Oncology Companion Diagnostics Market Trends, Demand and Business Opportunities 2030

 

The global oncology companion diagnostics market is poised for strong expansion, with projections indicating a compound annual growth rate (CAGR) of approximately 10% through 2030. This growth is fueled by the rapid adoption of precision medicine, the rising global cancer burden, and continuous technological innovations in molecular diagnostics, such as next-generation sequencing (NGS) and liquid biopsy. Supportive regulatory policies and the increasing number of partnerships between pharmaceutical and diagnostic companies are also accelerating market momentum.

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Market Overview
Oncology companion diagnostics (CDx) are specialized diagnostic tests designed to identify specific genetic biomarkers that help match cancer patients with the most effective targeted therapies. These tests play a pivotal role in the era of personalized medicine, ensuring that patients receive treatments best suited to their molecular profile—maximizing therapeutic benefit while minimizing unnecessary toxicity. As the global emphasis on individualized cancer care intensifies, companion diagnostics have become indispensable in clinical decision-making and drug development.

Rising Adoption of Targeted Cancer Therapies Driving CDx Demand
The growing prominence of targeted therapies in oncology is a key catalyst for the expansion of the companion diagnostics market. By detecting actionable mutations, CDx enables oncologists to tailor treatment strategies with greater precision and safety. Regulatory bodies, including the U.S. FDA, are increasingly endorsing the co-development of drugs and diagnostics, allowing a single test to guide multiple therapeutic options for a given biomarker. Despite this progress, diagnostic testing gaps persist—studies reveal that many patients with advanced cancers, such as non-small cell lung cancer (NSCLC), still do not undergo comprehensive biomarker screening before treatment initiation. Expanding testing access and awareness remains a critical priority to fully realize the benefits of personalized oncology care.

Technological Advancements Transforming Oncology Diagnostics
Emerging technologies such as liquid biopsy and NGS are revolutionizing cancer diagnostics by making genetic testing more accurate, accessible, and less invasive. Liquid biopsy, which analyzes circulating tumor DNA (ctDNA) in blood samples, enables real-time monitoring of tumor evolution and early detection of resistance mutations. Meanwhile, NGS allows simultaneous profiling of multiple genes in a single assay, streamlining the identification of relevant biomarkers. The integration of artificial intelligence (AI) and machine learning into diagnostic workflows is further enhancing analytical precision and interpretation speed. However, the pace of innovation in targeted therapies continues to challenge diagnostic developers to keep up with newly approved drugs. Regulatory agencies now require validated diagnostic tests to accompany each new targeted therapy, reinforcing standardization and clinical reliability. As these technologies mature, they are expected to drive broader adoption of precision oncology and improve patient survival outcomes.

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Competitive Landscape
The oncology companion diagnostics market is highly competitive, featuring both established players and emerging innovators. Leading companies include Agilent Technologies, Illumina, Thermo Fisher Scientific, QIAGEN, F. Hoffmann-La Roche, Foundation Medicine, Myriad Genetics, Abbott, BioMérieux, Leica Biosystems, Guardant Health, and EntroGen. These players are actively investing in new product development, regulatory approvals, and global expansion initiatives. Strategic alliances between diagnostics developers and pharmaceutical companies are increasingly common, fostering integrated drug–diagnostic solutions and expanding access to cutting-edge technologies across major oncology centers worldwide.

Outlook
As precision oncology continues to redefine cancer treatment paradigms, companion diagnostics will remain central to enabling targeted therapy success. Ongoing innovations in molecular profiling, automation, and AI-driven analytics are expected to enhance testing speed, scalability, and cost efficiency. Combined with supportive regulatory frameworks and collaborative industry ecosystems, these advances position the oncology companion diagnostics market for sustained growth and transformative impact on personalized cancer care.

Table Of Content:

1.      Research Methodology​

o    Secondary Research​

o    Primary Research​

o    Market Estimation​

§  Bottom-Up Approach​

§  Top-Down Approach​

o    Market Forecasting​

2.      Executive Summary

o    Oncology Companion Diagnostic Market Snapshot (2025-2030)​

o    Segment Overview​

o    Regional Snapshot​

o    Competitive Insights ​

  1. Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Technology, USD Million
    • Introduction​
    • Polymerase Chain Reaction (PCR)
    • Next-Generation Sequencing (NGS)
    • Immunohistochemistry (IHC)
    • In Situ Hybridization (ISH)
    • Others
  2. Global Oncology Companion Diagnostic Market Size & Forecast (2023-2030), By Cancer Type, USD Million
    • Introduction​
    • Lung Cancer
    • Breast Cancer
    • Leukaemia
    • Colorectal Cancer
    • Prostate Cancer
    • Others

About Us:

At Medi-Tech Insights, we are a global healthcare consulting firm committed to delivering premium insights and strategic solutions to help our clients navigate the complex and evolving healthcare landscape. Our team combines deep industry expertise with data-driven market intelligence to provide actionable insights that enable smarter decisions and sustainable success. With a strong focus on innovation, quality, and impact, Medi-Tech Insights has become a trusted partner for leading healthcare investors and corporates across the globe.

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