United States Next Generation Cancer Diagnostic Devices Market 2025: Industry Developments, Future Growth, Share & Industry Insights

"Global Next Generation Cancer Diagnostic Devices Market reached US$ 18.12 billion in 2024 and is expected to reach US$ 61.14 billion by 2033, growing at a CAGR of 15.2% during the forecast period 2025-2033." As per DataM intelligence research report

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USA - Recent Industry Developments 2025:

✅ 2025-01-02: Lucence - MolDX (Palmetto) decision / Medicare coverage recognition for LiquidHALLMARK® (ctDNA + ctRNA liquid biopsy), improving access and reimbursement pathways for next-gen liquid biopsies.

✅ 2025-01-10: Mayo Clinic Laboratories partners with Lucence to provide access to Lucence's LiquidHALLMARK testing through Mayo Clinic Labs (commercial & clinical access expansion).

✅ 2025-02-04: Guardant Health's blood-based colorectal screening (Shield) becomes available in early US rollouts (example: Austin clinics begin offering the test), marking MCED / organ-specific blood test commercial availability.

✅ 2025-04-28: Guardant Health launches Guardant360 Tissue - a tissue molecular profiling test with multi-omic analysis (new product expansion from a leading liquid-biopsy firm into tissue multi-omics).

✅ 2025 (multiple reports): FDA approvals and companion-diagnostic activity continue (Foundation Medicine/FDA approvals for FoundationOne CDx indications in Jan 2025), keeping comprehensive genomic profiling and companion diagnostics as an active launch/approval area.

Europe - Recent Industry Developments 2025:

✅ 2025-05-12 → 2025-07-24: Roche - multiple diagnostics initiatives and product rollouts across 2025 (upgrades to cobas systems, new mass-spec & digital pathology capabilities showcased at ADLM/Diagnostics events), underlining large-player investment in lab automation and oncology diagnostics.

✅ 2025-08-05 (deal announced): MDxHealth signs definitive agreement to acquire Exosome Diagnostics business from Bio-Techne (European player activity acquiring exosome/EV-based test assets enlargement of molecular diagnostics portfolios).

Japan - Recent Industry Developments 2025:

✅ 2025-07-23: MiRXES Japan + Nagawa Pharmaceutical - launch of a nationwide gastric-health public initiative using GASTROClearTM (miRNA blood test) with plans to screen up to 10,000 people - significant real-world roll-out of a next-gen non-invasive gastric-cancer test in Japan.

✅ 2025 (published study): Japanese clinical validation data for GASTROClear reported in 2025 (pilot cohort; shows promising sensitivity/AUC in detecting early gastric cancer) academic support for commercial roll-outs.

South Korea - Recent Industry Developments 2025:

✅ 2025-07-25: Seegene (Korea) announced plans to unveil / demonstrate CURECATM (fully automated PCR/processing system) and STAgora (global data platform) at ADLM 2025 - signals Korean vendors pushing automation + data-platform integrations (helps throughput for molecular oncology tests).

✅ 2025 (industry snapshots / conferences): KALC 2025 (Korean conference, Nov 6-7, 2025) and other APAC gatherings highlighted rapid uptake of liquid-biopsy R&D, AI-enabled MCED research, and local startup activity Korea remains active on MCED / AI-assisted diagnostics research.

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Regional share & dynamics:

➠ North America - market leader (largest share, ~40%+): mature healthcare systems, strong R&D, early adoption of NGS and liquid-biopsy tests, and improving Medicare/insurer coverage make North America the largest market.

➠ Europe - significant share, driven by established screening programs: good clinical infrastructure and reimbursement in major Western European countries support adoption, though uptake varies by country.

➠ Asia-Pacific - fastest growth (highest CAGR outlook): expanding healthcare access, government screening initiatives, rising cancer burden and growing local manufacturing/partnerships point to the strongest regional growth rates.

Key growth drivers:

✅ Rising cancer prevalence and ageing populations - increasing screening and monitoring needs drive demand for sensitive, scalable diagnostics.

✅ Shift to precision oncology & targeted therapies - clinicians require molecular profiling (NGS panels, companion diagnostics) to match patients to targeted drugs and immunotherapies.

✅ Technological advances & falling NGS costs - improved sequencing throughput, assay sensitivity and lower per-test costs make routine genomic testing more practical.

✅ Liquid biopsy momentum - blood-based assays for ctDNA/ctRNA enable minimally invasive early detection, treatment selection and recurrence monitoring; their commercialisation and reimbursement progress is a major adoption accelerator.

✅ AI and software analytics - AI for image analysis and multi-omic data interpretation improves diagnostic accuracy and speeds clinician workflows.

Market Major Players: GE HealthCare, Illumina, Inc., Novartis AG, F. Hoffmann-La Roche Ltd, Koninklijke Philips N.V, QIAGEN, Agilent Technologies, Inc., Abbott, Thermo Fisher Scientific Inc and BD.

Segment Covered in the Market:

By Technology - Next-generation Sequencing, qPCR & Multiplexing, Lab-on-a-chip (LOAC), Protein Microarrays, DNA Microarrays

By Cancer Type - Lung Cancer, Breast Cancer, Colorectal Cancer, Cervical Cancer, Others

By Application - Biomarker Development, CTC Analysis, Proteomic Analysis, Epigenetic Analysis, Genetic Analysis

By End User - Hospitals, Cancer Research Institutes, Diagnostic Centres

Research Process:

Both primary and secondary data sources have been used in the Next Generation Cancer Diagnostic Devices Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

Most Frequently Asked Questions in the Next Generation Cancer Diagnostic Devices Market Research Industry:

➠ Who leads the Next Generation Cancer Diagnostic Devices industry and what's their competitive positioning regarding capacity, performance, and profitability?
➠ What growth opportunities and market challenges do Next Generation Cancer Diagnostic Devices market vendors face?
➠ Which segments show the highest growth potential and market share distribution?
➠ What factors are driving or limiting Next Generation Cancer Diagnostic Devices market growth?
➠ What are the dominant sales and distribution strategies in the Next Generation Cancer Diagnostic Devices industry?

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Regional Analysis:

⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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✅ Consumer Behavior & Demand Analysis
✅ Import-Export Data Monitoring
✅ Live Market & Pricing Trends

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