Traumatic Brain Injury - Market Insight, Epidemiology And Market Forecast - 2034

Traumatic Brain Injury - Market Insight, Epidemiology And Market Forecast - 2034



Key Highlights
  • The Traumatic Brain Injury market is projected to witness consistent growth throughout the forecast period (2023–2034). The market size of Traumatic Brain Injury in the 7MM is expected to increase, driven by the launch of emerging therapies.
  • DelveInsight’s analyst projects that the total incident cases of Traumatic Brain Injury in 7MM were approximately 4,197 thousand in 2022 and these cases are further expected to increase during the forecasted period (2023–2034).
  • Most number of incident cases were estimated in the US, followed by Japan, Germany, France, and the UK in 2022.
  • In the US, the market mainly consisted of standard of care, which generated nearly USD 5,040 million in 2022.
  • The total size of the Traumatic Brain Injury treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely VAS203, CEVA101, and others.
DelveInsight’s “Traumatic Brain Injury – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the Traumatic Brain Injury, historical and forecasted epidemiology and the Traumatic Brain Injury market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Traumatic Brain Injury market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM, Traumatic Brain Injury market size from 2020 to 2034. The report also covers current Traumatic Brain Injury treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered
  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan
Study Period: 2020–2034

Disease Understanding and Treatment Algorithm

Traumatic Brain Injury Overview

Traumatic Brain Injury (TBI) is sudden damage to the brain caused by a blow or jolt to the head. Common causes include car or motorcycle crashes, falls, sports injuries, and assaults. Injuries can range from mild concussions to severe permanent brain damage. The injury that occurs at the moment of impact is known as the primary injury. Primary injuries can involve a specific lobe of the brain or can involve the entire brain. Sometimes, the skull may be fractured, but not always. During the impact of an accident, the brain crashes back and forth inside the skull, causing bruising, bleeding, and tearing of nerve fibers.

Symptoms of a TBI can be mild, moderate, or severe, depending on the extent of the damage to the brain. A person with a mild TBI may remain conscious or experience a loss of consciousness for a few seconds or minutes. Other symptoms of mild TBI include headache, confusion, lightheadedness, dizziness, blurred vision or tired eyes, ringing in the ears, bad taste in the mouth, fatigue or lethargy, a change in sleep patterns, behavioral or mood changes, and trouble with memory, concentration, attention, or thinking. A person with a moderate or severe TBI may show these same symptoms but may also have a headache that gets worse or does not go away, repeated vomiting or nausea, convulsions or seizures, an inability to awaken from sleep, dilation of one or both pupils of the eyes, slurred speech, weakness or numbness in the extremities, loss of coordination, and increased confusion, restlessness, or agitation.

Traumatic Brain Injury Diagnosis

No single test is able to confirm the diagnosis of TBI definitively. Doctors assess the history of the injury, the patient’s symptoms, the physical examination, and additional tests, including neuroradiology, to confirm a diagnosis of TBI. Many TBI patients experience a loss of consciousness (blacking out) at the time of their injury. Loss of consciousness most commonly lasts from seconds to minutes, but severe TBI may last for days (coma) and may persist indefinitely in the most severe cases. Patients with mild TBI (concussion) may not experience any loss of consciousness. Most TBI patients have some degree of amnesia (loss of memory) for the minutes to hours or longer surrounding their injury.

Further details related to country-based variations are provided in the report

Traumatic Brain Injury Treatment

The management of traumatic brain injury focuses on preventing primary and secondary injuries. Pre-hospital protocols ensure airway protection, oxygenation, and perfusion. Intracranial pressure (ICP) monitoring is pivotal, with a target of 20–25 mmHg. Brain multi-modality monitoring integrates various monitors for early detection and personalized intervention. Real-time data analysis tools aid in optimizing treatment. Key monitoring probes include brain tissue oxygenation and microdialysis. These approaches, guided by evidence-based guidelines, enhance neurocritical care, mitigating ischemic risks and improving outcomes for moderate to severe TBIs.

Traumatic Brain Injury Epidemiology

As the market is derived using the patient-based model, the Traumatic Brain Injury epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of TBI, Severity-specific Incident Cases of TBI, Gender-specific Incident Cases of TBI, and Age-specific Incident Cases of TBI in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034.

According to DelveInsight estimations, 4,197 thousand Incident Cases of Traumatic Brain Injury were found in 2022 in the 7MM.

As per DelveInsight’s estimations, the total number of cases with Traumatic Brain Injury in the United States were 2,964 thousand in 2022 and are projected to increase during the forecast period.

According to DelveInsight’s estimates, the Total Incident Cases of Traumatic Brain Injury in EU4 and the UK were found to be 906 thousand in 2022. The highest proportion of Traumatic Brain Injury cases was reported in Germany among the EU4 countries, while the least number of cases was found in Spain.

The estimates show the number of Traumatic Brain Injury cases in Japan was found to be 326 thousand in 2022, which is estimated to decrease by 2034.

Traumatic Brain Injury Drug Chapters

The drug chapter segment of the Traumatic Brain Injury report encloses a detailed analysis of Traumatic Brain Injury marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands Traumatic Brain Injury clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

Ronopterin (VAS203): VeriNOS Pharmaceuticals GmbH

Ronopterin (VAS203) is an allosteric iNOS inhibitor and rapidly lowers excessive production of NO resulting from acute iNOS activation. It does not materially affect the physiological production of NO by other constitutive enzymes, which are essential for brain function. By targeting both cerebral blood vessels and cerebral tissue in a region-specific manner, VAS203 represents a completely novel pharmacological approach to TBI that can be administrated in addition to the best standard of care.

The drug is currently in Phase III of clinical development for the treatment of moderate and severe traumatic brain injury.

CEVA101: Cellvation, Inc.

CEVA101 is a novel cellular product composed of Autologous Bone Marrow-derived Mononuclear Cells (BMMNCs), which are harvested and undergo isolation and processing. CEVA101 is intravenously infused within 48 h of injury by slow IV push. CEVA101 is currently being developed for the treatment of severe traumatic brain (closed head) injuries in adults and children.

Based on promising clinical results, Cellvation has initiated two Phase II randomized, placebo-controlled trials to confirm the beneficial clinical outcomes and the protective function of CEVA101 in both adult and pediatric patients with severe TBI.

Note: Detailed emerging therapies assessment will be provided in the final report of Traumatic Brain Injury

Traumatic Brain Injury Market Outlook

Treatment typically involves medical intervention, rehabilitation, and support to manage symptoms and improve outcomes. The treatment modalities vary extensively based on the severity of the injury and range from daily cognitive therapy sessions to radical surgery, such as bilateral decompressed craniotomies. Guidelines have been set forth regarding optimal TBI management, but they must be taken in the context of the situation and cannot be used in every individual circumstance.

Current treatment options for TBI include psychostimulants, antidepressants, antiparkinsonian agents, and anticonvulsants. These agents can play a role in managing the neuropsychiatric, neurocognitive, and neurobehavioral sequel of injury to the brain.

The market for Traumatic Brain Injury is expected to experience positive growth with the approval of potential drugs like Ronopterin (VAS203), CEVA1010 and others.
  • The total market size of Traumatic Brain Injury in the 7MM was around USD 6,354 million in 2022. This is estimated to increase by 2034 at a significant CAGR.
  • In the 7MM, most of the market share was accommodated by standard of care generating nearly USD 6,354 million in 2022.
  • Among the 7MM, the US captured the highest market in 2022, covering a total of 79% market, followed by Japan, which is anticipated to grow during the forecast period (2023–2034).
  • In 2022, EU4 and the UK captured nearly 15% of the total market in the 7MM.
  • Among the forecasted emerging therapies, CEVA101 is expected to capture the highest market in the 7MM by 2034.
Traumatic Brain Injury Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2023–2034. For example CEVA101 in the US is expected to be launched by 2028.

Further detailed analysis of emerging therapies drug uptake in the report…

Traumatic Brain Injury Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Traumatic Brain Injury emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Traumatic Brain Injury evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of Maryland School of Medicine, USA, Department of Neurological Surgery, University of Miami Miller School of Medicine, USA, National Academies of Sciences, Engineering, and Medicine, USA, BG University Hospital Bergmannsheil, Germany, Institut Guttmann Neurorehabilitation Hospital, Spain, Keio University School of Medicine, Japan and others.

DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Traumatic Brain Injury market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report
  • The report covers a segment of key events, an executive summary, descriptive overview of Traumatic Brain Injury, explaining its causes, signs and symptoms, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
  • Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will affect the current treatment landscape.
  • A detailed review of the Traumatic Brain Injury market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preference that help shape and drive the 7MM Traumatic Brain Injury market.
Traumatic Brain Injury Report Insights
  • Patient Population
  • Therapeutic Approaches
  • Traumatic Brain Injury Pipeline Analysis
  • Traumatic Brain Injury Market Size and Trends
  • Existing and Future Market Opportunity
Traumatic Brain Injury Report Key Strengths
  • 12 years Forecast
  • The 7MM Coverage
  • Traumatic Brain Injury Epidemiology Segmentation
  • Key Cross Competition
  • Conjoint Analysis
  • Drugs Uptake and Key Market Forecast Assumptions
Traumatic Brain Injury Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)
Key Questions

Market Insights
  • What was the Traumatic Brain Injury total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
  • What unmet needs are associated with the current treatment market of Traumatic Brain Injury?
  • What are the patents of emerging therapies for Traumatic Brain Injury?
  • Which drug is going to be the largest contributor by 2034?
  • What are the pricing variations among different geographies for off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights
  • What are the disease risk, burdens, and unmet needs of Traumatic Brain Injury? What will be the growth opportunities across the 7MM concerning the patient population of Traumatic Brain Injury?
  • What is the historical and forecasted Traumatic Brain Injury patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
  • What factors are affecting the diagnosis of the indication?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies
  • What are the current options for treating Traumatic Brain Injury? What are the current guidelines for treating Traumatic Brain Injury in the US and Europe?
  • How many companies are developing therapies for treating Traumatic Brain Injury?
  • How many emerging therapies are in the mid-stage and late stage of development for treating Traumatic Brain Injury?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the key designations that have been granted for the emerging therapies for Traumatic Brain Injury?
  • What is the cost burden of approved therapies on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
  • What are the 7MM historical and forecasted markets of Traumatic Brain Injury?
Reasons to Buy
  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Traumatic Brain Injury Market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
  • Detailed analysis, ranking of class-wise potential current, and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
  • To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.
Frequently Asked Questions

1. What is the forecast period covered in the report?

The Traumatic Brain Injury Epidemiology and Market Insight report for the 7MM covers the forecast period from 2023 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Traumatic Brain Injury market?

The Traumatic Brain Injury emerging market has many drugs. The major key players developing therapies for Traumatic Brain Injury are veriNOS pharmaceuticals GmbH, Cellvation, Abalonex, Hope Biosciences, and others.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as prevalent cases, treatment costs; revenue generated, and market trends.

4. What is the key driver of the Traumatic Brain Injury market?

The launch of emerging therapies is attributed to be the key driver for increasing Traumatic Brain Injury market.

5. What is the expected impact of emerging therapies or advancements in Traumatic Brain Injury treatment on the market?

Introducing new therapies, advancements in disease understanding and diagnostic techniques, and innovations in treatment approaches can significantly affect the Traumatic Brain Injury treatment market. Market forecast reports might provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Traumatic Brain Injury market.


1. Key Insights
2. Report Introduction
3. Traumatic Brain Injury (TBI) Market Overview by Therapy
3.1. Market Share (%) Distribution of TBI by Therapy in 2020
3.2. Market Share (%) Distribution of TBI by Therapy in 2034
4. Epidemiology and Market Methodology of TBI
5. Executive Summary of TBI
6. Key Events
7. Disease Background and Overview
7.1. Introduction
7.2. Symptoms
7.3. Etiology
7.4. Pathophysiology
7.5. Neurodegenerative Conditions Associated With TBI
7.6. Biomarkers
7.7. Diagnosis
7.7.1. Diagnostic Algorithm
7.7.2. Diagnostic Guidelines
7.7.2.1. The American Congress of Rehabilitation Medicine Diagnostic Criteria for Mild TBI
7.7.2.2. Guidelines for Adult Patients with Mild TBI (A part of CDC’s “Heads Up” Series)
7.7.2.3. Centers for Disease Control and Prevention Guideline on the Diagnosis and Management of Mild TBI among Children
7.7.2.4. Prehospital Guidelines for the Management of TBI
7.8. Treatment
7.8.1. Treatment Algorithm
7.8.2. Treatment Guidelines
7.8.2.1. Centers for Disease Control and Prevention Guideline for the Management of Mild TBI among Children
7.8.2.2. Guidelines by Brain Trauma Foundation
7.8.2.3. Prehospital Guidelines for the Management of TBI
7.8.2.4. S2e guideline on Traumatic Brain Injury in Adults: 2015
8. Epidemiology and Patient Population
8.1. Key Findings
8.2. Assumptions and Rationale: The 7MM
8.2.1. Incidence of TBI
8.2.2. Severity-specific Incidence of TBI
8.2.3. Gender-specific Incidence of TBI
8.2.4. Age-specific Incidence of TBI
8.3. Total Incident Cases of TBI in the 7MM
8.4. The United States
8.4.1. Total Incident Cases of TBI in the US
8.4.2. Severity-specific Incident Cases of TBI in the US
8.4.3. Gender-specific Incident Cases of TBI in the US
8.4.4. Age-specific Incident Cases of TBI in the US
8.5. EU4 and the UK
8.5.1. Total Incident Cases of TBI in EU4 and the UK
8.5.2. Severity-specific Incident Cases of TBI in EU4 and the UK
8.5.3. Gender-specific Incident Cases of TBI in EU4 and the UK
8.5.4. Age-specific Incident Cases of TBI in EU4 and the UK
8.6. Japan
8.6.1. Total Incident Cases of TBI in Japan
8.6.2. Severity-specific Incident Cases of TBI in Japan
8.6.3. Gender-specific Incident Cases of TBI in Japan
8.6.4. Age-specific Incident Cases of TBI in Japan
9. Patient Journey
10. Emerging Therapies
10.1. Key Cross Competition
10.2. Ronopterin (VAS203): VeriNOS Pharmaceuticals GmbH
10.2.1. Product Description
10.2.2. Other Development Activities
10.2.3. Clinical Development
10.2.4. Clinical Trials Information
10.2.5. Safety and Efficacy
10.2.6. Product Profile
10.2.7. Analysts’ Views
10.3. CEVA101: Cellvation, Inc.
10.3.1. Product Description
10.3.2. Other Development Activities
10.3.3. Clinical Development
10.3.4. Clinical Trials Information
10.3.5. Safety and Efficacy
10.3.6. Product Profile
10.3.7. Analysts’ Views
10.4. OXE-103 (Ghrelin/SUN11031): Oxeia Biopharmaceuticals
10.4.1. Product Description
10.4.2. Other Developmental Activities
10.4.3. Clinical Development
10.4.4. Clinical Trials Information
10.4.5. Safety and Efficacy
10.4.6. Product Profile
10.4.7. Analysts’ Views
10.5. ABX-101: Abalonex, LLC
10.5.1. Product Description
10.5.2. Clinical Development
10.5.3. Clinical Trials Information
10.5.4. Product Profile
10.5.5. Analysts’ Views
10.6. HB-AdMSCs: Hope Biosciences
10.6.1. Product Description
10.6.2. Other Development Activities
10.6.3. Clinical Development
10.6.4. Clinical Trials Information
10.6.5. Safety and Efficacy
10.6.6. Product Profile
10.6.7. Analysts’ Views
10.7. SB623 (vandefitemcel): The SanBio Group
10.7.1. Product Description
10.7.2. Other Development Activities
10.7.3. Clinical Development
10.7.4. Clinical Trials Information
10.7.5. Safety and Efficacy
10.7.6. Product Profile
10.7.7. Analysts’ Views
10.8. NeuroSTAT/OWL-1410: Abliva/Owl Therapeutics
10.8.1. Product Description
10.8.2. Other Development Activities
10.8.3. Clinical Development
10.8.4. Clinical Trials Information
10.8.5. Safety and Efficacy
10.8.6. Product Profile
10.8.7. Analysts’ Views
11. Traumatic Brain Injury: The Seven Major Market Analysis
11.1. Key Findings
11.2. Key Market Forecast Assumptions
11.3. Market Outlook
11.4. Conjoint Analysis
11.5. Total Market Size of TBI in the 7MM
11.6. Market Size of TBI by Therapies in the 7MM
11.7. The United States
11.7.1. Total Market Size of TBI in the United States
11.7.2. Market Size of TBI by Therapies in the United States
11.8. EU4 and the UK
11.8.1. Total Market Size of TBI in EU4 and the UK
11.8.2. Market Size by Therapies in EU4 and the UK
11.9. Japan
11.9.1. Total Market Size of TBI in Japan
11.9.2. Market Size of TBI by Therapies in Japan
12. Key Opinion Leaders’ Views
13. SWOT Analysis
14. Unmet Needs
15. Market Access and Reimbursement
15.1. The United States
15.1.1. Centre for Medicare and Medicaid Services (CMS)
15.2. In EU4 and the UK
15.2.1. Germany
15.2.2. France
15.2.3. Italy
15.2.4. Spain
15.2.5. The United Kingdom
15.3. Japan
15.3.1. MHLW
16. Appendix
16.1. Bibliography
16.2. Acronyms and Abbreviations
17. Report Methodology
18. DelveInsight Capabilities
19. Disclaimer

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