Companion Diagnostics for Oncology Market Size, Share & Trends Analysis Report By Products and Services (Assays, Kits, and Reagents, Software and Services), By Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS)), By Indication (Breast Cancer, Lung Cancer, Colorectal Cancer, Gastric Cancer, Melanoma, Others), By End-User (Pharmaceutical and Biopharmaceutical Companies, Laboratories, Contract Research Organizations, Others) and By Region (North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2026-2034

Companion Diagnostics for Oncology Market Size & Growth Analysis

The global companion diagnostics for oncology market size was valued at USD 5.48 billion in 2025 and is projected to grow from USD 6.73 billion in 2026 to USD 34.72 billion by 2034, registering a CAGR of 22.77% during the forecast period from 2026 to 2034. North America dominated the companion diagnostics for oncology market with a market share of 42.6% in 2025.

Products and Services Insights

In 2024, the assays, kits, and reagents segment dominated the market with a 66.1% share and is expected to grow at a CAGR of 24.10% over the forecast period. Assays, kits, and reagents are required to generate many DNA molecules using primers and prepare libraries from newly developed DNA molecules. The reagents and test kits unit vary with the number of reactions to be carried out.

• For instance, Camptosar (irinotecan) and Invader UGT1A1 are typical molecular assays used in IVD testing. In 2021, assays, kits, and reagents accounted for the largest market share owing to the development and commercialization of high-quality test kits by prominent key players such as Thermo Fisher Scientific, Inc., Qiagen, and Illumina Inc. Moreover, its continuous requirement by researchers, clinicians and other end-users is expected to drive the growth of this segment.

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Technology Insights

The polymerase chain reaction (PCR) segment is the highest contributor to the market and is expected to grow at a CAGR of 20.27% over the forecast period. Polymerase chain reaction (PCR) quickly makes multiple copies of a specific genetic material. In this technique, the patient sample is collected and amplified to make numerous copies of it and used to understand the patient's genetic makeup. This unique genetic sequence of the patient is analyzed with the drug molecule to determine its compatibility. This technique helps in screening the suitable treatment for the patient according to their genetic makeup and also helps to reduce the chances of adverse effects and improves medical outcomes.

PCR is the most widely utilized technology for developing companion diagnostics in cancer due to its ability to generate vast quantities of quantitative data for examination. One example of PCR-based companion diagnostics for oncology tests is the "cobas EGFR Mutation Test v2". In August 2018, F. Hoffmann-La Roche Ltd. was granted US FDA approval for the cobas EGFR Mutation Test v2 as a companion diagnostic to IRESSA (gefitinib) for treating patients with non-small cell lung cancer (NSCLC).

Indication Insights

The breast cancer segment owns the highest market share and is expected to grow at a CAGR of 22.82% over the forecast period. Oncology companion diagnostics for the disease are in high demand because breast cancer is one of the most prevalent cancers and has a high mortality rate. In 2019, the National Cancer Institute (NIH) reported that there were around 271,270 new instances of cancer identified in the U.S., and there were also approximately 42,260 cancer-related deaths. Furthermore, it is anticipated that a favorable reimbursement environment in important locations will promote the adoption of innovative breast cancer diagnostic methods. NGS was added to CMS's list of approved diagnostic procedures for patients with germline (inherited) breast cancer in January 2020.

End-User Insights

The pharmaceutical and biopharmaceutical companies segment is the highest contributor to the market and is expected to grow at a CAGR of 22.65% over the forecast period. The large share of pharmaceutical and biopharmaceutical companies can be attributed to the increased adoption of companion diagnostics for oncology in drug discovery and development by pharmaceutical and biotechnology companies.

The potential value of companion diagnostics for oncology has been widely accepted. The regulatory authorities, including the FDA and European Medicines Agency (EMEA), are choosing to accept and, in some cases demanding the use of companion diagnostics for oncology in combination with a specific therapeutic drug. Most companies, such as GlaxoSmithKline PLC, F. Hoffmann-La Roche AG., Pfizer, Astra Zeneca, Bristol Myers, and Eli Lilly, among others, use companion diagnostics for oncology, boosting the global market.

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Regional Analysis

In 2024, North America led the companion diagnostics for oncology market with a 44% share. Americas is the most significant shareholder in the global companion diagnostics for oncology market and is anticipated to grow at a CAGR of 20.92% during the forecast period. The market growth in the Americas is due to the high prevalence rate of cancer and other chronic disorders and rising healthcare expenditure. The National Institutes of Health predicted that 1,735,350 new cancer cases were discovered in the US in 2018. Furthermore, the increasing number of healthcare organizations working on generated genomic databases to understand the human genome and growing research activities in this region using companion diagnosis kits are also driving the market growth.

• For instance, the National Human Genome Research Institute in Maryland, US, funds different programs and projects such as the undiagnosed diseases network (UDN), genotype-tissue expression project (GTEx), and many more to improve healthcare for future generations. Under these programs, the sample is collected from donors, and a vast database is generated to develop new drugs using different techniques such as CDx. The increasing R&D and number of cancer cases in this region are likely to increase the demand for companion diagnostics for oncology products, boosting the market growth in the Americas.

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Europe Market Trends

Europe is estimated to grow at a CAGR of 23.38% over the forecast period. The European market is anticipated to grow strongly during the forecast period due to the presence of numerous companies, expanding research and development activity into developing targeted drug therapy for cancer patients, and rising per capita income increasing the preference for personalized medicine. The European Journal of Cancer estimates that there were 1.9 million cancer deaths and about 3.9 million new cases in Europe in 2018. The rising cancer incidence supports the market growth in this area.

Additionally, the market is growing due to rising product releases and acceptance of companion diagnostics. For instance, Roche reported in August 2019 that Ventana PD-L1 (SP142) Assay, the first companion diagnostic to detect triple-negative breast cancer patients eligible for treatment with Tecentriq, had acquired European Market Authorization. The reimbursement policies for companion diagnostics for oncology tests also act as a driving factor and support market growth. Many companies offering CDx products and kits in this region boost the market growth. Abbott and F. Hoffmann-La Roche Ltd are some key manufacturing companies offering CDx products.

Asia-Pacific Market Trends

Asia-Pacific is expected to experience the fastest growth over the forecast period. The rapid growth of the Asia-Pacific regional market is due to the growing number of cancer patients and the growing presence of market players. According to the Global Cancer Observatory, around 1157294 cases of cancer were reported in India in 2018. Additionally, increasing research funding, rising investments by pharmaceutical and biotechnology companies, and growing awareness about personalized therapeutics in several Asia-Pacific countries are expected to drive the growth of the Asia-Pacific market.

In addition, countries like Korea and Japan are involved in adopting this technology and publishing guidelines for the use of CDx for the development of personalized medicines.

• For instance, Precision Medicine Asia is one of the largest cancer clinics providing a platform for innovative oncology therapies and diagnostics development in Asia, as well as technical and regulatory expertise in CDx development. Thus, the presence of such clinics and laboratories in Asian countries supports market growth.

In the Middle East and Africa, the companion diagnostics for oncology market in countries such as Kuwait, the UAE, and Saudi Arabia is likely to show steady growth due to increasing cancer cases, rising drug discovery, and increasing preference for personalized medicines. Furthermore, the growing number of hospitals and research laboratories and increasing investment by healthcare companies in this region drive the growth of CDx in the Middle East and African countries.

List of Key and Emerging Players in Companion Diagnostics for Oncology Market