Oncology Molecular Diagnostics Market to Reach US$6.46 Billion by 2033, Growing at 6.2% CAGR | North America Dominates with 44.27% Market Share | DataM Intelligence

Leander, Texas and Tokyo, Japan - Dec 03, 2025
According to DataM Intelligence, the global oncology molecular diagnostics market size reached US$3.79 billion in 2024 from US$3.59 billion in 2023 and is expected to reach US$6.46 billion by 2033, growing at a CAGR of 6.2% during the forecast period 2025-2033. This steady growth is propelled by the rising global cancer burden, increasing adoption of personalized medicine, advancements in genomic technologies, growing demand for companion diagnostics for targeted therapies, and expanding applications in early detection and minimal residual disease (MRD) monitoring.

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Report Details:
• No. of Pages: 180
• Forecast Period: 2025-2033
• Market Size (2024): $3.79 Billion
• Market Size (2033): $6.46 Billion
• Compound Annual Growth Rate: 6.2%
• Regions Covered: Global

Global Recent Developments:
✅ November 2025: F. Hoffmann-La Roche Ltd received FDA approval for the "AVENIO Edge" system, a fully automated, cartridge-based NGS platform designed for clinical labs to run comprehensive genomic profiling (CGP) tests in under 24 hours, significantly reducing turnaround time for therapy selection.
✅ November 2025: Burning Rock Biotech (China) secured CE-IVD marking for its "6D" pan-cancer early detection blood test, combining methylation, fragmentomics, and protein biomarkers with AI analysis, signaling the next frontier of molecular diagnostics beyond therapy selection.
✅ October 2025: Guardant Health and Illumina announced a strategic co-development agreement to create an integrated, high-throughput liquid biopsy workflow combining Guardant's bioinformatics with Illumina's NovaSeqTM X Plus sequencer, aiming to lower the cost of liquid biopsy CGP.
✅ October 2025: The National Comprehensive Cancer Network (NCCN) updated clinical guidelines for Lung Cancer and Colorectal Cancer to recommend broader use of liquid biopsy for initial molecular testing when tissue is insufficient, a major driver for the reagents and consumables market.
✅ September 2025: QIAGEN launched its "QIAsure Digital PCR" platform for ultra-sensitive detection of circulating tumor DNA (ctDNA) for MRD monitoring, achieving detection limits down to 0.001% variant allele frequency, directly challenging the dominant Polymerase Chain Reaction (PCR) segment with next-gen digital PCR.

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Competitive Landscape
The market is highly competitive with a mix of large, diversified diagnostics companies and specialized oncology-focused players.

1. F. Hoffmann-La Roche Ltd (Foundation Medicine, Roche Diagnostics) maintained leadership with 28% global market share, leveraging its integrated portfolio from instruments (AVENIO, Cobas) to tissue and liquid biopsy CGP tests, reporting 20% revenue growth in 2024-2025.
2. Abbott Laboratories captured 18% market share, with a strong position in PCR-based companion diagnostics (e.g., for ALK, EGFR) and growing NGS offerings, achieving 15% growth.
3. QIAGEN held 15% market share, dominating the sample preparation and bioinformatics segments while expanding into digital PCR and NGS automation, reporting 22% growth.
4. Bio-Rad Laboratories, Inc. was a leader in the digital PCR niche for high-sensitivity applications with 12% market share, achieving 25% growth.
5. Illumina (via its clinical oncology segment and partnerships) drove the underlying Next-Generation Sequencing (NGS) technology adoption with 10% market share in the diagnostics space, growing at 30%.

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Segmentation Analysis
By Technology
• Based on technology, the Polymerase Chain Reaction (PCR) segment led the market with the largest revenue share of 52.12% in 2024, due to its entrenched use in high-volume, single-gene companion diagnostic tests (e.g., for EGFR, BRAF, KRAS), its cost-effectiveness, rapid turnaround, and widespread availability in Clinical Laboratories. However, it is growing at a slower rate than NGS.
• Next-Generation Sequencing (NGS) is the fastest-growing segment, driven by the need for multi-gene panels and comprehensive genomic profiling to guide complex treatment decisions with targeted therapies and immunotherapies.

By Application
• Lung Cancer and Breast Cancer are the largest application segments due to the high incidence of these cancers and the well-established landscape of actionable biomarkers (EGFR, ALK, ROS1, PD-L1, HER2, ESR1, PIK3CA).
• Blood Cancers are a high-growth segment due to the extensive use of molecular diagnostics for classification, prognosis, and MRD monitoring using highly sensitive PCR and NGS assays.

By End-User
• Clinical Laboratories are the largest end-user segment, as they perform the bulk of high-complexity molecular testing, including send-out tests for large NGS panels.
• Hospitals are increasing their in-house molecular diagnostics capabilities to accelerate treatment decisions, especially for time-sensitive cancers.

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Regional Analysis:
North America dominates the oncology molecular diagnostics market with the largest revenue share of 44.27% in 2024. This leadership is driven by high cancer care expenditure, favorable reimbursement for molecular tests (through CMS and private payers), a strong concentration of leading test developers and pharma companies, and well-established guidelines promoting biomarker testing.

The Asia Pacific is the fastest-growing region and is expected to grow at the fastest CAGR of 6.7% over the forecast period. Growth is fueled by rising cancer incidence, improving healthcare infrastructure, increasing awareness of personalized medicine, growing local manufacturing of instruments and reagents, and expansion of key global players into these high-potential markets.

Market Trends & Drivers
The Oncology Molecular Diagnostics Market is evolving from single-gene tests to comprehensive profiling. Key trends include the rapid adoption of liquid biopsy for its non-invasive nature and ability to capture tumor heterogeneity, the integration of AI for variant interpretation and reporting, the development of ultra-sensitive technologies (dPCR, NGS) for MRD detection, expansion into early cancer detection (multi-cancer early detection tests), and increasing partnerships between diagnostic companies and pharmaceutical firms for co-development of companion diagnostics. The precision medicine mandate, technological innovation, and expansion into new clinical utilities are driving growth.

Related Reports:
1. Companion Diagnostics Market - https://www.datamintelligence.com/research-report/companion-diagnostics-market?jd
2. Next Generation Sequencing Market - https://www.datamintelligence.com/research-report/next-generation-sequencing-ngs-market?jd
3. Liquid Biopsy Market - https://www.datamintelligence.com/research-report/liquid-biopsy-market?jd

Contact Us:
Sai Kiran
DataM Intelligence 4market Research LLP
Phone: +1 877-441-4866
Email: Sai.k@datamintelligence.com

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