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全球单克隆抗体治疗剂市场 - 2023-2030年
市场调查报告书
商品编码
1290357

全球单克隆抗体治疗剂市场 - 2023-2030年

Global Monoclonal Antibody Therapeutics Market - 2023-2030
出版日期: | 出版商: DataM Intelligence | 英文 195 Pages | 商品交期: 最快1-2个工作天内

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简介目录

市场概况

全球单克隆抗体疗法市场在2022年达到1,906.983亿美元，预计到2030年将见证有利可图的增长，达到5,313.146亿美元。在预测期内（2023-2030年），全球单克隆抗体疗法市场预计将呈现14.1%的复合增长率。

单克隆抗体治疗剂（mAbs）是由相同的抗体（或简单的抗体片段）以同质的方式产生。产品中每个抗体分子的抗原识别位点、生物相互作用、亲和力和下游的生物后果都是相同的。这使mAbs有别于多克隆抗体，后者的蛋白质序列和表位识别范围多种多样

全球单克隆抗体治疗剂市场正在扩大，其因素包括自身免疫性疾病的发病率不断提高，治疗管道的规模不断扩大，生物制药公司的投资及其在各国即将获得的医疗批准也为单克隆抗体治疗剂市场增长创造了积极的前景。

市场动态

越来越多的监管部门批准和推出的疗法推动了单克隆抗体治疗剂市场的增长

各监管机构对用于癌症或自身免疫性疾病的不同单克隆抗体疗法的监管批准数量不断增加，主要生物制药公司的临床试验不断增加，癌症患者人口增加，以及新的、创新的、技术先进的疗法，都有助于全球单克隆抗体疗法市场的增长。

此外，2023年1月5日，Nirsevimab的生物制剂许可申请（BLA）被美国FDA、药物评价和研究中心批准，用于治疗24个月以下、在整个第二轮RSV季节仍易发生严重呼吸道合胞病毒（RSV）疾病的儿童，以及进入或已经经历第一个RSV季节的婴儿和新生儿。因此，生物制药公司推出的新型疗法越来越多，推动了单克隆抗体治疗剂市场的发展。

生物技术公司在研究和开发方面的投资不断增加，为制造商创造了有利可图的机会

由于主要参与者或生物技术企业在研发能力方面的支出或投资不断增加，以实现独特的技术突破，单克隆抗体治疗剂的市场机会不断增加。推动单克隆抗体疗法市场的另一个趋势是呼吸系统疾病的发生率越来越高。

此外，2023年4月，杨森生物技术公司和纽约大学格罗斯曼医学院的研究人员进行的早期实验表明，一种生物工程的候选药物可以预防金黄色葡萄球菌的感染。

报告详细介绍了对mAbtyrins的初步评估，这是一种源自工程人类单克隆抗体（mAb）的组合分子，是一种能够粘附并识别金黄色葡萄球菌以便被免疫细胞吸收和根除的蛋白质。Centyrins是附着在mAb上的微小蛋白质，可以阻止这些病菌在人类免疫细胞中钻洞藏身。

较高的成本和严格的监管措施将阻碍市场的增长。

然而，包括单克隆抗体和重组蛋白在内的生物治疗剂已经发展成为当代医学的基础，但对于中低收入国家的人口来说，仍然在很大程度上遥不可及，部分原因在于其高昂的成本，尽管经常提供比标准护理更多的临床益处是对单克隆抗体治疗剂市场的一个制约因素。

一种mAb的平均年成本为96,731美元，对于34种mAb-适应症组合，它超过了100,000美元。尽管在获批的mAb-适应症组合中占40%，但血液学和肿瘤学mAb占价格在10万美元以上的组合中的85%以上。因此，上述这些因素限制了单克隆抗体治疗剂市场的增长。

COVID-19影响分析

各个行业的公司的财务健康都受到COVID-19大流行病和全世界众多国家封锁的影响。因此，在COVID-19公共卫生紧急情况期间，美国食品和药物管理局（FDA）发布了指导方针，其中包括帮助赞助商和研究人员的一般考虑因素，确保试验参与者的安全，坚持良好的临床实践（GCP），并尽量减少试验完整性的风险。

这些治疗性单克隆抗体也被用于控制COVID-19。例如，2022年2月11日，礼来公司宣布Bebtelovimab，一种对Omicron变体表现出中和作用的抗体，获得了美国食品和药物管理局（FDA）的紧急使用授权（EUA）。

俄乌战争影响分析

俄罗斯-乌克兰冲突估计对全球单克隆抗体疗法市场的影响不大，因为该地区的主要市场参与者数量较少。然而，在预测期内，原材料进出口的影响预计对全球单克隆抗体治疗剂市场的增长影响不大。

目录

第一章：方法和范围

  • 研究方法
  • 报告的研究目标和范围

第二章：定义和概述

第三章：执行摘要

  • 按产品类型分類的摘要
  • 按应用分类的摘要
  • 按终端用户分类
  • 按地区分类

第四章：动态变化

  • 影响因素
    • 驱动因素
      • 越来越多的监管部门批准和推出的治疗方法
      • 癌症和其他慢性病的发病率上升
    • 限制因素
      • 高成本和严格的监管措施
    • 机会
      • 生物技术公司对研究和开发的投资不断增加
    • 影响分析

第五章：行业分析

  • 波特的五力分析
  • 供应链分析
  • 价格分析
  • 监管分析

第六章：COVID-19分析

  • COVID-19的分析
    • COVID-19之前的情况
    • COVID-19期间的情况
    • COVID-19之后的情况
  • 在COVID-19期间的定价动态
  • 需求-供应谱系
  • 大流行期间与市场有关的政府倡议
  • 制造商的战略倡议
  • 结语

第七章：按产品类型

  • 裸体
  • 融合蛋白
  • 抗体片段
  • 共轭物
  • 多重特异性

第8章：按应用分类

  • 癌症
  • 自身免疫性疾病
  • 传染性疾病
  • 其他

第九章：按生产来源分类

  • 人类
  • 人源化
  • 嵌合体
  • 其他

第十章：按终端用户分类

  • 医院
  • 专科中心
  • 研究机构

第十一章：按地区划分

  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 意大利
    • 西班牙
    • 欧洲其他地区
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美其他地区
  • 亚太地区
    • 中国
    • 印度
    • 日本
      • 亚太其他地区
  • 中东和非洲
    • 关键区域的动态

第十二章 ：竞争格局

  • 竞争格局
  • 市场定位/份额分析
  • 合併和收购分析

第十三章 ：公司简介

  • F. Hoffmann-La Roche
    • 公司概述
    • 产品组合和说明
    • 财务概况
    • 主要发展情况
  • Novartis AG
  • Merck & Co. Inc.
  • Pfizer Inc.
  • Eli Lilly and Co. (Lilly)
  • Sanofi
  • AstraZeneca
  • Bayer AG
  • Regeneron Pharmaceuticals Inc.
  • GSK Plc

第十四章：附录

简介目录
Product Code: BT12

Market Overview

The Global Monoclonal Antibody Therapeutics Market reached US$ 190,698.3 million in 2022 and is projected to witness lucrative growth by reaching up to US$ 531,314.6 million by 2030. The global monoclonal antibody therapeutics market is expected to exhibit a CAGR of 14.1% during the forecast period (2023-2030).

Monoclonal antibody therapeutics (mAbs) are generated from identical antibodies (or simply antibody fragments) in a homogeneous manner. The antigen recognition site, biological interactions, affinity and downstream biologic consequences of every antibody molecule in the product are identical. This sets mAbs apart from polyclonal antibodies, which have a diverse range of protein sequences and epitope recognition

The global market for monoclonal antibody therapeutics is expanding as a result of factors including the increasing prevalence of autoimmune disorders, the growing size of the therapeutic pipeline, investment by biopharmaceutical companies and their upcoming medical approvals across countries are also creating a positive outlook for the monoclonal antibody therapeutics market growth.

Market Dynamics

Increasing Regulatory Approvals and Launch of Therapies Drive the Growth of the Monoclonal Antibody Therapeutics Market

The growing number of regulatory approvals by various regulatory bodies for different monoclonal antibodies therapeutics utilized for cancer or autoimmune diseases, the growing clinical trials by major biopharmaceutical companies, an increase in the population with cancer, and new, innovative, technologically sophisticated therapies are all contributing to the growth of the global market for monoclonal antibody therapeutics.

Furthermore, on January 5, 2023, Nirsevimab's Biologics License Application (BLA) was approved by the U.S. FDA, Center for Drug Evaluation and Research for the treatment of children up to 24 months old who are still susceptible to developing severe respiratory syncytial virus (RSV) disease throughout the second RSV season as well as for infants and newborns entering or already experiencing their first RSV season. Hence, the growing number of novel therapies launched by biopharmaceutical companies is driving the monoclonal antibody therapeutics market.

The Growing Investments in Research and Development by Biotechnology Companies Create Lucrative Opportunities for Manufacturers

Due to increasing spending or investments in research and development capabilities by key players or biotechnology businesses for unique technological breakthroughs, there is a growing market opportunity for monoclonal antibody therapeutics. Another trend driving the monoclonal antibody therapies market is the increasing occurrence of respiratory diseases.

Furthermore, in April 2023, early experiments conducted by researchers at Janssen Biotech, Inc. and NYU Grossman School of Medicine demonstrated that a bioengineered medication candidate can prevent infection with the bacterium species Staphylococcus aureus.

It details the preliminary evaluation of mAbtyrins, a combination molecule derived from an engineered human monoclonal antibody (mAb), a kind of protein that adheres to and identifies S. aureus for uptake and eradication by immune cells. Centyrins, tiny proteins that are attached to the mAb, stop these germs from drilling holes in the human immune cells where they hide.

Higher Costs and Strict Regulatory Measures will Hamper the Growth of the Market.

However, biotherapeutics, including monoclonal antibodies and recombinant proteins, which have grown into the foundation of contemporary medicine, are still largely beyond reach for populations in middle- and low-income countries, in part due to their high costs, despite often providing clinical benefits over the standard of care is a restraint for monoclonal antibody therapeutics market.

The average yearly cost of a mAb was $96,731, and for 34 mAb-indication combos, it exceeded $100,000. Despite making up 40% of the approved mAb-indication combinations, hematology and oncology mAbs accounted for over 85 percent of those with a price tag of $100,000 or higher. Hence these above mentioned factors are limiting the monoclonal antibody therapeutics market's growth.

COVID-19 Impact Analysis

The financial health of companies across all industries has been impacted by the COVID-19 pandemic and lockdown in numerous nations throughout the world. Therefore, for the period of the COVID-19 public health emergency, the U.S. Food and Drug Administration (FDA) issued guidelines that include general considerations to aid sponsors and researchers, ensuring the safety of trial participants, adhering to good clinical practice (GCP), and minimizing risks to trial integrity.

These therapeutic monoclonal antibodies were also used to control COVID-19. For instance, on February 11, 2022, Eli Lilly and Company announced that Bebtelovimab, an antibody that exhibits neutralization against the Omicron variant, received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a low impact on the global monoclonal antibody therapeutics market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global monoclonal antibody therapeutics market growth over the forecast period.

Segment Analysis

The global monoclonal antibody therapeutics market is segmented based on product type, application, production source, distribution channel and region.

Humanoid from the Production Source Segment Accounts for 45.79% of the Market Share Owing to Rising Novel Product Launches.

A humanized antibody possesses three advantages over a native mouse mAb: it is less immunogenic (since the immune response is primarily directed against the mouse Ig constant region); it can perform human effector functions; and its serum half-life in humans is significantly longer. Researchers have extracted the mouse CDRs targeted against a relevant human antigen and assembled them in a human antibody framework to further humanize these antibodies.

A humanized IgG4 anti-PD-1 monoclonal antibody called tislelizumab is being researched as a monotherapy and in conjunction with other treatments. Treatment of inoperable recurrent metastatic or locally progressed esophageal squamous cell carcinoma (ESCC) is possible in patients who had previously received systemic therapy with the anti-PD-1 immune checkpoint inhibitor tislelizumab.

Geographical Analysis

North America Accounted for Approximately 40.2% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Increasing Healthcare Infrastructure Investment

Manufacturers have chances to expand their operations in this region because of the rising demand for monoclonal antibody therapeutics for advancements in North America. The area has many producers and suppliers, and its rapid economic development has raised industrial production of monoclonal antibody therapeutics, which has increased the demand.

North America has a large number of producers and suppliers, and as a result of the swift economic development of the area, industrial production has increased, fueling the demand for monoclonal antibody therapeutics.

Rising new product types or applications will drive market growth. Growth is also fueled by rising technological advancements, regulatory approvals, and novel product launches. Researchers are becoming more aware of various kinds of treatment approaches for cancer or various other disorders, leading to the expansion of the market in this region.

Competitive Landscape

The major global players in the monoclonal antibody therapeutics market include: F. Hoffmann-La Roche, Sanofi, Merck & Co. Inc., Pfizer Inc., GSK Plc, Eli Lily and Co., Regeneron Pharmaceuticals Inc., AstraZeneca, and Bayers AG among others.

Why Purchase the Report?

  • To visualize the global monoclonal antibody therapeutics market segmentation based on product type, application, production source, end user and region, as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of monoclonal antibody therapeutics market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as Excel consisting of key products of all the major players.

The global monoclonal antibody therapeutics market report would provide approximately 53 tables, 54 figures and 195 Pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Product Type
  • 3.2. Snippet by Application
  • 3.3. Snippet by End User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Increasing Regulatory Approvals and Launch of Therapies
      • 4.1.1.2. Rising Incidence of Cancer and Other Chronic Diseases
    • 4.1.2. Restraints
      • 4.1.2.1. Higher Costs and Strict Regulatory Measures
    • 4.1.3. Opportunity
      • 4.1.3.1. The Growing Investments in Research and Development by Biotechnology Companies
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's 5 Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario Before COVID-19
    • 6.1.2. Scenario During COVID-19
    • 6.1.3. Scenario Post COVID-19
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Product Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 7.1.2. Market Attractiveness Index, By Product Type
  • 7.2. Naked *
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Fusion Protein
  • 7.4. Antibody Fragment
  • 7.5. Conjugate
  • 7.6. Multi-specific

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Cancer *
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Autoimmune Diseases
  • 8.4. Infectious Diseases
  • 8.5. Others

9. By Production Source

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 9.1.2. Market Attractiveness Index, By Production Source
  • 9.2. Human *
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Humanized
  • 9.4. Chimeric
  • 9.5. Others

10. By End User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.1.2. Market Attractiveness Index, By End User
  • 10.2. Hospital *
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Specialty Centers
  • 10.4. Research Institutes

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.7.1. The U.S.
      • 11.2.7.2. Canada
      • 11.2.7.3. Mexico
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.7.1. Germany
      • 11.3.7.2. The U.K.
      • 11.3.7.3. France
      • 11.3.7.4. Italy
      • 11.3.7.5. Spain
      • 11.3.7.6. Rest of Europe
  • 11.4. South America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.7.1. Brazil
      • 11.4.7.2. Argentina
      • 11.4.7.3. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.7.1. China
      • 11.5.7.2. India
      • 11.5.7.3. Japan

Australia

      • 11.5.7.4. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Production Source
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

  • 13.1. F. Hoffmann-La Roche *
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio and Description
    • 13.1.3. Financial Overview
    • 13.1.4. Key Developments
  • 13.2. Novartis AG
  • 13.3. Merck & Co. Inc.
  • 13.4. Pfizer Inc.
  • 13.5. Eli Lilly and Co. (Lilly)
  • 13.6. Sanofi
  • 13.7. AstraZeneca
  • 13.8. Bayer AG
  • 13.9. Regeneron Pharmaceuticals Inc.
  • 13.10. GSK Plc

LIST NOT EXHAUSTIVE

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us