1 Global Precision Cancer Diagnostic Tests Market Insight Analysis
The global Precision Cancer Diagnostic Tests market will be valued at USD 6,821 million in 2025, with a CAGR of 5.57% from 2025 to 2033.
Precision cancer diagnostic tests are designed to detect cancer at an early stage, monitor disease progression, and guide personalized treatment plans. These tests leverage advanced technologies such as imaging, molecular diagnostics, histology/cytology, tumor marker immunoassays, and point-of-care (POC) tests.
Figure Global Precision Cancer Diagnostic Tests Market Size (M USD) and CAGR (2025-2033)
2 Precision Cancer Diagnostic Tests Market Growth Drivers and Restraints
The growth of demand for precision medicine and the trend of personalized treatment
With the development of genomics and molecular biology, precision medicine has become the core direction of cancer treatment. Precision cancer diagnostic tests provide key evidence for personalized treatment by analyzing patients’ genes, proteins and other biomarkers, such as the suitability assessment of targeted therapy and immunotherapy. For example, Foundation Medicine’s FoundationOne CDx test can analyze multiple biomarkers at the same time to help doctors choose the best treatment plan. In addition, the rising incidence of cancer worldwide (such as 9.6 million cancer deaths worldwide in 2018) has led to a surge in demand for early detection and precision diagnosis, driving market expansion.
Technological progress and innovation in detection methods
Imaging technology upgrades: For example, Siemens’ PET/CT system improves the early detection rate of cancer through high-resolution imaging, and GE Healthcare’s 3D breast mammography technology can reduce the false positive rate.
Molecular diagnosis and liquid biopsy: Liquid biopsy (such as Exosome Diagnostics’ urine test) has gradually replaced traditional tissue biopsy due to its non-invasive advantages, and is suitable for cancer screening and efficacy monitoring.
High-throughput sequencing and AI integration: Illumina’s NGS technology and Cynvenio Biosystems’ AI analysis platform improve detection efficiency and accuracy, such as interpreting cancer markers in the blood through AI to optimize the diagnostic process.
Policy support and market demand expansion
Governments of various countries promote precision medicine programs, such as China’s “Precision Medicine Program” and the United States’ Cancer Moonshot Program, and accelerate technology transformation through financial investment and policy support.
Increased healthcare spending: North America and Europe dominate the market due to high medical budgets (North America accounted for 30.68% in 2020), while the Asia-Pacific region (such as China and India) has a large population base and economic development, and demand has increased significantly (China’s CAGR from 2020 to 2026 reached 9.12%).
Diversification of market participants and product innovation
Head companies such as Danaher and General Electric have consolidated their market position through product line expansion (such as pathology section automation and image analysis systems), while small and medium-sized enterprises focus on niche areas (such as Vela Diagnostics’ colorectal cancer NGS testing) to promote market diversification.
High cost and accessibility challenges
Precision diagnostic technologies (such as NGS, PET/CT) are expensive and difficult to popularize in developing countries. For example, primary hospitals may not be able to afford high-end imaging equipment, resulting in an imbalance in urban and rural medical resources. In addition, the lack of medical insurance coverage for testing costs and the high proportion of patients paying out of pocket limit market penetration.
Technical complexity and lack of standardization
The interpretation of results of different testing methods (such as immunohistochemistry and molecular testing) relies on professional pathologists and has subjective biases.
The lack of unified quality control standards around the world leads to poor comparability of test results. For example, the threshold setting for tumor marker testing varies from laboratory to laboratory, affecting diagnostic consistency.
Regulatory barriers and long approval cycles
Precision diagnostic products need to pass strict regulatory approval (such as FDA and CE certification), which is complex and time-consuming. For example, companion diagnostic reagents need to be developed simultaneously with targeted drugs to extend the time to market. The regulatory framework for emerging technologies (such as AI-assisted diagnosis) is not yet clear, which may delay the commercialization process.
Intense market competition and profit margin pressure
The market is highly fragmented, and leading companies (the top three account for 36.42% of the market share) face low-price competition from small and medium-sized manufacturers, especially in the low-end market. In addition, patent expiration and generic drug competition squeeze the profit margins of innovative companies, such as Myriad Genetics’ genetic testing patent dispute, which affects market exclusivity.
3 Technological Innovations in the Precision Cancer Diagnostic Tests Market
Multimodal diagnosis and liquid biopsy technology breakthroughs
Multi-omics integration: Combining genomic, proteomic and imaging omics data, such as NanoString’s GeoMx platform to achieve spatial proteomic analysis, improve the accuracy of tumor microenvironment research.
Popularization of liquid biopsy: GRAIL’s Galleri multi-cancer early screening blood test can detect more than 50 types of cancer at the same time, improve early detection rate through methylation analysis, and reduce unnecessary biopsies.
Artificial intelligence and digital transformation
AI-assisted imaging diagnosis: For example, the AI breast imaging analysis system developed by Hologic and RadNet reduces the missed diagnosis rate and improves screening efficiency through deep learning.
Digital pathology platform: Leica Biosystems’ Aperio GT 450 DX scanner realizes the digitization of pathology sections, supports remote diagnosis and big data analysis, and accelerates the application of telemedicine, especially during the epidemic.
Portability and point-of-care testing (POCT)
Vela Diagnostics’ Sentosa® platform shortens testing time through automated processes and is suitable for cancer screening in resource-limited areas. For example, POCT testing for colorectal cancer can be completed at primary care sites without relying on central laboratories.
Co-development of companion diagnostics and therapies
Roche’s VENTANA HER2 test is used in combination with the targeted drug Herceptin to accurately screen patients for benefits through companion diagnostics, promote the “drug + testing” integrated model, and become an industry standard.
Horizontal expansion of leading companies
Danaher: Through the acquisition of Leica Biosystems, it integrates the full-process pathology solution and strengthens the integrated layout from tissue processing to diagnosis. In 2020, its market share reached 13.90%, ranking first.
Siemens Healthineers: Acquired Varian Medical to expand the linkage between radiotherapy and diagnosis, build an “imaging-treatment” closed loop, and enhance the full-cycle service capabilities of tumor diagnosis and treatment.
Vertical integration of technology-based enterprises
Exact Sciences (acquisition of Genomic Health): By integrating Oncotype DX® gene testing products, it enhances its competitiveness in the field of breast cancer prognosis assessment and expands the liquid biopsy market.
**Thermo Fisher Scientific (proposed acquisition of Qiagen)**: Although it was not successful, it showed a strategic intention to enhance molecular diagnostic capabilities through mergers and acquisitions, especially in the synergy of NGS and sample preparation.
Strategic cooperation of emerging enterprises
Foundation Medicine cooperates with pharmaceutical companies: jointly develops companion diagnostics for KEYTRUDA with Merck to accelerate patient screening for PD-1 inhibitors, reflecting the “diagnosis-drug” collaborative innovation model.
Layout of Chinese enterprises: For example, BGI has increased its international market share through mergers and acquisitions of overseas companies (such as CGI), and at the same time cooperated with multinational pharmaceutical companies to promote the export of local precision diagnostic technology.
Small and medium-sized enterprises focus on niche areas
For example, Cynvenio Biosystems (now renamed LungLife AI) focuses on liquid biopsy for lung cancer, analyzes blood markers through AI, enters the clinical market after obtaining CLIA certification, and attracts venture capital to support technology transformation.
4 Global Precision Cancer Diagnostic Tests Market Size by Type
Imaging – based precision cancer diagnostic tests had a market revenue of 3491.91 million USD in 2025, accounting for 51.19% of the total market share. This type encompasses a wide range of technologies such as X – rays, computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET). These imaging modalities are crucial for visualizing tumors, determining their size, location, and extent of spread within the body.
For example, CT scans can provide detailed cross – sectional images of internal organs, helping doctors detect cancerous growths early. MRI is particularly useful for soft – tissue imaging, which is essential for diagnosing cancers in the brain, breast, and other soft – tissue organs. PET scans, on the other hand, can identify areas of abnormal metabolic activity, which may indicate cancer cells.
Molecular diagnostic tests for precision cancer had a revenue of 1918.71 million USD, holding a market share of 28.13%. These tests analyze the genetic and molecular characteristics of cancer cells. Techniques like polymerase chain reaction (PCR), gene sequencing, and fluorescence in – situ hybridization (FISH) fall under this category. Molecular diagnostics play a vital role in personalized medicine, as they can identify specific genetic mutations in cancer cells. This information is used to select targeted therapies that are more effective for individual patients. For instance, identifying a particular gene mutation in lung cancer patients can help determine if they are eligible for a specific targeted drug treatment.
Histology and cytology tests had a market revenue of 825.57 million USD in 2025, with a market share of 12.10%. Histology involves the examination of tissue samples obtained through biopsy to determine the type of cancer and its grade. Cytology, on the other hand, focuses on the study of individual cells, often obtained from body fluids or scrapings. These tests are fundamental in cancer diagnosis, providing a microscopic view of the tissue or cells to confirm the presence of cancer and assess its characteristics. Pathologists use these tests to make critical decisions regarding treatment plans.
Tumor marker immunoassays had a market revenue of 352.25 million USD, accounting for 5.16% of the market share. These tests detect specific proteins or other substances (tumor markers) in the blood or other body fluids that are associated with cancer. While tumor markers are not always conclusive for cancer diagnosis on their own, they can be useful in screening, monitoring the effectiveness of treatment, and predicting the recurrence of cancer. For example, the prostate – specific antigen (PSA) test is commonly used to screen for prostate cancer.
Point – of – care (POC) colon cancer tests had a market revenue of 232.55 million USD in 2025, with a market share of 3.41%. These tests are designed to provide rapid results at the point of care, such as in a doctor’s office or a clinic. They are convenient for patients and can help in early detection of colon cancer. Some POC colon cancer tests may use fecal occult blood testing or other innovative techniques to quickly identify potential signs of colon cancer.
Table Global Precision Cancer Diagnostic Tests Market Size and Share by Type in 2025
Type | Market Size (M USD) 2025 | Market Share 2025 |
|---|---|---|
Imaging | 3491.91 | 51.19% |
Molecular | 1918.71 | 28.13% |
Histology/Cytology | 825.57 | 12.10% |
Tumor Marker Immunoassays | 352.25 | 5.16% |
POC Colon Cancer Tests | 232.55 | 3.41% |
5 Global Precision Cancer Diagnostic Tests Market Size by Application
Among different applications, hospitals play a dominant role. The market revenue of precision cancer diagnostic tests in hospitals amounts to 4673.08 million USD, accounting for 68.51% of the total market share. Hospitals are the primary providers of cancer diagnosis services. They are equipped with advanced diagnostic facilities and professional medical teams, which makes them the preferred choice for patients seeking comprehensive cancer diagnosis. Moreover, hospitals often conduct research and clinical trials related to cancer diagnosis, further strengthening their position in the market.
Clinics also hold a significant portion of the market. The revenue from precision cancer diagnostic tests in clinics is 1962.59 million USD, taking up 28.77% of the market share. Clinics offer more accessible and sometimes more cost – effective diagnostic services compared to large hospitals. They are often located in more convenient areas for local patients, and some specialized clinics have developed expertise in certain types of cancer diagnosis, attracting patients who prefer a more focused and possibly quicker diagnostic experience.
Table Global Precision Cancer Diagnostic Tests Market Size and Share by Application in 2025
Application | Market Size (M USD) 2025 | Market Share 2025 |
|---|---|---|
Hospital | 4673.08 | 68.51% |
Clinic | 1962.59 | 28.77% |
Other | 185.33 | 2.72% |
6 Global Precision Cancer Diagnostic Tests Market Size by Region
North America leads the pack, with a market revenue of 1985.92 million USD in 2025. This region has long been at the forefront of medical innovation. It benefits from a well – developed healthcare infrastructure, high levels of research and development investment, and a relatively high awareness of advanced cancer diagnostic technologies among both healthcare providers and patients. The presence of major pharmaceutical and medical device companies, along with extensive clinical research facilities, has propelled North America to dominate the market.
Europe follows closely, with a market revenue of 1847.44 million USD. European countries have a strong tradition of high – quality healthcare systems. Stringent regulatory frameworks ensure the safety and efficacy of diagnostic tests, which in turn builds trust among patients. Moreover, collaborative research initiatives across European nations have facilitated the development and adoption of precision cancer diagnostic technologies. However, differences in economic development and healthcare spending among European countries can lead to some disparities in the adoption rate of these tests.
China has been rapidly emerging as a significant player in the global precision cancer diagnostic tests market. In 2025, its market revenue is estimated at 1123.30 million USD. The Chinese government’s increasing investment in healthcare, coupled with a growing awareness of early cancer detection among the population, has spurred the growth of this market segment. Additionally, the country’s burgeoning biotechnology and medical device industries are driving innovation, making precision cancer diagnostic tests more accessible and affordable within China and potentially for export.
Japan, with a market revenue of 503.52 million USD in 2025, has a highly advanced healthcare system. Japan’s focus on technological innovation in the medical field, along with its aging population (which has a higher prevalence of cancer), has contributed to the demand for precision cancer diagnostic tests. The country’s strict quality control measures and high – level expertise in medical research ensure the reliability of these tests.
Southeast Asia, with a market revenue of 136.63 million USD, is in a growth phase. As economies in the region develop, there is an increasing demand for better healthcare services, including advanced cancer diagnostics. However, challenges such as limited healthcare infrastructure in some areas and affordability issues still need to be addressed to fully realize the potential of the precision cancer diagnostic tests market.
India, with a market revenue of 449.92 million USD, has a large population base. The rising incidence of cancer in India, combined with growing awareness and improving healthcare access, is driving the demand for precision cancer diagnostic tests. The government’s initiatives to boost the domestic healthcare industry are also playing a role in promoting the adoption of these tests.
Central & South America, with a market revenue of 247.94 million USD, has been making progress in improving its healthcare services. However, economic and infrastructural challenges remain. Some countries in the region are working on increasing their investment in cancer diagnostics, but progress is gradual due to budget constraints and a need for more skilled medical personnel.
Figure Global Precision Cancer Diagnostic Tests Market Size (M USD) by Region in 2025
7 Global Precision Cancer Diagnostic Tests Market Analysis by Major Players
Danaher Corporation
Company Profile: Danaher Corporation, established in 1969 and headquartered in the USA, is a leading science and technology innovator that designs, manufactures, and markets professional, medical, industrial, and commercial products and services. The company serves customers in more than 100 countries and is known for its strong presence in the precision cancer diagnostic tests market.
Business Overview: Danaher operates in diverse sectors including life sciences, diagnostics, environmental solutions, and applied chemical markets. The company’s commitment to innovation and quality has made it a key player in the medical technology field. Danaher’s subsidiaries, such as Leica Biosystems, contribute significantly to the cancer diagnostics market with advanced solutions.
Product Offered: Danaher Corporation offers a range of precision cancer diagnostic tests, including the Bond Oracle HER2 System, which is a fully automated assay for determining HER2 oncoprotein status in breast cancer tissue. This system is designed to improve workflow efficiency and diagnostic confidence, providing accurate and consistent results that aid in assessing patients for Herceptin® treatment.
General Electric Company (GE)
Company Profile: Founded in 1892, General Electric Company (GE) is headquartered in the USA and operates worldwide. GE is a multinational conglomerate with businesses across aviation, energy, healthcare, and capital, among others. In the healthcare sector, GE is renowned for its medical technologies and digital solutions.
Business Overview: GE Healthcare, a segment of GE, provides medical technologies, digital infrastructure, data analytics, and decision support tools that assist healthcare professionals in diagnosing, treating, and monitoring their patients. GE’s Edison intelligence platform supports these technologies, aiming to digitize healthcare and improve patient outcomes.
Product Offered: GE offers a broad range of advanced imaging solutions for diagnostic workups, including Contrast Mammography, Seno Iris GE Mammography Solution, and SIGNA™ Architect AIR™ Edition. These products are designed to visualize various breast lesions and tissue, supported by workstations like Seno Iris, which features unique CAD and navigation tools for effective review of large datasets.
Siemens AG
Company Profile: Siemens AG, established in 1847 and headquartered in Germany, is a global technology powerhouse with a strong presence in the medical technology sector. Siemens operates in America, Europe, and Asia, serving customers worldwide with its innovative healthcare solutions.
Business Overview: Siemens Healthineers, a division of Siemens, focuses on empowering healthcare providers to deliver precision medicine, transform care delivery, and enhance patient experience through digitalizing healthcare. Siemens holds over 120 years of experience in medical technology and boasts over 18,500 patents globally.
Product Offered: Siemens provides a suite of precision cancer diagnostic tests, including syngo.via for image reading and reporting. This advanced visualization software is designed for both routine and challenging cases, offering 3D reading, modality-specific applications, structured reporting (like Lung-RADS™), and a server-client concept for efficient management.