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市場調查報告書

商品編碼

1830976

腫瘤生物相似藥市場

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個工作天內

價格

簡介目錄

2024 年腫瘤生物相似藥市場價值為 106.7 億美元，預計到 2031 年將成長至 247.1 億美元，2025 年至 2031 年的預計複合年成長率為 12.8%。

市場洞察與分析師觀點：生物相似藥是在安全性、有效性和品質方面與現有參考生物藥物非常相似（儘管它們並不完全相同）的生物製藥產品。現有的生物相似藥包括單株抗體和支持藥物，如非格司亭、培非格司亭、依泊汀 A 和依泊汀ζ，用於治療各種癌症。市場受到癌症發生率上升、生物相似藥的成本效益以及腫瘤生物相似藥核准增加等因素的驅動。此外，預計未來幾年生物相似藥製造商之間的合作和臨床試驗將為腫瘤生物相似藥市場帶來新的趨勢。然而，高昂的製造成本和生物相似藥生產的複雜性對市場成長構成了挑戰。

腫瘤生物相似藥市場規模和佔有率 - 市場促進因素：根據世界衛生組織 (WHO) 統計，2022 年全球報告約有 2000 萬例新發癌症病例和 970 萬例癌症相關死亡病例。世衛組織全球癌症觀察站的最新估計表明，10 種不同類型的癌症約佔 2022 年全球新病例和死亡人數的三分之二。肺癌最常見，新增病例 250 萬例，佔總數的 12.4%。女性乳癌緊追在後，為 230 萬例（11.6%），大腸癌佔新增病例的 9.6%。前列腺癌和胃癌分別位居第四和第五，分別為 150 萬例和 97 萬例。更實惠的腫瘤生物學名藥的推出可以減輕醫療成本，並增加獲得有效癌症治療的機會，因為它們在現實環境中已被證明是安全的和有效的，並有臨床證據和理化品質資料支持。例如，多學科數位出版研究所 (MDPI) 於 2023 年 7 月發表的一項研究比較了用於治療癌症的生物學名藥單株抗體 (mAb) 與其參考藥物的安全性，得出結論：貝伐單抗、曲妥珠單抗和利妥昔單抗等生物學名藥與其原廠藥之間的安全性沒有顯著差異。這支持使用生物相似藥作為生物製劑原廠藥的可行替代品。因此，日益加重的癌症負擔和不斷上升的死亡率使得人們需要負擔得起的治療選擇，從而推動腫瘤生物相似藥市場的成長。

策略洞察：細分與範圍：《腫瘤生物相似藥市場分析與預測（2030年）》是一項深入研究，重點關注全球市場動態，旨在識別關鍵促進因素、未來趨勢和獲利機會，從而幫助精準定位主要收入來源。報告概述了市場概況，並根據藥物類別、癌症類型和配銷通路進行了詳細細分。此外，報告還對主要市場參與者及其策略發展進行了深入分析。腫瘤生物相似藥市場報告涵蓋北美、歐洲、亞太地區、南美和中美以及中東和非洲的市場表現進行評估。

細分評估：市場按藥物類別細分為單株抗體、粒細胞集落刺激因子和紅血球生成促效劑 (ESA)。 2023 年，單株抗體佔據腫瘤生物相似藥市場最大佔有率，預計 2023 年至 2031 年期間的複合年成長率最高。單株抗體可以透過多種機制消除癌細胞，包括阻斷配體-受體生長和存活途徑。主要機制包括抗體依賴性細胞毒性 (ADCC) 和補體介導的細胞毒性。截至 2019 年 12 月，利妥昔單抗、曲妥珠單抗和貝伐單抗是歐洲藥品管理局 (EMA) 和美國食品藥物管理局 (FDA) 批准用於癌症治療的生物相似藥單株抗體的例子。

市場依癌症類型分為大腸直腸癌、子宮頸癌、乳癌、支持性治療、淋巴瘤等。支持性治療領域在 2023 年佔據了最大的市場佔有率，而結直腸癌預計在 2023 年至 2031 年期間的複合年成長率最高。據世界衛生組織稱，癌症是一個重大的健康問題，也是全球主要的死亡原因。隨著癌症發生率的上升，許多腫瘤生物相似藥製造商都專注於開發和推出新產品。例如，Celltrion 的 CT-P16、Prestige Biopharma 的 163 HD204、Cipla Biotech 的 CBT124 和北京天廣實生物科技的 MIL60 都是貝伐單抗的潛在生物學名藥，目前正處於 3 期研究中，正在評估其在治療非小細胞肺癌患者中的安全性和有效性。

根據配銷通路，市場細分為醫院藥房、零售藥房和線上藥房。 2022年，醫院藥局佔據最大市場佔有率，而線上藥局預計將在2023年至2031年期間實現最高複合年成長率。醫院藥局是病人購買處方藥（包括生物相似藥）的主要平台。

區域分析：就收入而言，2023年北美佔據了腫瘤生物相似藥市場的很大佔有率，其次是歐洲。預計在預測期內，癌症發病率的上升、用於治療癌症的生物學名藥獲批數量的增加以及先進的醫療基礎設施將推動北美腫瘤生物相似藥市場的發展。

癌症病例的增加、用於治療癌症的生物相似藥獲批數量的增加以及先進的醫療基礎設施預計將推動北美腫瘤生物相似藥市場的發展。生物製劑是美國最昂貴的藥物之一，預計生物相似藥將比其參考產品更具成本效益。 PubMed Central 於 2022 年 10 月發表的一篇文章中，基於截至 2021 年 6 月的美國藥品價格，分析了生物製劑和生物學名藥每單位的平均批發價 (AWP)，結果表明，生物學名藥可為貝伐單抗節省 15% 至 23% 的成本。在貝伐單抗生物相似藥中，Zirbes 的節省幅度明顯高於原廠產品 Avastin。用於支持性癌症治療的生物相似藥，例如非格司亭生物相似藥，與其參考產品相比可節省 17.3% 至 34%，而培非格司亭生物相似藥可節省 33% 至 37%。此外，Epogen 生物相似藥可節省 33.5%。根據 2022 年發布的 Cardinal Health 生物相似藥報告，FDA 已在美國批准了 33 種生物相似藥，其中 21 種已上市，17 種用於癌症治療。同一份報告估計，到 2025 年，生物相似藥可以減少美國藥品支出 1,330 億美元。因此，生物相似藥具有降低美國生物藥物成本的巨大潛力，使患者更容易獲得治療，促進創新和科學進步，從而推動該地區的腫瘤生物相似藥市場。

腫瘤生物相似藥市場報告範圍：產業發展與未來機會：腫瘤生物相似藥市場預測可以幫助利害關係人規劃其成長策略。以下是腫瘤生物相似藥市場主要參與者的一些關鍵發展和舉措：

2022年11月，Organon在加拿大推出了Avastin的生物相似藥AYBINTIO，針對某些侵襲性癌症患者，包括轉移性結直腸癌（mCRC）、轉移性肺癌和膠質母細胞瘤，從而擴大了該公司的生物相似藥產品組合。 2022年5月，Biocon Biologics和Viatris推出了羅氏Avastin（貝伐單抗）的生物相似藥Abemy，該藥已獲得加拿大衛生部批准用於治療四種癌症。 2020年4月，輝瑞獲得歐盟委員會（EC）批准，其單株抗體RUXIENCE可用於治療某些癌症，該藥是Mather（利妥昔單抗）的生物相似藥。 2020年1月，Chorus Biosciences與Innocents Biologics Co., Ltd.達成協議，在美國和加拿大開發和商業化貝伐單抗（Avastin）生物相似藥。競爭格局與主要公司：腫瘤生物相似藥市場包括CELLTRION公司、梯瓦製藥工業有限公司、輝瑞公司、山德士集團、Biocon公司、安進公司、三星Bioepis公司、Coherus BioSciences公司、BIOCAD公司和禮來公司。這些公司專注於推出新的高科技產品、改進現有技術並進行地理擴張，以滿足日益成長的全球消費者需求。

北美洲
- 美國
- 加拿大
- 墨西哥
歐洲
- 德國
- 法國
- 義大利
- 西班牙
- 英國
- 歐洲其他地區
亞太
- 澳洲
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
中東和非洲
- 南非
- 沙烏地阿拉伯
- 阿拉伯聯合大公國
- 中東和非洲其他地區
南美洲和中美洲
- 巴西
- 阿根廷
- 南美洲和中美洲其他地區

第 11 章：產業格局

併購
協議、合作、合資企業
新產品發布
擴張和其他策略發展

第 12 章：競爭格局

關鍵參與者的熱圖分析
公司定位與集中度

第 13 章：腫瘤生物相似藥市場 - 主要公司簡介

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：附錄

簡介目錄

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