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市场调查报告书
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1790231

美国帕金森氏症血液生物标记市场规模、份额及趋势分析报告（按生物标记类型、技术、最终用途及细分市场预测，2025-2033）

U.S. Blood-based Biomarker For Parkinson's Disease Market Size, Share & Trends Analysis Report By Biomarker Type, By Technology, By End Use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

市场规模和趋势

预计 2024 年美国帕金森氏症血液生物标记市场规模将达到 4,575 万美元，2025 年至 2033 年的复合年增长率将达到 18.33%。

美国帕金森氏症 (PD) 血液生物标记市场的发展受到患者人数不断增长的驱动，每年新增 9 万例确诊病例，且对早期非侵入性诊断工具的需求日益增长。不断扩展的研究活动，尤其是来自学术机构和製药公司的研究活动，正在加速生物标记的发现和检验。多重检测和基于人工智慧的平台的技术进步进一步推动了生物标誌物的采用。此外，美国国立卫生研究院 (NIH)、MJFF 和 Verily 之间的合作正在帮助标准化生物标记的使用。随着 α-突触核蛋白和 NfL 等检测方法获得监管部门核准，将其整合到临床实践中变得越来越可行。

美国帕金森氏症血液生物标记市场正蓬勃发展，这得益于对早期诊断、更精准的疾病监测以及更精准的临床检测患者分层的需求。据估计，目前美国有超过110万帕金森氏症患者，每年新增确诊病例9万例。

迄今为止，帕金森氏症的诊断严重依赖运动症状的存在与否，导致误诊频传和治疗延误。血液生物标记提供了一种非侵入性且便捷的替代方法，能够在症状出现前数年识别疾病的发生。目前正在研究的关键生物标记包括错误折迭的α-突触核蛋白、神经丝轻链 (NfL)、DJ-1、 Tau、发炎细胞激素（如IL-6和CRP）以及氧化压力标记。这些生物标记正在多个技术平台上开发，包括ELISA、多重蛋白质组学、基于外泌体的检测以及整合AI的体学。

美国诊断公司Amplion正在推进其SynRT™血液检测方法，用于检测错误折迭的α-突触核蛋白，这是帕金森氏症（PD）病理学的一个标誌。目前，此检测方法仅核准用于脑脊髓液（CSF），但正在进行血液检验的临床试验。以阿兹海默症PrecivityAD™检测方法而闻名的C2N Diagnostics正在将其平台扩展到帕金森氏症领域，利用质谱技术进行NfL和Tau的靶向检测。

製药公司也在将生物标记纳入治疗开发中。 Denali Therapeutics 和 Biogen 正在使用磷酸化 Rab10 作为 LRRK2 抑制剂临床试验中的动态学生物标记。罗氏/基因泰克正在与 AC Immune 合作，共同开发基于抗体的疗法，同时检验相关的 α-突触核蛋白生物标记。这些生物标记不仅对于确定治疗反应至关重要，而且对于选择合适的患者亚群（尤其是携带 LRRK2 或 GBA 突变的患者）也至关重要。

在技术方面，Olympus Proteomics 正在与迈克尔·J·福克斯基金会 (MJFF) 合作部署其邻近延伸分析 (PEA) 平台，以识别一组与 PD 相关的蛋白质，而 Verily Life Sciences（Alphabet 的子公司）正在构建一个基于 AI 的多组体学平台，以分析血液、脑脑脊髓液和帕金森脑标记倡议的一部分 MJFFMI 的一部分 MJFFMI 标记。

宾州大学、梅奥诊所和麻省总医院等学术机构也是生物标记生态系统的核心参与者。这些机构正在进行由美国国立卫生研究院 (NIH) 和麻省总医院 (MJFF) 资助的研究，以纵向队列研究的形式检验外泌体 α-突触核蛋白、miRNA 组和基于血液的神经纤维连接蛋白 (NfL)。这些努力对于推动生物标记候选物获得 CLIA 认证、FDA 验证以及最终获得 CMS 报销至关重要。随着市场向临床效用迈进，未来 5 到 10 年，随着医院和神经科专科诊所采用基于生物标记的血液检测进行诊断、治疗选择和疾病监测，生物标记检测可能会从研究阶段过渡到常规实践阶段。

美国帕金森氏症血液生物标记市场细分

该报告预测了2021年至2033年各国各国的收益成长，并分析了每个细分领域的最新行业趋势。在本研究中，Grand View Research, Inc. 根据生物标记类型、技术和最终用途，对美国帕金森氏症血液生物标记市场报告进行了细分。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国帕金森氏症血液生物标记市场变数、趋势和范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 美国帕金森氏症血液生物标记市场分析工具
    • 产业分析—波特五力分析
    • PESTEL分析

第四章美国帕金森氏症血液生物标记市场按生物标记类型进行的估计和趋势分析

  • 2024 年和 2033 年生物标记类型市场占有率
  • 细分仪表板
  • 美国帕金森氏症血液生物标记市场：生物标记类型变异分析
  • 美国帕金森氏症血液生物标记市场规模及趋势分析（按生物标记类型），2021-2033 年
  • 2021-2033年美国帕金森氏症血液生物标记市场收益估计与预测
  • 蛋白质生物标记
  • 发炎标记物
  • 代谢标记物
  • 转录组学/miRNA
  • 其他的

第五章美国帕金森氏症血液生物标记市场技术评估及趋势分析

  • 2024 年及 2033 年技术市场占有率
  • 细分仪表板
  • 美国帕金森氏症血液生物标记市场：技术视角
  • 2021年至2033年市场规模、预测与趋势分析
  • ELISA/免疫检测
  • 復用平台
  • NGS/qPCR（遗传学）
  • 质谱法
  • 其他的

第六章美国帕金森氏症血液生物标记市场最终用途的估计和趋势分析

  • 2024年和2033年的最终用途市场占有率
  • 细分仪表板
  • 美国帕金森氏症血液生物标记市场：最终用途视角
  • 2021年至2033年市场规模、预测与趋势分析
  • 学术实验室
  • 製药/生物技术（用于临床测试）
  • 医院
  • 临床诊断实验室
  • 其他的

第七章美国帕金森氏症血液生物标记市场各国估值及趋势分析

  • 2024 年及 2033 年各国市场
  • 各国市场仪表板
  • 美国市场概述
  • 2021-2033 年市场规模、预测趋势分析
  • 美国
    • 主要国家趋势
    • 法规结构/报销
    • 竞争场景

第八章 竞争态势

  • 主要市场参与企业的近期趋势和影响分析
  • 公司/竞争对手分类
  • 供应商格局
    • 主要经销商和通路合作伙伴名单
    • 2024年主要企业市场占有率分析
    • Amprion
    • C2N Diagnostics
    • Olink Proteomics
    • Denali Therapeutics
    • Biogen
    • Roche/Genentech
    • Verily Life Sciences
    • AC Immune
    • SomaLogic
    • Quanterix
Product Code: GVR-4-68040-661-5

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 a-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 a-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(TM) test, which detects misfolded a-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(TM) 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 a-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 a-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, Grand View Research 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

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Biomarker Type
    • 1.2.2. Technology
    • 1.2.3. End use
    • 1.2.4. Country scope
    • 1.2.5. Estimates and forecasts timeline.
  • 1.3. Research Methodology
  • 1.4. Information Procurement
    • 1.4.1. Purchased database
    • 1.4.2. GVR's internal database
    • 1.4.3. Secondary sources
    • 1.4.4. Primary research
    • 1.4.5. Details of primary research
  • 1.5. Information or Data Analysis
    • 1.5.1. Data analysis models
  • 1.6. Market Formulation & Validation
  • 1.7. Model Details
    • 1.7.1. Commodity flow analysis (Model 1)
    • 1.7.2. Approach 1: Commodity flow approach
    • 1.7.3. Volume price analysis (Model 2)
    • 1.7.4. Approach 2: Volume price analysis
  • 1.8. List of Secondary Sources
  • 1.9. List of Primary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Outlook
    • 2.2.1. Biomarker Type outlook
    • 2.2.2. Technology outlook
    • 2.2.3. End use outlook
    • 2.2.4. Country outlook
  • 2.3. Competitive Insights

Chapter 3. U.S. Blood-based Biomarker For Parkinson's Disease Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook.
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
    • 3.2.2. Market restraint analysis
  • 3.3. U.S. Blood-based Biomarker For Parkinson's Disease Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
    • 3.3.2. PESTEL Analysis

Chapter 4. U.S. Blood-based Biomarker For Parkinson's Disease Market: Biomarker Type Estimates & Trend Analysis

  • 4.1. Biomarker Type Market Share, 2024 & 2033
  • 4.2. Segment Dashboard
  • 4.3. U.S. Blood-based Biomarker For Parkinson's Disease Market: Biomarker Type Movement Analysis
  • 4.4. U.S. Blood-based Biomarker For Parkinson's Disease Market Size & Trend Analysis, by biomarker type, 2021 to 2033 (USD Million)
  • 4.5. U.S. Blood-based Biomarker For Parkinson's Disease Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6. Protein Biomarkers
    • 4.6.1. Protein biomarkers Market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.7. Inflammatory Markers
    • 4.7.1. Inflammatory Markers Market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.8. Metabolic Markers
    • 4.8.1. Metabolic Markers Market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.9. Transcriptomic/miRNA
    • 4.9.1. Transcriptomic/miRNA Market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.10. Others
    • 4.10.1. Others Market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 5. U.S. Blood-based Biomarker For Parkinson's Disease Market: Technology Estimates & Trend Analysis

  • 5.1. Technology Market Share, 2024 & 2033
  • 5.2. Segment Dashboard
  • 5.3. U.S. Blood-based Biomarker For Parkinson's Disease Market by Technology Outlook
  • 5.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
  • 5.5. ELISA/Immunoassay
    • 5.5.1. ELISA/Immunoassay Market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.6. Multiplex platforms
    • 5.6.1. Multiplex platforms Market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.7. NGS/qPCR (genetic)
    • 5.7.1. NGS/qPCR (genetic) Market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.8. Mass spectrometry
    • 5.8.1. Mass spectrometry Market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.9. Others
    • 5.9.1. Others Market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 6. U.S. Blood-based Biomarker For Parkinson's Disease Market: End use Estimates & Trend Analysis

  • 6.1. End use Market Share, 2024 & 2033
  • 6.2. Segment Dashboard
  • 6.3. U.S. Blood-based Biomarker For Parkinson's Disease Market by End use Outlook
  • 6.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
  • 6.5. Academic/Research Labs
    • 6.5.1. Academic/Research Labs Market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6. Pharmaceutical / Biotech (for Clinical Trials)
    • 6.6.1. Pharmaceutical / Biotech (for Clinical Trials) Market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.7. Hospitals
    • 6.7.1. Hospitals Market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.8. Clinical Diagnostic Labs
    • 6.8.1. Clinical Diagnostic Labs Market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.9. Others
    • 6.9.1. Others Market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. U.S. Blood-based Biomarker For Parkinson's Disease Market: Country Estimates & Trend Analysis

  • 7.1. Country Market Share Analysis, 2024 & 2033
  • 7.2. Country Market Dashboard
  • 7.3. U.S. Country Market Snapshot
  • 7.4. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
  • 7.5. U.S.
    • 7.5.1. Key country dynamics
    • 7.5.2. Regulatory framework/Reimbursement
    • 7.5.3. Competitive scenario
    • 7.5.4. U.S. market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Recent Developments & Impact Analysis, By Key Market Participants
  • 8.2. Company/Competition Categorization
  • 8.3. Vendor Landscape
    • 8.3.1. List of key distributors and channel partners
    • 8.3.2. Key customers
    • 8.3.3. Key company market share analysis, 2024
    • 8.3.4. Amprion
      • 8.3.4.1. Company overview
      • 8.3.4.2. Financial performance
      • 8.3.4.3. Biomarker Type benchmarking
      • 8.3.4.4. Strategic initiatives
    • 8.3.5. C2N Diagnostics
      • 8.3.5.1. Company overview
      • 8.3.5.2. Financial performance
      • 8.3.5.3. Biomarker Type benchmarking
      • 8.3.5.4. Strategic initiatives
    • 8.3.6. Olink Proteomics
      • 8.3.6.1. Company overview
      • 8.3.6.2. Financial performance
      • 8.3.6.3. Biomarker Type benchmarking
      • 8.3.6.4. Strategic initiatives
    • 8.3.7. Denali Therapeutics
      • 8.3.7.1. Company overview
      • 8.3.7.2. Financial performance
      • 8.3.7.3. Biomarker Type benchmarking
      • 8.3.7.4. Strategic initiatives
    • 8.3.8. Biogen
      • 8.3.8.1. Company overview
      • 8.3.8.2. Financial performance
      • 8.3.8.3. Biomarker Type benchmarking
      • 8.3.8.4. Strategic initiatives
    • 8.3.9. Roche / Genentech
      • 8.3.9.1. Company overview
      • 8.3.9.2. Financial performance
      • 8.3.9.3. Biomarker Type benchmarking
      • 8.3.9.4. Strategic initiatives
    • 8.3.10. Verily Life Sciences
      • 8.3.10.1. Company overview
      • 8.3.10.2. Financial performance
      • 8.3.10.3. Biomarker Type benchmarking
      • 8.3.10.4. Strategic initiatives
    • 8.3.11. AC Immune
      • 8.3.11.1. Company overview
      • 8.3.11.2. Financial performance
      • 8.3.11.3. Biomarker Type benchmarking
      • 8.3.11.4. Strategic initiatives
    • 8.3.12. SomaLogic
      • 8.3.12.1. Company overview
      • 8.3.12.2. Financial performance
      • 8.3.12.3. Biomarker Type benchmarking
      • 8.3.12.4. Strategic initiatives
    • 8.3.13. Quanterix
      • 8.3.13.1. Company overview
      • 8.3.13.2. Financial performance
      • 8.3.13.3. Biomarker Type benchmarking
      • 8.3.13.4. Strategic initiatives

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. Blood-based Biomarker For Parkinson's Disease, by biomarker type, 2021 - 2033 (USD Million)
  • Table 3 U.S. Blood-based Biomarker For Parkinson's Disease, by Technology, 2021 - 2033 (USD Million)
  • Table 4 U.S. Blood-based Biomarker For Parkinson's Disease, by end use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Primary interviews in U.S.
  • Fig. 5 Market research approaches
  • Fig. 6 Value-chain-based sizing & forecasting
  • Fig. 7 QFD modeling for market share assessment
  • Fig. 8 Market formulation & validation
  • Fig. 9 U.S. Blood-based Biomarker For Parkinson's Disease Market: market outlook
  • Fig. 10 U.S. Blood-based Biomarker For Parkinson's Disease competitive insights
  • Fig. 11 Parent market outlook
  • Fig. 12 Related/ancillary market outlook
  • Fig. 13 Penetration and growth prospect mapping
  • Fig. 14 Industry value chain analysis
  • Fig. 15 U.S. Blood-based Biomarker For Parkinson's Disease Market driver impact
  • Fig. 16 U.S. Blood-based Biomarker For Parkinson's Disease Market restraint impact
  • Fig. 17 U.S. Blood-based Biomarker For Parkinson's Disease Market strategic initiatives analysis
  • Fig. 18 U.S. Blood-based Biomarker For Parkinson's Disease Market: Biomarker Type movement analysis
  • Fig. 19 U.S. Blood-based Biomarker For Parkinson's Disease Market: Biomarker Type outlook and key takeaways
  • Fig. 20 Protein biomarkers market estimates and forecasts, 2021 - 2033
  • Fig. 21 Inflammatory markers market estimates and forecasts,2021 - 2033
  • Fig. 22 Metabolic markers market estimates and forecasts, 2021 - 2033
  • Fig. 23 Transcriptomic/miRNA market estimates and forecasts, 2021 - 2033
  • Fig. 24 Others market estimates and forecasts, 2021 - 2033
  • Fig. 25 U.S. Blood-based Biomarker For Parkinson's Disease Market: Technology movement analysis
  • Fig. 26 U.S. Blood-based Biomarker For Parkinson's Disease Market: Technology outlook and key takeaways
  • Fig. 27 ELISA/Immunoassay market estimates and forecasts, 2021 - 2033
  • Fig. 28 Multiplex platforms market estimates and forecasts, 2021 - 2033
  • Fig. 29 NGS/qPCR (genetic) market estimates and forecasts, 2021 - 2033
  • Fig. 30 Mass spectrometry market estimates and forecasts, 2021 - 2033
  • Fig. 31 Others market estimates and forecasts, 2021 - 2033
  • Fig. 32 U.S. Blood-based Biomarker For Parkinson's Disease Market: End use movement analysis
  • Fig. 33 U.S. Blood-based Biomarker For Parkinson's Disease Market: End use outlook and key takeaways
  • Fig. 34 Academic/Research Labs market estimates and forecasts, 2021 - 2033
  • Fig. 35 Pharmaceutical / Biotech (for Clinical Trials) market estimates and forecasts, 2021 - 2033
  • Fig. 36 Hospitals market estimates and forecasts, 2021 - 2033
  • Fig. 37 Clinical Diagnostic Labs market estimates and forecasts, 2021 - 2033
  • Fig. 38 Others market estimates and forecasts, 2021 - 2033
  • Fig. 39 U.S. Blood-based Biomarker For Parkinson's Disease Market: Country movement analysis
  • Fig. 40 U.S. Blood-based Biomarker For Parkinson's Disease Market: Country outlook and key takeaways
  • Fig. 41 U.S. Blood-based Biomarker For Parkinson's Disease Market share and leading players
  • Fig. 42 U.S. market estimates and forecasts, 2021 - 2033
  • Fig. 43 Market share of key market players- U.S. Blood-based Biomarker For Parkinson's Disease Market