Oncology Molecular Diagnostics Market
Report ID: SQMIG35A3002
Report ID: SQMIG35A3002
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Report ID:
SQMIG35A3002 |
Region:
Global |
Published Date: May, 2025
Pages:
187
|Tables:
129
|Figures:
77
Global Oncology Molecular Diagnostics Market size was valued at USD 2.76 Billion in 2024 and is poised to grow from USD 3.08 Billion in 2025 to USD 7.4 Billion by 2033, growing at a CAGR of 11.6% during the forecast period (2026–2033).
The market for oncology molecular diagnostics is growing very quickly as there is increasing demand for personalized medicine and an increased global burden of cancer. Because molecular diagnostics enable early tumour profiling and well-informed treatment selection, they are vital to the treatment of cancer. Physicians are able to identify specific genetic mutations and biomarkers that impact the progression of cancer and therapy response owing to the technological advancements in next-generation sequencing (NGS), polymerase chain reaction (PCR), and in situ hybridisation (ISH).
Precision oncology is one of the driving factors in the market. Companion diagnostics are now indispensable to treatment planning owing to advances in target therapy and increased knowledge about tumour biology. As drug manufacturers develop increasingly more medications based on biomarkers, there is an increased need for reliable diagnostic tools to stratify the patient population.
The oncology molecular diagnostics market is growing strongly with an increasing global burden of cancer and with more demand for personalised medicine. Molecular diagnostics are indispensable in the treatment and diagnosis of cancer by enabling early detection, correct tumour profiling, and informed treatment selection. Owing to technological advances in next-generation sequencing (NGS), polymerase chain reaction (PCR), and in situ hybridization (ISH), oncologists are able to identify specific genetic alterations and biomarkers impacting the progression of the tumour and the therapy response.
One strong driver fueling the market is the transition to precision oncology. The increased knowledge base regarding the biology of tumors and the surge in the use of targeted therapies has rendered companion diagnostics more critical in planning treatment. As pharmaceutical companies increasingly develop biomarker-driven drugs, the need for reliable diagnostic tools to stratify patients has surged. Furthermore, growing investments in cancer research and increased availability of molecular tests in clinical settings are expanding access to advanced diagnostics globally.
One of the primary restraints in this sector is the high expense of molecular diagnostics tests and the associated infrastructure costs. Healthcare systems in particular, especially in low- and middle-income countries are faced with issues of affordability and access, especially for molecular diagnostics tests. Complex regulatory approval pathways and the uncertainties surrounding reimbursement often creates commercialization delays for new diagnostic solutions and clinicians' adoption of them. While there are hurdles to development, further innovation, supportive health policies, and company, academic collaboration or partnerships are likely to help strengthen the market. The anticipated integration of artificial intelligence and digital pathology application to further enhance the efficiency of tests, accuracy of interpretation, and clinical utility of tests in oncology is also expected to fortify the market
Growing Adoption of Personalized Medicine
The market for oncology molecular diagnostics is expanding with the rising need for customized cancer therapies. Molecular diagnostics provide precise tumor profiling to help clinicians select targeted treatments. With the rising awareness and availability globally, the integration of molecular diagnostics into routine oncology care continues to gather momentum.
Market snapshot - 2026-2033
Global Market Size
USD 2.47 Billion
Largest Segment
Breast Cancer
Fastest Growth
Breast Cancer
Growth Rate
11.6% CAGR
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The global Oncology Molecular Diagnostics Market is segmented on the basis of type, product, technology, and region. By type, the market is segmented into breast cancer, prostate cancer, colorectal cancer, cervical cancer, liver cancer, lung cancer, blood cancer, kidney cancer, and other cancer. By product, the market is segmented into instruments, reagents and others. By technology, the market is segmented into PCR, In situ hybridization, INAAT, chips and microarrays, mass spectrometry, sequencing, TMA, and others. By end User, the market segmented into hospitals, diagnostic laboratories, academic & research institutes, and others. By region, the market is segmented into North America, Europe, Asia Pacific, the Middle East and Africa, and Latin America.
As among the several cancer types considered under the oncology molecular diagnostics segment, which also includes prostate, colorectal, cervical, liver, lung, blood, and kidney cancers, breast cancer became the market leader in revenue share in the year 2024. This is because of the high volume of diagnostic testing and the broad range of commercialized diagnostic products targeting breast cancer diagnosis. The innovations in early detection methods and the increased awareness initiatives have helped in further driving the strong uptake of molecular diagnostics in breast cancer, thus solidifying its position as a leader for oncology diagnostics.
Liver Cancer: Fastest-Growing Segment in Oncology Molecular Diagnostics
The liver cancer segment is growing at the fastest rate within the oncology molecular diagnostics market, due to an increase in occurrences worldwide, especially in Asia-Pacific, and poor prognosis due to delay in diagnosing the disease. Recent advances in the areas of liquid biopsy and NGS allow for earlier detection of hepatocellular carcinoma (HCC) leading to significantly better survival rates. Increased research in liver-specific biomarkers (i.e., AFP, DCP, circulating tumor DNA) adds to diagnostic accuracy, explaining growth. In addition, government supported screening programs and an increasing incidence of hepatitis b/c infection burden drive the adoption of tests. The need for non-invasive, repeatable tools to monitor high risk populations is once again further driving the growth of this segment of the market.
In 2024, the polymerase chain reaction (PCR) technology segment accounted for the largest revenue share at 31%. PCR technology is a significant technology in the oncology molecular diagnostics market. The advantages of PCR technology over other molecular testing technologies are strong sensitivity and specificity, fast turnaround time, and detection of cancer-related genetic mutations. PCR technology is useful for cancer diagnosis in early disease stages, for monitoring minimal residual disease, and for preparing personalized treatment plans for patients with cancer.
Driving factors of the PCR segment include the increasing hold of cancer around the world, high demand for precision medicine, improvements in various types of PCR (such as digital PCR and real-time PCR), and increased adoption of companion diagnostics. Furthermore, increasing support from government initiatives, enhancing applications of PCR technologies in liquid biopsy, and increasing awareness of genetic testing among clinicians and patients each play roles in increasing the demand for PCR technology in the oncology molecular diagnostics market.
The sequencing segment is expected to see a significant CAGR of 14.3% during the forecast period. The increase is due to a rise in R&D investments, as well as a growing use of sequencing technologies in clinical diagnostics, which offer various benefits, such as rapid processing and quick turnaround times that create a positive climate for market growth. For example, in 2021, BD launched the "BD COR PX/GX" system, a high-throughput, fully automated molecular diagnostics platform, designed for use in laboratories in the U.S. The platform includes robotics and integrated sample management software, offering a new standard for automation in molecular testing for infectious diseases.
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In North America, various factors such as high cancer incidence, advanced healthcare system, and the increasing adoption of precision medicine are contributing to fast growth of the oncology molecular diagnostics market. The U.S. is leading the region thanks to significant investments in R&D, increased use of high-throughput methodologies, such as PCR and NGS, and favorable reimbursement policies. The increasing demand for early and precise detection of cancer and awareness among both patients and clinicians is also driving the market. The region also benefits from a strong presence of major diagnostic companies and favorable regulatory environments, such as the accelerated approval process for diagnostics by the FDA. Growth of companion diagnostics for targeted therapies is another important factor contributing to market growth.
The oncology molecular diagnostics industry in the United States is advancing rapidly due to the strong focus on precision medicine and earlier cancer detection this factor are anticipated to drive the drive the market growth. The rising rates of cancer in the U.S. are also resulting in the use of molecular diagnostics, including tools such as next-gene sequencing (NGS), polymerase chain reaction (PCR), and liquid biopsies. These techniques support more personalized treatment options that are minimally invasive, deliver accurate treatment options, and results. Furthermore, encouraging government support, reimbursement considerations and robust R&D investments are supporting innovation. The influence of major market players as well as academic research institutions and organizations support the pace of innovation in the industry. Growing awareness among patients as well as physicians is also supporting the uptake of testing.
Key drivers include the increasing prevalence of cancer, particularly breast cancer, which is the largest and fastest-growing segment. Technological advancements, such as next-generation sequencing, enhance diagnostic accuracy and support personalized medicine approaches. Additionally, Canada's robust research infrastructure and government initiatives promoting early detection contribute to market expansion.
The Asia Pacific region is thought to be a highly favorable region in the oncology molecular diagnostics market due to its large, aging population, increasing incidents of cancer, and heightened awareness of health care needs. Rapid urbanization and shifts in lifestyle behaviors are also contributing to a greater prevalence of cancer vice which is leading to higher demand for early and accurate diagnosis. Additionally, government initiatives to improve health care infrastructure, increasing investments in genomics and biotechnology, and increasing saturation of personalized medicine contribute to the growth of the market. The favorable cost for conducting clinical trials and the increased access to advanced diagnostics capabilities broaden the attractiveness to current and new global players and aid in innovation driven growth as nations such as China and India and other emerging economies, including Southeast Asia discover paths forward.
Japan’s oncology molecular diagnostics market is seeing considerable growth due to key factors. The increasing cases of cancer, which are responsible for roughly 30% of deaths in Japan, represents the dire need for better diagnostics and activated demand. Additionally, Japan's rapidly growing aging population with the highest life expectancy also yields higher rates of cancer. These trends have driven demand in the market. Technological advancements, particularly in precision medicine, are improving diagnostic accuracy and treatment personalization.
The market for oncology molecular diagnostics in China is expanding rapidly during the forecast period. The incidence of cancer is growing, and the size and aged population puts additional pressure for earlier and more accurate diagnostics. There are also governmental factors, such as the addition of health-care infrastructure and practicing personalized medicine, helping advance the population's need for more oncology diagnostics. The market dynamic is also enhanced due to improvements in technology and many local and global start-up and investment activities.
The oncology molecular diagnostics industry in India is set for rapid expansion due to several factors, including the rising incidents of cancer, development of new approaches and technologies for diagnostics, and various government initiatives. The increase in the rate of cancers can be attributed to poor choices in lifestyle and population aging which indicates a need for accurate, sooner diagnostics. The new technologies like genomic analysis powered by AI and liquid biopsy have advanced personalized medicine methods and less invasive cancer diagnostics. The government programs like, the National Cancer Control Programme, and Ayushman Bharat Scheme are strengthening prevention and early detection of cancer, and allowing for further expansion.
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Rising Cancer Prevalence and Demand for Early Detection
Technological Advancements in Genomic Testing
High Cost of Advanced Diagnostic Technologies
Limited Access in Low-Resource Settings
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The oncology molecular diagnostics market is very competitive. Key players are utilizing strategic partnerships, launching products and using technological innovation to try to gain market share. For example, in 2023 Roche collaborated with Alnylam to develop RNA-based diagnostics that engage for personalized cancer treatment as part of Roche’s effort to bolster its precision oncology portfolio. Illumina continues its campaign of market dominance by adding AI-driven bioinformatics to its portfolio via Grail (accommodation), a company focused on multi-cancer early detection and intervention. Other companies are investing massively in liquid biopsy platforms, and next generation sequencing (NGS) to meet unmet diagnostic needs and sustain competitive edge in cancer care.
Technological Advancements Driving Innovation
Technology Development as Driving Next-generation sequencing (NGS) and advances in therapy liquid biopsy are revolutionizing oncology diagnostics. They are a faster, non-invasive, and more accurate way of detecting and monitoring cancer. Increased sensitivity and broader genomic coverage are proving to be an essential tool for both clinically and research purposes.
Emphasis on Early Detection and Screening
There is increasing emphasis on early detection of cancer using molecular diagnostics. Governments and other health organizations are promoting screening initiatives to enhance survival. The demand for rapid, cost-effective diagnostic tools is accelerating in areas of high burden and aging populations.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global market for oncology molecular diagnostics is experiencing significant growth as a result of increasing rates of cancer, advancements in genomic technologies, and the rising prevalence of precision medicine adoption. The market is rapidly evolving as new diagnostic modalities such as next generation sequencing (NGS) technology, liquid biopsies, and companion diagnostics that provide faster, more accurate, and less invasive cancer detection options become more available. Drug development and biomarker discovery efforts, which are now aided by strategic partnerships between the diagnostic and pharmaceutical industries, also bolster the market. Although the outlook is promising, the market is subject to regulatory complexities, high cost of testing, and uneven access to testing across regions. Dealing with these challenges through innovation, policy administration, and investing in infrastructure will be important to sustain the growth expected in the market.
| Report Metric | Details |
|---|---|
| Market size value in 2024 | USD 2.76 Billion |
| Market size value in 2033 | USD 7.4 Billion |
| Growth Rate | 11.6% |
| Base year | 2024 |
| Forecast period | 2026-2033 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Oncology Molecular Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Oncology Molecular Diagnostics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
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