Oncology Companion Diagnostic Market Size & Share 2025 – 2034

Oncology Companion Diagnostic Market Size

The global oncology companion diagnostic market was estimated at USD 4.6 billion in 2024. The market is expected to grow from USD 5.1 billion in 2025 to USD 12.7 billion by 2034 at a CAGR of 10.8% during the forecast period.

Oncology companion diagnostics are a medical device, includes test or assay, to offer essential information for the safe and effective use of a corresponding drug or biological product in cancer treatment. Companion diagnostics helps to identify a specific genetic markers, mutations, and other biomarkers in patients tumor to determine if they are likely to respond to a particular therapeutic agent.
 

The global oncology companion diagnostic market is experiencing significant growth, driven by the increasing prevalence of cancer. For instance, according to the World Health Organization (WHO), an estimated 20 million new cancer cases were reported in 2022, resulting in approximately 9.7 million deaths. It is estimated that 53.5 million people were living within five years of a cancer diagnosis. Globally, about 1 in 5 individuals will develop cancer during their lifetime, with around 1 in 9 men and 1 in 12 women succumbing to the disease.
 

Thus, this statistics highlights the urgent need for advanced oncology companion diagnostics to identify patients suited for targeted therapies, improving outcomes and reducing side effects. With rising cancer rates and complexity, precision medicine guided by companion diagnostics is key to enhancing survival and quality of life globally.
 

Additionally, the growing demand for targeted therapies in oncology companion diagnostics is primarily driven by the rising adoption of precision medicine to improve cancer treatment outcomes. Traditional cancer treatments are now replaced by personalized approaches, where therapies are now tailored to patients specific tumor characteristics and individuals genetic profile. For instance, according to the study conducted in National Institute of Health (NIH) states that, in breast cancers, targeted therapies such as trastuzumab and lapatinib has shown effectiveness in treatment. Thus, this significantly improves progression-free survival. Furthermore, advancements in genomic technologies and increased investment in research and development are propelling market growth.
 

 Oncology Companion Diagnostic Market Trends

• Advancements in genomic technologies have transformed the field of oncology, which is estimated to reach USD 866.1 billion by 2032, mainly in the development of companion diagnostics (CDx). These innovations are enabling more precise and personalized treatment approaches by identifying genetic changes within tumors that can guide therapy selection.
   
• Next-generation sequencing (NGS) has become a key tool in cancer diagnostics, which enables us to identify the genetic mutations, gene fusions, and alterations in tumors. Thus, this helps in selecting targeted therapies and predicting patient responses to specific drugs. NGS platforms can analyze multiple genes simultaneously, offering a comprehensive genetic profile of tumors.
   
• For instance, in August 2024, Illumina's announced that FDA had approved its   TruSight Oncology Comprehensive test, a 500+ gene panel that rapidly matches patients to targeted therapies by identifying relevant genetic mutations and alterations.
   
• In addition, liquid biopsy is becoming popular because of its non-invasive way to detect tumor-derived genetic material (e.g., ctDNA, cfRNA) in blood. This is especially helpful for monitoring disease progression, detecting minimal residual disease, and identifying genetic mutations that could inform treatment decisions.
   
• For example, Guardant Health’s FDA approved Guardant360 CDx test, a liquid biopsy that provides results in less than 7 days to inform treatment decisions.  Guardant360 CDx has broad commercial and Medicare coverage for all advanced solid tumors.
   
• This technology allows for the analysis of gene expression profiles at the single-cell level, which offers deeper insights into tumor heterogeneity and resistance mechanisms. It can assist in the development of personalized therapies based on specific tumor cell populations.
   
• Moreover, artificial intelligence in healthcare (AI) and machine learning (ML) are being incorporated into genomic analysis to improve the interpretation of complex genetic data. Further, these technologies can identify novel biomarkers, and also helps in predicting treatment outcomes, and support drug discovery in oncology, thereby enhancing the personalization of patient care.
   

Oncology Companion Diagnostic Market Analysis

Based on offering, the market is segmented into product and services. Further, product segment is bifurcated into instrument, consumables, and software. The global market was estimated at USD 4.2 billion in 2023. The product segment held revenue of USD 3 billion in 2024 and the segment is poised for significant growth at a CAGR of 10.6% during the forecast period.
 

• Oncology companion diagnostic (CDx) instruments, such as next-generation sequencers (NGS), polymerase chain reaction (PCR) systems, and automated liquid handlers, offers supreme sensitivity and accuracy in detecting genetic mutations and biomarkers. These instruments allow multiplexing, allowing the immediate analysis of multiple biomarkers in a single run, thereby saving time and reducing costs.
   
• For example, in September 2024, QIAGEN N.V. launched QIAcuityDx Digital PCR System, which provides highly precise, absolute quantitation of target DNA and RNA, which supports applications with less invasive liquid biopsies. This PCR system also helps in monitoring cancer progression, complementing routine cancer diagnoses, which are performed by using next-generation sequencers (NGS).
   
• Additionally, the consumables used in oncology CDx include reagents, assay kits, primers, probes, and sample preparation materials. These consumables are specifically designed for specific tests to ensure accurate and reliable results. Further, pre-packaged and ready-to-use formats of consumables streamline lab processes, saving time and reducing the potential for technical errors.
   
• Moreover, the software used in oncology CDx plays a vital role in data analysis and interpretation of results. Advanced programs which are integrated with genomic, clinical, and imaging data, offers a thorough view of a patient’s disease profile. Artificial intelligence (AI) and machine learning (ML) algorithms inserted in the software helps to predict therapeutic responses, identify novel biomarkers, and streamline complex data interpretation, thereby driving the market growth.
   

Learn more about the key segments shaping this market

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Based on technology, the oncology companion diagnostic market is bifurcated into polymerase chain reaction (PCR), next-generation sequencing (NGS), immunohistochemistry (IHC), in situ hybridization (ISH)/fluorescence in situ hybridization (FISH), and other technologies. The polymerase chain reaction (PCR) segment accounted for a 34.2% market share in 2024 and is projected for significant growth to reach USD 4.5 billion by 2034.
 

• PCR systems are highly sensitive, efficient in detecting minute amounts of DNA or RNA from cancerous tissues or liquid biopsies. This specificity ensures accurate identification of genetic mutations or biomarkers associated with specific cancers.
   
• PCR processes are relatively fast, which provides results within hours. This quick turnaround is crucial for timely clinical decision-making in oncology.
   
• Additionally, innovations in PCR technologies such as digital PCR (dPCR) and real-time PCR (qPCR), which allows for the simultaneous detection of various cancer biomarkers in a single test. This improves efficiency and minimizes the overall cost and time-required for multiple individual tests.
   
• For instance, Bio-Rad’s second-generation QX200 Droplet Digital PCR System which  provides absolute quantification of target DNA or RNA molecules using EvaGreen or TaqMan Hydrolysis Probes.
• Additionally, PCR targeted a wide range of genetic alterations, including single nucleotide polymorphisms (SNPs), insertions, deletions, and gene fusions. This supports multiple applications, such as mutation detection, copy number variation analysis, and methylation profiling. Thus, these advantages are driving the market growth.
   

Based on disease type, the oncology companion diagnostic market is bifurcated into breast cancer, non-small cell lung cancer, colorectal cancer, leukemia, melanoma, prostate cancer, and other disease types. The breast cancer segment accounted for a 34.7% market share in 2024.
 

• The rising prevalence of the breast cancer is one of the key driver for the growth of the segment.
   
• For instance, as per the data from the American Cancer Society, in the U.S. it is projected that in 2025 around 316,950 women will be diagnosed from the invasive breast cancer, about 59,080 women will be diagnosed with ductal carcinoma in situ and approximately 42,170 women will die due to the breast cancer across the nation. Thus, as the diagnosis rate of breast cancer increases so does the need for effective diagnostic test kits in order to combat the disease.
   
• Additionally, CDx is used to detect HER2 (human epidermal growth factor receptor 2) overexpression or amplification. Patients with HER2-positive breast cancer are eligible for HER2-targeted therapies, such as trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
   
• Further, the rising awareness and the research relating to the breast cancer is positively influencing the segmental growth. For instance, across the world breast cancer month is observed in the month of October and the month is named as “Pink October”. During this month across the world various awareness program are conducted regarding the early screening and early diagnosis of the breast cancer. Such awareness program, necessitates the need for advance companion diagnostic kits and equipment, thereby propelling the market growth.
   

Based on end use, the oncology companion diagnostic market is bifurcated into hospitals, diagnostic laboratories, academic and research institutions, and other end users. The hospitals segment accounted for a 38.4% market share in 2024.
 

• The growth of the segment is owed to the ability of the hospital to manage large amount of cancer patients which includes both inpatient and outpatient. For instance, the Manipal Hospital of India, known as the second largest hospital chain in the nation annually see a 400,000 cancer patient visit to their hospital.
   
• By detecting predictive biomarkers, companion diagnostics allows hospitals to manage treatments that are more likely to succeed, minimizing side effects and improving overall survival rates. This personalized approach leads to better patient experiences and outcomes, fostering trust in hospital services.
   
• Additionally, with CDx advancements, hospitals offer liquid biopsy-based diagnostics, which uses blood samples to detect cancer biomarkers. This non-invasive approach is less risky and is more comfortable for patients, particularly for those unable to undergo traditional tissue biopsies, further driving market growth for oncology companion diagnostic.
  
   

• The increasing prevalence of the cancer in the U.S. in the key driver for the growth of the market in the U.S.
   
• For instance, as per the data from the American Cancer Society in 2025, around 2,041,910 new cases of cancer are to be diagnosed, and 618,120 cases of cancer related deaths is projected to occur in the U.S.
   
• Additionally, the U.S. Food and Drug Administration (FDA) has implemented rigorous standards for companion diagnostic, escalating the development of new diagnostic kits and instruments in the U.S. with enhanced safety, efficacy, and stability to meet the growing demand for effective treatments.
   

Europe: The oncology companion diagnostic market in UK is expected to experience significant and promising growth from 2025 to 2034.
 

• The UK government is heavily investing in the oncology research, treatment advancement, and in early detection programs.
   
• For instance, in 2022, as per the data from University of Oxford, the Cancer Research UK had invested around EUR 11 million in the cancer science research in Oxford.
   
• Thus, these investment is predicted to stimulate innovative discovery in the research pertaining to cancer and enhance early diagnosis, accelerating the market growth in the country.
   

Asia Pacific: Japan oncology companion diagnostic market is anticipated to witness lucrative growth between 2025 – 2034.
 

• The country has one of speediest aging population which necessities frequent health monitoring. For instance, according to the World Health Organization, in 2021, Japan's elderly population, aged 65 and above, comprised 29.1% of the total population. This demographic shift has led to a rise in age-related diseases, with cancer as the leading cause of death, accounting for 27% of all fatalities in Japan, as reported by the National Cancer Center Japan in 2022.
   
• Thus, this increasing disease burden has surged the demand for effective targeted therapies, escalating the growth of the companion diagnostic in Japan.
   
• Hence, as the population ages in the country so does the chances of cancer, thereby fostering the market growth in the country.
   

Middle East and Africa: The oncology companion diagnostic market in Saudi Arabia is expected to experience significant and promising growth from 2025 to 2034.
 

• Saudi Arabia has experienced an increase in early cancer detection due to growing awareness and improved screening programs. This trend promotes earlier treatment and heightens the demand for oncology  companion diagnostic services.
   
• Further, Saudi Arabia’s advance healthcare infrastructure and rising investment in advanced healthcare technologies create opening for the development and adoption of advanced oncology companion diagnostic tailored to the country’s patient specific needs.
   

 Oncology Companion Diagnostic Market Share

The top 4 players of the market account for approximately 45% of the market share which includes companies such as Abbott Laboratories, F. Hoffmann-La Roche, Illumina, Thermo Fisher Scientific, among others. With every firm introducing new products such as instruments, kits, assay and using advanced technologies, modernization is extremely important. Moreover, strategic partnerships with research institutes, and government agencies play a primary role in advancing the development of new products and getting the necessary permits. The enhancement of public awareness about cancer and its health impact through the social media platform, will encourage more individuals to seek the treatment, assisting market players to strengthen their position in this growing sector.
 

 Oncology Companion Diagnostic Market Companies

Some of the eminent market participants operating in the oncology companion diagnostic industry include:

• Abbott Laboratories
• Agilent Technologies
• BioMérieux
• Biocartis
• Bio-Rad Laboratories
• EntroGen
• F. Hoffmann-La Roche
• Foundation Medicine
• Guardant Health
• Illumina
• Leica Biosystems
• Myriad Genetics
• QIAGEN
• Sysmex Corporation
• Thermo Fisher Scientific
   
• Agilent Technologies has robust geographical presence which enables it to enhance its market reach. Agilent Technologies operates in more than 110 countries thus comprising of a strong distribution network.
   
• F. Hoffmann-La Roche Ltd has strong global workforce of approximately 100,000+ employees, which enables the company to drive innovation, and deliver high-quality solutions.
   

Oncology Companion Diagnostic Industry News:

• In January 2024, Agilent Technologies Inc. partnered with Incyte to leverage its expertise in companion diagnostics (CDx) to support the development and commercialization of Incyte's hematology and oncology therapies. This collaboration boosted Agilent’s position in the growing precision medicine market, expanding its portfolio in oncology market.
   
• In June 2022, Biocartis Group partnered with AstraZeneca to develop a novel companion diagnostic test using its Idylla platform for use with AstraZeneca's Tagrisso treatment. This collaboration increased Biocartis' position in diagnostics, and also expanded its portfolio, and provided access to AstraZeneca’s oncology network in the global diagnostics market.
   

The oncology companion diagnostic market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Offering

• Product
  • Instrument
  • Consumables
  • Software
• Services

Market, By Technology

• Polymerase chain reaction (PCR)
• Next-generation sequencing (NGS)
• Immunohistochemistry (IHC)
• In situ hybridization (ISH)/fluorescence in situ hybridization (FISH)
• Other technologies

Market, By Disease Type

• Breast cancer
• Non-small cell lung cancer
• Colorectal cancer
• Leukemia
• Melanoma
• Prostate cancer
• Other disease types

Market, By End Use

• Hospitals
• Diagnostic laboratories
• Academic and research institutions
• Other end use

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America 
• Brazil
  • Mexico
  • Argentina
• Middle East and Africa 
  • South Africa
  • Saudi Arabia
  • UAE