AUSTIN, Texas and TOKYO, Nov. 18, 2025 /PRNewswire/ -- DataM Intelligence announces the latest insights into the rapidly transforming Oncology Molecular Diagnostics Market, which increased from US$3.59 billion in 2023 to US$3.79 billion in 2024, and is projected to achieve US$6.46 billion by 2033, expanding at a CAGR of 6.2% during the forecast period. As global cancer incidence rises and precision oncology becomes standard clinical practice, the molecular diagnostics segment is emerging as a critical enabler of personalized treatment decisions, early detection, recurrence monitoring, and optimized therapeutic selection.

The oncology molecular diagnostics landscape is undergoing a profound shift-driven by next-generation sequencing (NGS), liquid biopsy adoption, FDA-approved companion diagnostics, multi-cancer early detection (MCED) innovation, and a strong pipeline of novel oncology therapeutics requiring biomarker-guided testing. Each of these factors is reshaping clinical workflows across hospitals, clinical laboratories, and specialty cancer centers worldwide.

Precision-Oncology Adoption and Technology Expansion Accelerate Global Market Growth

The transformation of cancer care toward personalized therapies is significantly increasing the demand for molecular testing platforms. Cancer treatment decisions are now routinely anchored in genomic alterations, such as EGFR, ALK, ROS1, BRCA1/2, BRAF, KRAS, HER2, and emerging biomarkers like MET exon 14 skipping, RET, NTRK fusions, and tumor mutational burden (TMB).

By technology type, the market is dominated by PCR, owing to its affordability, high-throughput screening capabilities, and routine integration into hospital laboratories for actionable biomarker detection. However, NGS is the fastest-growing technology, supported by the industry's shift toward multi-gene panels, whole-genome sequencing (WGS), and liquid biopsy-based solutions. In situ hybridization (ISH) and other platforms continue to provide value in targeted diagnostics and histopathology-guided testing.

On the basis of products, reagents hold the majority share, driven by the recurring nature of consumable usage in PCR and NGS workflows. Instruments-including automated sequencing systems and digital PCR platforms-remain essential capital investments for advanced oncology research centers. Software is rapidly becoming indispensable, with AI-driven genomic analysis, variant interpretation tools, and clinical decision-support platforms streamlining the complexities of multi-omic data.

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Cancer-Specific Diagnostics Shape Market Demand Across Major Tumor Types

By application, the oncology molecular diagnostics market spans a broad landscape of high-burden cancers.
Breast cancer, driven by HER2 amplification and BRCA mutation testing, represents a significant share of the global diagnostic volume.
Lung cancer continues to be one of the most dynamic areas, with molecular panels essential for identifying biomarkers such as EGFR mutations, ALK and ROS1 rearrangements, and PD-L1 expression supporting immunotherapy decisions.
Colorectal and prostate cancers are increasingly reliant on genomic profiling to guide precision therapies.
Blood cancer diagnostics (including AML, ALL, and lymphomas) are rapidly transitioning toward NGS-based minimal residual disease (MRD) monitoring, further elevating the demand for high-sensitivity molecular assays.

Liver cancer, cervical cancer, and other tumor types continue to expand the market footprint as global screening initiatives and early-detection programs intensify.

Rising Clinical Adoption Across Hospitals and Labs Strengthens Market Penetration

Hospitals remain the leading end-user segment, driven by the integration of molecular diagnostics into pathologist workflows and multidisciplinary cancer care protocols.
Clinical laboratories are scaling their capabilities with advanced automated platforms, particularly in the U.S., Europe, and Japan, where adoption of NGS-based panels and liquid biopsy solutions is accelerating.

Specialty oncology centers and research institutes represent another growing market, propelled by their increased involvement in clinical trials, biomarker validation studies, and precision-medicine research.

Competitive Landscape: Major Diagnostics Leaders Expand Their Oncology Footprint

The Oncology Molecular Diagnostics Market features a competitive environment led by global innovators such as Abbott, QIAGEN, F. Hoffmann-La Roche Ltd, BD, Cepheid, Hologic Inc., Sysmex Corporation, Bio-Rad Laboratories, Foundation Medicine, and Asuragen. These companies continue to drive innovation across PCR kits, NGS panels, digital PCR systems, and companion diagnostics (CDx).

• Abbott strengthens its oncology testing solutions with versatile PCR platforms and high-throughput laboratory systems.
• QIAGEN maintains a significant foothold with its QIASymphony and QIAstat-Dx systems, along with expanding CDx collaborations.
• Roche continues to dominate the precision-diagnostics space with its broad NGS portfolio, including AVENIO liquid biopsy tests and the FoundationOne CDx platform.
• Cepheid accelerates point-of-care oncology diagnostics with rapid PCR testing.
• Hologic and Bio-Rad drive high-throughput molecular workflows across labs globally.
• Sysmex and Asuragen enhance their genetic testing and cancer mutation-detection portfolios.

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Regulatory Advancements: FDA Approvals Fuel Market Growth

FDA approvals remain a key growth accelerator for oncology molecular diagnostics. In recent years, the U.S. FDA has approved several landmark tests that reinforce the importance of molecular diagnostics in cancer care:

Notable Recent FDA Approvals in Molecular Oncology Diagnostics (Indicative Examples):

• FoundationOne CDx approvals for multiple targeted therapies including EGFR, ALK, BRAF, and RET inhibitors, reinforcing the role of comprehensive genomic profiling (CGP).
• Guardant360 CDx liquid biopsy approval for advanced non-small cell lung cancer biomarkers, enabling non-invasive companion diagnostics.
• Roche's cobas EGFR Mutation Test v2, which supports targeted therapy decisions for NSCLC patients.
• Next-generation sequencing-based MRD tests gaining traction in hematologic malignancies.
• HER2-low and HER2-advanced diagnostic approvals supporting new breast cancer therapeutic pathways.

These regulatory movements are reshaping treatment patterns by aligning drug approvals directly with advanced diagnostics, enabling faster clinical integration and broader patient access.

Pipeline Analysis: Emerging Therapies Reinforce Need for Molecular Diagnostics

The oncology pipeline is expanding rapidly, with more than 2,000 active clinical trials requiring biomarker-based screening and genomic profiling.
Notable pipeline directions influencing diagnostics demand include:

• Next-generation targeted therapies focused on KRAS G12C, HER2-low, CLDN18.2, and FGFR mutations.
• Multi-target RNA-based therapeutics requiring advanced transcriptomic diagnostics for patient stratification.
• Bispecific antibodies and CAR-T cell therapies, each of which depends on molecular characterization and MRD monitoring.
• Immunotherapy resistance markers, including TMB, MSI-H, and PD-L1, shaping next-line treatment decisions.
• Emerging MCED (Multi-Cancer Early Detection) pipelines, which are expected to revolutionize early screening using ctDNA, methylation markers, and AI-driven signal detection.

The convergence of diagnostics with therapeutic innovation is expected to significantly expand oncology testing volumes globally throughout 2025–2033.

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Market Outlook: Rising Cancer Burden and Precision Medicine Investments Will Accelerate Growth

With global cancer incidence projected to exceed 30 million cases annually by 2040, healthcare systems are pivoting toward earlier identification, accurate mutation detection, and real-time monitoring. Governments and private health systems are increasing investments in genomic infrastructure, molecular testing automation, reimbursement frameworks, and national cancer-mapping initiatives.

Asia-Pacific remains the fastest-growing region, driven by expanding genomic testing capabilities in China, India, Japan, and South Korea. North America continues to lead in adoption, with strong clinical demand, higher reimbursement levels, and rapid integration of CDx partnerships. Europe exhibits steady growth through precision-health initiatives and improved NGS accessibility.

About DataM Intelligence

DataM Intelligence is a global market research and consulting firm delivering actionable insights across healthcare, biotechnology, pharmaceuticals, and life sciences industries. With continuous database updates, in-depth competitive intelligence, and 360-degree market coverage, DataM Intelligence supports strategic decision-making for industry leaders worldwide.

Related Report:

1. DataM Intelligence Forecasts Molecular Diagnostics Market Size Growth from US$ 21.0 B in 2024 to US$ 37.2 B by 2033.
2. Point-of-Care Molecular Diagnostics Market Size to Grow from US $2.68 B in 2023 to US $4.17 B by 2031 - DataM Intelligence.
3. Cancer Molecular Diagnostics Market Size to Grow at 6.3% CAGR Through 2031 - According to DataM Intelligence.

About DataM Intelligence

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