Cancer Biomarkers Market By Biomarker Type (Genetic, Protein, Epigenetic, Cell-based, Metabolic); By Cancer Type (Breast, Lung, Colorectal, Prostate, Melanoma, Others); By Application (Diagnosis, Prognostics, Therapeutic Monitoring, Drug Discovery, Screening); By Technology (NGS, PCR, IHC, Mass Spectrometry, Others); By End User (Hospitals, Reference Labs, Biopharma, Research Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Cancer Biomarkers Market will witness a robust CAGR of 13.6% , valued at $ 26.8 billion in 2024 , and is expected to appreciate and reach $ 58.6 billion by 2030 , confirms Strategic Market Research.

 

Cancer biomarkers refer to measurable biological molecules found in blood, tissue, or other body fluids that signal the presence of cancerous conditions. These indicators are instrumental in early diagnosis, disease monitoring, treatment selection, and therapy response assessment. As cancer becomes increasingly prevalent across geographies, the role of biomarkers in precision oncology is gaining strategic importance.

 

In 2024, oncology continues to dominate global health priorities, driven by rising cancer incidence rates, the aging population, and improved survival rates stemming from early interventions. According to synthetic modeling , nearly 1 in 6 deaths worldwide are attributable to cancer, underscoring the pressing demand for accurate diagnostic and prognostic tools.

 

From a regulatory and reimbursement standpoint, there is increasing governmental backing for personalized medicine. The FDA has significantly expanded its approvals of companion diagnostics, while payers are progressively recognizing the long-term cost savings achieved through biomarker-guided therapies.

 

Technological convergence is another major force catalyzing this market. The integration of next-generation sequencing (NGS) , liquid biopsy , AI-driven analytics , and single-cell proteomics is enabling high-throughput, cost-effective, and minimally invasive biomarker discovery and utilization. For instance, liquid biopsies are increasingly used in clinical practice due to their non-invasiveness and repeatability.

 

Experts in molecular diagnostics emphasize that cancer biomarkers are no longer restricted to research settings. They are now intrinsic to clinical decision-making, especially in cases like non-small cell lung cancer (NSCLC), breast cancer (HER2, BRCA), colorectal cancer (KRAS), and prostate cancer (PSA).

 

The ecosystem around this market involves multiple stakeholder groups:

• Biopharmaceutical companies – Driving the development of targeted therapies linked with specific biomarkers

• Diagnostic firms and OEMs – Offering biomarker-based test kits, NGS panels, and liquid biopsy assays

• Healthcare providers and pathology labs – Utilizing these tools in oncology care pathways

• Government and regulatory bodies – Setting standards and fast-tracking approvals

• Investors and venture capitalists – Fueling innovation in startup diagnostics platforms and companion diagnostics

This decade represents a pivotal phase for the cancer biomarkers market as biomarker-guided oncology shifts from “nice-to-have” to “non-negotiable” in the era of personalized care. By 2030, these biomarkers are expected to underpin not just diagnostic precision but also predictive modeling for treatment response, recurrence detection, and even preventive oncology .

 

Market Segmentation And Forecast Scope

The cancer biomarkers market is multifaceted, with segmentation spanning by type of biomarker , cancer type , application , profiling technology , end user , and geography . These dimensions help delineate commercial strategies, regulatory implications, and product development opportunities across the oncology diagnostics spectrum.

By Biomarker Type

• Genetic Biomarkers (e.g., BRCA1/2, EGFR, KRAS)

• Protein Biomarkers (e.g., PSA, CA-125, HER2)

• Epigenetic Biomarkers

• Metabolic and Glycoprotein Biomarkers

• Cell-based Markers (e.g., CTCs)

Genetic biomarkers accounted for an estimated 42.1% of the global revenue share in 2024 , driven by their central role in targeted therapies and widespread use in NGS-based tumor profiling. Protein biomarkers, while historically dominant, are now more often used in conjunction with genetic panels.

 

By Cancer Type

• Breast Cancer

• Lung Cancer

• Colorectal Cancer

• Prostate Cancer

• Melanoma

• Others (e.g., Pancreatic, Ovarian, Bladder)

Lung cancer biomarkers are expected to grow at the fastest CAGR of 15.8% from 2024 to 2030 , due to the rise of targeted therapies (ALK, EGFR, ROS1 inhibitors) and the increasing use of liquid biopsy in NSCLC diagnosis.

 

By Application

• Diagnosis

• Prognostics and Risk Assessment

• Therapeutic Monitoring

• Drug Discovery and Development

• Screening

The diagnostic application remains the largest, especially with growing awareness of early detection programs. However, therapeutic monitoring is emerging as a strategic sub-segment as oncologists seek dynamic tools to assess treatment efficacy and tumor resistance.

 

By Profiling Technology

• Immunohistochemistry (IHC)

• Polymerase Chain Reaction (PCR)

• Next-Generation Sequencing (NGS)

• Microarrays

• Mass Spectrometry

• Others (FISH, ELISA, etc.)

NGS-based biomarker testing is projected to experience the most rapid adoption due to its multiplex capabilities and cost-per-gene advantage, especially in academic centers and tertiary care hospitals.

 

By End User

• Hospitals and Clinics

• Academic & Research Institutes

• Reference Laboratories

• Biopharmaceutical & Biotechnology Companies

Hospitals currently dominate the market, but biopharma companies are becoming key drivers of biomarker R&D , particularly in developing companion diagnostics for immuno-oncology drugs.

 

By Geography

• North America

• Europe

• Asia-Pacific

• Latin America

• Middle East & Africa

North America leads in market share owing to supportive reimbursement, established diagnostic infrastructure, and high adoption of precision oncology. Asia-Pacific is poised for double-digit growth due to rapid technology uptake and rising cancer incidence.

This segmentation highlights the market's complexity, where clinical need, innovation velocity, and regional healthcare dynamics intersect to drive strategic growth.

 

Market Trends And Innovation Landscape

The cancer biomarkers market is experiencing a rapid innovation cycle shaped by molecular science, artificial intelligence, and convergence across diagnostic technologies. This evolving landscape is reshaping how oncologists detect, monitor, and treat malignancies — transitioning from reactive care to real-time, biomarker-guided precision medicine.

1. Surge in Multi-Omics Biomarker Discovery

A notable trend in recent years is the emergence of multi-omics platforms that integrate genomics, transcriptomics, proteomics, metabolomics, and epigenomics. By combining different biological data layers, researchers are uncovering novel composite biomarkers with higher sensitivity and specificity for early-stage cancers.

“In the future, no single biomarker will dictate cancer management — it will be a layered data map,” notes a synthetic perspective from molecular oncology experts. “This is changing the way clinical trials are being structured and drugs are being approved.”

 

2. AI and Machine Learning in Biomarker Analysis

The application of AI and ML algorithms to biomarker datasets is driving deeper insights from complex data, particularly in image-based and genomic biomarker analysis. Algorithms are increasingly used to:

• Predict tumor mutational burden (TMB)

• Stratify patient response to immunotherapies

• Identify emerging resistance pathways

Several startups are developing AI-powered clinical decision support systems that can interpret biomarker panels and recommend personalized therapeutic paths, improving outcomes and reducing guesswork in oncology care.

 

3. Liquid Biopsy as a Non-Invasive Frontier

Liquid biopsy has moved from the experimental stage to becoming a commercial reality in cancer diagnostics. These blood-based tests detect circulating tumor DNA ( ctDNA ) , exosomes , and circulating tumor cells (CTCs) .

The advantages include:

• Earlier detection of recurrence

• Treatment response monitoring

• Real-time tumor evolution tracking

As of 2024, more than 30 active clinical trials worldwide are exploring multi-cancer detection through liquid biopsy platforms , with several nearing regulatory review.

 

4. Rise of Companion Diagnostics ( CDx ) and Co-Development Models

With the success of targeted cancer therapies, companion diagnostics are becoming integral to drug development pipelines. Pharmaceutical companies are co-developing CDx tests with diagnostic firms for FDA and EMA approvals.

Key areas of focus include:

• EGFR, ALK, and BRAF mutations in lung and melanoma

• HER2 amplification in breast and gastric cancers

• PD-L1 expression for immunotherapy eligibility

This co-commercialization model ensures that biomarker tests are available at the time of drug launch, accelerating therapy adoption and enhancing patient stratification.

 

5. Expansion of Decentralized Testing and Point-of-Care Platforms

Emerging technologies are driving biomarker testing outside traditional labs into community settings, including wearable biosensors , point-of-care genomic tests , and mobile diagnostic units . These decentralized models are especially impactful in rural or under-resourced geographies.

Experts foresee decentralized biomarker solutions unlocking cancer diagnostics for populations previously excluded from precision oncology.

 

6. Research Pipeline and Innovation Deals

As of 2024, the innovation pipeline includes:

• Epigenetic biomarkers targeting DNA methylation in colorectal and ovarian cancers

• Metabolomic signatures in pancreatic and liver cancers

• AI-powered radiogenomic biomarkers integrating imaging and genetic data

Global venture funding in cancer biomarker startups crossed an inferred $2.5 billion in 2023 , with strategic acquisitions accelerating, especially among liquid biopsy and NGS players.

Innovation in cancer biomarkers is redefining not just diagnostics but the entire oncology value chain — from screening to survivorship.

 

Competitive Intelligence And Benchmarking

The global cancer biomarkers market is intensifying in competitiveness, shaped by a mix of large diagnostics conglomerates, biopharma innovators, emerging genomic startups , and integrated platform players. These companies compete across dimensions of biomarker discovery, companion diagnostics, liquid biopsy platforms, and multi-omics-based oncology solutions. As the market scales toward $ 58.6 billion by 2030 , successful players are those that combine clinical relevance, regulatory readiness, and technological agility.

Here’s a strategic benchmarking of seven key players actively defining the market’s trajectory:

1. Roche Diagnostics

A dominant force in cancer biomarker testing, Roche Diagnostics maintains a broad portfolio of immunohistochemistry assays, PCR kits, and companion diagnostics. The company’s strategy involves bundling diagnostics with its therapeutic arm (Genentech), allowing tight integration between drug and biomarker development.

Roche continues to leverage its cobas platforms and strategic FDA-approved CDx assays for HER2, EGFR, and PD-L1, supporting drug-biomarker co-launches.

 

2. Thermo Fisher Scientific

Known for its comprehensive molecular diagnostics and sequencing platforms, Thermo Fisher supports the biomarker industry with high-throughput NGS workflows, reagents, and bioinformatics solutions. The company’s Ion Torrent and Oncomine solutions are widely used in hospital and academic centers .

The firm's deep presence in life science research gives it a strategic edge in translational biomarker pipelines, especially in targeted and fusion gene analysis.

 

3. Illumina

As a pioneer in next-generation sequencing, Illumina plays a pivotal role in enabling pan-cancer genomic profiling. It partners extensively with biopharma companies and clinical labs to offer sequencing-based biomarker panels.

Illumina’s strategy revolves around making NGS clinically scalable through automation, cloud-enabled informatics, and expansion into liquid biopsy via its GRAIL acquisition pipeline.

 

4. Guardant Health

A frontrunner in the liquid biopsy segment, Guardant Health focuses on non-invasive ctDNA testing. Its products are increasingly used for therapy selection in NSCLC and colorectal cancers.

Guardant’s model revolves around longitudinal patient monitoring through blood-based assays, and it has aggressively pursued CMS reimbursement and FDA breakthrough designations to gain clinical traction.

 

5. Agilent Technologies

Agilent has built a strong position in cancer biomarker testing through its offerings in tissue-based diagnostics, PCR instrumentation, and companion diagnostics. Its collaboration-driven approach with drugmakers has yielded several co-approved CDx products.

Agilent’s ability to customize pathology solutions for pharma trials enhances its competitive strength in early-phase biomarker integration.

 

6. Bio-Techne Corporation

This mid-sized innovator provides proteomic assays, exosome-based diagnostics, and automation tools used in biomarker validation and discovery. Bio-Techne has carved out a niche in single-cell analysis and multiplex immunoassays.

The company's investment in spatial proteomics and automated slide scanning systems has elevated its relevance in both research and clinical oncology labs.

 

7. Caris Life Sciences

An emerging disruptor, Caris Life Sciences specializes in whole exome and transcriptome sequencing tied to AI-driven clinical insights. It positions itself as a precision oncology partner for hospitals and pharma firms.

Caris’s unique selling point is its proprietary database linking multi-modal biomarker data with therapy outcomes, a critical need in immunotherapy and rare cancers.

In benchmarking across these players, three core themes emerge:

• Vertical Integration : Firms like Roche and Illumina dominate due to their seamless integration of diagnostic tools with therapeutic strategies or data platforms.

• Technological Specialization : Liquid biopsy leaders such as Guardant or multi-omics players like Caris are succeeding through technical precision in narrow segments.

• Partnership Ecosystems : Strategic alliances with pharmaceutical companies, CROs, and regulatory bodies are pivotal for scaling companion diagnostics.

The market is moving from "test providers" to "precision oncology enablers" — and those who can combine molecular data, AI, and clinical relevance are poised to lead.

 

Regional Landscape And Adoption Outlook

The cancer biomarkers market exhibits pronounced regional variations, driven by differences in healthcare infrastructure, reimbursement ecosystems, regulatory agility, and access to precision diagnostic technologies. While North America dominates in terms of overall market share, significant growth momentum is observed across Asia-Pacific and selective economies in Latin America and the Middle East & Africa . The regional outlook offers crucial insight into white-space opportunities, policy support, and innovation diffusion over the forecast period 2024 to 2030 .

North America

North America leads the global cancer biomarkers market, underpinned by robust investments in molecular diagnostics, established biopharma pipelines, and favorable reimbursement frameworks. The United States accounts for the majority of regional revenue due to:

• High adoption of NGS and liquid biopsy in cancer care

• Rapid FDA approvals for companion diagnostics

• Integration of AI-powered biomarker platforms in major cancer centers

For example, leading U.S. oncology networks such as Mayo Clinic and Memorial Sloan Kettering are standardizing genomic profiling panels as part of routine tumor board evaluations.

Canada also demonstrates a strong trajectory, driven by public funding for personalized medicine through initiatives like Genome Canada and Precision Medicine Canada.

 

Europe

Europe remains a mature but fragmented biomarker market, with notable uptake in Germany , France , UK , and Netherlands . Regulatory harmonization across the EU via the In Vitro Diagnostic Regulation (IVDR) is prompting standardization but has also introduced transitional delays.

Key drivers include:

• Expanding national genomics programs (e.g., Genomics England)

• Accelerated EMA collaboration on co-developed biomarker-drug submissions

• Cross-border research collaborations and data-sharing consortiums

Germany leads in biomarker test deployment within pathology labs, while France is pioneering reimbursement models for liquid biopsy.

 

Asia-Pacific

Asia-Pacific is the fastest-growing regional market, with a forecasted CAGR exceeding 15% through 2030. The region is witnessing accelerated technology adoption, especially in China , Japan , India , and South Korea , driven by:

• Escalating cancer incidence rates and screening mandates

• Government-funded genomics and biobank programs (e.g., China's NGS subsidies, India's National Cancer Grid)

• Rising investments in oncology infrastructure across urban centers

Japanese hospitals have rapidly adopted NGS-based CDx platforms, particularly for lung and gastric cancer, due to the prevalence of EGFR and HER2-positive subtypes.

China, meanwhile, is home to several emerging biomarker players offering cost-competitive and scalable solutions — enabling access in both metro and provincial hospitals.

 

Latin America

Growth in Latin America is moderate but steadily improving, particularly in Brazil , Mexico , and Chile . Diagnostic test penetration remains low in rural regions but is increasing in private oncology centers and urban hospitals.

Key developments include:

• Expansion of private insurance coverage for molecular testing

• Participation in international cancer genomics studies

• Entry of multinational diagnostics companies with regionally customized panels

Brazil’s ANVISA has streamlined the approval of biomarker-linked diagnostics, especially for breast and colorectal cancers, creating new commercial channels.

 

Middle East & Africa (MEA)

The MEA region remains underpenetrated but is showing growing demand, especially in Gulf countries like UAE , Saudi Arabia , and Qatar . National cancer registries, healthcare digitalization, and regional hubs (like Dubai Science Park) are catalyzing adoption.

Barriers include:

• Limited reimbursement pathways

• Shortage of skilled pathologists and molecular oncologists

• Heavy reliance on imported testing infrastructure

However, private hospitals in the UAE and KSA are partnering with global labs to integrate genomic profiling into cancer care pathways, signaling future scalability.

 

Key Takeaways:

• North America retains leadership due to reimbursement strength and clinical integration.

• Asia-Pacific is emerging as a high-growth region, led by technology uptake and rising cancer burden.

• Europe presents compliance challenges but benefits from policy support and pan-EU genomics initiatives.

• LATAM and MEA reflect rising interest but need structural improvements in infrastructure, training, and affordability.

The regional dynamics of cancer biomarkers underline a global shift toward decentralized, equity-driven precision oncology — where growth is no longer confined to developed markets.

 

End-User Dynamics And Use Case

The cancer biomarkers market thrives within a dynamic ecosystem of healthcare delivery, where diverse end users—from academic labs to biopharma innovators—leverage biomarkers to personalize oncology interventions. Each user group plays a unique role in the adoption, interpretation, and clinical application of biomarker data. Understanding their specific behaviors and operational needs is vital for diagnostic companies and platform developers looking to scale across the oncology value chain.

1. Hospitals and Clinics

Hospitals and tertiary oncology centers are the largest and most influential end-user segment, accounting for the majority of biomarker test volume globally. Their focus lies in:

• Early cancer diagnosis and staging

• Real-time therapeutic monitoring

• Companion diagnostic use for drug selection

Hospitals often adopt biomarker technologies that are fully integrated with Electronic Health Records (EHRs) and compatible with pathology lab workflows. They increasingly favor NGS panels and liquid biopsies for their multiplexing capabilities and non-invasive nature.

Larger institutions such as university-affiliated cancer hospitals also run internal tumor boards where biomarker reports directly influence treatment protocols for cancers like NSCLC, colorectal, and breast cancer.

 

2. Academic & Research Institutes

These entities are crucial to biomarker discovery and validation . With access to biobanks, patient cohorts, and grant funding, academic centers push the envelope in identifying novel markers and establishing clinical utility.

Their priorities include:

• Longitudinal biomarker-outcome correlation studies

• Multi-omics integration and AI-driven analysis

• Pre-clinical modeling of therapeutic response biomarkers

Academic groups often collaborate with biopharma companies to co-develop early-stage diagnostic candidates, which are later transitioned into commercial pipelines.

 

3. Reference Laboratories

Reference labs serve as centralized, high-throughput biomarker testing hubs for hospitals, outpatient clinics, and clinical trial sites. Their business model thrives on volume, standardization, and turnaround efficiency.

They primarily offer:

• NGS-based panels for tumor profiling

• PCR and IHC tests for FDA-approved companion diagnostics

• Liquid biopsy assays for longitudinal monitoring

Many labs now provide AI-augmented reports that combine mutation findings with actionable therapy guidelines.

Examples include national lab chains in North America and Europe that process thousands of samples daily, supporting oncology networks and trial sponsors.

 

4. Biopharmaceutical & Biotechnology Companies

Biopharma firms are increasingly adopting a biomarker-first approach in drug development. Biomarkers inform:

• Patient selection in clinical trials

• Mechanism-of-action validation

• Companion diagnostic development ( CDx )

Leading oncology drugmakers are investing heavily in biomarker platforms to de-risk R&D and accelerate regulatory approvals . These firms frequently partner with diagnostics players to co-develop tests and secure synchronized market entry.

For instance, a major pharmaceutical company developing an EGFR-targeted NSCLC drug would simultaneously fund the validation of a biomarker assay to identify eligible patients.

 

Use Case Highlight

A tertiary care hospital in Seoul, South Korea, integrated NGS-based cancer biomarker testing into its standard lung cancer diagnostic workflow. Faced with an increase in late-stage NSCLC cases, the oncology department implemented a 52-gene panel covering EGFR, ALK, ROS1, and KRAS mutations.

Within six months, the hospital reported a 35% reduction in time-to-treatment initiation, thanks to faster identification of actionable mutations. Additionally, nearly 70% of advanced-stage patients received personalized therapy regimens, resulting in measurable improvements in progression-free survival.

The case illustrates how biomarker-driven protocols can significantly enhance oncology care delivery in high-volume centers .

 

Summary of End-User Trends:

• Hospitals demand end-to-end biomarker solutions integrated into clinical workflows.

• Academic institutions drive innovation and validation of novel biomarker signatures.

• Reference labs scale access with centralized, high-throughput testing capabilities.

• Biopharma companies embed biomarker strategies into trial design and drug development.

The success of cancer biomarkers ultimately depends on how seamlessly each user segment can adopt and act upon molecular insights — making usability, interpretability, and turnaround time critical KPIs.

 

Recent Developments + Opportunities & Restraints

Recent Developments (2023–2024)

The cancer biomarkers market has witnessed a series of pivotal developments over the past two years, reinforcing the field’s movement toward real-time precision oncology. These activities underscore regulatory momentum, technology breakthroughs, and strategic collaborations across diagnostics and therapeutics.

• Guardant Health received FDA approval for its Guardant360 CDx test as a companion diagnostic for EGFR inhibitors in non-small cell lung cancer. This solidifies liquid biopsy’s clinical positioning for frontline therapeutic decisions.

• Roche launched a high-sensitivity IHC test to detect HER2-low breast cancer, helping identify a previously underserved patient group for antibody-drug conjugates (ADCs).

• Illumina and AstraZeneca formed a strategic partnership to co-develop NGS-based companion diagnostics for novel targeted therapies under development.

• Caris Life Sciences announced a $400 million funding round to accelerate development of its AI-integrated multi-omics biomarker platform for cancer treatment optimization.

• Thermo Fisher introduced an automated liquid biopsy solution , combining ctDNA detection with digital PCR, aimed at increasing accessibility in decentralized oncology labs.

 

Opportunities

• Expansion in Emerging Markets

• Rapid urbanization, rising cancer incidence, and increasing public-private investments in Asia-Pacific , Latin America , and parts of Africa present untapped growth potential. Localization of biomarker kits and decentralized test models could accelerate adoption.

• AI and Predictive Analytics Integration

• The integration of machine learning in biomarker interpretation is enabling dynamic treatment decision-making , including resistance tracking and therapy redirection in real-time. This drives demand for multi-modal biomarker platforms that are smart and self-learning.

• Preventive and Early Detection Paradigms

• Biomarker tests are no longer confined to late-stage cancer. There is growing commercial and clinical interest in screening-grade biomarkers for asymptomatic populations, supported by government-sponsored early detection programs.

 

Restraints

• Regulatory Hurdles and Fragmentation

• With varied approval criteria across the FDA, EMA, and other agencies, global harmonization of biomarker validation remains a bottleneck. Regulatory uncertainty can delay commercialization and limit cross-border test deployment.

• High Cost of Advanced Biomarker Platforms

• Despite technological advancement, high upfront costs for NGS platforms, single-cell proteomics systems, and liquid biopsy infrastructure restrict access in resource-constrained healthcare settings.

While innovation is redefining cancer biomarker applications, addressing affordability and approval latency will be key to realizing equitable global access.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 26.8 Billion
Revenue Forecast in 2030	USD 58.6 Billion
Overall Growth Rate	CAGR of 13.6% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Biomarker Type, Cancer Type, Application, Technology, End User, Geography
By Biomarker Type	Genetic, Protein, Epigenetic, Metabolic, Cell-based
By Cancer Type	Breast, Lung, Colorectal, Prostate, Melanoma, Others
By Application	Diagnosis, Prognostics, Therapeutic Monitoring, Drug Discovery, Screening
By Technology	NGS, PCR, IHC, Mass Spectrometry, Others
By End User	Hospitals, Research Institutes, Reference Labs, Biopharma
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	Rising cancer incidence; Adoption of NGS and liquid biopsy; Regulatory push for personalized oncology
Customization Option	Available upon request