The HER2+ breast cancer market is expected to experience low growth from $10.4bn in 2020 to $12.1bn in 2030 across the eight major markets (8MM*) at a compound annual growth rate (CAGR) of 1.5%, according to GlobalData. The leading data and analytics company notes that growth will be driven by the anticipated launch of five pipeline agents, label expansions of marketed agents in earlier settings and greater market access across the 8MM for premium priced agents.

GlobalData’s latest report, ‘HER2+ Breast Cancer – Global Drug Forecast and Markey Analysis to 2030’, notes that the main barriers for market growth are patent expiries and biosimilar erosion of leading brands such as Herceptin, Perjeta and Kadcyla.

Adam Pearson, PhD, Senior Oncology and Hematology Analyst at GlobalData, comments: “HER2+ breast cancer patients have benefited immensely from the innovation of HER2-directed therapeutics, which have been introduced in both the early and metastatic settings of the treatment paradigm.

“The current and upcoming patient expiries of the three leading brands in the space, Herceptin, Perjeta and Kadcyla, and the subsequent availability of biosimilars will represent the biggest barrier to market growth over the forecast period. Roche/Genentech, who market these agents, are strategizing to reduce the impact of biosimilar erosion with the development of sub-cutaneous reformulations of Herceptin and Perjeta. These reformulations provide more convenience for physicians and patients and will help curb the impact of biosimilar erosion of Roche/Genentech’s blockbusters.”

Despite significant progress in the treatment of HER2+ breast cancer, unmet needs remain in the market. Key opinion leaders interviewed by GlobalData highlight the need to improve curative outcomes for patients by moving effective therapies into earlier lines of therapy and further development and clinical utilization of antibody-drug conjugates (ADCs).

Dr Pearson continues: “While there is still an emphasis on improved treatment options, in particular curative interventions and treatment of patients with brain metastases, there is also an emphasis on patient quality of life. Other notable unmet needs include the need to stratify patients based on their specific molecular profile and how to effectively treat intratumor heterogeneity. Potential strategies to improve curative outcomes include label expansions of effective therapies for treating brain metastases, such as Seagen’s Tukysa, into earlier lines of therapy to reduce the chance of recurrence in the brain. Further hopes lie in the additional development and use of antibody-drug conjugates across multiple lines of therapy.”

Five novel pipeline agents are forecast to enter the market in the period to 2030 and label expansions of currently marketed drugs are positioned to change clinical practice.

Dr Pearson adds: “The benefit observed in the Phase III DESTINY-Breast03 trial, comparing Enhertu to Kadcyla in the second line metastatic setting, will transform the treatment paradigm in the metastatic setting. The potential to displace Kadcyla in the second-line setting is potentially blockbuster-enabling for AstraZeneca and Daiichi who are seeking further label expansions in the adjuvant setting (DESTINY-Breast05), which may further threaten Kadcyla’s position in the treatment paradigm.

“Further competition derives from the development of antibody-drug conjugates such as trastuzumab duocarmazine and disitamab vedotin in the HER2+ space. KOLs highlight the impressive preliminary efficacy data from Byondis’ trastuzumab duocarmazine, which harbors a novel payload and may enter the market from 2022, contingent on demonstrable efficacy. Seattle Genetics, an established player in the HER2+ space, has also invested in the ADC market, in a $2.6bn licensing agreement to market RemeGen’s disitamab vedotin outside of Asia. GlobalData expects the ADC market to grow over the next decade and HER2+ breast cancer to remain at the heart of innovation for this modality.”

* 8MM = US, France, Germany, Italy, Spain, UK, China and Japan.