HER2-Positive Breast Cancer Market to Reach $9.89 Billion by 2025

A new report from GlobalData UK indicates that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025, a compound annual growth rate (CAGR) of 4.4%.

The report, which examines the HER2-positive treatment market in the United States, the United Kingdom, France, Germany, Italy, Spain, Japan, and China, indicates that the adjuvant and neoadjuvant settings of the market, which the report’s authors say will reach $4.96 billion by 2025, are likely to emerge as the main drivers of sales. The biggest sales driver is expected to be the monoclonal antibody pertuzumab (Roche’s Perjeta) used in first-line therapy for HER2-positive metastatic breast cancer in combination with trastuzumab (Herceptin) and docetaxel.

Because pertuzumab and the reference trastuzumab are believed to work in complementary ways to increase death of cancer cells, increased use of pertuzumab could help protect sales of Herceptin in a landscape with growing numbers of biosimilar options, the authors say. Perjeta will also extend the duration of treatment, contributing to higher sales numbers.

Max Bourgognon, healthcare analyst for GlobalData, explained the staying power of the monoclonal antibodies in the marketplace, saying, “The dynamism of the adjuvant and neoadjuvant markets has prompted many companies to position their products in these settings. However, many agents have failed to demonstrate clinical benefit over the currently cemented standard of care, meaning the adjuvant and neoadjuvant settings will remain an exclusive market for anti-HER2 monoclonal antibodies, hence constituting the most lucrative opportunity for biosimilar developments.”

The report also indicates that the anticipated launch of Puma Biotechnology's neratinib in late 2017 could create a new treatment setting for the treatment of HER2-positive breast cancer: the extended adjuvant setting, a currently underexplored area that could boom as additional drug manufacturers seek market share. Neratinib, a tyrosine kinase inhibitor (TKI), blocks signal transduction through the epidermal growth factor receptors HER1, HER2, an HER4. Puma Biotechnology says that it sees the potential for the oral treatment to be used in several additional indications, including gastric cancer. The drug was recommended for approval by the FDA's Oncologic Drugs Advisory Committee (ODAC) in May.

As promising as new TKIs may be, the report notes that there remains room for new products, and that patients who have TKI-resistant HER2-positive cancer remain an especially underserved segment of the patient population that will require innovative therapies to meet their needs.