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Bladder Cancer: Disease and Pipeline Analysis

  • April 2014
  • -
  • Industry Standard Research
  • -
  • 89 pages

This report provides an overview of the current and future bladder cancer clinical development market, the activities of the key market players, and an outline of trial and commercial regulatory environments.

“The latest figures from the World Health Organization show that bladder cancer has a worldwide incidence of almost 430,000 diagnosed cases per year. This constitutes 3.1% of cancer incidence, making it the 9th most commonly diagnosed cancer globally,” explained Andrew Schafer, President of ISR. “There are currently more than 100 active clinical trials for bladder cancer, making this a very dynamic clinical development space.”

Bladder Cancer report provides:

• Insight into bladder cancer epidemiology
• Incidence and mortality rates in both major and emerging markets
• A look into the current treatments for bladder cancer by disease stage and therapy type
• An environmental analysis of the major and emerging markets by:
• Patient Population and Product Environment
• Trial and Recruitment Environment
• Regulatory Environment
• Competitive Product Landscape
• Pricing and Reimbursement Environment
• A unique view into new therapies in active development

“With these data,” Schafer continued, “sponsors can identify and enhance commercial and development opportunities, plan how products currently in development could impact this market, understand competitor involvement, and better plan clinical trial strategies.”

Table Of Contents

Bladder Cancer: Disease and Pipeline Analysis
Copyright and Usage Guidelines 5
Table of Acronyms 6
Chapter 1 - Disease Overview 8
Figure 1. Male and Female Urinary System 9
Transitional Cell Carcinoma (TCC) 10
Figure 2. Tumours within the Bladder as Viewed by Cystoscopy 10
Carcinoma in situ 10
Squamous Cell Carcinoma (SCC) 11
Other tumour types 11
Classification 11
Bladder Cancer Risk Factors 12
Cigarette Smoking 12
Occupational Exposure to Carcinogens 12
Medical Conditions and Procedures 12
Bilharzia 13
Heredity 13
Dietary factors 13
Gender 13
Chapter 2 - Bladder Cancer Epidemiology 14
Bladder Cancer Incidence 15
Table 1. Incidence of Bladder Cancer in the Major Markets 15
Figure 4. Countries with the Highest Rate of Bladder Cancer (2012), Both Sexes 16
Figure 5. Countries with the Highest Number of Bladder Cancer Cases (2012), Both Sexes 16
Table 2. Age at Diagnosis of Bladder Cancer 16
Table 3. Incidence Rate of Bladder Cancer by Ethnicity (US) 17
Bladder Cancer Mortality 18
Table 4. Bladder Cancer Mortality in the Major Markets 18
Figure 6. Countries with the Highest Age Standardized Mortality Rate of Bladder Cancer
(2012), Both Sexes …………… 19
Figure 7. Countries with the Highest Numbers of Deaths from Bladder Cancer (2012),
Both Sexes 19
Table 5. Age at Death from Bladder Cancer 19
Chapter 3 - Bladder Cancer Diagnosis and Staging 20
Initial Patient Assessment 21
Symptoms 21
Physical examination 21
Urinalysis 22
Urine Cytology 22
Urinary molecular marker tests 22
Table 6. Approved Urine Tests 23
Cystoscopy 24
Biopsy 25
Trans Urethral Resection (TUR) …… 26
Radiographic Imaging Techniques ………… 27
Chapter 4 - Bladder Tumour Classification 28
Table 7. Classification of Primary Tumour, Lymph Nodes and Metastases in Bladder
Cancer 29
Figure 8. The Extent of Bladder Tumour Penetration by Stage 30
Table 8. WHO Grading System 31
Chapter 5 - Treatment of Bladder Cancer 32
Treatment by Disease Stage 33
Low Grade Non Muscle Invasive Bladder Cancer (Ta) 34
High Grade Non Muscle Invasive Bladder Cancer (Tis, T1) 34
Treatment Failure of Non-Muscle Invasive Bladder Cancer 34
Muscle invasive bladder cancer (T2-T4) 34
Advanced Bladder Cancer 35
Palliative Care 36
Treatment of Bladder Cancer by Therapy Type 37
Trans Urethral Resection (TUR) of the Bladder Tumour 37
Radical Cystectomy 37
Immunotherapy 39
Chemotherapy 41
Chapter 6. Bladder Cancer Prognosis 44
Table 10. Bladder Cancer Stage at Diagnosis and Relative Survival 46
Table 11. EORTC-GUCG weighting used to calculate disease recurrence and progression
scores 47
Table 12. Probability of Recurrence and Progression based on EORTC-GUCG score…………… 48
Table 13. Probability of non-muscle invasive bladder cancer progression and recurrence - NCCN 48
Chapter 7. Environmental Analysis 49
Bladder Cancer Unmet Needs 50
Diagnosis 50
Treatment 50
Follow up 51
Major Market Analysis 52
Table 14. Bladder Cancer - Major Markets Patient Population and Product Environment 52
Trial and Recruitment Environment 53
Regulatory Environment 54
Competitive Product Landscape 54
Pricing and Reimbursement Environment 55
Emerging Market Analysis 58
Table 15. Bladder Cancer - Emerging Markets Patient Population and Product Environment…58
Trial and Recruitment Environment 59
Regulatory Environment 60
Competitive Product Landscape 61
Pricing and Reimbursement Environment 61
Patient Recruitment Environment 63
Figure 9. Geographic Distribution of Active Clinical Trials 63
Figure 10. Distribution of Active Bladder Cancer Trials by Phase 65
Table 16. Number of Patients in Each Phase of Clinical Trial 65
Drug Development Field 66
Chapter 8. Drug Development in Bladder Cancer 67
Angiogenesis Inhibition 68
Growth Factor Inhibitors 69
Figure 11. Major intracellular pathways targeted for the treatment of bladder cancer 70
Immunotherapeutics 70
Gene Therapy 70
New Therapies in Active Development for the Treatment of Bladder Cancer 72
Table 17. Bladder Cancer Development Pipeline 72
Urocidin, Bioniche Life Sciences 73
EOquin/Apaziquone , Spectrum Pharmaceuticals 74
CG0070, Cold Genesys 75
Vicinium (VB4-845), Viventia Biotech 76
OGX-427, Oncogenex Pharmaceuticals 77
BC-819, BioCancell Therapeutics 78
DN24-02, Dendreon 79
Dovitinib, Novartis Pharmaceuticals 80
Icrucumab, Eli Lilly 80
Instiladrin, FKD Therapies 80
MAGE-A3, GlaxoSmithKline (GSK) 81
Ramucirumab, Eli Lilly 82
Trebananib (AMG386), Amgen 82
ABI-009, Aadi LLC 83
ALT-801, Altor Bioscience 83
Eribulin (E7389), Eisai 84
HS-410, Heat Biologics 85
TRC-105, Tracon Pharma 85
Margetuximab (MGAH22), Macrogenics 86
Citations 87
Bladder Cancer Diagnosis and Treatment Guideline Citations 88
About Industry Standard Research 89

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