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 Epidemiology Statistics

1) By Age: TBI patterns differ sharply across age groups; falls are the primary cause in both the young and elderly, whereas road accidents are the main driver among youth and working adults.

• Adults aged 75 and older represent the highest-risk age group, accounting for 32% of TBI-related hospitalizations and 28% of fatalities, largely due to falls.
• The working-age population (18 – 64 years) faces a high burden of TBI, primarily caused by motor vehicle accidents, falls, and workplace injuries. These patients often require both emergency interventions and long-term rehabilitation.
• Among young adults (20 – 30 years), TBI is especially common due to road traffic accidents. A 2020 Brazilian study on 800 MVA-related TBI cases highlighted a concentration of cases among males in this age group.
• In children aged 0 – 17, falls remain the most frequent cause of TBI, responsible for 49% of emergency visits. Similarly, 81% of TBI-related emergency visits in adults over 65 are due to falls.

2) By Gender: TBI incidence is markedly higher in males

• Males experience significantly higher TBI rates than females, with a hospitalization rate of 79.9 per 100,000 compared to 43.7 for females and are three times more likely to die from TBI-related causes. This is linked to higher exposure to risky activities like sports, driving, and violence.

3) By Cause: Falls are the leading cause of TBI, especially in young children and the elderly, while sports-related TBIs are increasingly impacting youth

• Falls remain the most common cause of TBI, accounting for over 30% of cases and 52% of hospitalizations, particularly affecting older adults and young children. This makes fall prevention and treatment a key public health focus.
• Sports-related TBIs are on the rise, especially among youth. According to CDC 2024, over two-thirds of high school sports concussions are due to athlete-to-athlete collisions. In baseball, 25% of concussions result from being hit by pitches. In basketball, nearly two-thirds of concussions in boys and half in girls stem from collisions. Stanford Children’s Health reports that of the 3.5 million annual sports injuries among U.S. children, ~21% are TBIs.

4) By Severity: Mild TBIs Dominate, But High-Risk Lives Bear the Weight

TBIs are categorized as mild, moderate, or severe based on clinical impact. Mild TBIs are the most common, particularly in high-risk groups such as athletes, traffic accident victims, and military personnel. A 2020 study in urban Brazil found that 90% of 1,986 traffic-related TBI cases were mild, while 7% were severe.

Market Dynamics

Driver: Growing incidence of TBIs due to increasing sports injuries and road accidents

The rising number of sports-related injuries and road traffic collisions (RTCs) are the two leading causes of traumatic brain injury (TBI). Following a significant decline in sports related injuries in 2020, there has been a consistent upward trend with a 20% increase in 2021, 12% in 2022, and a further 2% in 2023. In the U.S., over 3.5 million children under 14 are injured in sports or recreation annually. While fatalities are rare, traumatic brain injury is the leading cause of sports-related deaths. Over 20% of TBIs in children stem from sports, with nearly half linked to bicycling, skateboarding, or skating. Additionally, as per the John Hopkins Medicine statistics, each year, 775,000+ children are treated for sports-related injuries, mainly from falls, collisions, and overexertion. This rising burden continues to drive demand for better traumatic brain injury (TBI) treatments and prevention.

Parallel to this, Road Traffic Collisions (RTCs) remain one of the most significant global causes of traumatic brain injury, particularly in low-and-middle-income countries (LMICs), where rapid urbanization has outpaced safety infrastructure. A 2022 report found that RTCs cause 1.35 million deaths and 50 million injuries annually, with 34 million involving traumatic brain injuries (TBIs). Head trauma is a leading consequence, present in 70% of RTC deaths.

Restraint: High cost of treating traumatic brain injuries

The substantial financial burden associated with treating traumatic brain injuries (TBIs) significantly hinders the growth of the TBI market, particularly in low-and-middle-income countries (LMICs) where healthcare resources are limited. In the United States, the cost of TBI treatment varies widely based on injury severity. For instance, according to Centre for Neuro Skills, a mild brain injury can cost ~$85,000, while moderate injuries may exceed $900,000, and severe TBIs can reach up to $3 million over a patient's lifetime. These expenses encompass emergency care, hospitalization, surgeries, rehabilitation, and long-term care. Emergency room visits alone can range from $150 to $3,000, with additional costs for imaging tests such as CT scans or MRIs, which can add $5,000 to $8,000. Hospitalization costs also vary; for example, inpatient stays for TBIs caused by motor vehicle accidents average around $31,000. Rehabilitation expenses are equally daunting, with physical therapy sessions costing between $50 and $250 per hour, and residential rehabilitation programs ranging from $1,000 to $2,500 per day.

These high treatment costs, especially in low- and-middle-income countries (LMICs), limit access to care and hinder traumatic brain injury (TBI) market growth, highlighting the urgent need for affordable and accessible solutions.

Opportunity: Integration Of Artificial Intelligence (AI) And Machine Learning (ML) Into Traumatic Brain Injury (TBI) Management

The integration of artificial intelligence (AI) and machine learning (ML) into traumatic brain injury (TBI) management is emerging as a powerful force propelling market growth, due to its ability to enhance diagnosis, treatment, rehabilitation, and outcome prediction. AI-based technologies are transforming traditional clinical workflows by offering faster, more accurate, and data-driven insights that improve patient care and reduce healthcare costs. For example, AI-enhanced CT imaging is being evaluated in ongoing clinical trials where TBI patients undergo serial scans and intensive monitoring to assess neurological outcomes. This approach allows for real-time tracking of injury progression and supports clinical decision-making with higher precision than conventional methods.

Machine learning models are also being applied to predict long-term cognitive and functional outcomes in TBI patients, enabling clinicians to tailor rehabilitation protocols based on individualized risk profiles. These advancements not only improve the quality of care but also attract substantial investments and partnerships between tech companies and healthcare providers, fueling the expansion of the TBI market. 

Segmental Analysis

Treatment Type: Medication Leads the Charge in Traumatic Brain Injury (TBI) Treatment Market 

Based on treatment type, the medication segment is expected to dominate the global traumatic brain injury (TBI) treatment market in 2024, driven by its widespread use in managing acute symptoms and stabilizing patients. While no therapeutic drugs are currently approved specifically for traumatic brain injury, management relies on symptomatic treatments such as anti-seizure drugs (e.g., phenytoin, levetiracetam), diuretics (e.g., mannitol), pain relievers, and antidepressants. Their accessibility, ease of administration, and broad applicability across traumatic brain injury severity levels contribute significantly to their market share. For example, levetiracetam is widely preferred for its favorable safety profile, distinct mechanism of action, and fewer drug interactions, especially in preventing post-traumatic seizures. Similarly, mannitol remains critical in managing elevated intracranial pressure in emergency care settings.

A significant development highlighting the segment’s potential is the advancement of NeuroSTAT (OWL-1410), a neuroprotective drug developed by Owl Therapeutics and Abliva. NeuroSTAT has received Orphan Drug Designation (ODD) in the U.S. and Europe and Fast Track status from the FDA. With promising preclinical data showing reduced neuronal injury biomarkers, it holds significant potential for both military and civilian TBI patients, highlighting growing interest in pharmacological treatments for TBI.

The medication segment is expected to not only retain a dominant market share but also achieve the highest CAGR through 2033, driven by advances in pharmacological therapies, growing use in symptom management, and targeted drug development. With strong clinical pipeline and increased reliance on medical imaging, the shift toward medication-based TBI treatment is accelerating.

The surgery segment, while essential in managing severe and life-threatening TBI cases – such as hematoma evacuation or decompressive craniectomy, holds a smaller growth trajectory due to its invasive nature and limited application to critical cases. 

Route of Administration: Oral Leads, IV Surges in Traumatic Brain Injury (TBI) Treatment Delivery

The global traumatic brain injury (TBI) treatment market is experiencing steady growth, with the oral route of administration expected to dominate in 2024 holding 57.5% of the total market. Oral medications are favored for their convenience, ease of use, and higher patient compliance. These medications are commonly used to manage symptoms such as pain, inflammation, seizures, and cognitive disturbances, making them essential for ongoing symptom control, particularly in chronic or less severe cases where patients can self-administer without clinical supervision.

The intravenous (IV) route, comprising 32.9%, is expected to register the highest CAGR, driven by its vital role in emergency and acute TBI care. Rapid drug delivery through IV administration is essential for timely intervention with life-saving and neuroprotective agents. Treatments like 3% hypertonic saline and mannitol, commonly used to reduce intracranial pressure, are more effective when delivered intravenously, with hypertonic saline also enhancing cerebral perfusion and oxygen delivery. Ongoing advancements in injectable formulations and growing clinical preference for IV protocols in critical care further support this growth, underscoring its importance in improving therapeutic outcomes for TBI patients.

The others category, including parenteral methods, accounts for a smaller 9.6% market share but represents an emerging segment. Innovative delivery systems in this category offer promising alternatives for targeted or sustained drug delivery.

Distribution Channel Insights: Hospital & Rehabilitation Centres Dominate the Traumatic Brain Injury (TBI) Treatment Market

The traumatic brain injury (TBI) treatment market can be segmented by distribution channels into hospitals & rehabilitation centers, and pharmacies. Among these, pharmacies hold the highest market share, as they are the primary source of medications during the acute, chronic, and emergency phases of TBI care. These pharmacies are critical for administering specialized drugs such as neuroprotective agents, anti-seizure medications, and intensive care treatments that are essential in the immediate aftermath of brain injuries. Amongst pharmacies, online pharmacies represent the fastest-growing distribution channel, supported by the digitalization of healthcare, rising internet penetration, and increasing consumer preference. As telehealth becomes more mainstream and patients seek accessible, remote options for treatment, the online segment is expected to gain further momentum in the coming years.

Regional Insights: North America Takes the Lead, Europe and APAC Accelerators of the Traumatic Brain Injury (TBI) Treatment Market 

The global traumatic brain injury (TBI) treatment market is expected to see significant growth across various regions, with North America (NA) maintaining its dominant position, projected to account for a substantial share of the market in 2024. This leadership can be attributed to the region's advanced healthcare infrastructure, high healthcare expenditure, and strong focus on cutting-edge treatment options. North America reports a high prevalence of TBI. According to the International Brain Injury Association, approximately one million Americans are treated and released from hospital emergency departments annually due to TBI. Around 230,000 are hospitalized and survive, and an estimated 80,000 are discharged with TBI-related disabilities. These figures are largely influenced by factors such as road traffic accidents and sports-related injuries. 

In contrast, the Asia-Pacific (APAC) region is expected to witness the highest compound annual growth rate (CAGR) in the TBI treatment market. This strong growth is fuelled by rapid urbanization, increasing road traffic accidents, and a growing emphasis on improving healthcare infrastructure across major countries such as China, India, Japan, and Australia. Japan is at the forefront of innovation, recently approving AKUUGO, a first-in-class stem cell therapy for chronic TBI. Meanwhile, China is investing heavily in research and development to address its high TBI-related mortality rate of 13 per 100,000 people. 

Europe (EU) holds a significant share of the TBI treatment market, with countries such as Germany, the United Kingdom, and France leading the charge in both acute care and long-term rehabilitation services. The region is home to a high incidence of TBI, particularly among the elderly population, which is more susceptible to falls and related injuries. 

Supported by well-established healthcare systems, Europe continues to prioritize improved outcomes through advanced therapies and integrated rehabilitation programs. Notably, the United Kingdom has made significant progress in TBI research, highlighted by the launch of TBI-REPORTER, a $12.61 million research initiative led by the University of Cambridge to unify health data and enhance diagnosis and treatment. 

Middle East & Africa (MEA) and South America (SA) are experiencing gradual market growth. In MEA, rising TBI rates – mainly from road accidents are prompting investment in trauma centres in the UAE and Saudi Arabia. 

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Recent Developments

Product Launch (Jan 2025): DRG Neuroscience (a division of DRG Instruments GmbH) launched its automatic CLIA tests for diagnosing suspected traumatic brain injury (TBI)

• DRG's automated CLIA platform – DxDATA is building platform for these tests
• The tests are rapid and can measure GFAP and UCH-L1 blood levels within 30 minutes, i.e., if the samples are collected within 12 hours of TBI injury in suspected patients
• These TBI tests by DRG’s tests are CE-marked and CLSI verified

Marketing Approval (Jul 2024): SanBio got time limited marketing approval for AKUUGO (Vandefitemcel) in Japan for improving chronic motor paralysis in traumatic brain injury (TBI)

• AKUUGO is world’s first (allogeneic) bone marrow-derived mesenchymal stem cell therapy for traumatic brain injury (TBI)
• Its approval was based on a global phase II clinical trial
• It is for Intracranial Implantation

Key Players in Traumatic Brain Injury Treatment Market 

• Cellvation
• Oragenics
• Oxeia Biopharmaceuticals
• BioVie
• Shinkei Therapeutics
• Abliva/Owl Therapeutics
• Other Prominent Players

Segments Covered in The Report 

By Treatment Type 

• Medication
  • Anti- seizures drugs
  • Diuretics
  • Pain relievers
  • Antidepressant
• Stem Cell Therapy
• Surgery
• Others (Rehabilitation Therapies, Physiotherapy, etc)

By Route of Administration     

• Intravenous
• Oral
• Others

By Distribution Channel

• Hospital & Rehabilitation Centres
• Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

By Geography 

• North America
  • The USA
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia & New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East & Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America