HER2 Therapy Market

HER2 Therapy Market Overview

The HER2 therapy market is estimated to be worth $8.9 billion in 2021 and is expected to grow at CAGR of 12% during the forecast period.

Human epidermal growth factor receptor 2 (HER2), a member of human epidermal growth factor receptor family, plays an important role in the development and progression of various types of cancers, especially breast cancer. Over time, it has been found to be an important target for the drug therapies intended for treating various types of breast cancer. HER2 targeting therapies have shown to be a promising treatment option, capable of preventing tumor cells from evading immune surveillance. In 1998, the FDA approved the first HER2 targeting monoclonal antibody, called Herceptin® (trastuzumab) for the treatment of metastatic breast cancer. Later, in 2006, the drug got approved for HER2 positive early breast cancer. Following its success in treating breast cancer, significant efforts were made to evaluate its potential in other conditions involving HER2 alterations, such as overexpression, amplifications and other mutations.

Eventually in 2010, the drug got FDA approval for HER2 positive metastatic stomach cancer as well.  In addition to Herceptin, more than five drugs have been approved and about 70 candidates are under development for breast cancer, HER2-positive biliary tract, colorectal, non-small-cell lung and gastric cancers. Further, combinatorial studies of HER2 targeting therapeutics along with immune checkpoint inhibitors have also shown positive results across various disease indications.

Presently, several companies, including well-established players and new entrants, are actively engaged in developing the HER2 targeting therapies for a wide variety of disease indications. Innovation in this field is mostly focused on improving the therapeutic efficacy and safety, and overall survival rate. The research activity has gained significant attention from private and public investors, which have extended their financial support to capable developer companies. The market has also witnessed substantial partnership activity over the last few years. Driven by the success of the currently available drugs / HER2 targeted therapy products and the encouraging clinical trial results, the market is poised to witness healthy market growth as multiple late stage drugs get approved and marketed over the forecast period.

Key Companies in HER2 Therapy Market

Examples of key companies engaged in HER2 therapy market (which have also been profiled in this market report; the complete list of companies is available in the full report) include AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, MacroGenics, Pfizer, Puma Biotechnology, Roche, Seagen (previously Seattle Genetics), Triumvira Immunologics and Zymeworks. This market report includes an easily searchable excel database of all the companies developing drugs targeting HER2 , worldwide.

Recent Developments in HER2 Therapy Market:

Several recent developments have taken place in the field of HER2 therapy market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In April 2026, Radiopharm Theranostics presented early Phase I HEAT trial data for its HER2 targeted radiopharmaceutical 177Lu RAD202 in advanced HER2 positive breast and urothelial cancers.
• In March 2026, AstraZeneca and Daiichi Sankyo announced that the FDA accepted the supplemental Biologics License Application and granted priority review for trastuzumab deruxtecan as adjuvant therapy in HER2 positive early breast cancer with residual disease.

Scope of the Report

The “HER2 Therapy Market, 2021-2031” market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities for the HER2 therapy market. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in HER2 therapy market.

In addition to other elements, the market research report includes:

• A detailed review of the current market landscape of HER2 targeting therapies, including analyses based on several parameters, such as current status of development (marketed, clinical, pre-clinical and discovery), phase of development (phase III, phase II/III, phase II, phase I/II and phase I) of lead candidates, type of molecule (biologic and small molecule), type of biologic (antibody drug conjugate, bispecific antibodies, CAR-T cell therapy, monoclonal antibodies, vaccines and others), type of therapy (monotherapy, combination therapy and both), target disease indication, target therapeutic area and route of administration (intravenous, intradermal, oral and others).
• A detailed analysis of completed, ongoing and planned clinical trials of HER2 targeting therapies, highlighting prevalent trends across various relevant parameters, such as trial registration year, trial phase, trial recruitment status, enrolled patient population, study design, leading industry sponsors / collaborators (in terms of number of trials conducted), trial focus, target therapeutic area, popular indications and regional distribution of trials.
• Elaborate profiles of the companies developing HER2 targeting therapies. Each profile features a brief overview of the company, details on its product portfolio, and recent developments and an informed future outlook.
• An in-depth analysis of grants awarded to various research institutes for projects related to HER2 targeting therapies, in the period between 2018 and 2021 (till March), on the basis of several parameters, such as year of award, amount awarded, funding institute center, support period, type of grant application, purpose of grant award, activity code, focus area, responsible study section, popular NIH departments, prominent program officers and type of recipient organizations. In addition, it highlights the geographical distribution of recipient organizations.
• An analysis of the partnerships established between various stakeholders in HER2 therapy market , during the period 2017-2021, covering R&D agreements, licensing agreements (specific to affiliated technology platforms and product candidates), product development and commercialization agreements, clinical trial agreements, manufacturing agreements, mergers and acquisitions, manufacturing agreements and other relevant types of deals. 
• A case study on HER2 targeting biosimilars, including a review of the current market landscape of HER2 targeting biosimilar molecules, and a detailed analysis based on several parameters, such as parent drug, phase of development and target disease indications. The chapter also provides information on the companies involved in the development of these HER2 targeting biosimilars.
• A case study on companion diagnostic tests developed / being developed for various HER2 targeting drug candidates, including a detailed analysis based on commercial availability, assay technique used, corresponding drug candidate and target disease indication. In addition, the chapter provides information on the companies engaged in the development of companion diagnostics for HER2 targeting drug candidates.

The key objective of HER2 therapy market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for HER2 therapy market during the forecast period. Based on multiple parameters, such as disease prevalence, anticipated adoption rates and likely selling price of HER2 targeting therapies, we have provided informed estimates on the evolution of the market for the forecast period 2021-2031. The market report also features the likely distribution of the current and forecasted opportunity across [A] different target indications (breast cancer, gastric cancer head and neck cancer and lung cancer) [B] type of molecule (small molecule and biologic), [C] type of therapy (monotherapy, combination therapy and both), [D] route of administration (intravenous and oral) and [E] key geographical regions (US, Europe, Asia-Pacific, Middle East and North Africa and Latin America). To account for the future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.  

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in the market research report are in USD, unless otherwise specified.