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市场调查报告书
商品编码
1755979
Herceptin生物相似药市场预测至 2032 年:按类型、剂量、分销管道、应用、最终用户和地区进行的全球分析Herceptin Biosimilar Market Forecasts to 2032 - Global Analysis By Type (Ogivri, Herzuma, Ontruzant, Trazimera and Other Types), Dosage, Distribution Channel, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2025 年全球Herceptin生物相似药市场价值为 48.9 亿美元,预计到 2032 年将达到 106.6 亿美元,预测期内复合年增长率为 11.77%。
与FDA核准的参考产品曲妥珠单抗(Herceptin)非常相似的生物製药称为Herceptin生物相似药。该药物由活细胞开发,透过靶向某些胃癌和乳癌中的HER2蛋白来抑制细胞生长。生技药品结构复杂,无法完全复製,但经过全面的测试,可以确保其在效力、安全性和纯度方面不存在临床显着差异。生物相似药具有相似的疗效和副作用,而且通常价格更低,从而增加了患者获得基本癌症治疗的机会。
Herceptin专利到期
Herceptin的专利到期为其他製药公司生产和销售完全相同的药物铺平了道路。生物相似药的涌现瞬间为市场带来了巨大的竞争,这对市场的成长至关重要。反过来,竞争的加剧降低了基于曲妥珠单抗的疗法的成本。更低的成本使这些拯救生命的疗法更容易被全球更多患者获得,并负担得起。最终,将垄断市场转变为竞争环境的主要驱动力是专利到期。
製造复杂性和监管挑战
生物相似药需要先进的生物技术工艺,因此难以复製并保持稳定的品质。严格的监管规定要求进行大规模临床试验以验证生物相似药的有效性,这进一步加剧了市场准入的复杂性。由于不同地区的核准途径不同,全球商业化也面临更多障碍。这些障碍阻碍了新进入者,限制了竞争,并减缓了市场成长。最终,患者可能无法获得更便宜的替代药物。
全球乳癌和胃癌发生率上升
随着越来越多患者的确诊,对曲妥珠单抗等高效能 HER2标靶治疗的需求必然会增加。Herceptin生物相似药将为昂贵的原厂药提供更经济、更重要的替代方案。这种成本效益将改善病患获得紧急医疗的管道,尤其是在医疗资金紧张的农村地区。因此,随着疾病负担的增加直接影响处方量和药物的采用,Herceptin生物相似药市场预计将大幅成长。
强大的品牌忠诚度和医疗保健提供者的抵制
许多专业人士和消费者偏好知名品牌,因为他们信赖产品和服务的可靠性。这种品牌忠诚度会阻碍人们尝试更新或不同的出行方式。此外,医疗专业人士通常不愿意推荐不知名的品牌,因为他们担心潜在的责任或病人不满意。这种抵制限制了新业务和原创设计进入市场,扼杀了竞争,并减缓了市场发展。
COVID-19的影响
新冠疫情对Herceptin生物相似药市场产生了多方面的影响。最初,它造成了供应链中断、生产延迟和临床试验延迟(尤其是在2020年初)。就诊人数的减少和医疗保健重点的转变也导致癌症治疗减少。然而,疫情同时也凸显了对经济高效的医疗保健解决方案的迫切需求。这促使包括Herceptin在内的生物相似药被接受和采用,因为医疗保健系统正在努力控制财务负担并改善基本药物的可及性,最终将在长期内加速市场渗透。
Hersma(曲妥珠单抗-PKRB)细分市场预计将成为预测期内最大的细分市场
由于竞争加剧和成本削减的驱动,Herzuma(曲妥珠单抗-PKRB)细分市场预计将在预测期内占据最大市场占有率。作为FDA核准的生物相似药,该药物提供了一种疗效和安全性均与参考产品相当的替代方案。生物相似药的广泛使用,尤其是在日本等市场占有较大份额的生物相似药,增加了患者获得重要HER2标靶治疗方法的可及性。这种竞争压力将鼓励生物相似药的更广泛应用,有助于降低整体医疗成本。最终,Herzuma的加入将促进全球曲妥珠单抗生物相似药市场更具活力、更容易取得。
预测期内大肠直肠癌领域预计将录得最高复合年增长率
由于大量患者可使用曲妥珠单抗治疗,预计大肠直肠癌领域将在预测期内达到最高成长率。Herceptin生物相似药是比原厂药更经济的替代方案,使HER2阳性大肠直肠癌患者更容易获得标靶治疗。这种可近性的提高,加上结直肠癌发病率的上升以及人们对HER2阳性在该适应症中作用的认识不断提高,正在推动对生物类似药的需求。此外,探索曲妥珠单抗对包括大肠直肠癌在内的其他HER2阳性恶性肿瘤疗效的研究和临床试验,也正在促进市场扩张。最终,Herceptin生物相似药在结直肠癌治疗中的成本效益和广泛应用,推动了市场的显着成长。
由于 HER2 阳性癌症发生率上升以及医疗保健可近性的不断扩大,预计亚太地区将在预测期内占据最大的市场占有率。印度和中国等国的本地製造能力以及简化的监管途径,正在加速产品上市和市场渗透的速度。由于有利的法规和较低的製造成本,具有成本效益的生物相似药製剂正越来越容易被中等收入者所接受。医疗保健专业人员和患者意识的不断提高,加上该地区庞大的人口规模,使得亚太地区在未来几年内将成为Herceptin生物相似药最具活力、增长最快的市场。
在预测期内,北美预计将呈现最高的复合年增长率。这得益于乳癌的高发生率、强大的医疗基础设施以及完善的生物相似药核准法律规范。在强大的支付方奖励和医生熟悉度的支持下,生物相似药的早期采用正在推动市场成长。大型製药公司正在积极进行生物相似药研究,美国FDA简化的核准流程进一步支持了商业化。该地区受益于全面的保险覆盖和成熟的报销制度,确保了广泛的患者可及性。然而,市场面临着日益激烈的价格竞争、来自替代HER2药物的竞争以及持续的处方谈判。
According to Stratistics MRC, the Global Herceptin Biosimilar Market is accounted for $4.89 billion in 2025 and is expected to reach $10.66 billion by 2032 growing at a CAGR of 11.77% during the forecast period. A biological medication that closely resembles trastuzumab (Herceptin), the original FDA-approved reference product, is known as a Herceptin biosimilar. Constructed from living cells, it blocks cell development by targeting the HER2 protein in some gastric and breast malignancies. Because biologics are complicated, they cannot be exactly replicated, but thorough testing guarantees that there are no clinically significant variations in potency, safety, or purity. Biosimilars increase patient access to essential cancer treatments by providing similar efficacy and side effect profiles, frequently at a cheaper cost.
Patent expiry of herceptin
It cleared the path for other pharmaceutical companies to create and market very identical versions once the patent protection expired. Significant market rivalry was instantly brought about by this flood of biosimilars, which is essential for market growth. Consequently, increased competition lowers the cost of treatments based on trastuzumab. Reduced costs make these life-saving procedures more accessible and affordable for a larger number of patients worldwide. In the end, the primary facilitator that turns a monopolised market into a competitive environment is patent expiration.
High manufacturing complexity and regulatory challenges
Biosimilars require advanced biotechnological processes, making them difficult to replicate with consistent quality. Regulatory challenges further complicate market entry, as stringent guidelines demand extensive clinical trials to prove biosimilarity. Approval pathways vary across regions, adding additional hurdles for global commercialization. These barriers discourage new entrants and limit competition, slowing market growth. As a result, patients may experience reduced access to affordable alternatives.
Rising incidence of breast and gastric cancers globally
The need for efficient HER2-targeted treatments, like as trastuzumab, inevitably rises as more people receive diagnoses. Biosimilars of Herceptin provide a vital, less expensive substitute for the pricey original medication. This cost-effectiveness increases patient access to life-saving care, especially in underdeveloped areas where healthcare finances are tight. Since a result, the market for Herceptin biosimilars is expected to develop significantly since the rising illness burden directly affects prescription volume and adoption.
Strong brand loyalty and resistance from healthcare providers
Many experts and consumers favour well-known brands because they have faith in the dependability of the products and services. This devotion makes people less inclined to try out newer or different mobility alternatives. Furthermore, medical professionals frequently hesitate to suggest unknown brands out of concern for potential liability or patient unhappiness. Such opposition restricts new businesses' and creative designs' ability to enter the market. As a result, this hinders competition and delays the general development of the market.
Covid-19 Impact
The COVID-19 pandemic presented a mixed impact on the Herceptin biosimilar market. Initially, it caused supply chain disruptions, manufacturing slowdowns, and delays in clinical trials, particularly in early 2020. Reduced hospital visits and shifted healthcare priorities also led to a decline in oncology treatments. However, the pandemic concurrently highlighted the urgent need for cost-effective healthcare solutions. This spurred greater acceptance and adoption of biosimilars, including Herceptin biosimilars, as healthcare systems sought to manage financial burdens and increase access to essential medicines, ultimately accelerating their market penetration in the long term.
The herzuma (trastuzumab-pkrb) segment is expected to be the largest during the forecast period
The herzuma (trastuzumab-pkrb) segment is expected to account for the largest market share during the forecast period, due to intensified competition and driving down costs. As an FDA-approved biosimilar, it offers a proven, equally efficacious, and safe alternative to the reference product. Its widespread availability, particularly in markets like Japan where it has captured substantial share, increases patient access to vital HER2-targeted therapy. This competitive pressure encourages broader adoption of biosimilars, contributing to overall healthcare cost savings. Ultimately, Herzuma's presence fosters a more dynamic and accessible market for trastuzumab biosimilars globally.
The colorectal cancer segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the colorectal cancer segment is predicted to witness the highest growth rate, due to the treatable patient population for trastuzumab. As Herceptin biosimilars offer a more affordable alternative to the originator drug, their use in HER2-positive colorectal cancer makes targeted therapy more accessible. This increased accessibility, coupled with rising colorectal cancer incidence and growing awareness of HER2 status in this indication, drives demand for biosimilars. Furthermore, research and clinical trials exploring trastuzumab's efficacy in other HER2-positive malignancies, including colorectal cancer, contribute to market expansion. Ultimately, the cost-effectiveness and broadened applicability of Herceptin biosimilars in colorectal cancer treatment foster significant market growth.
During the forecast period, the Asia Pacific region is expected to hold the largest market share due to rising incidence of HER2-positive cancers and expanding healthcare access. Local manufacturing capabilities in countries like India and China, along with streamlined regulatory pathways, have enabled faster product launches and greater market penetration. Cost-effective biosimilar alternatives are increasingly accessible to middle-income populations, supported by favorable regulations and reduced production costs. Growing awareness among healthcare professionals and patients, combined with the region's large population base, positions Asia Pacific as the most dynamic and rapidly expanding market for Herceptin biosimilars in the coming years.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to a high prevalence of breast cancer, robust healthcare infrastructure, and well-established regulatory frameworks for biosimilar approvals. The early adoption of biosimilars, supported by strong payer incentives and physician familiarity, has accelerated market growth. Major pharmaceutical companies actively conduct biosimilar research, and the U.S. FDA's streamlined approval process further supports commercialization. The region benefits from comprehensive insurance coverage and mature reimbursement systems, ensuring broad patient access. However, the market faces increasing pricing pressures, competition from alternative HER2 therapies, and ongoing formulary negotiations.
Key players in the market
Some of the key players profiled in the Herceptin Biosimilar Market include Amgen Inc., Celltrion Healthcare Co., Ltd., Pfizer Inc., Samsung Bioepis Co., Ltd., Biocon Biologics Limited, Viatris Inc., Teva Pharmaceutical Industries Ltd., Shanghai Henlius Biotech, Inc., Merck & Co., Inc., Stada Arzneimittel AG, Accord Healthcare Ltd., BIOCAD, AryoGen Pharmed Co., Ltd., Prestige BioPharma Limited, EirGenix Inc., Apotex Inc. and Gedeon Richter Plc.
In November 2024, Celltrion acquired Swiss-based iQone Healthcare for approximately 30 billion KRW. This strategic move aims to enhance Celltrion's European distribution and commercialization capabilities, particularly for biosimilars like Herzuma, by leveraging iQone's established regional market presence.
In December 2023, Pfizer and Roche (via Genentech) reached a confidential settlement resolving U.S. patent litigation over trastuzumab. This agreement cleared a key legal hurdle, enabling Pfizer to proceed with the future launch of its Herceptin biosimilar.
In June 2023, Celltrion expanded its partnership with Rani Therapeutics to supply CT-P17, its adalimumab biosimilar, for development in Rani's oral biologics platform. This collaboration reflects Celltrion's commitment to innovative drug delivery and global pipeline growth, aiming to transform injectable treatments into convenient oral alternatives.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.