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Pharmaceutical companies have made significant investments in traumatic brain injury drug development, although the late-stage pipeline remains limited. However, several early-phase clinical trials are ongoing, with promising mid- and late-stage trial results expected to expand the traumatic brain injury therapeutic market in the coming years. Historically, moderate-to-severe traumatic brain injuries have been the focus of research efforts, and concussive injuries (mild traumatic brain injuries) have been disregarded. Now, clinical research on mild traumatic brain injuries (mild TBI) is now gaining momentum, marking a crucial shift in their diagnosis, treatment, and long-term effects. LAS VEGAS, July 7, 2025 /PRNewswire/ -- DelveInsight's Traumatic Brain Injury Market Insights report includes a comprehensive understanding of current treatment practices, traumatic brain injury emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Traumatic Brain Injury Market Report According to DelveInsight's analysis, the market size for traumatic brain injury was found to be USD 1.3 billion in the 7MM in 2024. Among the 7MM, the US captured the highest market in 2024, covering a total 85% of the market, followed by Japan, which is anticipated to grow during the forecast period (2025–2034). In July 2024, SanBio' AKUUGO became the "first brain regeneration therapy" to receive conditional approval in Japan for the treatment of TBI. Among the forecasted emerging therapies, OXE103 is expected to capture the highest market in the 7MM by 2034. According to DelveInsight's assessment in 2024, the 7MM had 4.3 million incident cases of TBI, and these cases are expected to reach 4.5 million by 2034. In the 7MM, males represent a higher percentage of all TBI incident cases. Leading traumatic brain injury companies developing emerging therapies, such as Oxeia Biopharmaceuticals, Hope Biosciences, Oragenics, Cellvation, SHINKEI Therapeutics, and others, are developing novel traumatic brain injury drugs that can be available in the traumatic brain injury market in the coming years. The promising traumatic brain injury therapies in the pipeline include OXE113, HB-AdMSCs, ONP-002, CEVA111, MR-301, and others. Discover more about the mild traumatic brain injury treatment market @ Traumatic Brain Injury Medication Traumatic Brain Injury Market Dynamics The traumatic brain injury market dynamics are expected to change in the coming years. Decades of innovation have led to powerful diagnostic tools like modern CT scanners and MRI machines, which can detect neuro-traumatic disorders more quickly and accurately, providing critical information in the vital hours after injury. In 2024, AKUUGO became the world's first cell therapy approved in Japan for traumatic brain injury (TBI), setting a clinical and regulatory precedent that strengthens the market and opens new avenues for innovation. With growing recognition of TBI as a chronic health condition, particularly in moderate-to-severe cases, there is increasing focus on therapies that address its long-term effects, creating significant opportunities for companies to capture market share and shape the future of TBI treatment. AKUUGO has received multiple regulatory designations, including Sakigake designation (April 2019) and priority review designation (January 2022) from Japan's MHLW, orphan regenerative medicine designation (June 2020) from MHLW, RMAT designation (September 2019) from the US FDA, and ATMP designation (April 2019) from the EMA, recognizing its potential in treating chronic traumatic brain injury. Furthermore, potential therapies are being investigated for the treatment of traumatic brain injury, and it is safe to predict that the treatment space will significantly impact the traumatic brain injury market during the forecast period. Moreover, increased awareness of the silent epidemic of "mild injury", anticipated introduction of emerging therapies with improved efficacy, and a further improvement in the diagnosis trend of mild TBI are expected to drive the growth of the traumatic brain injury market in the 7MM. Most people ( up to 90%) suffer a mild TBI and lack of effective treatments for "mild TBI" on civilian, athlete, and military populations become increasingly apparent. Working together, developers, investors, and academic researchers are making progress in creating efficient medication solutions and addressing this unmet medical need. At present, drug development for concussions (mild TBI) is at an exciting moment, as several key players are targeting this untapped segment of TBI. However, several factors may impede the growth of the traumatic brain injury market. As many as 30% of concussion patients experience persistent post-concussion symptoms and long-term effects—a significantly higher occurrence than one might expect, especially given the limited awareness within the medical community. Despite this, there are currently no FDA-approved treatments for acute concussion, with rest and gradual return to activity remaining the standard of care. However, the development of new treatments is hindered by stringent regulatory requirements and lengthy approval processes, which can stifle innovation. Moreover, the prevalent use of polypharmacy in TBI management increases the risk of adverse drug interactions, side effects, and reduced efficacy, complicating patient care and driving up healthcare costs. Furthermore, traumatic brain injury treatment poses a significant economic burden and disrupts patients' overall well-being and quality of life (QoL). Furthermore, the traumatic brain injury market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing (especially for cell therapies), market access and reimbursement issues, and l ow compliance and adherence to the prescribed therapies. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the traumatic brain injury market growth. Traumatic Brain Injury Treatment Market Managing medications for individuals with traumatic brain injury is both complex and rewarding. These challenges are unsurprising given the intricacies of the brain and the many aspects that remain poorly understood. Although there are foundational principles that guide medication use, implementing them has become increasingly difficult due to systemic healthcare constraints, especially those related to reimbursement policies and rehabilitation timelines. Nonetheless, maintaining these principles is essential. TBI treatment involves a combination of medical interventions, rehabilitation, and ongoing support, with approaches tailored to the severity of the injury. This can range from cognitive therapies to surgical procedures such as bilateral decompressive craniotomies. While clinical guidelines provide a framework, they must be individualized for each patient. Currently, treatment often depends on off-label use of various drug classes targeting symptom management, though these approaches frequently face high discontinuation rates. In response to these challenges, numerous companies are actively pursuing more effective therapeutic options to improve outcomes for individuals with TBI. One notable advancement occurred in July 2024, when AKUUGO became the first brain regeneration therapy to receive conditional approval in Japan. This allogeneic cell therapy is intended for patients with chronic motor paralysis resulting from TBI. The company plans to conduct a post-marketing study during the seven-year approval period and aims to begin sales by late 2025, with intentions to pursue Phase III trials in discussions with the US FDA (Food and Drug Administration) and the EMA (European Medicines Agency). To know more about FDA-approved drugs for traumatic brain injury, visit @ Traumatic Brain Injury Treatment Traumatic Brain Injury Pipeline Therapies and Key Companies Some of the drugs in the pipeline include OXE103 (Oxeia Biopharmaceuticals), HB-AdMSCs (Hope Biosciences), ONP-002 (Oragenics), CEVA101 (Cellvation), MR-301 (SHINKEI Therapeutics), and others. OXE103 is a synthetic version of human ghrelin, a naturally occurring hormone. It can easily cross the blood–brain barrier and plays a role in restoring metabolic and energy imbalances in the brain following a concussion. OXE103 specifically targets the hippocampus, a brain region critical for memory and cognitive function. In February 2025, the company announced plans to begin Phase IIb clinical trials for OXE103 later in the year. In June 2024, Oxeia Biopharmaceuticals shared that findings from a study conducted at the University of Kansas Medical Center, examining OXE103's effectiveness in treating subacute concussion, were published in the April issue of Archives of Physical Medicine and Rehabilitation, a journal of the ACRM. HB-AdMSCs are mesenchymal stem cells derived from adipose (fat) tissue and developed using Hope Biosciences' proprietary culturing technology. The company specializes in the culturing and banking of stem cells. In June 2023, UTHealth Houston received a nearly USD 5 million, four-year clinical trial grant from the Department of Defense's CDMRP to study whether intravenous administration of Hope Biosciences' autologous HB-adMSCs can reduce chronic neuroinflammation in patients with severe traumatic brain injury (TBI). In May 2023, preliminary data from a prior Phase I/IIa study involving 24 patients (NCT04063215), sponsored by UTHealth, were presented at the 2023 Cellular Therapies and Transfusion Medicine in Trauma and Critical Care Conference in Scottsdale, Arizona. ONP-002 is a novel, first-in-class enantiomeric neurosteroid in development for mild traumatic brain injury (mTBI), such as concussion. Its intellectual property covers its molecular structure, synthesis, and therapeutic applications. In preclinical models, ONP-002 has shown rapid molecular and behavioral improvements following neuronal injury. In March 2025, Oragenics announced it had submitted an Investigator's Brochure (IB) in preparation for a Phase II clinical trial of ONP-002 in Australia. This step marks significant progress in developing this intranasal neurosteroid as a treatment for mTBI. A proof-of-concept Phase IIb trial is also planned (third quarter of 2025) in the U.S. under an open Investigational New Drug (IND) approved by the FDA. The anticipated launch of these emerging therapies are poised to transform the traumatic brain injury market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the traumatic brain injury market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about traumatic brain injury drugs in development @ Traumatic Brain Injury Clinical Trials Recent Developments in the Traumatic Brain Injury Market In March 2025, Oragenics announced the submission of its Investigator's Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia. This milestone represents an important step in advancing ONP-002, a novel intranasal neurosteroid, as a potential treatment for mTBI. In February 2025, SanBio announced that it had successfully secured the planned production yield for the second commercial production run of AKUUGO Suspension for Intracranial Implantation, conducted to meet the shipment conditions required for obtaining product approval, in December 2024. In February 2025, Oxeia Biopharmaceuticals announced that it is planning to initiate the Phase IIb trials for OXE103 later in 2025. In February 2025, Oragenics announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for TBI. In January 2025, SanBio entered into a manufacturing agreement with JCR Pharma for the production of AKUUGO. Traumatic Brain Injury Overview Traumatic brain injury (TBI) occurs when the brain is suddenly harmed due to a blow or jolt to the head. It often results from incidents such as vehicle collisions, falls, sports-related accidents, or violent assaults. The severity of injury can vary widely, from minor concussions to severe, lasting brain damage. The initial damage sustained at the moment of impact is referred to as the primary injury, which can affect either a specific region of the brain or the entire organ. While a skull fracture might be present, it's not always the case. During a traumatic event, the brain can move forcefully within the skull, leading to bruising, bleeding, or tearing of nerve tissue. TBI symptoms can be mild, moderate, or severe, depending on the extent of the brain injury. Someone with a mild TBI might stay conscious or briefly lose consciousness for just a few seconds or minutes. Other signs of mild TBI can include headache, dizziness, confusion, blurred or fatigued vision, ringing in the ears, unusual taste in the mouth, tiredness, changes in sleep, mood, or behavior shifts, and difficulties with memory, attention, or thinking. There isn't a single definitive test to diagnose TBI. Instead, doctors evaluate the injury through a combination of medical history, symptoms, physical examination, and imaging studies like neuroimaging. Many individuals with TBI lose consciousness at the time of injury—this may last from mere seconds to minutes, although in severe cases, it can extend to days or even longer. Not all mild TBI cases involve loss of consciousness, but many individuals experience some degree of memory loss around the time of the trauma, which can last from minutes to hours or more. Traumatic Brain Injury Epidemiology Segmentation The traumatic brain injury epidemiology section provides insights into the historical and current traumatic brain injury patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The traumatic brain injury market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of TBI Severity-specific Distribution of Incident Cases of TBI Gender-specific Distribution of Incident Cases of TBI Age-specific Distribution of Incident Cases of TBI Scope of the Traumatic Brain Injury Market Report Therapeutic Assessment: Traumatic Brain Injury current marketed and emerging therapies Traumatic Brain Injury Market Dynamics: Key Market Forecast Assumptions of Emerging Traumatic Brain Injury Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Traumatic Brain Injury Market Access and Reimbursement Download the report to understand the traumatic brain injury assessment & management devices market @ Traumatic Brain Injury Market Report Table of Contents Related Reports Traumatic Brain Injury Pipeline Traumatic Brain Injury Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key TBI companies, including Oragenics, Inc., SHINKEI Therapeutics, Inc., AlzeCure, Algernon Pharmaceutical, Mitochon Pharmaceuticals, Hoth Therapeutics, Biomed Industries, Inc., BioArctic, Tiziana Life Sciences, TikoMed AB, Levolta Pharmaceuticals, Inc., Boulder BioScience, LLC, International Stem Cell Corporation, Revalesio Corporation, Teleport Pharmaceuticals, among others. 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