赫赛汀市场机会、成长动力、产业趋势分析及 2025 - 2034 年预测

2024 年全球赫赛汀市场价值为 33 亿美元，预计到 2034 年将以 5.4% 的复合年增长率增长至 55 亿美元。赫赛汀，又称曲妥珠单抗，仍是 HER2 阳性乳癌的基石疗法，HER2 阳性乳癌是一种以 HER2 蛋白过度表现为特征的亚型，可加速肿瘤生长。随着乳癌继续位列全球最常见癌症之一，对赫赛汀等标靶疗法的需求正在急剧上升。对精准医疗的日益关注，以及全球晚期癌症治疗可近性的扩大，正在显着推动市场成长。此外，人们对早期癌症检测认识的提高、筛检计画的改进以及持续的研发努力以改进标靶疗法，共同推动了赫赛汀市场的蓬勃发展。医疗保健投资的增加、保险覆盖范围的扩大以及患者对生物製剂而非传统化疗的偏好日益增长，进一步支持了市场扩张。新兴经济体也不断崛起，为赫赛汀及其生物相似药创造了巨大的机会，特别是随着监管审批速度的加速和各地区医疗保健服务的改善。

赫赛汀是一种单株抗体，能够精准靶向并阻断 HER2 蛋白，从而抑制癌细胞的生长和扩散。透过干扰 HER2 讯号传导，赫赛汀可以减缓肿瘤进展并显着提高存活率，尤其适用于 HER2 阳性乳癌患者。这种乳癌以侵袭性强且对常规疗法反应不佳而闻名。对许多患者来说，赫赛汀如同一条生命线，在传统疗法无法发挥作用的情况下，带来更佳的临床疗效。

赫赛汀市场中生物相似药部分在2024年的营收为17亿美元，预计到2034年将以5.6%的复合年增长率成长。具有同等临床疗效的生物相似药正在使挽救生命的治疗更容易获得，尤其是在原研究生物製剂高昂成本限制患者获得治疗的地区。随着多种曲妥珠单抗生物相似药获得批准并以全球品牌进入市场，预计可负担的替代药物供应将大幅增加，使全球更多患者受益。

赫赛汀市场主要分为乳癌和胃癌两大类。乳癌在2024年占据最大份额，贡献了总收入的60%以上。乳癌发生率的上升，尤其是在女性族群中，持续推动了赫赛汀的需求，因为赫赛汀已被证实能够延长HER2阳性患者的生存期并降低復发率。

预计到 2034 年，美国赫赛汀市场规模将达到 22 亿美元，这得益于强大的医疗保健体系、高度的癌症意识以及标靶疗法的大力采用。

塑造竞争格​​局的领导者包括雷迪博士实验室 (Dr. Reddy's Laboratories)、安进 (Amgen)、AryoGen Pharmed、Biocon、Celltrion Healthcare、基因泰克 (Genentech)、迈兰 (Mylan NV)、辉瑞 (Pfizer)、上海復宏汉靓 (Shanghai Biolius Biolius Biomando)。这些公司正大力投资研发，推出生物相似药，拓展新兴市场，并加强病患支援计划，以提升治疗效果和市场占有率。

目录

第一章：方法论与范围

第二章：执行摘要

第三章：行业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • HER2阳性乳癌发生率上升
    • 提高对标靶癌症治疗的认识
    • 生物相似药的采用日益增多
    • 药物输送系统的技术进步
  • 产业陷阱与挑战
    • 与治疗相关的副作用
    • 严格的监管情景
• 成长潜力分析
• 监管格局
• 川普政府关税
  • 对贸易的影响
    • 贸易量中断
    • 报復措施
  • 对产业的影响
    • 供给侧影响（原料）
      • 主要材料价格波动
      • 供应链重组
      • 生产成本影响
    • 需求面影响（售价）
      • 价格传导至终端市场
      • 市占率动态
      • 消费者反应模式
  • 受影响的主要公司
  • 策略产业反应
    • 供应链重组
    • 定价和产品策略
    • 政策参与
  • 展望与未来考虑
• 技术格局
• 差距分析
• 波特的分析
• PESTEL分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第五章：市场估计与预测：按产品，2021 年至 2034 年

• 主要趋势
• 生物製剂
• 生物相似药

第六章：市场估计与预测：按应用，2021 年至 2034 年

• 主要趋势
• 乳癌
• 胃癌

第七章：市场估计与预测：依管理路线，2021 年至 2034 年

• 主要趋势
• 静脉
• 皮下

第八章：市场估计与预测：按配销通路，2021 年至 2034 年

• 主要趋势
• 医院药房
• 专业药房
• 网路药局

第九章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 沙乌地阿拉伯
  • 南非
  • 阿联酋

第十章：公司简介

• Amgen
• AryoGen Pharmed
• Biocon
• Celltrion Healthcare
• Dr. Reddy's Laboratories
• Genentech
• Mylan NV
• Pfizer
• Samsung Bioepis
• Sandoz
• Shanghai Henlius Biotech

The Global Herceptin Market was valued at USD 3.3 billion in 2024 and is estimated to grow at a CAGR of 5.4% to reach USD 5.5 billion by 2034. Herceptin, or trastuzumab, remains a cornerstone therapy for HER2-positive breast cancer, a subtype marked by the overexpression of the HER2 protein that accelerates tumor growth. As breast cancer continues to rank among the most commonly diagnosed cancers worldwide, the demand for targeted therapies like Herceptin is rising sharply. The increasing focus on precision medicine, along with expanding access to advanced cancer care globally, is significantly boosting market growth. Moreover, the heightened awareness around early cancer detection, improved screening programs, and continuous R&D efforts to refine targeted therapies are collectively driving momentum in the Herceptin landscape. Rising healthcare investments, expanding insurance coverage, and growing patient preference for biologics over traditional chemotherapy are further supporting market expansion. Emerging economies are also stepping up, creating vast opportunities for Herceptin and its biosimilars, particularly as regulatory approvals become faster and healthcare access improves across regions.

Herceptin, a monoclonal antibody, precisely targets and blocks the HER2 protein, disrupting the cancer cell's ability to grow and spread. By interfering with HER2 signaling, Herceptin slows tumor progression and significantly improves survival rates, particularly in HER2-positive breast cancer, which is known for its aggressive behavior and poor response to conventional therapies. For many patients, Herceptin offers a lifeline, delivering better clinical outcomes where traditional treatments fall short.

The biosimilars segment of the Herceptin market accounted for USD 1.7 billion in revenue in 2024 and is estimated to grow at a CAGR of 5.6% through 2034. Biosimilars with comparable clinical efficacy are making life-saving treatments more accessible, especially in regions where the high cost of original biologics limits patient access. As multiple trastuzumab biosimilars gain approval and enter the market under global brands, the availability of affordable alternatives is expected to rise substantially, benefiting a larger pool of patients worldwide.

The Herceptin market is primarily divided between breast cancer and gastric cancer applications. Breast cancer held the largest share in 2024, generating over 60% of total revenue. The rising prevalence of breast cancer, especially among women, continues to drive demand for Herceptin, given its proven ability to extend survival and reduce recurrence rates for HER2-positive patients.

The U.S. Herceptin Market is forecasted to reach USD 2.2 billion by 2034, supported by a robust healthcare system, high levels of cancer awareness, and strong adoption of targeted therapies.

Leading players shaping the competitive landscape include Dr. Reddy's Laboratories, Amgen, AryoGen Pharmed, Biocon, Celltrion Healthcare, Genentech, Mylan N.V., Pfizer, Shanghai Henlius Biotech, Samsung Bioepis, and Sandoz. These companies are investing heavily in research, launching biosimilars, expanding into emerging markets, and strengthening patient support initiatives to enhance treatment outcomes and market presence.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360⁰ synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising incidence of HER2-positive breast cancer
    • 3.2.1.2 Increasing awareness of targeted cancer therapies
    • 3.2.1.3 Growing adoption of biosimilars
    • 3.2.1.4 Technological advancement in drug delivery system
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Side effects associated with treatment
    • 3.2.2.2 Stringent regulatory scenario
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Trump administration tariffs
  • 3.5.1 Impact on trade
    • 3.5.1.1 Trade volume disruptions
    • 3.5.1.2 Retaliatory measures
  • 3.5.2 Impact on the Industry
    • 3.5.2.1 Supply-side impact (raw materials)
      • 3.5.2.1.1 Price volatility in key materials
      • 3.5.2.1.2 Supply chain restructuring
      • 3.5.2.1.3 Production cost implications
    • 3.5.2.2 Demand-side impact (selling price)
      • 3.5.2.2.1 Price transmission to end markets
      • 3.5.2.2.2 Market share dynamics
      • 3.5.2.2.3 Consumer response patterns
  • 3.5.3 Key companies impacted
  • 3.5.4 Strategic industry responses
    • 3.5.4.1 Supply chain reconfiguration
    • 3.5.4.2 Pricing and product strategies
    • 3.5.4.3 Policy engagement
  • 3.5.5 Outlook and future considerations
• 3.6 Technological landscape
• 3.7 Gap analysis
• 3.8 Porter's analysis
• 3.9 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Biologic
• 5.3 Biosimilars

Chapter 6 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Breast cancer
• 6.3 Stomach/gastric cancer

Chapter 7 Market Estimates and Forecast, By Route of Administration, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Intravenous
• 7.3 Subcutaneous

Chapter 8 Market Estimates and Forecast, By Distribution Channel, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals pharmacies
• 8.3 Specialty pharmacies
• 8.4 Online pharmacies

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 India
  • 9.4.3 Japan
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 South Africa
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Amgen
• 10.2 AryoGen Pharmed
• 10.3 Biocon
• 10.4 Celltrion Healthcare
• 10.5 Dr. Reddy’s Laboratories
• 10.6 Genentech
• 10.7 Mylan N.V.
• 10.8 Pfizer
• 10.9 Samsung Bioepis
• 10.10 Sandoz
• 10.11 Shanghai Henlius Biotech