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市场调查报告书

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1830976

肿瘤生物相似药市场

Oncology Biosimilars Market

出版日期: 2025年09月24日 | 出版商:

The Insight Partners | 英文 150 Pages | 商品交期: 1-5个工作天内

价格

简介目录

2024 年肿瘤生物相似药市场价值为 106.7 亿美元，预计到 2031 年将成长至 247.1 亿美元，2025 年至 2031 年的预计复合年增长率为 12.8%。

市场洞察与分析师观点：生物相似药是在安全性、有效性和品质方面与现有参考生物药物非常相似（儘管它们并不完全相同）的生物製药产品。现有的生物相似药包括单株抗体和支持药物，如非格司亭、培非格司亭、依泊汀 A 和依泊汀ζ，用于治疗各种癌症。市场受到癌症发生率上升、生物相似药的成本效益以及肿瘤生物相似药审批增加等因素的驱动。此外，预计未来几年生物相似药製造商之间的合作和临床试验将为肿瘤生物相似药市场带来新的趋势。然而，高昂的製造成本和生物相似药生产的复杂性对市场成长构成了挑战。

肿瘤生物相似药市场规模和份额 - 市场驱动因素：根据世界卫生组织 (WHO) 统计，2022 年全球报告约有 2000 万例新发癌症病例和 970 万例癌症相关死亡病例。世卫组织全球癌症观察站的最新估计表明，10 种不同类型的癌症约占 2022 年全球新病例和死亡人数的三分之二。肺癌最常见，新增病例 250 万例，占总数的 12.4%。女性乳癌紧追在后，为 230 万例（11.6%），大肠癌占新增病例的 9.6%。前列腺癌和胃癌分别位居第四和第五，分别为 150 万例和 97 万例。更实惠的肿瘤生物仿製药的推出可以减轻医疗成本，并增加获得有效癌症治疗的机会，因为它们在现实环境中已被证明是安全的和有效的，并有临床证据和理化品质资料支持。例如，多学科数位出版研究所 (MDPI) 于 2023 年 7 月发表的一项研究比较了用于治疗癌症的生物仿製药单株抗体 (mAb) 与其参考药物的安全性，得出结论：贝伐单抗、曲妥珠单抗和利妥昔单抗等生物仿製药与其原厂药之间的安全性没有显着差异。这支持使用生物相似药作为生物製剂原厂药的可行替代品。因此，日益加重的癌症负担和不断上升的死亡率使得人们需要负担得起的治疗选择，从而推动肿瘤生物相似药市场的成长。

策略洞察：细分与范围：《肿瘤生物相似药市场分析与预测（2030年）》是一项深入研究，重点关注全球市场动态，旨在识别关键驱动因素、未来趋势和获利机会，从而帮助精准定位主要收入来源。报告概述了市场概况，并根据药物类别、癌症类型和配销通路进行了详细细分。此外，报告还对主要市场参与者及其策略发展进行了深入分析。肿瘤生物相似药市场报告涵盖北美、欧洲、亚太地区、南美和中美以及中东和非洲的市场表现进行评估。

细分评估：市场按药物类别细分为单株抗体、粒细胞集落刺激因子和红血球生成刺激剂 (ESA)。 2023 年，单株抗体占据肿瘤生物相似药市场最大份额，预计 2023 年至 2031 年期间的复合年增长率最高。单株抗体可以透过多种机制消除癌细胞，包括阻断配体-受体生长和存活途径。主要机制包括抗体依赖性细胞毒性 (ADCC) 和补体介导的细胞毒性。截至 2019 年 12 月，利妥昔单抗、曲妥珠单抗和贝伐单抗是欧洲药品管理局 (EMA) 和美国食品药物管理局 (FDA) 批准用于癌症治疗的生物相似药单株抗体的例子。

市场依癌症类型分为大肠直肠癌、子宫颈癌、乳癌、支持性治疗、淋巴瘤等。支持性治疗领域在 2023 年占据了最大的市场份额，而结直肠癌预计在 2023 年至 2031 年期间的复合年增长率最高。据世界卫生组织称，癌症是一个重大的健康问题，也是全球主要的死亡原因。随着癌症发生率的上升，许多肿瘤生物相似药製造商都专注于开发和推出新产品。例如，Celltrion 的 CT-P16、Prestige Biopharma 的 163 HD204、Cipla Biotech 的 CBT124 和北京天广实生物科技的 MIL60 都是贝伐单抗的潜在生物仿製药，目前正处于 3 期研究中，正在评估其在治疗非小细胞肺癌患者中的安全性和有效性。

根据配销通路，市场细分为医院药房、零售药房和线上药房。 2022年，医院药局占据最大市场份额，而线上药局预计将在2023年至2031年期间实现最高复合年增长率。医院药局是病人购买处方药（包括生物相似药）的主要平台。

区域分析：就收入而言，2023年北美占据了肿瘤生物相似药市场的很大份额，其次是欧洲。预计在预测期内，癌症发病率的上升、用于治疗癌症的生物仿製药获批数量的增加以及先进的医疗基础设施将推动北美肿瘤生物相似药市场的发展。

癌症病例的增加、用于治疗癌症的生物相似药获批数量的增加以及先进的医疗基础设施预计将推动北美肿瘤生物相似药市场的发展。生物製剂是美国最昂贵的药物之一，预计生物相似药将比其参考产品更具成本效益。 PubMed Central 于 2022 年 10 月发表的一篇文章中，基于截至 2021 年 6 月的美国药品价格，分析了生物製剂和生物仿製药每单位的平均批发价 (AWP)，结果表明，生物仿製药可为贝伐单抗节省 15% 至 23% 的成本。在贝伐单抗生物相似药中，Zirbes 的节省幅度明显高于原厂产品 Avastin。用于支持性癌症治疗的生物相似药，例如非格司亭生物相似药，与其参考产品相比可节省 17.3% 至 34%，而培非格司亭生物相似药可节省 33% 至 37%。此外，Epogen 生物相似药可节省 33.5%。根据 2022 年发布的 Cardinal Health 生物相似药报告，FDA 已在美国批准了 33 种生物相似药，其中 21 种已上市，17 种用于癌症治疗。同一份报告估计，到 2025 年，生物相似药可以减少美国药品支出 1,330 亿美元。因此，生物相似药具有降低美国生物药物成本的巨大潜力，使患者更容易获得治疗，促进创新和科学进步，从而推动该地区的肿瘤生物相似药市场。

肿瘤生物相似药市场报告范围：产业发展与未来机会：肿瘤生物相似药市场预测可以帮助利害关係人规划其成长策略。以下是肿瘤生物相似药市场主要参与者的一些关键发展和倡议：

2022年11月，Organon在加拿大推出了Avastin的生物相似药AYBINTIO，针对某些侵袭性癌症患者，包括转移性结直肠癌（mCRC）、转移性肺癌和胶质母细胞瘤，从而扩大了该公司的生物相似药产品组合。 2022年5月，Biocon Biologics和Viatris推出了罗氏Avastin（贝伐单抗）的生物相似药Abemy，该药已获得加拿大卫生部批准用于治疗四种癌症。 2020年4月，辉瑞获得欧盟委员会（EC）批准，其单株抗体RUXIENCE可用于治疗某些癌症，该药是Mather（利妥昔单抗）的生物相似药。 2020年1月，Chorus Biosciences与Innocents Biologics Co., Ltd.达成协议，在美国和加拿大开发和商业化贝伐单抗（Avastin）生物相似药。竞争格局与主要公司：肿瘤生物相似药市场包括CELLTRION公司、梯瓦製药工业有限公司、辉瑞公司、山德士集团、Biocon公司、安进公司、三星Bioepis公司、Coherus BioSciences公司、BIOCAD公司和礼来公司。这些公司专注于推出新的高科技产品、改进现有技术并进行地理扩张，以满足日益增长的全球消费者需求。

北美洲
- 美国
- 加拿大
- 墨西哥
欧洲
- 德国
- 法国
- 义大利
- 西班牙
- 英国
- 欧洲其他地区
亚太
- 澳洲
- 中国
- 印度
- 日本
- 韩国
- 亚太其他地区
中东和非洲
- 南非
- 沙乌地阿拉伯
- 阿联酋
- 中东和非洲其他地区
南美洲和中美洲
- 巴西
- 阿根廷
- 南美洲和中美洲其他地区

第 11 章：产业格局

併购
协议、合作、合资企业
新产品发布
扩张和其他策略发展

第 12 章：竞争格局

关键参与者的热图分析
公司定位与集中度

第 13 章：肿瘤生物相似药市场 - 主要公司简介

Biocon
Celltrion Inc
Samsung Bioepis
Amgen Inc
Coherus BioSciences
Pfizer Inc
Sandoz International GmbH (A Novartis Division)
Teva Pharmaceutical Industries Ltd.
Lilly
BIOCAD

第 14 章：附录

简介目录

Product Code: TIPRE00002766

The oncology biosimilars market was valued at US$ 10.67 billion in 2024 and is expected to grow to US$ 24.71 billion by 2031, with a projected CAGR of 12.8% from 2025 to 2031.

Market Insights and Analyst View:Biosimilars are biopharmaceutical products that closely mimic existing reference biologic drugs in terms of safety, efficacy, and quality, though they are not identical. Available biosimilars include monoclonal antibodies and supportive agents like filgrastim, pegfilgrastim, epoetin a, and epoetin ζ, which are used to treat various cancers. The market is driven by factors such as an increase in cancer incidence, the cost-effectiveness of biosimilar drugs, and a rise in oncology biosimilar approvals. Furthermore, collaborations among manufacturers for biosimilars and clinical trials are expected to introduce new trends in the oncology biosimilars market in the coming years. However, high manufacturing costs and complexities in producing biosimilars pose challenges to market growth.

Oncology Biosimilars Market Size and Share - Market Drivers:According to the World Health Organization (WHO), approximately 20 million new cancer cases and 9.7 million cancer-related deaths were reported globally in 2022. The latest estimates from WHO's Global Cancer Observatory indicate that 10 different types of cancer accounted for about two-thirds of new cases and deaths worldwide in 2022. Lung cancer was the most prevalent, with 2.5 million new cases, representing 12.4% of the total. Female breast cancer followed with 2.3 million cases (11.6%), and colorectal cancer accounted for 9.6% of new cases. Prostate cancer and stomach cancer ranked fourth and fifth, with 1.5 million and 970,000 cases, respectively. The introduction of more affordable oncology biosimilars can alleviate healthcare costs and enhance access to effective cancer treatments due to their proven safety and efficacy in real-world settings, supported by clinical evidence and physicochemical quality data. For example, a study published by the Multidisciplinary Digital Publishing Institute (MDPI) in July 2023 compared the safety profiles of biosimilar monoclonal antibodies (mAbs) used in cancer with their reference counterparts, concluding that there were no significant differences in safety between biosimilars like bevacizumab, trastuzumab, and rituximab and their originators. This supports the use of biosimilars as viable alternatives to biologic originators. Consequently, the increasing cancer burden and rising mortality rates necessitate affordable treatment options, thereby driving the growth of the oncology biosimilars market.

Strategic Insights

Segmentation and Scope:The "Oncology Biosimilars Market Analysis and Forecast to 2030" is a detailed study focusing on global market dynamics to identify key drivers, future trends, and lucrative opportunities that can help pinpoint major revenue pockets. The report provides an overview of the market with detailed segmentation based on drug class, cancer type, and distribution channel. It also includes a thorough analysis of leading market players and their strategic developments. The scope of the oncology biosimilars market report encompasses an assessment of market performance across North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa.

Segmental Assessment:The market is segmented by drug class into monoclonal antibodies, granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs). In 2023, the monoclonal antibodies segment held the largest share of the oncology biosimilars market and is expected to register the highest CAGR from 2023 to 2031. Monoclonal antibodies can eliminate cancer cells through various mechanisms, including blocking ligand-receptor growth and survival pathways. Key mechanisms include antibody-dependent cellular cytotoxicity (ADCC) and complement-mediated cytotoxicity. Rituximab, Trastuzumab, and Bevacizumab are examples of biosimilar monoclonal antibodies approved by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) for cancer treatment as of December 2019.

The market is categorized by cancer type into colorectal cancer, cervical cancer, breast cancer, supportive care, lymphoma, and others. The supportive care segment held the largest market share in 2023, while colorectal cancer is projected to experience the highest CAGR from 2023 to 2031. According to WHO, cancer is a significant health issue and the leading cause of death globally. With the rising prevalence of cancer, many oncology biosimilar manufacturers are focused on developing and launching new products. For instance, CT-P16 by Celltrion, 163 HD204 by Prestige Biopharma, CBT124 by Cipla Biotech, and MIL60 by Beijing Mabworks Biotech are potential biosimilars of bevacizumab currently in phase 3 studies, being evaluated for safety and efficacy in treating patients with non-small cell lung cancer.

The market is segmented by distribution channel into hospital pharmacy, retail pharmacy, and online pharmacy. In 2022, the hospital pharmacy segment held the largest market share, while the online pharmacy segment is expected to register the highest CAGR from 2023 to 2031. Hospital pharmacies serve as the primary platform for patients to purchase prescription drugs, including biosimilars.

Regional Analysis:In terms of revenue, North America accounted for a significant share of the oncology biosimilars market in 2023, followed by Europe. The increasing incidence of cancer, growing approvals of biosimilars for cancer treatment, and advanced healthcare infrastructure are expected to drive the oncology biosimilars market in North America during the forecast period.

The rising cancer cases, increasing approvals of biosimilars for cancer treatment, and advanced healthcare infrastructure are anticipated to propel the oncology biosimilars market in North America. Biologics are among the most expensive medications in the US, and biosimilars are expected to be more cost-effective than their reference products. A cost comparison published in an article by PubMed Central in October 2022 analyzed the average wholesale price (AWP) per unit of biologics and biosimilars based on US drug prices as of June 2021, indicating that biosimilars could provide savings of 15-23% for bevacizumab. Among bevacizumab biosimilars, Zirbes offers significantly higher savings compared to the originator product, Avastin. Biosimilars for supportive cancer care agents, such as Filgrastim biosimilars, offer savings ranging from 17.3% to 34% compared to their reference products, while pegfilgrastim biosimilars provide savings from 33% to 37%. Additionally, Epogen biosimilars offer savings of 33.5%. According to the Cardinal Health Biosimilars Report published in 2022, the FDA has approved 33 biosimilars in the US, with 21 commercially available, 17 of which are used for cancer treatments. The same report estimates that biosimilars could reduce US drug expenditure by US$ 133 billion by 2025. Thus, biosimilars have significant potential to lower the costs of biologic medicines in the US, making care more accessible to patients and fostering innovations and scientific advancements, thereby driving the oncology biosimilars market in this region.

Oncology Biosimilars Market Report ScopeIndustry Developments and Future Opportunities:The oncology biosimilars market forecast can assist stakeholders in planning their growth strategies. Below are some key developments and initiatives undertaken by major players in the oncology biosimilars market:

In November 2022, Organon launched AYBINTIO, a biosimilar of Avastin, in Canada, aimed at patients with certain aggressive cancers, including metastatic colorectal cancer (mCRC), metastatic lung cancer, and glioblastoma, expanding the company's biosimilar portfolio.

In May 2022, Biocon Biologics and Viatris launched Abemy, a biosimilar to Roche's Avastin (Bevacizumab), which has been approved by Health Canada for four types of cancers.

In April 2020, Pfizer received approval from the European Commission (EC) for RUXIENCE, a monoclonal antibody biosimilar to Mather (rituximab), for treating certain cancers.

In January 2020, Chorus Biosciences entered into a licensing agreement with Innocents Biologics Co., Ltd. for the development and commercialization of a bevacizumab (Avastin) biosimilar in the US and Canada.

Competitive Landscape and Key Companies:Top players in the oncology biosimilars market include CELLTRION, Inc.; Teva Pharmaceutical Industries Ltd; Pfizer Inc; Sandoz Group AG; Biocon; Amgen Inc; Samsung Bioepis; Coherus BioSciences; BIOCAD; and Lilly. These companies focus on introducing new high-tech products, advancing existing technologies, and expanding geographically to meet the growing global consumer demand.

1. Introduction

1.1 Scope of the Study
1.2 Market Definition, Assumptions and Limitations
1.3 Market Segmentation

2. Executive Summary

2.1 Key Insights
2.2 Market Attractiveness Analysis

3. Research Methodology

4. Oncology Biosimilars Market Landscape

4.1 Overview
4.2 PEST Analysis
4.3 Ecosystem Analysis
- 4.3.1 List of Vendors in the Value Chain

5. Oncology Biosimilars Market - Key Market Dynamics

5.1 Key Market Drivers
5.2 Key Market Restraints
5.3 Key Market Opportunities
5.4 Future Trends
5.5 Impact Analysis of Drivers and Restraints

6. Oncology Biosimilars Market - Global Market Analysis

6.1 Oncology Biosimilars - Global Market Overview
6.2 Oncology Biosimilars - Global Market and Forecast to 2031

7. Oncology Biosimilars Market - Revenue Analysis (USD Million) - By Drug Class, 2021-2031

7.1 Overview
7.2 Monoclonal Antibodies
7.3 Erythropoiesis-Stimulating Agents
7.4 Granulocyte Colony-Stimulating Factor (G-CSF)

8. Oncology Biosimilars Market - Revenue Analysis (USD Million) - By Cancer Type, 2021-2031

8.1 Overview
8.2 Colorectal Cancer
8.3 Cervical Cancer
8.4 Breast Cancer
8.5 Supportive Care
8.6 Lymphoma
8.7 Others

9. Oncology Biosimilars Market - Revenue Analysis (USD Million) - By Distribution Channel , 2021-2031

9.1 Overview
9.2 Hospital Pharmacy
9.3 Retail Pharmacy
9.4 Online Pharmacy

10. Oncology Biosimilars Market - Revenue Analysis (USD Million), 2021-2031 - Geographical Analysis

10.1 North America
- 10.1.1 North America Oncology Biosimilars Market Overview
- 10.1.2 North America Oncology Biosimilars Market Revenue and Forecasts to 2031
- 10.1.3 North America Oncology Biosimilars Market Revenue and Forecasts and Analysis - By Drug Class
- 10.1.4 North America Oncology Biosimilars Market Revenue and Forecasts and Analysis - By Cancer Type
- 10.1.5 North America Oncology Biosimilars Market Revenue and Forecasts and Analysis - By Distribution Channel
- 10.1.6 North America Oncology Biosimilars Market Revenue and Forecasts and Analysis - By Countries
  - 10.1.6.1 United States Oncology Biosimilars Market
    - 10.1.6.1.1 United States Oncology Biosimilars Market, by Drug Class
    - 10.1.6.1.2 United States Oncology Biosimilars Market, by Cancer Type
    - 10.1.6.1.3 United States Oncology Biosimilars Market, by Distribution Channel
  - 10.1.6.2 Canada Oncology Biosimilars Market
    - 10.1.6.2.1 Canada Oncology Biosimilars Market, by Drug Class
    - 10.1.6.2.2 Canada Oncology Biosimilars Market, by Cancer Type
    - 10.1.6.2.3 Canada Oncology Biosimilars Market, by Distribution Channel
  - 10.1.6.3 Mexico Oncology Biosimilars Market
    - 10.1.6.3.1 Mexico Oncology Biosimilars Market, by Drug Class
    - 10.1.6.3.2 Mexico Oncology Biosimilars Market, by Cancer Type
    - 10.1.6.3.3 Mexico Oncology Biosimilars Market, by Distribution Channel
10.2 Europe
- 10.2.1 Germany
- 10.2.2 France
- 10.2.3 Italy
- 10.2.4 Spain
- 10.2.5 United Kingdom
- 10.2.6 Rest of Europe
10.3 Asia-Pacific
- 10.3.1 Australia
- 10.3.2 China
- 10.3.3 India
- 10.3.4 Japan
- 10.3.5 South Korea
- 10.3.6 Rest of Asia-Pacific
10.4 Middle East and Africa
- 10.4.1 South Africa
- 10.4.2 Saudi Arabia
- 10.4.3 U.A.E
- 10.4.4 Rest of Middle East and Africa
10.5 South and Central America
- 10.5.1 Brazil
- 10.5.2 Argentina
- 10.5.3 Rest of South and Central America

11. Industry Landscape

11.1 Mergers and Acquisitions
11.2 Agreements, Collaborations, Joint Ventures
11.3 New Product Launches
11.4 Expansions and Other Strategic Developments

12. Competitive Landscape

12.1 Heat Map Analysis by Key Players
12.2 Company Positioning and Concentration

13. Oncology Biosimilars Market - Key Company Profiles

13.1 Biocon
- 13.1.1 Key Facts
- 13.1.2 Business Description
- 13.1.3 Products and Services
- 13.1.4 Financial Overview
- 13.1.5 SWOT Analysis
- 13.1.6 Key Developments
13.2 Celltrion Inc
13.3 Samsung Bioepis
13.4 Amgen Inc
13.5 Coherus BioSciences
13.6 Pfizer Inc
13.7 Sandoz International GmbH (A Novartis Division)
13.8 Teva Pharmaceutical Industries Ltd.
13.9 Lilly
13.10 BIOCAD