United States Oncology Companion Diagnostics Industry Growth: Personalized Medicine & Innovative Tests 2025

DataM Intelligence has released an in-depth research report on "Oncology Companion Diagnostics Market Size 2025". This report delivers power-packed insights into key growth drivers, market segmentation, regional trends, CAGR forecasts, revenue performance of top players, and emerging opportunities. Gain a 360° market perspective with detailed analysis on value, volume, and future development trends your ultimate guide to spotting high-impact opportunities and staying ahead in this dynamic market.

With growing collaborations between pharmaceutical and diagnostic companies to develop drug-diagnostic pairs, demand for companion diagnostics is set to rise. Key players like Roche, Thermo Fisher Scientific, QIAGEN, and Agilent Technologies are driving innovation using NGS, PCR, and IHC-based platforms.

Mergers & Acquisitions

The oncology companion diagnostics space continues to see consolidation as major players bolster their genomic testing capabilities through acquisitions and partnerships, aiming for precision oncology leadership.

Companies like Illumina and Thermo Fisher have expanded collaborations with pharma to co-develop CDx tests paired with targeted therapies.

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FDA Approvals

In September 2025, FDA approved the Oncomine Dx Target Test (Thermo Fisher) as a companion diagnostic for zongertinib (Hernexeos) to treat patients with HER2-mutant non-small cell lung cancer.

Earlier approvals this year included Roche's VENTANA MET (SP44) RxDx Assay for telisotuzumab vedotin (Emrelis) in non-small cell lung cancer, opening new options for personalized treatment

Market Drivers

In June 2025, QIAGEN and Incyte partnered to develop a novel diagnostic panel for myeloproliferative neoplasms, supporting therapies including INCA033989. The panel will use NGS technology on the Illumina NextSeq 550Dx platform for global patient testing.

The increasing prevalence of cancer is a key driver of the oncology companion diagnostics market. The National Institutes of Health projects 29.9 million new cancer cases and 15.3 million deaths annually by 2040. Meanwhile, the International Agency for Research on Cancer estimates 21.3 million cases in 2025 and 24.1 million by 2030, highlighting a rising demand for targeted diagnostic solutions.

List of Top Key Players:

F. Hoffmann-La Roche Ltd, Agilent Technologies, Inc., Illumina, Inc., QIAGEN, Thermo Fisher Scientific Inc., Myriad Genetics, Inc., Guardant Health, Labcorp, Quest Diagnostics and Invivoscribe, Inc., among others.

Clinical Trials

Companion diagnostic-integrated trials continue to grow, with recent studies using NGS panel tests to match patients to targeted therapies in lung, breast, and hematologic cancers.

Research is focusing on liquid biopsy tests and molecular profiling to enable earlier detection of treatment resistance and tailor therapies dynamically.

Forecast Growth Projection:

Global Oncology Companion Diagnostics Market Positioned for Strong Growth 2025-2032, Building on the steady momentum of 2024, the market is poised for remarkable expansion as leading players embrace innovative technologies and strategic advancements. This evolving landscape is unlocking lucrative opportunities for businesses to invest, scale, and stay ahead in an increasingly competitive and fast-moving market.

Market Research Process:

The Oncology Companion Diagnostics Market research report by DataM Intelligence combines extensive Primary and Secondary research to provide powerful, in-depth insights. It examines key market drivers such as regulatory frameworks, evolving market conditions, competitive dynamics, historical trends, and breakthrough technologies, while spotlighting emerging innovations and potential challenges. This all-inclusive analysis uncovers high-growth opportunities and highlights possible barriers, equipping businesses to tackle market volatility and capture new avenues for success.

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Market Segments:

NGS leads oncology companion diagnostics with 34.43% share. in 2024

Product Type: Instruments, Consumables, Software

Technology: Polymerase Chain Reaction (PCR), Next‐Generation Sequencing (NGS), Immunohistochemistry (IHC), In Situ Hybridization (ISH/FISH), Liquid Biopsy, Others

Application: Non‐Small Cell Lung Cancer (NSCLC), Breast Cancer, Prostate Cancer, Colorectal Cancer, Others

End-User: Hospitals, Diagnostic Laboratories, Academic and Research Institutions, Others

Product Launches

Illumina expanded its oncology IVD portfolio, introducing TruSight Comprehensive and the Pillar oncoReveal CDx panel, offering broad genomic profiling with faster turnaround and more actionable insights for clinicians.

Global Growth Regions:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Opens the report with a comprehensive market overview, highlighting key segments by region, product type, and application. It presents a clear snapshot of market size, growth potential by segment, and both short- and long-term outlook.

Chapter 2: Showcases the most impactful insights, uncovering the emerging trends and disruptive forces shaping the industry's future.

Chapter 3: Delivers an in-depth competitive landscape analysis of the Oncology Companion Diagnostics market, covering revenue shares, strategic moves, and the latest mergers & acquisitions.

Chapter 4: Features detailed profiles of leading players, including their revenue streams, profit margins, product portfolios, and key milestones.

Chapters 5 & 6: Present a granular breakdown of regional and country-level revenue performance, offering a precise view of market size, opportunities, and development prospects worldwide.

Chapter 7: Analyzes market segmentation by product type, revealing the growth potential of each category and spotlighting high-impact.

Chapter 8: Examines application-based market growth, identifying the fastest-expanding sectors and lucrative opportunities for expansion.

Chapter 9: Maps the entire industry supply chain, providing insights into upstream and downstream activities for a complete market perspective.

Chapter 10: Concludes with key findings and actionable takeaways, guiding stakeholders toward strategic decisions and future growth opportunities.

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Q1: How Large is the Oncology Companion Diagnostics Market?

A: The Oncology Companion Diagnostics Market was valued at US$ 5.02 Billion in 2024 and is expected to experience substantial growth, reaching US$ 10.90 Billion by 2033.

Q2: How fast is the Oncology Companion Diagnostics Market growing?

A: The Market is experiencing strong growth and is projected to expand at a CAGR of 9.1% from 2025 to 2032.

Q3: Which Region Leads Oncology Companion Diagnostics Market growth?

A: North America leads oncology companion diagnostics at 42.73%.

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