The U.S. oncology molecular diagnostics market is projected to grow from approximately USD 909 million in 2025 to over USD 2.5 billion by 2034, driven by rising demand for personalized medicine, technological advances, and increased adoption of AI tools for early cancer detection, tumor subtyping, and therapy decision-making.

Market growth is fueled by the increasing global cancer burden, advancements in minimally invasive liquid biopsy techniques like ctDNA testing, and significant government investments in cancer research and diagnostics innovation.

Recent collaborations and product launches, such as OmniPathology’s partnership with Delta Medical Laboratories and Guardant Health’s collaboration with Pfizer, demonstrate ongoing industry innovation and strategic alliances.

Major industry players include Abbott Laboratories, Becton, Dickinson and Company, bioMerieux SA, Bio-Rad Laboratories, Danaher, Roche, Siemens, QIAGEN, Sysmex, and Thermo Fisher Scientific, competing through continuous innovation.

Stakeholders are focusing on strategic investments in AI platforms, partnerships, and regulatory alignment to maximize market share and clinical impact, with companies also leveraging collaborations across sectors.

Pharmaceutical and biotech firms utilize AI to optimize clinical trials, accelerate patient recruitment, and improve endpoint prediction, supporting faster development of targeted therapies.

Technological advancements include AI-powered radiology and pathology tools, genomic data integration, and AI deployment in clinical trials, all enhancing diagnostic accuracy and operational efficiency.

Key technological segments such as NGS, PCR, IHC, and liquid biopsy are primarily applied in cancers like lung, breast, prostate, and colorectal, with NGS holding a significant market share.

North America currently leads the market with over 42% share, driven by advanced healthcare infrastructure, while Asia Pacific is the fastest-growing region supported by startups and large patient populations.

Growth opportunities are centered around imaging analytics, genomics, clinical decision support, digital pathology, and AI-driven clinical trials, with regional and cancer-specific expansion.

Challenges to adoption include regulatory fragmentation, high implementation costs, data privacy concerns, and clinician trust issues, which could slow market expansion.

Recent FDA approvals in September 2025, such as Thermo Fisher’s Oncomine Dx Target Test and Roche’s VENTANA MET RxDx Assay, expand options for personalized cancer treatment.

The market continues to see innovation through the launch of multi-cancer detection tests and non-invasive cytology, with key players like Illumina, Thermo Fisher, and others leading the way.