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

  • January 2015
  • 360 pages
  • GlobalData
Report ID: 2838398


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


Breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-negative breast cancer market, with coverage of multiple settings; neoadjuvant, adjuvant, first-, second-, third-, and fourth-line metastatic.

Overall five year survival in breast cancer is relatively high, at around 90%, but this is subjective to the subtype and stage of the disease. Importantly this report segments HER2 negative breast cancer into its two major subtypes; hormone receptor positive (HR+) and triple negative breast cancer (TNBC).

HR+ disease accounts for around 90% of all HER2 negative breast cancers. It responds well to hormonal agents such tamoxifen and the 3rd generation aromatase inhibitors. The advent of hormonal therapy has alleviated some of the unmet needs for these patients, however opportunities still remain. The pipeline for the HR+ market is very strong, with several exciting new agents such as the PI3K and CDK 4/6 inhibitors. GlobalData believes these will have a phenomenal effect on the treatment paradigm for patients with the disease and address many of the unmet needs which patients currently face.

TNBC accounts for around 10% of all HER2 negative breast cancers. TNBC does not respond to hormonal agents and few chemotherapies have been shown to work effectively at managing the disease. The level of unmet need for patients with this form of the disease is very high; furthermore around 30% of TNBC patients will carry a BRCA mutation- these patients have an even worse outcome, with an ultra-high degree of unmet needs. The pipeline for the TNBC market exclusive of the BRCA population is non-existent. However in regards to the BRCA mutation 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.


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 Pfizer’s 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 AstraZeneca’s 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 Biopharma’s 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.


- 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.

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