The North America Biomarkers Market is projected to grow from USD 25.13 billion in 2025 to USD 42.25 billion by 2030, registering a CAGR of 11.0% during the forecast period. Growth is supported by accelerating adoption of precision medicine, expanding use of companion diagnostics, and sustained R&D investments across oncology, infectious diseases, and immunology.
Advances in genomic technologies, regulatory focus on safety validation, and strong public and private funding ecosystems are reinforcing biomarker integration across drug discovery, clinical trials, and diagnostic workflows.
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Safety Biomarkers Lead the Market by Type
The North America biomarkers market is segmented into safety, efficacy, and validation biomarkers. Efficacy biomarkers are further categorized into predictive, surrogate, pharmacodynamic, and prognostic biomarkers. The safety biomarkers segment accounted for the largest share of the biomarkers market in 2024. This is due to the adoption of safety biomarkers in drug development, advances in techniques and tools for toxicity testing, and early detection of potential adverse reactions. Regulatory bodies are demanding the use of safety biomarkers in candidate drugs to evaluate safety standards before progressing to other stages of clinical testing.
NGS Segment to Register the Fastest Growth
The North America biomarkers market is segmented by technology into immunoassays, NGS, PCR, mass spectrometry, chromatography, and other technologies. NGS technology is estimated to register the highest CAGR during the forecast period of 2025-2030. Next-generation sequencing (NGS) refers to a group of high-throughput DNA and RNA sequencing technologies that can read millions of fragments in parallel, enabling rapid, large-scale genomic analysis. These platforms underpin many biomarker applications, including whole-genome and exome sequencing, targeted gene panels, RNA-seq, and single-cell sequencing, which support the discovery and validation of complex genomic, transcriptomic, and epigenetic biomarkers in oncology and other disease areas.
United States Dominates Regional Revenue
The North America biomarkers market is divided primarily between the US and Canada, with the US accounting for the largest share of regional revenues. The country’s dominance reflects its dense concentration of biopharma headquarters, academic medical centers, and specialized reference laboratories, along with strong FDA oversight and rapid adoption of advanced diagnostic platforms and companion tests. Large oncology and immunology pipelines, robust NIH and cancer-focused funding, and an active clinical-trials ecosystem further cement the US as the primary engine of biomarker demand within North America.
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Competitive Landscape
Key players operating in the North America biomarkers market include: Abbott (US), Thermo Fisher Scientific Inc (US), Revvity (US), Laboratory Corporation Of America Holdings (US), Charles River Laboratories (US), Bio-Rad Laboratories, Inc (US), Agilent Technologies, Inc (US), Quanterix (US).
Strategic Outlook
The North America biomarkers market is increasingly central to drug development efficiency and personalized medicine delivery.
Companies that align safety validation strategies with genomic innovation and companion diagnostic expansion will be best positioned to capitalize on rising oncology and immunology pipelines through 2030.
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