Oncology Molecular Diagnostics Market

Global Oncology Molecular Diagnostics Market:

The global oncology molecular diagnostics market size reached USD 4.8 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 14.3 Billion by 2033, exhibiting a growth rate (CAGR) of 12.37% during 2025-2033. The rising prevalence of cancer, ongoing advancements in molecular diagnostic technologies, and increased adoption of precision medicine are primarily driving the market's growth.

Oncology Molecular Diagnostics Market Analysis:

• Major Market Drivers: The rising prevalence of cancer on account of changing lifestyles, the growing geriatric population, and the increasing trend of smoking represent one of the major factors impelling the global oncology molecular diagnostics market growth. Apart from this, the escalating demand for rapid and accurate diagnosis, along with advancements in next-generation sequencing (NGS) techniques, is contributing to the oncology molecular diagnostics market share.
• Key Market Trends: A rise in the number of individuals suffering from viral and bacterial infections and the increasing participation in blood donation campaigns is positively influencing the demand for oncology molecular diagnostics worldwide.
• Competitive Landscape: Some of the prominent oncology molecular diagnostics market companies Agilent Technologies, Inc., Abbott Laboratories, Bayer AG, Becton, Dickinson and Company, Danaher Corporation, F. Hoffmann-La Roche AG, Hologic, Inc., Qiagen N.V., Siemens Healthcare, and Sysmex Corporation, among many others.
• Geographical Trends: According to the oncology molecular diagnostics market dynamics, North America holds a prominent share of the oncology molecular diagnostics market, attributed to the high adoption of advanced diagnostic technologies and personalized medicine. Moreover, Europe is the second-largest region in the oncology molecular diagnostics market, driven by a robust regulatory framework and rising awareness about early cancer detection.
• Challenges and Opportunities: The high cost of advanced diagnostics and the rising competition among key players are hampering the oncology molecular diagnostics market growth. However, with the global rise in cancer incidence, the demand for accurate and early diagnosis is increasing. Molecular diagnostics play a pivotal role in detecting cancer at early stages, leading to better outcomes and increased demand for diagnostic solutions.

Oncology Molecular Diagnostics Market Trends:

Aging Population

The global aging population is one of the key factors driving the market’s growth. For instance, by 2030, one in every six persons in the world will be 60 or older. At this time, the proportion of the population aged 60 and up will rise from 1 billion in 2020 to 1.4 billion. By 2050, the global population of persons aged 60 and up will double (2.1 billion). As the elderly population grows, the demand for effective cancer diagnostics, particularly those based on molecular testing, is expected to rise. These factors further positively influence the oncology molecular diagnostics market growth.

Rising Prevalence of Cancer

Cancer rates are rising globally, with an increasing number of cases of various cancers across various regions, such as breast, lung, colorectal, and prostate cancer. For instance, according to an article published by the World Health Organization (WHO), over 35 million more cancer cases are expected in 2050, up 77% over the estimated 20 million in 2022. Similarly, according to an article published by the National Cancer Institute in 2024, in the United States, there are nearly 623,405 persons living with metastatic breast, prostate, lung, colorectal, or bladder cancer, as well as metastatic melanoma, with that figure predicted to rise to approximately 693,400 by 2025. This surge is driving the demand for more effective diagnostic tools to detect cancer at earlier stages, making molecular diagnostics a critical component of cancer care. These factors are expected to propel the oncology molecular diagnostics market share in the coming years.

Technological Advancements

NGS technology enables the rapid sequencing of entire genomes or specific genomic regions, providing detailed insights into cancer-related genetic mutations. Its ability to analyze multiple genes simultaneously has revolutionized cancer diagnostics, allowing for the comprehensive profiling of tumors. For instance, in October 2024, NeoGenomics, Inc., a provider of oncology diagnostic services company, launched AML Express, a next-generation sequencing (NGS) assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia (AML), thereby boosting the oncology molecular diagnostics market size.

Global Oncology Molecular Diagnostics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global oncology molecular diagnostics market report, along with forecasts at the global, regional, and country levels from 2025-2033. Our report has categorized the market based on cancer type, product, technology, and end-user.

Breakup by Cancer Type:

• Breast Cancer
• Prostate Cancer
• Colorectal Cancer
• Cervical Cancer
• Liver Cancer
• Lung Cancer
• Blood Cancer
• Others
   

The report has provided a detailed breakup and analysis of the oncology molecular diagnostics market based on the cancer type. This includes breast cancer, prostate cancer, colorectal cancer, cervical cancer, liver cancer, lung cancer, blood cancer, and others. 

According to the oncology molecular diagnostics market outlook, breast cancer remains one of the most common cancers globally, especially among women. The rising number of cases drives the demand for early detection tools and personalized treatment approaches. Moreover, the global rise in colorectal cancer cases, particularly in younger populations, is increasing the demand for early detection and prevention methods, where molecular diagnostics play a crucial role. Furthermore, the strong link between human papillomavirus (HPV) infection and cervical cancer has driven demand for molecular diagnostics that detect high-risk HPV strains (e.g., HPV-16, HPV-18), which are responsible for the majority of cervical cancer cases.

Breakup by Product:

• Instruments
• Reagents
• Others
   

The report has provided a detailed breakup and analysis of the oncology molecular diagnostics market based on the product. This includes instruments, reagents, and others.

According to the oncology molecular diagnostics market overview, the increasing global burden of cancer is driving demand for molecular diagnostic instruments, which are essential for early detection, accurate diagnosis, and treatment monitoring. As more patients are diagnosed with cancer, the need for instruments like Next-Generation Sequencing (NGS) systems, PCR systems, and liquid biopsy platforms grows. Moreover, as more diagnostic tests are conducted globally due to the rising incidence of cancer, the need for reagents (e.g., enzymes, primers, probes, and assays) used in these tests is also increasing. Every diagnostic procedure—whether based on PCR, NGS, or immunohistochemistry (IHC)—requires consumable reagents, is driving the continuous demand.

Breakup by Technology:

• Polymerase Chain Reaction (PCR)
• In Situ Hybridization
• Chips and Microarrays
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Mass Spectrometry
• DNA and NGS Sequencing
• Transcription Mediated Amplification (TMA)
• Others
   

The report has provided a detailed breakup and analysis of the oncology molecular diagnostics market based on the technology. This includes polymerase chain reaction (PCR), in situ hybridization, chips and microarrays, isothermal nucleic acid amplification technology (INAAT), mass spectrometry, DNA and NGS sequencing, transcription mediated amplification (TMA), and others.

PCR is a well-established and widely used technology in oncology molecular diagnostics for detecting specific genetic mutations and viral oncogenes. It is used to identify common cancer-related mutations, such as KRAS, EGFR, and BRAF. Moreover, ISH techniques like Fluorescence in Situ Hybridization (FISH) are key to detecting gene amplifications (e.g., HER2 in breast cancer) and chromosomal translocations, essential in certain cancer diagnoses, such as lymphomas. Besides this, microarrays are widely used for gene expression profiling, enabling researchers and clinicians to assess the activity of thousands of genes simultaneously. This is particularly useful for understanding cancer biology and identifying prognostic biomarkers.

Breakup by End-User:

• Hospitals and Clinics
• Reference Laboratories
• Others
   

The report has provided a detailed breakup and analysis of the oncology molecular diagnostics market based on the end-user. This includes hospitals and clinics, reference laboratories, and others.

The rising cancer incidence globally is pushing hospitals and clinics to adopt molecular diagnostic tools for early detection and diagnosis. Molecular diagnostics are particularly important in identifying cancer at earlier stages, where treatment is more likely to be effective. Moreover, reference laboratories handle a significant volume of oncology molecular diagnostics for multiple healthcare providers, including hospitals and clinics. They specialize in high throughput testing and advanced molecular diagnostics, creating a steady demand for technologies like NGS, PCR, and microarrays.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

According to the oncology molecular diagnostics market statistics, North America, particularly the United States, has one of the highest rates of cancer, which drives the demand for molecular diagnostics for early detection, treatment selection, and monitoring. Moreover, many European countries have national cancer screening programs, particularly for breast, colorectal, and cervical cancers, increasing the adoption of molecular diagnostic tools. Besides this, the Asia-Pacific region is seeing a surge in cancer cases due to aging populations, lifestyle changes, and increasing urbanization. This rise is propelling the oncology molecular diagnostics market share.

Competitive Landscape:

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major market companies have also been provided. Some of the key players in the market include: 

• Agilent Technologies, Inc.
• Abbott Laboratories
• Bayer AG
• Becton
• Dickinson and Company
• Danaher Corporation
• F. Hoffmann-La Roche AG
• Hologic, Inc.
• Qiagen N.V.
• Siemens Healthcare
• Sysmex Corporation
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Oncology Molecular Diagnostics Market Recent Developments

• October 2024: Qiagen introduced the new QIAcuityDx Digital PCR System for clinical oncology testing, expanding its digital polymerase chain reaction (PCR) range and entering the clinical testing industry in North America and the European Union.
• October 2024: NeoGenomics, Inc., a provider of oncology diagnostic services company, launched AML Express, a next-generation sequencing (NGS) assay designed to provide rapid, comprehensive genetic profiling for patients with acute myeloid leukemia (AML).
• September 2024: Variantyx, a molecular oncology diagnostics lab, launched Genomic Unity® 2.0, a new whole genome-based diagnostic test. This advanced test combines classic short-read genome sequencing with third-generation, long-read genome sequencing to uncover genetic variations.

Oncology Molecular Diagnostics Market Report Scope:

Key Questions Answered in This Report

• How has the global oncology molecular diagnostics market performed so far and how will it perform in the coming years?
• What has been the impact of COVID-19 on the global oncology molecular diagnostics market?
• What are the key regional markets?
• What is the breakup of the market based on the cancer type?
• What is the breakup of the market based on the product?
• What is the breakup of the market based on the technology?
• What is the breakup of the market based on the end-user?
• What are the various stages in the value chain of the industry?
• What are the key driving factors and challenges in the industry?
• What is the structure of the global oncology molecular diagnostics market and who are the key players?
• What is the degree of competition in the industry?

Key Benefits for Stakeholders:

• IMARC's report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the oncology molecular diagnostics market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global oncology molecular diagnostics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the oncology molecular diagnostics industry and its attractiveness.
• The competitive landscape allows stakeholders to understand their competitive environment and provides insight into the current positions of key players in the market.