United States Oncology Molecular Diagnostics Market to hit US$ 6.46 Billion by 2033: Forecasting in GCC and EMA

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

By 2040, new cancer cases worldwide are projected to surge to 29.9 million annually, with cancer-related deaths reaching 15.3 million. According to the International Agency for Research on Cancer, the global incidence of cancer is expected to hit 21.3 million cases in 2025, rising further to an estimated 24.1 million by 2030.

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United States: Recent Industry Developments

✅ November 2025: Foundation Medicine launched an expanded liquid biopsy panel enabling earlier detection of multiple cancer types.

✅ September 2026: Guardant Health introduced AI-powered molecular diagnostic platforms to enhance precision oncology workflows.

✅ August 2026: FDA approved a new companion diagnostic test for targeted therapy in non-small cell lung cancer (NSCLC).

GCC: Recent Industry Developments

✅ October 2025: King Faisal Specialist Hospital integrated next-gen sequencing (NGS) based molecular diagnostics for personalized cancer care.

✅ August 2026: GCC countries increased investments in molecular pathology labs to support precision oncology initiatives.

✅ July 2026: Launch of regional collaborations to improve access to advanced oncology diagnostics in Saudi Arabia and UAE.

MENA: Recent Industry Developments

✅ November 2025: Leading hospitals in Egypt and Jordan adopted multiplex molecular assays for comprehensive cancer profiling.

✅ September 2026: Regional healthcare providers focused on capacity building and training for molecular diagnostics specialists.

✅ August 2026: Partnerships formed with global diagnostic firms to enhance cancer biomarker testing infrastructure across MENA.

Key Players:

Abbott, QIAGEN, F. Hoffmann-La Roche Ltd, BD, Cepheid, Hologic, Inc., Sysmex Corporation, Bio-Rad Laboratories, Inc., Foundation Medicine, Inc., and ASURAGEN, INC.

Stragic Insights From This Report

1. North America leads the oncology molecular diagnostics market, commanding the largest revenue share of 44.27% in 2024.

2. Meanwhile, the Asia Pacific region is emerging as the fastest-growing market, projected to expand at a robust CAGR of 6.7% throughout the forecast period. On the technology front, the Polymerase Chain Reaction (PCR) segment dominates, capturing the highest revenue share of 52.12% in 2024.

Growth Forecast Projection:

The Global Oncology Molecular Diagnostics Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Oncology Molecular Diagnostics 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.

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Key Segmentation:

By Product Type: (Reagents, Instruments, and Software)

By Technology: (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), In Situ Hybridization (ISH), and Others)

By Application: (Breast Cancer, Prostate Cancer, Colorectal Cancer, Cervical Cancer, Liver Cancer, Lung Cancer, Blood Cancer, and others)

By End-User: (Hospitals, Clinical Laboratories, and Others)

Latest M&A

Deal frenzy:

1. Abbott-Exact Sciences ($23B, Nov 2025): Cancer screening/diagnostics powerhouse; adds Cologuard, Oncotype DX to Alinity portfolio.​

2. NeoGenomics-Pathline (Apr 2025): Expands molecular/hematology-oncology testing in Northeast US.​

3. Q3 oncology M&A $9.4B (biologics lead); Genmab-Merus ($8B bispecifics), Roche-89bio ($3.5B) include CDx pipelines. Consolidation targets tumor profiling/liquid biopsy startups.

Regional Analysis for Market:

⇥ 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)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Oncology Molecular Diagnostics producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Oncology Molecular Diagnostics revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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Government Regulations

FDA:

1. Nov 2025 proposed order: Down-classifies nucleic acid oncology CDx from PMA (Class III) to Class II (21 CFR 866.6075, 510(k)); analytical/clinical performance + label alignment with therapeutics.​

2. Q3 2025 approvals: 27 indications (25 solid/6 heme); Guardant360 CDx for ESR1 breast cancer (imlunestrant).​

3. EMA: Q3 2025 approvals (denosumab biosimilar, lazertinib); EMA Regulatory Science 2025 emphasizes AI/multi-omics validation. Harmonization accelerates global trials

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