The global human epidermal growth factor receptor type 2 (HER2)-positive breast cancer market is projected to grow from $6.4bn in 2015 to $9.89bn in 2025, witnessing a compound annual growth rate (CAGR) of 4.4%, according to a report by GlobalData.

Titled ‘HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2025’, the report covers a HER2-positive market of eight major countries, including the US, France, Germany, Italy, Spain, the UK, Japan and China.

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The adjuvant and neoadjuvant settings of the HER2-positive market are expected to emerge as the main growth drivers of sales, which are forecasted to reach $4.96bn in 2025.

The increase in sales will be driven by the launch of Perjeta in the adjuvant setting. The drug’s launch will help in increasing treatment duration and also protect Herceptin from competition from biosimilars in established markets.

The dynamic nature of the adjuvant and neoadjuvant markets has led many companies to establish their products within these segments, explains Max Bourgognon, PhD, PharmD, Healthcare Analyst for GlobalData.

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"The adjuvant and neoadjuvant settings of the HER2-positive market are expected to emerge as the main growth drivers of sales, which are forecasted to reach $4.96bn in 2025."

Many drugs, however, have failed to prove their clinical efficacy over existing therapies. The adjuvant and neoadjuvant settings are, therefore, anticipated to remain an exclusive market for anti-HER2 monoclonal antibodies (mAbs) providing a lucrative opportunity for the development of biosimilars.

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By the end of 2017, a new HER2-positive breast cancer setting is expected to be created with the launch of Puma Biotechnology’s neratinib in the extended adjuvant setting. The space is currently an immature and under-utilised setting and has strong potential for future growth as more companies launch new products.

The HER2-positive disease is one of the most aggressive forms of breast cancer. Although existing therapies increase the life expectancy of patients, they have failed to deliver benefits to patients with conditions such as brain metastases.

A number of pipeline agents, including tyrosine kinase inhibitors (TKIs) neratinib and tucatinib, and HER2-targeting mAb, margetuximab, are currently under development to serve this underserved patient population. Innovative therapies that serve the unmet needs of the TKI-resistant HER2-positive disease will also be required, the report adds.