Schedule a Meeting
Download Brochure
Table of Content
December 2024
The global oncology molecular diagnostics market size is calculated at USD 3.11 billion in 2024, grew to USD 3.48 billion in 2025, and is projected to reach around USD 9.76 billion by 2034. The market is expanding at a CAGR of 12.13% between 2025 and 2034. The rising prevalence of cancer, growing demand for personalized medicines, and technological advancements drive the market.
Unlock Infinite Advantages: Subscribe to Annual Membership
Molecular diagnostics is a laboratory technique used to identify a disease or the risk of developing a disease by studying molecules in DNA, RNA, and proteins. Oncology-based molecular diagnostics enable clinicians to identify potential biomarkers involved in cancer progression. Several molecular techniques, such as next-generation sequencing (NGS), allow for thorough cancer genomic profiling. Some common examples of molecular diagnostic tests for cancer include human papillomavirus (HPV), BRCA1 and BRCA2 genes, CA125 protein, HER2 gene, and KIT gene. These tests also help to determine whether a person should undergo more intensive screening or take preventive measures.
Numerous factors contribute to market growth, including the rising incidence and prevalence of cancer and its complexity, which necessitates advanced diagnosis. Growing research and development activities and increasing investments favor the development of novel and more advanced molecular diagnostics. Favorable government policies and initiatives facilitate screening and early detection of cancer. Technological advancements drive the latest innovations in molecular diagnostic tests. Additionally, the growing demand for personalized medicines and advancements in genomics and proteomics potentiate market growth.
Artificial intelligence (AI) has disrupted the healthcare and biotechnology sectors, revolutionizing every aspect. AI introduces automation in molecular diagnostic techniques, enhancing precision and reducing errors. It helps to improve the speed, accuracy, and reliability of some cancer screenings. It simplifies all the tasks of laboratory professionals, from sample preparation to result analysis. AI is widely used to analyze complex genomic data from tumor samples. It also enhances the efficiency of several diagnostic tests. It can detect entire genomes to identify gene mutations linked to diseases. It can identify even minute changes in human genes that are undetectable by a human. Additionally, AI can predict the risk of developing cancer in a human. It enables researchers to develop tailored treatment regimens based on molecular diagnostic tests.
Liquid Biopsy
The major growth factor of the oncology molecular diagnostics market is the advancements in liquid biopsy. Tumor cells often release their fragments, such as single cells or clusters, DNA, RNA, or proteins, into various body fluids. Hence, scientists have developed a novel, non-invasive method, liquid biopsy. Liquid biopsy enables the analysis of circulating DNA or some other tumor-derived molecules, and drug sensitization mutations. Technological advancements have led to the latest innovations and enabled their integration into clinical practice. Liquid biopsy overcomes several challenges faced by tissue biopsy, such as invasiveness and other potential complications, such as bleeding, injury, and infection. Liquid biopsy aids in early cancer detection, cancer staging, prognosis evaluation, and real-time monitoring of tumor progression. The U.S. Food and Drug Administration (FDA) has approved a total of five liquid biopsy test kits owing to their rising demand.
Access to LMICs
The major challenge faced by the market is the access of oncology molecular diagnostics to low- and middle-income countries (LMICs). LMICs lack the necessary resources to develop and adopt advanced molecular diagnostics for cancer detection. They face the logistical challenges of importation and shelf life issues. They also have limited access to technical support due to the lack of trained professionals and high maintenance costs. Moreover, stringent regulations necessitate the local registration of the test, hindering its adoption.
Personalized Medicine
The future of the oncology molecular diagnostics market is promising, driven by the growing demand for personalized medicine. Personalized medicine refers to the treatment given to the patient based on the individual’s genetic profile. Numerous government organizations and regulatory agencies also support the development of personalized medicines. Currently, there are no perfect treatments available to cure the root cause of the disease. Researchers are getting closer to this goal with the help of targeted therapy and molecular diagnostics. Molecular diagnostics can identify the patient’s conditions and allow researchers to develop a novel treatment regimen, providing tailored care. Healthcare professionals have been trying to deliver personalized medicine and are becoming more precise with improved diagnostic and therapeutic tools. Thus, precision medicine is a rapidly evolving field backed by molecular diagnostics that acts as a fundamental component in detecting these molecules.
By type, the breast cancer segment held a dominant presence in the oncology molecular diagnostics market in 2024. The rising incidences and prevalence of breast cancer and favorable policies boost the segment’s growth. Breast cancer is the most common type of cancer among women and is the leading cause of death globally. The WHO has launched the Global Breast Cancer Initiative (GBCI) to reduce global breast cancer mortality by 2.5% per year. It aims to avert 25% of breast cancer deaths by 2030 and 40% by 2040 among women under 70 years. Molecular biomarkers for breast cancers include Ki-67, ER, PR, HER2, and p53.
By type, the liver cancer segment is predicted to witness significant growth in the market over the forecast period. Liver cancer is the sixth most common cancer globally. Alcohol consumption and hepatitis B and C infection are the most common causes of liver cancer. The rising incidences of liver cancer and growing research and development activities fuel the segment’s growth. Researchers are developing novel molecular diagnostic tools to detect diagnostic markers involved in liver carcinogenesis. Microarray-based gene profiling is widely used to predict early liver cancer.
By product, the reagents segment led the global oncology molecular diagnostics market in 2024 and is estimated to gain significant growth in the market over the coming years. Reagents are essential components of molecular diagnostic tests. Several manufacturers offer reagents to refill their chemical requirements during research and diagnosis. Some common examples of reagents include polymerase enzymes, dNTPs, PCR buffers, loading dye, and nucleic acid extraction solutions. The affordability and easy availability of reagents potentiate the segment’s growth.
By technology, the PCR segment held the largest share of the oncology molecular diagnostics market in 2024. Polymerase chain reaction (PCR) is a nucleic acid amplification method to denature and renature short fragments of DNA. The advent of the PCR technique has revolutionized molecular diagnostics and led to an enormous breakthrough in clinical DNA testing. PCR technique is predominantly used due to its superior benefits. It requires simple instrumentation and infrastructure and utilizes only a minute amount of biological samples, leading to accuracy and precision. Additionally, it is highly compatible with clinical routine, augmenting the segment’s growth.
By technology, the sequencing segment is anticipated to show lucrative growth in the oncology molecular diagnostics market during the forecast period. Sequencing is an advanced technique to determine the sequence of nucleic acids. The availability of next-generation sequencing (NGS) and technological advancements promote the segment’s growth. Advancements in technologies have led to the development of novel, rapid, and cost-effective sequencing techniques. These techniques are more accurate and versatile than other conventional techniques. They can detect abnormalities across the genomes, enhancing their efficiency and precision.
North America dominated the global market in 2024. Technological advancements and advanced healthcare infrastructure are the major growth factors of the market. Government organizations from North American countries necessitate screening and early diagnosis of cancer, increasing the demand for molecular diagnostics. State-of-the-art research and development facilities allow researchers to develop novel diagnostic tools for cancer. The presence of trained professionals and the increasing number of specialized clinics also contribute to the oncology molecular diagnostics market.
The rising incidences and prevalence of cancer facilitate early detection using molecular diagnostics. In 2025, more than 2 million new cancer cases and 0.6 million cancer-related deaths are estimated in the U.S. Favorable regulatory frameworks and government policies drive the market. Government organizations such as the National Cancer Institute (NCI) provide funding for conducting cancer research. The NCI provided $1.8 billion from FY2017 to FY2023 for the Cancer Moonshot initiative.
The increasing geriatric population leads to rising incidences of cancer, augmenting the market. According to the Canadian Cancer Statistics, 44% of Canadian women and 45% of Canadian men are estimated to develop cancer during their lifetime. Favorable reimbursement policies and increasing investments also support the market. Genome Canada recently announced the launch of the Canadian Precision Health Initiative (CPHI) with an investment of CAD 81 million.
Asia-Pacific is anticipated to grow at the fastest rate in the oncology molecular diagnostics market during the forecast period. The rising geriatric population, increasing adoption of advanced technologies, and growing research and development activities drive the market. The increasing investments and favorable government policies contribute to market growth. Many government and private research institutions organize symposiums, workshops, and conferences to create awareness among the general public for early cancer detection.
The increasing incidences of cancer due to the rising population and genetic abnormalities promote the oncology molecular diagnostics market. The growing number of clinical trials owing to increasing research and development activities also augment the market. Chinese researchers are primarily focused on numerous clinical trials for specific molecular targets or signaling pathways that yield promising results. The Chinese government makes constant efforts to improve access to advanced diagnosis and treatment of cancer.
The growing awareness among the general public through campaigns and social media increases the need for oncology molecular diagnostics. The increasing collaborations and mergers & acquisitions propel the market. Favorable government policies and increasing investments drive the market. The Ministry of Health and Family Welfare announced an investment of Rs 99,858.56 crore for prioritizing cancer care in the Union Budget 2025-26.
Europe is observed to grow at a considerable growth rate in the oncology molecular diagnostics market in the upcoming period. Suitable regulatory frameworks and government initiatives fuel the development of molecular diagnostics for early cancer detection. The European Union (EU) is working to improve access to molecular diagnostics for cancer through several initiatives, including the PCM4EU project, the Mission on Cancer, and the European Cancer Imaging Initiative.
The burgeoning healthcare sector and the rising disposable income provide state-of-the-art facilities for early diagnosis and treatment of cancer. Favorable reimbursement policies also favor market growth. In the future, 55 statutory health insurers in Germany will cover the costs of comprehensive molecular cancer diagnostics for cancer children who have relapsed or have a high disease risk.
The rising incidences and prevalence of cancer are major growth factors of the market in the UK. Cancer Research UK estimates that there will be 69,900 new cancer cases annually in the UK by 2038-2040. Apart from this, the increasing investments have led to advanced cancer research. The UK government announced an investment of a total of £82.6 million in three innovative British research projects to transform cancer care.
Dr. Shridhar Ganesan, Director of the Center for Molecular Oncology, commented that the center was developed to bring the advances of molecular analysis of cancers and the application of targeted therapies to every patient diagnosed with cancer at any of their locations. This will help the center treat individuals better and help them classify and organize diseases to advance their understanding of cancer in general and develop novel treatments.
By Type
By Product
By Technology
By Region
December 2024
December 2024
November 2024
November 2024