Breast Cancer Treatment Market Outlook to 2022:

Breast Cancer Treatment Market Outlook to 2022: Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions

The global breast cancer treatment market was valued at $12.1bn in 2016 and is forecast to grow at a strong 8.3.% CAGR between 2016 and 2022, resulting in 2022 global sales of $21.3bn. Breast cancer is the most frequent form of cancer with multiple drugs available but still presents high unmet need.


Exhibit 1:

Breast Cancer Treatment Market Size – 2016-2022 ($million)

Breast Cancer Types:

Breast cancer is the most common form of cancer and it can be segmented into three different types: (1) the hormone-sensitive population that account for 65% of the total population, (2) Her2+ mutated tumors, which account for 15% of the total and (3) the triple-negative breast cancer population (20%) usually younger and with more severe symptoms with difficult prognosis and limited treatment options apart from chemotherapy. The triple-negative breast cancer category presents the most unmet medical need.

In its early stages, breast cancer may have no symptoms and can be detected only through mammography screening. During more advanced stages, symptoms include tenderness, swelling, lumps, and skin irritation. The use of mammography screening has accelerated earlier diagnosis and reduced mortality.

Current Standard of Care:

The treatment paradigm for breast cancer depends on the stage of the cancer at presentation normally through Stage I to IV, and on whether the tumor is hormone positive, HER2 positive, or triple negative.

For HER2+ disease, a variety of HER2-receptor targeted agents have been developed that have improved the prognosis of the disease. These include Roche’s Herceptin, Perjeta, Kadcyla, and GSK’s Tykerb,

Patients diagnosed with early-stage breast cancer are normally treated with surgery to remove the tumor. Following surgery, a combination of radiation therapy and/or adjuvant chemotherapy and/or hormonal therapy is used to treat women with early-stage breast cancer. In HER2+ patients, a Herceptin-containing regimen, often with a taxane or other chemotherapy.

In metastatic breast cancer, there are several treatment options available, including Roche’s Perjeta that received FDA approved June 2012, GSK’s Tykerb with FDA approval in March 2007 and Roche’s Kadcyla, FDA approved in February 2013.


Future Treatment Paradigm:

The CDK4/6 inhibitor class is of great interest given its potential effectiveness at treating patients with hormone-sensitive tumors and who represent the largest breast cancer population. In February 2015, the FDA approved Pfizer’s Ibrance (palbociclib) as an add-on therapy to letrozole in post-menopausal ER+/HER2- mBC as a first-line therapy.

Historically, aromatase inhibitors have been used to treat this population. These products are now off patent but still remains the cornerstone of treatments for these patients and the CDK4/6 class is used in combination with these drugs.

The CDK4/6 inhibitor class addresses 70% of the breast cancer population with three competitors. Pfizer’s Ibrance is set to remain the leader (with a 55% market share). Novartis’ Kisqali is in the launch phase in the US (end-17 in the EU) with safety and efficacy profile closer to those of Ibrance. Eli Lilly is developing abemaciclib, a selective CDK4/6 inhibitor that has more potent activity against both CDK4 and CDK6 compared to palbociclib and ribociclib. Eli Lilly’s abemaciclib appears more potent, but has symptomatic gastro-intestinal side effects. Hence it should be reserved for severe sufferers and is unlikely to reach the market before the end of 2018.

The next leg of growth for CDK4/6 is likely expansion into the adjuvant/neoadjuvant setting, as well as use of the same or other CDK4/6 agents post-progression, and potential for use beyond the HR+ patient population due to synergy with other agents.

The next generations HER2 ADC Therapies are currently in development. While Kadcyla is currently the only approved anti-HER2 ADC, there are at least five other HER2-targeted ADCs in the early stages of clinical development.

The Road Ahead

Triple Negative Breast Cancer (TNBC) accounts for roughly 20% of all breast cancers and makes the hardest form of cancer to treat and presents multibillion dollar opportunity. The pharmaceutical industry is now prioritizing development of immunotherapies (IO) to treat TNBC. Currently Roche and Merck are most active in TNBC.

Puma is developing Neratinib in several treatment settings for HER2+ breast cancer. Neratinib produced a statistically significant DFS benefit in the extended-adjuvant setting (given for one year after one year of Herceptin) and received FDA approval in July 2017.

Biosimilar competition is also on the horizon and the first biosimilar Herceptin is expected to enter Europe from 2018 and potentially in the U.S. from 2019.

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