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市场调查报告书
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1450883

2024-2032 年生物相似药市场报告（按分子、适应症、製造类型和地区）

Biosimilar Market Report by Molecule, Indication, Manufacturing Type, and Region 2024-2032
出版日期: | 出版商: IMARC | 英文 145 Pages | 商品交期: 2-3个工作天内

价格

2023年全球生物相似药市场规模达212亿美元。展望未来， IMARC Group预计到2032年市场规模将达到1,645亿美元，2024-2032年复合年增长率（CAGR）为25.1%。重磅生物药物的专利即将到期、人们对生物仿製药的功效和成本效益的认识不断提高、全球慢性病患病率的上升以及生物製药製造技术的不断进步是推动市场的一些主要因素。

生物相似药是与 FDA 批准的现有参考产品高度相似且没有临床意义差异的生物製品。它们的作用机转、给药途径、剂型和强度与原产品相同。虽然由于其复杂的性质和生产方法，它们与参考产品并不相同，但它们保持了相当的安全性、纯度和效力。这些生物药物为高成本的参考生物製剂提供了更实惠的替代品，创造了竞争，并使患者更容易获得治疗。它们在市场上的推出需要经过严格的测试和严格的监管审查，以确保治疗等效性和患者安全。近年来，生物相似药在肿瘤、糖尿病和自体免疫疾病等不同治疗领域中获得了巨大的吸引力。

推动市场的关键因素之一是几种重磅生物製剂的专利即将到期，为生物相似药打开了领域，为市场扩张创造了充足的机会。由于生物相似药是昂贵的生物疗法的较便宜的替代品，因此它们具有节省医疗成本的巨大潜力，对医疗保健系统和患者俱有吸引力。再加上全球慢性疾病负担不断增加，包括癌症、糖尿病和自体免疫疾病（生物製剂在这些疾病的管理中发挥至关重要的作用），也增加了产品需求。除此之外，FDA 和 EMA 等多个监管机构也简化了生物相似药的审批途径，鼓励其开发和市场进入。此外，生物相似药公司正在迅速全球化，希望将其足迹扩展到未开发的市场。除此之外，生物製药製造技术的不断创新使得生产高效、安全的生物相似药成为可能，进一步推动市场成长。

生物相似药市场趋势/驱动因素：

重磅药物的专利即将到期

品牌生物製剂专利到期是推动市场成长的关键因素之一。生物製剂通常受到强大的专利组合的保护，可以长期防止竞争产品进入。然而，一旦这些专利到期，就会为公司开发和销售类似的、更实惠的替代品打开大门。未来几年，多种年销售额数十亿的重磅生物製剂将失去专利保护。因此，这些专利保护的结束为製造商提供了巨大的机会，可以将其替代品推向市场并获得可观的市场份额，从而促进市场成长。

成本效益

生物相似药的生产成本低于参考生物製剂，主要是由于研发 (R&D) 成本降低，因为製造商不需要重复为参考产品进行的所有原始临床试验。因此，生物相似药的价格可以显着降低，为通常昂贵的生物疗法提供负担得起的替代品。这种成本效益对于努力管理不断增加的医疗保健成本的医疗保健系统以及可能与生物疗法的高成本作斗争的患者特别有吸引力。此外，在以前可能无法负担生物疗法的新兴市场，生物相似药可以让人们更容易获得基本治疗。

慢性病盛行率增加

癌症、自体免疫疾病和糖尿病等慢性疾病的盛行率在全球范围内呈上升趋势。这些疾病通常需要使用生物製剂进行长期治疗，从而刺激了对这些药物的需求。由于生物相似药具有与原厂生物製剂相似的功效和安全性，但成本较低，因此它们在治疗这些慢性疾病中的应用日益成为首选。例如，使用肿瘤坏死因子抑制剂等生物药物治疗的类风湿性关节炎和牛皮癣等疾病的发生率不断上升，为这些药物的生物相似药提供了巨大的市场。随着全球慢性病负担持续增加，产品需求预计将同样增加，推动市场成长。

生物相似药市场细分：

IMARC Group提供了全球生物相似药市场报告各细分市场主要趋势的分析，以及 2024 年至 2032 年全球和区域层面的预测。我们的报告根据分子、适应症和製造类型对市场进行了分类。

依分子分解：

英夫利西单抗

甘精胰岛素

阿尔法依泊汀

依那西普

非格司亭

生长激素

利妥昔单抗

促卵泡素阿尔法

阿达木单抗

聚乙二醇非格司亭

曲妥珠单抗

贝伐珠单抗

其他的

英夫利西单抗代表最大的细分市场

该报告根据分子提供了详细的市场区隔和分析。这包括英夫利西单抗、甘精胰岛素、依泊汀阿尔法、依那西普、非格司亭、生长激素、利妥昔单抗、促卵泡素阿尔法、阿达木单抗、培非格司亭、曲妥珠单抗、贝伐珠单抗等。报告称，英夫利西单抗占据了市场的大部分份额。

英夫利西单抗是一种单株抗体，用于治疗多种慢性疾病，如类风湿性关节炎、干癣性关节炎、僵直性脊椎炎、克隆氏症、斑块状干癣和溃疡性结肠炎。这些疾病在世界范围内的高盛行率增加了对有效治疗的需求。此外，广泛的适应症导致大量患者可能受益于英夫利西单抗。

原始参考产品 Remicade 已上市很长时间，具有良好的疗效和安全性。专利到期后，英夫利西单抗生物相似药的进入为这些慢性病提供了更具成本效益的治疗选择。此外，与其他生物製剂相比，Remicade 的专利到期相对较早，这极大地促进了其广泛流行。除此之外，英夫利西单抗等单株抗体的生产流程和配方现已完善，促进了生物相似药的开发和生产，从而推动了该细分市场的成长。

按指示细分：

自体免疫疾病

血液失调

糖尿病

肿瘤学

生长不足

女性不孕症

其他的

自体免疫疾病主导市场

该报告根据该指标提供了详细的市场细分和分析。这包括自体免疫疾病、血液疾病、糖尿病、肿瘤、生长缺陷、女性不孕症等。报告称，自体免疫疾病占最大部分。

自体免疫疾病包括类风湿性关节炎、牛皮癣和发炎性肠道疾病等疾病，这些疾病在世界各地普遍流行，影响数百万人。这种高盛行率导致对有效治疗的需求大幅增加。这些疾病通常是慢性的，需要长期治疗，导致对相关疗法的持续需求。多年来，生物製剂彻底改变了许多自体免疫疾病的治疗方法，改善了控制和预后。其中许多生物製剂现已失去或正在失去专利保护，为生物相似药开闢了道路。此外，用于治疗自体免疫疾病的原始生物製剂可能价格昂贵，对医疗保健系统和患者造成经济负担。由于生物相似药提供了更实惠的替代品，因此它们正在成为患者和医疗保健专业人员的首选。此外，由于生物相似药与参考生物製剂具有相似的功效和安全性，医生、患者和医疗保健系统越来越多地接受用于治疗自体免疫疾病的生物相似药，这也推动了这一领域的增长。

按製造类型细分：

内部製造

合约起草（名词

内部製造占大部分市场份额

该报告根据製造类型对市场进行了详细的细分和分析。这包括内部和合约製造。报告称，内部製造占最大部分。

内部製造可以完全控制产品质量，这对于生物相似药至关重要。鑑于生物製剂的复杂性及其製造的严格规定，公司通常更愿意自行处理生产，以确保达到高标准。此外，生物製造过程通常涉及专有方法和技术。内部生产有助于保护这些商业机密，使其成为製造类型的首选。虽然初始设定成本可能很高，但随着时间的推移，维持内部生产可以显着降低单位成本。此外，内部製造使公司能够最大限度地降低供应链中断的风险，确保产品的持续供应，同时促进生产的灵活性和敏捷性，包括根据需要对产品或流程进行调整或适应。

按地区划分：

欧洲

德国

法国

义大利

西班牙

英国

欧洲其他地区

美国

日本

印度

韩国

其他的

欧洲在市场上表现出明显的主导地位

该报告还对所有主要区域市场进行了全面分析，其中包括欧洲（德国、法国、义大利、西班牙、英国和欧洲其他地区）；美国、日本、印度、韩国等。报告称，欧洲占了最大的市场份额。

欧洲占了最大的市场份额，因为该地区拥有支持性的监管环境，使得多种生物相似药能够先于其他地区进入欧洲市场。这一早期起步使欧洲获得了相当大的市场份额。此外，自 2005 年以来，欧洲药品管理局 (EMA) 一直是为生物相似药审批创建明确和支持性监管框架的先行者，早于许多其他地区。这个早期框架鼓励了该地区生物相似药的开发和行销。欧洲多个国家已将医疗保健系统国有化，并专注于成本控制。由于生物相似药可提供与原厂生物製剂相当的临床结果，但成本较低，因此它们已成为这些环境中有吸引力的选择。除此之外，欧洲用生物製剂治疗的疾病的盛行率很高，例如自体免疫疾病和癌症。这种高需求正在支持该地区市场的成长。除此之外，欧洲医疗保健专业人员和患者对生物相似药的认识和接受度不断提高，推动了生物相似药的使用，促进了市场的成长。

竞争格局：

市场上主要参与者正在采取越来越多的策略性倡议，旨在占领更大的市场份额。该公司正在大力投资研发 (R&D) 活动，以推出新的生物相似药并改进其製造流程。许多供应商正在建立策略联盟、合作伙伴关係和授权交易，以利用其他公司的专业知识并加快其生物相似药的开发、生产和行销。除此之外，一些行业参与者正在寻求监管机构批准其生物相似药在新的地理市场上的发展，以扩大其全球足迹。为了建立对其生物相似药的信任和信心，领先的製造商正在进行上市后监督研究，以确认其产品的长期安全性和有效性。我们还预计，在预测期内，市场将见证产品创新的激增、新患者支援计划的推出以及主要参与者之间的併购 (M&A) 的增加，以推动该领域内的健康竞争。

该报告对市场竞争格局进行了全面分析。也提供了所有主要公司的详细资料。市场上的一些主要参与者包括：

山德士国际有限公司

辉瑞公司

梯瓦製药工业股份有限公司

赛特瑞恩公司

百康有限公司

三星生物製剂

安进公司

雷迪博士实验室有限公司

斯塔达阿兹内米特尔股份公司

最近的发展：

2023 年 1 月，安进公司宣布，修美乐（阿达木单抗）的生物相似药 AMJEVITA（阿达木单抗-atto）现已在美国上市。 AMJEVITA 是美国食品药物管理局 (FDA) 于 2016 年批准的第一个 Humira 生物相似药。

2022年10月，Biocon Ltd.的子公司Biocon Biologics Ltd.宣布与日本製药公司Yoshindo Inc.签订策略授权协议。根据该协议条款，Yoshindo将获得该药物的独家商业化权。该公司两种在研生物相似药资产bUstekinumab 和bDenosumab 的日本市场。

2020年6月，辉瑞的Neulasta（pegfilgrastim）生物相似药NYVEPRIA（pegfilgrastim-apgf）获得美国（US）食品药物管理局（FDA）的批准。此生物相似药可降低接受骨髓抑制抗癌药物（与临床上显着的发烧性嗜中性白血球减少症发生率相关）的非髓性恶性肿瘤患者的感染发生率，如发烧性嗜中性白血球减少症所表现的感染发生率。

本报告回答的关键问题

  • 2023年全球生物相似药市场规模是多少
  • 2024-2032年全球生物相似药市场的预期成长率是多少
  • 推动全球生物相似药市场的关键因素是什么
  • COVID-19 对全球生物相似药市场有何影响
  • 基于分子的全球生物相似药市场的细分是什么
  • 根据适应症，全球生物相似药市场的细分如何
  • 根据製造类型，全球生物相似药市场的细分如何
  • 全球生物相似药市场的重点区域有哪些
  • 全球生物相似药市场的主要公司/参与者有哪些

本报告回答的关键问题

  • 2023年全球生物相似药市场规模有多大？
  • 2024-2032年全球生物相似药市场的预期成长率是多少？
  • 推动全球生物相似药市场的关键因素是什么？
  • COVID-19 对全球生物相似药市场有何影响？
  • 基于该分子的全球生物相似药市场的细分情况如何？
  • 根据此适应症，全球生物相似药市场的细分情况如何？
  • 根据製造类型，全球生物相似药市场的细分情况如何？
  • 全球生物相似药市场的重点区域有哪些？
  • 全球生物相似药市场的主要公司/参与者有哪些？

目录

第一章：前言

第 2 章：范围与方法

  • 研究目的
  • 利害关係人
  • 资料来源
    • 主要资源
    • 二手资料
  • 市场预测
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第 3 章：执行摘要

第 4 章：生物相似药市场 - 简介

  • 概述
  • WHO 和 FDA 生物相似药术语
  • 生物相似药和仿製药
  • 生物相似药和品牌生物製品

第 5 章：为什么生物相似药如此有利可图？

  • 重磅生物药专利到期
  • 生物相似药和创新药之间存在显着的价格差异
  • 为政府和第三方付款人节省开支
  • 生活方式疾病的盛行率上升
  • 对处方者、药剂师和患者的激励措施
  • 欧洲和新兴市场新参与者的出现
  • 製造商与给药设备公司合作，提高产品差异化

第 6 章：生物相似药研究、开发与製造

  • 研究与发展：生物相似药与创新药
  • 製造：生物相似药与创新药物

第 7 章：全球生物相似药市场

  • 市场概况
  • 历史表现
  • COVID-19 的影响
  • 市场区隔：按细分市场
  • 市场区隔：依製造类型
  • 市场区隔：依指标
  • 市场区隔：按地区
  • 市场预测
  • 生物相似药专利格局
    • 美国的专利格局
    • 欧洲的专利格局
    • 日本的专利格局
  • SWOT分析
    • 概述
    • 优势
    • 弱点
    • 机会
    • 威胁
  • 价值链分析
    • 表征现有创新药物
    • 研究与开发
      • 生物相似药的表征
      • 开发独特的细胞株
    • 产品开发
      • 预测试
      • 中间临床测试（PK/PD）
      • 验证性临床III期
    • 最终产品配方
    • 行销与分销
  • 波特五力分析
    • 概述
    • 买家的议价能力
    • 供应商的议价能力
    • 竞争程度
    • 新进入者的威胁
    • 替代品的威胁
  • 价格分析
    • 主要价格指标
    • 价格趋势
    • 利润分析

第 8 章：市场区隔：依分子

  • 英夫利西单抗
  • 甘精胰岛素
  • 阿尔法依泊汀
  • 依那西普
  • 非格司亭
  • 生长激素
  • 利妥昔单抗
  • 促卵泡素阿尔法
  • 阿达木单抗
  • 聚乙二醇非格司亭
  • 曲妥珠单抗
  • 贝伐珠单抗
  • 其他的

第 9 章：市场区隔：依製造类型

  • 内部製造
    • 市场走向
    • 市场预测
  • 合约起草（名词
    • 市场走向
    • 市场预测

第 10 章：市场区隔：依迹象

  • 自体免疫疾病
    • 市场走向
    • 市场预测
  • 血液失调
    • 市场走向
    • 市场预测
  • 糖尿病
    • 市场走向
    • 市场预测
  • 肿瘤学
    • 市场走向
    • 市场预测
  • 生长不足
    • 市场走向
    • 市场预测
  • 女性不孕症
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 11 章：市场区隔：按地区

  • 欧洲
    • 市场业绩
    • 关键参与者和生物相似药
    • 市场细分：按国家/地区
    • 市场预测
    • 义大利
      • 市场业绩
      • 关键参与者和生物相似药
      • 市场预测
    • 德国
      • 市场业绩
      • 关键参与者和生物相似药
      • 市场预测
    • 法国
      • 市场业绩
      • 关键参与者和生物相似药
      • 市场预测
    • 英国
      • 市场业绩
      • 关键参与者和生物相似药
      • 市场预测
    • 西班牙
      • 市场业绩
      • 关键参与者和生物相似药
      • 市场预测
    • 欧洲其他地区
      • 市场业绩
      • 市场预测
  • 美国
    • 当前市场趋势
    • 关键参与者和生物相似药
    • 市场预测
  • 日本
    • 市场业绩
    • 关键参与者和生物相似药
    • 市场预测
  • 印度
    • 当前市场趋势
    • 关键参与者和生物相似药
    • 市场预测
  • 韩国
    • 当前市场趋势
    • 关键参与者和生物相似药
    • 市场预测
  • 世界其他地区
    • 当前市场趋势
    • 市场预测

第 12 章：设立生物相似药工厂的要求

  • 製造流程
  • 原料要求
  • 原料图片
  • 土地和建设要求
  • 机械和基础设施需求
  • 机械图片
  • 工厂布局
  • 包装要求
  • 实用要求
  • 人力需求

第13章：竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • Sandoz International GmbH
    • Pfizer Inc.
    • Teva Pharmaceutical Industries Limited
    • Celltrion Inc.
    • Biocon Limited
    • Samsung Biologics
    • Amgen, Inc.
    • Dr. Reddy's Laboratories Limited
    • Stada Arzneimittel Ag
Product Code: SR112024A497

The global biosimilar market size reached US$ 21.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 164.5 Billion by 2032, exhibiting a growth rate (CAGR) of 25.1% during 2024-2032. The upcoming expiry of patents on blockbuster biologic drugs, growing awareness about the efficacy and cost-effectiveness of biosimilars, rising prevalence of chronic diseases worldwide, and continual advancements in biopharmaceutical manufacturing technologies are some of the major factors propelling the market.

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. They are developed to have the same mechanism of action, route of administration, dosage form, and strength as the original product. While they are not identical to their reference products due to their complex nature and production methods, they maintain comparable safety, purity, and potency. These biologic drugs offer a more affordable alternative to high-cost reference biologics, creating competition, and making treatment more accessible for patients. Their introduction in the market is subject to rigorous testing and stringent regulatory scrutiny to ensure therapeutic equivalence and patient safety. In recent years, biosimilars have gained immense traction biosimilars in different therapeutic areas such as oncology, diabetes, and autoimmune diseases.

One of the key factors driving the market is the upcoming expiry of patents for several blockbuster biologics, which has opened the field for biosimilars, creating ample opportunities for market expansion. As biosimilars are less expensive alternatives to costly biologic therapies, they offer significant potential for healthcare cost savings, making them appealing for healthcare systems and patients. This, coupled with the rising global burden of chronic diseases including cancer, diabetes, and autoimmune disorders, where biologics play a crucial role in management, is also augmenting the product demand. In addition to this, various regulatory bodies such as the FDA and EMA have streamlined the approval pathways for biosimilars, encouraging their development and market entry. Moreover, the rapid globalization of biosimilar companies looking to expand their footprint to unexplored markets. Besides this, continual innovations in biopharmaceutical manufacturing technologies have made it feasible to produce biosimilars with high efficacy and safety, further driving the market growth.

Biosimilar Market Trends/Drivers:

Upcoming Patent Expiry of Blockbuster Drugs

The expiry of patents on branded biologics is one of the key factors driving the growth of the market. Biologics are often protected by robust patent portfolios that prevent the entry of competing products for extended periods. However, once these patents expire, it opens the door for companies to develop and market comparable, more affordable alternatives. Over the next few years, multiple blockbuster biologics with billions in annual sales are set to lose patent protection. The end of these patent protections, therefore, represents a massive opportunity for manufacturers to bring their alternatives to market and gain a substantial market share, catalyzing the market growth.

Cost-Effectiveness

Biosimilars are less expensive to produce than their reference biologics, mainly due to reduced research and development (R&D) costs, as manufacturers do not need to repeat all the original clinical trials that were done for the reference product. Therefore, biosimilars can be priced significantly lower, offering an affordable alternative to often costly biologic therapies. This cost-effectiveness is particularly appealing for healthcare systems striving to manage increasing healthcare costs and for patients who may struggle with the high cost of biologic therapies. Furthermore, in emerging markets where biologic therapies may have previously been unaffordable, biosimilars can facilitate easier access to essential treatments.

Increase in Prevalence of Chronic Diseases

The prevalence of chronic diseases such as cancer, autoimmune disorders, and diabetes is on the rise worldwide. These conditions typically require long-term treatment with biologics, fueling the demand for these drugs. As biosimilars offer similar efficacy and safety profiles to the original biologics but at a lower cost, their use in the treatment of these chronic diseases is increasingly becoming the preferred choice. For instance, the rising incidences of diseases, including rheumatoid arthritis and psoriasis, which are managed with biologic drugs like tumor necrosis factor inhibitors, presents a large market for biosimilars of these drugs. As the global burden of chronic diseases continues to grow, it is anticipated that the product demand will similarly increase, propelling the market growth.

Biosimilar Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global biosimilar market report, along with forecasts at the global and regional levels from 2024-2032. Our report has categorized the market based on molecule, indication and manufacturing type.

Breakup by Molecule:

Infliximab

Insulin Glargine

Epoetin Alfa

Etanercept

Filgrastim

Somatropin

Rituximab

Follitropin Alfa

Adalimumab

Pegfilgrastim

Trastuzumab

Bevacizumab

Others

Infliximab represents the largest market segment

The report has provided a detailed breakup and analysis of the market based on the molecule. This includes Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, Adalimumab, Pegfilgrastim, Trastuzumab, Bevacizumab, and others. According to the report, infliximab accounted for the majority of the share in the market.

Infliximab, a monoclonal antibody, is used for the treatment of several chronic conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. A high prevalence of these conditions worldwide has augmented the demand for effective treatments. Moreover, the wide range of indications leads to a large patient population that could potentially benefit from infliximab.

The original reference product, Remicade, has been on the market for a long time, with a well-established efficacy and safety profile. Once its patent expired, the entry of infliximab biosimilars offered a more cost-effective treatment option for these chronic conditions. Furthermore, the relatively earlier patent expiry of Remicade compared to other biologics has significantly contributed to its widespread popularity. Besides this, the manufacturing process and formulation for monoclonal antibodies such as infliximab are now well-established, facilitating the development and production of biosimilars, thereby propelling the segment growth.

Breakup by Indication:

Auto-Immune Diseases

Blood Disorder

Diabetes

Oncology

Growth Deficiency

Female Infertility

Others

Auto-immune diseases dominate the market

The report has provided a detailed breakup and analysis of the market based on the indication. This includes auto-immune diseases, blood disorders, diabetes, oncology, growth deficiency, female infertility, and others. According to the report, auto-immune diseases represented the largest segment.

Autoimmune diseases include conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, which are prevalent worldwide, affecting millions of people. This high prevalence results in a substantial increase in the demand for effective treatments. These diseases are typically chronic, requiring long-term treatment, leading to a consistent demand for the associated therapies. Over the years, biologics have revolutionized the treatment of numerous autoimmune diseases, offering improved control and prognosis. Many of these biologics have now lost or are losing patent protection, opening the way for biosimilars. Additionally, the original biologics used to treat autoimmune diseases can be expensive, placing a financial burden on healthcare systems and patients. Since biosimilars offer a more affordable alternative, they are becoming the preferred choice for patients and healthcare professionals. Furthermore, the increasing acceptance of biosimilars among physicians, patients, and healthcare systems for treating autoimmune diseases owing to their similar efficacy and safety profiles to the reference biologics is fueling the growth of this segment.

Breakup by Manufacturing Type:

In-house Manufacturing

Contract Manufacturing

In-house manufacturing accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house and contract manufacturing. According to the report, in-house manufacturing represented the largest segment.

In-house manufacturing allows complete control over the product quality, which is essential for biosimilars. Given the complexity of biologics and the strict regulations surrounding their manufacture, companies usually prefer to handle production themselves to ensure high standards are met. Moreover, biologic manufacturing processes often involve proprietary methods and technologies. In-house production helps protect these trade secrets, making it the preferred choice of manufacturing type. While the initial setup cost may be high, maintaining production in-house can significantly reduce costs per unit over time. Also, in-house manufacturing enables companies to minimize the risk of supply chain disruptions, ensuring a consistent supply of their products while facilitating flexibility and agility in production, including making adjustments or adaptations to the product or process as needed.

Breakup by Region:

Europe

Germany

France

Italy

Spain

United Kingdom

Rest of Europe

United States

Japan

India

South Korea

Others

Europe exhibits a clear dominance in the market

The report has also provided a comprehensive analysis of all the major regional markets, which include Europe (Germany, France, Italy, Spain, the United Kingdom, and Rest of Europe); the United States, Japan, India, South Korea, and Others. According to the report, Europe accounted for the largest market share.

Europe held the biggest share in the market since the region has a supportive regulatory environment, allowing several biosimilars to enter the European market well before other regions. This early start enabled Europe to gain a significant share of the market. Furthermore, the European Medicines Agency (EMA) has been a forerunner in creating a clear and supportive regulatory framework for the approval of biosimilars since 2005, earlier than many other regions. This early framework encouraged the development and marketing of biosimilars in the region. Various European countries have nationalized healthcare systems focused on cost-containment. Since biosimilars offer comparable clinical results to original biologics but at lower costs, they have become an attractive option in these settings. In addition to this, Europe has a high prevalence of diseases treated with biologics, such as autoimmune conditions and cancers. This high demand is supporting the growth of the market in the region. Apart from this, the increasing awareness and acceptance of biosimilars among healthcare professionals and patients in Europe has fueled their uptake, contributing to the market growth.

Competitive Landscape:

The market is experiencing a rise in strategic initiatives by key players aimed at capturing a larger share of the market. Companies are investing heavily in research and development (R&D) activities to introduce new biosimilars and improve their manufacturing processes. Numerous vendors are entering into strategic alliances, partnerships, and licensing deals to leverage the expertise of other companies and speed up the development, production, and marketing of their biosimilars. Besides this, several industry players are seeking regulatory approval for their biosimilars in new geographic markets to expand their global footprint. To build trust and confidence in their biosimilars, the leading manufacturers are conducting post-marketing surveillance studies to confirm the long-term safety and efficacy of their products. We also expect the market to witness a surge in product innovations, launch of new patient support programs, and rise in mergers and acquisitions (M&As) among key players to drive healthy competition within the domain during the forecast period.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Sandoz International GmbH

Pfizer Inc.

Teva Pharmaceutical Industries Limited

Celltrion Inc.

Biocon Limited

Samsung Biologics

Amgen, Inc.

Dr. Reddy's Laboratories Limited

Stada Arzneimittel Ag

Recent Developments:

In Jan 2023, Amgen Inc. announced that AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.

In October 2022, Biocon Biologics Ltd., a subsidiary of Biocon Ltd., announced that it has entered into a strategic out-licensing agreement with Japanese pharmaceuticals company Yoshindo Inc. Under the terms of this deal, Yoshindo will get exclusive commercialization rights in the Japanese market for two of the company's pipeline biosimilar assets, bUstekinumab and bDenosumab.

In June 2020, Pfizer Inc. received the approval from the United States (U.S.) Food and Drug Administration (FDA) for NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). This biosimilar is indicated to lower the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Key Questions Answered in This Report

  • 1. What was the size of the global biosimilar market in 2023?
  • 2. What is the expected growth rate of the global biosimilar market during 2024-2032?
  • 3. What are the key factors driving the global biosimilar market?
  • 4. What has been the impact of COVID-19 on the global biosimilar market?
  • 5. What is the breakup of the global biosimilar market based on the molecule?
  • 6. What is the breakup of the global biosimilar market based on the indication?
  • 7. What is the breakup of the global biosimilar market based on the manufacturing type?
  • 8. What are the key regions in the global biosimilar market?
  • 9. Who are the key companies/players in the global biosimilar market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Biosimilar Market - Introduction

  • 4.1 Overview
  • 4.2 WHO and FDA Terminology on Biosimilars
  • 4.3 Biosimilars and Generics
  • 4.4 Biosimilars and Branded Biological Products

5 Why are Biosimilars So Lucrative?

  • 5.1 Patent Expiry of Blockbuster Biological Drugs
  • 5.2 Significant Price Differential between Biosimilars and Innovator Drugs
  • 5.3 Savings for the Government and Third Party Payers
  • 5.4 Rising Prevalence of Lifestyle Diseases
  • 5.5 Incentives for Prescribers, Pharmacists and Patients
  • 5.6 Emergence of New Players in Europe and Emerging Markets
  • 5.7 Increasing Product Differentiation as Manufacturers Tie-Up with Drug Delivery Device Companies

6 Biosimilar Research, Development and Manufacturing

  • 6.1 Research and Development: Biosimilars vs. Innovator Drugs
  • 6.2 Manufacturing: Biosimilars vs. Innovator Drugs

7 Global Biosimilar Market

  • 7.1 Market Overview
  • 7.2 Historical Performance
  • 7.3 Impact of COVID-19
  • 7.4 Market Breakup by Segment
  • 7.5 Market Breakup by Manufacturing Type
  • 7.6 Market Breakup by Indication
  • 7.7 Market Breakup by Region
  • 7.8 Market Forecast
  • 7.9 Biosimilar Patent Landscape
    • 7.9.1 Patent Landscape in the US
    • 7.9.2 Patent Landscape in Europe
    • 7.9.3 Patent Landscape in Japan
  • 7.10 SWOT Analysis
    • 7.10.1 Overview
    • 7.10.2 Strengths
    • 7.10.3 Weaknesses
    • 7.10.4 Opportunities
    • 7.10.5 Threats
  • 7.11 Value Chain Analysis
    • 7.11.1 Characterizing the Existing Innovator Drug
    • 7.11.2 Research and Development
      • 7.11.2.1 Characterization of Biosimilars
      • 7.11.2.2 Developing a Unique Cell Line
    • 7.11.3 Product Development
      • 7.11.3.1 Pre-Testing
      • 7.11.3.2 Intermediary Clinical Testing (PK/PD)
      • 7.11.3.3 Confirmatory Clinical Phase-III
    • 7.11.4 Final Product Formulation
    • 7.11.5 Marketing and Distribution
  • 7.12 Porter's Five Forces Analysis
    • 7.12.1 Overview
    • 7.12.2 Bargaining Power of Buyers
    • 7.12.3 Bargaining Power of Suppliers
    • 7.12.4 Degree of Competition
    • 7.12.5 Threat of New Entrants
    • 7.12.6 Threat of Substitutes
  • 7.13 Price Analysis
    • 7.13.1 Key Price Indicators
    • 7.13.2 Price Trends
    • 7.13.3 Margin Analysis

8 Market Breakup by Molecule

  • 8.1 Infliximab
  • 8.2 Insulin Glargine
  • 8.3 Epoetin Alfa
  • 8.4 Etanercept
  • 8.5 Filgrastim
  • 8.6 Somatropin
  • 8.7 Rituximab
  • 8.8 Follitropin Alfa
  • 8.9 Adalimumab
  • 8.10 Pegfilgrastim
  • 8.11 Trastuzumab
  • 8.12 Bevacizumab
  • 8.13 Others

9 Market Breakup by Manufacturing Type

  • 9.1 In-house Manufacturing
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Contract Manufacturing
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast

10 Market Breakup by Indication

  • 10.1 Auto-Immune Diseases
    • 10.1.1 Market Trends
    • 10.1.2 Market Forecast
  • 10.2 Blood Disorder
    • 10.2.1 Market Trends
    • 10.2.2 Market Forecast
  • 10.3 Diabetes
    • 10.3.1 Market Trends
    • 10.3.2 Market Forecast
  • 10.4 Oncology
    • 10.4.1 Market Trends
    • 10.4.2 Market Forecast
  • 10.5 Growth Deficiency
    • 10.5.1 Market Trends
    • 10.5.2 Market Forecast
  • 10.6 Female Infertility
    • 10.6.1 Market Trends
    • 10.6.2 Market Forecast
  • 10.7 Others
    • 10.7.1 Market Trends
    • 10.7.2 Market Forecast

11 Market Breakup by Region

  • 11.1 Europe
    • 11.1.1 Market Performance
    • 11.1.2 Key Players and Biosimilars
    • 11.1.3 Market Breakup by Country
    • 11.1.4 Market Forecast
    • 11.1.5 Italy
      • 11.1.5.1 Market Performance
      • 11.1.5.2 Key Players and Biosimilars
      • 11.1.5.3 Market Forecast
    • 11.1.6 Germany
      • 11.1.6.1 Market Performance
      • 11.1.6.2 Key Players and Biosimilars
      • 11.1.6.3 Market Forecast
    • 11.1.7 France
      • 11.1.7.1 Market Performance
      • 11.1.7.2 Key Players and Biosimilars
      • 11.1.7.3 Market Forecast
    • 11.1.8 United Kingdom
      • 11.1.8.1 Market Performance
      • 11.1.8.2 Key Players and Biosimilars
      • 11.1.8.3 Market Forecast
    • 11.1.9 Spain
      • 11.1.9.1 Market Performance
      • 11.1.9.2 Key Players and Biosimilars
      • 11.1.9.3 Market Forecast
    • 11.1.10 Rest of Europe
      • 11.1.10.1 Market Performance
      • 11.1.10.2 Market Forecast
  • 11.2 United States
    • 11.2.1 Current Market Trends
    • 11.2.2 Key Players and Biosimilars
    • 11.2.3 Market Forecast
  • 11.3 Japan
    • 11.3.1 Market Performance
    • 11.3.2 Key Players and Biosimilars
    • 11.3.3 Market Forecast
  • 11.4 India
    • 11.4.1 Current Market Trends
    • 11.4.2 Key Players and Biosimilars
    • 11.4.3 Market Forecast
  • 11.5 South Korea
    • 11.5.1 Current Market Trends
    • 11.5.2 Key Players and Biosimilars
    • 11.5.3 Market Forecast
  • 11.6 Rest of the World
    • 11.6.1 Current Market Trends
    • 11.6.2 Market Forecast

12 Requirements for Setting Up a Biosimilar Manufacturing Plant

  • 12.1 Manufacturing Process
  • 12.2 Raw Material Requirements
  • 12.3 Raw Material Pictures
  • 12.4 Land and Construction Requirements
  • 12.5 Machinery and Infrastructure Requirements
  • 12.6 Machinery Pictures
  • 12.7 Plant Layout
  • 12.8 Packaging Requirements
  • 12.9 Utility Requirements
  • 12.10 Manpower Requirements

13 Competitive Landscape

  • 13.1 Market Structure
  • 13.2 Key Players
  • 13.3 Profiles of Key Players
    • 13.3.1 Sandoz International GmbH
    • 13.3.2 Pfizer Inc.
    • 13.3.3 Teva Pharmaceutical Industries Limited
    • 13.3.4 Celltrion Inc.
    • 13.3.5 Biocon Limited
    • 13.3.6 Samsung Biologics
    • 13.3.7 Amgen, Inc.
    • 13.3.8 Dr. Reddy's Laboratories Limited
    • 13.3.9 Stada Arzneimittel Ag

List of Figures

  • Figure 1: Global: Biosimilar Market: Sales Value (in Billion US$), 2018-2023
  • Figure 2: Global: Biosimilar Market: Breakup by Molecule (in %), 2023
  • Figure 3: Global: Biosimilar Market: Breakup by Manufacturing Type (in %), 2023
  • Figure 4: Global: Biosimilar Market: Breakup by Indication (in %), 2023
  • Figure 5: Global: Biosimilar Market: Breakup by Region (in %), 2023
  • Figure 6: Global: Biosimilar Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 7: Global: Biosimilars Industry: SWOT Analysis
  • Figure 8: Global: Biosimilar Industry: Value Chain Analysis
  • Figure 9: Global: Biosimilars Industry: Porter's Five Forces Analysis
  • Figure 10: Global: Biosimilar Market: Average Price Trends of Inflectra
  • Figure 11: Global: Biosimilar Market: Average Price Trends of Zarxio
  • Figure 12: Biosimilars Industry: Breakup of Profit Margins at Various Level of the Value Chain
  • Figure 13: Infliximab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 14: Infliximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 15: Insulin Glargine: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 16: Insulin Glargine: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 17: Epoetin Alfa: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 18: Epoetin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 19: Etanercept: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 20: Etanercept: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 21: Filgrastim: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 22: Filgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 23: Somatropin: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 24: Somatropin: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 25: Rituximab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 26: Rituximab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 27: Follitropin Alfa: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 28: Follitropin Alfa: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 29: Adalimumab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 30: Adalimumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 31: Pegfilgrastim: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 32: Pegfilgrastim: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: Trastuzumab: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 34: Trastuzumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Bevacizumab: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 36: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: In-House Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 38: In-House Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: Contract Manufacturing: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 40: Contract Manufacturing: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: Global: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Global: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2024-2032
  • Figure 43: Global: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2018 & 2023
  • Figure 44: Global: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2024-2032
  • Figure 45: Global: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2018 & 2023
  • Figure 46: Global: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2024-2032
  • Figure 47: Global: Biosimilar Market (Oncology): Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Global: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2024-2032
  • Figure 49: Global: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Global: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2024-2032
  • Figure 51: Global: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2018 & 2023
  • Figure 52: Global: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2024-2032
  • Figure 53: Global: Biosimilar Market (Others): Sales Value (in Million US$), 2018 & 2023
  • Figure 54: Global: Biosimilar Market Forecast (Others): Sales Value (in Million US$), 2024-2032
  • Figure 55: Europe: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 56: Europe: Biosimilar Market: Breakup by Country (in %), 2023
  • Figure 57: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 58: Italy: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 59: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 60: Germany: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 61: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 62: France: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 63: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 64: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 65: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 66: Spain: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 67: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 68: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 69: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 70: United States: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 71: United States: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 72: Japan: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 73: Japan: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 74: India: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 75: India: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 76: South Korea: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 77: South Korea: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 78: Others: Biosimilar Market: Sales Value (in Million US$), 2018-2023
  • Figure 79: Others: Biosimilar Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 80: Biosimilar Manufacturing: Detailed Process Flow
  • Figure 81: Biosimilar Manufacturing Plant: Raw Materials Requirement
  • Figure 82: Biosimilar Manufacturing Process: Conversion Rates of Feedstocks
  • Figure 83: Biosimilar Manufacturing Plant: Machinery Costs (in US$)
  • Figure 84: Biosimilar Manufacturing Plant: Primary Packaging
  • Figure 85: Biosimilar Manufacturing Plant: Secondary Packaging
  • Figure 86: Biosimilar Manufacturing Plant: Tertiary Packaging

List of Tables

  • Table 1: Global: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$), 2023
  • Table 2: Global: Biosimilar Market: Biosimilars Vs Innovators Drug Development
  • Table 3: Global: Biosimilar Market: Biosimilars Vs Biologics Manufacturing
  • Table 4: Global: Biosimilar Market: Key Industry Highlights, 2023 and 2032
  • Table 5: US: Biosimilar Market: Patent Landscape
  • Table 6: Europe: Biosimilar Market: Patent Landscape
  • Table 7: Japan: Biosimilar Market: Patent Landscape
  • Table 8: Global: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
  • Table 9: Global: Biosimilar Market: Breakup by Molecule (in Million US$), 2024-2032
  • Table 10: Global: Infliximab: Brand & Biosimilar Market Overview
  • Table 11: Global: Insulin Glargine: Brand & Biosimilar Market Overview
  • Table 12: Global: Epoetin Alfa: Brand & Biosimilar Market Overview
  • Table 13: Global: Etanercept: Brand & Biosimilar Market Overview
  • Table 14: Global: Filgrastim: Brand & Biosimilar Market Overview
  • Table 15: Global: Somatropin: Brand & Biosimilar Market Overview
  • Table 16: Global: Rituximab: Brand & Biosimilar Market Overview
  • Table 17: Global: Follitropin Alfa: Brand & Biosimilar Market Overview
  • Table 18: Global: Adalimumab: Brand & Biosimilar Market Overview
  • Table 19: Global: Pegfilgrastim: Brand & Biosimilar Market Overview
  • Table 20: Global: Trastuzumab: Brand & Biosimilar Market Overview
  • Table 21: Global: Bevacizumab: Brand & Biosimilar Market Overview
  • Table 22: Global: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2024-2032
  • Table 23: Global: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2024-2032
  • Table 24: Global: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2024-2032
  • Table 25: Europe: Biosimilar Market: Key Players and Biosimilars
  • Table 26: Italy: Biosimilar Market: Key Players and Biosimilars
  • Table 27: Germany: Biosimilar Market: Key Players and Biosimilars
  • Table 28: France: Biosimilar Market: Key Players and Biosimilars
  • Table 29: United Kingdom: Biosimilar Market: Key Players and Biosimilars
  • Table 30: Spain: Biosimilar Market: Key Players and Biosimilars
  • Table 31: United States: Biosimilar Market: Key Players and Biosimilar
  • Table 32: United States: Biosimilar Market: Launch of Expected Biosimilar
  • Table 33: Japan: Biosimilar Market: Key Players and Biosimilars
  • Table 34: India: Biosimilar Market: Key Players and Biosimilars
  • Table 35: South Korea: Biosimilar Market: Key Players and Biosimilar
  • Table 36: Biosimilar Manufacturing Plant: Manpower Requirements
  • Table 37: Biosimilar Market: Competitive Structure
  • Table 38: Global: Biosimilar Market: Key Players