PUBLISHER: Global Industry Analysts, Inc. | PRODUCT CODE: 1795811
PUBLISHER: Global Industry Analysts, Inc. | PRODUCT CODE: 1795811
Global Companion Diagnostic Tests in Oncology Market to Reach US$10.0 Billion by 2030
The global market for Companion Diagnostic Tests in Oncology estimated at US$6.3 Billion in the year 2024, is expected to reach US$10.0 Billion by 2030, growing at a CAGR of 8.1% over the analysis period 2024-2030. Protein Detection-Immunohistochemistry, one of the segments analyzed in the report, is expected to record a 6.9% CAGR and reach US$4.1 Billion by the end of the analysis period. Growth in the DNA Detection-Polymerase Chain Reaction segment is estimated at 9.7% CAGR over the analysis period.
The U.S. Market is Estimated at US$1.7 Billion While China is Forecast to Grow at 12.4% CAGR
The Companion Diagnostic Tests in Oncology market in the U.S. is estimated at US$1.7 Billion in the year 2024. China, the world's second largest economy, is forecast to reach a projected market size of US$2.1 Billion by the year 2030 trailing a CAGR of 12.4% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 4.2% and 7.7% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.4% CAGR.
Global Companion Diagnostic Tests in Oncology Market - Key Trends & Drivers Summarized
Why Are Companion Diagnostic Tests Revolutionizing Cancer Treatment Worldwide?
Companion diagnostic tests in oncology are fundamentally transforming how cancers are detected, classified, and treated by aligning specific therapies with individual patient profiles. These tests identify biomarkers that predict a patient’s response to a targeted therapy, making treatment more precise, effective, and personalized. Unlike conventional diagnostic approaches, companion diagnostics allow clinicians to match patients with the therapies most likely to benefit them while avoiding ineffective or potentially harmful treatments. This represents a major shift in oncology from a one-size-fits-all model to a precision medicine approach. As cancer types become increasingly segmented by genetic mutations and molecular signatures, these diagnostics are becoming indispensable in guiding therapeutic decisions. For instance, tests that detect HER2 expression in breast cancer or EGFR mutations in non-small cell lung cancer help determine eligibility for specific biologics or tyrosine kinase inhibitors. The clinical value of such testing is particularly high in cancers with well-defined genetic drivers, where outcomes are closely tied to molecular profiles. As pharmaceutical companies develop more targeted oncology drugs, the co-development of companion diagnostics is emerging as a standard strategy to gain regulatory approval and improve clinical trial success rates. The integration of these tests into early-stage cancer management is also facilitating timely intervention, improving prognosis, and enhancing patient quality of life. This confluence of clinical, economic, and technological benefits is positioning companion diagnostic tests as essential tools in the modern oncology care continuum.
How Are Technological Innovations Driving Advancements in Companion Diagnostics?
Technological innovation is playing a pivotal role in enhancing the accuracy, speed, and utility of companion diagnostic tests in oncology. Advances in genomic sequencing, especially next-generation sequencing (NGS), have revolutionized how multiple cancer-related mutations can be identified from a single sample. This capability has made it feasible to develop multiplexed assays that screen for various actionable biomarkers simultaneously, providing a more comprehensive understanding of the tumor’s molecular landscape. Additionally, the emergence of liquid biopsy technology is enabling non-invasive testing through blood or other bodily fluids, eliminating the need for tissue biopsies in many cases and allowing for easier monitoring of treatment response and disease progression. Machine learning and artificial intelligence are being incorporated into companion diagnostic platforms to analyze complex genomic data, detect patterns, and generate actionable insights that support clinical decision-making. Digital pathology and imaging techniques are also contributing to improved biomarker identification by integrating visual data with molecular profiles. Furthermore, automation in laboratory workflows is increasing throughput, reducing error rates, and shortening turnaround times, making these tests more accessible to clinicians and patients. Companion diagnostics are now being integrated into digital health platforms and electronic medical records, facilitating seamless coordination between diagnostic labs, oncologists, and treatment centers. These technological advances are not only improving test sensitivity and specificity but are also expanding the range of detectable biomarkers across cancer types. As innovation accelerates, companion diagnostic tests are becoming more scalable and cost-effective, supporting their integration into routine oncology practice on a global scale.
What Market and Regulatory Trends Are Shaping the Growth of Companion Diagnostics in Oncology?
The growth of the companion diagnostic market in oncology is being shaped by dynamic shifts in regulatory policy, payer reimbursement, and collaborative commercialization strategies. Regulatory agencies such as the FDA, EMA, and PMDA are increasingly recognizing the critical role of companion diagnostics in therapeutic decision-making and have established frameworks for co-approval of drugs and their corresponding diagnostic tests. These parallel approval pathways are encouraging pharmaceutical and diagnostics companies to engage in early-stage partnerships, integrating biomarker development into the drug discovery process. Reimbursement policies are evolving to support broader test accessibility, especially as health systems begin to recognize the long-term cost savings associated with precision medicine approaches that reduce treatment failure rates and adverse effects. Value-based healthcare models are emphasizing clinical utility, requiring that diagnostics demonstrate clear benefit in guiding treatment and improving outcomes. In response, diagnostic developers are investing in real-world evidence studies and health economics analyses to strengthen their value proposition to payers and providers. Intellectual property and data-sharing agreements are also becoming central to industry collaborations, as stakeholders seek to balance innovation with affordability and data interoperability. Market competition is intensifying, with both large in vitro diagnostic firms and smaller molecular diagnostics startups racing to develop biomarker panels for a growing list of targeted therapies. In parallel, governments and healthcare institutions are launching precision oncology initiatives to expand access to genomic testing and build national databases that support biomarker research. These regulatory and market forces are collectively creating a more favorable environment for the expansion of companion diagnostics, especially in high-incidence cancers and advanced therapeutic areas.
What Factors Are Driving the Global Demand for Companion Diagnostic Tests in Oncology?
The growth in the companion diagnostic tests in oncology market is driven by a convergence of clinical, technological, demographic, and commercial factors that reflect the evolving landscape of cancer treatment. The increasing global cancer burden, particularly the rising incidence of solid tumors and hematologic malignancies, is creating a strong demand for diagnostics that can personalize therapy and improve treatment outcomes. As cancer care shifts toward targeted and immunotherapies, companion diagnostics are becoming essential for identifying the right patients for the right treatments, thereby enhancing efficacy and minimizing toxicity. Growing awareness among oncologists and patients about precision medicine is accelerating test adoption, particularly in developed markets with advanced healthcare infrastructure. The expanding pipeline of targeted oncology drugs, many of which require biomarker validation for regulatory approval, is fueling the co-development of companion diagnostics. Pharmaceutical companies are investing in partnerships with diagnostics firms to improve clinical trial enrollment and align drug launches with diagnostic readiness. Technological advancements such as NGS, AI-based analytics, and digital health integration are making diagnostics faster, more accurate, and easier to deploy. Government support for precision medicine initiatives and favorable reimbursement trends are further contributing to market growth. Additionally, the proliferation of molecular testing laboratories and the decentralization of diagnostic services are making companion diagnostics more accessible in emerging markets. As healthcare systems worldwide strive for more personalized, data-driven approaches to cancer care, companion diagnostic tests are emerging as indispensable tools that bridge the gap between molecular insights and therapeutic decisions. These factors collectively underscore the rapid expansion of this market and its central role in the future of oncology.
SCOPE OF STUDY:
The report analyzes the Companion Diagnostic Tests in Oncology market in terms of units by the following Segments, and Geographic Regions/Countries:
Segments:
Detection Technique (Protein Detection-Immunohistochemistry, DNA Detection-Polymerase Chain Reaction, Next-Generation Sequencing, In-Situ Hybridization, Other Detection Techniques); Biomarker (EGFR Biomarker, KRAS Biomarker, HER2 Biomarker, BRAF V600E Biomarker, Other Biomarkers); Cancer Type (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Melanoma, Other Cancer Types); End-User (Hospitals End-User, Specialty Clinics End-User, Diagnostic Labs End-User, Other End-Users)
Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.
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