Oncology Companion Diagnostic Market Size Is Anticipated To Reach USD 8.38 Billion By 2030

 San Francisco, 3 November 2025: The Report Oncology Companion Diagnostic Market (2025 - 2030) Size, Share & Trends Analysis Report By Product & Service, By Technology (PCR, IHC, NGS), By Disease Type (Breast Cancer), By End Use, By Region, And Segment Forecasts

The global oncology companion diagnostic market size is expected to reach USD 8.38 billion by 2030, expanding at a CAGR of 9.02% from 2025 to 2030, according to a new report by Grand View Research, Inc. Expanding access to important genomic information with the aid of companion diagnostics enables informed decision making for designing the targeted treatment approaches for their patients, thereby increasing demand for comprehensive genomic testing and oncology companion diagnostics.

The commercial launch of drugs including Gleevec (imatinib) and Herceptin (trastuzumab) that require Companion Diagnostics (CDx) testing before prescription has increased revenue generation in the oncology companion diagnostics field. This growth is expected to continue in the future owing to a substantial number of CDx associated oncology drugs in clinical trials. Apart from functioning as exclusive or inclusive tests for therapies, CDx also plays a crucial role during participant selection in clinical trials. This is because there is an increased potential for a novel drug candidate to show a better response rate if the patient has its biomarker target.

The economic incentives associated with the use of CDx have encouraged drug developers to combine their drugs with diagnostic tests. However, the diagnostic manufacturers face conflicting demands from payers/providers on one hand and drug manufacturers on the other hand. The regulatory bodies also have stringent policies to align the development timelines of diagnostics and drugs. Therefore, the diagnostic companies are expected to broaden their scope of CDx development instead of focusing on the attainment of a match between a single diagnostic with a specific drug.

 

Access Research Report of Oncology Companion Diagnostic  Market @ https://www.grandviewresearch.com/industry-analysis/oncology-companion-diagnostics-market

Key Market Trends & Insights

• North America dominated the market with the largest revenue share of 40.17 % in 2024.
• The U.S. oncology companion diagnostic market is expected to grow over the forecast period.
• By product & services, the products segment dominated the market with a share of 66.14% in 2024.
• By technology, the Polymerase Chain Reaction (PCR) segment dominated the market with a share of 28.03% in 2024.
• By disease the, non-small cell lung cancer segment dominated the market, with a share of 30.32% in 2024.

Recent Developments

• In May 2025, the U.S. FDA approved the VENTANA MET (SP44) RxDx Assay as a companion diagnostic for telisotuzumab vedotin (Emrelis) in non-small cell lung cancer (NSCLC). This immunohistochemistry-based test identifies patients with high c-MET protein overexpression, a key biomarker for selecting candidates for this targeted therapy. The approval was supported by data from the Phase 2 LUMINOSITY trial, which demonstrated a 35% overall response rate in patients with high c-MET expression treated with telisotuzumab vedotin.
• In January 2025, the U.S. FDA approved FoundationOne CDx as the first and only companion diagnostic for OJEMDA (tovorafenib), a technology II RAF inhibitor, to treat pediatric patients aged six months and older with relapsed or refractory BRAF-altered low-grade glioma (pLGG). This approval enables clinicians to identify patients whose tumors harbor BRAF fusions, rearrangements, or BRAF V600 mutations, facilitating targeted therapy with tovorafenib. Previously, no FDA-approved treatments existed for tumors with BRAF fusions, which are present in approximately 80% of BRAF-altered pLGG cases.

Oncology Companion Diagnostic Market Report Scope

Market size value in 2025	USD 5.44 billion
Revenue forecast in 2030	USD 8.38 billion
Growth Rate	CAGR of 9.02% from 2025 to 2030
Base year for estimation	2024
Historical data	2018 - 2023
Forecast period	2025 - 2030

 

Grand View Research has segmented the global oncology companion diagnostic market report based on product & services, technology, disease type, end use, and region

Oncology Companion Diagnostic Product & Services Outlook (Revenue, USD Million, 2018 - 2030)

• Product
  • Instrument
  • Consumables
  • Software
• Services

Oncology Companion Diagnostic Technology Outlook (Revenue, USD Million, 2018 - 2030)

• Polymerase Chain Reaction (PCR)
• Next-generation Sequencing (NGS)
• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
• Other Technologies

Oncology Companion Diagnostic Disease Type Outlook (Revenue, USD Million, 2018 - 2030)

• Breast Cancer
• Non-small Cell Lung Cancer
• Colorectal Cancer
• Leukemia
• Melanoma
• Prostate Cancer
• Others

Oncology Companion Diagnostic End Use Outlook (Revenue, USD Million, 2018 - 2030)

• Hospital
• Pathology/Diagnostic Laboratory
• Academic Medical Center

Oncology Companion Diagnostic Regional Outlook (Revenue, USD Million, 2018 - 2030)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

List of Key Players of Oncology Companion Diagnostic Market

• Agilent Technologies, Inc.
• Illumina, Inc.
• QIAGEN
• Thermo Fisher Scientific Inc.
• Foundation Medicine, Inc.
• Myriad Genetics, Inc.
• Hoffmann-La Roche Ltd
• BIOMÉRIEUX
• Abbott
• Leica Biosystems Nussloch GmbH
• Guardant Health
• EntroGen, Inc.

Access Press Release of Oncology Companion Diagnostic  Market @ https://www.grandviewresearch.com/press-release/global-oncology-companion-diagnostics-market