Oncology Molecular Diagnostic Market Size, Share, Trends, Growth and Forecast 2034

Oncology Molecular Diagnostic Industry Prospective:

The global oncology molecular diagnostic market was valued at approximately USD 2.54 billion in 2024 and is expected to reach around USD 7.91 billion by 2034, growing at a compound annual growth rate (CAGR) of roughly 12.03% between 2025 and 2034.

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Oncology Molecular Diagnostic Market: Overview

Oncology molecular diagnostics are advanced laboratory tests that examine genetic changes, mutations, and biomarkers in cancer cells to help doctors make informed treatment decisions for cancer patients. These tests analyze the molecular makeup of tumors to identify cancer types, predict how a patient may respond to treatment, and track disease progression.

The market includes hospitals focused on personalized care, labs offering advanced testing, research centers developing therapies, and cancer clinics providing targeted treatments. These diagnostics are essential for early detection and treatment planning, making them a vital part of modern cancer care and precision medicine.

The increasing prevalence of cancer worldwide and growing demand for personalized treatment options are expected to drive substantial growth in the global oncology molecular diagnostic industry over the forecast period.

Key Insights:

• As per the analysis shared by our research analyst, the global oncology molecular diagnostic market is estimated to grow annually at a CAGR of around 12.03% over the forecast period (2025-2034)
• In terms of revenue, the global oncology molecular diagnostic market size was valued at around USD 2.54 billion in 2024 and is projected to reach USD 7.91 billion by 2034.
• The oncology molecular diagnostic market is projected to grow significantly due to increasing cancer incidence rates, advancements in genomic technologies, and the rising adoption of companion diagnostics for targeted therapy selection.
• Based on technology type, next-generation sequencing leads the segment and is expected to continue dominating the global market.
• Based on cancer type, breast cancer is expected to lead the market.
• Based on sample type, tissue samples are anticipated to command the largest market share.
• Based on end-users, hospitals are expected to lead the market during the forecast period.
• Based on region, North America is projected to lead the global market during the forecast period.

Oncology Molecular Diagnostic Market: Growth Drivers

Increasing cancer prevalence and the aging population

The oncology molecular diagnostic market is growing as global cancer rates rise, especially with aging populations facing higher risks. Cancer remains one of the top causes of death, creating a strong need for early and accurate diagnosis to improve survival rates.

According to the World Health Organization, cancer cases are expected to increase by 60% in the next 20 years, raising the demand for advanced diagnostic tools.

Molecular diagnostics help detect cancer early, leading to better treatment results and lower healthcare costs through timely care. Healthcare providers and patients now understand the benefits of molecular testing for diagnosis and treatment planning, boosting its use.

Advancements in precision medicine and targeted therapies

The oncology molecular diagnostic industry is growing as precision medicine becomes the standard. Pharmaceutical companies are creating more targeted therapies that need companion diagnostics to identify patients who will benefit. Personalized treatment plans based on a person’s genetic profile have transformed cancer care, making molecular testing vital for the best outcomes.

Doctors are using these tests more to choose the right therapies and avoid treatments that may cause harm without helping. The use of artificial intelligence and machine learning in testing platforms is enhancing accuracy and speed, making these tools more accessible and easier to use in healthcare settings worldwide.

Oncology Molecular Diagnostic Market: Restraints

High costs and reimbursement challenges

Despite growing demand, the oncology molecular diagnostic industry faces several challenges. The high cost of advanced testing technologies and complicated reimbursement systems make access difficult for many patients and healthcare providers.

Molecular tests can cost thousands of dollars per patient, so without insurance or with limited healthcare funding, access becomes difficult. Many healthcare systems struggle to invest in expensive diagnostic equipment and the trained staff needed to perform these tests.

Reimbursement policies differ between countries and insurance providers, making it unclear and risky for healthcare providers to adopt new molecular diagnostic technologies.

Oncology Molecular Diagnostic Market: Opportunities

Expansion into emerging markets and developing countries

The oncology molecular diagnostic market is expanding as healthcare infrastructure improves in emerging markets and developing countries. Cancer rates are rising in these regions, but access to advanced diagnostic tools remains limited. Investments in healthcare across Asia-Pacific, Latin America, and Africa are increasing the need for high-end diagnostic tools to support cancer care programs. Government efforts to improve cancer diagnosis and treatment are creating growth opportunities for global diagnostics companies.

More affordable and portable molecular tests are making these technologies usable in smaller hospitals and low-resource areas. International diagnostics companies are working with local healthcare providers to share technology and offer training programs that support long-term market development.

Oncology Molecular Diagnostic Market: Challenges

Technical complexity and the need for a specialized workforce

The oncology molecular diagnostic market faces challenges due to the technical complexity of molecular testing and the need for a specialized workforce. These tests require lab professionals skilled in molecular biology, genomics, and bioinformatics, but many regions face shortages of trained staff.

As molecular diagnostic technology continues to evolve rapidly, laboratory workers require ongoing training to stay current with new testing methods and platforms. Ensuring quality control and standardization across laboratories is challenging, as test result variations can impact treatment decisions.

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Oncology Molecular Diagnostic Market: Report Scope

Oncology Molecular Diagnostic Market: Segmentation

The global oncology molecular diagnostic market is segmented into technology type, cancer type, sample type, end-user, and region.

Based on technology type, the market is segregated into polymerase chain reaction, next-generation sequencing, in situ hybridization, and immunohistochemistry. Next-generation sequencing leads the market due to its comprehensive genomic analysis capabilities, decreasing costs, and widespread adoption for cancer genomic profiling and personalized treatment selection.

Based on cancer type, the oncology molecular diagnostic industry is classified into breast cancer, lung cancer, colorectal cancer, prostate cancer, and blood cancer. Breast cancer holds the largest market share due to established screening programs, high prevalence rates, well-defined biomarkers for targeted therapy selection, and strong advocacy for personalized treatment approaches.

Based on sample type, the oncology molecular diagnostic market is divided into tissue samples, blood samples, urine samples, and other biological samples. Tissue samples are expected to lead the market during the forecast period due to their comprehensive genetic information content, established clinical protocols, and gold standard status for cancer diagnosis and molecular profiling.

Based on the end-user, the market is segmented into hospitals, diagnostic laboratories, research institutes, and cancer centers. Hospitals lead the market share due to their central role in cancer care delivery, increasing adoption of molecular testing for treatment planning, and growing integration of precision medicine approaches in clinical practice.

Oncology Molecular Diagnostic Market: Regional Analysis

North America to lead the market

North America leads the global oncology molecular diagnostic market because of its advanced healthcare systems, high cancer rates, and strong reimbursement support for testing. The region also hosts many top diagnostic companies and research institutions. It makes up about 42% of the global market, with the U.S. being the biggest user of these services.

Many healthcare centers have adopted full-scale molecular testing programs, which keeps demand high for advanced diagnostics and personalized cancer care.

The region supports strong research in diagnostics and biomarker discovery through its research and development ecosystem. Partnerships among pharmaceutical companies, diagnostic firms, and healthcare providers have built a solid network for precision oncology. Government investment in cancer research and precision medicine is also boosting the use of these technologies across healthcare systems.

Europe is expected to show substantial growth.

Europe is experiencing robust growth in the oncology molecular diagnostic market as healthcare systems transition toward precision medicine. Governments across EU countries are launching national cancer strategies that support this transition. Europe’s focus on quality care and patient outcomes aligns well with the advantages of molecular diagnostics in cancer treatment.

Healthcare providers are using these tools for treatment planning and for choosing patients in clinical trials. The region has a strong pharmaceutical industry and takes part in global cancer research, driving demand for advanced tests. European regulations support innovation and new diagnostic approvals while ensuring patient safety and test reliability.

Recent Market Developments:

• In April 2025, Roche Diagnostics launched a comprehensive tumor profiling assay that can analyze over 500 cancer-related genes from a single tissue sample, enabling more precise treatment selection for oncology patients.
• In March 2025, Illumina announced a partnership with major cancer centers to develop next-generation sequencing protocols for liquid biopsy applications in early cancer detection and monitoring.

Oncology Molecular Diagnostic Market: Competitive Analysis

The global oncology molecular diagnostic market is led by players like:

• Roche Diagnostics
• Illumina Inc.
• Thermo Fisher Scientific Inc.
• Agilent Technologies Inc.
• QIAGEN N.V.
• Abbott Laboratories
• Danaher Corporation
• Bio-Rad Laboratories Inc.
• PerkinElmer Inc.
• Genomic Health Inc.
• Foundation Medicine Inc.
• Guardant Health Inc.
• Exact Sciences Corporation
• Myriad Genetics Inc.
• NeoGenomics Inc.
• Castle Biosciences Inc.
• Veracyte Inc.
• Molecular MD Corp.
• Personal Genome Diagnostics Inc.
• Tempus Labs Inc.

The global oncology molecular diagnostic market is segmented as follows:

By Technology Type

• Polymerase Chain Reaction
• Next-Generation Sequencing
• In Situ Hybridization
• Immunohistochemistry

By Cancer Type

• Breast Cancer
• Lung Cancer
• Colorectal Cancer
• Prostate Cancer
• Blood Cancer

By Sample Type

• Tissue Samples
• Blood Samples
• Urine Samples
• Other Biological Samples

By End User

• Hospitals
• Diagnostic Laboratories
• Research Institutes
• Cancer Centers

By Region

• North America
  • The U.S.
  • Canada
• Europe
  • France 
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa