows.

• Pharmaceutical and Biotech Companies captured nearly 22% share in 2024, valued at around USD 6.29 billion, and are projected to grow at a strong CAGR through 2024–2030 as biomarkers become core to clinical trials, companion diagnostics, and patient stratification strategies.

• Academic and Research Institutions represented approximately 13% of the market in 2024, corresponding to an estimated value of about USD 3.72 billion, driven by biomarker discovery programs, translational research, and public-private collaborations.

 

Strategic Questions Driving the Next Phase of the Global Blood Based Biomarkers Market

1. What biomarker technologies, analytes, and test formats are explicitly included within the blood based biomarkers market, and which diagnostic approaches fall outside its commercial scope?

2. How does the blood based biomarkers market differ structurally from tissue-based diagnostics, imaging-led diagnostics, and non-blood molecular testing platforms in terms of adoption dynamics and revenue models?

3. What is the current and forecasted size of the global blood based biomarkers market, and how is value distributed across major biomarker classes such as proteomics, genomics, cfDNA/RNA, and extracellular vesicles?

4. How is revenue allocated between single-analyte assays, multi-biomarker panels, and integrated liquid biopsy platforms, and how is this mix expected to evolve over the forecast period?

5. Which clinical application areas—oncology, neurology, cardiology, infectious diseases, and autoimmune disorders—represent the largest and fastest-expanding revenue pools?

6. Which biomarker segments generate outsized commercial value due to premium pricing, longitudinal testing, or companion diagnostic positioning rather than test volume alone?

7. How does clinical demand vary across early screening, disease diagnosis, therapy selection, and longitudinal disease monitoring use cases, and how does this shape test utilization patterns?

8. How are biomarker testing pathways evolving across early-stage, confirmatory, and treatment-monitoring settings within clinical workflows?

9. What role do testing frequency, repeat-use economics, and long-term patient monitoring play in driving recurring revenue across biomarker segments?

10. How do disease prevalence, screening uptake, physician awareness, and access to advanced diagnostics influence demand growth across regional blood based biomarker markets?

11. Which analytical, clinical validation, regulatory, or reimbursement challenges limit penetration for specific biomarker technologies or disease indications?

12. How do pricing pressure, payer evidence requirements, and reimbursement variability impact revenue realization across centralized laboratory testing and decentralized testing models?

13. How robust is the current biomarker development pipeline, and which emerging biomarker modalities are likely to create entirely new diagnostic segments?

14. To what extent will next-generation biomarkers expand the addressable tested population versus intensify competition within existing oncology and chronic disease segments?

15. How are advances in assay sensitivity, multiplexing, automation, and AI-enabled interpretation improving diagnostic accuracy, scalability, and clinical adoption?

16. How will intellectual property positioning, data exclusivity, and technology standardization affect competitive differentiation across biomarker platforms?

17. What role will low-cost assays, laboratory-developed tests (LDTs), and emerging local diagnostic players play in pricing compression and access expansion?

18. How are leading diagnostic companies, biotech firms, and platform developers aligning their biomarker portfolios to secure long-term competitive advantage?

19. Which geographic regions are expected to outperform global growth in the blood based biomarkers market, and which clinical applications are driving this acceleration?

20. How should diagnostic developers, healthcare providers, and investors prioritize biomarker modalities, applications, and regions to maximize long-term value creation?

 

Segment-Level Insights and Market Structure - Blood Based Biomarkers Market

The Blood Based Biomarkers Market is organized around distinct biomarker technologies, clinical application areas, end-user environments, and testing models that reflect differences in diagnostic purpose, analytical complexity, and clinical decision-making value. Each segment contributes uniquely to overall market revenue, adoption momentum, and innovation intensity, shaped by disease burden, testing frequency, and integration into clinical pathways. As healthcare systems increasingly prioritize early detection and minimally invasive diagnostics, the structure of this market continues to evolve toward multi-analyte and longitudinal testing approaches.

 

Biomarker Type Insights

Proteomic Biomarkers
Proteomic biomarkers form the backbone of current clinical adoption due to their long-standing validation, analytical reliability, and relatively lower cost compared to advanced molecular assays. These biomarkers are widely used in oncology, cardiology, and inflammatory disease diagnostics, often serving as first-line indicators for disease presence or progression. From a market perspective, proteomic biomarkers benefit from broad reimbursement acceptance and established laboratory workflows, making them a stable contributor to test volume and recurring revenue.

Genomic Biomarkers
Genomic biomarkers play a critical role in risk stratification, disease susceptibility assessment, and therapy selection. Their value lies in enabling personalized diagnostic insights, particularly in hereditary disease screening and precision oncology. Although adoption is more selective than proteomic testing, genomic biomarkers are gaining importance as sequencing costs decline and molecular profiling becomes increasingly embedded in clinical practice.

Metabolomic Biomarkers
Metabolomic biomarkers provide insight into dynamic biochemical changes associated with metabolic disorders, cardiovascular disease, and drug response. Their strength lies in capturing functional disease states rather than static genetic risk. Commercially, this segment remains smaller but strategically important, as metabolomic profiles are increasingly used to complement genomic and proteomic data for more comprehensive diagnostic interpretation.

Cell-Free DNA (cfDNA) and RNA Biomarkers
cfDNA and RNA biomarkers represent one of the most transformative segments within the market, driven by their central role in liquid biopsy, cancer detection, and minimal residual disease monitoring. These biomarkers enable real-time insights into tumor dynamics through non-invasive sampling, making them highly valuable for treatment selection and disease monitoring. Their growing clinical relevance positions them as a major driver of premium-priced diagnostic offerings.

Exosome-Based Biomarkers
Exosome-based biomarkers are emerging as a high-growth innovation segment due to their stability in circulation and ability to carry complex molecular information. These biomarkers are gaining attention in neurology and neurodegenerative disease research, where traditional diagnostic tools are limited. While still early in commercial adoption, continued advances in isolation technologies and analytical platforms are expected to expand their clinical utility.

 

Application Insights

Oncology
Oncology remains the dominant application area for blood based biomarkers, supported by extensive use in early cancer detection, therapy selection, and disease monitoring. Biomarkers are increasingly embedded into cancer care pathways, enabling clinicians to make data-driven decisions across multiple stages of treatment. The high frequency of testing and premium pricing associated with oncology diagnostics make this segment the largest revenue contributor.

Cardiology
In cardiology, blood based biomarkers are used to assess disease risk, monitor disease progression, and guide therapeutic intervention. Their role is particularly important in acute care and chronic disease management, where timely and accurate diagnostic information can significantly impact patient outcomes. This segment benefits from high testing volumes and routine clinical integration.

Neurology
Neurology represents one of the most rapidly evolving application areas, driven by the need for less invasive diagnostic tools for neurodegenerative disorders. Blood based biomarkers are increasingly explored as alternatives to cerebrospinal fluid analysis and advanced imaging. Growing research activity and unmet diagnostic needs position neurology as a key growth engine within the market.

Infectious Diseases
Blood based biomarkers are widely used in infectious disease diagnostics for early detection, disease severity assessment, and treatment monitoring. The demand for rapid and minimally invasive testing has reinforced the importance of this segment, particularly in hospital and emergency care settings.

Autoimmune Disorders
In autoimmune diseases, biomarkers support disease activity tracking and treatment response evaluation. Their use helps clinicians differentiate between flare-ups and remission, enabling more precise disease management. Although smaller in market size, this segment benefits from recurring testing patterns and long-term patient monitoring.

 

Segment Evolution Perspective

The Blood Based Biomarkers Market is transitioning from single-analyte testing toward integrated, multi-biomarker platforms that support longitudinal disease monitoring. Established biomarker types continue to anchor current diagnostic practices, while emerging molecular and vesicle-based biomarkers are redefining the boundaries of non-invasive diagnostics. Simultaneously, end-user dynamics are shifting toward centralized laboratories and precision-medicine-driven pharmaceutical applications, reshaping how value is distributed across the market over the forecast period.

 

Market Segmentation And Forecast Scope

The blood based biomarkers market breaks down across four primary dimensions: by biomarker type , by application , by end user , and by region . Each dimension reflects the diverse ways in which biomarkers are being discovered, validated, and applied across the clinical landscape. This segmentation also helps spotlight where innovation is most concentrated and where commercial traction is accelerating fastest.

By Biomarker Type

The market includes several biomarker categories, but the core segments are:

• Proteomic Biomarkers

• Genomic Biomarkers

• Metabolomic Biomarkers

• Cell-free DNA (cfDNA) and RNA Biomarkers

• Exosome-based Biomarkers

Among these, cfDNA and RNA biomarkers account for approximately 26% of the market in 2024, driven by their role in cancer diagnostics and minimal residual disease (MRD) monitoring. However, exosome-based biomarkers are gaining rapid traction due to their stability in circulation and growing relevance in neurodegenerative diseases.

Many researchers are shifting toward RNA signatures and extracellular vesicles because they offer more dynamic readouts — not just snapshots but evolving profiles over time.

 

By Application

Blood-based biomarkers are being applied across multiple domains, including:

• Oncology

• Cardiology

• Neurology

• Infectious Diseases

• Autoimmune Disorders

Oncology remains the heavyweight, contributing nearly 47% of total revenue in 2024, thanks to widespread adoption in lung, breast, colorectal, and prostate cancer diagnostics. But the fastest-growing segment is neurology , particularly for Alzheimer’s and Parkinson’s diagnostics, where traditional imaging and CSF-based methods are too invasive or costly.

 

By End User

The key end users driving demand are:

• Hospitals and Clinics

• Academic and Research Institutions

• Diagnostic Laboratories

• Pharmaceutical and Biotech Companies

Diagnostic laboratories — especially centralized reference labs and emerging decentralized models — dominate market share. But pharma and biotech firms are increasing their footprint as they embed biomarker strategies into clinical trial design, companion diagnostics, and patient stratification.

 

By Region

Geographically, the market spans:

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

North America leads the market due to strong R&D infrastructure, rapid test approvals, and active reimbursement pathways. Asia Pacific , however, is the most dynamic growth engine, fueled by genomic medicine initiatives in China, South Korea, and Singapore, and large undiagnosed populations.

Several APAC countries are skipping legacy diagnostics and going straight to liquid biopsy and multi-biomarker panels, especially in oncology and prenatal testing.

 

Market Trends And Innovation Landscape

The blood based biomarkers market is evolving fast — not just in scale, but in scientific complexity. What started as a hunt for a single diagnostic protein has transformed into multi-dimensional biomarker panels powered by AI and validated through real-world evidence. Across biotech, diagnostics, and pharma, there's a common goal: earlier detection, more precise stratification, and real-time disease monitoring.

From Single Biomarkers to Multi-Omics Panels

One of the most visible shifts is the transition from isolated protein or gene markers toward multi- omic panels — integrating genomics, transcriptomics, proteomics, and metabolomics from a single blood draw. Platforms are now capable of detecting not only known mutations or proteins but also methylation signatures, microRNAs, and epigenetic shifts that hint at disease progression well before symptoms arise.

“We’re no longer looking for one smoking gun. We’re building entire molecular fingerprints,” explained a biotech executive during a recent AACR panel.

 

Tech Innovation: AI + Blood = Predictive Models

Artificial intelligence is playing a big role in this transition. Startups and research labs are feeding raw omics data into machine learning models to develop predictive algorithms — capable of identifying disease stages, therapy response, or relapse risks. This is especially useful in oncology, where liquid biopsies supported by AI can now monitor tumor evolution over time.

Beyond oncology, these tools are entering cardiology and neurodegeneration. Early-stage studies show that blood-based AI models may one day predict Alzheimer's risk years before onset — a game-changer for pharma and public health.

 

Pipeline and Partnering Momentum

Biotech and diagnostic firms are doubling down on biomarker-based strategies. In the past 18 months, several high-value partnerships have emerged:

• Biopharma companies are co-developing companion diagnostics for targeted therapies.

• IVD players are licensing novel biomarker IP from academic labs to expand their panels.

• CROs are embedding liquid biopsy endpoints into oncology trials to enhance recruitment and reduce failure rates.

Startups are also pushing the frontier. A wave of VC-backed firms is working on multi-cancer early detection (MCED) tests and blood-based assays for neuroinflammation , both of which are currently underserved by traditional tools.

 

R&D Priorities Are Shifting

While cancer remains the research focus, pipeline data show increasing biomarker activity in:

• Chronic inflammatory diseases (e.g., Crohn’s, lupus)

• Metabolic disorders (e.g., NASH, diabetes)

• Neurological conditions (e.g., ALS, MS)

These areas lack reliable biomarkers today. But the biology is there — and with the right analytical tools, companies are trying to make the leap from discovery to clinical use.

 

Competitive Intelligence And Benchmarking

The blood based biomarkers market is defined by a mix of global diagnostics giants, nimble biotech innovators, and specialized research-driven firms. While some players dominate with proprietary platforms and regulatory reach, others differentiate through speed, specialization, or deep clinical partnerships. Competitive intensity is increasing — not just in oncology, but across neurology, infectious disease, and inflammation monitoring.

Here are the key players shaping this market:

Roche Diagnostics

A leader in integrated diagnostics, Roche continues to expand its biomarker portfolio through its cobas platform and partnerships in liquid biopsy. Its strength lies in oncology diagnostics and its ability to combine lab hardware with blood-based assay development. Roche also invests heavily in co-development with pharma, especially in companion diagnostics.

 

Bio-Techne

Bio-Techne has quietly built a strong presence through acquisitions and focused expansion in protein and exosome-based biomarkers. Its ExoDx Prostate test is one of the few commercially available exosomal diagnostics, and it’s investing in scaling blood-based neurology applications next.

 

Guardant Health

Focused on precision oncology, Guardant is one of the top players in liquid biopsy. Its blood tests for tumor profiling and residual disease monitoring are increasingly used in both clinical and trial settings. Guardant’s analytics platform is a key differentiator — enabling continuous patient monitoring from a simple blood draw.

 

Quanterix

Quanterix brings ultra-sensitive detection to the biomarker game. With its Simoa platform , it enables single-molecule protein analysis — useful for detecting early neurological markers and low-abundance cancer signals. Though still scaling commercially, its tech is widely used in pharma R&D.

 

Illumina

While primarily a sequencing firm, Illumina is instrumental in the biomarker ecosystem. Through its partnerships with diagnostics firms and CROs, it provides the genomic infrastructure for cfDNA and methylation-based panels. Its acquisition and spin-off of GRAIL highlight its push into early cancer detection.

 

Freenome

A rising star in early cancer detection, Freenome is building blood-based tests that combine cfDNA, epigenetics, and machine learning. Its platform aims to catch colorectal and other cancers before symptoms emerge — making it attractive to both payers and pharma.

 

Abcam

Known for antibodies and reagents, Abcam plays a foundational role in biomarker validation and assay development. Many startups and research groups rely on its catalog to build new blood-based diagnostic assays across multiple disease areas.

What sets these companies apart isn't just assay sensitivity — it's platform scalability, regulatory traction, and how well their solutions plug into pharma pipelines or clinical workflows.

Across the board, firms are investing in partnerships — not just to expand IP, but to fast-track clinical trials and meet payers' evidence demands. The ability to offer validated, scalable, and reimbursable blood-based tests is quickly becoming a key competitive differentiator.

 

Regional Landscape And Adoption Outlook

Adoption of blood based biomarkers varies sharply by region — depending on health infrastructure, reimbursement maturity, and the speed of regulatory approval. While North America remains the innovation and revenue leader, momentum is shifting in parts of Europe and Asia, where governments and academic institutions are aggressively investing in non-invasive diagnostics.

North America

The U.S. dominates both revenue and clinical trial activity. With robust reimbursement frameworks, a high density of biopharma sponsors, and strong academic partnerships, North America accounts for more than 40% of global market share in 2024. The FDA’s Breakthrough Device Designation program and growing Medicare coverage for liquid biopsy have helped accelerate test adoption, especially in oncology.

Canada lags slightly behind the U.S. but benefits from government-backed innovation hubs and public-private genomics initiatives. Several provinces are piloting biomarker use in population screening programs.

 

Europe

Europe is home to strong clinical research networks and a rapidly evolving regulatory landscape. Countries like Germany , France , and the UK are integrating blood-based diagnostics into national cancer screening pathways and personalized medicine initiatives.

What’s holding back faster scale-up? Fragmented reimbursement across EU states. However, the EU In Vitro Diagnostic Regulation (IVDR) is creating a standardized path for diagnostic approvals — a step that could streamline future commercialization across borders.

Some regional health systems are already using blood biomarkers to triage patients for advanced imaging or biopsy — saving both time and cost.

 

Asia Pacific

This is the fastest-growing region in the market, with countries like China , Japan , South Korea , and Singapore investing heavily in biomarker-driven medicine. China, in particular, is pushing forward with national genomics strategies and local IVD innovation to reduce dependency on Western platforms.

Japan’s aging population and high rates of cancer are also fueling demand for early diagnostic tools. Meanwhile, Singapore is positioning itself as a biomarker R&D hub, supporting both academic consortia and multinational clinical trials.

Unlike the West, many APAC countries are skipping over legacy diagnostic infrastructure and moving directly to advanced blood-based platforms — especially in cancer, infectious diseases, and maternal health.

 

Latin America and Middle East & Africa

These regions are still early in adoption, with limited market penetration due to infrastructure and cost challenges. That said, Brazil and Saudi Arabia are exploring national screening programs and pilot partnerships with international diagnostic firms. Most current usage is centered in urban academic hospitals or private specialty clinics.

There's growing interest in using blood biomarkers for affordable population-level screening — but lack of reimbursement remains a major hurdle.

 

End-User Dynamics And Use Case

End-user adoption of blood based biomarkers is expanding fast — but the pace and priorities differ across institutions. Hospitals are focused on actionable results that guide care decisions. Biopharma companies are using them to optimize trials. And diagnostic labs are racing to scale test volume with automation and precision.

Hospitals and Clinics

These are the primary clinical users, especially in oncology, cardiology, and infectious disease settings. Blood biomarkers offer a major advantage here: speed. Instead of waiting days for tissue biopsy results, clinicians can often get blood-based insights within 24–48 hours — making it easier to start or adjust treatment.

Many hospitals now embed biomarker testing into diagnostic workflows for lung, colorectal, and prostate cancers. Some are expanding use into stroke and cardiac event triage, where time-sensitive decisions benefit from rapid, non-invasive tools.

 

Diagnostic Laboratories

Centralized and decentralized labs are driving both test development and volume-based revenue. Labs like Quest Diagnostics , Labcorp , and regional players run high-throughput assays for everything from minimal residual disease monitoring to metabolic screening. Their edge lies in logistics, insurance contracts, and scale.

Decentralized labs — especially in emerging markets — are investing in modular liquid biopsy kits that can be adapted to local disease burdens. They’re also key partners for test developers looking to reach wider patient populations.

 

Biopharmaceutical and Biotechnology Firms

For these companies, blood biomarkers aren't just diagnostics — they're strategic assets. Biomarkers help stratify trial participants, predict therapy response, and flag toxicity early. As personalized medicine expands, drug approvals increasingly depend on validated companion diagnostics, many of which are blood-based.

Several firms have integrated biomarker endpoints into oncology, Alzheimer’s, and autoimmune disease trials — not just for patient selection, but for dynamic dosing and early efficacy signals.

 

Academic and Research Institutions

Universities and research hospitals are crucial in early-stage biomarker discovery and validation. These groups often collaborate with diagnostics firms to move promising markers from bench to bedside. They also conduct the longitudinal cohort studies needed to validate emerging markers in real-world populations.

 

Use Case: Early Alzheimer’s Risk Detection in South Korea

A tertiary care hospital in Seoul partnered with a biotech startup to validate a blood test that detects plasma phosphorylated tau and amyloid beta ratios — two critical biomarkers linked to early-stage Alzheimer’s. Traditionally, PET imaging or cerebrospinal fluid (CSF) analysis were needed, both costly and invasive.

By integrating the blood-based test into outpatient neurology clinics, the hospital screened over 5,000 seniors in six months. Those with elevated biomarkers were referred for further imaging and care planning.

The result? Quicker interventions, reduced reliance on invasive diagnostics, and a potential new model for national dementia screening.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Past 2 Years)

• Guardant Health received FDA approval for its Guardant360 CDx as a companion diagnostic for multiple targeted therapies — reinforcing the role of blood-based biomarkers in personalized oncology.

• Freenome raised $254 million in a Series D financing round to expand its multi-cancer early detection blood test platform, signaling strong investor confidence in blood-based screening models.

• Quanterix announced partnerships with major pharma companies to develop neurodegenerative biomarker panels for Alzheimer’s and ALS, based on their Simoa technology.

• Bio-Techne launched a new exosome-based test for prostate cancer risk stratification, expanding non-invasive diagnostics into urology.

• The UK National Health Service (NHS) began trials for a blood test to detect over 50 cancers early — in partnership with GRAIL. Results from these population-based studies may shape future screening guidelines.

 

Opportunities

• Shift to Preventive Diagnostics: As healthcare systems move from reactive care to early intervention, blood biomarkers are poised to play a foundational role in population-wide screening and risk-based triage — particularly in oncology and neurology.

• AI + Omics Integration: Advanced analytics platforms are turning biomarker data into predictive models . This enables not just diagnosis, but prognosis, treatment response forecasting, and real-time monitoring — unlocking new business models for diagnostics firms and digital health startups.

• Emerging Markets Leapfrogging: In Asia Pacific, Middle East, and parts of Latin America, clinical systems are bypassing legacy pathology infrastructure and adopting blood-based platforms for scalable, cost-effective disease detection.

 

Restraints

• Clinical Validation and Reimbursement Delays: Regulatory pathways for novel blood-based biomarkers are still maturing. Lack of large-scale validation data and fragmented payer policies make it difficult for tests to achieve broad adoption and reimbursement.

• Cost and Complexity of Multi-Omics Testing: While technology is improving, multi- omic tests remain expensive and are often limited to academic settings or high-income health systems. Bridging this cost gap is essential for wider clinical integration.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 28.6 Billion
Revenue Forecast in 2030	USD 60.6 Billion
Overall Growth Rate	CAGR of 13.2% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Biomarker Type, By Application, By End User, By Region
By Biomarker Type	Proteomic, Genomic, cfDNA/RNA, Metabolomic, Exosomal
By Application	Oncology, Cardiology, Neurology, Infectious, Autoimmune
By End User	Hospitals & Clinics, Diagnostic Labs, Academia, Biotech
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, etc.
Market Drivers	AI integration, Preventive healthcare adoption, Pharma diagnostics alignment
Customization Option	Available upon request