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March 2025
The U.S. oncology molecular diagnostics market size is calculated at USD 810 million in 2024, grew to USD 909.14 million in 2025, and is projected to reach around USD 2570.17 million by 2034. The market is expanding at a CAGR of 12.24% between 2025 and 2034. The growing demand for personalized medicines and technological advancements drive the market.
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Oncology molecular diagnostics is a laboratory technique for identifying potential biomarkers in cancer progression. Cancer biomarkers include DNA, mRNA, proteins, metabolites, or processes. These biomarkers are released from tumor cells in response to cancer or other associated conditions, such as inflammation. Identifying gene mutations in the tumor tissue has become an important predictive biomarker for selecting the right therapeutic strategy. Numerous advanced techniques, such as PCR, immunohistochemistry, and gene sequencing, are used to identify cancer biomarkers. The oncology molecular diagnostic tests detect the presence of cancer or predict the chances of developing cancer in high-risk individuals.
Several factors contribute to market growth, including the rising incidences and prevalence of cancer and growing research and development activities. Favorable regulatory frameworks and government policies and initiatives support the development of molecular diagnostics. The increasing investments, collaborations, and mergers & acquisitions boost the market. Additionally, technological advancements lead to the development of novel and more advanced molecular diagnostics. The growing demand for personalized medicines also favors the market.
Artificial intelligence (AI) has immense potential in molecular diagnostics, revolutionizing how cancer is diagnosed. AI and machine learning (ML) algorithms aid in cancer pathology and histology analysis, imaging results, and circulating tumor nucleic acid analysis, leading to early cancer detection and precision medicine advancements. AI streamlines the entire research workflow, enhancing efficiency and precision. It has been widely applied in multi-omics research to provide specific insights for personalized cancer treatment. It enables oncologists to design targeted therapies based on a comprehensive understanding of genetic mutations and cancer subtypes. AI introduces automation in molecular diagnostic tests, reducing manual errors. Thus, AI helps to improve the speed, accuracy, and reliability of some cancer screening and detection methods.
Personalized Medicines
The major growth factor of the U.S. oncology molecular diagnostics market is the growing demand for personalized medicines. Personalized medicines are therapeutics developed based on a patient’s genetic profile. The rapidly changing demographics and the rising geriatric population necessitate the development of personalized medicines. The increasing cancer prevalence and its complexity also lead to novel therapeutics. Through the FDA, the U.S. government supports the development of personalized medicines. President Obama launched the Precision Medicine Initiative (PMI) to revolutionize the treatment of diseases, improving the patient’s health. The National Institute of Health (NIH) provides funding for research and clinical trials related to precision medicines. Oncology molecular diagnostics gives a deeper understanding of cancer progression, allowing researchers to design novel personalized medication.
High Cost
The market's major challenge is the high cost of oncology molecular diagnostic tests. The average cost of oncology molecular diagnostics may range from several hundred to several thousand dollars. This limits the affordability of several patients from low- and middle-income groups and those without medical insurance, restricting market growth.
Advancements in Genomics
The future of the U.S. oncology molecular diagnostics market is promising, driven by the latest advancements in genomics. Technological advancements and research and development activities drive the latest innovations in molecular diagnostics. Advanced techniques offer unmatched precision, sensitivity, and adaptability in identifying genetic and proteomic changes associated with cancer. Advancements also lead to rapid, more accurate testing, reduced costs, and improved data analysis. They also promote the development of point-of-care diagnostics to eliminate the need for patients to visit the clinic. Several government and private organizations provide funding, resulting in advancements in genomics. Several researchers aim to make genomic sequencing available, affordable, and accessible to patients with genetic diseases. Additional efforts and initiatives will be made to increase the representation and inclusion of underrepresented and genomically uncharacterized populations globally, opening doors for early cancer detection.
By type, the breast cancer segment dominated the U.S. oncology molecular diagnostics market in 2024. The rising incidences and prevalence of breast cancer necessitate the development of molecular diagnostics. American Cancer Society estimated that, in 2025, approximately 3,78,830 breast cancer cases will be diagnosed in both men and women, resulting in 42,680 deaths. It is the most common type of cancer among women. Favorable regulatory frameworks also potentiate the segment’s growth. The U.S. FDA approved 18 molecular diagnostics for breast cancer as of February 2025. Various government programs such as the “National Breast and Cervical Cancer Early Detection Program” increase awareness for screening and early detection of breast cancer among the general pubic.
By type, the liver cancer segment is projected to expand significantly in the U.S. oncology molecular diagnostics market in the coming years. The increasing prevalence and complexity of liver cancer promote the segment’s growth. Some common examples of liver cancer biomarkers include alpha-fetoprotein (AFP), osteopontin (OPN), Golgi protein 73 (GP73), and microRNAs (miRNA). The growing research and development activities lead to the development of molecular diagnostic tests for identifying liver cancer. There are currently no FDA-approved molecular diagnostic tests for liver cancer, necessitating the need for their development.
By product, the reagents segment held the largest share of the U.S. oncology molecular diagnostics market in 2024 and is predicted to witness significant growth in the market over the forecast period. Numerous key players provide reagents for researching and diagnosing cancer in pathology labs. Thermo Fisher Scientific is the leading global provider of reagents for molecular diagnostic test kits. Diagnostic reagents include polymerase enzymes, dNTPs, PCR buffers, loading dye, and nucleic acid extraction solutions. Their demand will likely increase in the coming years due to their affordability and accessibility.
By technology, the PCR segment led the global market in 2024. Polymerase chain reaction (PCR) is the most widely used and conventional technique for identifying the sequence of nucleic acids. The segmental growth is attributed to its high specificity, sensitivity, versatility, and efficiency. Technological advancements led to the development of qPCR (quantitative PCR), further enhancing the accuracy, speed, and precision compared to the conventional PCR technique. It has proved to be a robust, highly reproducible, and sensitive method.
By technology, the sequencing segment is projected to show notable growth in the U.S. oncology molecular diagnostics market during the forecast period. Sequencing techniques determine the order of DNA bases or RNA molecules. They are more advanced techniques offering superior benefits over conventional techniques. Next-generation sequencing (NGS) is one of the most advanced sequencing techniques. NGS offers high throughput, cost-effectiveness, speed, high resolution, versatility, and accuracy. Hence, the demand for sequencing is increasing due to the need for faster, cheaper, and more accurate methods.
The U.S. oncology molecular diagnostics market has positive potential in the U.S. due to the increasing adoption of advanced technologies and the rising prevalence of cancer. According to the American Cancer Society, more than 2 million new cancer cases are estimated in 2025. Favorable government initiatives and regulatory frameworks drive the market. The U.S. Food and Drug Administration (FDA) approved approximately 143 molecular diagnostic tests. Advanced healthcare infrastructure and state-of-the-art research and development facilities also contribute to the market. The increasing investments and collaborations favor the development of oncology molecular diagnostics. The National Cancer Institute (NCI) provides funding for cancer research. It granted $7.22 billion from October 1, 2024, to March 14, 2025. Moreover, the increasing number of specialized cancer centers fuels the market. There are around 72 NCI-Designated Cancer Centers in the U.S.
George Daneker, President and Chief Clinical Officer of Oncology, Myriad Genetics, commented on its collaboration with Lumea, Inc., that clinicians need ready access to molecular diagnostic tools at the point of care to improve cancer outcomes. The collaboration with Lumea ensures that precision-based insights are delivered promptly to empower patients and providers to make informed decisions.
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