Market Introduction

The global precision oncology diagnostics market was valued at USD 110 billion in 2024 and grew at a CAGR of 8% from 2025 to 2034. The market is expected to reach USD 237.48 billion by 2034. The increasing incidence and prevalence of cancer will drive the growth of the global precision oncology diagnostics market.

Precision oncology diagnostics involves testing a cancer patient’s genes, molecules and cells to find the best treatment. Unlike previously available cancer drugs, precision oncology uses personal information about a tumour to choose treatments that work more effectively while sparing patients from possible side effects. Most modern precision oncology techniques such as next-generation sequencing (NGS) and polymerase chain reaction (PCR), rely on molecular profiling. Clinicians use these tools to spot genetic changes, gene expression, epigenetic effects and biomarkers that contribute to cancer. Detecting changes in BRCA1/2, EGFR or KRAS genes can show if a patient will benefit from targeted treatment or immunotherapy. In precision oncology, companion diagnostics mean tests that help decide whether a person is suitable for a certain drug. With this way of working, the correct drugs are provided to the correct patients when needed, making the most of efforts and avoiding pointless treatments. Matching bioinformatics technology with artificial intelligence has improved the precision of oncology. The use of these technologies makes it possible to review genomic data rapidly and accurately for clinical analysis. Advances in precision oncology diagnostics are improving cancer care by helping catch the disease early, giving accurate predictions and watching how the patient responds to treatment.

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Recent Development

• The JITO Incubation and Innovation Foundation (JIIF) and Rebalance Angels have closed their pre-seed fundraising round for Akrivia Biosciences, a deep-tech firm in oncology precision diagnostics based in Mumbai. This money will be used for scientific publications that support its ground-breaking cancer therapy breakthroughs, Proof of Concept trials, and the establishment of an internal R&D team. Akrivia Biosciences' next-generation molecular subtyping tests are transforming the diagnoses of cancer. Akrivia is revolutionising cancer treatment by using a multi-omics method to give doctors accurate and thorough data to inform tailored treatments. This breakthrough is changing the way cancer is identified and treated, decreasing overtreatment, and increasing patient outcomes.

Market Dynamics

Drivers

The rising incidence of cancer worldwide and technological advancements – The reasons behind increased demand for precision oncology diagnostics have to do mainly with the increasing incidence and prevalence of cancer worldwide, new technological developments and industry changes. A major reason for this is that NGS technology has now made acquiring accurate genetic information faster, comprehensive and more affordable. Doctors can identify particular genetic mutations and biomarkers that help choose the right therapy for each person’s cancer because of these new techniques. AI and bioinformatics are now being integrated into the ways laboratories diagnoses diseases. They support the study of difficult genomic information, resulting in quicker, accurate and more reliable diagnoses. AI helps create predictions and offers tailored advice for diagnosis which adds more value to precision diagnostics. Targeted therapies and companion diagnostics are becoming more available and popular which is fuelling the demand for targeted cancer medicines. Additionally, less invasive techniques such as liquid biopsy, are changing the way diagnostics are carried out. Using these devices, changes in cancer and its response to treatment can be quickly detected with simple blood tests, so surgery is needed less often and diagnostics are simpler for patients. The combination of advances in diagnostics, use of AI and changes in oncology practice is leading to a rapid growth in demand for precision oncology diagnostics.

Restraints

High costs, technical and operations hurdles associated with precision oncology diagnostics – A major obstacle is that many precision diagnostic tests are expensive. Technologies such as NGS and whole-genome profiling are associated with expensive equipment, chemicals and trained staff making it hard for both healthcare providers and patients to use them, especially in developing countries. Data interpretation can also be extremely complicated. Since precision oncology produces a huge volume of genetic and molecular data, it must be analysed by expert professionals and advanced computer tools. Yet, many clinicians find it hard to use these new tools since the training is often unavailable or restricted, resulting in unclear choices about treatment or not using test results to the fullest. In some cases, even with precise diagnostics, the usefulness for clinical treatment is not well defined. Although these drugs are very effective for lung, breast and melanoma cancers, many other forms of cancer do not have useful biomarkers or approved targeted treatments. Because of this, there are doubts about how widely these tests are useful. Since standards and validation are lacking in lab equipment and solutions, the adoption is even more difficult. Using different measures and methods for testing, preparing results and understanding findings often results in inconsistency and can reduce doctors’ confidence when planning treatments.

Opportunities

Increasing healthcare investment and supportive regulatory framework – the rising incidence and prevalence of cancer worldwide has led to a strong demand for better and faster ways to diagnose and treat patients. Healthcare providers are turning more often to precise oncology diagnostics to detect cancer in early stages and offer effective personalized treatments given the rising number of cancer patients. In addition, there is now a shift globally toward personalized medicine, as patients, medical professionals and policymakers realize the benefits of personal care plans over the same care for all. The government and private companies are playing an important role too. government funding, supportive laws and regulations and help from private entities is fostering an environment for the growth of precision oncology diagnostics globally. furthermore, the rising awareness about cancer, the importance of early screening and the availability of modern medicine in the general populace is also driving the market’s growth. Because patients are now more aware of different medical technologies and remedies, they are more interested in getting treatments designed specifically for them. Increased health care spending and expanded medical facilities in developing countries are giving new opportunities to precision oncology diagnostics. They are increasing their use of advanced testing, helping spread the use of personalized cancer treatment worldwide.

Segment Analysis

Regional segmentation analysis

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America emerged as the most significant global precision oncology diagnostics market, with a 40% market revenue share in 2024.

This region has a developed healthcare system, supported by well-known hospitals, doctoral research entities and advanced diagnostic laboratories. A key reason North America leads is the huge investment in research and development made by both government and private companies. In the United States, much of the world’s financial support for precision medicine is concentrated on NGS, identifying biomarkers and improving companion diagnostics. Thanks to its powerful research and development community, it’s possible to create and commercialize new diagnostic tests driving the regional market’s growth. The region is aided by regulations that make it faster and easier for precision oncology diagnostics to get approval and become available. On top of this, having many cases of cancer and more people aware of their health is why demand for new kinds of diagnostics and targeted drugs is rising.

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• Spesana's best-in-class portfolio of clinical collaboration, patient navigation, and oncology clinical decision support tools was acquired by Aranscia, a global provider of award-winning clinical workflow and diagnostic technology solutions. Carla Balch, the founder and CEO of Spesana and a well-known pioneer in the fields of healthcare and oncology information systems, will take on the position of Executive Director for all Aranscia software products as part of the acquisition. Managing Spesana's ongoing technological and commercial growth is part of this.

Technology Segment Analysis

The technology segment is divided into Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH), Immunohistochemistry (IHC), Microarray and others. The Next-Generation Sequencing (NGS) segment dominated the market, with a market share of around 37% in 2024. NGS is leading the way in precision oncology diagnostics given its unique high-throughput genome analysis. NGS is different from PCR and microarrays because it can test hundreds of thousands of fragments in one look, uncovering mutations and biomarkers in different genes all at the same time. The importance of this capacity appears in oncology, as spotting many forms of genetic changes helps doctors choose the best targeted treatments. Scalability and speed are among the main benefits of NGS. Improvements in sequencing technology and lower costs make it more accessible and affordable, thereby by making NGS more popular in both hospital and laboratory settings. Its versatility enables it's use with tissue biopsies and blood samples which makes it helpful for both diagnosis and progress monitoring. NGS helps oncologists decide if patients are eligible for the targeted drugs designed for their disease. It also helps find biomarkers and develop individualized treatments. The use of NGS together with advanced bioinformatics and AI technology helps clarify complex data, increase the accuracy of diagnosis and support clinical trials. Basically, NGS is dominant in this market because it has extensive features, is becoming cheaper and ensures cancer can be treated in a personalized way. Its ongoing development will probably maintain its strength in oncology, making care more effective and adapted to individual patients.

• In order to introduce Stratipath Breast, an AI-based prognostic risk profile tool, to healthcare practitioners in the UK and Europe, Diagnexia has partnered with Stratipath AB. Through this partnership, Diagnexia's digital pathology network and Stratipath's technology are combined to provide quicker and more accurate cancer diagnosis. The collaboration seeks to enhance the process of choosing treatments for breast cancer. Stratipath Breast classifies tumours into high- and low-risk groups by analysing standard H&E-stained slides. It lowers expenses and makes precision oncology more accessible by producing quick results in less than an hour. In order to improve workflow efficiency and assist clinicians in making treatment decisions, Diagnexia intends to broaden the application of AI-based diagnostics.

Application Segment Analysis

The application segment is divided into biomarker discovery, companion diagnostics, prognostics, monitoring and recurrence and early detection and screening. The biomarker discovery segment dominated the market, with a market share of around 35% in 2024. The importance of personalized cancer care and targeted therapy development makes biomarker discovery the leading technology in this market. Biomarkers are molecules found in our biology—such as genes, proteins or mutations—that mark the beginning, changes or details of cancer. Discovering trustworthy biomarkers helps in understanding cancer, predicting therapy effects and guiding medicine in choosing clinical approaches. Enhancing cancer diagnosis, prognosis and choosing the best treatment are the main reasons why biomarker discovery is so important. The use of high-throughput methods such as next-generation sequencing and proteomics, has greatly improved the way biomarkers are discovered in tumours. Moreover, discovering biomarkers helps produce companion diagnostics which are necessary to find the best targeted therapies and immunotherapies for patients. In addition, studying biomarkers makes it possible to detect and monitor cancer at an earlier stage, so treatment can be given sooner. Biomarker discovery is a major priority for pharmaceutical and research groups, as they believe it improves their performance and advances innovation in cancer medicine.

• Ataraxis AI, a medical technology business based in New York, has announced $4 million in seed funding, coming out of stealth mode. The startup is focused on creating cancer diagnostics powered by artificial intelligence (AI) that can assist doctors in determining the best course of treatment for their patients and forecasting their prognosis. Ataraxis launched its first test, Ataraxis Breast, concurrently with the announcement of its launch and seed funding. According to the business, this is the first AI-native prognostic/predictive test for breast cancer in the world.

Cancer Type Segment Analysis

The cancer type segment is divided into lung cancer, breast cancer, colorectal cancer, prostate cancer, leukemia and others. The lung cancer segment dominated the market, with a market share of around 34% in 2024. Lung cancer is the number one reason for the growth of precision oncology diagnostics because it is commonly found, has a high death rate and strongly requires personalized treatments. Due to the variation between lung tumours, it is important to have precise diagnostics because they let doctors find the unique genetic changes and chemical markers that drive treatment plans. Moreover, the market for oncology is dominated by lung cancer since there are many molecular targets, for which some targeted therapies have been approved. Additionally, there is a strong need for improved ways to diagnose and treat lung cancer which drives substantial funding from the pharmaceutical sector, research groups and healthcare providers to improve precision oncology diagnostics.

End-User Segment Analysis

The end-user segment is divided into hospitals & clinics, diagnostic laboratories, academic & research institutes and biopharmaceutical companies. The hospitals & clinics segment dominated the market, with a share of around 38% in 2024. Hospitals and clinics, as the main providers of cancer care, take up the largest share of users in the precision oncology diagnostics market. They are key places where cancer patients are diagnosed, have their treatment outline created and are monitored over time, so precision diagnostics can happen there. Advanced testing equipment in extended care allows oncologists to review full genetic and molecular information about patients before making treatment decisions. An important reason why cancer care is so effective is that qualified experts including oncologists, pathologists and genetic counsellors cooperate closely in hospitals and clinics. By uniting all kinds of expertise, it becomes possible to better explain test results and choose treatments which leads to improved results for patients. Besides, hospitals and clinics generally have what it takes to carry out precision diagnostics themselves or arrange such testing with specialized laboratories. As people learn more about how effective personalized medicine can be, hospitals and clinics are adding new technologies and training to make these tests part of their routine work. Regulatory and insurance rules generally benefit practicing precision diagnostics in hospitals, leading doctors to provide these services as part of treating cancer.

Some of the Key Market Players

• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Exact Sciences Corporation
• Foundation Medicine, Inc. (a Roche company)
• Freenome Holdings, Inc.
• Guardant Health, Inc.
• Illumina, Inc.
• Myriad Genetics, Inc.
• Personalis, Inc.
• QIAGEN N.V.
• Roche Diagnostics
• Thermo Fisher Scientific Inc.

Report Description

• Market Introduction
• Market Dynamics
• Segment Analysis
• Some of the Key Market Players