Moderate to severe Traumatic Brain Injury (TBI) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Moderate to severe Traumatic Brain Injury (TBI) Market Outlook and Forecast

Moderate to severe Traumatic Brain Injury (TBI) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Published Date : 2022-09-02

Updated On : 2023-06-18

Pages : 156

Moderate to severe Traumatic Brain Injury (TBI) Market Outlook

Thelansis’s “Moderate to severe Traumatic Brain Injury (TBI) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Moderate to severe Traumatic Brain Injury treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Moderate to severe Traumatic Brain Injury (TBI) Overview

Traumatic Brain Injury (TBI) is a disruption in the brain's normal functioning caused by physical impact to the head, such as a blow, bump, or jolt, or when an object penetrates the skull and enters the brain tissue. Clinical signs indicating an alteration in normal brain function include loss of consciousness or decreased consciousness, memory loss (amnesia) for events before or after the injury, focal neurological deficits like muscle weakness or loss of vision, and changes in mental state such as disorientation or difficulty concentrating. The frontal and temporal areas of the brain are primarily affected. Mild TBI, also known as brain concussion, has gained significant attention due to its potential adverse neuropsychological outcomes in civilian populations (e.g., athletes in contact sports) and military personnel. Moderate to severe TBI is a major cause of injury-related death and disability. TBI symptoms can range from mild to severe, depending on the extent of brain damage. Mild cases may temporarily alter mental state or consciousness, while severe cases can lead to prolonged unconsciousness, coma, or even death. There are two main types of head injuries: Penetrating TBI, which occurs when an object pierces the skull and damages a specific area of the brain, and non-penetrating TBI, caused by a strong external force that moves the brain within the skull. Causes of non-penetrating TBI include falls, motor vehicle accidents, sports injuries, blast injuries, and being struck by an object. Clinical features of TBI may include prolonged coma, headache, nausea, aphasia (language difficulties), seizures, amnesia, and behavioral abnormalities such as aggression and anxiety. These symptoms can occur within seconds to minutes after the injury and may persist for months or years. The severity of TBI is evaluated using measures such as level of consciousness (LOC), altered mental status (AMS), post-traumatic amnesia (PTA), and the Glasgow Coma Scale (GCS). TBI causes damage to neuronal tissues, which can be classified into two categories: primary injury, directly caused by the mechanical forces during the initial insult, and secondary injury, which refers to further tissue and cellular damage after the primary insult. The differential diagnosis for TBI includes stroke, spontaneous acute subdural hematoma, Alzheimer's disease, cerebral aneurysms, frontal lobe syndrome, and hydrocephalus. TBI is a significant cause of death and disability among children and young adults in the United States.

  • It is estimated that 1.5 million Americans sustain a TBI yearly, resulting in approximately 230,000 hospitalizations, 50,000 deaths, and 80,000 to 90,000 cases of long-term disability.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Moderate to severe Traumatic Brain Injury (TBI) Competitive Landscape

S. no Asset Company Stage
1 VAS203 ICON plc Phase 3
2 AMG 334 Amgen Phase 2
3 Exenatide Invex Therapeutics Phase 3

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Moderate to severe Traumatic Brain Injury (TBI) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Moderate to severe Traumatic Brain Injury (TBI) Market Forecast

1.       Moderate to severe Traumatic Brain Injury (TBI) – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Moderate to severe Traumatic Brain Injury (TBI) market scenario 2022
                     1.2.2. Moderate to severe Traumatic Brain Injury (TBI) scenario 2025
                     1.2.3. Moderate to severe Traumatic Brain Injury (TBI) market scenario 2032

2. Moderate to severe Traumatic Brain Injury (TBI) Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Moderate to severe Traumatic Brain Injury (TBI)
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Moderate to severe Traumatic Brain Injury (TBI) Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Moderate to severe Traumatic Brain Injury (TBI) management
         2.16.  Market Opportunity for Moderate to severe Traumatic Brain Injury (TBI)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Moderate to severe Traumatic Brain Injury (TBI)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Moderate to severe Traumatic Brain Injury (TBI) Epidemiology in US (2022-2032)
                             3.2.1.1.              Incidence of Moderate to severe Traumatic Brain Injury (TBI)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Moderate to severe Traumatic Brain Injury (TBI) Epidemiology in EU-5 (2022-2032)
                             3.2.2.1.              Incidence of Moderate to severe Traumatic Brain Injury (TBI)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Moderate to severe Traumatic Brain Injury (TBI) Epidemiology in Japan (2022-2032)
                             3.2.3.1.              Incidence of Moderate to severe Traumatic Brain Injury (TBI)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Moderate to severe Traumatic Brain Injury (TBI) Epidemiology in China (2022-2032)
                             3.2.4.1.              Incidence of Moderate to severe Traumatic Brain Injury (TBI)
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Moderate to severe Traumatic Brain Injury (TBI) Market Forecast 2022-2032
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Moderate to severe Traumatic Brain Injury (TBI)
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Moderate to severe Traumatic Brain Injury (TBI) Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Moderate to severe Traumatic Brain Injury (TBI)
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Moderate to severe Traumatic Brain Injury (TBI) Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer