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Who are the Target Population and What is The Global Patient Pool?

The target population in the oncology companion diagnostic market is primarily comprised of patients diagnosed with advanced or metastatic solid tumors and hematologic malignancies that harbor specific, "actionable" genomic alterations. While historically focused on late-stage disease, the demographic is expanding significantly in 2025 to include early-stage cancer patients eligible for adjuvant and neoadjuvant therapies.

The global patient pool is vast and growing, driven unfortunately by the rising incidence of cancer. With the global cancer burden estimated at approximately 20 million new cases annually, the addressable market for companion diagnostics is substantial.

However, the "eligible" pool is a more specific subset of this figure. The oncology companion diagnostic market analysis suggests that between 30% and 40% of all advanced solid tumor patients are now candidates for genomic testing to guide therapy choices. This translates to a direct addressable patient pool of roughly 6 to 8 million individuals worldwide each year. This population is not static; it is expanding as researchers discover new biomarkers and as regulatory approvals extend to earlier stages of disease management, such as monitoring for Minimal Residual Disease (MRD) in survivors.

Where is this demand mainly concentrated?

Geographically, the demand for the oncology companion diagnostic market mirrors the maturity of healthcare infrastructure and the robustness of reimbursement frameworks. North America remains the dominant powerhouse, commanding approximately 40-45% of the global market share. This hegemony is driven by the United States, where a sophisticated regulatory environment encourages the simultaneous approval of drugs and their diagnostics, alongside high adoption rates of Next-Generation Sequencing (NGS) for cell and gene therapy. Following closely is Europe, which holds roughly a quarter of the market. Here, countries like Germany, France, and the UK are central hubs, though the market is currently navigating the complexities of the new In Vitro Diagnostic Regulation (IVDR), which has raised the bar for quality compliance.

Meanwhile, the Asia-Pacific region represents the oncology companion diagnostic market’s aggressive growth engine. With a Compound Annual Growth Rate (CAGR) exceeding 12%, nations such as China and Japan are witnessing a surge in demand. This momentum is fueled by rapidly aging populations, increasing lung cancer prevalence, and aggressive government initiatives aimed at modernizing cancer care infrastructure to match Western standards.

What are most prominent diagnostics techniques witnessing higher demand?

Technological evolution is reshaping the oncology companion diagnostic market growth curve, driving a decisive shift from single-analyte tests to comprehensive genomic profiling. While traditional methods remain in rotation, Next-Generation Sequencing (NGS) has firmly established itself as the "Gold Standard" in 2025. Unlike older techniques that query one gene at a time, NGS panels analyze hundreds of genes simultaneously, capturing rare mutations and gene fusions in a single run. Consequently, demand is skyrocketing for Comprehensive Genomic Profiling (CGP) because it maximizes the utility of limited tissue samples.

Running parallel to the NGS boom is the exponential rise of Liquid Biopsy in the oncology companion diagnostic market. This segment is witnessing the most aggressive growth because it addresses a critical unmet need: non-invasive testing. By detecting circulating tumor DNA (ctDNA) in the blood, liquid biopsies allow for repeatable monitoring without the pain or risk of surgical tissue removal. Despite these advancements, traditional Polymerase Chain Reaction (PCR) remains a volume leader for simple, single-biomarker tests due to its speed and cost-efficiency. Similarly, Immunohistochemistry (IHC) maintains a steady baseline demand, continuing to be the essential methodology for protein-based biomarkers like PD-L1 and HER2.

What are top brands currently active in the market and offering oncology companion diagnostics services?

The competitive landscape of the oncology companion diagnostic market is a dynamic ecosystem of established diagnostic giants and agile genomic innovators. Roche Diagnostics stands as a formidable leader, creating a comprehensive ecosystem that spans tissue-based IHC via its Ventana portfolio and genomic profiling through its subsidiary, Foundation Medicine. Foundation Medicine has become synonymous with high-quality CGP, setting the benchmark for the industry. Agilent Technologies is another titan, particularly dominant in the "PharmDx" space where they partner directly with pharma majors to develop companion tests for blockbuster immunotherapies.

In the realm of decentralized testing, Thermo Fisher Scientific leads with its Oncomine Dx solutions, empowering hospital laboratories to perform complex sequencing in-house rather than outsourcing. Guardant Health has effectively captured the liquid biopsy narrative, with its Guardant360 platform becoming a standard of care for blood-based profiling. Other key players like Qiagen and Illumina provide the essential infrastructure and kits that fuel the market, with Illumina increasingly moving downstream to offer direct diagnostic solutions.

What are key cancers that drives higher demand for oncology companion diagnostics?

The competitive landscape of the oncology companion diagnostic market is a dynamic ecosystem of established diagnostic giants and agile genomic innovators.

Roche Diagnostics stands as a formidable leader, creating a comprehensive ecosystem that spans tissue-based IHC via its Ventana portfolio and genomic profiling through its subsidiary, Foundation Medicine. Foundation Medicine has become synonymous with high-quality CGP, setting the benchmark for the industry.

Agilent Technologies is another titan, particularly dominant in the "PharmDx" space where they partner directly with pharma majors to develop companion tests for blockbuster immunotherapies.

Thermo Fisher Scientific leads the oncology companion diagnostic market  in terms of decentralized testing with its Oncomine Dx solutions, empowering hospital laboratories to perform complex sequencing in-house rather than outsourcing.

Guardant Health has effectively captured the liquid biopsy narrative, with its Guardant360 platform becoming a standard of care for blood-based profiling.

Other key players like Qiagen and Illumina provide the essential infrastructure and kits that fuel the market, with Illumina increasingly moving downstream to offer direct diagnostic solutions.

What are key cancers that drives higher demand for oncology companion diagnostics?

The demand for the oncology companion diagnostic market is intrinsically linked to the biology of specific cancers; those with high densities of "druggable" mutations drive the highest revenue.

• Non-Small Cell Lung Cancer (NSCLC): Without question, the dominant driver of the market. With over a dozen FDA-approved targeted therapies for mutations in genes like EGFR, ALK, ROS1, and KRAS, comprehensive testing is now mandatory for virtually every NSCLC patient.
• Breast Cancer: Remains a historic and vital volume driver, evolving from standard HER2 testing to more complex analysis of PIK3CA mutations and BRCA1/2 status.
• Colorectal Cancer: Commands a significant share of the diagnostic volume of the oncology companion diagnostic market, with standard-of-care protocols requiring testing for KRAS, NRAS, and BRAF mutations to determine the efficacy of EGFR inhibitors.
• Prostate Cancer: Emerging as a rapidly growing segment. The recent approvals of PARP inhibitors for patients with homologous recombination repair (HRR) gene mutations have necessitated a new wave of genetic screening in urology practices, further expanding the market's scope.

What are top 4 trends shaping the growth momentum of the market?

Several transformative trends in the oncology companion diagnostic market are actively reshaping the market's trajectory in 2025:

1. Decentralization: Hospitals and cancer centers are increasingly moving away from sending samples to central reference labs, preferring instead to adopt "kitted" NGS solutions that allow for in-house testing. This shift drastically reduces turnaround times from weeks to mere days, accelerating treatment initiation.
2. Pan-Tumor Approvals: Regulatory bodies are approving drugs based on biomarkers like MSI-H or NTRK fusions regardless of the tumor's location, decoupling diagnostics from specific organs and broadening their utility.
3. AI Integration: A pivotal trend in the oncology companion diagnostic market is the integration of Artificial Intelligence (AI) into pathology. AI algorithms are now assisting pathologists in scoring complex biomarkers, such as PD-L1 or HER2-low, with a level of consistency and precision that the human eye alone cannot match.
4. Multi-Cancer Early Detection (MCED): This creates a "halo effect," normalizing genomic testing in the public consciousness and driving investment into sequencing technologies that benefit the entire CDx ecosystem.

Segmental Analysis

Non-Small Cell Lung Cancer Predominance in Disease-Specific Diagnostics

Non-small cell lung cancer (NSCLC) represents the absolute dominant disease segment in the oncology companion diagnostic market, driven by a prevalence rate of 87% among global lung cancer cases. This segment is not just growing; it is evolving into a complex ecosystem of targeted therapies. The expansion is propelled by the clinical necessity to detect a wide array of actionable mutations—specifically EGFR, ALK, ROS1, and KRAS—which are now strict prerequisites for prescribing FDA-approved therapies.

• Market Valuation: The NSCLC diagnostics sector is projected to reach USD 13.3 billion in 2025, with a trajectory toward USD 27.4 billion by 2035.
• Regulatory Catalysts: Growth is accelerated by recent FDA authorizations, such as HER2-targeted therapies (HYRNUO) and EGFR exon 20 inhibitors (ZEGFROVY), which mandate rigorous biomarker testing.
• Immunotherapy Impact: Beyond mutations, the demand is intensified by standard-of-care PD-L1 expression testing. Data indicates that optimally stratified patients achieve a median overall survival of 26.3 months, far outperforming chemotherapy.
• Guideline Mandates: With National Comprehensive Cancer Network (NCCN) guidelines mandating biomarker testing prior to first-line immunotherapy, NSCLC remains the primary revenue engine for the market.

Hospital-Based Diagnostic Infrastructure Leading Market Implementation

The hospitals segment leads the oncology companion diagnostic market by end-use. This dominance is not accidental; it is driven by the shift toward "patient-centric" care where diagnostics and treatment occur under one roof. Hospitals provide the centralized testing infrastructure, expert molecular diagnostic laboratories, and integrated multidisciplinary cancer teams necessary to interpret complex genomic data.

Operational Advantage: In-house testing allows oncologists to immediately align therapy selection with biomarker results, drastically reducing the "time-to-treatment."

• Centers of Excellence: Major academic medical centers in the oncology companion diagnostic market   are increasingly establishing internal "centers of excellence" equipped with high-throughput NGS platforms and digital pathology systems, reducing reliance on external reference labs.
• Strategic Examples: Initiatives such as the NHS Borders' Rapid Cancer Diagnostic Service demonstrate how hospitals are systematically cutting turnaround times.
• System Integration: By integrating companion diagnostics directly into Hospital Information Systems (HIS), institutions are streamlining the ordering and interpretation process, firmly establishing hospitals as the primary drivers of market implementation.

By Technology, NGS Dominates with 38% Market Share in Companion Cancer Diagnostics Market

Next-Generation Sequencing (NGS) has solidified its leadership in precision oncology, now controlling a dominant 38% revenue share of the companion cancer diagnostics market as of 2025. This surge is driven by the industry’s decisive shift from single-biomarker PCR tests to Comprehensive Genomic Profiling (CGP). Unlike legacy methods, NGS allows oncologists to analyze hundreds of genes simultaneously, a capability now essential for matching patients with the growing list of agnostic targeted therapies. This "one-test, multiple-answers" efficiency has become the gold standard for clinical decision-making, significantly increasing the revenue per test and establishing NGS as the primary engine for sector growth.

While the broader market grows, the NGS segment specifically is outperforming competitors with a projected CAGR of 14.3% through 2030. Wherein, innovation remains the catalyst. Notably, on January 15, 2025, Tempus AI announced the nationwide commercial availability of its xT CDx, a 648-gene NGS assay, setting a new benchmark for accessible, broad-panel solid tumor profiling in the US.

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Regional Analysis

Asia-Pacific Market as Fastest-Growing Region for Oncology Companion Diagnostics

The Asia-Pacific (APAC) region has emerged as the most aggressive growth engine within the oncology companion diagnostic market, with a projected Compound Annual Growth Rate (CAGR) of 13.3% to 13.55% through 2030. This expansion substantially exceeds global average rates, driven by a "perfect storm" of large patient populations, rising cancer incidence due to lifestyle changes, and forceful government intervention.

• China's Genomic Boom: China establishes itself as a major market contributor, with domestic companies rapidly developing proprietary NGS and AI-driven diagnostics to tackle the national cancer burden under the "Healthy China 2030" plan.
• Japan's Regulatory Alignment: Japan is aggressively implementing regulatory frameworks that parallel FDA standards, thereby accelerating the simultaneous approval of drugs and their companion diagnostics.
• India's Emerging Potential: India represents a massive untapped opportunity, with a projected 13.9% CAGR and an estimated market size of USD 255.4 million by 2030.

Infrastructure Shift: The region is witnessing a decline in sequencing costs and a rise in public-private collaborations. National genome projects in Thailand, India, and Japan are democratizing access to precision medicine, with particular momentum seen in NSCLC and breast cancer diagnostics.

North American Market Leadership with Sustained Regulatory Advantage

North America continues to dominate the global landscape, controlling 40% to 41% of the oncology companion diagnostic market share. This leadership is built on a mature, three-pillar foundation: advanced healthcare infrastructure, comprehensive regulatory support, and deep-rooted precision medicine adoption.

• Market Size & Growth: The United States market, valued at USD 1.89 billion in 2024, is experiencing robust growth at an 8.18% CAGR.
• The FDA Factor: The FDA's proactive strategy of simultaneously endorsing therapeutic drugs and their requisite diagnostics creates a predictable pathway for innovation, establishing North America as the global epicenter for CDx development.
• Reimbursement Frameworks: Unlike many other regions, the U.S. benefits from strong reimbursement coverage (including Medicare expansion) for biomarker testing, removing financial barriers for patients.
• Innovation Pipeline: Extensive pharmaceutical research pipelines and professional guidelines (such as ASCO and NCCN) have normalized molecular testing as the standard of care. The region is currently seeing a surge in demand for immunotherapy biomarkers (PD-L1) and liquid biopsy applications, ensuring continued expansion despite the market's maturity.

Top 5 Recent Developments in Oncology Companion Diagnostic Market

1. Illumina KRAS Partnership (September 2025)
Illumina partnered with global pharma companies to develop tumor-agnostic KRAS companion diagnostics (CDx) using the TruSight Oncology Comprehensive test. This advances standardized, globally distributable precision oncology for broad patient identification.

2. Roche AI Breakthrough (April 2025)
Roche’s VENTANA TROP2 RxDx received FDA Breakthrough Device Designation for NSCLC. By combining immunohistochemistry with AI-driven digital pathology, it achieves diagnostic precision superior to traditional manual scoring.

3. Thermo Fisher Approval (November 2025)
The Oncomine Dx Target Test gained FDA approval as a CDx for Bayer’s sevabertinib (HYRNUO) to treat HER2-mutant NSCLC. The test secured broad reimbursement across the US, Europe, Canada, and Israel, addressing accessibility barriers.

4. Foundation Medicine Milestone (December 2025)
Foundation Medicine reached 100 approved CDx indications globally (57 US, 43 Japan) across its FoundationOne tissue and liquid platforms. They have delivered over 1.5 million genomic reports, supporting access to over 35 medicines.

5. Mainz Biomed Screening (October 2025)
Mainz Biomed reported positive eAArly DETECT 2 results for non-invasive blood-based colorectal and pancreatic cancer screening. Integrating mRNA biomarkers and AI, the pancreatic test achieved 95% sensitivity and 98% specificity.

Top Companies in the Oncology Companion Diagnostic Market

• Abbott Laboratories
• Agilent Technologies
• Bio-Rad Laboratories
• Biocartis
• Exact Sciences
• Genedrive
• Genomic Health
• Guardant Health
• Illumina
• Invivoscribe
• Myriad Genetics
• QIAGEN
• Roche Diagnostics
• Sysmex Corporation
• Thermo Fisher Scientific
• Other Prominent Players

Market Segmentation Overview

By Product & Services

• Product
  • Instrument
  • Consumables
• Software
  • Services

By Technology

• Polymerase Chain Reaction (PCR)
• Next-generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
• Other Technologies

By Disease Type

• Breast Cancer
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Leukemia
• Melanoma
• Prostate Cancer
• Others

By End-use

• Hospital
• Pathology/Diagnostic Laboratory
• Academic Medical Center

By Region

• North America
  • The US
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America