Oncology Companion Diagnostic Market is poised for substantial growth driven by advancements in personalized medicine and targeted therapies.
Pune, Feb. 25, 2025 (GLOBE NEWSWIRE) — Oncology Companion Diagnostic Market Size & Growth Analysis:
“According to SNS Insider, The global Oncology Companion Diagnostic Market size was valued at USD 4.12 billion in 2023 and is projected to grow to USD 10.60 billion by 2032. This growth trajectory reflects a robust compound annual growth rate (CAGR) of 11.09% from 2024 to 2032.”
The surge is primarily attributed to the increasing adoption of personalized medicine and the development of targeted cancer therapies, necessitating precise diagnostic tools to identify suitable patient populations.
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Market Overview
Oncology companion diagnostics are at the center of the paradigm shift in personalized cancer treatment. These diagnostics allow for the detection of certain biomarkers, which in turn allow healthcare practitioners to customize treatments that suit one’s specific genetic makeup. The rising incidence of cancer globally has increased the demand for such highly specific diagnostic technologies, so patients can be administered the most beneficial treatments with minimal side effects.
The joint initiatives of pharmaceutical firms and diagnostic developers have played a key role in the growth of this market. Through the co-development of drugs and companion diagnostics, such collaborations guarantee that novel treatments are followed by tests capable of correctly determining patient suitability. Regulatory authorities have also come to appreciate the value of these diagnostics, making approval procedures simpler to enable faster arrival of bundled therapeutic and diagnostic solutions.
Major Players Analysis Listed in this Report are:
- Agilent Technologies, Inc.: Dako HER2 IQFISH pharmDx
- Illumina, Inc.: TruSight Oncology 500
- QIAGEN: therascreen EGFR RGQ PCR Kit
- Thermo Fisher Scientific Inc.: Oncomine Dx Target Test
- Foundation Medicine, Inc.: FoundationOne CDx
- Myriad Genetics, Inc.: BRACAnalysis CDx
- F. Hoffmann-La Roche Ltd.: VENTANA PD-L1 (SP142) Assay
- BioMérieux: THxID-BRAF Kit
- Abbott: PathVysion HER-2 DNA Probe Kit
- Leica Biosystems: BOND Oracle HER2 IHC System
- Guardant Health, Inc.: Guardant360 CDx
- EntroGen, Inc.: EGFR Mutation Analysis Kit
- Abbott Laboratories: Vysis ALK Break Apart FISH Probe Kit
- Bio-Rad Laboratories: QXDx BCR-ABL %IS Kit
- Biocartis: Idylla NRAS-BRAF Mutation Test
- Exact Sciences: Oncotype DX
- Genedrive: MT-RNR1 ID Kit
- Genomic Health: Oncotype DX
- Invivoscribe: LeukoStrat CDx FLT3 Mutation Assay
- Sysmex Corporation: OncoBEAM RAS CRC Kit
Oncology Companion Diagnostic Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | US$ 4.12 billion |
| Market Size by 2032 | US$ 10.60 billion |
| CAGR | CAGR of 11.09% From 2024 to 2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Key Regional Coverage | North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East]), Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia Rest of Latin America) |
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Segment Analysis
By Product & Services
In 2023, the product segment was the market leader, capturing a large share of the oncology companion diagnostics market. This is due to ongoing innovation and development of sophisticated diagnostic instruments and consumables. On the other hand, the services segment is expected to witness the highest growth in the forecast period due to growing demand for specialty diagnostic services and outsourcing of test procedures to specialized labs.
By Technology
Polymerase Chain Reaction (PCR) technology dominated the market in 2023 with its established existence and trust factor for identifying mutations linked to various types of cancer. Next-Generation Sequencing (NGS), however, is expected to grow at the fastest rate during the forecasted period. NGS provides an all-encompassing genomic analysis that allows the detection of multiple mutations at once, which is critically useful in cases of intricate cancer genomics.
By Disease Type
Non-Small Cell Lung Cancer (NSCLC) accounted for the leading disease segment during 2023, due to the high prevalence of this form of cancer and the presence of several targeted treatments that need to be accompanied by companion diagnostics. In the future, the fastest growth is predicted to come from the breast cancer segment, fueled by an increased understanding of breast cancer subtypes and the resultant creation of targeted therapy that will require companion diagnostic testing.
By End-Use
Hospitals were the largest end-users in 2023, making extensive use of oncology companion diagnostics to inform treatment decisions and enhance patient outcomes. Pathology and diagnostic laboratories are predicted to record the highest growth, as the shift towards specialized and centralized diagnostic services picks up pace, providing high-throughput testing capacity and specialized knowledge.
Oncology Companion Diagnostic Market Segmentation
By Product & Services
- Product
- Instrument
- Consumables
- Software
- Services
By Technology
- Polymerase Chain Reaction (PCR)
- Next-generation Sequencing (NGS)
- Immunohistochemistry (IHC)
- In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
- Other Technologies
By Disease Type
- Breast Cancer
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Leukemia
- Melanoma
- Prostate Cancer
- Others
By End-Use
- Hospital
- Pathology/Diagnostic Laboratory
- Academic Medical Center
Regional Outlook
North America dominated the oncology companion diagnostic market in 2023, fueled by a well-developed healthcare infrastructure, high research and development investment, and early uptake of sophisticated diagnostic technologies. The region’s active regulatory framework and high level of cooperation between pharmaceutical and diagnostic firms have also contributed to market growth.
The Asia Pacific region is witnessing unprecedented growth in the oncology companion diagnostic market. The reasons for this growth are rising cancer incidence, growing healthcare spending, and expanding awareness of personalized medicine strategies. Nations like China and India are spending significantly on healthcare infrastructure and are emerging as hotspots for clinical trials, further driving market growth in the region.
Recent Developments
- January 2025: Roche received FDA approval for a label expansion of its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. This approval marks it as the first companion diagnostic capable of identifying HER2-ultralow metastatic breast cancer patients eligible for ENHERTU treatment, a HER2-directed antibody-drug conjugate developed in collaboration with Daiichi Sankyo and AstraZeneca.
- December 2024: Guardant Health, Inc. announced a partnership with Boehringer Ingelheim to advance the regulatory approval and commercialization of the Guardant360 CDx liquid biopsy. This collaboration aims to establish the test as a companion diagnostic for zongertinib, an investigational HER2-selective tyrosine kinase inhibitor targeting non-small cell lung cancer (NSCLC).
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Table of Contents – Major Key Points
1. Introduction
2. Executive Summary
3. Research Methodology
4. Market Dynamics Impact Analysis
5. Statistical Insights and Trends Reporting
6. Competitive Landscape
7. Oncology Companion Diagnostic Market by Product & Services
8. Oncology Companion Diagnostic Market by Technology
9. Oncology Companion Diagnostic Market by Disease Type
10. Oncology Companion Diagnostic Market by End-Use
11. Regional Analysis
12. Company Profiles
13. Use Cases and Best Practices
14. Conclusion
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