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Pancreatic Cancer: Opportunity Analysis and Forecast to 2026

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Pancreatic Cancer: Opportunity Analysis and Forecast to 2026


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Pancreatic Cancer: Opportunity Analysis and Forecast to 2026

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Pancreatic Cancer: Opportunity Analysis and Forecast to 2026



Executive Summary

Pancreatic Cancer: Opportunity Analysis and Forecast to 2026

Summary

Pancreatic cancer is set to become the second leading cause of cancer-related deaths in the US in 2020 after lung cancer, despite accounting for only 3% of new cancer diagnoses. Patients with advanced pancreatic cancer have a median survival of approximately 2.8-5.7 months, even in light of recent therapeutic innovations and elucidation of fundamental biological mechanisms of the disease. In the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) approximately two-thirds of patients are diagnosed with unresectable Stage III or Stage IV metastatic disease, and a significant proportion of resectable Stage III disease (85%) progresses to metastatic pancreatic cancer.

Since 2013, the FDA and European Medicines Agency (EMA) have approved Celgene's Abraxane (nab-paclitaxel), followed by Ipsen's Onivyde (irinotecan liposome injection). On the one hand, the addition of these novel therapeutic agents to existing regimens provides renewed hope to improve the treatment outcomes of patients with pancreatic cancer. On the other hand though, the pancreatic cancer field is littered with numerous clinical trial failures and successful readouts are notably sparse. In 2016, five Phase III agents were discontinued from development, exacerbating the aridity of a barren pancreatic cancer pipeline. However, there are general grounds for optimism as the therapeutic landscape is being transformed by novel frontline combination regimens as well as concrete options beyond this, for cases of disease progression. The integration of second-line therapy into the treatment algorithm of advanced pancreatic adenocarcinoma requires refinement in order to become an essential strategic component against the disease.

Key Questions Answered

- What are the key drivers behind the uptake and sustained dominance of Abraxane in the pancreatic cancer space, and what are the prevailing trends regarding its use over the forecast period?

- The pancreatic cancer market is characterized by a number of unmet needs. What are the main unmet needs in this market? Will the pipeline drugs under development fulfil these unmet needs?

- What impact will label expansion of advanced treatments into the lucrative adjuvant setting and targeted therapies into the front-line setting have?

Scope

- Overview of pancreatic cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

- Annualized pancreatic cancer therapeutics market revenue, cost of therapy per patient, treatment usage patterns in five patient segments, and forecasts from 2016 to 2026.

- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the pancreatic cancer therapeutics market.

- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for pancreatic cancer. The most promising candidates in Phase III development are profiled.

- Analysis of the current and future market competition in the global pancreatic cancer market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to-

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

- Develop business strategies by understanding the trends shaping and driving the global pancreatic cancer market.

- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global pancreatic cancer market in the future.

- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 8

1.2 List of Figures 9

2 Pancreatic Cancer: Executive Summary 11

2.1 Modest Growth in the Pancreatic Cancer Market Expected from 2016-2026 12

2.2 Reformulation Strategies and Second-Generation Products Used by Companies to Preserve or Establish Market Dominance 15

2.3 High Unmet Needs Exist in Pancreatic Cancer, Particularly for Patients with Poor Performance Status 16

2.4 High Commercial Opportunity for Metastatic and Adjuvant Treatments that Improve Survival Outcomes 17

2.5 Late-Stage Pipeline Agents to Have Moderate Impact on the Future Pancreatic Cancer Landscape 17

2.6 What Do Physicians Think? 19

3 Introduction 21

3.1 Catalyst 21

3.2 Related Reports 22

3.3 Upcoming Related Reports 22

4 Disease Overview 23

4.1 Etiology and Pathophysiology 25

4.1.1 Etiology 25

4.1.2 Pathophysiology 26

4.2 Classification or Staging Systems 28

4.3 Symptoms 30

4.4 Prognosis 31

4.5 Quality of Life 31

5 Epidemiology 33

5.1 Disease Background 33

5.2 Risk Factors and Comorbidities 34

5.3 Global and Historical Trends 34

5.3.1 Incidence 34

5.4 Forecast Methodology 36

5.4.1 Sources 37

5.4.2 Forecast Assumptions and Methods 40

5.4.3 Diagnosed Incident Cases of Pancreatic Cancer (Excluding PNETs) 41

5.4.4 Diagnosed Incident Cases of Pancreatic Cancer (Excluding PNETs) by Cancer Stages at Diagnosis 46

5.4.5 Diagnosed Incident Cases of Familial Pancreatic Cancer 47

5.4.6 Diagnosed Incident Cases of Familial Pancreatic Cancer by Germline Mutations 48

5.4.7 Diagnosed Incident Cases of Pancreatic Cancer (Excluding PNETs) by Other Mutations 48

5.4.8 Five-Year Diagnosed Prevalent Cases of Pancreatic Cancer (Excluding PNETs) 50

5.5 Epidemiological Forecast for Pancreatic Cancer (2016-2026) 51

5.5.1 Diagnosed Incident Cases of Pancreatic Cancer 51

5.5.2 Age-Specific Diagnosed Incident Cases of Pancreatic Cancer 52

5.5.3 Sex-Specific Diagnosed Incident Cases of Pancreatic Cancer 53

5.5.4 Diagnosed Incident Cases of Pancreatic Cancer by Cancer Stages at Diagnosis 54

5.5.5 Diagnosed Incident Cases of Familial Pancreatic Cancer 55

5.5.6 Diagnosed Incident Cases of Familial Pancreatic Cancer by Germline Mutations 56

5.5.7 Diagnosed Incident Cases of Pancreatic Cancer by Other Mutations 57

5.5.8 Five-Year Diagnosed Prevalent Cases of Pancreatic Cancer 57

5.6 Discussion 58

5.6.1 Epidemiological Forecast Insight 58

5.6.2 Limitations of Analysis 59

5.6.3 Strengths of Analysis 60

6 Current Treatment Options 61

6.1 Overview 61

6.2 Diagnosis and Treatment 64

6.2.1 Diagnosis 64

6.2.2 Treatment Guidelines and Leading Prescribed Drugs 66

6.3 Clinical Practice 68

6.4 Abraxane (nab-paclitaxel) 70

6.4.1 Overview 70

6.4.2 Efficacy 72

6.4.3 Safety 73

6.4.4 SWOT Analysis 74

6.5 Tarceva (erlotinib) 74

6.5.1 Overview 74

6.5.2 Efficacy 76

6.5.3 Safety 77

6.5.4 SWOT Analysis 78

6.6 TS-1 (gimeracil + oteracil + tegafur) 78

6.6.1 Overview 78

6.6.2 Efficacy 80

6.6.3 Safety 82

6.6.4 SWOT Analysis 83

6.7 Onivyde (liposomal irinotecan) 83

6.7.1 Overview 83

6.7.2 Efficacy 85

6.7.3 Safety 86

6.7.4 SWOT Analysis 87

6.8 Sutent (sunitinib malate) 87

6.8.1 Overview 87

6.8.2 Efficacy 88

6.8.3 Safety 89

6.8.4 SWOT Analysis 90

6.9 Gemcitabine 90

6.9.1 Overview 90

6.9.2 Efficacy 92

6.9.3 Safety 93

6.10 Other Therapeutic Classes 94

7 Unmet Needs and Opportunity Assessment 96

7.1 Overview 96

7.2 Improved Frontline Regimens, Particularly in Advanced Patients with Poor Performance Status 97

7.2.1 Unmet Need 97

7.2.2 Gap Analysis 98

7.2.3 Opportunity 99

7.3 Effective Adjuvant Treatments and Improved Patient Care 100

7.3.1 Unmet Need 100

7.3.2 Gap Analysis 102

7.3.3 Opportunity 102

7.4 Earlier Diagnosis of Disease 103

7.4.1 Unmet Need 103

7.4.2 Gap Analysis 103

7.4.3 Opportunity 104

7.5 Targeted Therapies and Predictive Biomarkers 104

7.5.1 Unmet Need 104

7.5.2 Gap Analysis 106

7.5.3 Opportunity 107

7.6 Treatment Options for Second-Line Metastatic Patients 107

7.6.1 Unmet Need 107

7.6.2 Gap Analysis 108

7.6.3 Opportunity 109

8 R&D Strategies 110

8.1 Overview of R&D Strategies 110

8.1.1 Reformulation Strategies and Second-Generation Products 110

8.1.2 Risk-Mitigation Strategies in Drug Development in Pancreatic Cancer for Small- to Medium-Sized Companies 112

8.1.3 Indication Expansion and Sequencing 112

8.2 Clinical Trials Design 113

8.2.1 Optimal Primary Endpoints Reappraised in the Metastatic and Adjuvant Settings 113

8.2.2 Gemcitabine + Abraxane Combination: Backbone Therapy and Standard Active Comparator for First-Line Metastatic Trials 115

8.2.3 Slow Clinical Trial Accrual Rates and Use of Early Determinants of Response 116

9 Pipeline Assessment 119

9.1 Overview 119

9.2 Promising Drugs in Clinical Development 123

9.3 Pegvorhyaluronidase alfa (PEGPH20) 124

9.3.1 Overview 124

9.3.2 Efficacy 126

9.3.3 Safety 127

9.3.4 SWOT Analysis 128

9.4 Imbruvica (ibrutinib) 129

9.4.1 Overview 129

9.4.2 Efficacy 131

9.4.3 Safety 131

9.4.4 SWOT Analysis 131

9.5 Napabucasin (BBI608) 132

9.5.1 Overview 132

9.5.2 Efficacy 133

9.5.3 Safety 134

9.5.4 SWOT Analysis 135

9.6 Lynparza (olaparib) 135

9.6.1 Overview 135

9.6.2 Efficacy 138

9.6.3 Safety 139

9.6.4 SWOT Analysis 140

9.7 Acelarin (NUC-1031) 140

9.7.1 Overview 140

9.7.2 Efficacy 142

9.7.3 Safety 142

9.7.4 SWOT Analysis 143

9.8 Masiviera (masitinib) 143

9.8.1 Overview 143

9.8.2 Efficacy 146

9.8.3 Safety 147

9.8.4 SWOT Analysis 148

9.9 Pegilodecakin (AM0010) 148

9.9.1 Overview 148

9.9.2 Efficacy 150

9.9.3 Safety 151

9.9.4 SWOT Analysis 152

9.10 Glufosfamide 153

9.10.1 Overview 153

9.10.2 Efficacy 155

9.10.3 Safety 155

9.10.4 SWOT Analysis 156

9.11 TLP0-001 156

9.11.1 Overview 156

9.11.2 Efficacy 159

9.11.3 Safety 159

9.11.4 SWOT Analysis 160

9.12 Innovative Early Stage Approaches 161

9.13 Other Drugs in Development 165

10 Pipeline Valuation Analysis 167

10.1 Clinical Benchmark of Key Pipeline Drugs 167

10.2 Commercial Benchmark of Key Pipeline Drugs 169

10.3 Competitive Assessment 172

10.3.1 Pegvorhyaluronidase alfa Competitive Assessment 172

10.3.2 Imbruvica Competitive Assessment 173

10.3.3 Napabucasin Competitive Assessment 173

10.3.4 Lynparza Competitive Assessment 174

10.3.5 Acelarin Competitive Assessment 175

10.3.6 Pegilodecakin Competitive Assessment 175

10.3.7 Glufosfamide Competitive Assessment 175

10.3.8 TLP0-001 Competitive Assessment 176

10.4 Top-Line 10-Year Forecast 177

10.4.1 US 181

10.4.2 5EU 182

10.4.3 Japan 183

11 Appendix 184

11.1 Bibliography 184

11.2 Abbreviations 197

11.3 Methodology 204

11.3.1 Forecasting Methodology 204

11.3.2 Diagnosed Patients 204

11.3.3 Percent Drug-Treated Patients 205

11.3.4 Drugs Included 205

11.3.5 Launch and Patent Expiry Dates 206

11.3.6 General Pricing Assumptions 207

11.3.7 Individual Drug Assumptions 208

11.3.8 Generic Erosion 211

11.3.9 Pricing of Pipeline Agents 211

11.4 Primary Research-KOLs Interviewed for This Report 217

11.5 Primary Research-Prescriber Survey 220

11.6 About the Authors 221

11.6.1 Analysts 221

11.6.2 Therapy Area Director 221

11.6.3 Epidemiologist 222

11.6.4 Reviewer 222

11.6.5 Global Director of Therapy Analysis and Epidemiology 223

11.6.6 Global Head and EVP of Healthcare Operations and Strategy 224

11.7 About GlobalData 224

11.8 Contact Us 225

11.9 Disclaimer 225

To know more information on Purchase by Section, please send a mail to sales@kenresearch.com

1.2 List of Figures

Figure 1: Global Sales Forecast by Country for Pancreatic Cancer in 2016 and 2026 14

Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Abraxane 18

Figure 3: 7MM, Age-Standardized Diagnosed Incidence of Pancreatic Cancer (Cases per 100,000 Population), Men, Ages ?15 Years, 2006 to 2026 36

Figure 4: 7MM, Age-Standardized Diagnosed Incidence of Pancreatic Cancer (Cases per 100,000 Population), Women, Ages ?15 Years, 2006 to 2026 36

Figure 5: 7MM, Sources Used for Diagnosed Incident Cases of Pancreatic Cancer 38

Figure 6: 7MM, Sources Used for Relative Survival Proportions to Forecast the Five-Year Diagnosed Prevalent Cases of Pancreatic Cancer 39

Figure 7: 7MM, Sources Used for Diagnosed Incident Cases of Pancreatic Cancer by Cancer Stages at Diagnosis 40

Figure 8: 7MM, Sources Used for Diagnosed Incident Cases of Familial Pancreatic Cancer 41

Figure 9: 7MM, Sources Used for Diagnosed Incident Cases of Familial Pancreatic Cancer by Germline Mutations 42

Figure 10: 7MM, Sources Used for Diagnosed Incident Cases of Familial Pancreatic Cancer by Other Mutations 43

Figure 11: 7MM, Diagnosed Incident Cases of Pancreatic Cancer, Both Sexes, Ages ?15 Years, N, 2016 55

Figure 12: 7MM, Age-Specific Diagnosed Incident Cases of Pancreatic Cancer, Both Sexes, Ages ?15 Years, N, 2016 56

Figure 13: 7MM, Sex-Specific Diagnosed Incident Cases of Pancreatic Cancer, Ages ?15 Years, N, 2016 57

Figure 14: 7MM, Diagnosed Incident Cases of Pancreatic Cancer by Cancer Stages at Diagnosis, Both Sexes, Ages ?15 Years, N, 2016 58

Figure 15: 7MM, Diagnosed Incident Cases of Familial Pancreatic Cancer by Germline Mutations, Both Sexes, Ages ?15 Years, N, 2016 to 2026 60

Figure 16: 7MM, Diagnosed Incident Cases of Pancreatic Cancer by Other Mutations, Both Sexes, Ages ?15 Years, N, 2016 to 2026 61

Figure 17: 7MM, Five-Year Diagnosed Prevalent Cases of Pancreatic Cancer, Both Sexes, Ages ?15 Years, N, 2016 62

Figure 18: Treatment Algorithm for Resectable and Borderline Resectable Disease 73

Figure 19: Treatment Algorithm for Locally Advanced Unresectable and Metastatic Disease 74

Figure 20: Abraxane's Development in Pancreatic Cancer 76

Figure 21: TS-1's Development in Pancreatic Cancer 85

Figure 22: Onivyde's Development in Pancreatic Cancer 90

Figure 23: Unmet Need and Opportunity in Pancreatic Cancer, 2018 101

Figure 24: Overview of the Development Pipeline in PDAC 127

Figure 25: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for PDAC in the 7MM During the Forecast Period 128

Figure 26: Pegvorhyaluronidase alfa's Development in Pancreatic Cancer 132

Figure 27: Imbruvica's Development in Pancreatic Cancer 137

Figure 28: Napabucasin's Development in Pancreatic Cancer 140

Figure 29: Lynparza's Development in Pancreatic Cancer 145

Figure 30: Acelarin's Development in Pancreatic Cancer 149

Figure 31: Masiviera's Development in Pancreatic Cancer 153

Figure 32: Pegilodecakin's Development in Pancreatic Cancer 158

Figure 33: Glufosfamide's Development in Pancreatic Cancer 162

Figure 34: TLP0-001's Development in Pancreatic Cancer 167

Figure 35: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Abraxane 185

Figure 36: Global (7MM) Sales Forecast by Country for Pancreatic Cancer in 2016 and 2026 188

1.1 List of Tables

Table 1: Pancreatic Cancer: Key Metrics in the 7MM 11

Table 2: Selected Genetic Syndromes with Associated Pancreatic Cancer Risk 26

Table 3: AJCC TNM Classification System for Pancreatic Cancer 28

Table 4: AJCC TNM Staging System for Pancreatic Cancer 29

Table 5: Common Pancreatic Cancer Symptoms 30

Table 6: Risk Factors for Pancreatic Cancer 34

Table 7: 7MM, Diagnosed Incident Cases of Familial Pancreatic Cancer, Ages ?15 Years, N, Both Sexes, Select Years 2016-2026 59

Table 8: Imaging Methods Used For Pancreatic Cancer Staging 69

Table 9: Treatment Guidelines for Disease Pancreatic Cancer 71

Table 10: Most Commonly Used Regimens for Pancreatic Cancer in the 7MM 72

Table 11: Product Profile-Abraxane 76

Table 12: Abraxane SWOT Analysis, 2018 78

Table 13: Product Profile-Tarceva (erlotinib) 81

Table 14: Tarceva (erlotinib) SWOT Analysis, 2018 83

Table 15: Product Profile-TS-1 (gimeracil + oteracil + tegafur) 84

Table 16: Efficacy Results of the Phase III JASPAC 01 Trial 85

Table 17: Efficacy Results of the Phase III GEST Trial 86

Table 18: Safety Results of the Phase III JASPAC 01 Trial 87

Table 19: TS-1 SWOT Analysis, 2018 88

Table 20: Product Profile-Onivyde (liposomal irinotecan) 89

Table 21: Efficacy Results of the Phase III NAPOLI-1 Trial 91

Table 22: Safety Results of the Phase III NAPOLI-1 Trial 91

Table 23: Onivyde SWOT Analysis, 2018 92

Table 25: Product Profile-Sutent (sunitinib malate) 93

Table 26: Efficacy Results of the Phase II PACT-12 Trial 94

Table 27: Sutent SWOT Analysis, 2018 94

Table 24: Product Profile -Gemcitabine 97

Table 28: Summary of Other Commonly Used Chemotherapy Regimens in Pancreatic Cancer, 2018 100

Table 29: Recently Completed and Ongoing Clinical Trials in the Adjuvant Setting in Pancreatic Cancer 119

Table 30: Comparison of Therapeutic Classes in Development for Pancreatic Cancer, 2016-2026 128

Table 31: Product Profile-Pegvorhyaluronidase alfa 131

Table 32: Efficacy Results of the Phase II HALO-202 Study 132

Table 33: Safety Results of the Phase II HALO-202 Trial 134

Table 34: Pegvorhyaluronidase alfa SWOT Analysis, 2018 135

Table 35: Product Profile-Imbruvica 136

Table 36: Imbruvica SWOT Analysis, 2018 138

Table 37: Product Profile-Napabucasin 140

Table 38: Safety Results of Napabucasin + Gemcitabine + Abraxane 141

Table 39: Napabucasin SWOT Analysis, 2018 142

Table 40: Product Profile-Lynparza 144

Table 41: Efficacy of Lynparza in Heavily Treated Pancreatic Cancer 145

Table 42: Safety of Lynparza in Heavily Treated Pancreatic Cancer 146

Table 43: Lynparza SWOT Analysis, 2018 147

Table 44: Product Profile-Acelarin 148

Table 45: Acelarin SWOT Analysis, 2018 151

Table 46: Product Profile-Masiviera 152

Table 47: Efficacy of Masiviera + Gemcitabine in Treatment-Naive PDAC 154

Table 48: Safety of Masiviera + Gemcitabine in Treatment-Naive PDAC 155

Table 49: Masiviera SWOT Analysis, 2018 156

Table 50: Product Profile-Pegilodecakin 157

Table 51: Efficacy of Pegilodecakin + FOLFOX in 2L PDAC 158

Table 52: Safety of Pegilodecakin + FOLFOX in 2L PDAC 159

Table 53: Pegilodecakin SWOT Analysis, 2018 160

Table 54: Product Profile-Glufosfamide 162

Table 55: Safety of Glufosfamide + BSC in Metastatic PDAC After a 1L Gemcitabine-Containing Regimen 163

Table 56: Glufosfamide SWOT Analysis, 2018 165

Table 57: Product Profile-TLP0-001 166

Table 58: TLP0-001 SWOT Analysis, 2018 169

Table 59: Innovative Early Stage Approaches Involving Immune Checkpoint Inhibitors for Pancreatic Cancer, 2018 170

Table 60: Innovative Early Stage Approaches for Pancreatic Cancer, 2018 172

Table 61: Other Drugs in Development for Pancreatic Cancer, 2018 173

Table 62: Clinical Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Pegvorhyaluronidase Alfa, Napabucasin, and Lynparza) 176

Table 63: Clinical Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Imbruvica, Acelarin, and Pegilodecakin) 176

Table 64: Clinical Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Glufosfamide and TLP0-001) 178

Table 65: Commercial Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Pegvorhyaluronidase Alfa, Napabucasin, and Lynparza) 179

Table 66: Commercial Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Imbruvica, Acelarin, and Pegilodecakin) 179

Table 67: Commercial Benchmark of Key Pipeline Drugs-Pancreatic Cancer (Glufosfamide and TLP0-001) 180

Table 68: Key Events Impacting Sales for Pancreatic Cancer, 2016-2026 189

Table 69: Pancreatic Cancer Market-Global Drivers and Barriers, 2016-2026 190

Table 70: Key Historical and Projected Launch Dates for Pancreatic Cancer 216

Table 71: Key Historical and Projected Patent Expiry Dates for Pancreatic Cancer 216

Table 72: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 230

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Ipsen

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