Oncology-Based Molecular Diagnostics Market Report Scope & Overview:

The Oncology-Based Molecular Diagnostics Market was valued at USD 2.76 billion in 2023 and is expected to reach USD 7.71 billion by 2032, growing at a CAGR of 12.12% over the forecast period of 2024-2032. This report features adoption and use patterns of molecular diagnostic tests by region and cancer type, spurred by advances in precision medicine and growing awareness of early detection of cancer. The report analyzes reimbursement and healthcare expenditures on oncology molecular diagnostics, varied by payer type and region, affecting accessibility to the market. Further, it delves into pipeline development and R&D directions, focusing on novel biomarker-based tests and liquid biopsy technologies likely to revolutionize cancer diagnostics. Trends in regulatory and approval processes are also vital in market growth, as changing guidelines across geographies influence test validation, commercialization, and market entry strategies.

The U.S. Oncology-Based Molecular Diagnostics Market was valued at USD 0.90 billion in 2023 and is expected to reach USD 2.29 billion by 2032, growing at a CAGR of 10.99% over the forecast period of 2024-2032. In the United States, the oncology molecular diagnostics market is experiencing robust growth, driven by increasing government spending on cancer research, increased insurance coverage for genetic testing, and the incorporation of AI-powered diagnostics to increase early detection and treatment accuracy.

Market Dynamics

Drivers

• The growing shift toward precision medicine and the increasing demand for early cancer detection are major drivers of the oncology-based molecular diagnostics market.

Molecular diagnosis facilitates personalized treatment by detecting genetic mutations and biomarkers, for which targeted therapies can be more effective. The increasing incidence of cancer—estimated at 20 million new cases worldwide in 2023 (WHO)—has further strengthened the call for early and precise diagnosis. Sophisticated molecular diagnostic methods such as next-generation sequencing (NGS) and liquid biopsy have found universal acceptance because they can identify cancer at an early stage with high precision. In addition, the pharmaceutical industry is working with diagnostic companies to produce companion diagnostics, and more than 80% of oncology drugs under development necessitate testing for biomarkers (FDA, 2023). Ongoing innovation, including AI-based molecular diagnostics and diminishing costs of genomic testing, contributes further to drive the market growth. The broadening use of liquid biopsy, which is set to substitute standard biopsy in numerous applications, also contributes significantly towards driving adoption. In addition, regulatory agencies such as the FDA and EMA are accelerating approvals for new molecular diagnostics, which is spurring innovation in this area. With more focus on personalized oncology therapy and better patient outcomes, molecular diagnostics will transform cancer care.

Restraints

• The high cost of oncology-based molecular diagnostics remains a significant barrier to widespread adoption.

Most of these advanced methods, including next-generation sequencing (NGS) and liquid biopsy, are costly, requiring specialized personnel and expensive machinery, and are thus not accessible to most health facilities. Comprehensive genomic profiling costs between USD 2,000 and USD 5,000 per test, which restricts access, especially in developing countries where the health infrastructure is not strong. Furthermore, reimbursement issues are an added obstacle because most insurance providers fail to provide comprehensive coverage of molecular diagnostics, so patients must carry the expense. Only 60% of cancer molecular diagnostic tests are paid for by insurance plans, with affordability being the major concern (American Cancer Society, 2023). Regulation is also another impediment slowing down market penetration. Although the FDA cleared more than 20 new oncology molecular tests in 2023, the process of approval is still long and complicated, hindering market entry for innovative diagnostics. Infrastructure issues, such as a shortage of trained molecular pathologists and the requirement for specialized laboratories, also limit the use of these sophisticated tests. Until the cost is brought down and reimbursement policies are optimized, access to oncology-based molecular diagnostics will continue to be an issue in most areas.

Opportunities

• Technological advancements in molecular diagnostics present a significant opportunity for market expansion, particularly with the growing adoption of liquid biopsy.

In contrast to conventional tissue biopsies, liquid biopsies provide a less invasive method for identifying circulating tumor DNA (ctDNA) and other biomarkers in blood tests. The international market for liquid biopsies is anticipated to expand by more than 20% CAGR over the forecast period, which is fueled by its potential to identify cancer early and track response to treatment in real time. In addition, artificial intelligence (AI) and machine learning (ML) are transforming molecular diagnostics through enhanced accuracy of data analysis and the automation of genetic variant interpretation. Guardant Health and Illumina are utilizing AI-based algorithms to increase the precision of cancer detection and choice of treatment. A further key opportunity is to expand companion diagnostics, where molecular tests direct targeted therapies. As more than 60% of emerging cancer drugs in development need biomarker-based patient stratification (GlobalData, 2023), diagnostic companies can partner with pharmaceutical companies to fuel innovation. In addition, the increasing demand for home-test kits, like liquid biopsy kits for the early detection of cancer, offers new growth opportunities. With technology advancing and prices coming down, molecular diagnostics will find its way to more people, opening up rich market opportunities.

Challenges

• The oncology-based molecular diagnostics market faces significant challenges due to regulatory complexities and data privacy concerns.

The process of approval of molecular diagnostics is rigorous, with regulatory agencies such as the FDA, EMA, and CFDA demanding substantial clinical verification before tests are permitted to be marketed. The 2023 FDA diagnostic reform has added scrutiny to laboratory-developed tests (LDTs), raising uncertainty for diagnostic companies. Further, differences in global regulatory regimes complicate companies' ability to commercialize tests in several markets, pushing product launches. Another key issue is data protection and cybersecurity. Molecular diagnostics use genetic information, which is very sensitive and requires strict privacy measures such as HIPAA (United States), GDPR (Europe), and China's Data Security Law. Data theft is a huge threat, and more than 35% of healthcare organizations faced cyberattacks in 2023 (IBM Security Report). Anxiety regarding patient data security can put the brakes on the uptake of cloud-based molecular diagnostic platforms. Additionally, physician and patient resistance to the implementation of new genomic testing technologies, out of ignorance or mistrust in test reliability, is an ongoing issue. In the absence of streamlined regulations and stronger data protection protocols, the broad adoption of molecular diagnostics may encounter serious impediments.

Segmentation Analysis

By Type

Breast cancer was the largest revenue contributor to the oncology-based molecular diagnostics market in 2023. Breast cancer's high incidence rate, with more than 2.3 million new cases reported worldwide in 2023 (WHO), has created demand for molecular diagnostics. The existence of several biomarker-based tests, including HER2, BRCA1/BRCA2, and hormone receptor testing, also boosted its dominance. Furthermore, elevated awareness, large-scale screening programs, and improvements in liquid biopsy technologies have contributed to market expansion.

Liver and prostate cancer diagnostics, however, are seeing tremendous growth. Molecular diagnostics of liver cancer are growing because of the growing incidence of hepatocellular carcinoma (HCC), which causes 75-85% of liver cancers, and the growing adoption of liquid biopsy for the early detection of circulating tumor DNA (ctDNA). Likewise, diagnostics in prostate cancer are increasing at a rapid pace with molecular tests based on PSA and next-generation sequencing (NGS) increasing in popularity. The emergence of non-invasive diagnostic technologies, including urine-based molecular tests, is also fuelling growth in this sector.

By Product

The reagents segment held 62.02% of the total market revenue in 2023 and was the leading product category. Reagents are key materials for molecular diagnostic tests such as PCR kits, sequencing reagents, and immunohistochemistry (IHC) assays. The demand for personalized medicine and biomarker-based cancer diagnosis has increased, contributing to increased consumption of reagents. Also, the growing adoption of companion diagnostics in targeted therapies for cancer has driven segment growth.

The instruments segment is also expected to grow strongly as laboratories and research institutions invest in newer molecular diagnostic platforms. The growing demand for automated PCR, NGS systems, and mass spectrometry-based analyzers is fueling the growth. The integration of AI-powered diagnostics and cloud-based data analytics is further enriching the functionalities of contemporary molecular diagnostic instruments, making them an important area of growth.

By Technology

Polymerase chain reaction (PCR) was the market leader with the highest revenue share of 36% in 2023. PCR is the gold standard for the detection of cancer biomarkers because it has high sensitivity, short turnaround time, and is cost-effective. PCR is universally used to identify genetic mutations, oncogenes, and fusion transcripts in a variety of cancer forms, such as BRAF (melanoma), EGFR (lung cancer), and KRAS (colorectal cancer). The growing use of real-time PCR (qPCR) and digital PCR (dPCR) in cancer diagnosis also strengthens its market leadership.

The sequencing segment is expected to observe the fastest expansion as a result of the growing use of next-generation sequencing (NGS) for broad genomic profiling. As the demand for personalized cancer therapy grows, NGS is being made necessary in detecting various genetic mutations at one time, facilitating targeted therapy. Technical progress in whole genome sequencing (WGS) and RNA sequencing is propelling further use in cancer diagnostics. Further, declining costs of sequencing and the presence of AI-driven genomic interpretation software are making sequencing affordable for routine clinical use.

Regional Analysis

North America was the largest oncology-based molecular diagnostics market in 2023, led by sophisticated healthcare infrastructure, rapid precision medicine adoption, and robust research grants. Having major market players like Thermo Fisher Scientific, Illumina, and Roche Diagnostics has also fortified the region's position in the market. The U.S. enjoys the largest market share, buoyed by supportive reimbursement regimes and high cancer screening rates. The FDA approval of more than 20 new oncology molecular diagnostic tests during 2023 has also helped speed up market growth. The increasing usage of companion diagnostics for targeted cancer therapy is also driving demand.

Asia-Pacific is the region growing most rapidly, with a greater emphasis on early cancer detection and molecular testing. The region is set to grow extensively with rising incidences of cancer, enhanced healthcare accessibility, and precision medicine initiatives from the government. More than 9.5 million new cancer cases were reported in Asia in 2023, as per the World Health Organization (WHO), and these represented close to 50% of global cases. China, India, and Japan are at the forefront of this growth, with rising investments in AI-based diagnostics, liquid biopsy, and NGS. Growing partnerships between pharmaceutical companies and diagnostic players, as well as reducing the cost of sequencing, are further driving the market in this region.

Key Players

• Abbott – Alinity m RT-PCR, Vysis FISH Assays, RealTime IDH1 and IDH2 Assays

• Bayer AG – NTRK Companion Diagnostics, Liquid Biopsy for Oncology

• BD (Becton, Dickinson and Company) – BD MAX MDR-TB Assay, BD Onclarity HPV Assay

• Cepheid – Xpert Bladder Cancer Monitor, Xpert BCR-ABL Ultra

• Agilent Technologies, Inc. – SureSelect XT HS2 DNA Target Enrichment, Dako HER2 CISH PharmDx Kit

• Danaher – DxH 900 Hematology Analyzer, HER2 FISH, and IHC Assays

• Hologic, Inc. – Aptima HPV and Cervical Cancer Assays, Panther Fusion Oncology Tests

• Qiagen – therascreen KRAS RGQ PCR Kit, QIAseq Targeted DNA Panels

• F. Hoffmann-La Roche Ltd. – cobas EGFR Mutation Test, FoundationOne CDx

• Siemens Healthineers – Atellica Solution Molecular Diagnostics, ADVIA Centaur Oncology Markers

• Sysmex – HISCL Tumor Marker Assays, OncoBEAM Liquid Biopsy Assays

Recent Developments

• In July 2024, Lantern Pharma made significant progress in developing a molecular diagnostic for patient selection and stratification in oncology clinical trials using its drug candidate LP-184. The diagnostic, based on qRT-PCR technology, measures PTGR1 RNA levels in tumor samples to assess sensitivity to LP-184.

• In Nov 2023, Amoy Diagnostics (AmoyDx) and Cell Signaling Technology (CST) expanded their partnership to advance the development of companion diagnostics (CDx) in China. This collaboration will provide AmoyDx access to CST's highly validated antibodies for critical CDx targets, supporting the growing demand for precision oncology therapeutics in the region.