Oncology Molecular Diagnostics Market Report 2025

This Oncology Molecular Diagnostics market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The oncology molecular diagnostics market size has grown rapidly in recent years. It will grow from $4.84 billion in 2024 to $5.65 billion in 2025 at a compound annual growth rate (CAGR) of 16.7%. The growth in the historic period can be attributed to market entry of early tests, genomic profiling advancements, introduction of next-generation sequencing (NGS), early biomarker identification, targeted therapies development.

The oncology molecular diagnostics market size is expected to see rapid growth in the next few years. It will grow to $8.99 billion in 2029 at a compound annual growth rate (CAGR) of 12.3%. The growth in the forecast period can be attributed to advancements in liquid biopsy, rise of companion diagnostics, integration of artificial intelligence (AI), expansion of ngs applications, evolving biomarker identification. Major trends in the forecast period include global accessibility, biomarker discovery and validation, regulatory framework refinement, technological platform enhancements, patient-centric care models.

The increasing number of cancer cases worldwide is expected to drive the growth of the oncology molecular diagnostics market. For example, the American Cancer Society reported approximately 1.9 million new cancer cases and 609,360 cancer-related deaths in the U.S. in 2022. Estimates for 2023 are similar, with about 1,958,310 new cases and 609,820 deaths due to cancer. The four most common types of cancer globally are lung, prostate, bowel, and female breast cancer. Consequently, the rising incidence of cancer is anticipated to boost demand for the oncology molecular diagnostics market in the coming years.

The growing preference for personalized medicine is anticipated to fuel the future growth of the oncology molecular diagnostics market. Personalized medicine represents an innovative medical treatment approach that tailors decisions, practices, interventions, and drug therapies to individual patients. In the realm of cancer care, oncology molecular diagnostics play a crucial role in delivering personalized treatment plans, optimizing drug selection, and implementing more precise, effective, and individualized treatment strategies. This approach ultimately enhances patient outcomes and improves the overall quality of life. As of October 2022, reports from the US-based health news company STAT indicated that there were over 75,000 genetic testing products and 300 personalized medicines. Hence, the rising demand for personalized medicine is a driving force behind the growth of the oncology molecular diagnostics market.

Advanced technology in genomics is a significant trend in the oncology molecular diagnostics market. Innovations in cancer genome sequencing, computational analysis, tumor models, and modern research methodologies facilitate early detection of cancer and its mutations. For example, in May 2024, OncoHelix-CoLab, a Canada-based company specializing in precision oncology, launched an advanced molecular diagnostics and immune profiling testing laboratory at Burjeel Medical City in the UAE. This state-of-the-art facility, developed in collaboration with Burjeel Holdings, offers comprehensive capabilities in molecular and cellular immunology, as well as transplant diagnostics. By performing complex tests locally, the lab aims to enhance diagnostic accuracy and efficiency, eliminating the need to send samples abroad. Its offerings include advanced testing for various cancers, such as prostate cancer, in partnership with Nanostics for the ClarityDX Prostate test.

Leading companies in the oncology molecular diagnostics market are directing their efforts toward innovative products, such as oncology liquid biopsy products, to enhance market revenues. Oncology liquid biopsy products serve as advanced diagnostic tools and tests facilitating the non-invasive detection and monitoring of cancer by analyzing various biomarkers and genetic material. In July 2022, BillionToOne Inc., a US-based biotechnology company specializing in molecular diagnostics and genetic testing, launched oncology liquid biopsy products, namely NorthStar Select and NorthStar Response. NorthStar Select is a comprehensive somatic mutation profiling panel for cancer, identifying actionable mutations with a significant limit of detection due to BillionToOne's proprietary molecular counting method, known as quantitative counting templates (QCTs). NorthStar Response is a tissue-neutral, methylation-based treatment response monitoring test, providing an accurate estimation of the burden of methylation circulating tumor DNA (ctDNA) using molecular counting technologies.

In October 2024, LabGenomics USA, a biotechnology company based in the U.S., acquired Integrated Molecular Diagnostics (IMD) CLIA labs, increasing its total number of CLIA-certified labs in the country to four. This acquisition enhances LabGenomics' strategic development and broadens its diagnostic services nationwide, particularly in the area of molecular technology. Integrated Molecular Diagnostics (IMD) CLIA labs is also a U.S.-based integrated molecular diagnostics company.

Oncology molecular diagnostics involve procedures and services aimed at diagnosing cancers. These diagnostics utilize tests that examine genetic information, proteins, or related molecules, providing valuable insights into health or disease conditions.

The primary products within the oncology molecular diagnostics market include instruments, reagents, and other related items. Instruments play a crucial role in cancer diagnosis, employing various technologies such as polymerase chain reaction (PCR), in-situ hybridization (ISH), isothermal nucleic acid amplification technology (INNAT), chips and microarrays, sequencing, mass spectrometry, transcription-mediated amplification (TMA), among others. These technologies find applications across diverse end-users, including hospitals, diagnostic centers, academic and research institutes, and other healthcare institutions.

The oncology molecular diagnostics market research report is one of a series of new reports that provides oncology molecular diagnostics market statistics, including oncology molecular diagnostics industry global market size, regional shares, competitors with a oncology molecular diagnostics market share, detailed oncology molecular diagnostics segments, market trends and opportunities, and any further data you may need to thrive in the oncology molecular diagnostics industry. This oncology molecular diagnostics research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Major companies operating in the oncology molecular diagnostics market include F. Hoffmann-La Roche AG, Bayer AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthcare AG, Becton Dickinson and Company, Agilent Technologies Inc., HTG Molecular Diagnostics Inc., Hologic Inc., Illumina Inc., bioMérieux SA, Beckman Coulter Inc., Sysmex Corporation, Bio-Rad Laboratories Inc., Qiagen N.V., Exact Sciences Corp., Bio-Techne Corporation, OPKO Health Inc., Myriad Genetics Inc., Guardant Health AMEA, Veracyte Inc., Adaptive Biotechnologies Corp., Foundation Medicine Inc., Pacific Biosciences of California Inc., NanoString Technologies Inc., Genomic Health Inc.

North America was the largest region in the oncology molecular diagnostics market in 2024. Western Europe was the second largest region in the global oncology molecular diagnostics market report. The regions covered in the oncology molecular diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the oncology molecular diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The oncology molecular diagnostics market includes revenues earned by oncology molecular diagnostics tools and kits. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

This product will be delivered within 3-5 business days.