生物製劑藥物研發市場－全球產業規模、佔有率、趨勢、機會、預測：按類型、方法、生產類型、地區和競爭格局分類，2021-2031年

全球生物製劑藥物研發市場預計將從 2025 年的 96.6 億美元成長到 2031 年的 154.9 億美元，複合年成長率為 8.19%。

該領域專注於研究和分離生物來源的治療藥物，例如重組蛋白和單株抗體，以滿足複雜的醫療需求。推動市場成長的關鍵因素包括：自體免疫疾病和癌症等慢性疾病在全球日益普遍，這些疾病需要標靶治療；以及主要生物製藥專利的到期，加速了生物相似藥的研發。

阻礙市場發展的主要障礙在於研發階段法律規範，這導致研發週期延長和失敗率居高不下。根據國際藥品製造商協會聯合會（IFPMA）2024年發布的報告，生物製劑約佔全球目前處於臨床研發階段的12700種藥物的50%。如此高的比例凸顯了儘管面臨巨大的營運和財務挑戰，生物製藥業仍然高度依賴這一先進的治療領域。

市場促進因素

人工智慧 (AI) 和機器學習 (ML) 的融合正在透過最佳化複雜候選藥物的檢測和篩選，改變全球生物製劑藥物研發市場。透過利用先進的演算法進行新型蛋白質設計和預測建模，製藥公司可以顯著降低早期生物製藥開發階段通常較高的失敗率。這種技術融合能夠實現快速的基因組數據分析和精準的創業投資抗體設計，加速從標靶檢驗到臨床試驗的整個流程。正如賽諾菲在 2025 年 9 月的新聞稿中所宣布的，該公司承諾向其風險投資部門追加 6.25 億美元，以加速對數位醫療和人工智慧領域的投資，這凸顯了該行業向電腦輔助藥物研發方法的戰略轉型。

生物製藥研發領域投資和支出的增加，正成為推動雙特異性抗體和基因療法等先進生物製藥持續研發的根本催化劑。生物製藥研發高成本，源自於複雜的生產要求和嚴格的安全測試，因此需要持續的資金投入來維持強大的新治療方法管線。例如，強生公司在2025年1月發布的2024會計年度全年財報中披露，其研發總支出高達174億美元，顯示實現治療創新需要巨額投資。這種投資環境直接提升了監管機構的工作效率。美國食品藥物管理局（FDA）於2025年1月發布的《2024年新藥核准報告》記錄了50種新藥認證，凸顯了這些巨額研發投入如何轉化為核准的治療方案。

市場挑戰

生物製劑研發過程中固有的巨額資金需求和嚴格的監管是限制全球生物製劑市場成長的主要障礙。這些障礙迫使企業投入大量資金研發，往往導致資金無法用於產品線多元化。衛生組織制定的嚴格標準要求進行廣泛的安全評估和臨床試驗，延長了研發週期，並增加了後期研發失敗的風險。因此，中小型生物技術公司往往難以在沒有外部夥伴關係的情況下業務永續營運，導致市場整合，並阻礙了產品上市和創新的整體步伐。

這些財務壁壘的規模顯著影響製藥業拓展業務和有效向患者提供新療法的能力。藥物發現和開發這一複雜領域所需的巨額投資，正是這種負擔的體現。根據歐洲製藥工業協會聯合會（EFPIA）2024年的數據，歐洲製藥業在研發方面的投資約為550億歐元。如此巨額的支出凸顯了市場參與企業在控制成本的同時履行監管合規義務所面臨的巨大壓力，這種情況直接限制了全球市場的成長潛力。

市場趨勢

抗體藥物複合體（ADC）在癌症治療領域的出現，正從根本上改變全球生物製劑藥物研發市場。這導致策略性收購激增，旨在獲取專有的有效載荷和連接子技術。製藥公司日益重視精準醫療，以期在提高療效的同時降低全身毒性。這種轉變正在推動整個產業的高價值整合，以獲取成熟的平台。主要企業整合自身專長以強化其癌症治療產品組合的舉措，充分體現了對下一代資產的激烈競爭。例如，強生公司在2024年3月的新聞稿中宣布，已完成對Ambrx Biopharma的收購，交易金額約為20億美元（以股權為以金額為準）。此舉旨在加速開發用於治療固體癌和前列腺癌的精準抗體藥物複合體。

由於生物製藥的複雜性需要專業的外部技術支持，與受託研究機構（CRO）建立外包合作關係正成為主流營運趨勢。創新企業正逐漸拋棄完全垂直整合的模式，轉而選擇與擁有功能篩檢、細胞株開發和可擴展生產等先進技術的綜合服務供應商合作。透過利用這些策略夥伴關係，企業可以克服技術壁壘，加速市場准入，而無需承擔資本密集基礎設施的全部負擔。根據三星生物製劑於2025年1月發布的2024年第四季及全年財報，該公司錄得創紀錄的4.55兆韓元合併銷售額，同比成長23%，這主要得益於針對複雜生物製藥的專屬服務的成功推出以及生產設施的擴建。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球生物製劑藥物研發市場展望

• 市場規模及預測
  • 按金額
• 市佔率及預測
  • 按類型（單株抗體、重組蛋白、其他）
  • 方法（標靶辨識/檢驗、先導化合物生成/檢驗、先導化合物辨識、先導藥物最適化）
  • 依製造類型（內部製造、外包製造）
  • 按地區
  • 按公司（2025 年）
• 市場地圖

第6章：北美生物製劑藥物研發市場展望

• 市場規模及預測
• 市佔率及預測
• 北美洲：國別分析
  • 美國
  • 加拿大
  • 墨西哥

第7章：歐洲生物製劑藥物研發市場展望

• 市場規模及預測
• 市佔率及預測
• 歐洲：國別分析
  • 德國
  • 法國
  • 英國
  • 義大利
  • 西班牙

第8章：亞太地區生物製劑藥物研發市場展望

• 市場規模及預測
• 市佔率及預測
• 亞太地區：國別分析
  • 中國
  • 印度
  • 日本
  • 韓國
  • 澳洲

第9章：中東和非洲生物製劑藥物研發市場展望

• 市場規模及預測
• 市佔率及預測
• 中東與非洲：國別分析
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 南非

第10章：南美洲生物製劑藥物研發市場展望

• 市場規模及預測
• 市佔率及預測
• 南美洲：國別分析
  • 巴西
  • 哥倫比亞
  • 阿根廷

第11章 市場動態

• 促進因素
• 任務

第12章 市場趨勢與發展

• 併購
• 產品發布
• 近期趨勢

第13章：全球生物製劑藥物研發市場：SWOT分析

第14章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的議價能力
• 顧客權力
• 替代品的威脅

第15章 競爭格局

• 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16章 策略建議

第17章：關於研究公司及免責聲明

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