Unlocking Precision: The Rise of Oncology Companion Diagnostics in Personalized Cancer Care | DataM Intelligence

Oncology companion diagnostics enable precise cancer treatment by pairing targeted drugs with patient-specific genetic profiles.

AUSTIN, TX, UNITED STATES, August 11, 2025 /EINPresswire.com/ -- The oncology landscape is shifting, with companion diagnostics (CDx) now unleashing the full potential of precision oncology, allowing doctors to treat the cancer patients with precision medicine based on the genetic profiles. The worldwide CDx market has shifted from niche to key infrastructure, owing to the rise of tailored therapies and biomarker-driven treatments. Companion diagnostics (CDx) have revolutionized cancer treatment by helping improve the safety and tolerability of targeted drugs. To date, there are nearly 180 FDA-approved CDx, but only four are outside approved outside the oncology space (for hemophilia and obesity). Notable FDA-approved CDx innovations include: Roche’s VENTANA FOLR1 RxDx Assay an immunohistochemistry test identifying ovarian cancer patients who may benefit from ELAHERE (mirvetuximab soravtansine). Guardant Health’s Guardant360 CDx an FDA-approved liquid biopsy that detects actionable genomic mutations (e.g., ESR1 in breast cancer) via circulating tumor DNA, Myriad Genetic’s BRCA Analysis CDx for detecting BRCA 1 and BRCA 2 mutations in whole blood of for ovarian cancer and patients with these over expressed genes may benefit from targeted treatment with Olaparib.

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Market Dynamics:
The oncology companion diagnostics (CDx) market is entering a transformative era, fueled by the convergence of molecular biology, advanced sequencing technologies, and precision medicine. At its core, the market is dynamically shaped by rising global cancer incidence, an accelerating pipeline of biomarker-driven therapies, and increasing regulatory clarity around drug-diagnostic co-development. Companion diagnostics serve as critical gatekeepers, enabling oncologists to match patients with the most effective, targeted therapies based on individual genetic profiles. This shift away from traditional, one-size-fits-all approaches is unlocking unprecedented precision in cancer care.

Market dynamics are strongly influenced by the growing pharmaceutical-diagnostics partnerships, wherein CDx is developed in parallel with oncology drugs. Companies like Roche, Illumina, Thermo Fisher, and QIAGEN are leading this evolution with FDA-approved tests such as FoundationOne CDx, Oncomine Dx Target Test, and VENTANA PD-L1 assays, respectively. Furthermore, the market is increasingly shaped by technology disruptors like next-generation sequencing (NGS) and liquid biopsy, which allow comprehensive tumor profiling using minimal samples and faster turnaround, particularly essential in late-stage or metastatic cancer cases.

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Market Size:
According to the DataM Intelligence: The global oncology companion diagnostics market size was valued as US$ 5.02 Billion in 2024 and is expected to reach US$ 10.90 Billion by 2033, growing at a CAGR of 9.1% during the forecast period 2025-2033.

Major Companies:
Major companies working towards the market's growth include F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., Illumina, Inc., QIAGEN, Thermo Fisher Scientific Inc., Myriad Genetics, Inc., Guardant Health, Labcorp, Quest Diagnostics, Invivoscribe, Inc. and among others.

Emerging Companies:
Tempus AI, Inc., , MolecularMD (ICON PLC), Epigene Labs, and Freenome.

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Author: Gundreddy Gopinadh is a dedicated healthcare research analyst with a strong track record in the market research industry, bringing deep expertise across the medical devices, pharmaceuticals, biotechnology, and in-vitro diagnostics (IVD) sectors. With a focus on delivering actionable insights, he has supported numerous healthcare organizations by analyzing market trends, evaluating competitive landscapes, and identifying growth opportunities. Gopinadh’s work helps industry stakeholders make informed decisions in product development, strategic planning, and market expansion, reinforcing their role as a valuable contributor to data-driven innovation in the global healthcare space.

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