With five-year survival only approximately 5%, pancreatic cancer is characterized as a disease with some of the highest unmet need in oncology. This report focuses on the current treatment landscape, unmet needs, pipeline and commercial opportunity in the pancreatic cancer market with coverage of both the early stage resectable and advanced settings. Celgene’s Abraxane was launched in the US and Europe in 2013 and 2014, respectively, and was the first drug approved in this disease in nearly a decade. Due to the high unmet need, GlobalData forecasts the rapid uptake of Abraxane, and sales of this drug are expected to drive the overall pancreatic cancer market and are forecast to represent greater than 50% of total market sales in 2017. GlobalData also forecasts the launch of five new pipeline agents into the pancreatic cancer market. Despite the launch of new agents, GlobalData expects significant opportunities to remain for developers of drugs with predictive biomarker-driven strategies. The challenge for new entrants will be to design adequate clinical studies that assess pipeline drugs in carefully selected patient populations and incorporate the current standard-of-care chemotherapies, such as GemAbrax, as backbone regimens. With Big Pharma being actively involved in early-stage innovative projects, GlobalData expects clinical development in pancreatic cancer to accelerate at the end of the forecast period and beyond.
Key Questions Answered
- What are the areas of highest unmet need in pancreatic cancer?
- What are the R&D and clinical trial design strategies pursued by companies in the pancreatic cancer space?
- What are the most promising pipeline agents for pancreatic cancer? How do their clinical and commercial attributes compare to one another and the current standard of care?
- What opportunities will remain for future players following the launch of these pipeline agents?
- What is the potential for predictive biomarkers and targeted therapies in the pancreatic cancer setting?
- What exciting, innovative approaches are being investigated in pancreatic cancer?
- The pancreatic cancer market, in the 6MM is forecasted to rapidly increase from $529m in 2012 to $1.63bn in 2017, at a CAGR of 25.2%. This growth is driven by the adoption of premium-priced Abraxane into clinical practice, as well as the launch of five novel pipeline agents towards the end of the forecast period.
- Although the approval of Abraxane has been welcomed by KOLs, they are not satisfied with the overall survival benefit of two months compared with gemcitabine monotherapy, and call for novel, predictive, biomarker-driven targeted therapies in order to substantially extend survival.
- Of the pipeline agents expected to launch during the forecast period, only NewLink Genetics’ immunotherapy algenpantucel-L is being investigated in the early-stage resectable setting. GlobalData expects the lack of treatment options for resectable patients to facilitate the rapid uptake of this therapy in the US.
- The early stage pipeline for pancreatic cancer is strong and is indicative of the remaining high commercial opportunities. Strikingly, in comparison with the late-stage pipeline, Big Pharma is playing a much stronger role in the investigation of these strategies.
- Overview of pancreatic cancer, including epidemiology, etiology, pathophysiology, symptoms, prognosis, and clinical staging.
- Topline pancreatic cancer therapeutics market revenue from 2012–2017. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the pancreatic cancer therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline drugs. An interactive clinical and commercial analyzer tool is available.
- Analysis of the current and future market competition in the 6MM pancreatic cancer therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
- 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 6MM pancreatic cancer market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 6MM pancreatic cancer therapeutics 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.
1.1 List of Tables
1.2 List of Figures
2.2 Related Reports
2.3 Upcoming Related Reports
3 DISEASE OVERVIEW
3.1 Etiology and Pathophysiology
3.3 Clinical Staging
4.1 Disease Overview
4.2 Risk Factors and Comorbidities
4.2.1 The risk of developing pancreatic cancer increases with age
4.2.2 Tobacco smokers have a two-fold increased risk of pancreatic cancer
4.2.3 Diabetes and obesity increase the risk of developing pancreatic cancer
4.2.4 At least 10% of pancreatic cancer cases result from a hereditary predisposition
4.3 Global Trends
4.3.1 United States
4.3.6 United Kingdom
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Forecast Assumptions and Methods
4.4.3 Sources Not Used
4.5 Epidemiology Forecast
4.5.1 Incident Cases of Pancreatic Cancer
4.5.2 Total Five-Year Prevalent Cases of Pancreatic Cancer
4.6.1 Conclusions on Epidemiological Trends
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 CURRENT TREATMENT OPTIONS
5.2 Product Profiles — Major Brands
6 UNMET NEEDS ASSESSMENT AND OPPORTUNITY ANALYSIS
6.2 Unmet Needs Analysis
6.2.1 Therapies That Improve Overall Survival Outcomes for Advanced Patients
6.2.2 Effective Adjuvant Treatments That Prevent Recurrence of Disease
6.2.3 Earlier Diagnosis of Disease
6.2.4 Discovery of Predictive Biomarkers and Understanding of Underlying Causes of Disease
6.2.5 Treatment Options for Gemcitabine-Refractory Metastatic Patients
6.3 Opportunity Analysis
6.3.1 Predictive Biomarker-Driven Targeted Therapies in Combination with Chemotherapy Regimens
6.3.2 Treatment for Patients with Early-Stage, Localized Pancreatic Cancer
6.3.3 Target Patients with Poor Performance Status
6.3.4 Effective Drug Delivery
6.3.5 Establish New Chemotherapy to be Standard-of-Care Cytotoxic
6.3.6 Development of New Standard of Care for Gemcitabine-Refractory Advanced Patients
7 RESEARCH AND DEVELOPMENT STRATEGIES
7.1.1 Reformulation strategies
7.1.2 Small/Medium-Sized Pharmaceutical Companies Driving R&D
7.1.3 Large Pharmaceutical Companies Betting On Targeted Drug Approaches
7.2 Clinical Trial Design
7.2.2 Overall Survival is the Primary Endpoint of Choice in Both Adjuvant and Metastatic Trials
7.2.3 The Majority of Metastatic Trials Are in Second-Line and Later Patients
7.2.4 Gemcitabine: Backbone Therapy and Standard Active Comparator for First-Line Metastatic Trials
8 PIPELINE ASSESSMENT
8.2 Promising Drugs in Clinical Development
8.2.6 90Y-Clivatuzumab Tetraxetan
8.3 Innovative Early-Stage Approaches
8.3.1 Vaccine and Immunotherapy Combination
8.3.2 JAK Inhibition
8.3.3 Dual MEK/PI3K inhibition
8.3.4 Cancer Stem Cell Targeting
8.3.5 Poly (ADP-Ribose) Polymerase Inhibitors
8.3.6 Drug Delivery Mechanisms
8.3.7 Hedgehog Pathway
9 PIPELINE VALUATION ANALYSIS
9.1 Clinical Benchmarking of Key Pipeline Drugs
9.2 Commercial Benchmarking of Key Pipeline Drugs
9.3 Competitive Assessment
9.4 Top-Line Five-Year Forecast
10.4 Forecasting Methodology
10.4.1 Diagnosed Pancreatic Cancer Patients
10.4.2 Percent Drug-Treated
10.4.3 Drugs Included in Each Therapeutic Class
10.4.4 Launch and Patent Expiry Dates
10.4.5 General Pricing Assumptions
10.4.6 Individual Drug Assumptions
10.4.7 Generic Erosion
10.5 Physicians and Specialists Included in this Study
10.6 About the Authors
10.6.3 Global Head of Healthcare
10.7 About GlobalData
LIST OF FIGURES
Figure 1: Pancreatic Cancer Staging According to the AJCC TNM System
Figure 2: US, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 3: France, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 4: Germany, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 5: Italy, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 6: Spain, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 7: UK, Incidence and Mortality Rates of Pancreatic Cancer, All Ages, Men and Women, 2008
Figure 8: 6MM, Incident Cases of Pancreatic Cancer, Ages ≥15 Years, Men and Women, Select Years, 2012-2022
Figure 9: 6MM, Incident Cases of Pancreatic Cancer, by Age, Men and Women, N, 2012
Figure 10: 6MM, Incident Cases of Pancreatic Cancer by Sex, Ages ≥15 Years, 2012
Figure 11: 6MM, Age-Standardized Pancreatic Cancer Incidence, 2012
Figure 12: 6MM, Incident Cases of Pancreatic Cancer by Stage at Diagnosis, Ages ≥15 Years, Men and Women, 2012
Figure 13: 6MM, Total Incident Biomarker Cases of Pancreatic Cancer, Ages ≥15 Years, Men and Women, 2012
Figure 14: 6MM, Total Five-Year Prevalent Cases of Pancreatic Cancer, Ages ≥15 Years, Men and Women, Select Years, 2012-2022
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in Pancreatic Cancer, 2012-2017
Figure 16: Global Sales for Pancreatic Cancer by Region, 2012-2017
New Drug Launches Will Drive Rapid Growth in the US and EU
GlobalData estimates that the value of the pancreatic cancer market in the US and 5EU in 2012 was $529m. This market is defined as sales of branded drugs and major generic regimens commonly prescribed for pancreatic cancer patients across the six major markets (6MM). Just over half of these sales, $275m were generated in the US, while sales in the 5EU were estimated at $254m. By 2017, the end of the forecast period, GlobalData projects pancreatic cancer sales to rise to $1.63 billion in the US and 5EU, at a high CAGR of 25.2%. GlobalData expects the proportion of sales from the US to increase to 72%, with market share in the 5EU decreasing to 28% by 2017.
The overall rapid increase in the market size across the 6MM is attributed to the launch of Celgene’s Abraxane in 2013 in the US and 2014 in Europe, and the incorporation of five pipeline agents into US clinical practice by the end of the forecast period. GlobalData forecasts sales of Abraxane to rise significantly, from $21m in 2012 to $954m in 2017, at a CAGR of 115%; sales of Abraxane will represent nearly 60% of the pancreatic cancer market by the end of the forecast period.
Strong Early-Stage Pipeline is Indicative of Remaining High Commercial Opportunities in Pancreatic Cancer
GlobalData has identified a strong early-stage pipeline for pancreatic cancer. Innovative strategies include immunotherapies, janus kinase/signal transducer and activator of transcription (JAK/STAT) inhibition, mitogenactivated protein kinase/ phosphatidylinositol-4,5- bisphosphate 3-kinase (MAPK/PI3K) pathway inhibitors, cancer stem cell-targeting agents, and poly (ADP-ribose) polymerase (PARP) inhibitors. Strikingly, in comparison with the late-stage setting, Big Pharma is playing a much stronger role in the investigation of these strategies.
Companies such as GlaxoSmithKline, Novartis, Roche, AbbVie, and AstraZeneca are involved in investigating drugs in early-stage clinical studies in pancreatic cancer patients. GlobalData anticipates a high commercial reward for the developers of drugs that are able to fulfill some of the remaining high unmet need across the patient segments in pancreatic cancer. In particular, GlobalData expects the developers of efficacious immunotherapies or novel, predictive, biomarker-driven targeted therapies to be able to command premium prices in the US.
Major drivers of the pancreatic cancer market in the US and 5EU during the forecast period include the following:
- The greatest driver of the pancreatic cancer market across the 6MM will be the strong and rapid adoption of premium-priced Abraxane in place of generic chemotherapy regimens, such as FOLFIRINOX (5-flourouracil [5-FU]/leucovorin/irinotecan/oxaliplatin) and gemcitabine monotherapy. GlobalData forecasts particularly strong growth in the US, the largest market for pancreatic cancer therapeutics, and the market where Abraxane is priced the highest.
- Of the five new pipeline agents that will be launched during the forecast period, NewLink Genetics Corporation's algenpantucel-L is expected to garner the highest sales, and is expected to launch in both the resectable and unresectable locally-advanced settings. Other drugs with significant forecast sales by 2017 include Threshold Pharmaceuticals/Merck's TH-302, and Merrimack Pharmaceuticals' MM-398.
- The incidence of pancreatic cancer is increasing across the 6MM, resulting in further treatment opportunities for premium-priced therapeutics.
The material was prepared in October, 2014.
Table 1: AJCC TNM Classification System for Pancreatic Cancer
Table 2: AJCC TNM Staging System for Pancreatic Cancer
Table 3: Common Pancreatic Cancer Symptoms
Table 4: Risk Factors for Pancreatic Cancer
Table 5: 6MM, Sources of Pancreatic Cancer Incidence Data
Table 6: 6MM, Incident Cases of Pancreatic Cancer, Ages ≥15 Years, Men and Women, Select Years, 2012-2022
Table 7: 6MM, Incident Cases of Pancreatic Cancer, by Age, Men and Women, N, 2012
Table 8: 6MM, Incident Cases of Pancreatic Cancer, by Sex, Ages ≥15 Years, N (Row %), 2012
Table 9: 6MM, Five-Year Prevalent Cases of Pancreatic Cancer, Ages ≥15 Years, Men and Women, Select Years, 2012-2022
Table 10: Leading Treatments for Pancreatic Cancer in the US and 5EU
Table 11: Product Profile - Abraxane
Table 12: Abraxane SWOT Analysis
Table 13: Gemcitabine SWOT Analysis
Table 14: Product Profile - Tarceva
Table 15: Tarceva SWOT Analysis
Table 16: Overall Unmet Needs - Current Level of Attainment
Table 17: Design of Pipeline Phase III Trials in Pancreatic Cancer
Table 18: Pancreatic Cancer - Late Stage Pipeline
Table 19: Product Profile - Algenpantucel-L
Table 20: Algenpantucel-L SWOT Analysis
Table 21: Product Profile - TH-302
Table 22: TH-302 SWOT Analysis
Table 23: Product Profile - Lipoplatin
Table 24: Lipoplatin SWOT Analysis
Table 25: Product Profile - MM-398
Table 26: MM-398 SWOT Analysis
Table 27: Product Profile - Glufosfamide
Table 28: Glufosfamide SWOT Analysis
Table 29: Product Profile - 90Y-Clivatuzumab Tetraxetan
Table 30: 90Y-Clivatuzumab Tetraxetan SWOT Analysis
Table 31: Early-Stage Pipeline Products in Pancreatic Cancer
Table 32: Clinical Benchmarking of Key Pipeline Drugs - Pancreatic Cancer
Table 33: Commercial Benchmarking of Key Pipeline Drugs - Pancreatic Cancer
Table 34: Top-Line Sales Forecast ($m) for Pancreatic Cancer, 2012-2017
Table 35: Key Events Impacting Sales for Pancreatic Cancer, 2012-2017
Table 36: Pancreatic Cancer Market - Drivers and Barriers, 2013
Table 37: Key Launch Dates 2012-2017
Table 38: Key Patent Expiries 2012-2017