Annual Information Service: EPiQ Market Intelligence Program: Pancreatic Cancer TOC

I. EXECUTIVE SUMMARY.......................................................................................................1
II. Introduction and Methodology.............................................................................................1
- A. Background................................................................................................................2
- B. Objectives of EPiQ Pancreatic Cancer Market Intelligence Program...................................3
- C. Methodology..............................................................................................................4
- D. Definitions..................................................................................................................6
III. Disease Definition and Staging............................................................................................7
- A. Exocrine Pancreatic Cancer..........................................................................................8
  - 1. Etiology and risk factors........................................................................................9
  - 2. Symptoms and pathology......................................................................................9
  - 3. Diagnosis............................................................................................................10
  - 4. Staging.............................................................................................................13
  - 5. Prognosis..........................................................................................................14
- B. Endocrine Pancreatic Cancer......................................................................................15
  - 1. Etiology and risk factors......................................................................................15
  - 2. Symptoms and Pathology......................................................................................15
  - 3. Diagnosis and Staging..........................................................................................17
  - 4. Prognosis............................................................................................................18
- C. References...................................................................................................................19
IV. Epidemiology...................................................................................................................20
- A. Incidence.................................................................................................................22
- B. Prevalence................................................................................................................25
- C. Mortality..................................................................................................................28
- D. Drug-Treated Populations............................................................................................31
  - 1. Drug-Treated Patients by Type of Cancer and Stage, 2003.....................................32
  - 2. Drug-Treated Patients by Line of Therapy -- Overall and by Type of Cancer, 2003.....32
  - 3. Drug-Treated Population Forecast, 2003-2013......................................................36
- E. Patient Demographics................................................................................................39
  - 1. Gender.............................................................................................................39
  - 2. Age 39
  - 3. Body Surface Area.............................................................................................39
  - 4. Physician Practice Setting.......................................................................................40
  - F. References................................................................................................................44
V. Current Treatment.............................................................................................................45
- A. Standards of Care.....................................................................................................46
  - 1. Surgical options....................................................................................................46
  - 2. Radiation therapy.................................................................................................48
  - 3. Chemotherapy...................................................................................................48
- B. Top Drug Regimens -- By Cancer Type.........................................................................51
  - 1. All pancreatic cancer -- top drug regimens............................................................51
  - 2. Exocrine pancreatic cancer -- top drug regimens....................................................52
  - 3. Endocrine pancreatic cancer -- top drug regimens..................................................53
- C. Top Drug Regimens -- By Line of Therapy......................................................................55
  - 1. First-line drug regimens..........................................................................................55
  - 2. Second-line drug regimens.....................................................................................55
- D. Top Agents -- By Stage and Line of Therapy..................................................................59
  - 1. Exocrine pancreatic cancer.................................................................................59
  - 2. Endocrine pancreatic cancer...............................................................................63
- E. Trends in Monthly Share for Top Agents.......................................................................64
- F. Additional Features of Pancreatic Cancer........................................................................65
  - 1. Annual cost of top agents...................................................................................65
  - 2. Lines of therapy per patient................................................................................65
  - 3. Average Length of Therapy.................................................................................66
- G. References................................................................................................................68
VI. UNMET NEEDS................................................................................................................69
- A. Improved Diagnostics, Sub-Typing, and Monitoring.......................................................70
  - 1. Screening and diagnosis....................................................................................70
  - 2. Determining course of therapy and monitoring......................................................70
  - B. Effective, Low-Toxicity Anti-Cancer Drug Treatments.......................................................72
  - C. Improved Understanding of Molecular Pathology..........................................................73
  - D. Better Supportive Care...............................................................................................74
  - E. Improved Clinical Trial Design....................................................................................75
    - 1. Large, randomized trials with homogeneous populations...........................................75
    - 2. Careful endpoint selection...................................................................................75
  - F. References................................................................................................................76
VII. Pipeline Development........................................................................................................77
- A. Technical Assessment.................................................................................................78
  - 1. Immunotherapies................................................................................................78
  - 2. Vascular endothelial growth factor (VEGF) antagonists...........................................79
  - 3. Epidermal growth factor receptor (EGFR) inhibitors................................................80
  - 4. Platinum analogs...............................................................................................81
  - 5. Taxanes (anti-microtubule agents).........................................................................81
  - 6. COX-2 inhibitors................................................................................................81
  - 7. Farnesyl transferase inhibitors..............................................................................82
  - 8. Metalloproteinase inhibitors................................................................................82
  - 9. DNA topoisomerase I inhibitors...........................................................................82
- B. Commercial Evaluation..............................................................................................83
  - 1. Preregistered agents...........................................................................................83
  - 2. Phase III agents..................................................................................................85
  - 3. Phase II.............................................................................................................89
  - 4. Phase I.............................................................................................................99
- C. References..............................................................................................................104
VIII. Current and Future Market Projections...............................................................................105
- A. Total Pancreatic Cancer Market Forecast, Methodology, and Assumptions.....................105
- B. Exocrine Pancreatic Cancer -- Market Forecast, by Drug Class and by Line of Therapy and Drug Class.............................................................................................................112
  - 1. Exocrine pancreatic cancer, all lines of drug therapy...........................................112
  - 2. Exocrine pancreatic cancer, first-line drug therapy...............................................114
  - 3. Exocrine pancreatic cancer, second-line drug therapy..........................................116
  - 4. Exocrine pancreatic cancer third-plus-line drug therapy.........................................117
- C. Endocrine Pancreatic Cancer -- Market Forecast, by Drug Class....................................119
- D. References..............................................................................................................121

LIST OF FIGURES

Figure IV-1: Pancreatic Cancer Epidemiology Forecast.................................................................21
Figure IV-2: Pancreatic Cancer Incidence Forecast......................................................................23
Figure IV-3: Historical Incidence of Pancreatic Cancer.................................................................23
Figure IV-4: Pancreatic Cancer Prevalence Forecast.....................................................................26
Figure IV-5: Historical Prevalence of Pancreatic Cancer...............................................................26
Figure IV-6: Pancreatic Cancer Mortality Forecast.......................................................................29
Figure IV-7: Historical Mortality of Pancreatic Cancer..................................................................29
Figure IV-8: Number of Exocrine Pancreatic Cancer Patients By Line of Therapy.............................34
Figure IV-9: Number of Endocrine Pancreatic Cancer Patients By Line of Therapy...........................35
Figure IV-10: Drug-Treated Pancreatic Cancer Population Forecast................................................37
Figure IV-11: Pancreatic Cancer Drug-Treated Population Forecast, by Type and Line of Therapy......38
Figure IV-12: Patients by Physician Practice Setting, 2003............................................................42
Figure IV-13: Physicians by Practice Setting, 2003......................................................................43
Figure V-1: Top Regimens Used to Treat Pancreatic Cancer, 2003................................................52
Figure V-2: Top Regimens Used to Treat Exocrine Pancreatic Cancer, 2003...................................53
Figure V-3: Top Regimens Used to Treat Endocrine Pancreatic Cancer, 2003.................................53
Figure V-4: Pancreatic Cancer Treatment Tree.............................................................................58
Figure V-5: Longitudinal Comparison of Top Regimens Across Lines of Therapy for Exocrine Pancreatic Cancer, 2003.................................................................................................................59
Figure V-6: Monthly Share for Top Drugs in First-Line Therapy, Stage III/IV, Exocrine Pancreatic Cancer64
Figure V-7: Lines of Therapy Received Per Patient........................................................................66
Figure V-8: Average Length of Drug Regimen (Exocrine Pancreatic Cancer), 2003..........................67
Figure VIII-1: Pancreatic Cancer Drug Market Forecast, by Drug/Drug Class, 2013.....................107
Figure VIII-2: Pancreatic Cancer Drug Market Forecast, by Patient Segment, 2003-2013..............107

LIST OF TABLES

Table II-1: General Summary of Considerations in Market Forecast
Table III-1: Diagnostic Methods for Pancreatic Cancer
Table III-2: AJCC Classification for Pancreatic Cancer
Table III-3: Endocrine Tumors of the Pancreas
Table IV-1: Drug-Treated Population by Type and Stage of Pancreatic Cancer, 2003
Table IV-2: Drug-Treated Population by Patient Body Surface Area, 2003
Table V-1: Annual Cost of Top Agents Used to Treat Pancreatic Cancer, 2003
Table VII-1: Summary by Phase of Drugs in Clinical Development for Pancreatic Cancer, 2004
Table VII-2: Drugs in Phase III, Preregistration, or Registration for Pancreatic Cancer Worldwide, 2004
Table VII-3: Launched Drugs in US Phase II Clinical Trials for Pancreatic Cancer, 2004
Table VII-4: Pipeline Drugs in US Phase II Clinical Trials for Pancreatic Cancer, 2004 -- Part 1 of 3
Table VII-5: Pipeline Drugs in US Phase II Clinical Trials for Pancreatic Cancer, 2004 -- Part 2 of 3
Table VII-6: Pipeline Drugs in US Phase II Clinical Trials for Pancreatic Cancer, 2004 -- Part 3 of 3
Table VII-7: Pipeline Drugs in US Phase II Clinical Trials for Pancreatic Cancer, 2004 -- Part 1 of 3
Table VII-8: Drugs in Ex-US Phase II Clinical Trials for Pancreatic Cancer, 2004
Table VII-9: Launched Drugs in US Phase I Clinical Trials for Pancreatic Cancer, 2004
Table VII-10: Pipeline Drugs in US Phase I Clinical Trials for Pancreatic Cancer, 2004 -- Part 1 of 2
Table VII-11: Pipeline Drugs in US Phase I Clinical Trials for Pancreatic Cancer, 2004 -- Part 2 of 2
Table VII-12: Drugs in Ex-US Phase I Clinical Trials for Pancreatic Cancer, 2004
Table VIII-1: Assumptions Regarding Clinical Eligibility and Treatment Rates, by Patient Segment, 2008-2013
Table VIII-2: Total Pancreatic Cancer Drug Treatment Market Forecast, by Drug/Drug Class, 2003-2013
Table VIII-3: Exocrine Pancreatic Cancer Drug Treatment (All Lines of Therapy) Market Forecast, by Drug/Drug Class, 2003-2013
Table VIII-4: Exocrine Pancreatic Cancer First-Line Drug Treatment Market Forecast, by Drug/Drug Class, 2003-2013
Table VIII-5: Exocrine Pancreatic Cancer Second-Line Drug Treatment Market Forecast, by Drug/Drug Class, 2003-2013
Table VIII-3: Exocrine Pancreatic Cancer Third-Plus-t-Line Drug Treatment Market Forecast, by Drug/Drug Class, 2003-2013
Table VIII-3: Endocrine Pancreatic Cancer Drug Treatment (All Lines of Therapy) Market Forecast, by Drug/Drug Class, 2003-2013

EPiQ Market Intelligence Program: Pancreatic Cancer

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