Oncology Biomarker Diagnostics, Global, 2024-2030

Regulatory Approvals, Companion Diagnostic Partnerships, and Precision Medicine are Driving Transformational Growth in the Industry, Fueled by Advances in Genomic Profiling and AI Integration

This research service offers a comprehensive analysis of the global oncology biomarker diagnostics market, which has transformed with the convergence of clinical demand, advances in technology, and strategic collaborations/partnerships coupled with precision medicine initiatives. It categorizes the market by technology (omics, immunoassays, bioinformatics, and liquid biopsy), providing a 6-year revenue forecast and an analysis of key industry participants. Regional analyses are provided for North America; Europe; Asia-Pacific; the Middle East, North Africa, and South Asia; and Latin America.

The report discusses prevalent and emerging business models, analyzes trends in market access and reimbursement for oncology biomarkers, and offers competitive assessments and revenue share analyses. It examines market drivers and restraints, offering insights into development trends, partnerships, and the investment landscape. The report highlights companies developing disruptive NGS and liquid biopsy technology.

Based on technological advancements, business models, and competitive dynamics, the report identifies growth opportunities in this space for market players and other stakeholders. The base year is 2024, and the forecast period is 2025 to 2030.

Revenue Forecast

The revenue estimate for the base year 2023 is $23.28 billion, with a CAGR of 13.9% for the study period from 2024 to 2030, mainly driven by growth in the oncology biomarker diagnostics market.

The Impact of the Top 3 Strategic Imperatives on the Global Oncology Biomarker Diagnostics Industry

Disruptive Technologies

• Why:
• The demand for tests that can diagnose cancer early without invasive procedures is growing in the oncology biomarker diagnostics market.
• Traditional tissue biopsies are time-consuming, painful for patients, and frequently fail to capture essential data regarding the progression of a tumor. Therefore, the global liquid biopsy market, particularly those that use ctDNA, is seen as a game changer.
• With a simple blood sample, these tests can identify mutations linked to cancer in the precision oncology diagnostics market and speed up simplified diagnosis and monitoring.
• For instance, Guardant Health's Guardant360(R) CDx, a US Food and Drug Administration (FDA)-approved test (2020), provides comprehensive results in 7 days without requiring tissue sample. With its non-invasive monitoring, quick turnaround, and wider patient eligibility, this signifies a move toward precision diagnostics and the NGS-based cancer biomarker market.
• Frost Perspective:
• Tests such as Guardant360(R) are gaining traction and remapping business trends in the oncology biomarker diagnostics market. They are evolving from optional add-ons to an essential part of standard oncology biomarker diagnostics.
• With the rise of these tests, healthcare professionals can detect gene alterations in real time and make guided treatment decisions faster, avoiding costly trial and error in the multi-analyte biomarker testing market.
• This technology is expected to become widely adopted across the oncology practice, which could improve patient outcomes and ease pressure on healthcare systems.

Industry Convergence

• Why:
• Industry convergence is observed with developments in AI, digital pathology, and biomarker discovery that combine to provide a precise and efficient approach to cancer care in the oncology biomarker diagnostics market.
• The convergence of these technologies allows precise tumor profiling and faster detection of key mutations, which results in more targeted therapies in the global liquid biopsy market.
• For instance, AI and ctDNA liquid biopsy are being used by companies such as Guardant Health to identify mutations and forecast how cancers might evolve and rest treatment. Tempus is integrating ML and genetic sequencing to offer physicians relevant insights and tailor treatment plans based on comprehensive data analysis in the precision oncology diagnostics market.
• The convergence leads to a more comprehensive, data-driven approach to cancer, which is pushing the limits of traditional diagnostics in the NGS-based cancer biomarker market.
• Frost Perspective:
• This convergence revolutionized oncology biomarker diagnostics and treatment. With the help of real-time genetic sequencing and advanced AI algorithms, more precise and personalized treatments are made in the multi-analyte biomarker testing market.
• This convergence will reduce cancer death rates, improve patient outcomes, and expand access to care while increasing the efficiency of biopsies.
• Leading biomarker companies believe it is possible to move towards personalized therapy and clinical intervention more swiftly, which can lead to better and faster decisions in patient management.

Competitive Intensity

• Why:
• Competition is increasing, fueled by leading and emerging players addressing the demand for personalized care and precision in the oncology biomarker diagnostics market and driving advancements in NGS technology and liquid biopsy.
• Guardant Health and Foundation Medicine are pushing the boundaries of liquid biopsy and NGS technology. Guardant360, an FDA-approved liquid biopsy test, is becoming a widely adopted test for offering a comprehensive genomic profile for advanced solid tumors. The FoundationOne CDx NGS test is becoming an essential tool to identify mutations in tumors and develop strategic partnerships with companies such as Roche.
• New players, such as Grail and Clarify Life Sciences, are launching innovative genomic solutions for personalized treatment and early detection of cancer in the global liquid biopsy market.
• Frost Perspective:
• With the presence of both leading and emerging players, the industry is witnessing fierce competition for market dominance in the precision oncology diagnostics market.
• Developments in this industry, such as Thermo Fisher's recent acquisition of OncoLabs, ASG's NGS platform expands access to innovative solutions, resulting in a more viable, regulatory-compliant market.
• As others can obtain FDA approval from strategic partnerships, there is a rising demand for real-world clinical efficacy will be expected, and the potential to differentiate products in the competitive arena will result from this intense rivalry.

Scope of Analysis

Oncology biomarkers are substances found in tissues or blood that detect the presence of cancer, its progression, or how well it will respond to treatment. They are essential for early detection, diagnosis, monitoring, therapy selection, and prognosis. Many oncology biomarkers are linked to alterations in genes that promote cancer growth and affect how well a treatment works. This study focuses on the global oncology biomarker diagnostics market, offering a detailed 6-year revenue forecast from 2024 to 2030 in the precision oncology diagnostics market.

This study focuses on the global oncology biomarker diagnostics market, offering a detailed 6-year revenue forecast from 2024 to 2030. It analyzes omics technologies (genomics, transcriptomics, proteomics, and metabolomics), immunoassays (IHC, ELISA, and CLIAs), bioinformatics (computational biology and AI-driven biomarker discovery) and liquid biopsy (circulating tumor DNA [ctDNA], CTCs, and exosomes) to understand trends in the NGS-based cancer biomarker market.

Regional analyses are provided for North America, Europe, Asia-Pacific, Latin America, and MENASA (the Middle East, North Africa, and South Asia).

Imaging-based oncology biomarker diagnostics, such as PET, CT, and MRI, are not included in this study, nor are laboratory-developed tests (LDTs) that have not received regulatory approval. Considering their significance in data interpretation and multi-omics integration, bioinformatics tools and AI-driven platforms are included in the multi-analyte biomarker testing market.

The vendor landscape consists of companies that provide software platforms, consumables, assay kits, reagents, and tools for the diagnosis of cancer biomarkers within the oncology biomarker diagnostics market. The study offers global and regional analyses of the use of oncology biomarkers in a variety of molecular and non-molecular testing settings, including hospital/diagnostics labs, biopharmaceutical companies and CROs, research and academic institutions, and others (private practices, specialty clinics, health IT and AI/ML companies supporting biomarker integration, and healthtech platforms).

Growth Drivers

• The demand for biomarker-based diagnostics in oncology care pathways is expanding rapidly due to the increasing adoption of personalized medicine (e.g., the KEYNOTE-189 trial utilizing PD-L1 testing for pembrolizumab in patients with non-small cell lung cancer).
• Advanced biomarker testing is becoming more accessible to patients due to increased payer support and reimbursement for companion diagnostics. For instance, in 2024, CMS expanded coverage for FoundationOne CDx in colorectal and NSCLC, which is crucial for the global liquid biopsy market.
• Fast-track designations and accelerated regulatory approvals for biomarker-linked therapies are simplifying the integration of diagnostics into treatment in the precision oncology diagnostics market. For instance, Grail's Galleri test was designated an FDA breakthrough.
• Diagnostic capabilities are evolving beyond tissue-based testing due to developments in liquid biopsy and multi-omics technologies, which are becoming part of the NGS-based cancer biomarker market. For instance, the Shield test for CRC early detection from Guardant Health was launched in 2024.
• Expanding pharmaceutical collaborations for companion diagnostics co-development contributes to early market entrance and reliable revenue streams. For instance, AstraZeneca's Tagrisso combined with Thermo Fisher's Oncomine Dx in the oncology biomarker diagnostics market.
• The uptake of biomarker testing is steadily growing due to increased patient and oncologist education and awareness, particularly in emerging markets. Roche's 2023-2024 awareness initiatives in Southeast Asia are an example in the global liquid biopsy market.

Growth Restraints

• Long approval processes and complicated regulations can delay entry into the oncology biomarker diagnostics market.
• Economic pressures and limited reimbursement regulations limit patient access, especially in developing regions, which impacts the global liquid biopsy market.
• The lack of standardization and fragmentation of technology have resulted in inconsistent integration of biomarker diagnostics with clinical workflows, affecting the precision oncology diagnostics market.
• Midsize and smaller companies are strained by high R&D expenses and technological challenges in biomarker validation, which could impede innovation in the NGS-based cancer biomarker market.
• Large-scale data sharing and analytics are constrained by ethical and data privacy issues related to genetic and biomarker data, impacting the multi-analyte biomarker testing market.
• The lack of qualified workers in bioinformatics and molecular diagnostics hinders adoption and reduces efficiency across the oncology biomarker diagnostics market.

Competitive Environment

Number of Competitors

• About 200

Competitive Factors

• Clinical accuracy, regulatory approval, turnaround time, test sensitivity/specificity, cost-effectiveness, payer coverage, partnerships with pharma/clinics in the oncology biomarker diagnostics market.

Key End-User Industry Verticals

• Hospitals, diagnostic laboratories, academic research centers, oncology clinics, biopharmaceutical companies within the global liquid biopsy market.

Leading Competitors

• Roche Diagnostics, Thermo Fisher Scientific, Exact Sciences, Illumina Inc., Agilent Technologies, Guardant Health

Revenue Share of Top 5 Competitors (2024)

• Estimated 46.9%

Other Notable Competitors

• Myriad Genetics Inc., Hologic Inc., Bio-Rad Laboratories, Natera, QIAGEN, Caris Life Sciences, NeoGenomics

Distribution Structure

• Direct-to-hospital/lab partnerships, diagnostic lab networks, collaborations with biopharma, integrated with EHR and LIS systems in the precision oncology diagnostics market.

Notable Acquisitions and Mergers

• In 2025, Roche Holding AG acquired Poseida Therapeutics, a clinical-stage cell and gene therapy (CGT) developer. The finalization of a $1.5 billion deal will be a strategic move to expand its presence in CAR-T cell therapy.

Key Competitors by Technology

• Omics
• Roche
• Thermo Fisher Scientific Inc.
• Illumina, Inc.
• QIAGEN N.V.
• Agilent Technologies, Inc.
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Myriad Genetics, Inc.
• Siemens Healthineers
• Exact Sciences
• Caris Life Sciences
• Freenoem Holdings Inc.
• Guardant Health
• NanoString Technologies
• Personalis Inc.
• 10x Genomics
• Adaptive Biotechnologies
• BD Biosciences
• BGI Genomics
• Biodesix, Inc.
• Bruker Corporation
• Epigenomics AG
• Bioinformatics
• Roche
• Thermo Fisher Scientific Inc.
• Illumina, Inc.
• QIAGEN N.V.
• Agilent Technologies, Inc.
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Myriad Genetics, Inc.
• Siemens Healthineers
• Exact Sciences
• Hologic Inc.
• Freenoem Holdings Inc.
• Guardant Health
• NanoString Technologies
• Personalis Inc.
• Aiforia Technologies
• Almac Diagnostics
• Berkeley Lights, Inc.
• C2i Genomics
• Deep Genomics
• Deep Lens
• Flagship Biosciences
• Liquid Biopsy
• Grail
• Exact Sciences
• Biocpet Inc.
• DiaCarta
• Invitae
• Lucene Health Inc.
• MDX Health
• Medgemone
• Novigenix
• OncoDNA
• ScreenCell
• Luigile All Inc.
• Bio-Techne
• NeoGenomics Laboratories
• ArcherDX
• Olink Proteomics
• Guardant Health
• Freenoem Holdings
• Tempus
• C2i Genomics
• Caris Life Sciences
• Immunoassays
• Roche
• Thermo Fisher Scientific Inc.
• Agilent Technologies, Inc.
• Abbott Laboratories
• Bio-Rad Laboratories, Inc.
• Siemens Healthineers
• Exact Sciences
• Hologic Inc.
• DiaSorin
• Beckman Coulter
• Ortho Clinical Diagnostics
• Grifols
• QIAGEN