2030 年单克隆抗体治疗 (mAB) 市场报告(按细分市场、地域、动态、最新发展和战略见解)

  • Report Code : TIPRE00003417
  • Category : Life Sciences
  • No. of Pages : 150
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[研究报告] 单克隆抗体疗法(mAB)市场规模预计将从 2022 年的 1920.4 亿美元增长到 2030 年的 5428.0 亿美元;预计 2022-2030 年期间市场复合年增长率为 13.9%。

 

 

市场洞察和分析师观点:

强劲的研究和开发以及慢性病患病率的上升可能会对未来几年单克隆抗体疗法 (mAB) 市场预测产生重大影响

单克隆抗体 (mAbs) 药物是具有针对选定靶抗原特异性的同质抗体集合。治疗性 mAbs 的生产过程需要哺乳动物表达系统,该系统提供糖基化、折叠、定向和共价结合抗体肽链所必需的细胞机制,以产生完整且具有生物功能的分子。双特异性和三特异性抗体等新型抗体可识别单个抗原上的多个表位,而单域抗体可以更轻松地穿透组织。这种先进的抗体类型可以提高抗体疗法的效率,从而扩大其应用领域。这些抗体还可以形成抗体-药物偶联物,以提高化疗药物针对特定细胞类型的效率。生产用于治疗多种疾病的 mAb 类药物推动了市场的发展。制造商通过战略发展推出的创新产品是有利可图的市场机会。此外,含有 mAB 的联合药物是 mAbs 治疗市场的市场趋势。

 

市场驱动因素

 

生产用于治疗多种疾病的 mAB 药物推动市场增长

 

单克隆抗体疗法 (mAB) 用于治疗多种疾病,包括癌症、自身免疫性疾病和代谢疾病。生物制药公司和科研机构生产的此类药物由于其特异性高、靶向性强、毒性和副作用低,在全球市场上引起了极大关注。因此,预计 mAB 疗法生产能力的提高将推动单克隆抗体疗法 (mAB) 市场的增长

 

欧盟和美国批准的治疗性 mAB

 

产品

 

品牌名称

 

疾病指征

 

批准年份:欧盟

 

批准年份:美国

波泽利单抗

维奥波兹

CHAPLE 病

不适用

2023

艾拉那单抗

艾雷克斯菲奥

多发性骨髓瘤

2023

2023

罗扎诺利珠单抗

瑞斯蒂格

全身性重症肌无力

2024

2023

塔奎单抗

塔尔维

多发性骨髓瘤

2023

2023

埃克替尼

艾金利

弥漫性大 B 细胞淋巴瘤

2023

2023

米利珠单抗

奥姆沃

溃疡性结肠炎

2023

2023

来源:抗体学会

 

市场机会

 

 

通过制造商的战略发展推出创新产品

治疗性 mAB 制造商推出产品等有机发展可能会在未来几年推动单克隆抗体治疗 (mAB) 市场的发展。2022 年 3 月,Adagio Therapeutics, Inc. 宣布推出 ADG20 (ADINTREVIMAB)。这款新推出的产品是首个通过寻求美国紧急使用授权 (EUA) 满足 COVID-19 暴露前和暴露后预防和治疗的主要终点且具有统计学意义的单克隆抗体。

此外,并购等无机发展将导致引入新的治疗性 mAB。例如,2023 年 7 月,Elli Lilly 宣布收购 Versanis,这是一家私营临床阶段生物制药公司,旨在治疗心脏代谢疾病。Elli Lilly 收购 Versanis 以获得其核心产品组合,包括名为 bimagrumab 的单克隆抗体产品。该产品目前正在“BELIEVE 第 2b 阶段研究”中作为独立分子进行评估。它还与 semaglutide 联合研究,以了解其在减少脂肪量、保持肌肉量和为肥胖和肥胖相关并发症患者提供更好患者结果方面的综合潜力。上述因素是未来几年单克隆抗体治疗 (mAB) 市场增长的重要原因。

 

单克隆抗体治疗 (mAB) 市场趋势

 

 

含有单克隆抗体 (mAB) 的联合药物

根据美国国立卫生研究院 (NIH) 2021 年的报告,罗氏和 Regeneron(制药公司)启动了2/3 期临床试验,以评估组合单克隆抗体对轻度至中度 COVID-19 患者的疗效。他们正在研究“REGN-COV2”,这是一种由两种单克隆抗体(casirivimab 和 imdevimab)组合而成的鸡尾酒药物,用于治疗 COVID-19。这些公司预计,这种 mAB 药物的组合将使住院率降低 70%,并且对 12 岁以上(体重超过 40 公斤)的儿童更有效。研究人员正在强烈寻找更多这样的单克隆抗体治疗组合。例如,礼来公司开发的bamlanivimab和etesivimab在2022年对COVID-19的临床治疗中取得了积极的效果。因此,用于治疗多种疾病的单克隆抗体联合药物将在未来几年受到广泛关注,从而成为单克隆抗体治疗(mAB)市场的一个突出趋势。

 

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单克隆抗体治疗 (mAB) 市场:

Monoclonal Antibody Therapeutics (mABs) Market
  • 获取此报告的关键市场趋势。
    这个免费样品将包括数据分析,从市场趋势到估计和预测。

 

报告细分和范围:

单克隆抗体疗法 (mAB) 市场分析考虑了以下几个部分:产品、应用和分销渠道

根据产品,市场分为重组单克隆抗体、抗体-药物偶联物、双特异性和多特异性单克隆抗体、生物仿制药和其他。根据应用,单克隆抗体治疗 (mAB) 市场分为肿瘤学、自身免疫性疾病和其他。自身免疫性疾病市场进一步细分为类风湿性关节炎、牛皮癣、溃疡性结肠炎和其他。根据分销渠道,单克隆抗体治疗 (mAB) 市场分为医院药房、零售药房和其他。

就产品而言,重组 mAB 领域在 2022 年占据了最大的单克隆抗体治疗 (mAB) 市场份额。预计抗体-药物偶联物领域在预测期内的复合年增长率将达到 18.5%,是最快的。根据 ACS 出版物报告,治疗性重组单克隆抗体反映了最先进的生物医学研究,通过规划有效的策略来治疗多种尚无有效治疗方法的疾病。托珠单抗是一种重组 mAB 药物,用于治疗关节炎、特发性关节炎和类风湿性关节炎 (RA)。此外,重组 mAB 还可用于治疗自身免疫性疾病和癌症等疾病。贝伐单抗是一种重组 mAB 药物,目前用于治疗乳腺癌、肺癌和结直肠癌;HIV-1;细菌毒素感染/反应以及 SARS-CoV-2 和埃博拉病毒感染。

抗体-药物偶联物(ADC)是一类快速崛起的治疗药物,也是利用化疗和免疫疗法相结合的新兴高效药物。根据美国国立卫生研究院的报告,目前,ADC 主要基于免疫球蛋白 G(IgG),到目前为止,美国食品药品管理局(FDA)已批准 13 种 ADC。此外,还有 90 多种 ADC 正在临床开发/试验中。

 

序号

 

产品(已批准的 ADC)

 

疾病指征

1

麦罗塔格

复发性急性髓性白血病

2

艾德西特里斯 

复发性霍奇金淋巴瘤和复发性系统性间变性大细胞淋巴瘤

3

卡德西拉

HER2 阳性转移性乳腺癌

4

贝斯蓬萨

复发或难治性 CD22 阳性 B 细胞前体急性淋巴细胞白血病

5

路莫西丁

复发或难治性毛细胞白血病或 HCL

6

波利维

复发或难治性 (R/R) 弥漫性大 B 细胞淋巴瘤或 DLBCL

7

帕德切夫

转移性尿路上皮癌

8

恩赫尔图

转移性 HER2 阳性乳腺癌

9

特罗德尔维

转移性三阴性乳腺癌

10

布伦雷普

复发或难治性多发性骨髓瘤

11

佐尼洛塔

大B细胞淋巴瘤

12

蒂夫达克

复发性或转移性宫颈癌的治疗

十三

埃拉希尔

铂类耐药性卵巢癌

来源:一次性使用支持文章

因此,在预测期内,ADC 的监管批准和针对罕见疾病治疗方法的正在进行的临床试验将推动抗体-药物偶联物领域单克隆抗体治疗 (mAB) 市场的增长。

 

区域分析:

根据地理位置,单克隆抗体治疗 (mAB) 市场报告涵盖北美、欧洲、亚太地区、中东和非洲以及南美和中美洲。2022 年,北美占据全球单克隆抗体治疗 (mAB) 最大的市场份额。预计亚太地区在 2022-2030 年期间的复合年增长率最高。在北美,美国占据最大的市场份额。mAB 治疗药物的加速产品审批程序使该国市场受益。根据发表在 BioMed Central 杂志上的一项研究显示的统计数据,截至 2019 年 12 月,美国 FDA 已批准 79 种治疗性 mAB。在 79 种治疗性 mAB 中,有 30 种用于癌症治疗。2021 年 5 月,FDA 宣布授权 EUA 使用一种新的治疗性 mAB——Sotrovimab——用于门诊治疗患有严重 COVID-19 疾病的人。 2022 年 2 月,FDA 宣布为 Elli Lilly and Company 生产的 bebtelovimab 颁发 EUA,这是针对 Omicron 变体的 mAB 的一个例子。此外,etesevimab 也是美国 FDA 批准的治疗性 mAB 的一个例子。

 

 

单克隆抗体治疗 (mAB) 市场区域洞察

Insight Partners 的分析师已详细解释了预测期内影响单克隆抗体治疗 (mAB) 市场的区域趋势和因素。本节还讨论了北美、欧洲、亚太地区、中东和非洲以及南美和中美洲的单克隆抗体治疗 (mAB) 市场细分和地理位置。

Monoclonal Antibody Therapeutics (mABs) Market
  • 获取单克隆抗体治疗 (mAB) 市场的区域特定数据

单克隆抗体治疗 (mAB) 市场报告范围

报告属性细节
2022 年市场规模1920.4亿美元
2030 年的市场规模5428亿美元
全球复合年增长率(2022 - 2030 年)13.9%
史料2020-2022
预测期2022-2030
涵盖的领域按产品
  • 重组 mAB
  • 抗体药物偶联物
  • 双特异性和多特异性 mAB
  • 生物仿制药
按应用
  • 肿瘤学
  • 自身免疫性疾病
按分销渠道
  • 医院药房
  • 零售药店
覆盖地区和国家北美
  • 我们
  • 加拿大
  • 墨西哥
欧洲
  • 英国
  • 德国
  • 法国
  • 俄罗斯
  • 意大利
  • 欧洲其他地区
亚太
  • 中国
  • 印度
  • 日本
  • 澳大利亚
  • 亚太其他地区
南美洲和中美洲
  • 巴西
  • 阿根廷
  • 南美洲和中美洲其他地区
中东和非洲
  • 南非
  • 沙特阿拉伯
  • 阿联酋
  • 中东和非洲其他地区
市场领导者和主要公司简介
  •  
  • 葛兰素史克
  • 霍夫曼-拉罗歇
  • 拜耳公司
  • 安进
  • 诺华
  • 艾伯维
  • 百时美施贵宝
  • 杨森制药
  • 默克集团

市场参与者密度:了解其对商业动态的影响

单克隆抗体治疗 (mAB) 市场正在快速增长,这得益于终端用户需求的不断增长,而这些需求又源于消费者偏好的不断变化、技术进步以及对产品优势的认识不断提高等因素。随着需求的增加,企业正在扩大其产品范围,进行创新以满足消费者的需求,并利用新兴趋势,从而进一步推动市场增长。

市场参与者密度是指在特定市场或行业内运营的企业或公司的分布情况。它表明在给定市场空间中,相对于其规模或总市场价值,有多少竞争对手(市场参与者)存在。

在单克隆抗体治疗 (mAB) 市场运营的主要公司有:

  1. 葛兰素史克
  2. 霍夫曼-拉罗歇
  3. 拜耳公司
  4. 安进
  5. 诺华

免责声明上面列出的公司没有按照任何特定顺序排列。


Monoclonal Antibody Therapeutics (mABs) Market

 

  • 获取单克隆抗体治疗 (mAB) 市场顶级关键参与者概览

 

 

单克隆抗体疗法(mAB)行业发展和未来机遇:

 

以下列出了单克隆抗体疗法 (mAB) 市场主要参与者的各种战略发展:

  • 2023年1月,阿斯利康的Evusheld在欧盟获得批准。Evusheld是两种长效抗体——tixagevimab(AZD8895)和cilgavimab(AZD1061)的组合。美国政府通过卫生与公众服务部、战略防范与应对管理局和生物医学高级研究与发展局的联邦资金为该产品的开发提供了支持。
  • 2023 年 8 月,Regeneron Pharmaceuticals, Inc. 与美国生物医学高级研究与发展局 (BARDA) 达成协议,以支持针对 COVID-19 的下一代单克隆抗体疗法的临床开发、临床制造和监管许可流程。根据该协议,Regeneron 计划与 BARDA 合作评估并进一步开发和制造该疗法,并开展监管活动。

 

竞争格局和重点公司:

葛兰素史克、罗氏、拜耳、安进、诺华、艾伯维、百时美施贵宝、杨森制药、默克和阿斯利康是单克隆抗体治疗 (mAB) 市场上的知名公司。单克隆抗体治疗 (mAB) 市场报告包括公司定位和集中度,以评估市场主要参与者的表现。

  • Historical Analysis (2 Years), Base Year, Forecast (7 Years) with CAGR
  • PEST and SWOT Analysis
  • Market Size Value / Volume - Global, Regional, Country
  • Industry and Competitive Landscape
  • Excel Dataset
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

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to country scope.

Frequently Asked Questions


What are the driving factors for the monoclonal antibody therapeutics market across the globe?

Key factors that are driving the growth of this market are production of mabs-based drugs to treat several infectious diseases is expected to boost the market growth for the monoclonal antibody therapeutics over the years.

What is the market CAGR value of monoclonal antibody therapeutics market during forecast period?

The CAGR value of the monoclonal antibody therapeutics market during the forecasted period of 2022-2030 is 13.9%.

Which product segment leads the monoclonal antibody therapeutics market?

The recombinant mABs segment held the largest share of the market in the global monoclonal antibody therapeutics market and held the largest market share in 2022.

Which are the top companies that hold the market share in monoclonal antibody therapeutics market?

Amgen and GlaxoSmithKline are the top two companies that hold huge market shares in the monoclonal antibody therapeutics market.

What is monoclonal antibody therapeutics market?

Monoclonal antibody (mAbs) therapeutics is a homogenous collection of antibodies used to treat illness and are selected to target antigens. Therapeutic mAbs require a mammalian expression system offering the cell machinery required to glycosylate, fold, orient, and covalently bind antibody peptide chains to produce complete and biologically functional molecules. Also, the therapeutic antibody is expanding the use of new modality antibodies such as bispecific and trispecific antibodies to recognize the multiple epitopes on the same antigen and single domain antibodies that can more easily penetrate tissues and antibody-drug conjugates for targeting chemotherapy agents to specific cell types.

Which application segment held the largest share in the monoclonal antibody therapeutics market?

The autoimmune disease segment dominated the global monoclonal antibody therapeutics market and held the largest market share in 2022.

Who are the key players in the monoclonal antibody therapeutics market?

The monoclonal antibody therapeutics market majorly consists of the players such GlaxoSmithKline, F.Hoffmann-La-Roche, Bayer AG, Amgen, Novartis, AbbVie, Bristol-Myers Squibb, Janssen Pharmaceutical, Merck KgaA, and AstraZeneca, and amongst others.

Which region is expected to witness significant demand for monoclonal antibody therapeutics market in the coming years?

Global monoclonal antibody therapeutics market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa and South & Central America. North America held the largest market share of the monoclonal antibody therapeutics market in 2022.

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The List of Companies - Monoclonal Antibody Therapeutics (mABs) Market

  1. GlaxoSmithKline
  2. F.Hoffmann-La-Roche
  3. Bayer AG
  4. Amgen
  5. Novartis
  6. AbbVie
  7. Bristol-Myers Squibb
  8. Janssen Pharmaceutical
  9. Merck KgaA
  10. AstraZeneca

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The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.

Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.

  1. Primary Research:

The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.

For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.

A typical research interview fulfils the following functions:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.

  1. Data Analysis:

Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.

  • Macro-Economic Factor Analysis:

We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.

  • Country Level Data:

Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.

  • Company Profile:

The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.

  • Developing Base Number:

Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.

  1. Data Triangulation and Final Review:

The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.

We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.

We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.