The HER2 therapy market is expected to reach USD 441 million in 2021 and anticipated to grow at a CAGR of 8% during the forecast period 2021-2030.

Human epidermal growth factor receptor 2 (HER2), part of the human epidermal growth factor receptor family, plays a crucial role in the development and progression of various cancers, particularly breast cancer. It has become a significant focus for therapeutic interventions aimed at addressing different forms of breast cancer. Treatments targeting HER2 have shown significant promise in hindering tumor cells’ ability to evade immune detection. A pivotal moment occurred in 1998 when the FDA approved the first HER2-targeting monoclonal antibody, known as Herceptin? (trastuzumab), for treating metastatic breast cancer. Later in 2006, its use was extended to early-stage HER2-positive breast cancer. This success prompted extensive research into its effectiveness in other conditions characterized by HER2 alterations, such as overexpression, amplifications, and mutations. In 2010, FDA approval was granted for HER2-positive metastatic stomach cancer. Apart from Herceptin, regulatory authorities have authorized over five drugs, with approximately 70 candidates in different developmental stages for various cancers including breast cancer, HER2-positive biliary tract, colorectal, non-small-cell lung, and gastric cancers. Additionally, studies combining HER2-targeting therapeutics with immune checkpoint inhibitors have shown promising results across different disease indications.

Currently, numerous entities, including established companies and emerging players, are actively engaged in developing HER2-targeting therapies tailored for various disease indications. The primary focus of innovation in this field revolves around enhancing therapeutic effectiveness, improving safety profiles, and increasing overall survival rates. Research efforts in this area have garnered significant attention and financial support from both private and public investors, supporting capable developer companies. Furthermore, the market has witnessed substantial collaborative initiatives in recent years. With the successes of existing drugs and HER2-targeted therapy products, along with promising outcomes from clinical trials, the market is poised for substantial growth. Anticipated approvals and subsequent market entries of multiple late-stage drugs are expected to drive this growth in the foreseeable future.

Report Coverage

  • The report comprehensively examines the HER2 Therapy market, focusing on the route of administration, therapy type, molecule type, targeted disease indication, and geographic considerations.
  • Analysis within the report delves into various factors, such as drivers, restraints, opportunities, and challenges impacting market growth.
  • It evaluates potential advantages and obstacles present in the market, providing insights into the competitive landscape for leading market players.
  • Revenue forecasts are provided for market segments across five major regions.
  • A detailed examination of the current market landscape concerning HER2-targeting therapies is conducted. This includes analysis across multiple parameters such as developmental status, developmental phase, molecular type, biologic subtype, therapy type, targeted disease indication, therapeutic area, and administration route.
  • The report offers a thorough analysis of completed, ongoing, and planned clinical trials for HER2-targeting therapies, highlighting trends across various parameters such as trial registration year, phase, patient population, study design, and regional distribution of trials.
  • Elaborate company profiles engaged in developing HER2-targeting therapies encompass a company overview, product portfolio details, recent developments, and future outlook.
  • In-depth analysis of grants awarded to research institutes for HER2-targeting therapy projects between 2018 and 2021, focusing on parameters like award year, funding amount, grant purpose, and geographical distribution.
  • Examination of partnerships established between stakeholders in the HER2 therapy market between 2017 and 2021, covering various agreements and collaborations.
  • Case studies on HER2-targeting biosimilars and companion diagnostic tests, reviewing the market landscape, developmental phases, target disease indications, and involved companies in their development.


Key Market Companies

  • AstraZeneca
  • Boehringer Ingelheim
  • GlaxoSmithKline
  • MacroGenics
  • Pfizer
  • Puma Biotechnology
  • Roche
  • Seagen (previously Seattle Genetics)
  • Triumvira Immunologics
  • Zymeworks