The global oncology companion diagnostic market size was valued at USD 5.18 billion in 2023 and is projected to surpass around USD 12.15 billion by 2033, registering a CAGR of 8.9% over the forecast period of 2024 to 2033.
The U.S. Oncology Companion Diagnostic market size was valued at USD 1.46 billion in 2023 and is anticipated to reach around USD 3.58 billion by 2033, growing at a CAGR of 9.4% from 2024 to 2033.
North America—particularly the United States—dominates the global oncology companion diagnostic market. This leadership is attributed to a robust healthcare infrastructure, extensive R&D activity, and favorable regulatory support from the FDA. The U.S. is home to numerous pharma-diagnostic partnerships that have pioneered the co-approval of therapies and associated tests. High cancer incidence, strong reimbursement frameworks, and a mature genomics ecosystem further contribute to this region’s dominance. Additionally, organizations like the NIH and NCI fund large-scale genomics research that fuels innovation in companion diagnostics.
Asia-Pacific is the fastest-growing region, fueled by increasing cancer prevalence, expanding healthcare infrastructure, and supportive government initiatives. Countries like China, Japan, South Korea, and India are investing heavily in precision medicine, genomics, and digital health platforms. Regulatory agencies across Asia are streamlining approval processes, making it easier for CDx tests and targeted therapies to enter the market. The presence of local biotech startups and contract research organizations is also catalyzing growth. Rising awareness among oncologists and patients about the benefits of biomarker-driven therapies is expected to sustain the region’s rapid expansion.
The oncology companion diagnostic market has evolved into a cornerstone of precision medicine, bridging the gap between targeted therapies and effective cancer treatment. Companion diagnostics (CDx) are in vitro medical devices used to determine the eligibility of patients for specific oncologic drugs based on biomarker expression, genetic mutations, or other molecular signatures. These tests guide oncologists in selecting the most effective treatment while minimizing unnecessary exposure to toxic drugs and maximizing cost-efficiency.
The increasing prevalence of cancer globally, particularly in the form of lung, breast, colorectal, and prostate cancers, has pushed healthcare systems and pharmaceutical companies to adopt biomarker-guided therapies. According to the World Health Organization, cancer is responsible for nearly 10 million deaths annually, with millions more diagnosed each year. This burden underscores the critical need for stratified medicine supported by robust diagnostic tools.
The oncology CDx market is characterized by a collaborative ecosystem involving diagnostic developers, pharmaceutical giants, contract research organizations, and academic institutions. Co-development models between diagnostics and drug developers have gained momentum, with regulatory authorities such as the FDA increasingly approving therapies with associated companion diagnostics. Advancements in next-generation sequencing (NGS), digital pathology, and real-time PCR technologies are redefining the possibilities in biomarker discovery and diagnostics.
As pharmaceutical pipelines increasingly shift toward molecularly targeted therapies and immuno-oncology, the demand for companion diagnostics is set to rise significantly. The market is expected to witness robust double-digit growth through 2034, supported by growing investments, public-private partnerships, and continuous innovation in genomic technologies.
Rise in FDA Approvals for Co-developed Drugs and Diagnostics: The trend of simultaneous drug-diagnostic approvals is accelerating, especially for precision oncology treatments like EGFR and ALK inhibitors.
Shift Toward NGS-Based Multiplex Panels: Single-gene tests are gradually being replaced by multiplex NGS panels, enabling comprehensive genomic profiling from a single sample.
Increased Use of Liquid Biopsies: Non-invasive diagnostic methods such as liquid biopsies are gaining traction for real-time monitoring of tumor evolution and minimal residual disease.
AI and Machine Learning Integration: Artificial intelligence is being utilized in image analysis, variant interpretation, and CDx software platforms to enhance diagnostic accuracy and speed.
Strategic Collaborations and Licensing Agreements: Pharma-diagnostic collaborations (e.g., Foundation Medicine and Roche, Thermo Fisher and Illumina) are shaping the competitive landscape.
Expansion into Emerging Markets: Pharmaceutical companies are increasingly targeting Asia-Pacific and Latin America for CDx penetration, driven by rising healthcare expenditure and favorable policies.
Growth of Immunotherapy-Driven CDx: The demand for PD-L1 and TMB testing is expanding alongside the adoption of immuno-oncology drugs.
| Report Attribute | Details |
| Market Size in 2024 | USD 5.64 Billion |
| Market Size by 2033 | USD 12.15 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 8.9% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Product & Services, technology, disease type, end use, region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Agilent Technologies Inc.; Illumina Inc.; QIAGEN; Thermo Fisher Scientific Inc.; Foundation Medicine Inc.; Myriad Genetics, Inc.; F. Hoffmann-La Roche Ltd.; BioMérieux; Abbott; Leica Biosystems; Guardant Health, Inc.; EntroGen, Inc. |
The most influential driver of the oncology companion diagnostic market is the growing global shift toward personalized medicine, particularly in oncology. Modern cancer care is increasingly relying on targeted therapies that act on specific molecular pathways altered in tumors. These therapies, such as EGFR inhibitors for non-small cell lung cancer or HER2 inhibitors for breast cancer, are only effective in patients with certain genetic mutations or protein overexpression.
Companion diagnostics are essential for identifying eligible patients, optimizing treatment response, and avoiding ineffective or harmful drugs. Regulatory agencies have recognized the value of such tools, exemplified by FDA approvals that mandate a companion diagnostic test as part of the therapeutic label. With the increasing availability of molecular targets across multiple cancer types, pharmaceutical companies now routinely integrate diagnostic development into their drug pipelines. This alignment not only improves clinical outcomes but also accelerates drug development timelines and enhances payer confidence in reimbursing high-cost oncology therapies.
A significant restraint in the oncology companion diagnostic market is the variability and limitations in reimbursement policies. Companion diagnostic tests, particularly those using advanced technologies like NGS, can be costly. In many healthcare systems, insurance coverage does not consistently keep pace with innovation, creating access barriers for patients and limiting test adoption by providers.
In the U.S., while CMS has made strides in expanding Medicare coverage for some tests, reimbursement policies for multi-gene panels or emerging biomarkers are still evolving. In Europe and developing regions, reimbursement often lags behind regulatory approval, causing delays in patient access. Additionally, stakeholders must demonstrate clinical utility and cost-effectiveness through real-world evidence, which requires long-term investments. This financial uncertainty often discourages smaller labs and diagnostic companies from entering the market or launching new tests, limiting innovation and slowing adoption rates.
One of the most transformative opportunities in the oncology CDx market lies in the integration of liquid biopsy technologies. Liquid biopsies allow the detection of tumor-derived biomarkers through blood or other bodily fluids, enabling non-invasive, real-time insights into tumor genetics and treatment response. These tests are particularly valuable for patients who are not candidates for tissue biopsies or when tumors are in anatomically challenging locations.
With advancements in ctDNA (circulating tumor DNA) analysis, liquid biopsies are being used to detect mutations in genes like EGFR, BRAF, and ALK. Companies like Guardant Health, Biocept, and Foundation Medicine are investing heavily in this domain. Liquid biopsy-based CDx platforms are also being evaluated for early cancer detection and treatment monitoring, paving the way for longitudinal disease management. As regulatory pathways become clearer and technology matures, the market for liquid biopsy-based companion diagnostics is expected to unlock a new frontier in precision oncology.
Consumables accounted for the largest share of the oncology companion diagnostic market due to their recurrent usage in diagnostic procedures. Reagents, assay kits, slides, and test cartridges are essential components across PCR, NGS, IHC, and FISH-based diagnostic platforms. Given that each test run requires fresh consumables, their demand scales directly with test volumes. Hospitals, diagnostic labs, and CROs rely on these consumables for routine and specialized testing. The high frequency of use, along with increasing test volumes for targeted therapies, underpins the dominance of this segment.
Software, while currently a smaller segment, is experiencing the fastest growth. With the increasing complexity of data generated from NGS and multiplex panels, bioinformatics platforms and AI-enabled analysis software are becoming indispensable. These tools assist in interpreting large genomic datasets, identifying actionable mutations, and generating clinical reports. Integrated software platforms such as PierianDx and SOPHiA GENETICS are transforming diagnostics by offering cloud-based, scalable, and interoperable solutions. As precision medicine becomes more data-intensive, software will play a central role in diagnostic workflows.
Polymerase Chain Reaction (PCR) remains the leading technology due to its affordability, speed, and high sensitivity. PCR-based tests are widely used for detecting specific gene mutations like EGFR, BRAF, and KRAS. Real-time PCR and quantitative PCR have proven to be highly effective in both clinical and laboratory settings for diagnostic and prognostic applications. The technique's established regulatory pathway and ease of use in decentralized settings maintain its dominance in the market.
However, Next-generation Sequencing (NGS) is the fastest-growing segment, driven by its capacity to analyze multiple genes simultaneously. NGS-based companion diagnostics are increasingly being adopted for tumor profiling in complex cancers like NSCLC and colorectal cancer. Companies like Foundation Medicine, Thermo Fisher, and Illumina offer comprehensive NGS-based CDx platforms approved by the FDA. As sequencing costs continue to drop and bioinformatics tools become more user-friendly, NGS adoption is set to accelerate across both academic and clinical settings.
Non-Small Cell Lung Cancer (NSCLC) holds the largest share in the oncology CDx market. NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases. Numerous targeted therapies—such as EGFR inhibitors (e.g., osimertinib), ALK inhibitors (e.g., crizotinib), and PD-L1-based immunotherapies—require companion testing for treatment initiation. The extensive pipeline of targeted drugs and robust biomarker research in NSCLC drive test volumes and regulatory approvals in this indication.
In contrast, Prostate Cancer is emerging as the fastest-growing segment. The increased focus on BRCA1/2 and other homologous recombination repair (HRR) gene mutations for guiding PARP inhibitor therapy is propelling demand for prostate cancer-specific CDx. Companies are developing tests to identify patients who will benefit from therapies like olaparib. Furthermore, advancements in liquid biopsy and MRI-guided biopsies are making CDx testing more accessible for prostate cancer management. The growing prevalence and innovation in precision treatments make this segment a key growth area.
Hospitals segment dominated the oncology companion diagnostic market with a share of 52.11% in 2023. They are often the primary point of care for cancer diagnosis, treatment, and monitoring. Most hospitals, particularly tertiary care and cancer specialty centers, maintain in-house pathology and molecular testing labs capable of handling high-throughput diagnostic workloads. Hospitals often have access to high-end technologies, trained personnel, and multidisciplinary tumor boards that utilize CDx results for therapeutic decision-making.
Academic Medical Centers, meanwhile, are growing rapidly due to their central role in clinical trials, biomarker discovery, and translational research. These institutions are often early adopters of emerging technologies and are actively engaged in the co-development of novel CDx platforms with pharma partners. Many serve as innovation hubs where AI, big data analytics, and multi-omics integration are being tested for real-world implementation. Their research-driven approach and access to diverse patient populations position academic medical centers as crucial players in the CDx value chain.
The following are the leading companies in the oncology companion diagnostic market. These companies collectively hold the largest market share and dictate industry trends.
Foundation Medicine (March 2024): Announced a collaboration with Janssen Pharmaceuticals to develop a new NGS-based CDx for a targeted prostate cancer therapy, currently under FDA review.
Roche Diagnostics (February 2024): Received CE-IVD marking for its Avenio ctDNA Expanded Kit, a liquid biopsy platform that supports multiple CDx applications in solid tumors.
Guardant Health (January 2024): Launched a real-world evidence study across U.S. cancer centers to validate its liquid biopsy CDx for early detection of minimal residual disease in colorectal cancer.
Illumina and Agendia (December 2023): Expanded their partnership to develop RNA-seq based companion diagnostics for breast cancer subtyping, with potential application in therapy stratification.
Thermo Fisher Scientific (November 2023): Entered a strategic alliance with AstraZeneca to expand NGS-based companion diagnostic panels for oncology drugs targeting rare mutations.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Oncology Companion Diagnostic market.
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