Herceptin Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Biologic, Biosimilar), By Application (Breast Cancer, Stomach/Gastric Cancer, Others), By Distribution Channel (Hospital Pharmacy, Specialty Pharmacy, Others), By Region and Competition, 2020-2030F

Market Overview

Global Herceptin Market was valued at USD 3.51 Billion in 2024 and is expected to reach USD 4.92 Billion in the forecast period with a CAGR of 5.77% through 2030. The Global Herceptin Market is experiencing robust momentum driven by the rising incidence of HER2-positive breast and gastric cancers. Herceptin (trastuzumab), a monoclonal antibody therapy, continues to play a central role in targeted cancer treatment. The widespread adoption of precision medicine and increased awareness among oncologists about HER2 testing are supporting greater use of trastuzumab in both early-stage and metastatic cancer cases. Strong clinical evidence supporting its efficacy in improving survival rates and delaying disease progression is further reinforcing its demand. Increasing healthcare spending, improved diagnostic capabilities, and integration of trastuzumab into standardized treatment protocols are key contributors to market expansion across both public and private healthcare systems.

Current market trends include the growing shift toward combination therapies that enhance the therapeutic effectiveness of trastuzumab by pairing it with chemotherapeutic agents or other biologics. The launch of subcutaneous formulations is improving patient compliance by reducing hospital visits and infusion times. Another significant trend is the expanding role of trastuzumab biosimilars, which are contributing to cost savings and increasing accessibility without compromising clinical outcomes. As biosimilar adoption grows, competition is intensifying, pushing originator brands to focus on lifecycle management strategies. Efforts to personalize HER2 treatment through advanced diagnostic tools and companion diagnostics are also reshaping clinical decisions and boosting market adaptability.

The market faces several challenges that could constrain growth. Patent expirations and the rise of biosimilar competitors are exerting pricing pressure on branded Herceptin products, impacting revenue potential for manufacturers. Limited reimbursement frameworks and cost barriers in lower-income settings restrict access to HER2-targeted therapies for a broader patient population. The emergence of newer-generation HER2-targeted drugs, including antibody-drug conjugates and dual-targeting therapies, is gradually shifting prescriber preference away from trastuzumab monotherapy. Logistical issues related to cold chain storage and the need for continuous HER2 testing infrastructure further complicate implementation in underdeveloped regions. Regulatory complexities and delays in biosimilar approvals across certain markets also create roadblocks for market penetration, making sustained innovation and competitive pricing essential for long-term growth.

Key Market Drivers

Rising Prevalence of HER2-Positive Cancers

​The rising prevalence of HER2-positive cancers is a key driver propelling the growth of the Global Herceptin Market. HER2, or human epidermal growth factor receptor 2, is a protein that promotes the growth of cancer cells, and its overexpression is observed in a significant subset of breast and gastric cancers. This biomarker has become critical in cancer diagnostics, enabling more targeted and effective treatment approaches. With breast cancer being the most commonly diagnosed cancer globally, accounting for approximately 2.3 million new cases in 2022 according to the World Health Organization (WHO), the number of patients eligible for HER2-targeted therapies like Herceptin continues to expand. In the United States, data from the Surveillance, Epidemiology, and End Results (SEER) Program indicates that HER2-positive subtypes, including HR+/HER2+ and HR-/HER2+, constitute approximately 13.6% of all female breast cancer cases. In addition to breast cancer, HER2-positive gastric and gastroesophageal junction (GEJ) cancers are on the rise, particularly in regions such as East Asia and Eastern Europe, where lifestyle and genetic factors contribute to higher incidence rates.​

Advances in diagnostic technologies have improved the detection of HER2 status, leading to more widespread and accurate identification of patients who can benefit from targeted therapies. Oncologists are increasingly integrating HER2 testing as a standard practice in cancer diagnostics, supported by updated clinical guidelines and increased awareness among healthcare providers. This has resulted in a larger diagnosed patient pool eligible for Herceptin-based regimens. With its proven efficacy in improving progression-free and overall survival, Herceptin has become a cornerstone in treatment protocols for HER2-positive cancers. The expanding patient base and integration of Herceptin into early-line treatment regimens for multiple cancer types significantly enhance its market demand. The rising trend of combination therapies, involving trastuzumab with chemotherapy or immunotherapy, further strengthens its clinical relevance. As cancer incidence continues to climb globally and HER2 testing becomes more accessible, the demand for Herceptin is expected to rise steadily, positioning this biologic therapy as a critical component in the evolving oncology landscape.

Favorable Government Initiatives and Reimbursement Policies

Favorable government initiatives and reimbursement policies are significantly contributing to the expansion of the Global Herceptin Market. In many developed countries, public healthcare systems cover the full or partial cost of trastuzumab, reducing out-of-pocket expenses and ensuring greater accessibility for patients. In the United States, Medicare covers trastuzumab under Part B for eligible oncology indications, improving affordability for elderly and disabled populations. In Canada, provincial health plans include Herceptin in their reimbursement lists for breast and gastric cancers, supporting uniform access across regions. The National Health Service (NHS) in the United Kingdom also provides Herceptin free of cost for patients meeting clinical criteria, underscoring strong institutional support for this biologic treatment. These reimbursement frameworks play a crucial role in improving early diagnosis-to-treatment transitions, encouraging physicians to incorporate trastuzumab into standard care protocols.

Governments in emerging economies are also adopting measures to enhance access to high-cost oncology drugs. India’s Ministry of Health and Family Welfare, for instance, has facilitated the availability of biosimilar trastuzumab at lower prices through centralized procurement and inclusion under national cancer care programs. In Brazil, the Unified Health System (SUS) covers trastuzumab for eligible patients, helping reduce the economic burden of treatment for HER2-positive cancers. China's National Healthcare Security Administration (NHSA) included trastuzumab and its biosimilars in its National Reimbursement Drug List (NRDL), resulting in price negotiations that improved patient access. According to NHSA reports from 2023, such negotiations have led to up to 60% cost reductions for some oncology biologics, including trastuzumab. These efforts have encouraged widespread treatment adoption, improved survival outcomes, and catalyzed market growth. As governments continue prioritizing oncology care through drug coverage expansions, pricing negotiations, and public-private partnerships, the global Herceptin market is expected to witness sustained momentum. The alignment of health policy with access objectives is reinforcing trastuzumab’s role in cancer therapy on a global scale.

Development of New Formulations

The development of new formulations is significantly driving the growth of the Global Herceptin Market. Pharmaceutical innovations have led to the introduction of more patient-centric versions of trastuzumab, including subcutaneous (SC) formulations, which offer greater convenience, reduced administration time, and improved patient compliance compared to the traditional intravenous (IV) versions. These innovations have transformed the treatment landscape by minimizing the burden on healthcare facilities and reducing the time patients spend in clinical settings. For instance, subcutaneous trastuzumab can be administered in approximately 2–5 minutes compared to the 30–90 minutes required for IV infusion, allowing for more efficient use of healthcare resources.​

The development of fixed-dose combinations, such as trastuzumab with pertuzumab in a single subcutaneous injection, has also gained momentum. These combinations enhance therapeutic efficacy while improving the overall patient experience. In 2020, the U.S. Food and Drug Administration (FDA) approved Phesgo, a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for subcutaneous use, marking a significant advancement in breast cancer treatment. This approval was based on the pivotal phase III FeDeriCa study, which demonstrated that Phesgo produced non-inferior levels of pertuzumab and trastuzumab in the blood compared to IV administration, with comparable efficacy and safety profiles. The European Commission also approved Phesgo in December 2020 for the treatment of early and metastatic HER2-positive breast cancer. These regulatory approvals have contributed to greater adoption across oncology practices and accelerated uptake in both developed and emerging markets.​

New formulations have also shown strong potential in addressing resistance to trastuzumab monotherapy. Research and development are ongoing to design next-generation antibody-drug conjugates and biosimilars with modified structures that offer enhanced stability, targeted delivery, and reduced side effects. These innovations expand therapeutic options and reinforce Herceptin’s position as a foundational therapy in HER2-positive cancer treatment. By improving delivery mechanisms, extending patient access, and enhancing therapeutic value, the evolution of trastuzumab formulations plays a pivotal role in shaping the future trajectory of the Herceptin market and driving sustained global demand.

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Key Market Challenges

Patent Expiry and Growing Biosimilar Competition

The patent expiry of Herceptin has triggered a significant shift in the competitive landscape of the global market. As the exclusivity period ended in key regions such as the United States and the European Union, several biosimilar versions of trastuzumab have entered the market, intensifying price competition and eroding the brand’s market share. Biosimilars, which are highly similar to the reference biologic with no clinically meaningful differences, offer a cost-effective alternative for healthcare systems and patients. With multiple players launching biosimilars globally, including large pharmaceutical firms and emerging biotech companies, pricing pressures have become a critical concern for the originator. In countries with strong cost-containment policies or where healthcare budgets are tightly regulated, biosimilars are rapidly adopted due to their affordability, leading to reduced sales volumes of the innovator product.

Healthcare providers and payers are increasingly favoring biosimilars in treatment protocols, particularly when supported by favorable reimbursement policies and procurement frameworks. The market dynamics are further influenced by the successful demonstration of biosimilar efficacy and safety in large-scale clinical studies, which has enhanced physician confidence and supported regulatory approvals. In regions such as Europe, biosimilar penetration has been particularly strong due to strategic policy incentives. As a result, Roche, the manufacturer of Herceptin, faces significant revenue decline and must navigate strategies such as lifecycle management, patient support programs, or shifting focus toward combination therapies and newer biologics. The intensifying competition also limits pricing flexibility and profitability in several mature markets. For manufacturers of the original molecule, the need to differentiate through brand value, clinical outcomes, or next-generation therapies becomes essential. As biosimilars continue to gain ground and regulatory frameworks evolve to support their faster approval, the challenge of maintaining market share in a post-patent environment remains one of the most pressing issues facing the Herceptin market globally.

Adverse Effects and Resistance Concerns

One of the most pressing challenges in the Global Herceptin Market is the issue of adverse effects and the growing concerns regarding resistance among patients undergoing trastuzumab therapy. Herceptin, while being a cornerstone in the treatment of HER2-positive cancers, is associated with several side effects that can impact patient compliance and treatment outcomes. Common side effects include fever, chills, nausea, headaches, and fatigue, which are often manageable but can reduce the quality of life. More severe adverse reactions, such as cardiotoxicity, pose significant clinical concerns. Cardiac dysfunction, especially congestive heart failure, has been documented in a subset of patients receiving Herceptin, particularly when used in combination with anthracyclines. This necessitates continuous cardiac monitoring during treatment, increasing the burden on healthcare systems and patients alike.

Beyond adverse reactions, a critical issue that limits Herceptin’s long-term efficacy is the emergence of resistance. Both primary and acquired resistance mechanisms have been reported, where cancer cells adapt and become less responsive to trastuzumab therapy. Molecular alterations such as the activation of alternative signaling pathways, loss of HER2 expression, or mutations in the PI3K/Akt pathway contribute to this resistance. These biological adaptations diminish the effectiveness of the drug, leading to disease progression despite treatment. Resistance challenges complicate treatment planning, often requiring a shift to second-line or combination therapies, which may not be as well-tolerated or widely accessible. The development of novel HER2-targeted agents is underway, but their availability and integration into standard protocols remain limited in many regions. This ongoing issue not only hampers patient prognosis but also restricts the full therapeutic potential of Herceptin in oncology care. Addressing these challenges requires greater investment in predictive diagnostics, alternative therapeutic strategies, and supportive care mechanisms to enhance treatment tolerability and durability.

Key Market Trends

Shift Toward Combination and Sequential Therapies

​ A growing trend shaping the Global Herceptin Market is the strategic shift toward combination and sequential therapies, aimed at enhancing the efficacy of HER2-targeted treatment while overcoming resistance in HER2-positive cancers. Herceptin (trastuzumab), once used primarily as monotherapy or alongside standard chemotherapy, is now widely incorporated in multi-drug regimens that include other monoclonal antibodies, small molecule inhibitors, and antibody-drug conjugates (ADCs). This trend is largely driven by increasing clinical evidence supporting superior patient outcomes when Herceptin is used in combination approaches. For instance, combining Herceptin with pertuzumab and docetaxel in metastatic breast cancer has been shown to significantly improve progression-free and overall survival, a finding that has been integrated into major oncology treatment guidelines.

Antibody-drug conjugates like trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (Enhertu) have also entered the clinical landscape, leveraging Herceptin’s targeting ability while delivering potent cytotoxic payloads directly to HER2-expressing cells. Sequential therapy strategies, wherein patients receive Herceptin followed by ADCs or tyrosine kinase inhibitors (TKIs), are also becoming standard practice, especially in relapsed or refractory cases. These advancements have expanded Herceptin’s utility from initial-line treatment to a cornerstone role across the treatment continuum.

The National Cancer Institute (NCI) reported in 2023 that approximately 20% of breast cancers diagnosed in the United States are HER2-positive, underscoring the substantial patient population that could benefit from these evolving treatment paradigms. Additionally, data from the U.S. Centers for Disease Control and Prevention (CDC) highlights that breast cancer remains the most diagnosed cancer among women, accounting for over 290,000 new cases in 2023 alone. With HER2-positive subtypes making up a significant portion, the demand for therapies that improve treatment outcomes including Herceptin-based combinations is expected to remain high. This transition toward multi-agent regimens solidifies Herceptin’s continued relevance in precision oncology and fuels market expansion.

Increased Use of Real-World Evidence (RWE)

​The integration of Real-World Evidence (RWE) has become a significant trend in the Global Herceptin Market, influencing clinical decisions, regulatory evaluations, and reimbursement strategies. RWE encompasses data derived from various sources, including electronic health records, insurance claims, patient registries, and observational studies, providing insights into the effectiveness and safety of treatments in routine clinical practice. In the context of Herceptin (trastuzumab), RWE has been instrumental in assessing the comparative performance of the originator drug and its biosimilars. A comprehensive study analyzing data from over 31,000 patients in Japan and global adverse event reports from the World Health Organization’s VigiBase found no significant differences in safety profiles between the original trastuzumab and its biosimilars. This evidence supports the clinical interchangeability of biosimilars, promoting their adoption and contributing to cost savings in healthcare systems. ​

The growing emphasis on RWE is also shaping the development and approval processes of oncology drugs. Health technology assessments increasingly require evidence of real-world effectiveness and value, prompting pharmaceutical companies to invest in post-marketing studies and comparative effectiveness research. This trend ensures that treatments like Herceptin demonstrate not only clinical efficacy in controlled trials but also tangible benefits in everyday clinical settings. The utilization of RWE facilitates a more nuanced understanding of treatment outcomes across diverse patient populations, informing personalized medicine approaches and optimizing therapeutic strategies. As healthcare stakeholders continue to prioritize value-based care, the role of RWE in the Herceptin market is expected to expand, reinforcing its importance in guiding clinical practice and policy decisions.

Segmental Insights

Product Insights

Based on the Product, Biosimilar emerged as the dominant segment in the Global Herceptin Market in 2024. This is due to their growing acceptance as cost-effective alternatives to the reference biologic, trastuzumab. Patent expirations of branded Herceptin in major markets such as the United States, Europe, and Japan opened the gateway for multiple biosimilar entries, leading to increased competition and reduced pricing. Healthcare systems, particularly in developing and cost-sensitive regions, prioritized biosimilars to manage oncology treatment expenses while maintaining therapeutic efficacy. Regulatory agencies like the FDA and EMA have established robust guidelines to ensure biosimilar safety, quality, and equivalence, which further strengthened physician and payer confidence in prescribing these therapies. The broader availability of trastuzumab biosimilars through national tenders and public reimbursement programs also played a critical role in enhancing patient access, especially in regions where affordability was a barrier.

Distribution Channel Insights

Based on the Distribution Channel, Hospital Pharmacy emerged as the dominant segment in the Global Herceptin Market in 2024. This dominance is due to the nature of trastuzumab administration, which typically requires intravenous or subcutaneous infusion under professional supervision. As a targeted biologic therapy primarily used in the treatment of HER2-positive breast and gastric cancers, Herceptin is most often administered in oncology centers and specialized hospital settings where proper monitoring and dosing precision can be ensured. Hospitals also have the infrastructure to manage potential adverse reactions, track patient progress, and comply with safety protocols, making them the preferred point of access for such therapies. Moreover, many governments and insurance providers channel high-cost biologics through hospital pharmacies to regulate inventory, facilitate centralized procurement, and control reimbursements under institutional budgets. This structure helps in managing drug utilization more efficiently and supports bulk purchasing agreements that reduce costs for healthcare systems.

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Regional Insights

North America emerged as the dominant region in the Global Herceptin Market in 2024. This is primarily due to its well-established healthcare infrastructure, high prevalence of HER2-positive breast and gastric cancers, and early adoption of both branded and biosimilar versions of trastuzumab. The United States, in particular, has a high rate of cancer screening and diagnosis, leading to timely and consistent treatment with targeted therapies like Herceptin. Strong reimbursement frameworks through private insurers and public programs such as Medicare and Medicaid ensure broader access to trastuzumab across diverse patient groups. Regulatory support from agencies like the U.S. FDA and Health Canada has facilitated the approval and integration of biosimilars, boosting competition and affordability while maintaining treatment standards.

Asia-Pacific emerged as the fastest growing region in the Global Herceptin Market during the forecast period. This is due to a rising cancer burden, particularly breast and gastric cancers, and expanding access to advanced oncology treatments. Rapid urbanization, changing lifestyles, and dietary patterns have contributed to increasing incidences of HER2-positive cancers in countries like China, India, South Korea, and Japan. Governments across the region have intensified efforts to improve cancer care by investing in early screening programs, modernizing healthcare infrastructure, and subsidizing biologic therapies. The growing number of public-private partnerships has facilitated the establishment of specialized oncology centers, increasing patient access to trastuzumab. As awareness campaigns and physician education initiatives have expanded, HER2 testing has become more prevalent, allowing for timely identification of eligible patients. In parallel, national health insurance schemes and cancer drug reimbursement programs in countries like South Korea and Japan have improved the affordability and uptake of Herceptin and its biosimilars, contributing significantly to market growth.

Recent Developments

• In February 2025, results from the phase 2 ABCSG-52/ATHENE trial published in Nature Cancer confirmed that adding atezolizumab (Tecentriq) to trastuzumab (Herceptin) and pertuzumab, along with abbreviated epirubicin monotherapy, is effective and safe for treating early HER2-positive breast cancer. The treatment achieved a 60.3% pathologic complete response (pCR) rate in the intent-to-treat population. Patients receiving the atezolizumab-based combination had a higher pCR rate of 65.5%, compared to 55.2% in those treated with trastuzumab and pertuzumab alone.
• In January 2025, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adults with unresectable or metastatic, hormone receptor–positive, HER2-low or HER2-ultralow breast cancer that has progressed after at least one endocrine therapy. Approval was based on results from the phase 3 DESTINY-Breast06 trial, where Enhertu reduced the risk of disease progression or death by 36% compared to chemotherapy. Patients treated with Enhertu had a median progression-free survival of 13.2 months versus 8.1 months with chemotherapy, and a 62.6% overall response rate, significantly higher than the 34.4% seen with chemotherapy.
• In September 2024, the FDA approved trastuzumab-strf, a 420 mg trastuzumab biosimilar, for the treatment of HER2-positive cancers, including metastatic breast and gastric/gastroesophageal junction cancers. Accord BioPharma aims to improve access to affordable cancer therapies through biosimilars, addressing both clinical needs and cost challenges in oncology care
• In September 2024, Accord BioPharma, Inc., the U.S. specialty arm of Intas Pharmaceuticals, announced FDA approval of a 420mg dose of HERCESSI (trastuzumab-strf), a biosimilar to Herceptin, for treating HER2-positive breast and gastric cancers. This follows the earlier approval of a 150mg dose and positions the company to launch its first U.S. biosimilar in early 2025.
• In July 2024, Prestige Biopharma announced that the European Medicines Agency’s CHMP has recommended marketing authorization for Tuznue, its biosimilar to Herceptin (trastuzumab). Backed by successful Phase 1 and Phase 3 trials confirming its similarity in efficacy, safety, and immunogenicity, Tuznue is set to become the first Singaporean biosimilar to enter the EU market pending final approval from the European Commission.
• In February 2024, Merck, known as MSD outside the U.S. and Canada, announced that Health Canada approved KEYTRUDA (pembrolizumab) in combination with trastuzumab and chemotherapy for first-line treatment of adults with HER2-positive, PD-L1-expressing advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The approval is based on positive results from the Phase 3 KEYNOTE-811 trial, which showed significant improvement in progression-free survival.
• In February 2024, Biocon Biologics Ltd announced a five-year partnership with Sandoz AG, granting Sandoz exclusive rights to promote and distribute its biosimilars OGIVRI (Trastuzumab) and ABEVMY (Bevacizumab) in Australia. The agreement ensures continued patient access to these cancer therapies, previously distributed by another company, with a combined market value of AUD 80 million. Both biosimilars are listed on Australia’s Pharmaceutical Benefits Scheme (PBS).

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 Global Herceptin Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Herceptin Market, By Product:

o   Biologic

o   Biosimilar

• Herceptin Market, By Application:

o   Breast Cancer

o   Stomach/Gastric Cancer

o   Others

• Herceptin Market, By Distribution Channel:

o   Hospital Pharmacy

o   Specialty Pharmacy

o   Others

• Herceptin Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

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

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Company Information

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

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