Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Brochure More information from http://www.researchandmarkets.com/reports/3146899/ Traumatic Brain Injury: Therapeutic and Diagnostic Pipeline Assessment and Commercial Prospects Description: Traumatic brain injury (TBI) is the single leading cause of death and disability worldwide in children and young adults following an injury. With around 10 million new cases diagnosed and 1.5 million deaths occurring per annum globally; this ‘silent’ epidemic accounts for more fatalities than diabetes or lung cancer. Despite three decades of intensive research and development effort, translating benchside to bedside success remains the single greatest challenge in TBI. All 33 Phase III TBI clinical trials testing the efficacy of neuroprotective agents have failed over the past 20 years. Consequently, no FDA-approved TBI therapy exists. Nevertheless, 2013 witnessed the creation of a National Research Action Plan (NRAP) to address the current unmet needs in TBI. Point-of-care (POC) diagnostic devices look set to revolutionize the diagnosis of TBI. By year end 2014, a number of POC diagnostic devices may be approved by the FDA. Key Features: - Identification of the major challenges within TBI R&D including unmet needs, clinical trial design and alternative R&D approaches, the potential of biomarkers, regulatory hurdles and ethical issues - Clinical and commercial analysis of key Phase III TBI drug candidates and point-of-care diagnostic devices - An assessment of the potential financial TBI market, with seven major market forecasts to 2020 for key pipeline drug candidates and point-of-care diagnostic devices Purchase of this report will enable you to: - Assess opportunities and challenges influencing strategic TBI R&D - Identify key TBI drug candidates and point- of-care diagnostic devices in late-phase development based on sales forecasts to 2020 - Gain an impartial perspective of strategies that can be used to enhance commercial success Key questions answered: - What are the major unmet needs in the treatment of TBI? - What are the leading potential TBI biomarkers? - Who are the key specialist players involved in the TBI market and what business models are they using to raise company performance? - What lessons can investors learn from failed TBI drug candidates? - How can companies optimize strategic TBI R&D to maximize commercial success? - What are the key leading drug candidates in the TBI pipeline? - What are the key leading point-of-care diagnostic devices in the TBI pipeline? - What are the anticipated revenues for key pipeline drug candidates? - What are the anticipated revenues for key pipeline point-of-care diagnostic devices? Contents: 1. EXECUTIVE SUMMARY 1.1. Scope of Traumatic Brain Injury Research and Development Highlights 2014 1.2. Methodology 1.3. Traumatic Brain Injury is the Leading Cause of Death and Disability Following an Injury 1.4. Supportive Management Forms the Cornerstone of TBI Treatment 1.5. Failure of Over 30 Phase III Trials Presents Major Research and Development (R&D) Challenges in TBI 1.6. There are Numerous Unmet Needs in TBI 1.7. The Late-Stage Therapeutic TBI Pipeline is Limited 1.8. Emerging TBI Diagnostic Products 1.9. Financial Analysis of the Potential TBI Market 2. TRAUMATIC BRAIN INJURY: DISEASE BACKGROUND 2.1. An Introduction to Traumatic Brain Injury 2.2. There is No Clear, Concise Definition of TBI 2.3. TBI is a Complex Disorder with a Range of Typologies 2.3.1. Primary TBI 2.3.2. Secondary TBI 2.3.3. Focal TBI 2.3.4. Diffuse TBI 2.3.5. Open TBI 2.3.6. Closed TBI 2.4. Falls are the Leading Cause of TBI 2.5. Specific Symptoms are Indicative of TBI 2.6. Two Pathological Stages are Involved in TBI 2.7. There is No Gold-Standard TBI Diagnostic Test 2.7.1. Glasgow Coma Score 2.7.2. Rancho Los Amigos Scale 2.7.3. Westmead Post Traumatic Amnesia (PTA) Scale 2.8. The Staging of TBI is Dependent Upon Brain Injury Severity 2.8.1. Mild TBI 2.8.2. Moderate TBI 2.8.3. Severe TBI 2.8.4. The Majority of the TBI Patient Population Sustain Mild Brain Injuries 2.9. Predicting the Prognosis of TBI is Difficult 2.9.1. Glasgow Outcome Scale 2.9.2. Disability Rating Scale 2.9.3. The NIH's International Mission for Prognosis and Clinical Trial (IMPACT) Prognosis Model 2.9.4. The MRC's Corticosteroid Randomization After Significant Head Injury (CRASH) Prognosis Model 2.10. The Prognosis of Severe TBI is Particularly Poor 2.10.1. Numerous Complications are Associated with TBI 3. THE EPIDEMIOLOGY AND FINANCIAL IMPLICATIONS OF TBI 3.1. Epidemiology of TBI in the Seven Major Markets 3.1.1. Road Traffic Accidents Set To Become the Third Leading Cause of Global Disease and Disability 3.1.2. The incidence of Combat-Related TBI is Rising 3.2. The Financial Impact of TBI is High 4. THE CURRENT MANAGEMENT OF TBI 4.1. The Management of TBI 4.2. Acute Complications of Mild TBI are a Priority Concern 4.3. The Management of Moderate and Severe TBI Attempts to Minimize Secondary Injury 4.4. Pharmacological Treatment Forms the Cornerstone of Post TBI Complications 4.5. TBI Rehabilitation Involves a Multi Therapy Approach 5. THE MAJOR CHALLENGES OF TBI RESEARCH AND DEVELOPMENT (R&D) 5.1. Failure of Over 30 TBI Phase III Clinical Trials of Neuroprotectives in the Past 20 Years 5.2. The Vision of TBI Research 5.3. Obama's National Research Action Plan 5.4. TBI Clinical Trial Challenges 5.4.1. Heterogeneity of the TBI Population 5.4.2. Clinical Trial Design 5.4.3. International Mission on Prognosis and Clinical Trials in TBI (IMPACT) Recommendations 5.5. Alternative Approaches to TBI Research 5.5.1. Systems Biology Research in TBI 5.5.2. Comparative Effectiveness Research in TBI 5.6. The Potential of TBI Biomarkers to Aid R&D 5.6.1. Proteomics-Based Biomarker Discovery in TBI 5.6.2. TBI Diagnostic and Patient Monitoring Platform Development 5.6.3. The Potential of Theranostics in TBI R&D 5.7. TBI Regulatory Issues 5.8. TBI Ethical Challenges 6. UNMET NEEDS IN THE TBI MARKET 6.1. Lack of a Universally Accepted Definition of TBI 6.2. Lack of a Gold-Standard TBI Diagnostic Test 6.3. Under Diagnosis of Mild TBI 6.4. Management of TBI is Not Standardized 6.5. No Approved TBI Treatment is Available 6.6. Elderly TBI Patients are Underserved 6.7. Lack of Big Pharma/Biotech Investment in the TBI Arena 6.8. International TBI Collaborations and Alliances are Required 7. TBI THERAPEUTIC PIPELINE ANALYSIS 7.1. Introduction to the TBI Therapeutics Pipeline 7.2. BHR Pharma'S BHR-100 (Progesterone) 7.2.1. BHR-100's SyNAPSe Trial 7.3. Teva Pharmaceuticals/Cephalon's Nuvigil (Armodafinil) 7.3.1. Nuvigil's Phase II Trial Results 7.4. Key Neurotek Pharmaceuticals' KN38-7271 7.5. Neuren Pharmaceuticals' NNZ-2566 7.5.1. NNZ-2566's Intrepid- 2566 Trial 7.5.2. NNZ-2566 Oral Formulation Trials 7.6. NNZ-2566'S Commercialization Potential 7.7. Neurohealing Pharmaceuticals' NH001 (Apomorphine) 7.8. Neurovive Pharmaceuticals' NEUROSTAT (Ciclosporin-A) 7.8.1. NeuroSTAT's Clinical Trials 7.8.2. NeuroSTAT's Commercialization Potential 7.9. Oxygen Biotherapeutics' Oxycyte (Perflurocarbon Oxygen Carrier) 7.10. Vasopharm's VAS203 7.10.1. VAS203's Nostra Trial Results 7.11. Remedy Pharmaceuticals' RP-1127 7.11.1. RP-1127 Clinical Trials 7.11.2. RP-1127 Commercialization Potential 8. OVERVIEW OF KEY ACADEMIC AND GOVERNMENTAL TBI RESEARCH 8.1. Introduction to Academia and Governmental TBI Research 8.2. Review of Leading TBI Pipeline Drug Classes 8.2.1. Acetylcholinesterase Inhibitors 8.2.2. Erythropoietin 8.2.3. Growth Hormone 8.2.4. Stem Cells 8.3. Academic Research for the Discovery of New TBI Drug Targets 8.3.1. 5-Lipoxgenase Activating Proteins (FLAP) Inhibitors 8.3.2. Purinergic Receptor Antagonists 8.3.3. Proinflammatory Cytokine Inhibitors 8.3.4. Cysteine Protease Inhibitors 8.3.5. Transcranial Delivery of Glutathione Used in Innovative Dynamic Imaging Study of Mild TBI 8.3.6. Membrane Attack Complex (MAC) of the Terminal Complemental Pathway 8.4. US Governmental Agency Research for the Discovery of New TBI Drug Targets 8.4.1. US Department of Veterans Affairs 8.4.2. US Department of Defense 8.4.3. National Institute of Neurological Disorders and Stroke 9. POTENTIAL TBI BIOMARKERS 9.1. Introduction to Potential TBI Biomarkers 9.2. S100 B Caclcium Binding Protein 9.3. Neuron Specific Enolase (NSE) 9.4. Glial Fibrillary Acidic Protein (GFAP) 9.5. Neurofilament Light Protein (NFL) 9.6. Spectrin Breakdown Products 9.7. Beta-Amyloid Protein (AB) 9.8. Myelin Basic Protein (MBP) 9.9. Ubiquitin Carboxyl-Terminal Hydrolase Isoenzyme L1 (UCH-L1) 9.10. Tau Proteins 9.11. Ampar Peptide/GLUR1 9.12. TBI Biomarker Assay Services 9.12.1. Grace Laboratories 9.12.2. Banyan Biomarkers 10. TBI POINT OF CARE DIAGNOSTIC DEVICES PIPELINE ANALYSIS 10.1. Introduction to the TBI Point of Care Diagnositc Devices Pipeline 10.2. Luoxis Diagnostics/Ampio Pharmaceuticals' Redoxsys Diagnostic System 10.2.1. RedoxSYS Diagnostic System's Phase III Isolated TBI Trial Results 10.2.2. RedoxSYS Diagnostic System's Commercialization Potential 10.3. Banyan Biomarkers' UCH-L1/GFAP Detection Assay 10.3.1. UCH-L1/GFAP Detection Assay Commercialization Potential 10.4. Biodirections' Tbit Test Platform 10.4.1. Tbit Test Platform's Commercialization Potential 10.5. SFC Fluidics' TBI Diagnostic Platforms 10.5.1. SFC Fluidics' TBI Diagnostic Platforms Commercialization Potential 10.6. Brainscope's Ahead M-100 10.6.1. Ahead M-100's Clinical Trial Results 10.6.2. Ahead M-100 Commercialization Potential 10.7. Cerora's Mindreader Biosensor Biomarker Program 10.7.1. Mindreader's Commercialization Potential 10.8. ELMindA's BNA Platform 10.8.1. BNA Platform's Commercialization Potential 10.9. Neuro Assessment Systems' Neuro-Screen 10.9.1. Neuro-Screen's Commercialization Potential 11. FINANCIAL FORECAST OF THE POTENTIAL TBI MARKET 11.1. The Analysis of the Potential Therapeutic TBI Market 11.2. Analysis of the Potential TBI POC Diagnostic Devices Market 11.3. SWOT Analysis of the Potential TBI Market 11.4. Summary of the Potential TBI Market 12. COMPANY BRIEFS 12.1. Banayan Biomarkers Inc. 12.2. BHR Pharma LLC 12.3. Biodirection Inc. 12.4. Brainscope Company Inc. 12.5. Cerora Inc. 12.6. ElMindA Ltd. 12.7. Grace Laboratories LLC 12.8. KeyNeurotek Pharmaceuticals AG 12.9. Luoxis Diagnostics 12.10. Neuro Assessment Systems 12.11. Neurohealing Pharmaceuticals 12.12. Neuren Pharmaceuticals Ltd. 12.13. Neurovive Pharmaceuticals AB 12.14. Oxygen Biotherapeutics Inc. 12.15. Phlogistix LLC 12.16. Remedy Pharmaceuticals Inc. 12.17. SFC Fluidics LLC 12.18. TEVA Pharmaceutical Industries Ltd. 12.19. Vasopharm 13. BIBLIOGRAPHY List of Tables Table 1: TBI Incidence Forecast in 2014 and 2020 in the Seven Major Markets Table 2: TBI Pipeline Candidates Undergoing Late-Stage Clinical Development by Pharma/Biotech Companies Table 3: Late-stage TBI POC Diagnostic Devices Pipeline, Jan 2014 Table 4: Financial Forecast of the Potential TBI Market, in 2014 and 2020 in the US and EU ($ billions) Table 5: The Glasgow Coma Score Table 6: The Ranchos Los Amigos Scale Table 7: Summary of TBI Severity Stratification Table 8: The Glasgow Outcome Scale Table 9: The Disability Rating Scale Table 10: The Disability Rating Scale Prognosis Outcome Table 11: Complications Associated with TBI Table 12: Crude Incidence Rate of TBI (per 100,000) in the Seven Major Markets, 2014 Table 13: TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Table 14: Mild TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Table 15: Moderate TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Table 16: Severe TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Table 17: Brain Trauma Foundation Guidelines for the Acute Management of Severe TBI Table 18: Management of Common Post-TBI Complications Table 19: Failed Phase III Clinical Trials of Novel Neuroprotectives in Moderate and Severe TBI over the Past 30 Years Table 20: National Research Action Plan Deadline Targets in TBI Table 21: IMPACT Recommendations for the Use of Common Outcome Measures in TBI Table 22: Applications of TBI Diagnostic and Patient Monitoring Platforms Table 23: Incentives Granted to Orphan Drug Developers Table 24: TBI Therapeutic Pipeline, Jan 2014 Table 25: Comparison of ProTECT II and Xiao Clinical Trials Table 26: Comparison of SyNAPSe and ProTECT III Clinical Trials Table 27: TBI Point- of-Care Diagnostic Devices Pipeline, Jan 2014 Table 28: The Financial Forecast of the Potential Therapeutic TBI Market in the US and EU, 2014-2020 ($ millions) Table 29: The Financial Forecast of the Potential TBI POC Diagnostic Devices Market in the US and EU, 20142020 ($ millions) Table 30: The Financial Forecast of the Potential TBI Market in the US and EU, 2014-2020 ($ billions) List of Figures Figure 1: TBI Incidence Forecast in 2014 and 2020 in the Seven Major Markets Figure 2: Major Unmet Needs in TBI Figure 3: Finanical Forecast of the Potential TBI Market, in 2014 and 2020 in the US and EU ($ billions) Figure 4: The Anatomy of the Human Brain Figure 5: Cause of all TBIs within the US General Population, 2010 Figure 6: The Pathophysiological Pathways Involved in Secondary Brain Injury Figure 7: TBI Patient Population by Brain Injury Severity Figure 8: TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Figure 9: Mild TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Figure 10: Moderate TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Figure 11: Severe TBI Incidence Forecast in the Seven Major Markets, 2014-2020 Figure 12: Info graphic on Global Road Traffic Accidents Figure 13: Number of Persons Injured in a Road Traffic Accident within the US, 2000-2011 Figure 14: Total Worldwide Number of TBIs Diagnosed in US Military Personnel, 2000-2012 Figure 15: The Total Worldwide Number of Combat-Related TBIs Diagnosed in US Military Personnel, 20002012 Figure 16: Management Algorithm of TBI According to Glasgow Coma Score Figure 17: NRAP's Approach to Address the Current Unmet Needs in TBI R&D Figure 18: The Use of Biomarkers to Maximize TBI R&D Figure 19: Systems Biology-Based Selection of Potential TBI Biomarkers, Figure 20: Number of Phase III Randomized Controlled Trials in Moderate and Severe TBI per Five -Year Time Period Between1980 to 2005 Figure 21: Potential TBI Biomarkers Figure 22: Illustrative of BNA Platform's Brain Network Activation Patterns Figure 23: The Financial Forecast of the Potential Therapeutic TBI Market in the US and EU, 2014-2020 ($ millions) Figure 24: The Financial Forecast of the Potential TBI Therapeutics Market in the US and EU, 2014-2020 ($ millions) Figure 25: SWOT Analysis of the TBI Market, 2014 Figure 26: The Financial Forecast of the Potential TBI Market in the US and EU, 2014-2020 ($ billions) Ordering: Order Online - http://www.researchandmarkets.com/reports/3146899/ Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland. Page 1 of 2 Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to 646-607-1907 (from USA) or +353-1-481-1716 (from Rest of World). If you have any questions please visit http://www.researchandmarkets.com/contact/ Order Information Please verify that the product information is correct and select the format(s) you require. Product Name: Traumatic Brain Injury: Therapeutic and Diagnostic Pipeline Assessment and Commercial Prospects Web Address: http://www.researchandmarkets.com/reports/3146899/ Office Code: SCHL3FA7 Product Formats Please select the product formats and quantity you require: Quantity Electronic (PDF) Single User: USD 1750 Electronic (PDF) Enterprisewide: USD 3500 Contact Information Please enter all the information below in BLOCK CAPITALS Title: First Name: Mr Mrs Dr Miss Last Name: Email Address: * Job Title: Organisation: Address: City: Postal / Zip Code: Country: Phone Number: Fax Number: * Please refrain from using free email accounts when ordering (e.g. Yahoo, Hotmail, AOL) Ms Prof Page 2 of 2 Payment Information Please indicate the payment method you would like to use by selecting the appropriate box. Pay by credit card: You will receive an email with a link to a secure webpage to enter your credit card details. Pay by check: Please post the check, accompanied by this form, to: Research and Markets, Guinness Center, Taylors Lane, Dublin 8, Ireland. Pay by wire transfer: Please transfer funds to: Account number 833 130 83 Sort code 98-53-30 Swift code ULSBIE2D IBAN number IE78ULSB98533083313083 Bank Address Ulster Bank, 27-35 Main Street, Blackrock, Co. Dublin, Ireland. If you have a Marketing Code please enter it below: Marketing Code: Please note that by ordering from Research and Markets you are agreeing to our Terms and Conditions at http://www.researchandmarkets.com/info/terms.asp Please fax this form to: (646) 607-1907 or (646) 964-6609 - From USA +353-1-481-1716 or +353-1-653-1571 - From Rest of World