HER2-Positive Breast Cancer Market to Increase Substantially

Spending on treatments for human epidermal growth factor receptor type 2 (HER2)-positive breast cancer is projected to increase from $6.4 billion in 2015 to $9.89 billion by 2025 across 8 major countries, according to a report from GlobalData

The 4.4% annual growth rate for these treatments is being driven by markets in the United States, France, Germany, Italy, Spain, the UK, Japan, and China.

The investigators found that adjuvant and neoadjuvant treatments are driving the increasing sales of the drugs, with projections reaching $4.96 billion by 2025, according to GlobalData. These treatments alone represent half of the total market.

The authors indicate that the increase in market size will be driven by the pending launch of pertuzumab (Perjeta). This treatment is likely to increase adjuvant treatment duration compared with the neoadjuvant setting, according to the report.

Additionally, the launch of pertuzumab would reduce a dip in revenue related to the emergence of biosimilars to trastuzumab (Herceptin), since pertuzumab is to be used in combination with trastuzumab.

“The dynamism of the adjuvant and neoadjuvant markets has prompted many companies to position their products in these settings,” said Max Bourgognon, PhD, PharmD, healthcare analyst for GlobalData. “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 (mAbs), hence constituting the most lucrative opportunity for biosimilar developments.”

The authors also reported that the launch of nertatinib will create a novel treatment setting within the disease space. The drug is expected to receive FDA approval by the end of 2017 in the extended adjuvant setting, which is not currently utilized for the treatment of HER2-positive breast cancer, according to the study. The investigators expect the approval to lead to additional growth in this underutilized area.

“Although the efficacy of HER2-targeted therapies substantially improves the life expectancy of patients with HER2-positive disease, it is by nature one of the most aggressive forms of breast cancer, with a poorer prognosis and worse outcomes than for patients with HER2-negative (and HR-positive) disease,” Dr Bourgognon said.

While the market is growing, the investigators state that additional therapies are necessary, especially those that can effectively treat aggressive, metastatic HER2-positive disease, according to the study. These factors may play a role in increasing the market.

“HER2-targeting mAbs, for example, have failed to deliver benefits to patients with brain metastases, because they cannot pass the blood-brain barrier,” Dr Bourgognon said. “There are numerous pipeline agents that look to target this underserved patient population, notably the tyrosine kinase inhibitors (TKIs) neratinib and tucatinib, as well as the HER2-targeting mAb margetuximab. However, resistance to kinase inhibitors is common, so innovative therapies to treat TKI-resistant HER2-positive disease will also be required.”