U.S. Blood-based Biomarker For Parkinson's Disease Market Size, Share & Trends Analysis Report By Biomarker Type (Protein Biomarkers, Inflammatory Markers), By Technology (ELISA/Immunoassay, Multiplex Platforms), By End Use, And Segment Forecasts, 2025 - 2033

Market Size & Trends

The U.S. blood-based biomarker for parkinson’s disease market size was estimated at USD 45.75 million in 2024, and is projected to grow at a CAGR of 18.33% from 2025 to 2033. The U.S. Parkinson’s disease (PD) blood-based biomarkers market is driven by a growing patient population, with 90,000 new diagnoses annually, and increasing demand for early, non-invasive diagnostic tools. Expanding research efforts, especially in academic and pharmaceutical settings, are accelerating biomarker discovery and validation. Technological advancements in multiplex assays and AI-based platforms are further supporting adoption. In addition, collaborations involving the NIH, MJFF, and Verily are helping standardize biomarker use. As assays such as α-synuclein and NfL progress toward regulatory approval, their integration into clinical practice is becoming increasingly viable.

The U.S. blood-based biomarker for parkinson’s disease market is gaining significant momentum, fueled by the need for earlier diagnosis, improved disease monitoring, and more precise patient stratification in clinical trials. With over 1.1 million Americans currently living with Parkinson’s disease and an estimated 90,000 new diagnoses each year-a 50% increase over prior estimates-there is growing urgency for scalable, non-invasive diagnostic tools that go beyond traditional clinical evaluation and imaging.

Historically, PD diagnosis has relied heavily on the presence of motor symptoms, leading to frequent misdiagnoses and delayed treatment. Blood-based biomarkers offer a non-invasive, accessible alternative that can identify disease onset years before symptoms emerge. Key biomarkers under investigation include misfolded α-synuclein, neurofilament light chain (NfL), DJ-1, tau, inflammatory cytokines (e.g., IL-6, CRP), and oxidative stress markers. These are being developed across multiple technological platforms, including ELISA, multiplex proteomics, exosome-based assays, and AI-integrated multi-omics.

Amprion, a U.S.-based diagnostics company, is advancing a blood-based version of its SynRT™ test, which detects misfolded α-synuclein-a hallmark of PD pathology. Although currently approved only for cerebrospinal fluid (CSF), this test is undergoing clinical studies for blood validation. C2N Diagnostics, known for its Alzheimer’s PrecivityAD™ test, is extending its platform to PD with targeted assays for NfL and tau using mass spectrometry.

Pharmaceutical companies are also integrating biomarkers into therapeutic development. Denali Therapeutics and Biogen are utilizing phosphorylated Rab10 as a pharmacodynamic biomarker in trials for their LRRK2 inhibitors. Roche/Genentech is partnering with AC Immune to co-develop antibody-based therapies, while simultaneously validating associated α-synuclein biomarkers. These biomarkers are essential not only for determining therapeutic response but also for selecting appropriate patient subgroups-particularly those with LRRK2 or GBA mutations.

On the technology front, Olink Proteomics has deployed its Proximity Extension Assay (PEA) platform to identify PD-relevant protein panels, in partnership with the Michael J. Fox Foundation (MJFF). Meanwhile, Verily Life Sciences (an Alphabet subsidiary) is building AI-based multi-omic platforms to analyze blood, cerebrospinal fluid, and digital biomarkers as part of the MJFF-funded Parkinson’s Progression Markers Initiative (PPMI).

Academic institutions such as the University of Pennsylvania, Mayo Clinic, and Massachusetts General Hospital are also central to the biomarker ecosystem. They are running NIH- and MJFF-funded studies to validate exosomal α-synuclein, miRNA panels, and blood-based NfL as part of longitudinal cohorts. These efforts are critical for advancing biomarker candidates toward CLIA certification, FDA validation, and eventual CMS reimbursement. As the market moves toward clinical utility, the next 5-10 years will likely witness a transition from research to routine care, with hospitals and specialty neurology clinics beginning to incorporate biomarker-based blood tests for diagnosis, treatment selection, and disease monitoring.

U.S. Blood-based Biomarker For Parkinson’s Disease Market Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented U.S. blood-based biomarker for Parkinson’s disease market report on the basis of biomarker type, technology, and end use:

Biomarker Type Outlook (Revenue, USD Million, 2021 - 2033)

• Protein biomarkers
• Inflammatory markers
• Metabolic markers
• Transcriptomic/miRNA
• Others

Technology Outlook (Revenue, USD Million, 2021 - 2033)

• ELISA/Immunoassay
• Multiplex platforms
• NGS/qPCR (genetic)
• Mass spectrometry
• Others

End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Academic/Research Labs
• Pharmaceutical / Biotech (for Clinical Trials)
• Hospitals
• Clinical Diagnostic Labs
• Others

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