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生物製劑分子標靶治療學

市場調查報告書

商品編碼

1830981

單株抗體治療（mAB）市場

Monoclonal Antibody Therapeutics (mABs) 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

預計單株抗體療法 (mAB) 市場規模將從 2024 年的 2.4914 億美元擴大到 2031 年的 6.196 億美元，2025 年至 2031 年的預估複合年成長率為 13.9%。

市場洞察與分析師觀點：密集的研究和開發工作以及慢性病發病率的上升預計將對未來幾年單株抗體療法 (mAB) 市場的預測產生重大影響。

單株抗體 (mAb) 是一類特異性靶向特定抗原的統一抗體集合。治療性 mAb 的生產需要哺乳動物表達系統，該系統提供糖基化、正確折疊、定向和抗體肽鏈共價結合所需的細胞機制，產生完整且具有生物活性的分子。雙特異性抗體和三特異性抗體等創新抗體模式可以辨識單一抗原上的多個表位，而單域抗體則更容易穿透組織。這些先進的抗體類型可以提高抗體治療的療效，從而拓寬其應用領域。此外，這些抗體可以形成抗體-藥物偶聯物，增強化療藥物對特定細胞類型的標靶效率。基於 mAb 的藥物在各種疾病中的生產正在推動市場成長。製造商的策略性產品發佈為市場帶來了豐厚的利潤。此外，包含 mAb 的複方藥物趨勢在 mAb 治療市場中日益興起。

市場促進因素

基於單株抗體（mAB）的多種疾病藥物產量成長單株抗體療法（mAB）用於治療多種疾病，包括癌症、自體免疫疾病和代謝性疾病。這些由生物製藥公司和研究機構開發的藥物因其高特異性、有效的標靶能力以及極低的毒性和副作用，在全球市場上引起了廣泛關注。因此，mAB療法產能的提升預計將推動單株抗體療法（mAB）市場的成長。

市場機遇

透過製造商的策略發展推出創新產品

透過治療性單株抗體（mAB）製造商的產品上市，有機成長有望在不久的將來增強單株抗體治療（mAB）市場。 2022年3月，Adagio Therapeutics, Inc.宣布推出ADG20 (ADINTREVIMAB)，這是首個在COVID-19暴露前和暴露後預防及治療方面均達到具有統計學意義的主要終點的單克隆抗體，目前正在申請美國緊急使用授權（EUA）。

此外，透過併購實現的無機成長預計將帶來新型治療性單株抗體（mAB）的推出。例如，2023年7月，禮來公司宣布收購Versanis，這是一家專注於治療心臟代謝疾病的私人臨床階段生物製藥公司。此次收購使禮來公司能夠獲得Versanis的核心產品組合，其中包括一款名為bimagrumab的單克隆抗體產品，該產品目前正在進行“BELIEVE 2b期臨床研究”，旨在評估其作為獨立療法以及與司美格魯肽聯合用藥在減少脂肪量、保持肌肉量以及改善肥胖及相關併發症患者預後的潛力。預計這些因素將在未來幾年顯著促進單株抗體治療（mAB）市場的成長。

單株抗體治療（mAB）市場趨勢

以單株抗體 (mAB) 為特色的組合藥物：根據美國國立衛生研究院 (NIH) 2021 年的報告，羅氏和再生元（製藥公司）啟動了一項 2/3 期臨床試驗，以評估組合單株抗體對輕度至中度 COVID-19 患者的效果。他們正在評估“REGN-COV2”，這是一種結合兩種單株抗體（casirivimab 和 imdevimab）的雞尾酒療法，用於治療 COVID-19。兩家公司預計，這種組合單株抗體藥物可將住院率降低 70%，並且對 12 歲以上（體重超過 40 公斤）的兒童尤其有效。研究人員正在積極探索更多單株抗體的治療組合。例如，禮來公司開發的 bamlanivimab 和 etesevimab 在 2022 年對 COVID-19 表現出了積極的臨床效果。因此，利用單株抗體治療各種疾病的聯合用藥趨勢預計將在未來幾年在單株抗體療法 (mAB) 市場中獲得顯著的吸引力。

戰略洞察

報告細分和範圍：單株抗體療法（mAB）市場的分析是透過考慮以下細分進行的：產品、應用和配銷通路。

依產品類型，市場分為重組單株抗體 (mAB)、抗體-藥物偶聯物、雙特異性和多特異性單株抗體、生物相似藥及其他。按應用類型，單株抗體治療 (mAB) 市場細分為腫瘤學、自體免疫疾病及其他。自體免疫疾病細分市場進一步細分為類風濕性關節炎、牛皮癬、潰瘍性結腸炎及其他。配銷通路細分，包括醫院藥房、零售藥房及其他。

就產品而言，重組單株抗體 (mAB) 領域在 2022 年佔據了單株抗體治療 (mAB) 市場的最大佔有率。預計抗體-藥物偶聯物領域在預測期內的複合年成長率最快，為 18.5%。根據 ACS Publications 的報告，治療性重組單株抗體代表了尖端生物醫學研究，旨在開發有效的策略來治療目前尚無有效治療方法的多種疾病。托珠單抗是一種重組單株抗體，用於治療關節炎、特發性關節炎和類風濕性關節炎 (RA)。此外，重組單株抗體也可用於治療自體免疫疾病和癌症。貝伐單抗是一種重組單株抗體，目前用於治療乳癌、肺癌和大腸癌，以及 HIV-1、細菌毒素感染/反應以及 SARS-CoV-2 和伊波拉病毒感染。

抗體藥物偶聯物 (ADC) 是一類快速崛起的治療藥物，它將化療和免疫療法結合起來。根據美國國立衛生研究院 (NIH) 的報告，ADC 主要基於免疫球蛋白 G (IgG)，迄今已有 13 種 ADC 獲得美國食品藥物管理局 (FDA) 的批准。此外，目前有超過 90 種 ADC 正在處於臨床開發或試驗階段。

序號產品（已核准的 ADC）疾病適應症1

麥洛塔爾

復發性急性骨髓性白血病

2

阿德塞特里斯

復發性霍奇金淋巴瘤和復發性系統性間變性大細胞淋巴瘤

3

卡德西拉

HER2陽性轉移性乳癌

4

貝斯蓬薩

復發或難治性CD22陽性B細胞前驅急性淋巴性白血病

5

魯莫西提

復發或難治性毛細胞白血病或HCL

6

波利維

復發或難治性（R/R）瀰漫大B細胞淋巴瘤或DLBCL

7

帕德切夫

轉移性尿路上皮癌

8

恩赫圖

轉移性 HER2 陽性乳癌

9

特羅德爾維

轉移性三陰性乳癌

10

布倫雷普

復發或難治性多發性骨髓瘤

11

茲尼洛塔

大B細胞淋巴瘤

12

蒂夫達克

復發性或轉移性子宮頸癌治療

十三

埃拉希爾

鉑類抗藥性卵巢癌

來源：單次使用支援文章

因此，預計 ADC 的監管批准和針對罕見疾病治療策略的正在進行的臨床試驗將推動單株抗體療法 (mAB) 市場的成長，特別是在預測期內的抗體-藥物偶聯物領域。

區域分析：從地理上講，單株抗體治療 (mAB) 市場報告涵蓋北美、歐洲、亞太地區、中東和非洲以及南美和中美。 2022 年，北美在全球單株抗體治療 (mAB) 市場中佔有最大佔有率。預計亞太地區在 2022 年至 2030 年期間的複合年成長率最高。在北美，美國佔最大的市場佔有率，受益於 mAB 治療藥物的快速產品核准流程。根據發表在《BioMed Central》雜誌上的一項研究，截至 2019 年 12 月，美國 FDA 已批准 79 種治療性 mAB。其中，30 種用於癌症治療。 2021 年 5 月，FDA 批准了一種新的治療性 mAB-Sotrovimab 的 EUA，該藥物旨在用於治療重症 COVID-19 患者的門診治療。 2022年2月，FDA為禮來公司開發的針對Omicron變體的bebtelovimab頒發了緊急使用授權（EUA）。此外，etesevimab也是美國FDA核准的治療性單株抗體藥物之一。

單株抗體治療 (mAB) 市場報告範圍：產業發展與未來機會：單株抗體治療 (mAB) 市場主要參與者的幾項策略舉措概述如下：

2023年1月，阿斯特捷利康的Evusheld在歐盟獲得批准。 Evusheld是兩種長效抗體－替吉奧維馬單抗（Tixagevimab，AZD8895）和西加維馬單抗（Cilgavimab，AZD1061）的組合。美國政府透過美國衛生與公眾服務部、戰略防範與因應管理局（SRA）和生物醫學高級研究與發展管理局（BARDA）的聯邦資金支持該產品的開發。 2023年8月，再生元製藥公司（Regeneron Pharmaceuticals, Inc.）與生物醫學高級研究與發展管理局（BARDA）達成協議，以促進針對COVID-19的下一代單株抗體療法的臨床開發、生產和監管許可。根據該協議，再生元計劃與生物醫學高級研究與發展局 (BARDA) 合作，評估、進一步開發和生產該療法，並開展監管活動。競爭格局和主要公司：單株抗體療法 (mAB) 市場的知名公司包括葛蘭素史克、羅氏製藥、拜耳、安進、諾華、艾伯維、百時美施貴寶、楊森製藥、默克和阿斯特捷利康。單株抗體療法 (mAB) 市場報告包含公司定位和集中度分析，以評估市場主要參與者的表現。

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：單株抗體治療市場 - 關鍵公司簡介

F. Hoffmann-La-Roche
AstraZeneca
Bayer AG
Merck KGaA
GlaxoSmithKline plc
Amgen
Novartis AG
AbbVie Inc.
Janssen Pharmaceuticals
Bristol-Myers Squibb Company

第 14 章：附錄

簡介目錄

Product Code: TIPRE00003417

The market for monoclonal antibody therapeutics (mABs) is anticipated to expand from US$ 249.14 million in 2024 to US$ 619.6 million by 2031, reflecting a projected CAGR of 13.9% from 2025 to 2031.

Market Insights and Analyst Perspective:Intensive research and development efforts, along with a rising incidence of chronic diseases, are expected to significantly influence the forecast for the monoclonal antibody therapeutics (mABs) market in the upcoming years.

A monoclonal antibody (mAbs) is a uniform collection of antibodies that specifically target designated antigens. The manufacturing of therapeutic mAbs necessitates a mammalian expression system that provides the cellular machinery required for glycosylation, proper folding, orientation, and covalent binding of antibody peptide chains to create complete and biologically active molecules. Innovative antibody modalities, such as bispecific and trispecific antibodies, can recognize multiple epitopes on a single antigen, while single-domain antibodies can more easily penetrate tissues. These advanced antibody types can improve the efficacy of antibody therapeutics, thereby broadening their application areas. Additionally, these antibodies can form antibody-drug conjugates to enhance the targeting efficiency of chemotherapy agents towards specific cell types. The production of mAB-based drugs for various diseases is driving market growth. Strategic product launches by manufacturers present lucrative opportunities in the market. Moreover, the trend of combination drugs that include mABs is gaining traction in the mAbs therapeutic market.

Market Driver

Growth in Production of mAB-Based Drugs for Various Diseases

Monoclonal antibody therapeutics (mABs) are utilized to treat a diverse array of diseases, including cancer, autoimmune disorders, and metabolic conditions. These drugs, developed by biopharmaceutical companies and research institutions, have garnered significant attention in the global market due to their high specificity, effective targeting capabilities, and minimal toxicity and side effects. Consequently, an increase in the production capacity of mAB therapeutics is expected to propel the growth of the monoclonal antibody therapeutics (mABs) market.

Market Opportunity

Innovative Product Launches Through Strategic Developments by Manufacturers

Organic growth through product launches by manufacturers of therapeutic mABs is likely to enhance the monoclonal antibody therapeutics (mABs) market in the near future. In March 2022, Adagio Therapeutics, Inc. announced the launch of ADG20 (ADINTREVIMAB), the first monoclonal antibody to achieve primary endpoints with statistical significance for both pre-and post-exposure prophylaxis and treatment of COVID-19, seeking US Emergency Use Authorization (EUA).

Additionally, inorganic growth through mergers and acquisitions is expected to lead to the introduction of new therapeutic mABs. For example, in July 2023, Eli Lilly announced the acquisition of Versanis, a private clinical-stage biopharmaceutical company focused on treating cardiometabolic diseases. This acquisition allows Eli Lilly to access Versanis's core product portfolio, which includes a monoclonal antibody product named bimagrumab, currently being evaluated in the "BELIEVE Phase 2b study" as a standalone treatment and in combination with semaglutide for its potential to reduce fat mass, preserve muscle mass, and improve outcomes for individuals with obesity and related complications. These factors are anticipated to significantly contribute to the growth of the monoclonal antibody therapeutics (mABs) market in the coming years.

Monoclonal Antibody Therapeutics (mABs) Market Trends

Combination Drugs Featuring Monoclonal Antibodies (mABs)As per the National Institute of Health (NIH) 2021 report, Roche and Regeneron (pharmaceutical companies) initiated a phase 2/3 clinical trial to assess combination monoclonal antibodies for patients with mild to moderate COVID-19. They are evaluating "REGN-COV2," a cocktail drug that combines two monoclonal antibodies-casirivimab and imdevimab-for COVID-19 treatment. These companies anticipate that this combination mAB drug could reduce hospitalization by 70% and be particularly effective for children over 12 years old (weighing more than 40 kg). Researchers are actively exploring more therapeutic combinations of monoclonal antibodies. For instance, bamlanivimab and etesevimab developed by Eli Lilly demonstrated positive clinical outcomes for COVID-19 in 2022. Therefore, the trend of combination drugs utilizing monoclonal antibodies for various diseases is expected to gain significant traction in the monoclonal antibody therapeutics (mABs) market in the coming years.

Strategic Insights

Report Segmentation and Scope:The analysis of the monoclonal antibody therapeutics (mABs) market has been conducted by considering the following segments: product, application, and distribution channel.

The market is categorized by product into recombinant mABs, antibody-drug conjugates, bispecific and multispecific mABs, biosimilars, and others. By application, the monoclonal antibody therapeutics (mABs) market is segmented into oncology, autoimmune diseases, and others. The autoimmune diseases segment is further divided into rheumatoid arthritis, psoriasis, ulcerative colitis, and others. The distribution channel segmentation includes hospital pharmacies, retail pharmacies, and others.

In terms of product, the recombinant mABs segment held the largest share of the monoclonal antibody therapeutics (mABs) market in 2022. The antibody-drug conjugates segment is projected to exhibit the fastest CAGR of 18.5% during the forecast period. According to a report by ACS Publications, therapeutic recombinant monoclonal antibodies represent cutting-edge biomedical research aimed at developing effective strategies to treat a wide range of diseases for which no effective treatments currently exist. Tocilizumab is an example of a recombinant mAB used to treat arthritis, idiopathic arthritis, and rheumatoid arthritis (RA). Furthermore, recombinant mABs can also be utilized for treating autoimmune diseases and cancer. Bevacizumab is a recombinant mAB currently employed in the treatment of breast, lung, and colorectal cancers, as well as HIV-1, bacterial toxin infections/reactions, and infections from SARS-CoV-2 and the Ebola virus.

Antibody-drug conjugates (ADCs) are a rapidly emerging class of therapeutic agents that combine chemotherapy and immunotherapy. According to a NIH report, ADCs are primarily based on immunoglobulin G (IgG), with 13 ADCs having received approval from the US Food and Drug Administration (FDA) to date. Additionally, over 90 ADCs are currently in clinical development or trials.

Thus, the regulatory approvals of ADCs and ongoing clinical trials for treatment strategies targeting rare diseases are expected to drive the growth of the monoclonal antibody therapeutics (mABs) market, particularly in the antibody-drug conjugates segment during the forecast period.

Regional Analysis:Geographically, the Monoclonal Antibody Therapeutics (mABs) market report encompasses North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. In 2022, North America held the largest share of the global monoclonal antibody therapeutics (mABs) market. The Asia Pacific region is projected to experience the highest CAGR from 2022 to 2030. Within North America, the US represents the largest market share, benefiting from expedited product approval processes for mAB therapeutics. As of December 2019, 79 therapeutic mABs had been approved by the US FDA, according to a study published in the BioMed Central journal. Among these, 30 are intended for cancer treatment. In May 2021, the FDA granted EUA for a new therapeutic mAB-Sotrovimab-designed for outpatient use in treating individuals with severe COVID-19. In February 2022, the FDA issued EUA for bebtelovimab, developed by Eli Lilly and Company, targeting the Omicron variant. Additionally, etesevimab is another example of therapeutic mABs approved by the US FDA.

Monoclonal Antibody Therapeutics (mABs) Market Report Scope: Industry Developments and Future Opportunities:Several strategic initiatives by leading players in the monoclonal antibody therapeutics (mABs) market are outlined below:

In January 2023, AstraZeneca received approval for Evusheld in the European Union (EU). Evusheld is a combination of two long-acting antibodies-tixagevimab (AZD8895) and cilgavimab (AZD1061). The US government supported the development of this product through federal funding from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority.

In August 2023, Regeneron Pharmaceuticals, Inc. entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA) to facilitate clinical development, manufacturing, and regulatory licensure for next-generation monoclonal antibody therapy against COVID-19. Under this agreement, Regeneron aims to collaborate with BARDA to evaluate, further develop, and manufacture this therapy, as well as conduct regulatory activities.

Competitive Landscape and Key Companies:Prominent companies in the monoclonal antibody therapeutics (mABs) market include GlaxoSmithKline, F. Hoffmann-La Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KGaA, and AstraZeneca. The monoclonal antibody therapeutics (mABs) market report includes an analysis of company positioning and concentration to assess the performance of key players in the market.

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. Monoclonal Antibody Therapeutics Market Landscape

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

5. Monoclonal Antibody Therapeutics 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. Monoclonal Antibody Therapeutics Market - Global Market Analysis

6.1 Monoclonal Antibody Therapeutics - Global Market Overview
6.2 Monoclonal Antibody Therapeutics - Global Market and Forecast to 2030

7. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Product, 2020-2030

7.1 Overview
7.2 Recombinant Monoclonal Antibodies (mABs)
7.3 Antibody-Drug Conjugates
7.4 Bi-Multi Specific Monoclonal Antibodies (mABs)
7.5 Biosimilars
7.6 Others

8. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Application, 2020-2030

8.1 Overview
8.2 Cancer
8.3 Autoimmune Diseases
- 8.3.1 Rheumatoid Arthritis (RA)
- 8.3.2 Psoriasis
- 8.3.3 Ulcerative Colitis
- 8.3.4 Others
8.4 Others

9. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million) - By Distribution Channel, 2020-2030

9.1 Overview
9.2 Hospital Pharmacies
9.3 Retail Pharmacies
9.4 Others

10. Monoclonal Antibody Therapeutics Market - Revenue Analysis (USD Million), 2020-2030 - Geographical Analysis

10.1 North America
- 10.1.1 North America Monoclonal Antibody Therapeutics Market Overview
- 10.1.2 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts to 2030
- 10.1.3 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Product
- 10.1.4 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Application
- 10.1.5 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Distribution Channel
- 10.1.6 North America Monoclonal Antibody Therapeutics Market Revenue and Forecasts and Analysis - By Countries
  - 10.1.6.1 United States Monoclonal Antibody Therapeutics Market
    - 10.1.6.1.1 United States Monoclonal Antibody Therapeutics Market, by Product
    - 10.1.6.1.2 United States Monoclonal Antibody Therapeutics Market, by Application
    - 10.1.6.1.3 United States Monoclonal Antibody Therapeutics Market, by Distribution Channel
  - 10.1.6.2 Canada Monoclonal Antibody Therapeutics Market
    - 10.1.6.2.1 Canada Monoclonal Antibody Therapeutics Market, by Product
    - 10.1.6.2.2 Canada Monoclonal Antibody Therapeutics Market, by Application
    - 10.1.6.2.3 Canada Monoclonal Antibody Therapeutics Market, by Distribution Channel
  - 10.1.6.3 Mexico Monoclonal Antibody Therapeutics Market
    - 10.1.6.3.1 Mexico Monoclonal Antibody Therapeutics Market, by Product
    - 10.1.6.3.2 Mexico Monoclonal Antibody Therapeutics Market, by Application
    - 10.1.6.3.3 Mexico Monoclonal Antibody Therapeutics 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. Monoclonal Antibody Therapeutics Market - Key Company Profiles

13.1 F. Hoffmann-La-Roche
- 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 AstraZeneca
13.3 Bayer AG
13.4 Merck KGaA
13.5 GlaxoSmithKline plc
13.6 Amgen
13.7 Novartis AG
13.8 AbbVie Inc.
13.9 Janssen Pharmaceuticals
13.10 Bristol-Myers Squibb Company