Driven by the anticipated launches of 5 pipeline agents and the label expansions of currently marketed drugs, theHER2-postive breast cancer market is expected to experience low growth from 2020 to 2030.
Driven by the anticipated launches of 5 pipeline agents and the label expansions of currently marketed drugs, theHER2-postive breast cancer market is expected to experience low growth from 2020 to 2030, according to a report by data and analytics company GlobalData. The market is estimated to rise at a compound annual growth rate of 1.5%, from $10.4 billion to $12.1 billion, across the 8 major markets of the United States, France, Germany, Italy, Spain, the United Kingdom, China, and Japan.1
“The current and upcoming patent expiries of the 3 leading brands in the space, [trastuzumab] Herceptin, [pertuzumab] Perjeta and [trastuzumab emtansine; T-DM1] Kadcyla, and the subsequent availability of biosimilars will represent the biggest barrier to market growth over the forecast period,” Adam Pearson, PhD, Senior Oncology and Hematology Analyst at GlobalData, in a press release. “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.”
The patent for trastuzumab, a HER2/neu receptor antagonist indicated for the treatment of patients with HER2-overexpressing breast cancer, has already expired in both the US and Europe, in August 2015 and June 2019, respectively.2,3
Pertuzumab, a HER2/neu receptor antagonist, is indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior antiHER2 therapy or chemotherapy for metastatic disease. The patent for pertuzumab is set to expire in May 2023 in Europe and June 2024 in the US.3,4
T-DM1, a HER2-targeted antibody and microtubule inhibitor conjugate, is currently indicated as a single agent in the second line setting for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. It’s also indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. The patent expiry date for T-DM1 in Europe was June 2020. The patent is set to expire in September 2026 in the US.3,5
“The potential to displace T-DM1 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 T-DM1’s position in the treatment paradigm,” Pearson noted in a press release, noting the successes reported with fam-trastuzumab deruxtecan-nxki (Enhertu) in the phase 3 DESTINY-Breast03 trial (NCT03529110).1
Investigators of DESTINY-Breast03 compared trastuzumab deruxtecan with the standard of care T-DM1 in patients with previously treated HER2-positive metastatic breast cancer. Data from the trial showed that the median progression-free survival was not reached (95% CI, 18.5-not estimable) in the 261 patients in the trastuzumab deruxtecan arm vs 6.8 months (95% CI, 5.6-8.2) among the 263 patients treated with T-DM1. No drug-related deaths occurred in either arm and the incidence of grade 3/4 drug-related treatment-emergent adverse effects were similar in both arms, 45.5% with trastuzumab deruxtecan vs 39.8% with T-DM1.6
The report noted that the main obstacles for market growth include patent expiries and biosimilar erosion of leading brands. Further, investigators also identified a need to continue moving effective therapies into earlier lines of treatment and to further the clinical utilization of antibody-drug conjugates (ADCs) to improve curative outcomes for patients.
“Further competition derives from the development of ADCs such as trastuzumab duocarmazine and disitamab vedotin in the HER2-positive space,” Pearson said. “Key opinion leaders 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. GlobalData expects the ADC market to grow over the next decade and HER2-positive breast cancer to remain at the heart of innovation for this modality.”