Companion Diagnostics for Oncology Market Size & Outlook, 2025-2033

Companion Diagnostics for Oncology Market Overview

The global companion diagnostics for oncology market size was valued at USD 4.46 Billion in 2024 and is projected to grow from USD 5.48 Billion in 2025 to reach USD 28.27 Billion by 2033, exhibiting a CAGR of 22.77% during the forecast period (2025-2033). The rising incidence of cancer globally, growing demand for personalized medicine, and increasing adoption of assays, kits, reagents and PCR-based diagnostic technologies are key drivers for this steep growth in the global market.

Key Market Indicators

• North America dominated the companion diagnostics for oncology industry and accounted for a 44% share in 2024.
• Based on products and services, the assays, kits, and reagents segment dominated the market with the largest share of 66.1% in 2024. Driven by advancements in personalized medicine and the proliferation of high-quality test kits by major players.
• Based on technology, the polymerase chain reaction (PCR) segment held the leading share of the market in 2024 and is expected to expand at a CAGR of 20.27%, owing to its widespread use in generating precise genetic data and FDA-approved applications in oncology diagnostics.
• Based on indication, the breast cancer segment accounted for the highest share in 2024 and is forecasted to grow at a CAGR of 22.82%, supported by the high prevalence of breast cancer cases and favorable reimbursement for advanced diagnostic procedures.

Market Size & Forecast

• 2024 Market Size : USD 4.46 Billion
• 2033 Projected Market Size : USD 28.27 Billion
• CAGR (2025–2033) : 22.77%
• Largest market in 2024 : North America
• Fastest-growing region : Europe

Companion diagnostic (CDx) is a diagnostic testing kit majorly used by pharmaceutical companies for the development of personalized medicine. CDx tests provide information about the effective use of a corresponding therapeutic product by analyzing the genetic material. Doctors may also use them to alter the course of treatment because they can demonstrate how well a treatment works. With the rise in cancer prevalence and an increase in strategic initiatives, there has been a massive demand for companion diagnostics in the oncology area. Companion diagnostics for non-oncology tests are also gaining wide acceptance in the medical field. Significant drivers driving revenue growth in the companion diagnostics for oncology market include growing unmet medical needs, shifting healthcare sector dynamics, and increasing cancer occurrence globally.

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Market Drivers

Rising Preference for Personalized Medicine

Personalized or targeted medicine is one of the upcoming trends in medical innovation. It is one of the most significant fields that creates the need for companion diagnostics products. Healthcare providers are focusing on using companion diagnostics for targeted cancer drug development based on specific genetic biomarkers in significant fields of oncology. Personalized medicines are also used to treat diseases caused due to mutation in a specific gene by targeting the particular mutation. Further, the US FDA is collaborating with drug and device manufacturers to develop tests known as companion diagnostics to understand the positive and negative effects of a specific drug or therapy on the patient's body. 

The growing prevalence of cancer across the globe is increasing the preference for targeted therapy, affecting the demand for CDx tests. Additionally, healthcare organizations are involved in launching healthcare programs and platforms to develop better treatment options. The increasing R&D activity and different healthcare programs to support the development of personalized or companion diagnostics for targeted cancer drugs targeted medicine will increase the demand for companion diagnostic products in oncology.

Increasing Global Incidence of Cancer

Companion diagnostic tests are utilized for various cancer types to identify particular genetic/somatic abnormalities in patient samples that are candidates for targeted therapy. Cancer cases are increasing globally, eventually driving the oncology companion diagnostics market. For instance, the American Cancer Society estimated that in 2020, around 1.8 million people would be diagnosed with cancer in the United States.

Additionally, according to the American Cancer Society, there were 1.9 million cancer deaths and an estimated 3.9 million new cancer diagnoses in Europe in 2018. The most prevalent cancers on the continent were lung, prostate, colorectal, and breast cancers, accounting for about half of all cancer cases, accounting for up to 13%. These rising cancer cases all over the globe are driving the market for companion diagnostics in oncology.

Market Restraint

Lack of Reimbursement in Developing Regions

In most countries, delayed reimbursement or lack of funding for diagnostics acts as a critical barrier to market growth. Reimbursement for companion diagnostic tests is a complex process. The complexity of the reimbursement process itself acts as a challenge for this market. In molecular diagnosis, reimbursement is granted for the process or technology, not the value. In this process, a single test could necessitate several procedures, and occasionally the process repetitions make it difficult for the payer to grasp what they are paying. 

Additionally, the reimbursement is based on the current procedural terminology (CPT) code. The coding is challenging due to the use of different techniques for individual tests such as (e.g., immunohistochemistry, polymerase chain reaction, and fluorescence in situ hybridization), which increases the complexity. This complex coding structure can lead to insufficient reimbursements for some tests. The high cost of NGS-based CDx decreases the patient preference for the CDx test. Thus, the lack of reimbursement or low funding for diagnosis, especially cancer in developing countries, hamper the market growth.

Market Opportunity

Entry of Market Players into Emerging Economies

Developing economies pose an opportunity for various markets as they have undeveloped research and development sectors owing to which they are unable to address upcoming health challenges. Despite huge demand, the African region depends on imported medicines and other health technologies. Although there is a high requirement for treatment, poor economic conditions lead to the slow growth of the healthcare industry within the African region. Further, according to the global Cancer Observatory, there were around 1,055,172 new cancer cases in the African area in 2018. Additionally, due to cancer, 506,000 cancer deaths occurred in sub-Saharan Africa in 2018. Hence the rising need for the treatment of companion diagnostics for cancer in developing economies act as an opportunity for market growth.

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.

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. 

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.

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.

List of key players in Companion Diagnostics for Oncology Market

1. Qiagen N.V.
2. F. Hoffmann La Roche Ltd
3. Agilent Technologies
4. Thermo Fisher Scientific
5. Abbott
6. Amoy diagnostics
7. BioMérieux SA
8. Archerdx
9. Illumina, Inc.
10. Foundation Medicine, Inc.

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Recent Developments

• In September 2025 : The FDA moved to rescind the stricter oversight rule for LDTs after court decisions and stakeholder pushback. This rollback lowers near-term regulatory burden for many lab-developed companion tests and may slow the pace at which some labs convert LDTs into FDA-cleared/approved CDx products , with implications for access, innovation incentives, and payer negotiations.
• In April 2025 : FoundationOne®CDx was FDA-approved as a companion diagnostic for OJEMDA™ (tovorafenib) in pediatric low-grade glioma, marking the first CDx indication exclusively for children with BRAF alterations.
• In March 2025 : The U.S. court vacated FDA’s rule to regulate all lab-developed tests (LDTs) as devices, allowing oncology companion diagnostics (CDx) to continue as LDTs without mandatory premarket approval. This creates short-term flexibility for labs to innovate in liquid biopsy and biomarker assays, but uncertainty remains as drug labels often require FDA-approved CDx.
• In January 2025 : Thermo Fisher’s Oncomine Dx Target Test was FDA-approved as a companion diagnostic for HERNEXEOS (zongertinib) to identify NSCLC patients with activating HER2 mutations.