生物製剂药物研发市场－全球产业规模、份额、趋势、机会、预测：按类型、方法、生产类型、地区和竞争格局划分，2021-2031年

全球生物製剂药物研发市场预计将从 2025 年的 96.6 亿美元成长到 2031 年的 154.9 亿美元，复合年增长率为 8.19%。

该领域专注于研究和分离生物来源的治疗药物，例如重组蛋白和单株抗体，以满足复杂的医疗需求。推动市场成长的关键因素包括：自体免疫疾病和癌症等慢性疾病在全球日益普遍，这些疾病需要标靶治疗；以及主要生物製药专利的到期，加速了生物相似药的研发。

阻碍市场发展的主要障碍在于研发阶段法律规范，这导致研发週期延长和失败率居高不下。根据国际药品製造商协会联合会（IFPMA）2024年发布的报告，生物製剂约占全球目前处于临床研发阶段的12700种药物的50%。如此高的比例凸显了儘管面临巨大的营运和财务挑战，生物製药业仍然高度依赖这一先进的治疗领域。

市场驱动因素

人工智慧 (AI) 和机器学习 (ML) 的融合正在透过优化复杂候选药物的检测和筛选，改变全球生物製剂药物研发市场。透过利用先进的演算法进行新型蛋白质设计和预测建模，製药公司可以显着降低早期生物製药开发阶段通常较高的失败率。这种技术融合能够实现快速的基因组数据分析和精准的创业投资抗体设计，加速从标靶检验到临床试验的整个流程。正如赛诺菲在 2025 年 9 月的新闻稿中所宣布的，该公司承诺向其风险投资部门追加 6.25 亿美元，以加速对数位医疗和人工智慧领域的投资，这凸显了该行业向电脑辅助药物研发方法的战略转型。

生物製药研发领域投资和支出的增加，正成为推动双特异性抗体和基因疗法等先进生物製药持续研发的根本催化剂。生物製药研发高成本，源自于复杂的生产要求和严格的安全测试，因此需要持续的资金投入来维持强大的新治疗方法管线。例如，强生公司在2025年1月发布的2024财年全年财报中披露，其研发总支出高达174亿美元，显示实现治疗创新需要巨额投资。这种投资环境直接提升了监管机构的工作效率。美国食品药物管理局（FDA）于2025年1月发布的《2024年新药核准报告》记录了50种新药认证，凸显了这些巨额研发投入如何转化为核准的治疗方案。

市场挑战

生物製剂研发过程中固有的巨额资金需求和严格的监管是限制全球生物製剂市场成长的主要障碍。这些障碍迫使企业投入大量资金研发，往往导致资金无法用于产品线多元化。卫生组织制定的严格标准要求进行广泛的安全评估和临床试验，延长了研发週期，并增加了后期研发失败的风险。因此，中小型生物技术公司往往难以在没有外部伙伴关係的情况下业务永续营运，导致市场整合，并阻碍了产品上市和创新的整体步伐。

这些财务壁垒的规模显着影响製药业拓展业务和有效向患者提供新疗法的能力。药物发现和开发这一复杂领域所需的巨额投资，正是这种负担的体现。根据欧洲製药工业协会联合会（EFPIA）2024年的数据，欧洲製药业在研发方面的投资约为550亿欧元。如此巨额的支出凸显了市场参与企业在控製成本的同时履行监管合规义务所面临的巨大压力，这种情况直接限制了全球市场的成长潜力。

市场趋势

抗体药物复合体（ADC）在癌症治疗领域的出现，正从根本上改变全球生物製剂药物研发市场。这导致策略性收购激增，旨在获取专有的有效载荷和连接子技术。製药公司日益重视精准医疗，以期在提高疗效的同时降低全身毒性。这种转变正在推动整个产业的高价值整合，以获取成熟的平台。主要企业整合自身专长以强化其癌症治疗产品组合的倡议，充分体现了对下一代资产的激烈竞争。例如，强生公司在2024年3月的新闻稿中宣布，已完成对Ambrx Biopharma的收购，交易金额约为20亿美元（以股权为以金额为准）。此举旨在加速开髮用于治疗固体癌和前列腺癌的精准抗体药物复合体。

由于生物製药的复杂性需要专业的外部技术支持，与受託研究机构（CRO）建立外包合作关係正成为主流营运趋势。创新企业正逐渐抛弃完全垂直整合的模式，转而选择与拥有功能筛检、细胞株开发和可扩展生产等先进技术的综合服务供应商合作。透过利用这些策略伙伴关係，企业可以克服技术壁垒，加速市场准入，而无需承担资本密集基础设施的全部负担。根据三星生物製剂于2025年1月发布的2024年第四季及全年财报，该公司录得创纪录的4.55万亿韩元合併销售额，同比增长23%，这主要得益于针对复杂生物製药的专属服务的成功推出以及生产设施的扩建。

目录

第一章概述

第二章：调查方法

第三章执行摘要

第四章：客户心声

第五章：全球生物製剂药物研发市场展望

• 市场规模及预测
  • 按金额
• 市占率及预测
  • 按类型（单株抗体、重组蛋白、其他）
  • 方法（标靶辨识/检验、先导化合物生成/检验、先导化合物辨识、先导药物最适化）
  • 依製造类型（内部製造、外包製造）
  • 按地区
  • 按公司（2025 年）
• 市场地图

第六章：北美生物製剂药物研发市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国别分析
  • 我们
  • 加拿大
  • 墨西哥

第七章：欧洲生物製剂药物研发市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国别分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区生物製剂药物研发市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国别分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲生物製剂药物研发市场展望

• 市场规模及预测
• 市占率及预测
• 中东与非洲：国别分析
  • 沙乌地阿拉伯
  • 阿拉伯聯合大公国
  • 南非

第十章：南美洲生物製剂药物研发市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国别分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章 市场动态

• 促进因素
• 任务

第十二章 市场趋势与发展

• 併购
• 产品发布
• 近期趋势

第十三章：全球生物製剂药物研发市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的议价能力
• 顾客权力
• 替代品的威胁

第十五章 竞争格局

• AbbVie, Inc.
• Astellas Pharma, Inc.
• AstraZeneca PLC
• Bayer AG
• Bicon Ltd.
• Boehringer Ingelheim International GmbH
• Eli Lilly and Company
• F. Hoffmann-La Roche Ltd.
• Gilead Sciences, Inc.
• Catalent, Inc.

第十六章 策略建议

第十七章：关于研究公司及免责声明

The Global Biologics Drug Discovery Market is projected to expand from a valuation of USD 9.66 Billion in 2025 to USD 15.49 Billion by 2031, reflecting a CAGR of 8.19%. This sector focuses on the research and isolation of therapeutic agents originated from living systems, such as recombinant proteins and monoclonal antibodies, to satisfy intricate medical requirements. Primary factors fueling this market growth encompass the increasing worldwide prevalence of chronic conditions like autoimmune disorders and cancer that demand targeted therapies, alongside the expiration of patents for major biologics which encourages the creation of biosimilars.

A major obstacle hindering market progression is the substantial capital investment and stringent regulatory oversight needed during the development stage, resulting in extended timelines and higher failure rates. As reported by the International Federation of Pharmaceutical Manufacturers and Associations in 2024, biologics represented roughly 50% of the 12,700 distinct drugs currently in global clinical development. This significant share underscores the industry's dependence on this sophisticated therapeutic class, notwithstanding the considerable operational and financial challenges associated with it.

Market Driver

The incorporation of Artificial Intelligence (AI) and Machine Learning (ML) is transforming the Global Biologics Drug Discovery Market by optimizing the detection and refinement of intricate therapeutic candidates. By utilizing sophisticated algorithms for de novo protein design and predictive modeling, pharmaceutical firms can considerably reduce the high failure rates typically linked to early-phase biologics creation. This technological convergence facilitates rapid genomic data analysis and exact monoclonal antibody engineering, speeding up the progression from target validation to clinical testing. As noted in a September 2025 press release, Sanofi pledged an extra $625 million to its venture capital division to hasten investments in digital health and artificial intelligence, highlighting the industry's strategic shift toward computational discovery methods.

Increasing investment and expenditure in biopharmaceutical R&D act as a fundamental catalyst, driving the ongoing investigation of advanced biologics like bispecific antibodies and gene therapies. The elevated costs associated with developing biologics, driven by complex manufacturing needs and strict safety testing, necessitate continuous capital funding to maintain a strong pipeline of new treatments. For instance, Johnson & Johnson reported in its January 2025 results for the full year 2024 a total R&D spend of $17.4 billion, demonstrating the massive financial dedication needed to achieve therapeutic innovations. This investment landscape directly bolsters regulatory productivity; the FDA's 'Novel Drug Approvals for 2024' report from January 2025 noted the approval of 50 new drugs, emphasizing how these significant R&D expenditures successfully translate into authorized therapies.

Market Challenge

The intense capital requirements and strict regulatory oversight inherent in the development process serve as major impediments to the growth of the Global Biologics Drug Discovery Market. These obstacles force companies to direct massive financial assets into research and development, frequently shifting funds away from pipeline diversification efforts. The rigorous standards mandated by health agencies require extensive safety evaluations and clinical trials, which extend development schedules and heighten the risk of failure in later stages. Consequently, smaller biotech enterprises often face difficulties maintaining operations without external partnerships, resulting in market consolidation that hampers the general rate of product introduction and innovation.

The scale of these financial hurdles heavily affects the industry's capacity to expand operations and deliver new treatments to patients effectively. This strain is evident in the massive investments necessary to maneuver through the complicated discovery and development terrain. According to data from the European Federation of Pharmaceutical Industries and Associations in 2024, the pharmaceutical sector allocated roughly €55 billion to research and development across Europe. This substantial financial outlay highlights the severe pressure on market participants to control expenses while meeting compliance mandates, a situation that directly limits the overall growth potential of the global market.

Market Trends

The emergence of Antibody-Drug Conjugates (ADCs) within oncology pipelines is radically altering the Global Biologics Drug Discovery Market, prompting a wave of strategic acquisitions aimed at securing proprietary payload and linker technologies. Pharmaceutical firms are increasingly prioritizing these precise therapies to enhance treatment efficacy while reducing systemic toxicity, a transition that has triggered high-value consolidation in the industry to obtain proven platforms. This vigorous chase for next-generation assets is illustrated by leading players merging specialized skills to strengthen their cancer portfolios. For example, Johnson & Johnson announced in a March 2024 press release the completion of its acquisition of Ambrx Biopharma for an equity value of roughly $2.0 billion, a strategic action intended to fast-track the creation of precision antibody-drug conjugates for treating solid tumors and prostate cancer.

The growth of outsourcing partnerships with Contract Research Organizations (CROs) has emerged as a prevailing operational trend, as the intricacy of biologic modalities demands specialized external knowledge. Innovators are shifting away from complete vertical integration, choosing instead to cooperate with comprehensive service providers that possess advanced skills in functional screening, cell line development, and scalable production. Relying on these strategic alliances enables companies to overcome technical obstacles and hasten market entry without shouldering the entire weight of capital-heavy infrastructure. As stated in Samsung Biologics' financial results for the fourth quarter and fiscal year 2024 released in January 2025, the firm recorded a record consolidated revenue of KRW 4.55 trillion, a 23% rise attributed to the successful launch of dedicated services for complex biologics and the increased capacity of its manufacturing facilities.

Key Market Players

• AbbVie, Inc.
• Astellas Pharma, Inc.
• AstraZeneca PLC
• Bayer AG
• Bicon Ltd.
• Boehringer Ingelheim International GmbH
• Eli Lilly and Company
• F. Hoffmann-La Roche Ltd.
• Gilead Sciences, Inc.
• Catalent, Inc.

Report Scope

In this report, the Global Biologics Drug Discovery Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biologics Drug Discovery Market, By Type

• Monoclonal Antibodies
• Recombinant Proteins
• Others

Biologics Drug Discovery Market, By Method

• Target Identification/ validation
• Hit Generation/ Validation
• Lead Identification
• Lead Optimization

Biologics Drug Discovery Market, By Manufacture Type

• In-House
• Outsourced

Biologics Drug Discovery Market, By Region

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biologics Drug Discovery Market.

Available Customizations:

Global Biologics Drug Discovery Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Biologics Drug Discovery Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (Monoclonal Antibodies, Recombinant Proteins, Others)
  • 5.2.2. By Method (Target Identification/ validation, Hit Generation/ Validation, Lead Identification, Lead Optimization)
  • 5.2.3. By Manufacture Type (In-House, Outsourced)
  • 5.2.4. By Region
  • 5.2.5. By Company (2025)
• 5.3. Market Map

6. North America Biologics Drug Discovery Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Method
  • 6.2.3. By Manufacture Type
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biologics Drug Discovery Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Method
      • 6.3.1.2.3. By Manufacture Type
  • 6.3.2. Canada Biologics Drug Discovery Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Method
      • 6.3.2.2.3. By Manufacture Type
  • 6.3.3. Mexico Biologics Drug Discovery Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Method
      • 6.3.3.2.3. By Manufacture Type

7. Europe Biologics Drug Discovery Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Method
  • 7.2.3. By Manufacture Type
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Biologics Drug Discovery Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Method
      • 7.3.1.2.3. By Manufacture Type
  • 7.3.2. France Biologics Drug Discovery Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Method
      • 7.3.2.2.3. By Manufacture Type
  • 7.3.3. United Kingdom Biologics Drug Discovery Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Method
      • 7.3.3.2.3. By Manufacture Type
  • 7.3.4. Italy Biologics Drug Discovery Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Type
      • 7.3.4.2.2. By Method
      • 7.3.4.2.3. By Manufacture Type
  • 7.3.5. Spain Biologics Drug Discovery Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Type
      • 7.3.5.2.2. By Method
      • 7.3.5.2.3. By Manufacture Type

8. Asia Pacific Biologics Drug Discovery Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Method
  • 8.2.3. By Manufacture Type
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Biologics Drug Discovery Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Method
      • 8.3.1.2.3. By Manufacture Type
  • 8.3.2. India Biologics Drug Discovery Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Method
      • 8.3.2.2.3. By Manufacture Type
  • 8.3.3. Japan Biologics Drug Discovery Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Method
      • 8.3.3.2.3. By Manufacture Type
  • 8.3.4. South Korea Biologics Drug Discovery Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Type
      • 8.3.4.2.2. By Method
      • 8.3.4.2.3. By Manufacture Type
  • 8.3.5. Australia Biologics Drug Discovery Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Type
      • 8.3.5.2.2. By Method
      • 8.3.5.2.3. By Manufacture Type

9. Middle East & Africa Biologics Drug Discovery Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Method
  • 9.2.3. By Manufacture Type
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Biologics Drug Discovery Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Method
      • 9.3.1.2.3. By Manufacture Type
  • 9.3.2. UAE Biologics Drug Discovery Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Method
      • 9.3.2.2.3. By Manufacture Type
  • 9.3.3. South Africa Biologics Drug Discovery Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Method
      • 9.3.3.2.3. By Manufacture Type

10. South America Biologics Drug Discovery Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By Method
  • 10.2.3. By Manufacture Type
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Biologics Drug Discovery Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Type
      • 10.3.1.2.2. By Method
      • 10.3.1.2.3. By Manufacture Type
  • 10.3.2. Colombia Biologics Drug Discovery Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Type
      • 10.3.2.2.2. By Method
      • 10.3.2.2.3. By Manufacture Type
  • 10.3.3. Argentina Biologics Drug Discovery Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Type
      • 10.3.3.2.2. By Method
      • 10.3.3.2.3. By Manufacture Type

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Biologics Drug Discovery Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. AbbVie, Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. Astellas Pharma, Inc.
• 15.3. AstraZeneca PLC
• 15.4. Bayer AG
• 15.5. Bicon Ltd.
• 15.6. Boehringer Ingelheim International GmbH
• 15.7. Eli Lilly and Company
• 15.8. F. Hoffmann-La Roche Ltd.
• 15.9. Gilead Sciences, Inc.
• 15.10. Catalent, Inc.

16. Strategic Recommendations

17. About Us & Disclaimer