United States Herceptin Market By Product, By Application, By Distribution Channel, By Region, Competition, Forecast & Opportunities, 2020-2030F

The United States Herceptin Market was valued at USD 1.32 billion in 2024 and is projected to reach USD 1.74 billion by 2030, growing at a CAGR of 4.66%. The market is advancing steadily due to rising cases of HER2-positive breast and gastric cancers, for which trastuzumab remains a key therapeutic agent. Greater awareness of cancer, improved diagnostic practices, and early screenings have expanded the patient base eligible for Herceptin. Oncologists continue to rely on monoclonal antibody therapies, supported by clinical efficacy and survival data, reinforcing Herceptin's role in frontline and adjuvant settings. Strong insurance support and structured healthcare infrastructure further enable access to treatment. Notably, the market is undergoing a transformation with the increasing presence of trastuzumab biosimilars, making therapies more affordable and accessible. Combination treatments and precision medicine approaches are also being adopted, while pharmaceutical firms engage in value-based contracts to maintain access despite rising cost pressures.

Key Market Drivers

Rising Prevalence of HER2-Positive Cancers

The growth of the United States Herceptin market is closely tied to the increasing prevalence of HER2-positive cancers and advancements in precision oncology. HER2 plays a pivotal role in tumor aggressiveness, and its identification has become essential for treatment planning. According to SEER, HER2-positive subtypes account for roughly 13.6% of all female breast cancer cases in the U.S., representing a significant need for targeted treatments like Herceptin. With breast cancer being the most diagnosed cancer globally, there is a strong demand for HER2-directed therapies. Routine HER2 testing and the integration of Herceptin in first-line and adjuvant therapy strategies continue to drive its utilization across clinical settings.

Key Market Challenges

Patent Expiry and Growing Biosimilar Competition

A major challenge confronting the United States Herceptin market is the expiration of Herceptin's primary patents in 2019, leading to an influx of FDA-approved biosimilars such as Kanjinti, Ogivri, Trazimera, Herzuma, and Ontruzant. These alternatives offer comparable safety and efficacy at reduced costs, generating pricing pressure and compelling the originator to adopt discounting strategies to retain market share. By 2023, biosimilars represented over 60% of trastuzumab prescriptions in large U.S. oncology networks. Favorable policies by payers and procurement departments have promoted biosimilar use, and growing physician confidence backed by real-world data has accelerated the shift. As biosimilar producers scale up manufacturing and distribution, Herceptin's dominance is increasingly challenged in a cost-sensitive healthcare environment.

Key Market Trends

Shift Toward Combination and Sequential Therapies

An emerging trend in the United States Herceptin Market is the pivot toward combination and sequential therapies to improve outcomes in HER2-positive cancers. Herceptin, once primarily used as monotherapy, is now widely used in conjunction with monoclonal antibodies, small molecule inhibitors, and antibody-drug conjugates. Clinical data show that combinations such as Herceptin with pertuzumab and docetaxel in metastatic breast cancer significantly enhance progression-free and overall survival. These findings are being incorporated into key oncology guidelines, influencing broader adoption of multidrug regimens to combat resistance and improve patient prognosis.

Key Market Players

• Roche Holding AG
• Pfizer Inc.
• Samsung Bioepis Co., Ltd.
• Amgen Inc.
• Celltrion Healthcare Co., Ltd.
• Biocon Limited
• Mylan N.V. (Viatris)
• Prestige Biopharma
• Shanghai Henlius Biotech, Inc.
• Dr. Reddy's Laboratories

Report Scope:

In this report, the United States Herceptin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

United States Herceptin Market, By Product:

• Biologic
• Biosimilar

United States Herceptin Market, By Application:

• Breast Cancer
• Stomach/Gastric Cancer
• Others

United States Herceptin Market, By Distribution Channel:

• Hospital Pharmacy
• Specialty Pharmacy
• Others

United States Herceptin Market, By Region:

• North-East
• Mid-West
• West
• South

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the United States Herceptin Market.

Available Customizations:

United States Herceptin Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).