PharmaPoint: HER2-Negative Breast Cancer - Global Drug Forecast and Market Analysis to 2023


#258276

360pages

GlobalData

$ 10995

In Stock

tation positive market, huge changes are to occur which could potentially redefine the way these patients are treated. This will be chiefly due to the entrance of several PARP inhibitors in the market.

Highlights

Key Questions Answered

- How is the disease management evolving? What is the impact for drug manufacturers?
- What are the R&D strategies being used by drug makers?
- What opportunities remain for future players?
- How large are the neoadjuvant, adjuvant, and metastatic markets for TNBC and HR+ breast cancer?
- What exciting, innovative approaches are being investigated in HER2-negative breast cancer?
- What to KOLs think about the latest therapies and drug development strategies?

Key Findings

- The HER2-negative breast cancer market will increase by 4-fold; from $1.45 billion in 2013 to $6.12 billion in 2023 at a CAGR of 15.5%. Growth will be driven by the rapid uptake of new premium priced agents in both the HR+ and TNBC settings. Presently the HR + and TNBC settings have around an equal share of the HER2 negative market, by 2023 this is expected to change drastically to around 80% and 20% respectively.
- In the HR+ setting, the launch of a number of innovative premium-priced products namely, the PI3K and CDK 4/6 inhibitors, will act as the main drivers for growth. The collective sales from these agents alone will account for $3.6 billion and 79% of the global sales in the HR+ setting in 2023. GlobalData expects Pfizers Palbociclib to capture sales of $1.85 billion in 2023, making it the highest grossing drug in the HR+ setting and HER2 negative breast cancer as a whole.
- In the TNBC setting, the launch of several PARP inhibitors will act as the main drivers for growth. The collective sales from all of the PARP inhibitors will account for $1.02 billion and 94% of the global sales in the TNBC setting in 2023. Chief amongst them will be AstraZenecas Lynparza which will capture sales of $926.3m in 2023.
- By 2023, the adjuvant setting will prove to be the most lucrative setting in both HR+ and TNBC. Galena Biopharmas NeuVax (nelipepimut-S/E75) will enter the adjuvant setting (HR+) in the US and 5EU; even with relatively low patient shares (<10%), it will score comparatively high global sales of $567m by 2023. AstraZeneca's Lynparza will also enter the adjuvant setting (TNBC), indeed the vast majority of its 2023 sales are expected to come from here 79%; $731m.

Scope

- Overview of HER2-negative breast cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized HER2-negative breast cancer therapeutics market revenue, cost of therapy, and treatment usage patterns in 15 patient segments, forecast from 2013 to 2023.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the HER2-negative breast cancer therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for different lines of therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global HER2-negative breast 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.

Reasons to buy

- 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 HER2-negative breast cancer therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global HER2-negative breast 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 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 23
2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Etiology and Pathophysiology 28
3.1.1 Etiology 28
3.1.2 Pathophysiology 29
3.1.3 Basic Breast Anatomy 30
3.2 Disease Classification/Staging Systems 31
3.3 Symptoms 33
3.4 Prognosis 33
3.5 Quality of Life 34
4 Epidemiology 37
4.1 Disease Background 37
4.2 Risk Factors and Comorbidities 37
4.2.1 A family history of breast cancer and BRCA1/2 gene mutations significantly increase the breast cancer risk 39
4.2.2 Reproductive hormonal factors influence the risk of breast cancer 39
4.2.3 Modifiable lifestyle-related factors increase the risk of mortality in breast cancer patients 41
4.2.4 Screening programs have been shown to reduce breast cancer mortality, although the benefits need to be carefully weighed against the risks 43
4.3 Global Trends 46
4.3.1 Incidence 46
4.3.2 Prevalence and Survival 52
4.4 Forecast Methodology 56
4.4.1 Sources Used 58
4.4.2 Sources Not Used 62
4.4.3 Forecast Assumptions and Methods 63
4.5 Epidemiological Forecast for Breast Cancer (2013-2023) - Diagnosed Incident Cases 66
4.5.1 Diagnosed Incident Cases of Breast Cancer 66
4.5.2 Diagnosed Incident Cases of Breast Cancer by Age 68
4.5.3 Diagnosed Incident Cases of Breast Cancer by Menopausal Status 70
4.5.4 Diagnosed Incident Cases of Breast Cancer Segmented by Stage at Diagnosis 72
4.5.5 Age-Standardized Diagnosed Incidence Rate of Breast Cancer 73
4.6 Epidemiological Forecast for Breast Cancer (2013-2023) Diagnosed Prevalent Cases 74
4.6.1 Five-Year Diagnosed Prevalent Cases of Breast Cancer 74
4.6.2 Five-Year Diagnosed Prevalent Cases by Menopausal Status 76
4.6.3 Five-Year Diagnosed Prevalent Cases by Hormone Receptor Subtypes 77
4.7 Discussion 79
4.7.1 Epidemiological Forecast Insight 79
4.7.2 Limitations of the Analysis 81
4.7.3 Strengths of the Analysis 82
5 Disease Management 84
5.1 Diagnosis and Treatment Overview 84
5.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 84
5.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIC) 86
5.1.3 Treatment Guidelines and Leading Prescribed Drugs 90
5.2 US 91
5.2.1 Diagnosis 91
5.2.2 Clinical Practice 92
5.3 France 95
5.3.1 Diagnosis 95
5.3.2 Clinical Practice 96
5.4 Germany 99
5.4.1 Diagnosis 99
5.4.2 Clinical Practice 100
5.5 Italy 103
5.5.1 Diagnosis 103
5.5.2 Clinical Practice 104
5.6 Spain 106
5.6.1 Diagnosis 106
5.6.2 Clinical Practice 107
5.7 UK 110
5.7.1 Diagnosis 110
5.7.2 Clinical Practice 111
5.8 Japan 114
5.8.1 Diagnosis 114
5.8.2 Clinical Practice 115
5.9 China 117
5.9.1 Diagnosis 117
5.9.2 Clinical Practice 119
6 Competitive Assessment 122
6.1 Overview 122
6.2 Product Profiles (Branded Therapies) 123
6.2.1 Abraxane (nab-paclitaxel) 123
6.2.2 Afinitor (everolimus) 128
6.2.3 Avastin (bevacizumab) 133
6.2.4 Doxil/Caelyx (pegylated liposomal doxorubicin) 137
6.2.5 Halaven (eribulin mesylate) 142
6.2.6 Ixempra (ixabepilone) 145
6.2.7 Xeloda (capecitabine) 148
6.3 Product Profiles (Hormonal Agents) 151
6.3.1 Tamoxifen 151
6.3.2 Faslodex (fulvestrant) 151
6.3.3 Aromatase Inhibitors 152
7 Unmet Need and Opportunity 156
7.1 Overview 156
7.1.1 Defined treatment plan for BRCA mutation-positive patients and prevention of prophylactic surgeries 158
7.1.2 Specific treatment options for TNBC patients 160
7.1.3 Prevention of brain metastasis 161
7.1.4 Neoadjuvant therapy that can downstage tumors 163
7.1.5 For HR+patients, reduced resistance to hormonal agents 164
7.1.6 Improved convenience of administration of hormonal agents 166
8 Pipeline Assessment 168
8.1 Overview 168
8.1.1 Abemaciclib (LY2835219) 169
8.1.2 Buparlisib (BKM- 120) 175
8.1.3 Javlor (vinflunine) 181
8.1.4 LEE011 185
8.1.5 NeuVax (nelipepimut-S/E75) 190
8.1.6 Niraparib (MK4827) 195
8.1.7 NKTR- 102 (etirinotecan pegol) 200
8.1.8 Lynparza (olaparib) 204
8.1.9 Palbociclib (PD-0332991) 209
8.1.10 Talazoparib (BMN 673) 215
8.1.11 Veliparib (ABT-888) 219
8.2 Promising Drugs in Clinical Development 224
8.2.1 PD-/PD-L 1 Immunotherapies 225
9 Current and Future Players 227
9.1 Overview 227
9.2 Trends in Corporate Strategy 229
9.3 Company Profiles 232
9.3.1 AstraZeneca 232
9.3.2 Bristol-Myers Squibb 233
9.3.3 Eli Lilly 235
9.3.4 Pfizer 236
9.3.5 Novartis/GlaxoSmithKline 239
10 Market Outlook 241
10.1 Global Markets 241
10.1.1 Forecast 241
10.1.2 Drivers and Barriers - Global Issues 247
10.2 US 249
10.2.1 Forecast 249
10.2.2 Key Events 252
10.2.3 Drivers and Barriers 253
10.3 France 255
10.3.1 Forecast 255
10.3.2 Key Events 258
10.3.3 Drivers and Barriers 259
10.4 Germany 260
10.4.1 Forecast 260
10.4.2 Key Events 264
10.4.3 Drivers and Barriers 265
10.5 Italy 266
10.5.1 Forecast 266
10.5.2 Key Events 270
10.5.3 Drivers and Barriers 271
10.6 Spain 272
10.6.1 Forecast 272
10.6.2 Key Events 275
10.6.3 Drivers and Barriers 276
10.7 UK 277
10.7.1 Forecast 277
10.7.2 Key Events 281
10.7.3 Drivers and Barriers 282
10.8 Japan 284
10.8.1 Forecast 284
10.8.2 Key Events 287
10.8.3 Drivers and Barriers 288
10.9 China 289
10.9.1 Forecast 289
10.9.2 Key Events 292
10.9.3 Drivers and Barriers 292
11 Appendix 294
11.1 Bibliography 294
11.2 Abbreviations 321
11.3 Methodology 329
11.4 Forecasting Methodology 329
11.4.1 Diagnosed HER2-Negative Breast Cancer Patients 329
11.4.2 Percentage of Drug-Treated Patients 330
11.4.3 Drugs Included in Each Therapeutic Class 330
11.4.4 Launch and Patent Expiry Dates 331
11.4.5 General Pricing Assumptions 332
11.4.6 Individual Drug Assumptions 334
11.4.7 Generic Erosion 342
11.4.8 Pricing of Pipeline Agents 342
11.5 Primary Research - KOLs Interviewed for This Report 353
11.6 Primary Research - High-Prescriber Survey 355
11.7 About the Authors 356
11.7.1 Analyst 356
11.7.2 Director of Oncology 356
11.7.3 Epidemiologist 357
11.7.4 Director of Epidemiology 357
11.7.5 Global Head of Healthcare 358
11.8 About GlobalData 359
11.9 Disclaimer 359

1.1 List of Tables
Table 1: AJCC Stage Definitions for Breast Cancer 32
Table 2: Prognosis for Breast Cancer 33
Table 3: Selected Major Risk Factors and Comorbidities for Breast Cancer 38
Table 4: Breast Cancer Mortality Attributable to Lifestyle-Related Risk Factors 42
Table 5: 8MM, Current Status and Plans of Large-Scale Breast Cancer Screening Programs 45
Table 6: 8MM, Relative Survival Rate for Breast Cancer, All Ages*, Women, %, 1991-2004** 53
Table 7: Conversion of Common Staging Systems for Breast Cancer Used in the Forecast 57
Table 8: 8MM, Sources of the Breast Cancer Diagnosed Incidence Data Used in the Epidemiological Forecast 57
Table 9: 8MM, Diagnosed Incident Cases of Breast Cancer, Ages

NA

NA