PUBLISHER: Grand View Research | PRODUCT CODE: 1701376
PUBLISHER: Grand View Research | PRODUCT CODE: 1701376
The global herceptin market size is anticipated to reach USD 4.10 billion by 2030 and is projected to grow at a CAGR of 5.5% from 2025 to 2030, according to a new report by Grand View Research, Inc. The key driver of the Herceptin market is its established efficacy in treating HER2-positive cancers, particularly breast and gastric cancers. As one of the earliest and most successful targeted therapies, Herceptin revolutionized the treatment paradigm by directly inhibiting the HER2 receptor, halting tumor growth, and activating immune-mediated cytotoxicity. Its inclusion as a standard-of-care therapy in both early-stage and metastatic settings continues to anchor its global demand. Herceptin's role in combination regimens-especially with chemotherapy and newer HER2-targeted agents like pertuzumab-further boosts its therapeutic relevance. Approvals in neoadjuvant and adjuvant contexts have expanded its patient base, while real-world evidence continues to support its long-term survival benefits.
However, Herceptin's market has undergone significant transformation due to the expiration of key patents-in the U.S. (2019) and Europe (2014)-which has opened the door to a wave of biosimilar competition. This shift has led to intense pricing pressures and reduced exclusivity for the originator product, especially in price-sensitive markets. In response, Roche has implemented lifecycle management strategies, including the development of a subcutaneous (SC) formulation and the co-formulated fixed-dose combination Phesgo (pertuzumab + trastuzumab SC), aimed at improving convenience, reducing administration time, and maintaining patient loyalty. These innovations not only enhance healthcare efficiency but also offer a competitive edge against biosimilars in clinical practice.
The biosimilar landscape for trastuzumab is robust and rapidly expanding, with multiple players such as Pfizer, Amgen, Biocon Biologics, Samsung Bioepis, and Celltrion securing approvals across global markets. The growing adoption of trastuzumab biosimilars in both high-income and emerging regions has democratized access to HER2-targeted therapy, significantly lowering treatment costs. While this benefits healthcare systems and patients, it also presents market share erosion risks for Roche's branded Herceptin. Regulatory authorities worldwide have supported biosimilar adoption through clear interchangeability guidelines and incentivized procurement models, further accelerating their uptake. The increasing number of country-specific biosimilars in regions like India, China, and Latin America is intensifying competition, especially where cost containment is a priority.
Despite these headwinds, opportunities remain strong in the Herceptin market through expanding indications, strategic partnerships, and regional growth. The uptake of SC Herceptin and Phesgo in outpatient and community settings is poised to grow, particularly as healthcare systems seek more efficient delivery options. Additionally, the inclusion of trastuzumab in combination regimens with immune checkpoint inhibitors, such as pembrolizumab in HER2-positive gastric cancer, is opening new frontiers for its use. These novel combinations are being evaluated in clinical trials and could expand Herceptin's role beyond traditional HER2-positive indications. Furthermore, rising awareness, increasing screening rates, and improving access to diagnostics in low-to-middle-income countries are expected to fuel volume growth, even if unit prices decline due to biosimilar competition.
Looking ahead, the Herceptin market will likely stabilize at a new equilibrium, where originator and biosimilar coexistence is the norm. Roche's strategic pivot toward value-added products and real-world outcomes data will be critical in retaining market presence. Meanwhile, biosimilar manufacturers are poised to benefit from scale, cost leadership, and local partnerships, which will help them penetrate underserved markets. Emerging delivery innovations and digital treatment monitoring tools may also enhance trastuzumab's utility in evolving care models. Overall, while Herceptin may no longer dominate in terms of exclusivity or pricing power, it will continue to play a pivotal role in HER2-targeted oncology, especially as part of broader combination strategies and integrated care solutions.