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Breast Cancer Therapeutics in Major Developed Markets to 2021 - Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence

Breast Cancer Therapeutics in Major Developed Markets to 2021 - Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence

Summary

Breast cancer, a malignant neoplasm, is the second most common cancer and the most common cancer in women worldwide, accounting for 16% of all female cancers, making the disease exceedingly prevalent. The number of women diagnosed with breast cancer has increased over the past few decades, but the number of deaths has declined due to earlier diagnosis and better treatment options.

Breast cancer treatment has been revolutionized in the past four decades, especially with increasing usage of targeted therapies. The marketed products landscape comprises a wide range of treatment options, including hormonal therapies, chemotherapies, combination therapies, and targeted therapies. Nevertheless, significant unmet need remains for products that can improve overall survival rate, time to disease progression, and overall response.

Scope

The current breast cancer market contains novel products, including Perjeta, a targeted therapy; Kadcyla, a human antibody-drug conjugate; and Halaven, a novel chemotherapeutic agent.

  • What are the competitive advantages of the existing novel drugs?
With over 700 active pipeline molecules, most of the investigational drug candidates are being evaluated for the first-line or second-line treatment of advanced-stage breast cancer, featuring new combination therapies, targeted therapies, and promising immunotherapies, as well as chemotherapy drug candidates.
  • Which classes of novel drugs are most prominent within the pipeline?
  • Is there strong potential for the pipeline to address unmet needs within the breast cancer market?
Analysis of clinical trials since 2006 identified that the failure rates of breast cancer molecules were highest in Phase II (41%), with the overall attrition rate for breast cancer in development being 61%.
  • How do failure rates vary by product stage of development, molecule type, and mechanism of action?
  • How do other factors, such as average trial duration and trial size influence the costs and risks associated with product development?
Over the 2014–2021 forecast period, the breast cancer therapeutics market in the eight major markets is expected to increase in value at a CAGR of 7.3%, from $10.4 billion to over $17.2 billion.
  • Which markets make the most significant contribution to the current market size?
  • What are the epidemiology trends in these markets?
  • Will new market entrants lead to substantial changes in annual therapy costs?
  • How will different treatment usage patterns impact growth in the eight major markets?
Rising breast cancer incidence and new product approvals will lead to significant market growth over the forecast period, despite generic sales erosion resulting from patent expirations.
  • Will patent expirations or emerging pipeline molecules threaten the commercial success of existing drugs?
  • Which patent expirations will have the most significant impact on the market?
Reasons to buy

This report will enable you to -
  • Understand the clinical context of breast cancer by considering symptoms, etiology, pathophysiology, epidemiology, diagnosis, and treatment options.
  • Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
  • Identify key pipeline trends in molecule type, administration route, mechanism of action, and novelty.
  • Consider market opportunities and potential risks by examining trends in breast cancer clinical trial size, duration, and failure rate by stage of development, molecule type, and mechanism of action.
  • Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in breast cancer by examining clinical trial data and multi-scenario product forecast projections.
  • Compare treatment usage patterns, annual therapy costs, and market growth projections for the US, Canada, the UK, France, Germany, Italy, Spain, and Japan.
  • Discover trends in licensing and co-development deals concerning breast cancer products and identify the major strategic consolidations that have shaped the commercial landscape.


Global Breast Cancer Treatment Market Will Reach $17.2 Billion by 2021, says GBI Research

The global breast cancer therapeutics market is set to increase in value from $10.4 billion in 2014 to $17.2 billion by 2021, at a Compound Annual Growth Rate (CAGR) of 7.3%, according to business intelligence provider GBI Research.

The company’s latest report* states that this strong growth will be primarily due to substantial increases in the prevalence of breast cancer, with rates of the disease expected to rise over the forecast period due to an aging population, changing lifestyles and higher survival rates.

Furthermore, Deekshita Allavarapu, Analyst for GBI Research, says that the introduction of several new therapies will help to drive breast cancer treatment market growth by 2021.

Allavarapu explains: “In terms of upcoming breast cancer treatments, the overall pipeline is strong, with 743 products, and the early pipeline has many experimental molecules designed to target novel pathways.

“Promising pipeline drugs include abemaciclib, buparlisib, LEE 011, Olaparib and NeuVax, all of which are expected to be approved within the forecast period and have demonstrated significant clinical benefits in trials. In addition, rapid uptake of premium-priced biologics, such as Perjeta and Kadcyla, in all settings of the disease will contribute to the market growth.”

Despite this, the analyst notes that the late-stage breast cancer pipeline is weak, with only 6% of candidates in Phase III of development, and targeted therapies, currently unrepresented by marketed products, almost non-existent within this phase.

GBI Research’s report also states that the market will face some limitations due to patent expirations creating substantial opportunity for generic and biosimilar manufacturers.

Allavarapu continues: “The patents for a number of key breast cancer drugs, including Afinitor, Avastin and Herceptin, are expected to expire during the forecast period. However, the use of combinations of branded therapies in both the early-stage and metastatic settings will increase the Annual Cost of Therapy (ACoT) and offset the impact of patent expiries.

“For example, the ACoT for the combination of Perjeta with Herceptin is three times that of Herceptin monotherapy in both adjuvant and metastatic settings in the US. Therefore, even though Herceptin is set to expire in the near future, this will be offset by the approval of newer combination therapies and the growth of current premium therapies.”

*Breast Cancer Therapeutics in Major Developed Markets to 2021 - Growth Driven by Rapid Uptake of Premium Priced Biologics and Rising Incidence

This report provides analysis of the breast cancer treatment pipeline, stratified by stage of development, molecule type and mechanism of action. It includes information on the current clinical and commercial landscape, unmet needs, and annualized market data from 2014 and forecast to 2021.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Introduction
2.2 Symptoms
2.3 Etiology
2.4 Pathophysiology
2.5 Epidemiology
2.6 Diagnosis and Classification
2.7 Prognosis and Disease Staging
2.8 Treatment Options
2.8.1 Surgery and Radiation Therapy
2.8.2 Chemotherapy
2.8.3 Hormonal Therapies
2.8.4 Targeted Therapies
2.8.5 Resistance to Pharmacological Therapies
2.9 Treatment Guidelines
3 Marketed Products
3.1 Overview
3.1.1 Herceptin (trastuzumab) – Genentech
3.1.2 Perjeta (pertuzumab) – Genentech
3.1.3 Afinitor (everolimus) – Novartis
3.1.4 Tykerb/ Tyverb (lapatinib ditosylate monohydrate) – Novartis
3.1.5 Ibrance (palbociclib) – Pfizer
3.1.6 Ixempra (ixabepilone) – Bristol-Myers Squibb
3.1.7 Halaven (eribulin mesylate) – Eisai
3.1.8 Avastin (bevacizumab) – Genentech
3.1.9 Kadcyla (ado-trastuzumab emtansine) – Genentech
3.1.10 Marketed Products Heatmap
3.1.11 Measuring the Effectiveness of Treatment
3.2 Conclusion
4 Pipeline Products
4.1 Pipeline Products
4.1.1 Overall Pipeline
4.1.2 Pipeline by Molecular Target
4.2 Clinical Trials
4.2.1 Failure Rate
4.2.2 Patient Enrollment and Clinical Trial Size
4.2.3 Duration
4.3 Competitive Clinical Trials Metrics Analysis
5 Promising Drug Candidates in Pipeline
5.1 Abemaciclib – Eli Lily
5.1.1 Abemaciclib Forecast
5.2 Buparlisib – Novartis
5.2.1 Buparlisib Forecast
5.3 NeuVax (nelipepimut-S) – Galena Biopharma
5.3.1 NeuVax Forecast
5.4 Niraparib – Tesaro
5.4.1 Niraparib Forecast
5.5 Lynparza (Olaparib) – AstraZeneca
5.5.1 Lynparza Forecast
5.6 Veliparib – AbbVie
5.6.1 Veliparib Forecast
5.7 Neratinib – Puma Biotechnology
5.7.1 Neratinib Forecast
5.8 Ribociclib – Novartis
5.8.1 Ribociclib Forecast
5.9 Talazoparib – BioMarin
5.10 Alpelisib – Novartis
5.11 Atezolizumab – Roche
5.12 Entinostat – Syndax
5.13 Margetuximab – MacroGenics
5.14 Taselisib – Genentech
5.15 OBI-822/821 – OBI Pharma
5.16 Heat Map for Pipeline Products
6 Market Forecast to 2021
6.1 Geographical Markets
6.2 Global Market
6.3 North America
6.3.1 Treatment Usage Patterns
6.3.2 Annual Cost of Therapy
6.3.3 Market Size
6.4 Five Leading European Markets
6.4.1 Treatment Usage Patterns
6.4.2 Annual Cost of Therapy
6.4.3 Market Size
6.5 Japan
6.5.1 Treatment Usage Patterns
6.5.2 Annual Cost of Therapy
6.5.3 Market Size
7 Drivers and Barriers for the Disease Market
7.1 Drivers
7.1.1 Increased Uptake of Targeted and Combination Therapies for Breast Cancer
7.1.2 Growth and Aging of Western Populations
7.1.3 Launch of Premium-Priced Products with Greater Efficacy than Existing Therapies
7.2 Barriers
7.2.1 Patent Expiries
7.2.2 High Level of Competition
7.2.3 Problems with the Reimbursement of Premium-Priced Therapeutics will Limit their Uptake
8 Deals and Strategic Consolidations
8.1 Licensing Deals
8.1.1 Sprint Bioscience Enters Licensing Agreement with Bayer HealthCare
8.1.2 Takeda Enters Licensing Agreement with ImmunoGen
8.1.3 Oncothyreon Enters Licensing Agreement with Array BioPharma for ONT-380
8.1.4 Halozyme Therapeutics Enters Licensing Agreement with Janssen Biotech
8.1.5 CTI BioPharma Enters Licensing Agreement with Servier for Pixuvri
8.2 Co-development Deals
8.2.1 MacroGenics Enters Agreement with Merck
8.2.2 Color Genomics Partners with University of California Health
8.2.3 Lycera Enters Co-development Agreement with Celgene
8.2.4 Roche Holding Enters Agreement with Oryzon to Develop Epigenetics-Based Medicines
8.2.5 Tracon Enters Co-development Agreement with Santen Pharma
9 Appendix
9.1 All Pipeline Drugs by Phase of Development
9.1.1 Discovery
9.1.2 Preclinical
9.1.3 IND/CTA-filed
9.1.4 Phase I
9.1.5 Phase II
9.1.6 Phase III
9.1.7 Pre-registration
9.2 Market Forecasts to 2021
9.2.1 Global
9.2.2 US
9.2.3 Canada
9.2.4 UK
9.2.5 France
9.2.6 Germany
9.2.7 Italy
9.2.8 Spain
9.2.9 Japan
9.3 Bibliography
9.4 Abbreviations
9.5 Research Methodology
9.5.1 Secondary Research
9.5.2 Marketed Product Profiles
9.5.3 Late-Stage Pipeline Candidates
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
9.5.5 Forecasting Model
9.5.6 Deals Data Analysis
9.6 Contact Us
9.7 Disclaimer
1.1 List of Tables
Table 1: Breast Cancer Therapeutics, US, Disease Stage at Diagnosis (%), 2013
Table 2: Breast Cancer Therapeutics, Global, Tumor, Nodes and Metastasis Staging, 2010–2013
Table 3: Breast Cancer Therapeutics, US, Disease Stage at Diagnosis and Five-Year Relative Survival (%), 2013
Table 4: Breast Cancer Therapeutics Market, Global, Pipeline Products, Discovery, 2015
Table 5: Breast Cancer Therapeutics Market, Global, Pipeline Products, Preclinical, 2015
Table 6: Breast Cancer Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2015
Table 7: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase I, 2015
Table 8: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase II, 2015
Table 9: Breast Cancer Therapeutics Market, Global, Pipeline Products, Phase III, 2015
Table 10: Breast Cancer Therapeutics Market, Global, Pipeline Products, Pre-registration, 2015
Table 11: Breast Cancer Therapeutics Market, Global, Market Forecast, 2014–2021
Table 12: Breast Cancer Therapeutics Market, US, Market Forecast, 2014–2021
Table 13: Breast Cancer Therapeutics Market, Canada, Market Forecast, 2014–2021
Table 14: Breast Cancer Therapeutics Market, UK, Market Forecast, 2014–2021
Table 15: Breast Cancer Therapeutics Market, France, Market Forecast, 2014–2021
Table 16: Breast Cancer Therapeutics Market, Germany, Market Forecast, 2014–2021
Table 17: Breast Cancer Therapeutics Market, Italy, Market Forecast, 2014–2021
Table 18: Breast Cancer Therapeutics Market, Spain, Market Forecast, 2014–2021
Table 19: Breast Cancer Therapeutics Market, Japan, Market Forecast, 2014–2021
1.2 List of Figures
Figure 1: Breast Cancer Therapeutics, Eight Leading Markets, Age-Standardized Incidence Rates of Breast Cancer (per 100,000), 2012
Figure 2: Breast Cancer Therapeutics, US, Age-Specific Incidence Rates of Breast Cancer in Women (per 100,000), 1992–2012
Figure 3: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stages I–III, 2015
Figure 4: Breast Cancer Therapeutics, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV, 2015
Figure 5: Breast Cancer Therapeutics Market, Global, Heat Map
Figure 6: Breast Cancer Therapeutics Market, Global, Overview of Pipeline Products
Figure 7: Breast Cancer Therapeutics Market, Global, Molecular Target in the Pipeline
Figure 8: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase, 2006–2015
Figure 9: Breast Cancer Therapeutics Market, Global, Clinical Trial Overall Attrition Rate and Failure Rate by Phase and Molecule Type (%), 2006–2015
Figure 10: Breast Cancer Therapeutics Market, Global, Clinical Trial Attrition Rate and Failure Rate by Phase and Molecular Target (%), 2006–2015
Figure 11: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006–2015
Figure 12: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006–2015
Figure 13: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecular target (participants), 2006–2015
Figure 14: Breast Cancer Therapeutics Market, Global, Clinical Trial Size per Individual Trial by Molecular Target (participants), 2006–2015
Figure 15: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006–2015
Figure 16: Breast Cancer Therapeutics Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006–2015
Figure 17: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type
Figure 18: Breast Cancer Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Mechanism of Action
Figure 19: Breast Cancer Therapeutics Market, Global, Abemaciclib, Market Forecast ($m), 2020–2021
Figure 20: Breast Cancer Therapeutics Market, Global, Buparlisib, Market Forecast ($m), 2020–2021
Figure 21: Breast Cancer Therapeutics Market, Global, NeuVax, Market Forecast ($m), 2020–2021
Figure 22: Breast Cancer Therapeutics Market, Global, Niraparib, Market Forecast ($m), 2020–2021
Figure 23: Breast Cancer Therapeutics Market, Global, Lynparza, Market Forecast ($m), 2020–2021
Figure 24: Breast Cancer Therapeutics Market, Global, Lynparza, Market Forecast ($m), 2020–2021
Figure 25: Breast Cancer Therapeutics Market, Global, Neratinib, Market Forecast($m) 2020–2021
Figure 26: Breast Cancer Therapeutics Market, Global, Ribociclib, Market Forecast ($m), 2020–2021
Figure 27: Breast Cancer Therapeutics Market, Global, Pipeline Heat Map, 2015
Figure 28: Breast Cancer Therapeutics Market, Global, Treatment Patterns (million) and Market Size ($bn), 2014–2021
Figure 29: Breast Cancer Therapeutics Market, North America, Treatment Patterns (‘000), 2014–2021
Figure 30: Breast Cancer Therapeutics Market, North America, Annual Cost of Therapy ($), 2014–2021
Figure 31: Breast Cancer Therapeutics Market, North America, Market Size ($bn), 2014–2021
Figure 32: Breast Cancer Therapeutics Market, Five Leading European Markets, Treatment Patterns (‘000), 2014–2021
Figure 33: Breast Cancer Therapeutics Market, Five Leading European Market, Annual Cost of Therapy ($), 2014–2021
Figure 34: Breast Cancer Therapeutics Market, Five Leading European Markets, Market Size ($m), 2014–2021
Figure 35: Breast Cancer Market, Japan, Treatment Usage Patterns (‘000), 2014–2021
Figure 36: Breast Cancer Market, Japan, Annual Cost of Therapy ($), 2014–2021
Figure 37: Breast Cancer Therapeutics Market, Japan, Market Size ($m), 2014–2021
Figure 38: Breast Cancer Therapeutics Market, Global, Licensing Deals by Region, 2006–2015
Figure 39: Breast Cancer Therapeutics Market, Global, Licensing Deals by Deal Value, 2006–2015
Figure 40: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006–2015
Figure 41: Breast Cancer Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006–2015
Figure 42: Breast Cancer Therapeutics Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006–2015
Figure 43: Breast Cancer Therapeutics Market, Global, Co-development Deals by Region, 2006–2015
Figure 44: Breast Cancer Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year and Value, 2006–2015
Figure 45: Breast Cancer Therapeutics Market, Global, Co-development Deals by Stage of Development, 2006–2015
Figure 46: Breast Cancer Therapeutics Market, Global, Co-development Deals by Molecular Target, 2006–2015

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