Traumatic Brain Injury Biomarkers Market (2025 - 2033) Size, Share & Trends Analysis Report By Type (Protein Biomarkers, Genetic Biomarkers), By Sample Type, By Application, By End-use, By Region, And Segment Forecasts

Traumatic Brain Injury Biomarkers Market Summary

The global traumatic brain injury biomarkers market size was estimated at USD 1.04 billion in 2024 and is projected to reach USD 4.73 billion by 2033, growing at a CAGR of 18.84% from 2025 to 2033. The market is facing significant growth driven by rising incidents of traumatic brain injuries, growing demand for rapid and point-of-care diagnostics, and a shift towards personalized medicine and telehealth.

Traumatic brain injury (TBI) remains a major global health concern, ranking among the leading causes of long-term disability and mortality. According to the Centers for Disease Control and Prevention, in 2024, 2.8 million people in America were diagnosed with brain injury every year, and more than 56,000 people died as a result of TBI. Although everyone is at risk of sustaining a traumatic brain injury (TBI), males are approximately 1.5 times more likely than females to experience a TBI and have a mortality rate that is three times higher.

Factors such as increasing road traffic accidents, sports-related injuries, falls among the elderly, and military combat injuries contribute significantly to this trend. Each year, traumatic brain injury (TBI) results in disability for six times more individuals than spinal cord injuries, multiple sclerosis, HIV/AIDS, and breast cancer combined. The pie chart below illustrates leading causes of TBI: 

This surge in TBI cases fuels demand for reliable, early diagnostic tools like biomarkers that can aid in timely detection and treatment, ultimately driving market growth.

Individuals aged 65 and above are the most vulnerable to hospitalization and death caused by traumatic brain injury (TBI), with falls being the leading cause. Across all age groups, men experience higher rates of severe TBI compared to women, and they are not only more frequently hospitalized but also face nearly triple the risk of death from TBI.

Thus, there is a growing need for rapid, portable, and point-of-care diagnostic tools for TBI, particularly in pre-hospital environments such as accident scenes, sports fields, and military battlefields. Biomarker-based tests that provide quick and accurate results enable timely clinical decisions, improving patient outcomes and reducing healthcare costs.

Studies are being conducted to investigate whether biomarkers can be used in clinical trials to support the development of new treatments for traumatic brain injury (TBI). These biomarkers could improve the diagnosis and evaluation of TBI severity, facilitating the selection of suitable patients for participation in drug trials. One such study reported by the USFDA, conducted in September 2022, focused on identifying and validating diagnostic biomarkers that accurately detected traumatic brain injury (TBI) and assessed the severity to improve early diagnosis and patient management. The study successfully identified potential biomarkers that demonstrated a strong correlation with TBI presence and severity, laying the groundwork for improved diagnostic tools and enabling more precise patient selection in future clinical trials.

The increasing focus on personalized medicine is driving demand for biomarker-based diagnostics tailored to individual patient profiles and severity of injury. Biomarkers enable clinicians to customize treatment strategies, improving outcomes and reducing adverse effects. Innovations in biomarker identification tests are in development with a focus on personalized medicine.

For instance, in May 2024, bioMerieux received U.S. FDA 510(k) clearance for VIDAS TBI, a serum-based test designed to assist in evaluating patients with mild traumatic brain injury (mTBI), including concussions. This test assists in detecting patients who are unlikely to have acute intracranial lesions (ICL), which helps decrease the number of unnecessary head CT scans. VIDAS TBI also enables healthcare providers to make faster, better-informed decisions tailored to individual patient needs. Thus, inculcating such approaches promotes continuous monitoring and timely intervention, supporting market growth by integrating biomarker testing into personalized therapeutic approaches.

Innovative Advances in Traumatic Brain Injury Biomarkers: Transforming Diagnosis, Prognosis and Therapeutic Targeting

Key innovative insights related to traumatic brain injury (TBI) biomarkers from recent research reported in February 2024, include:

• New Multidimensional Framework for TBI Characterization: A novel framework called CBI-M integrates four pillars of clinical assessment, biomarkers, imaging, and modifiers to provide a comprehensive evaluation of TBI severity and guide personalized treatment. Biomarkers measured in blood tests serve as objective indicators of tissue damage, helping to distinguish true TBI from minor head impacts and identify patients who need further imaging or intervention. This framework also supports better patient stratification for clinical trials and targeted therapies.

• Biomarkers as Critical Tools in Drug Development: Biomarkers are increasingly used to understand secondary injury mechanisms, classify injury severity, and monitor treatment response. Their integration into preclinical models enhances alignment with human TBI pathology, improving the translation of neuroprotective drugs from animal studies to clinical use.

• Emerging Pharmacological Targets: Breakdown products of biomarkers implicated in secondary injury pathways represent promising new drug targets. Targeting these molecules may mitigate neurotoxicity and improve recovery, opening avenues for innovative pharmacological interventions.

• Discovery of Novel Biomarkers: Bioinformatics and animal model studies identify a promising new biomarker for TBI diagnosis and prognosis. Expression of these biomarkers correlates with neuroinflammation and immune cell changes post-injury, offering potential for liquid biopsy development and insights into TBI-related immune responses.

• Advances in Data Analysis and Biomarker Validation: Enhanced statistical and computational methods are transforming complex biomarker, genomic, and imaging data into clinically actionable diagnostics, accelerating biomarker validation and regulatory approval processes.

Market Concentration & Characteristics

The TBI biomarkers industry is witnessing significant innovation, driven by advancements in biomarker discovery, assay technologies, and point-of-care diagnostics. Innovative research focuses on identifying novel biomarkers and enhancing test accuracy, enabling earlier diagnosis and personalized treatment. Continuous innovation is essential for improving clinical outcomes and expanding market potential. For instance, in April 2024, the USFDA announced launch of Abbott's i-STAT TBI Plasma test as the first rapid test on a portable analyzer to receive FDA 510(k) clearance and developed in collaboration with the U.S. Department of Defense (DoD).

Mergers and acquisitions are moderate in the traumatic brain injury biomarkers industry as companies seek to expand their product portfolios and geographic reach. Strategic partnerships and acquisitions enable technology integration, accelerate product development, and strengthen competitive positioning. This consolidation trend supports rapid market growth and fosters collaboration between diagnostics and pharmaceutical firms.

Regulatory frameworks significantly influence the traumatic brain injury biomarkers industry by ensuring product safety, efficacy, and quality. Approvals from bodies like the FDA and EMA validate biomarker tests for clinical use, boosting market confidence. However, stringent regulations can extend development timelines and increase costs, impacting market entry and innovation pace.

Product substitutes in the traumatic brain injury biomarkers industry include traditional imaging techniques like CT scans and MRI, as well as clinical assessment tools and neuropsychological tests. While these methods aid diagnosis, they lack the sensitivity and specificity of biomarker tests, driving demand for advanced, minimally invasive diagnostic alternatives.

Hospitals and clinics dominate the end-user segment in the traumatic brain injury biomarkers industry due to their frontline role in diagnosis and patient management. Increasing TBI incidence and awareness have amplified demand for rapid, accurate biomarker tests in these settings. Expansion in specialized neurological centers also contributes to growing end-user concentration.

Type Insights

The protein biomarkers segment led the market with the largest revenue share of 55.73% in 2024, driven by their critical role in early diagnosis, prognosis, and monitoring of TBI. Protein biomarkers such as glial fibrillary acidic protein (GFAP), ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), tau protein, and neurofilament light chain (NF-L) provide sensitive, non-invasive indicators of neuronal and glial injury. The high specificity and sensitivity of these proteins in blood and cerebrospinal fluid samples make them invaluable tools for clinicians. Growing investment in research and FDA approvals of protein-based diagnostic tests continue to drive market growth globally.

The metabolomic biomarkers segment is anticipated to grow at the fastest CAGR during the forecast period, driven by their potential to provide comprehensive insights into the biochemical changes following brain injury. Metabolomic profiles analyze small molecules and metabolic pathways, enabling a more dynamic and detailed understanding of TBI pathophysiology. Advances in high-throughput technologies like mass spectrometry and nuclear magnetic resonance (NMR) have accelerated metabolomic research. This growth is further propelled by increasing investments in personalized medicine and the demand for more precise diagnostic and prognostic tools in TBI management, making metabolomic biomarkers a key focus for future innovation.

Sample type Insights

The blood-based biomarkers segment led the market with the largest revenue share of 63.70% in 2024 and is anticipated to grow at the fastest CAGR during the forecast period, due to their minimally invasive nature and ease of collection. Blood samples enable rapid detection of key biomarkers such as GFAP, UCH-L1, and neurofilament light chain, which are critical for early diagnosis and severity assessment. A recent study indicates that blood-based biomarkers can detect prolonged axonal injury following pediatric mild traumatic brain injury (mTBI), highlighting their importance for improved diagnosis, ongoing monitoring, and guiding treatment to prevent long-term neurological complications in children. Advances in assay technologies have enhanced sensitivity and specificity, making blood tests increasingly reliable for clinical use.

Growing demand for point-of-care testing and ongoing regulatory approvals further drive market expansion, positioning blood-based diagnostics at the forefront of TBI biomarker development worldwide. These biomarkers provide objective assessments of injury severity, guiding clinicians in making informed decisions regarding patient monitoring and treatment. In addition, their use helps reduce unnecessary CT scans, minimizing radiation exposure and healthcare costs. Advances in rapid point-of-care testing further enhance timely clinical interventions.

Application Insights

The diagnosis segment led the market with the largest revenue share of 56.26% in 2024, due to the critical need for rapid and accurate identification of brain injuries. Biomarkers are essential tools that enable early detection and classification of TBI severity. The segment’s growth is fueled by increasing TBI incidence, advancements in biomarker assay technologies, and rising adoption of non-invasive diagnostic methods. Furthermore, regulatory approvals and the demand for point-of-care testing contribute to the expansion of the diagnosis segment, solidifying its dominance in the TBI biomarkers market worldwide.

The monitoring treatment response segment is expected to grow at the fastest CAGR during the forecast period. Rising adoption in clinical trials and rehabilitation programs to track biomarker changes over time and growing interest in using biomarkers for longitudinal management of TBI fuel the market growth. Sport-related concussion rehabilitation and follow-up protocols utilize a comprehensive, multidimensional strategy to ensure symptoms fully resolve and functional abilities return to baseline before advancing through return-to-play stages. This method reduces the risk of re-injury and supports a successful, sustainable return to sport and everyday life. Biomarkers enable clinicians to monitor ongoing brain injury and inflammation, providing critical insights into treatment efficacy.

End Use Insights

The research institutes segment led the market with the largest revenue share of 38.70% in 2024, driven by expanding investments in TBI research and biomarker discovery. Most exploration biomarker work (especially metabolomic, genetic, and exosome-based) is driven by academic centers and research hospitals through collaboration. For instance, in August 2022, researchers involved in the Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study analyzed the levels of two key proteins: glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), which are found in brain cells, nearly 1,700 patients with traumatic brain injury. TRACK-TBI is an observational study focused on enhancing the understanding and diagnosis of TBIs, with the goal of developing more effective blood-based biomarkers treatments for patients affected by these injuries. The dynamic research environment and focus on personalized medicine position research institutes at the forefront of growth in the TBI biomarkers industry.

The hospitals and clinics segment is anticipated to grow at the fastest CAGR during the forecast period, due to growing adoption of FDA-cleared biomarkers (like GFAP/UCH-L1) for emergency triage and acute care but still lagging research-driven demand. The healthcare settings are equipped with advanced diagnostic tools and personnel skilled in biomarker testing, enabling timely decision-making for effective patient care. The increasing incidence of TBI cases, coupled with growing awareness among clinicians about biomarker utility, fuels adoption in hospitals and clinics. Furthermore, integration of point-of-care testing and regulatory approvals has strengthened this segment’s dominance, making it pivotal to the global TBI biomarkers market growth.

Regional Insights

North America dominated the traumatic brain injury biomarkers market with the largest revenue share of 43.90% in 2024, driven by increasing TBI incidence from road accidents, sports, and falls. Technological advancements in neuroimaging and biomarker diagnostics are enhancing early detection and personalized treatment. The market benefits from strong healthcare infrastructure, regulatory support and rising awareness.

U.S. Traumatic Brain Injury Biomarkers Market Trends

The traumatic brain injury biomarkers market in the U.S is growing rapidly, driven by funding initiatives, along with an aging population. Advances in neuroimaging, biomarker diagnostics are enhancing early detection and personalized treatment. Regulatory support and increased healthcare spending further fuel growth, reflecting strong demand for improved TBI diagnosis. The Defense Appropriations Act is expected to allocate funds to the Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) to advance research focused on the prevention, diagnosis, and treatment of traumatic brain injury (TBI), as well as improving psychological health. The Congressionally Directed Medical Research Programs (CDMRP) within the U.S. Army Medical Research and Development Command (USAMRDC) will oversee these funding opportunities.

Europe Traumatic Brain Injury Biomarkers Market Trends

The traumatic brain injury biomarkers market in Europe is expanding significantly driven by increasing TBI incidence and rising awareness and government healthcare initiatives. Advances in neuroimaging, biomarker research are enhancing diagnosis and personalized treatment. Governments worldwide have initiated several programs to advance the use of biomarkers in traumatic brain injury (TBI) classification and management. For example, in January 2025, Braini was initiated to focus on blood biomarkers for enhancing the diagnosis and management of mild traumatic brain injury (mTBI), enabling faster, more accurate assessments and improving patient outcomes through personalized care.

The UK traumatic brain injury biomarkers market is steadily growing, driven by rising funding and increasing research and development. Support from governments, increasing funding for biomarker diagnostic technologies, and partnerships between academic institutions and the industry are driving significant growth in this field. The UK Dementia Research Institute’s research underscores the potential of fluid biomarkers in monitoring chronic TBI progression. It highlights the need for further studies to validate these biomarkers for clinical application.

The traumatic brain injury biomarkers market in Germany is experiencing robust growth, driven by increased TBI incidence, an aging population, and advancements in diagnostic technologies. Key players such as Siemens Healthineers, Roche, and bioMérieux are leading the market with innovative biomarker-based diagnostic solutions. Recent advancements include the development of blood-based biomarkers like GFAP and NfL, which enable early detection and monitoring of TBI. Collaborations between academic institutions and industry partners further accelerate research and development in this field, positioning Germany as a leader in TBI biomarker innovation.

Asia Pacific Traumatic Brain Injury Biomarkers Market Trends

The traumatic brain injury biomarkers market in Asia Pacific is anticipated to witness at the fastest CAGR of 19.40% over the forecast period, driven by increasing TBI incidence, advancements in diagnostic technologies, and rising healthcare investments. Key players such as Siemens Healthineers, Roche, and bioMérieux are leading the market with innovative biomarker-based diagnostic solutions. Recent advancements include the development of blood-based biomarkers like GFAP and NfL, enabling early detection and monitoring of TBI. Collaborations between academic institutions and industry partners further accelerate research and development in this field, positioning the region as a leader in TBI biomarker innovation.

The China traumatic brain injury biomarkers market is expanding rapidly, driven by increasing TBI incidence, advancements in diagnostic technologies, and government support for healthcare research. Recent advancements include the development of serum exosomes miR-206 and miR-549a-3p as potential biomarkers, as well discovery of novel biomarkers such as KDM5D, enabling early detection and monitoring of TBI. Collaborations between academic institutions and industry partners further accelerate research and development in this field, positioning China as a leader in TBI biomarker innovation.

The traumatic brain injury biomarkers market in Japan is witnessing steady growth, fueled by increasing awareness of TBI and government initiatives promoting advanced diagnostics. Leading companies like Sysmex Corporation, Fujifilm Holdings, and Shimadzu Corporation are pioneering biomarker research and diagnostic solutions. Collaborative study, involving researchers from the University of Miami, King’s College London, and Nippon Medical School in Tokyo, Japan, highlights recent advances in traumatic brain injury biomarkers, emphasizing their potential to improve diagnosis and patient care. Furthermore, partnerships between academic researchers and industry stakeholders are driving innovation, making Japan a notable player in the evolving TBI biomarker landscape.

Latin America Traumatic Brain Injury Biomarkers Market Trends

The traumatic brain injury biomarkers market in Latin America is growing steadily, driven by a high incidence of TBI primarily due to road traffic accidents and violence. Key drivers include growing awareness and increased research and development efforts, such as the LATINO-BIO-TBI study across Latin America and the Caribbean, which evaluates serum biomarkers, specifically Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase L1 (UCH-L1), to assess traumatic brain injury (TBI) severity and predict patient outcomes.

The Brazil traumatic brain injury biomarkers market is rapidly expanding, with advances in neuroimaging and biomarker diagnostics enhancing early diagnosis and personalized treatment. Research and development initiatives through collaborations and partnerships are fueling market growth.

Middle East & Africa Traumatic Brain Injury Biomarkers Market Trends

The traumatic brain injury biomarkers market in the Middle East and Africa (MEA) is witnessing steady growth, driven by increasing TBI incidence from road accidents, falls, and sports injuries, alongside rising awareness and improving healthcare infrastructure. Innovations such as bioMérieux’s VIDAS TBI test (GFAP, UCH-L1) enhance early and accurate diagnosis, reduce unnecessary CT scans and emergency overcrowding.

The Saudi Arabia traumatic brain injury biomarkers market is growing steadily, driven by increasing TBI incidence from road accidents and falls, rising healthcare investments, and government initiatives under Vision 2030 promoting precision medicine and advanced diagnostics. Key players are expanding their presence through collaborations and innovative biomarker test launches.

Key Traumatic Brain Injury Biomarkers Company Insights

Some of the key players operating in the market include Quanterix Corporation, Inc., Abbott Laboratories, Illumina, Inc., GE Healthcare, Qiagen NV and Merck KGaA. Innovations in artificial intelligence, next-generation sequencing, and liquid biopsy are enhancing the accuracy and efficiency of traumatic brain injury biomarker diagnostics. These developments underscore the dynamic nature of the traumatic brain injury biomarker market, with established companies and emerging technologies shaping its future trajectory.

Recent Developments

• In January 2025, Braini was initiated to focus on blood biomarkers for enhancing the diagnosis and management of mild traumatic brain injury (mTBI), enabling faster, more accurate assessments and improving patient outcomes through personalized care.

• In April 2024, the USFDA announced the launch of Abbott's i-STAT TBI Plasma test as the first rapid test on a portable analyzer to receive FDA 510(k) clearance, and developed in collaboration with the U.S. Department of Defense (DoD), can help determine the need for a CT scan.

Traumatic Brain Injury Biomarkers Market Report Scope

Global Traumatic Brain Injury Biomarkers Market Report Segmentation

This report forecasts revenue growth at the global, regional, and 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 the global traumatic brain injury biomarkers market report based on type, sample type, application, end use, and region:

• 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

• Regional Outlook (Revenue in USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait