HER2 Low Cancers Market: Epidemiology, Therapies, Companies, DelveInsight

HER2 Low Cancers Market, DelveInsight

HER2 Low Cancers treatments such as ENHERTU, DATROWAY (datopotamab deruxtecan), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), DB-1303, BNT323 (trastuzumab pamirtecan), Eftilagimod alpha (IMP321), Ifinatamab deruxtecan, BB-1701, ZIIHERA (zanidatamab), and others are anticipated to significantly drive the HER2 Low Cancers Market over the forecast period.

DelveInsight has introduced its latest publication, “HER2 Low Cancers - Market Insights, Epidemiology, and Market Forecast-2034,” offering a comprehensive evaluation of HER2 Low Cancers, including historical and projected epidemiology along with detailed market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

Discover more about the HER2 Low Cancers market report  https://www.delveinsight.com/report-store/her2-low-cancers-market-forecast?utm_source=apac&utm_medium=pressrelease&utm_campaign=akpr 

Key Highlights from the HER2 Low Cancers Market Report:

As of 2024, the HER2-low cancer market in the United States was valued at nearly USD 1.6 billion, the highest among the 7 major markets (7MM), and is expected to witness robust growth through 2034.

In April 2025, Allogene’s dual-targeted allogeneic CAR-T therapy ALLO-329 (CD19/CD70) received FDA Fast Track Designation for refractory HER2 Low Cancers, including dermatomyositis, necrotizing myopathy, and anti-synthetase syndrome, along with lupus and scleroderma. The therapy is projected to initiate its Phase I RESOLUTION study by mid-2025, with proof-of-concept data anticipated by the end of the year.

In January 2025, RESTEM’s umbilical cord-derived stem cell therapy Restem-L obtained FDA Fast Track and Orphan Drug Designation for polymyositis and dermatomyositis. Early Phase I findings demonstrated 78% clinical improvement and a 35% reduction in steroid use. A Phase II/III trial (IIMPACT) is planned for Q1 2025.

Within the 7MM, breast cancer represents the largest share of HER2-low cases, followed by colorectal cancer, while ovarian cancer accounts for the smallest proportion. As the global population ages, breast cancer prevalence in older individuals continues to rise, and HER2-low tumors now constitute more than half of conventional breast cancer diagnoses.

Until 2022, HER2-low patients were generally treated similarly to HER2-negative patients, primarily with chemotherapy or endocrine therapy, particularly in HR-negative disease. A major milestone occurred in August 2022 when the FDA approved ENHERTU (trastuzumab deruxtecan) for HER2-low breast cancer based on the DESTINY-Breast04 trial. This landmark approval validated HER2-low as a distinct therapeutic target and paved the way for further advancements and earlier-line treatment strategies.

The HER2-low classification is also being explored across additional solid tumors, including gastric and urothelial cancers, thereby broadening its clinical significance. Key industry players in this dynamic space include AstraZeneca and Daiichi Sankyo (DATROWAY), Pfizer (disitamab vedotin), Gilead Sciences (TRODELVY), Duality Biologics and BioNTech (DB-1303/BNT323), Bliss Biopharmaceutical (BB-1701), and Merck and Daiichi Sankyo (ifinatamab deruxtecan).

Pipeline candidates targeting HER2-low cancers encompass TROP2-directed ADCs such as TRODELVY and DATROWAY, bispecific antibodies like zanidatamab, and immunotherapies including eftilagimod alpha, notable for its subcutaneous administration that enables at-home treatment and improved patient convenience.