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Global Oncology Companion Diagnostic Market to grow at 10% CAGR, aided by regulations 2030

 


The oncology companion diagnostic market is projected to grow at a CAGR of ~10% over the forecast period. The market is driven by the growing adoption of precision medicine, rising cancer incidence, and advancements in molecular diagnostics, including next-generation sequencing (NGS) and liquid biopsy. Regulatory support for personalized medicine and increasing collaborations between pharmaceutical and diagnostic firms further accelerate growth. 

Oncology companion diagnostics are specialized tests that help determine the most effective cancer treatment for individual patients by identifying specific biomarkers. These diagnostics ensure that targeted therapies are administered to patients who are most likely to benefit, improving treatment efficacy and minimizing adverse effects. They play a crucial role in personalized medicine by guiding oncologists in selecting therapies based on a patient's genetic profile. The development of these tests is often linked with targeted cancer drugs, making them essential in modern oncology care.

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Expanding role of companion diagnostics in targeted cancer therapies

The increasing reliance on targeted therapies in oncology has significantly driven the demand for companion diagnostics (CDx). These diagnostics help identify specific cancer mutations, enabling precise treatment selection and minimizing side effects. Regulatory agencies like the FDA advocate for broader CDx applications, allowing single tests to guide multiple drug options for the same mutation, improving clinical efficiency. Despite these advancements, gaps in genomic testing remain—highlighted by a 2020 study showing that nearly a quarter of advanced NSCLC (Non-Small Cell Lung Cancer) patients in the US did not receive recommended biomarker testing before treatment. Given that most NSCLC patients could benefit from targeted therapy, improving CDx accessibility and adoption remains critical. As awareness of personalized medicine grows and regulatory support strengthens, oncology companion diagnostics continue to play an essential role in optimizing cancer treatment outcomes.

Technological innovations enhancing companion diagnostics market growth

Advancements in liquid biopsy and next-generation sequencing (NGS) are transforming oncology diagnostics by enabling non-invasive, comprehensive genetic testing. Liquid biopsy allows for ctDNA analysis from blood samples, improving early cancer detection and treatment monitoring. Meanwhile, NGS facilitates multi-gene profiling in a single test, enhancing precision in therapy selection. However, the rapid development of targeted therapies has created challenges in aligning CDx availability with new drug launches. To address this, regulatory agencies require clinical validation of at least one diagnostic test per drug class, ensuring consistent biomarker detection. AI-driven analytics further refine diagnostic accuracy and efficiency, accelerating the integration of personalized medicine. As these technologies advance, they are expected to enhance accessibility, improve patient outcomes, and drive the continued expansion of the oncology companion diagnostics market.

Competitive Landscape Analysis

The global oncology companion diagnostic market is marked by the presence of established and emerging market players such as 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.; and EntroGen, Inc. among others. Some of the key strategies adopted by market players include new product development, strategic partnerships and collaborations, and geographic expansion.

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Global Oncology Companion Diagnostic Market Segmentation

This report by Medi-Tech Insights provides the size of the global oncology companion diagnostic market at the regional- and country-level from 2023 to 2030. The report further segments the market based on product & services, technology, cancer type, and end-user.

Market Size & Forecast (2023-2030), By Product & Services, USD Million

  • Product
    • Instrument
    • Consumables
    • Software
  • Services

Market Size & Forecast (2023-2030), By Technology, USD Million

  • Polymerase Chain Reaction (PCR)
  • Next-Generation Sequencing (NGS)
  • Immunohistochemistry (IHC)
  • In Situ Hybridization (ISH)
  • Others

Market Size & Forecast (2023-2030), By Cancer Type, USD Million

  • Lung Cancer
  • Breast Cancer
  • Leukaemia
  • Colorectal Cancer
  • Prostate Cancer
  • Others

Market Size & Forecast (2023-2030), By End-user, USD Million

  • Hospitals
  • Diagnostic Laboratory
  • Academic & Research Institutes
  • Others

Market Size & Forecast (2023-2030), By Region, USD Million

  • North America
    • US
    • Canada
  • Europe
    • UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Rest of Asia Pacific
  • Latin America
  • Middle East & Africa

 About Medi-Tech Insights

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services in the areas of market assessments, due diligence, competitive intelligence, market sizing and forecasting, pricing analysis & go-to-market strategy. Our methodology includes rigorous secondary research combined with deep-dive interviews with industry-leading CXO, VPs, and key demand/supply side decision-makers.

Contact:

Ruta Halde
 Associate, Medi-Tech Insights
 +32 498 86 80 79
 info@meditechinsights.com 

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