Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019 - Crowded Late-Stage Pipelines and Favorable Market Conditions Encourage Robust Growth





Published: December 2013 | Pages: 106 | Format: PDF

 Summary 

 GBI Research has released the pharma report “Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019 - Crowded Late-Stage Pipelines and Favorable Market Conditions Encourage Robust Growth” Gastric and esophageal cancers are two orphan cancers of the gastrointestinal tract. They are often diagnosed at advanced, incurable stages due to a late onset of symptoms, but are also associated with low survival rates in the early stages of disease. 

 Currently the primary treatment options are chemotherapy and surgery, which are used wherever possible. One monoclonal Antibody (mAb), Herceptin (trastuzumab) is marketed for use in suitable patients with advanced gastric or gastro-esophageal junction cancer. 

 However, the late-stage pipelines for these indications include many promising mAb candidates which are anticipated to enter the market during the forecast period. Additionally, current market conditions are favorable for new mAbs, with high pricing patterns and weak impact from biosimilar exposure. As a result of this, GBI Research believes the global market has the potential to grow to a value of $766m by 2019. 

 Scope 

 

  •  A brief introduction to the two indications, including the disease’s pathogenesis, risk factors, diagnosis and treatment algorithms. 
  •  In-depth analysis of Herceptin, including analysis of its safety, efficacy, treatment patterns and strengths/weaknesses. 
  •  A comprehensive review of the pipeline for mAbs in gastric and esophageal cancer, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets. 
  •  Additional in-depth analysis of pipeline drug clinical trials by phase, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action. 
  •  Multi-scenario forecast data of the market to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Canada, Japan, Germany, the UK, France, Italy and Spain. 
  •  Discussion of the drivers and barriers for market growth. 

 

 Reasons to buy 

 

  •  Understand the unmet need in the treatment of these cancers, the role of Herceptin and the areas of opportunity for other mAbs to enter the market. 
  •  Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent. 
  •  Observe the trends in clinical trial duration, size and molecule types across the phases of development and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for mAbs in gastric and esophageal cancers. 
  •  Observe the shift in clinical trial endpoints with clinical phase, and use this data to potentially influence any future developmental programs. 
  •  Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the market for mAbs in gastric and esophageal cancers. 

 

 Additional Information 

 Gastric and esophageal cancers are two similar, overlapping groups of rare diseases, with their respective prevalence populations in the top eight markets estimated to be 392,000 and 169,000. However, their mortality rates are far higher than for other cancers, with poor prognoses even being assigned to patients diagnosed at an early stage of the disease. As such, there is a very strong unmet need for effective treatments, and so there is a strong commercial opportunity which has not yet been exploited in these indications. 

 A New Market Currently led by Herceptin 

 Due to their ability to bind to extracellular and membrane-bound molecular targets with a high degree of specificity, monoclonal Antibodies (mAbs) have represented strong clinical improvements over chemotherapies and targeted small molecule approaches in other indications such as breast and colorectal cancers. Due to certain inherent properties and favorable market conditions, these products have also been very strong commercial successes, with mAbs such as Herceptin generating $6.3 billion of revenues worldwide in 2012, and Avastin generating $6.2 billion in the same year. 

 One mAb, Herceptin, is currently marketed for the treatment of gastric and esophageal cancers. Although, commercially speaking, its primary indication is breast cancer, its Food and Drug Administration (FDA) approval for the treatment of gastric and esophageal cancers in 2010 is anticipated to represent a significant additional source of revenue. 

 Favorable Market Conditions to Drive Steady Growth Despite Weak Late-Stage Pipelines 

 There are currently 125 and 33 products in the pipelines for gastric and esophageal cancer respectively. Of these, there are 33 mAbs in the pipeline for gastric cancer and eight for esophageal cancer. The late-stage pipelines for these indications do include a number of novel products which have shown a reasonable degree of potential, both clinically and commercially. However, none of these products is anticipated to offer significant improvements over existing therapies. As such, their commercial potential is expected to be moderate. 

 The market for mAbs in gastric cancer is anticipated to grow from $256m in 2012 to $501m in 2019 at a Compound Annual Growth Rate (CAGR) of 10.0%. The market for mAbs in esophageal cancer is also anticipated to grow from $137m in 2012 to $265m in 2019 at a CAGR of 9.9%. This is due to favorable market conditions in terms of pricing structures in the US and rising disease prevalence in certain geographies and the anticipated approval of a number of late-stage pipeline drugs, particularly towards the end of the forecast period. 

 Country 

 Global 

 Sector 

 Oncology 

 1 Table of Contents 

 1.1 List of Tables 

 1.2 List of Figures 

 2 Introduction 

 2.1 Symptoms 

 2.1.1 Early Gastric Cancer 

 2.1.2 Early Esophageal Cancer 

 2.1.3 Advanced Gastric or Esophageal Cancer 

 2.2 Etiology 

 2.2.1 Esophageal Cancer 

 2.2.2 Gastric Cancer 

 2.3 Epidemiology 

 2.4 Pathophysiology 

 2.5 Diagnosis 

 2.6 Prognosis and Disease Staging 

 2.7 Treatment Options 

 2.7.1 Chemotherapy 

 2.7.2 Targeted Therapies 

 2.7.3 Treatment Guidelines 

 2.7.4 Resistance to Pharmacological Therapies 

 3 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Marketed Products 

 3.1 Herceptin (Trastuzumab) - Hoffman La Roche 

 4 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Developmental Pipeline 

 4.1 Gastric Cancer 

 4.1.1 Overall Pipeline 

 4.1.2 Molecular Targets 

 4.1.3 Clinical Trials 

 4.1.4 Conclusion 

 4.2 Esophageal Cancer 

 4.2.1 Overall Pipeline 

 4.2.2 Molecular Targets 

 4.2.3 Clinical Trials 

 4.2.4 Conclusion 

 4.3 Key Late-Stage Pipeline Products 

 4.3.1 AMG 102 (rilotumumab) - Amgen 

 4.3.2 IMC-1121B (Ramucirumab) - Eli Lilly and Company 

 4.3.3 Theraloc (Nimotuzumab) - YM Biosciences 

 4.3.4 MetMAb (Onartuzumab) - F. Hoffmann-La Roche 

 4.3.5 Perjeta (pertuzumab) - F. Hoffmann-La Roche 

 4.3.6 Kadcyla (ado-trastuzumab emtansine) - F. Hoffmann-La Roche 

 4.4 Conclusion 

 5 Monoclonal Antibodies Market in Gastric and Esophageal Cancers to 2019- Market Forecast to 2019 

 5.1 Gastric Cancer 

 5.1.1 Global 

 5.1.2 US 

 5.1.3 Canada 

 5.1.4 Europe 

 5.1.5 Japan 

 5.2 Esophageal Cancer 

 5.2.1 Global 

 5.2.2 US 

 5.2.3 Canada 

 5.2.4 Europe 

 5.2.5 Japan 

 5.3 Drivers and Barriers 

 5.3.1 Drivers 

 5.3.2 Barriers 

 6 Deals and Strategic Consolidations 

 6.1 Licensing Agreements 

 6.1.1 Gastric Cancer 

 6.1.2 Esophageal Cancer 

 6.2 Co-Development Agreements 

 6.2.1 Gastric Cancer 

 6.2.2 Esophageal Cancer 

 7 Appendix 

 7.1 Market Definitions 

 7.2 Abbreviations 

 7.3 References 

 7.4 All Pipeline Products, by Stage of Development 

 7.4.1 Gastric Cancer 

 7.4.2 Esophageal Cancer 

 7.5 Tabular Forecast Data 

 7.5.1 Gastric Cancer 

 7.5.2 Esophageal Cancer 

 7.6 Research Methodology 

 7.6.1 Coverage 

 7.6.2 Secondary Research 

 7.6.3 Therapeutic Landscape 

 7.6.4 Epidemiology-Based forecasting 

 7.6.5 Market Size by Geography 

 7.6.6 Geographical Landscape 

 7.6.7 Pipeline Analysis 

 7.6.8 Competitive Landscape 

 7.6.9 Expert Panel Validation 

 7.7 Contact Us 

 7.8 Disclaimer 

 1.1 List of Tables 

 Table 1: Market for mAbs in Gastrointestinal Tract Cancer, US, Epidemiology, 2008 

 Table 2: Market for mAbs in Gastrointestinal Tract Cancer, US, Diagnosis by Stage, 2008 

 Table 3: Market for mAbs in Gastrointestinal Tract Cancer, US, Five-Year Relative Survival by Stage, 2003-2009 

 Table 4: Market for mAbs in Gastric Cancer, Global, TNM Staging, 2010-2013 

 Table 5: Gastric Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 

 Table 6: Gastric Cancer Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 

 Table 7: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 

 Table 8: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 

 Table 9: Gastric Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-registration), 2013 

 Table 10: Gastric Cancer Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 

 Table 11: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 

 Table 12: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Preclinical and IND/CTA-filed), 2013 

 Table 13: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 

 Table 14: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 

 Table 15: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-registration), 2013 

 Table 16: Esophageal Cancer Therapeutics, Global, All Pipeline Products (Undisclosed), 2013 

 Table 17: Market for mAbs in Gastric Cancer, Global, Forecast Data, 2012-2019 

 Table 18: Market for mAbs in Gastric Cancer, US, Forecast Data, 2012-2019 

 Table 19: Market for mAbs in Gastric Cancer, Canada, Forecast Data, 2012-2019 

 Table 20: Market for mAbs in Gastric Cancer, UK, Forecast Data, 2012-2019 

 Table 21: Market for mAbs in Gastric Cancer, France, Forecast Data, 2012-2019 

 Table 22: Market for mAbs in Gastric Cancer, Germany, Forecast Data, 2012-2019 

 Table 23: Market for mAbs in Gastric Cancer, Italy, Forecast Data, 2012-2019 

 Table 24: Market for mAbs in Gastric Cancer, Spain, Forecast Data, 2012-2019 

 Table 25: Market for mAbs in Gastric Cancer, Japan, Forecast Data, 2012-2019 

 Table 26: Market for mAbs in Esophageal Cancer, Global, Forecast Data, 2012-2019 

 Table 27: Market for mAbs in Esophageal Cancer, US, Forecast Data, 2012-2019 

 Table 28: Market for mAbs in Esophageal Cancer, Canada, Forecast Data, 2012-2019 

 Table 29: Market for mAbs in Esophageal Cancer, UK, Forecast Data, 2012-2019 

 Table 30: Market for mAbs in Esophageal Cancer, France, Forecast Data, 2012-2019 

 Table 31: Market for mAbs in Esophageal Cancer, Germany, Forecast Data, 2012-2019 

 Table 32: Market for mAbs in Esophageal Cancer, Italy, Forecast Data, 2012-2019 

 Table 33: Market for mAbs in Esophageal Cancer, Spain, Forecast Data, 2012-2019 

 Table 34: Market for mAbs in Esophageal Cancer, Japan, Forecast Data, 2012-2019 

 1.2 List of Figures 

 Figure 1: Gastric Cancer: Treatment Algorithm 

 Figure 2: Esophageal Cancer: Treatment Algorithm (Locoregional Tumor) 

 Figure 3: Market for mAbs in Gastrointestinal Tract Cancer, Global, Sales of Herceptin ($bn), 1999-2012 

 Figure 4: Market for mAbs in Gastric Cancer, Global, Overall Pipeline, 2013 

 Figure 5: Market for mAbs in Gastric Cancer, Global, Pipeline mAbs by Mechanism of Action and Molecular Target, 2013 

 Figure 6: Market for mAbs in Gastric Cancer, Global, Developmental Pipeline Failure Rate, 2006-2013 

 Figure 7: Market for mAbs in Gastric Cancer, Global, Clinical Trial Sizes, 2006-2013 

 Figure 8: Market for mAbs in Gastric Cancer, Global, Clinical Trial Sizes by Molecule Type, 2006-2013 

 Figure 9: Market for mAbs in Gastric Cancer, Global, Clinical Trial Durations, 2006-2013 

 Figure 10: Market for mAbs in Gastric Cancer, Global, Clinical Trial Durations by Molecule Type, 2006-2013 

 Figure 11: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints (All Molecule Types), 2006-2013 

 Figure 12: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints (mAbs Only), 2006-2013 

 Figure 13: Market for mAbs in Gastric Cancer, Global, Clinical Trial Primary Endpoints by Developmental Program (mAbs Only), 2006-2013 

 Figure 14: Market for mAbs in Esophageal Cancer, Global, Overall Pipeline, 2013 

 Figure 15: Market for mAbs in Esophageal Cancer, Global, Pipeline mAbs by Mechanism of Action, 2013 

 Figure 16: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Sizes, 2006-2013 

 Figure 17: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Sizes by Molecule Type, 2006-2013 

 Figure 18: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Durations, 2006-2013 

 Figure 19: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Durations by Molecule Type, 2006-2013 

 Figure 20: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints (All Molecule Types), 2006-2012 

 Figure 21: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints (mAbs Only), 2006-2012 

 Figure 22: Market for mAbs in Esophageal Cancer, Global, Clinical Trial Primary Endpoints by Developmental Program (mAbs Only), 2006-2012 

 Figure 23: Market for mAbs in Gastric Cancer, Global, Market Size and Growth, 2012-2019 

 Figure 24: Market for mAbs in Esophageal Cancer, Global, Market Size and Growth, 2012-2019 

 Figure 25: Market for mAbs in Gastric Cancer, Global, Treatment Usage Patterns, 2012-2019 

 Figure 26: Market for mAbs in Gastric Cancer, Global, Market Size ($m), 2012-2019 

 Figure 27: Market for mAbs in Gastric Cancer, US, Treatment Patterns, 2012-2019 

 Figure 28: Market for mAbs in Gastric Cancer, US, Market Size ($m), 2012-2019 

 Figure 29: Market for mAbs in Gastric Cancer, Canada, Treatment Usage Patterns, 2012-2019 

 Figure 30: Market for mAbs in Gastric Cancer, Canada, Market Size ($m), 2012-2019 

 Figure 31: Market for mAbs in Gastric Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019 

 Figure 32: Market for mAbs in Gastric Cancer, Top Five European Markets, Annual Cost of Therapy, 2012-2019 

 Figure 33: Market for mAbs in Gastric Cancer, Top Five European Markets, Market Size ($m), 2012-2019 

 Figure 34: Market for mAbs in Gastric Cancer, Japan, Treatment Usage Patterns, 2012-2019 

 Figure 35: Market for mAbs in Gastric Cancer, Japan, Market Size ($m), 2012-2019 

 Figure 36: Market for mAbs in Esophageal Cancer, Global, Treatment Usage Patterns, 2012-2019 

 Figure 37: Market for mAbs in Esophageal Cancer, Global, Market Size ($m), 2012-2019 

 Figure 38: Market for mAbs in Esophageal Cancer, US, Treatment Patterns, 2012-2019 

 Figure 39: Market for mAbs in Esophageal Cancer, US, Market Size ($m), 2012-2019 

 Figure 40: Market for mAbs in Esophageal Cancer, Canada, Treatment Patterns, 2012-2019 

 Figure 41: Market for mAbs in Esophageal Cancer, Canada, Market Size ($m), 2012-2019 

 Figure 42: Market for mAbs in Esophageal Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019 

 Figure 43: Market for mAbs in Esophageal Cancer, Top Five European Markets, Annual Cost of Therapy ($), 2012-2019 

 Figure 44: Market for mAbs in Esophageal Cancer, Top Five European Markets, Market Size ($m), 2012-2019 

 Figure 45: Market for mAbs in Esophageal Cancer, Japan, Treatment Patterns, 2012-2019 

 Figure 46: Market for mAbs in Esophageal Cancer, Japan, Market Size ($m), 2012-2019 

 Figure 47: Market for mAbs in Gastric Cancer, Global, Licensing Deals (Countries), 2006-2013 

 Figure 48: Market for mAbs in Gastric Cancer, Global, Licensing Deals by Year and Value, 2006-2013 

 Figure 49: Market for mAbs in Gastrointestinal Tract Cancers, Global, Licensing Deals, 2006-2013 

 Figure 50: Market for mAbs in Gastric Cancer, Global, Co-Development Deals, 2006-2013 

 Figure 51: GBI Research Market Forecasting Model