美国创伤性脑损伤生物标记市场规模、份额、趋势分析报告：按类型、样本类型、应用、最终用途、细分预测，2025-2033

市场规模与趋势：

美国创伤性脑损伤生物标记市场规模预计在 2024 年为 4.096 亿美元，预计到 2033 年将达到 18.5473 亿美元，2025 年至 2033 年的复合年增长率为 18.8%。

由于对儿科 TBI 诊断的需求不断增加、对脑损伤的认识和资金不断增加以及学术界和工业界之间的合作不断加速，美国创伤性脑损伤 (TBI) 生物标誌物市场正在经历显着增长。

创伤性脑损伤 (TBI) 是指头部受到意外撞击，可能导致轻度至重度神经损伤，甚至死亡。根据美国脑损伤协会 (Brain Injury Association of America) 2025 年的报告，美国约有 1,140 万 40 岁及以上人士因创伤性脑损伤 (TBI) 而失去意识，目前处于残疾状态。此外，每年约有 290 万例与 TBI 相关的急诊就诊，凸显了脑损伤带来的沉重医疗负担。

儿童和青少年特别容易受到因跌倒、运动伤害和事故造成的 TBI 的影响。在美国，每年约有 50 万次儿童 TBI 急诊就诊。虽然儿童死亡率总体较低，约占所有 TBI 相关死亡人数的 5%，但如果考虑到生命损失年数和残疾生活年数，其更广泛的影响就显而易见。这些长期影响在儿童中明显大于成人，凸显了儿童 TBI 对公共卫生和生活品质造成的严重且持久的负担。儿科保健提供者越来越多地转向生物标记诊断，以便做出更安全、更快速的决策，并减少不必要的辐射暴露，尤其是来自电脑断层扫描的辐射暴露。

基于血液的生物标记提供了一种非侵入性且客观的方法来评估年轻患者的损伤风险和严重程度。瑞士和西班牙知名医院于2024年6月进行的一项合作研究发现，血液生物标记可以显着改善儿童轻度创伤性脑损伤 (mTBI) 的诊断和治疗。这项由ABCDx、日内瓦大学和Vall d'Hebron医院参与的多中心研究强调了血液生物标记在准确区分有无颅内损伤 (ICI) 儿童方面的潜力。这可以减少不必要的电脑断层扫描，缩短住院观察期，并提高儿科mTBI护理的效率。

研究型大学、生物技术公司和医疗保健提供者之间的紧密合作正在推动生物标誌物的检验和商业化。研究机构正在与生物技术和诊断公司合作，将实验室发现转化为临床试验。新的临床试验在推动TBI诊断和治疗方面具有巨大潜力。这些临床试验专注于评估创新的诊断工具和治疗方法，可以为更有效、更及时的干预铺平道路，并有可能改变急性和长期TBI管理中的患者预后。此类伙伴关係有助于加速临床试验、FDA申报和市场准入。此外，数据资源和生物样本库的共用支持纵向研究，从而提高生物标记的可靠性。美国生态系统透过公私合作促进创新的能力，是扩大TBI生物标记市场的主要竞争优势。

医疗、社会和製度因素的共同作用，推动了美国市场对TBI生物标记的资金投入增加。社会对TBI长期影响的认识不断提高，尤其是在体育和军事领域，这推动了对更准确、更及时的诊断工具的需求。传统的影像学检查通常无法检测到轻微或早期损伤，因此需要基于生物标记的解决方案，以提供客观、快速和非侵入性的评估。 2024年2月，美国指导医学研究计画 (CDMRP) 和美国医学研究与发展司令部 (USAMRDC) 等政府机构将增加创伤性脑损伤和心理健康研究计画 (TBIPHRP) 等计画的投资。这些计画旨在推动早期发现、治疗和预防策略，同时应对TBI的心理影响。这些资金的涌入，加上商业化潜力和日益增长的创业投资兴趣，正在加速创新，重塑美国TBI生物标记领域的格局。

目录

第一章调查方法与范围

第二章执行摘要

第三章美国创伤性脑损伤生物标记市场变数、趋势与范围

• 市场展望
  • 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
• 美国创伤性脑损伤生物标记市场分析工具
  • 产业分析-波特五力分析
  • PESTEL分析

第四章美国创伤性脑损伤生物标记市场：类型估计和趋势分析

• 2024 年及 2033 年各类型市场占有率
• 细分仪表板
• 美国创伤性脑损伤生物标记市场：类型变异分析
• 美国创伤性脑损伤生物标记市场规模与趋势分析（2021-2033年）
• 2021-2033年美国创伤性脑损伤生物标记市场收益估计及预测
• 蛋白质生物标记
• 基因生物标记
• 代谢体学学生物标誌物

第五章美国创伤性脑损伤生物标记市场：样本类型估计与趋势分析

• 样本类型市场占有率，2024 年和 2033 年
• 细分仪表板
• 美国创伤性脑损伤生物标记市场：样本类型展望
• 2021年至2033年市场规模、预测与趋势分析
• 以血液为基础
• 基于脑脊髓液（CSF）
• 尿基

第六章美国创伤性脑损伤生物标记市场：应用评估与趋势分析

• 2024 年和 2033 年应用市场占有率
• 细分仪表板
• 美国创伤性脑损伤生物标记市场：应用前景
• 2021年至2033年市场规模、预测与趋势分析
• 诊断
• 预后
• 监测治疗反应

第七章美国创伤性脑损伤生物标记市场：最终用途估计和趋势分析

• 2024年及2033年最终用途市场占有率
• 细分仪表板
• 美国创伤性脑损伤生物标记市场：最终用途展望
• 2021年至2033年市场规模、预测与趋势分析
• 医院和诊所
• 诊断实验室
• 研究所

第八章美国创伤性脑损伤生物标记市场：国家估计和趋势分析

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

第九章 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
  • Key customers
  • Key company market share analysis, 2024
  • Quanterix.
  • Banyan Biomarkers, Inc.
  • Abbott
  • GE Healthcare.
  • Thermo Fisher Scientific Inc.
  • Immunarray.
  • Oculogica
  • NeuroTrauma Sciences, LLC
  • BRAINBox Solutions, Inc.
  • Myriad Genetics, Inc.
  • Abcam Limited

Market Size & Trends:

The U.S. traumatic brain injury biomarkers market size was estimated at USD 409.60 million in 2024, is projected to reach 1,854.73 million by 2033, and is forecasted to grow at a CAGR of 18.8% from 2025 to 2033. The U.S. traumatic brain injury (TBI) biomarkers market is expanding significantly due to increasing demand for pediatric TBI diagnosis, growing awareness and funding related to brain injury, and accelerating collaboration between academic institutions and industry.

TBI refers to an unintentional impact to the head that can lead to outcomes ranging from mild impairment to severe neurological damage or even death. According to a report by the Brain Injury Association America, 2025, the U.S. reported approximately 11.4 million individuals over the age of 40 who experienced a traumatic brain injury (TBI) resulting in loss of consciousness are currently living with a disability. In addition, around 2.9 million TBI-related emergency department visits are reported each year, indicating the significant healthcare burden associated with brain injuries.

Children and adolescents are particularly vulnerable to TBIs from falls, sports injuries, and accidents, yet symptoms can be subtle or delayed. Every year in the U.S., pediatric TBI leads to an estimated 500,000 emergency department visits. While children have a lower overall mortality rate, accounting for about 5% of all TBI-related deaths, the broader impact is more evident when considering years of life lost and years lived with disability. These long-term effects are notably greater in children than in adults, with the serious and lasting burden pediatric TBI poses on public health and quality of life. Pediatric care providers are increasingly turning to biomarker diagnostics to make safer and faster decisions, especially to reduce unnecessary radiation exposure from CT scans.

Blood-based biomarkers offer a non-invasive, objective method to assess injury risk and severity in young patients. A collaborative study conducted in June 2024, by renowned hospitals in Switzerland and Spain, discovered potential blood biomarkers that could significantly improve the diagnosis and management of mild traumatic brain injury (mTBI) in children. This multi-center research, involving ABCDx, the University of Geneva, and Vall d'Hebron Hospital, highlighted the potential of these blood biomarkers to accurately differentiate children with intracranial injuries (ICI) from those without. This reduced unnecessary CT scans and shorter hospital observation periods, improving efficiency in pediatric mTBI care.

Strong collaboration between research universities, biotech companies, and healthcare providers is advancing biomarker validation and commercialization. Institutions are working with biotech and diagnostics companies to translate laboratory discoveries into clinical tests. A new clinical trial holds significant promise for advancing the diagnosis and treatment of TBI. Focused on evaluating innovative diagnostic tools or therapeutic approaches, this trial could pave the way for more effective and timely interventions, potentially transforming patient outcomes in acute and long-term TBI management. These partnerships help accelerate clinical trials, FDA submissions, and market entry. In addition, shared data resources and biobanks support longitudinal studies that strengthen biomarker credibility. The U.S. ecosystem's ability to foster innovation through public-private-academic collaboration is a major competitive advantage in expanding the TBI biomarker market.

A convergence of medical, social, and institutional factors drives rising funding for TBI biomarkers in the U.S. market. Growing public awareness of TBIs' long-term consequences, particularly in sports and military populations, has amplified demand for more accurate and timely diagnostic tools. Traditional imaging often falls short in detecting mild or early-stage injuries, creating a critical need for biomarker-based solutions to provide objective, rapid, and non-invasive assessments. In February 2024, government agencies such as the Congressionally Directed Medical Research Programs (CDMRP) and the U.S. Army Medical Research and Development Command (USAMRDC) have increased investments in initiatives like the Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP). These efforts aim to advance early detection, treatment, and prevention strategies, while also addressing the psychological effects of TBI. Coupled with growing commercialization potential and venture capital interest, this influx of funding is accelerating innovation and reshaping the TBI biomarker landscape in the United States.

U.S. Traumatic Brain Injury Biomarkers Market Report 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. traumatic brain injury biomarkers market report based on type, sample type, application, and end use:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Protein Biomarkers
• Genetic Biomarkers
• Metabolomic Biomarkers
• Sample Type Outlook (Revenue, USD Million, 2021 - 2033)
• Blood-based
• Cerebrospinal fluid (CSF)-based
• Urine-based
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Diagnosis
• Prognosis
• Monitoring treatment response
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics
• Diagnostic Laboratories
• Research Institutes

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type
  • 1.2.2. Sample Type
  • 1.2.3. Application
  • 1.2.4. End user
  • 1.2.5. Country scope
  • 1.2.6. 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. Type outlook
  • 2.2.2. Sample type outlook
  • 2.2.3. Application outlook
  • 2.2.4. End use outlook
  • 2.2.5. Country outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Traumatic Brain Injury Biomarkers 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. Traumatic Brain Injury Biomarkers Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
  • 3.3.2. PESTEL Analysis

Chapter 4. U.S. Traumatic Brain Injury Biomarkers Market: Type Estimates & Trend Analysis

• 4.1. Type Market Share, 2024 & 2033
• 4.2. Segment Dashboard
• 4.3. U.S. Traumatic Brain Injury Biomarkers Market: Type Movement Analysis
• 4.4. U.S. Traumatic Brain Injury Biomarkers Market Size & Trend Analysis, by type, 2021 to 2033 (USD Million)
• 4.5. U.S. Traumatic Brain Injury Biomarkers Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Protein biomarkers
  • 4.6.1. Protein biomarkers Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.7. Genetic biomarkers
  • 4.7.1. Genetic biomarkers Market estimates and forecasts, 2021 - 2033 (USD Million)
• 4.8. Metabolomic biomarkers
  • 4.8.1. Metabolomic biomarkers Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Traumatic Brain Injury Biomarkers Market: Sample type Estimates & Trend Analysis

• 5.1. Sample type Market Share, 2024 & 2033
• 5.2. Segment Dashboard
• 5.3. U.S. Traumatic Brain Injury Biomarkers Market by Sample type Outlook
• 5.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
• 5.5. Blood-based
  • 5.5.1. Blood-based Market estimates and forecasts, 2021 - 2033 (USD Million)
• 5.6. Cerebrospinal fluid (CSF)-based
  • 5.6.1. Cerebrospinal fluid (CSF)-based Market estimates and forecasts, 2021 - 2033 (USD Million)
• 5.7. Urine-based
  • 5.7.1. Urine-based Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Traumatic Brain Injury Biomarkers Market: Application Estimates & Trend Analysis

• 6.1. Application Market Share, 2024 & 2033
• 6.2. Segment Dashboard
• 6.3. U.S. Traumatic Brain Injury Biomarkers Market by Application Outlook
• 6.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
• 6.5. Diagnosis
  • 6.5.1. Diagnosis Market estimates and forecasts, 2021 - 2033 (USD Million)
• 6.6. Prognosis
  • 6.6.1. Prognosis Market estimates and forecasts, 2021 - 2033 (USD Million)
• 6.7. Monitoring treatment response
  • 6.7.1. Monitoring treatment response, Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Traumatic Brain Injury Biomarkers Market: End use Estimates & Trend Analysis

• 7.1. End Use Market Share, 2024 & 2033
• 7.2. Segment Dashboard
• 7.3. U.S. Traumatic Brain Injury Biomarkers Market by End use Outlook
• 7.4. Market Size & Forecasts and Trend Analyses, 2021 to 2033 for the following
• 7.5. Hospitals & Clinics
  • 7.5.1. Hospitals & Clinics Market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.6. Diagnostic Laboratories
  • 7.6.1. Diagnostic Laboratories Market estimates and forecasts, 2021 - 2033 (USD Million)
• 7.7. Research Institutes
  • 7.7.1. Research Institutes Market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Traumatic Brain Injury Biomarkers Market: Country Estimates & Trend Analysis

• 8.1. Country Market Share Analysis, 2024 & 2033
• 8.2. Country Market Dashboard
• 8.3. U.S. Country Market Snapshot
• 8.4. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 8.5. U.S.
  • 8.5.1. Key country dynamics
  • 8.5.2. Regulatory framework/Reimbursement
  • 8.5.3. Competitive scenario
  • 8.5.4. U.S. market estimates and forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Recent Developments & Impact Analysis, By Key Market Participants
• 9.2. Company/Competition Categorization
• 9.3. Vendor Landscape
  • 9.3.1. List of key distributors and channel partners
  • 9.3.2. Key customers
  • 9.3.3. Key company market share analysis, 2024
  • 9.3.4. Quanterix.
    • 9.3.4.1. Company overview
    • 9.3.4.2. Financial performance
    • 9.3.4.3. Services benchmarking
    • 9.3.4.4. Strategic initiatives
  • 9.3.5. Banyan Biomarkers, Inc.
    • 9.3.5.1. Company overview
    • 9.3.5.2. Financial performance
    • 9.3.5.3. Services benchmarking
    • 9.3.5.4. Strategic initiatives
  • 9.3.6. Abbott
    • 9.3.6.1. Company overview
    • 9.3.6.2. Financial performance
    • 9.3.6.3. Services benchmarking
    • 9.3.6.4. Strategic initiatives
  • 9.3.7. GE Healthcare.
    • 9.3.7.1. Company overview
    • 9.3.7.2. Financial performance
    • 9.3.7.3. Services benchmarking
    • 9.3.7.4. Strategic initiatives
  • 9.3.8. Thermo Fisher Scientific Inc.
    • 9.3.8.1. Company overview
    • 9.3.8.2. Financial performance
    • 9.3.8.3. Services benchmarking
    • 9.3.8.4. Strategic initiatives
  • 9.3.9. Immunarray.
    • 9.3.9.1. Company overview
    • 9.3.9.2. Financial performance
    • 9.3.9.3. Services benchmarking
    • 9.3.9.4. Strategic initiatives
  • 9.3.10. Oculogica
    • 9.3.10.1. Company overview
    • 9.3.10.2. Financial performance
    • 9.3.10.3. Services benchmarking
    • 9.3.10.4. Strategic initiatives
  • 9.3.11. NeuroTrauma Sciences, LLC
    • 9.3.11.1. Company overview
    • 9.3.11.2. Financial performance
    • 9.3.11.3. Services benchmarking
    • 9.3.11.4. Strategic initiatives
  • 9.3.12. BRAINBox Solutions, Inc.
    • 9.3.12.1. Company overview
    • 9.3.12.2. Financial performance
    • 9.3.12.3. Services benchmarking
    • 9.3.12.4. Strategic initiatives
  • 9.3.13. Myriad Genetics, Inc.
    • 9.3.13.1. Company overview
    • 9.3.13.2. Financial performance
    • 9.3.13.3. Services benchmarking
    • 9.3.13.4. Strategic initiatives
  • 9.3.14. Abcam Limited
    • 9.3.14.1. Company overview
    • 9.3.14.2. Financial performance
    • 9.3.14.3. Services benchmarking
    • 9.3.14.4. Strategic initiatives

List of Tables

• Table 1 List of abbreviations
• Table 2 U.S Traumatic Brain Injury biomarkers market, by type, 2021 - 2033 (USD Million)
• Table 3 U.S Traumatic Brain Injury biomarkers market, by sample type, 2021 - 2033 (USD Million)
• Table 4 U.S Traumatic Brain Injury biomarkers market, by application, 2021 - 2033 (USD Million)
• Table 5 U.S Traumatic Brain Injury biomarkers market, 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 the 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. Traumatic Brain Injury biomarkers market: market outlook
• Fig. 10 U.S. Traumatic Brain Injury biomarkers 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. Traumatic Brain Injury Biomarkers Market Driver Impact
• Fig. 16 U.S. Traumatic Brain Injury Biomarkers market restraint impact
• Fig. 17 U.S. Traumatic Brain Injury Biomarkers Market Strategic Initiatives Analysis
• Fig. 18 U.S. Traumatic Brain Injury Biomarkers market: Type movement analysis
• Fig. 19 U.S. Traumatic Brain Injury Biomarkers market: Type outlook and key takeaways
• Fig. 20 Protein biomarkers market estimates and forecasts, 2021 - 2033
• Fig. 21 Genetic biomarkers market estimates and forecasts, 2021 - 2033
• Fig. 22 Metabolomic biomarkers market estimates and forecasts, 2021 - 2033
• Fig. 23 U.S. Traumatic Brain Injury Biomarkers Market: Sample type movement analysis
• Fig. 24 U.S. Traumatic Brain Injury Biomarkers market: Sample type outlook and key takeaways
• Fig. 25 Blood-based market estimates and forecasts, 2021 - 2033
• Fig. 26 Cerebrospinal fluid (CSF)-based market estimates and forecasts, 2021 - 2033
• Fig. 27 Urine-based market estimates and forecasts, 2021 - 2033
• Fig. 28 U.S. Traumatic Brain Injury Biomarkers Market: Application movement analysis
• Fig. 29 U.S. Traumatic Brain Injury Biomarkers market: Application outlook and key takeaways
• Fig. 30 Diagnosis market estimates and forecasts, 2021 - 2033
• Fig. 31 Prognosis market estimates and forecasts, 2021 - 2033
• Fig. 32 Monitoring treatment response market estimates and forecasts, 2021 - 2033
• Fig. 33 U.S. Traumatic Brain Injury Biomarkers Market: End use movement analysis
• Fig. 34 U.S. Traumatic Brain Injury Biomarkers market: End use outlook and key takeaways
• Fig. 35 Hospitals & Clinics market estimates and forecasts, 2021 - 2033
• Fig. 36 Diagnostic Laboratories market estimates and forecasts, 2021 - 2033
• Fig. 37 Research Institutes market estimates and forecasts, 2021 - 2033
• Fig. 38 U.S. Traumatic Brain Injury Biomarkers market: Country movement analysis
• Fig. 39 U.S. Traumatic Brain Injury Biomarkers market: Country outlook and key takeaways
• Fig. 40 U.S. Traumatic Brain Injury Biomarkers market share and leading players
• Fig. 41 U.S. market estimates and forecasts, 2021 - 2033
• Fig. 42 Market share of key market players- U.S. Traumatic Brain Injury biomarkers market