The global oncology companion diagnostic market was valued at USD 3.45 billion in 2023 and is projected to reach USD 10.33 billion by 2032, growing at a compound annual growth rate (CAGR) of 13.3% during the forecast period. The market is experiencing robust growth as precision medicine and personalized cancer treatment approaches gain global traction, supported by advances in genomics, biomarkers, and targeted therapy development.
Oncology companion diagnostics are in-vitro diagnostic tools used to identify patients most likely to benefit from a particular cancer therapy or who may experience serious side effects. These tests ensure that the right patients receive the right treatments, improving therapeutic outcomes and minimizing trial-and-error prescribing practices.
Market Dynamics
Growth Drivers
The growing adoption of personalized medicine in oncology is the most significant driver of this market. As cancer treatment becomes increasingly tailored to individual genetic profiles, the need for companion diagnostics to guide therapeutic decisions has surged. These diagnostics are crucial in matching patients with molecularly targeted therapies, particularly in cancers such as non-small cell lung cancer, breast cancer, colorectal cancer, and melanoma.
Regulatory support is further accelerating the market. The U.S. FDA and EMA are increasingly approving new targeted oncology drugs alongside companion diagnostic tests. These co-approvals are establishing a strong precedent for integrating diagnostics into the drug development pipeline, thereby expanding the market.
Technological advancements such as next-generation sequencing (NGS), liquid biopsy, and digital PCR are improving the speed, accuracy, and accessibility of oncology diagnostics. The shift from tissue-based to non-invasive methods such as liquid biopsy is opening new avenues for early cancer detection and monitoring, bolstering the use of companion diagnostics throughout the cancer care continuum.
Challenges
Despite the positive outlook, several hurdles could temper market growth. One major barrier is the high cost of companion diagnostics, particularly those based on advanced sequencing technologies. Reimbursement issues, especially in emerging economies, can further limit patient access.
Another significant challenge is the complexity of biomarker discovery and validation. The identification of clinically relevant biomarkers for different cancers requires extensive research, long development timelines, and strict regulatory oversight, all of which pose commercial risks.
In addition, limited awareness and infrastructure in developing regions restrict the integration of companion diagnostics into routine oncology care. Diagnostic capacity gaps in low-income countries continue to limit the market’s full potential globally.
Opportunities
The oncology companion diagnostic market is ripe with opportunities, particularly as pharmaceutical companies continue to develop targeted therapies and immunotherapies. The increasing approval of biomarker-based drugs—particularly PD-L1, EGFR, BRCA, BRAF, and ALK inhibitors—drives parallel growth in companion diagnostics.
Significant investments in liquid biopsy technologies also present lucrative opportunities. As these non-invasive tools gain regulatory acceptance, their use as companion diagnostics for early detection, treatment selection, and disease monitoring is expected to surge.
The growing availability of multi-gene panels and NGS-based tests is enabling comprehensive tumor profiling, allowing for the identification of multiple actionable mutations from a single test. This expands clinical utility and aligns with the broader goals of precision oncology.
Furthermore, increasing collaborations between diagnostic companies and pharmaceutical firms for co-development of drugs and companion diagnostics is expected to drive innovation and streamline the regulatory path for integrated treatment solutions.
Market Segmentation
The oncology companion diagnostic market can be segmented based on technology, indication, sample type, and end-user.
By Technology:
- Polymerase Chain Reaction (PCR)
- In Situ Hybridization (ISH)
- Immunohistochemistry (IHC)
- Next-Generation Sequencing (NGS)
- Others (Gene Expression Profiling, etc.)
Next-Generation Sequencing (NGS) is the fastest-growing segment, owing to its capability to assess multiple genetic alterations in a single test, particularly in complex cancers. PCR and IHC continue to dominate in terms of volume due to their affordability and routine use in clinical laboratories.
By Cancer Type:
- Non-Small Cell Lung Cancer (NSCLC)
- Breast Cancer
- Colorectal Cancer
- Melanoma
- Prostate Cancer
- Others (Leukemia, Ovarian Cancer, etc.)
NSCLC leads the market, driven by widespread use of EGFR, ALK, and PD-L1 testing. Breast cancer also holds a significant share due to extensive biomarker testing for HER2, BRCA1/2, and hormone receptors, which are essential for determining treatment strategies.
By Sample Type:
- Tissue Biopsy
- Liquid Biopsy
- Others
While tissue biopsy remains the standard, liquid biopsy is rapidly gaining traction due to its non-invasive nature, quicker turnaround time, and potential for real-time disease monitoring.
By End-User:
- Pharmaceutical & Biotechnology Companies
- Hospitals & Clinics
- Diagnostic Laboratories
- Academic & Research Institutes
Pharmaceutical and biotechnology companies dominate the end-user segment, driven by their involvement in co-developing and commercializing companion diagnostics in parallel with targeted cancer drugs.
Regional Analysis
North America is the largest regional market, driven by strong R&D infrastructure, high cancer prevalence, and early adoption of precision medicine. The U.S. leads in regulatory approvals, industry partnerships, and availability of advanced diagnostic technologies.
Europe follows closely, with countries like Germany, the UK, and France implementing national strategies for precision oncology. EU initiatives supporting personalized medicine and biomarker-driven clinical trials are enhancing market growth.
Asia-Pacific is projected to witness the fastest CAGR during the forecast period. Increasing cancer incidence, growing awareness about personalized treatment, and improving healthcare infrastructure in countries such as China, India, Japan, and South Korea are boosting regional demand.
Latin America and Middle East & Africa are gradually adopting companion diagnostics, with improvements in diagnostic access, rising healthcare investments, and local partnerships supporting market entry.
Key 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
These companies are actively engaged in strategic collaborations, product innovation, regulatory approvals, and geographic expansions to strengthen their market positions. For instance, Roche Diagnostics and Thermo Fisher Scientific are leading developers of FDA-approved companion diagnostic tests, while Guardant Health is pioneering liquid biopsy-based solutions.
Recent Developments
- Illumina and Roche announced a strategic agreement to co-develop NGS-based companion diagnostics to support cancer drug approvals globally.
- Guardant Health received FDA approval for its liquid biopsy-based companion diagnostic for NSCLC, enhancing early detection capabilities.
- Myriad Genetics expanded its BRACAnalysis CDx portfolio to support additional breast and ovarian cancer therapies.
- QIAGEN launched therascreen KRAS test as a companion diagnostic for Amgen’s lung cancer therapy, approved by the FDA.
- Agilent Technologies introduced a new PD-L1 IHC assay to predict response to checkpoint inhibitors in multiple cancers.
Conclusion
The oncology companion diagnostic market is witnessing explosive growth, fueled by the rise of precision medicine, the development of targeted therapies, and ongoing advancements in molecular diagnostic technologies. As the cancer burden continues to rise worldwide, companion diagnostics are playing a vital role in personalizing treatment strategies, improving clinical outcomes, and reducing unnecessary side effects.
With the continued integration of genomics, AI, and real-time monitoring tools into diagnostic platforms, the industry is moving toward a more personalized and proactive model of oncology care. Strategic partnerships between pharmaceutical and diagnostic companies, along with investments in innovative technologies like liquid biopsy and NGS, will continue to unlock new frontiers in the global oncology companion diagnostic landscape.
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