Oncology Molecular Diagnostics Market

Oncology Molecular Diagnostics Market By Product (Oncology Molecular Diagnostic Reagents & Kits, Instruments, Services & Software), By Technology (Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH)), By End User, By Region - Global Insights to 2031

Analysis of Oncology Molecular Diagnostics market covering 30 + countries including analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Oncology Molecular Diagnostics Market Outlook

The global oncology molecular diagnostics market was valued at around US$ 1.7 Billion in 2020 and is anticipated to reach a valuation of US$ 4 Billion by 2031.

Demand for oncology molecular diagnostics is driven by increasing prevalence of infectious diseases and cancer, rising funding towards R&D, increase in PoC (point of care) testing devices, and various technological advancements.

Usage Analysis of Oncology Molecular Diagnostics from 2016 -2020 Vs Future Market Outlook for 2021 – 2031

According to Fact.MR, a market research and competitive intelligence provider, the global oncology molecular diagnostics market was estimated at US$ 1.3 Bn in 2016 and is anticipated to expand at a CAGR of 11% from 2021 to 2031. The market is being driven by sales of oncology molecular diagnostic instruments, kits, and reagents used for diagnosing cancer.

Molecular diagnostics are tests for oncology diagnose genetic information, proteins or related molecules, and provide health or disease information. This study is usually performed on blood, saliva, or tumor tissue samples.

Rise in the number of cancer cases across the globe is contributing to the growth of the market. According to the American Cancer Society, there were 1.7 million new cases and 0.6 million cancer deaths in 2019, in the U.S.

The four most common types of cancers worldwide are lung, prostate, bowel, and female breast cancer. Therefore, rise in cancer incidence rate globally is anticipated to boost demand for oncology molecular diagnostic for cancer detection over the coming years.

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How Does Oncology Molecular Diagnostics Help in Early Detection?

Oncology molecular diagnostics identify the presence of cancer cells by analyzing their biological molecules. Several tests are performed on the blood, saliva, and tumor tissue samples for detecting and measuring specific genetic sequences in the DNA, RNA, and cell proteins.

Oncology molecular diagnostics help perform rapid analysis and provide detailed information that is further utilized in the personalized treatment of cancer.

These diagnostic solutions find application in clinical and point-of-care (PoC) testing for early detection of cancer. They are also used in blood banks to identify pathogens and infectious diseases present in the donated blood samples.

What are the Main Factors Stimulating Demand for Oncology Based Molecular Diagnostics?

Rising prevalence of cancer on account of changing lifestyles, growing geriatric population, and increasing trend of smoking represents one of the major factors driving global market growth.

Apart from this, escalating demand for rapid and accurate diagnosis, along with advancements in next generation sequencing (NGS) techniques for oncology molecular diagnostics is contributing to the growth of the market.

Furthermore, rise in the number of individuals suffering from viral and bacterial infections and increasing participation in blood donation campaigns are positively influencing demand for oncology molecular diagnostic tests worldwide.

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What are the Key Restrains Affecting Sales of Oncology Molecular Diagnostics?

A molecular diagnostic instrument is expensive. The variable costs of the reagents needed, and those fixed by the suppliers thereof, add to the overall expenditure.

Furthermore, maintenance and insurance, laboratory supervision, and overhead costs (including utilities, space, and administration) are also additional expenses.

High volume of molecular diagnostic instruments may be affordable only for large hospitals and reference laboratories with good capital budgets. Most small laboratories, physician’s offices, and sole practitioners have no capital budgets and may not be able to afford a very large-sized analyzer.

Thus, high-cost requirements might restrain the growth of the cancer molecular diagnostics market over the coming years.

What are the Key Trends in the Oncology Molecular Diagnostics Market?

Advanced technology in genomics is a key trend in the said market. Advancements in cancer genome sequencing technology, computational analysis, tumor models, and innovation of modern cancer research methods promote early detection of cancer and its mutation.

For instance, Roche Molecular Systems, a U.S.-based company, developed Cobas EGFR Mutation Test for non-small cell lung cancer patients. This test is a real-time test that detects 42 mutations of the epidermal growth factor receptor (EGFR) gene, along with the resistant mutation of cancer. In June 2020, FDA approved Cobas EGFR Mutation Test.

Such technological advancements are playing a major role in promoting the usage of molecular diagnostic tests for oncology.

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What are the Regional Opportunities Awaiting Manufacturers of Oncology Molecular Diagnostics?

North America accounts for the largest share of around 34% of the global market. The North America’s market growth can be attributed to the highly developed healthcare system in the U.S. and Canada, the presence of many leading national clinical laboratories, and the easy accessibility to technologically advanced instruments.

The market in Asia Pacific is expected to expand at the fastest CAGR of 16% during the forecast period. Increasing incidence of cancer among the low- and middle-income population in the Asia Pacific region can be attributed to the aging populations and changes in lifestyle associated with economic development and epidemiologic transition.

India, China, and Australia are expected to offer immense potential for this industry, mainly due to growing economy and high unmet medical needs.

Demand for oncology molecular diagnostic instruments in China is set to expand at a CAGR of 9% across the assessment period. Also, sales of molecular diagnostic kits in Australia are expected to increase significantly over the next ten years.

Oncology molecular diagnostics market by Fact.MR

Country-wise Analysis

Will the U.S. Remain a Lucrative Market for Suppliers of Oncology Molecular Diagnostics?

The U.S. oncology molecular diagnostics market was estimated at US$ 491 Mn in 2020. Incidence of cancer cases have been on the rise since many years in the country.

Most common sites of cancer are lung, liver, stomach, colorectal, and breast. Hence the rising cancer cases are driving the sales of oncology molecular diagnostics in the country.

Furthermore, rising awareness levels among patients and healthcare professionals for early detection and differentiation of cancer is estimated to enhance the usage rates of molecular diagnostic techniques for oncology.

Category-wise Analysis

Will Demand for Reagents & Kits Remain High Across the Assessment Period?

The reagents & kits segment accounts for the largest share in this market. The frequent purchase of these products due to their recurrent usage drives the market growth of this segment.

Demand for oncology molecular diagnostic reagents & kits is estimated to expand at a CAGR of 12.8% across the assessment period.

Why is Demand for PCR in Oncology Molecular Diagnostics Dominating the Market?

The polymerase chain reaction (PCR) segment accounted for the largest market share by technology. This can be attributed to the growing use of PCR in proteomics and genomics, use of RT-PCR in COVID-19 test, automation of PCR instruments, and the emergence of advanced technologies like qRT-PCR (Real-Time Quantitative Reverse Transcription PCR) drive this segment's growth.

Competitive Landscape

Top service providers of oncology molecular diagnostics, in an attempt to gain stability, are adopting strategies such as specialized product development. Leading market players in oncology molecular diagnostics are also entering into collaborations with top oncology molecular diagnostic instrument brands, for development of companion diagnostic pertaining to cancer.

Some of the key developments are:

  • In September 2015; Roche launched the Cobas EGFR Mutation Test v2, which is used for diagnosis of Non-Small Cell Lung Cancer (NSCLC), which is expected to drive the growth of this market.
  • Qiagen and Lilly announced their plans to co-develop companion diagnostics for targeting common cancer biomarkers.
  • In February 2019, ICON plc, a US-based biotechnology company, acquired MolecularMD for an undisclosed amount. The acquisition enhances ICON’s laboratory offering in molecular diagnostic testing and brings to ICON expanded testing platforms, including next-generation sequencing, and immunohistochemistry (IHC).

Oncology Molecular Diagnostic Market Report Scope



Market size value in 2020

USD 1.7 Billion

Market forecast value in 2031

USD 4 Billion

Growth Rate

CAGR of 11% from 2021 to 2031

Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value & ‘000 Units for Volume

Key Regions Covered

  • North America
  • Europe
  • Asia Pacific
  • Central & South America
  • Middle East & Africa

Key Countries Covered

  • USA
  • Canada
  • Germany
  • France
  • the UK
  • Russia
  • Italy
  • China
  • Japan
  • South Korea
  • India
  • Australia
  •  Middle East
  • Latin America

Key Market Segments Covered

  • Product
  • Technology
  • End User
  • Region

Key Companies Profiled

  • F. Hoffmann-La Roche Ltd
  • Hologic
  • BioMérieux SA
  • Abbott Laboratories
  • Thermo Fisher Scientific Inc.
  • Siemens Healthineers AG
  • Danaher Corporation
  • Myriad Genetics Inc.
  • Illumina Inc.
  • Agilent Technologies Inc.
  • Becton
  • Dickinson and Company
  • DiaSorin S.p.A
  • Grifols
  • Quidel Corporation
  • Genetic Signatures
  • MDxHealth
  • Exact Sciences Corporation
  • Biocartis NV
  • TBG Diagnostics Ltd.
  • GenMark Diagnostics Inc
  • Luminex Corporation
  • HTG Molecular Diagnostics
  • Vela Diagnostics
  • Amoy Diagnostics Co.
  • Molbio Diagnostics Pvt. Ltd.
  • ELITechGroup
  • Savyon Diagnostics Ltd
  • ABACUS Diagnostica Oy, and
  • GeneOmbio Technologies Pvt. Ltd


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Key Segments Covered in Oncology Molecular Diagnostic Industry Research

  • By Product

    • Oncology Molecular Diagnostic Reagents & Kits
    • Oncology Molecular Diagnostic Instruments
      • Oncology Molecular Diagnostic Tabletop Instruments
      • Oncology Molecular Diagnostic Portable & PoC Instruments
    • Oncology Molecular Diagnostic Services & Software
  • By Technology

    • Polymerase Chain Reaction (PCR) in Oncology Molecular Diagnostics
    • Isothermal Nucleic Acid Amplification Technology (INAAT) for Oncology Molecular Diagnostics
    • DNA Sequencing & Next-Generation Sequencing (NGS) for Oncology Molecular Diagnostics
    • In Situ Hybridization (ISH) Technology for Oncology Molecular Diagnostics
    • DNA Chips and Microarrays for Oncology Molecular Diagnostics
  • By End User

    • Oncology Molecular Diagnostic Used in Diagnostic Laboratories
    • Oncology Molecular Diagnostic Used in Hospitals & Clinics

- FAQs -

What are the challenges impacting the market for oncology molecular diagnostics?

Challenges affecting the market are changing regulatory landscape, operational barriers, and introduction of alternative technologies.

What are the different types of oncology molecular diagnostic instruments used?

Different types of instruments are tabletop and portable & point-of-care instruments.

Who are the key end users of oncology molecular diagnostics?

Based on key end users, the market is segmented into diagnostic laboratories, hospitals, and clinics.

What is the expected growth rate of the market?

The global oncology molecular diagnostic market is expected to expand at a CAGR of 11% across the forecast period.

Which region is set to be a lucrative market for oncology molecular diagnostics?

Emerging economies in the Asia Pacific region will be lucrative markets for oncology molecular diagnostics over the next ten years. 

Which diagnostic technology dominates the market?

Polymerase chain reaction (PCR) diagnostic technology dominates the market due to its robust results and early detection.

Which are the different types of cancers for detection of which mass spectrometry is used?

Mass spectrometry is used for oncology molecular diagnostics of colorectal cancer, blood cancer, and lung cancer.

Loop-mediated isothermal amplification (LAMP) is used for the diagnosis of which tumours?

Loop-mediated isothermal amplification is used for oncology molecular diagnosis of prostate cancer, liver cancer, and cervical cancer.

Who are the top manufacturers of oncology molecular diagnostic kits?

Roche, QIAGEN, Hologic, Grifols, and Abbott Laboratories are some of the top manufacturers of oncology molecular diagnostic kits.

What are the latest trends related to oncology molecular diagnostic tests?

Rising demand for PCR in oncology molecular diagnostics is the latest trend in the market.

Why is demand for PCR in oncology molecular diagnostics in Germany on the rise?

Due to rising cases of oncology in Germany, use of PCR for oncology molecular diagnostics is growing in the country.

How is demand for oncology molecular diagnostic instruments shaping up in China?

Demand for oncology molecular diagnostic instruments in China is expected to expand at a CAGR of 7% through 2031.

Oncology Molecular Diagnostics Market

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