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Traumatic Brain Injury
R&D Pipeline Assessment and Market Prospects
| Publication Date | August 2010 |
| ISBN | n/a |
| Pages | n/a |
| Tables | n/a |
| Figures | n/a |
PDF £805 $1265 Single user |
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Some sources estimate that TBI is ten times as prevalent as spinal cord injury and on an annual basis, at least 150 people per 100,000 population are treated in hospitals for TBI. In the United States, statistics provided by the National Centers for Disease Control (CDC) report that – on an annual basis - some one million people are impacted by TBI.
As a consequence of increased military engagement, more soldiers are returning from combat theaters with TBIs. It has been estimated that up to 83 percent of soldiers returning from Afghanistan and Iraq exhibit a variety of brain injury symptoms. To add to this picture, increased attention is being paid to athletes affected by TBI and the link to early-onset dementia.
Currently, no effective TBI therapy exists, with patients treated through a combination of surgery, rehabilitation and pharmacological agents managing post-trauma conditions such as depression. Consequently, the considerable target population leads Arrowhead Publishers to estimate that the global market value for TBI therapy is in the region of US$1-2 billion, with the majority of this accounted for by potential demand across Europe and in the United States.
Traumatic Brain Injury: R&D Pipeline Assessment and Market Prospects takes a closer look at TBI and its future treatment prospects. It provides a thorough examination of its causes, symptoms, prognosis, treatment, epidemiology and unmet clinical need. In addition, it provides the reader with an overview of key potential markets for TBI therapeutics and assesses various therapies currently in development for TBI. Future trends in TBI research are also discusses at length. Finally, financial forecasts for the TBI therapeutic market are provided along with an analysis of the challenges and opportunities facing developers of TBI therapies.
What questions does this report answer?
- What are the major issues involved in the research and development of more effective TBI therapeutics?
- What is the current status of the TBI pipeline?
- What types of TBI therapeutics are currently in research and development?
- What is the anticipated market for potential TBI treatments?
- Which TBI pipeline candidates are having the best clinical trial results?
Highlights of this report include:
- A discussion of the problems associated with the current treatment options for TBI
- Focused analysis of the global prevalence of TBI
- Identification of the potential key markets for TBI product candidates
- Valuable input from leaders in TBI research
- Discussion of the wider social and economic considerations leading to increased interest in TBI
Reasons to buy this report:
- It provides a comprehensive assessment of the challenges and opportunities for those engaged in the field of TBI R&D
- Discusses key candidates and their commercialization prospects
- Describes emerging trends in R&D
Unique features of this report include:
- Critical assessment of likely success of leading clinical candidates
- Forecasts of the global and US markets for TBI therapies
- Thorough discussion of important areas of research and development in TBI
1 REPORT OBJECTIVES
2 METHODOLOGY
3 EXECUTIVE SUMMARY
4 TBI AND THE BIOPHARMACEUTICAL INDUSTRY
4.1 LOSS OF PATENT PROTECTION
4.2 TIGHTER REIMBURSEMENT CRITERIA
5 TRAUMATIC BRAIN INJURY (TBI) BACKGROUND
5.1 DEFINITIONS
5.2 TYPOLOGIES
5.3 CAUSES
5.4 SYMPTOMS
5.5 PROGNOSIS
5.6 STATISTICS AND TRENDS
5.7 TREATMENT
5.8 COMMON CONDITIONS FOLLOWING BRAIN INJURIES
6 COMMERCIAL SIGNIFICANCE OF TBI
6.1 THE UNMET TREATMENT NEED
6.2 INCREASED VISIBILITY OF TBI
6.3 COST-CONSIDERATIONS: CARING FOR TBI PATIENTS
7 OVERVIEW OF KEY POTENTIAL MARKETS
7.1 DEMOGRAPHIC AND ETIOLOGICAL CONSIDERATIONS
7.2 QUALITY OF LIFE: A MORE HUMANE APPROACH
7.3 INCREASED HEALTH AWARENESS
7.4 LEADING (POTENTIAL) GLOBAL TBI MARKETS
7.4.1 UNITED STATES
7.4.2 EUROPEAN UNION (EU)
7.4.3 JAPAN
7.5 GLOBAL OVERVIEW
8 TRAUMATIC BRAIN INJURY (TBI) RESEARCH PIPELINE
8.1 OVERVIEW
8.2 CLINICAL TRIAL DESIGNS
8.3 KEY PRODUCT CANDIDATES IN THE TBI PIPELINE
8.3.1 NUVIGIL (ARMODAFINIL)/CEPHALON
8.3.1.1 CLINICAL DEVELOPMENT
8.3.1.2 PRODUCT ASSESSMENT
8.3.2 BHR-100 (PROGESTERONE)/BHR PHARMA
8.3.2.1 CLINICAL DEVELOPMENT
8.3.2.2 PRODUCT ASSESSMENT
8.3.3 NH001 (APOMORPHINE)/NEUROHEALING PHARMACEUTICALS
8.3.3.1 CLINICAL DEVELOPMENT
8.3.3.2 PRODUCT ASSESSMENT
8.3.4 NNZ-2566/NEUREN PHARMACEUTICALS
8.3.4.1 CLINICAL DEVELOPMENT
8.3.4.2 PRODUCT ASSESSMENT
8.3.5 VAS-203/VASOPHARM
8.3.5.1 CLINICAL DEVELOPMENT
8.3.5.2 PRODUCT ASSESSMENT
8.3.6 OXYCYTE/OXYGEN BIOTHERAPEUTICS
8.3.6.1 CLINICAL DEVELOPMENT
8.3.6.2 PRODUCT ASSESSMENT
8.3.7 ZOLPIDEM/REGEN THERAPEUTICS
8.3.7.1 CLINICAL DEVELOPMENT
8.3.7.2 PRODUCT ASSESSMENT
8.3.8 ATORVASTATIN/BAYLOR COLLEGE OF MEDICINE
8.3.8.1 CLINICAL DEVELOPMENT
8.3.8.2 PRODUCT ASSESSMENT
8.3.9 KN38-7271/KEYNEUROTEK PHARMACEUTICALS
8.3.9.1 CLINICAL DEVELOPMENT
8.3.9.2 PRODUCT ASSESSMENT
8.3.10 NTX428/STEM CELL THERAPEUTICS (SCT)
8.3.10.1 CLINICAL DEVELOPMENT
8.3.10.2 PRODUCT ASSESSMENT
8.4 EARLY STAGE RESEARCH
8.4.1 TT-301/TRANSITION THERAPEUTICS
8.4.2 HUPERZINE A/CHILDREN’S HOSPITAL BOSTON (CHB)
8.4.3 PEPTIDOMIMETICS/ARDANE
8.4.4 REMYELATION/ACORDA
8.4.5 MULTISTEM/ATHERSYS
8.5 OTHER AREAS OF RESEARCH
8.5.1 STEM CELL TREATMENT
8.5.2 HYPERBARIC OXYGEN (HBO) CHAMBER
8.5.3 RIBAVIRIN
8.6 FAILED RESEARCH
8.6.1 SALINE SOLUTIONS
8.6.2 SLV334
9 THE TBI MARKET: FINANCIAL FORECASTS
9.1 CHALLENGES AND OPPORTUNITIES IN TBI R&D
9.2 FINANCIAL FORECASTS FOR THE TRAUMATIC BRAIN INJURY MARKET
10 FUTURE TRENDS IN TBI RESEARCH
10.1 MEDICAL IMAGING: THE HELPING HAND
10.2 INDUSTRY COLLABORATION: THE BIG AND THE SMALL
10.3 GENDER, AGE AND RELATED CONSIDERATIONS
10.4 PSYCHOLOGICAL AND SOCIAL ISSUES
10.5 REGULATORY ISSUES
10.6 COMPLEX PROBLEM: COMPLEX SOLUTION
10.7 NEW DIRECTIONS
APPENDIX I: KEY COMPANIES AND INSTITUTIONS INVOLVED IN TRAUMATIC BRAIN INJURY RESEARCH
TABLES
TABLE 4.1 PATENT EXPIRATION DATES FOR SELECTED PRODUCTS
TABLE 5.1 THE GLASGOW COMA SCALE
TABLE 5.2 THE RANCHOS LOS AMIGOS SCALE
TABLE 5.3 TOOLS FOR DIAGNOSING THE SEVERITY OF TRAUMATIC BRAIN INJURY
TABLE 5.4 THE GLASGOW OUTCOME SCALE
TABLE 5.5 THE DISABILITY RATING SCALE
TABLE 5.6 THE DISABILITY RATING SCALE - INTERPRETATION OF SCORES
TABLE 5.7 INCIDENCE OF RECOVERY OF CONSCIOUSNESS AND FUNCTION IN ADULTS AND CHILDREN IN A PERSISTENT VEGETATIVE STATE (PVS) AFTER TRAUMATIC OR NONTRAUMATIC BRAIN INJURY
TABLE 5.8 COMMON CONSEQUENCES OF TRAUMATIC BRAIN INJURY
TABLE 7.1 SPORTS-RELATED HEAD INJURIES BY TYPE OF SPORT (2007)
TABLE 7.2 TBI MORTALITY RATE BY 100,000 POPULATION IN SELECT COUNTRIES/REGIONS
TABLE 7.3 BURDEN OF NEUROLOGICAL DISORDERS, IN YEARS OF HEALTHY LIFE LOST TO DISABILITY (YLDS), AS PERCENTAGE OF TOTAL, BY CAUSE - PROJECTIONS FOR 2005, 2015 AND 2030
TABLE 8.1 DIFFICULTIES FACING DESIGNERS OF TBI CLINICAL TRIALS
TABLE 8.2 OVERVIEW OF TRAUMATIC BRAIN INJURY PIPELINE
TABLE 9.1 KEY CHALLENGES AND OPPORTUNITIES IN TBI R&D
TABLE 9.2 ESTIMATES OF PEAK SALES AND POTENTIAL LAUNCH DATES FOR SELECT TBI PIPELINE CANDIDATES
GRAPHS
GRAPH 5.1 TRAUMATIC BRAIN INJURY CASES BY CAUSE
GRAPH 5.2 TRAUMATIC BRAIN INJURY CASES BY SEVERITY
GRAPH 6.1 ESTIMATE OF DIRECT AND INDIRECT COSTS OF TRAUMATIC BRAIN INJURY AS PERCENTAGE OF TOTAL GLOBAL COSTS PER ANNUM
GRAPH 7.1 NUMBER OF ROAD ACCIDENTS, 1994-2004
GRAPH 7.2 THE NUMBER OF PERSONS KILLED IN ROAD ACCIDENTS, 1994-2004
GRAPH 7.3 THE NUMBER OF PERSONS INJURED IN ROAD ACCIDENTS, 1994-2004
GRAPH 7.4 CASES OF TRAUMATIC BRAIN INJURY BY CAUSE IN THE UNITED STATES
GRAPH 7.5 ETIOLOGY OF TRAUMATIC BRAIN INJURIES IN THE UNITED STATES
GRAPH 7.6 TOP TEN CAUSES OF HEAD INJURIES IN CHILDREN AGED 14 AND YOUNGER
GRAPH 7.7 EXTERNAL CAUSES OF TRAUMATIC BRAIN INJURY IN SELECTED GEOGRAPHICAL AREAS
GRAPH 9.1 FORECAST VALUE OF THE TRAUMATIC BRAIN INJURY MARKET IN THE UNITED STATES 2015-2020
FIGURES
FIGURE 8.1 THE NEURON – THE BRAIN CELL
FIGURE 8.2 THE DIAGRAM OF THE BRAIN
FIGURE 8.3 EFFECTS OF ICV INJECTION OF RIBAVIRIN
2 METHODOLOGY
3 EXECUTIVE SUMMARY
4 TBI AND THE BIOPHARMACEUTICAL INDUSTRY
4.1 LOSS OF PATENT PROTECTION
4.2 TIGHTER REIMBURSEMENT CRITERIA
5 TRAUMATIC BRAIN INJURY (TBI) BACKGROUND
5.1 DEFINITIONS
5.2 TYPOLOGIES
5.3 CAUSES
5.4 SYMPTOMS
5.5 PROGNOSIS
5.6 STATISTICS AND TRENDS
5.7 TREATMENT
5.8 COMMON CONDITIONS FOLLOWING BRAIN INJURIES
6 COMMERCIAL SIGNIFICANCE OF TBI
6.1 THE UNMET TREATMENT NEED
6.2 INCREASED VISIBILITY OF TBI
6.3 COST-CONSIDERATIONS: CARING FOR TBI PATIENTS
7 OVERVIEW OF KEY POTENTIAL MARKETS
7.1 DEMOGRAPHIC AND ETIOLOGICAL CONSIDERATIONS
7.2 QUALITY OF LIFE: A MORE HUMANE APPROACH
7.3 INCREASED HEALTH AWARENESS
7.4 LEADING (POTENTIAL) GLOBAL TBI MARKETS
7.4.1 UNITED STATES
7.4.2 EUROPEAN UNION (EU)
7.4.3 JAPAN
7.5 GLOBAL OVERVIEW
8 TRAUMATIC BRAIN INJURY (TBI) RESEARCH PIPELINE
8.1 OVERVIEW
8.2 CLINICAL TRIAL DESIGNS
8.3 KEY PRODUCT CANDIDATES IN THE TBI PIPELINE
8.3.1 NUVIGIL (ARMODAFINIL)/CEPHALON
8.3.1.1 CLINICAL DEVELOPMENT
8.3.1.2 PRODUCT ASSESSMENT
8.3.2 BHR-100 (PROGESTERONE)/BHR PHARMA
8.3.2.1 CLINICAL DEVELOPMENT
8.3.2.2 PRODUCT ASSESSMENT
8.3.3 NH001 (APOMORPHINE)/NEUROHEALING PHARMACEUTICALS
8.3.3.1 CLINICAL DEVELOPMENT
8.3.3.2 PRODUCT ASSESSMENT
8.3.4 NNZ-2566/NEUREN PHARMACEUTICALS
8.3.4.1 CLINICAL DEVELOPMENT
8.3.4.2 PRODUCT ASSESSMENT
8.3.5 VAS-203/VASOPHARM
8.3.5.1 CLINICAL DEVELOPMENT
8.3.5.2 PRODUCT ASSESSMENT
8.3.6 OXYCYTE/OXYGEN BIOTHERAPEUTICS
8.3.6.1 CLINICAL DEVELOPMENT
8.3.6.2 PRODUCT ASSESSMENT
8.3.7 ZOLPIDEM/REGEN THERAPEUTICS
8.3.7.1 CLINICAL DEVELOPMENT
8.3.7.2 PRODUCT ASSESSMENT
8.3.8 ATORVASTATIN/BAYLOR COLLEGE OF MEDICINE
8.3.8.1 CLINICAL DEVELOPMENT
8.3.8.2 PRODUCT ASSESSMENT
8.3.9 KN38-7271/KEYNEUROTEK PHARMACEUTICALS
8.3.9.1 CLINICAL DEVELOPMENT
8.3.9.2 PRODUCT ASSESSMENT
8.3.10 NTX428/STEM CELL THERAPEUTICS (SCT)
8.3.10.1 CLINICAL DEVELOPMENT
8.3.10.2 PRODUCT ASSESSMENT
8.4 EARLY STAGE RESEARCH
8.4.1 TT-301/TRANSITION THERAPEUTICS
8.4.2 HUPERZINE A/CHILDREN’S HOSPITAL BOSTON (CHB)
8.4.3 PEPTIDOMIMETICS/ARDANE
8.4.4 REMYELATION/ACORDA
8.4.5 MULTISTEM/ATHERSYS
8.5 OTHER AREAS OF RESEARCH
8.5.1 STEM CELL TREATMENT
8.5.2 HYPERBARIC OXYGEN (HBO) CHAMBER
8.5.3 RIBAVIRIN
8.6 FAILED RESEARCH
8.6.1 SALINE SOLUTIONS
8.6.2 SLV334
9 THE TBI MARKET: FINANCIAL FORECASTS
9.1 CHALLENGES AND OPPORTUNITIES IN TBI R&D
9.2 FINANCIAL FORECASTS FOR THE TRAUMATIC BRAIN INJURY MARKET
10 FUTURE TRENDS IN TBI RESEARCH
10.1 MEDICAL IMAGING: THE HELPING HAND
10.2 INDUSTRY COLLABORATION: THE BIG AND THE SMALL
10.3 GENDER, AGE AND RELATED CONSIDERATIONS
10.4 PSYCHOLOGICAL AND SOCIAL ISSUES
10.5 REGULATORY ISSUES
10.6 COMPLEX PROBLEM: COMPLEX SOLUTION
10.7 NEW DIRECTIONS
APPENDIX I: KEY COMPANIES AND INSTITUTIONS INVOLVED IN TRAUMATIC BRAIN INJURY RESEARCH
TABLES
TABLE 4.1 PATENT EXPIRATION DATES FOR SELECTED PRODUCTS
TABLE 5.1 THE GLASGOW COMA SCALE
TABLE 5.2 THE RANCHOS LOS AMIGOS SCALE
TABLE 5.3 TOOLS FOR DIAGNOSING THE SEVERITY OF TRAUMATIC BRAIN INJURY
TABLE 5.4 THE GLASGOW OUTCOME SCALE
TABLE 5.5 THE DISABILITY RATING SCALE
TABLE 5.6 THE DISABILITY RATING SCALE - INTERPRETATION OF SCORES
TABLE 5.7 INCIDENCE OF RECOVERY OF CONSCIOUSNESS AND FUNCTION IN ADULTS AND CHILDREN IN A PERSISTENT VEGETATIVE STATE (PVS) AFTER TRAUMATIC OR NONTRAUMATIC BRAIN INJURY
TABLE 5.8 COMMON CONSEQUENCES OF TRAUMATIC BRAIN INJURY
TABLE 7.1 SPORTS-RELATED HEAD INJURIES BY TYPE OF SPORT (2007)
TABLE 7.2 TBI MORTALITY RATE BY 100,000 POPULATION IN SELECT COUNTRIES/REGIONS
TABLE 7.3 BURDEN OF NEUROLOGICAL DISORDERS, IN YEARS OF HEALTHY LIFE LOST TO DISABILITY (YLDS), AS PERCENTAGE OF TOTAL, BY CAUSE - PROJECTIONS FOR 2005, 2015 AND 2030
TABLE 8.1 DIFFICULTIES FACING DESIGNERS OF TBI CLINICAL TRIALS
TABLE 8.2 OVERVIEW OF TRAUMATIC BRAIN INJURY PIPELINE
TABLE 9.1 KEY CHALLENGES AND OPPORTUNITIES IN TBI R&D
TABLE 9.2 ESTIMATES OF PEAK SALES AND POTENTIAL LAUNCH DATES FOR SELECT TBI PIPELINE CANDIDATES
GRAPHS
GRAPH 5.1 TRAUMATIC BRAIN INJURY CASES BY CAUSE
GRAPH 5.2 TRAUMATIC BRAIN INJURY CASES BY SEVERITY
GRAPH 6.1 ESTIMATE OF DIRECT AND INDIRECT COSTS OF TRAUMATIC BRAIN INJURY AS PERCENTAGE OF TOTAL GLOBAL COSTS PER ANNUM
GRAPH 7.1 NUMBER OF ROAD ACCIDENTS, 1994-2004
GRAPH 7.2 THE NUMBER OF PERSONS KILLED IN ROAD ACCIDENTS, 1994-2004
GRAPH 7.3 THE NUMBER OF PERSONS INJURED IN ROAD ACCIDENTS, 1994-2004
GRAPH 7.4 CASES OF TRAUMATIC BRAIN INJURY BY CAUSE IN THE UNITED STATES
GRAPH 7.5 ETIOLOGY OF TRAUMATIC BRAIN INJURIES IN THE UNITED STATES
GRAPH 7.6 TOP TEN CAUSES OF HEAD INJURIES IN CHILDREN AGED 14 AND YOUNGER
GRAPH 7.7 EXTERNAL CAUSES OF TRAUMATIC BRAIN INJURY IN SELECTED GEOGRAPHICAL AREAS
GRAPH 9.1 FORECAST VALUE OF THE TRAUMATIC BRAIN INJURY MARKET IN THE UNITED STATES 2015-2020
FIGURES
FIGURE 8.1 THE NEURON – THE BRAIN CELL
FIGURE 8.2 THE DIAGRAM OF THE BRAIN
FIGURE 8.3 EFFECTS OF ICV INJECTION OF RIBAVIRIN