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市場調查報告書
商品編碼
1941026

蛋白質療法市場－全球產業規模、佔有率、趨勢、機會及預測（按蛋白質功能、產品類型、地區和競爭格局分類，2021-2031年）

Protein Therapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Protein Function, By Product Type, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 181 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球蛋白質療法市場預計將從 2025 年的 3,011.9 億美元成長到 2031 年的 4,474.6 億美元，複合年成長率達到 6.82%。

這些療法由生物來源的藥理活性物質組成，例如單株抗體或重組激素，旨在取代缺失的蛋白質或靶向特定的疾病標記。市場成長的主要驅動力是全球慢性疾病（例如腫瘤和自體免疫疾病）盛行率的不斷上升，這些疾病需要強力的治療性介入；此外，生物工程技術的進步也使得合成具有更高療效的複雜分子成為可能。

市場概覽
預測期 2027-2031
市場規模：2025年 3011.9億美元
市場規模：2031年 4474.6億美元
複合年成長率：2026-2031年 6.82%
成長最快的細分市場 促紅血球生成素
最大的市場 北美洲

然而，由於研發和生產高成本，該領域面臨嚴峻的挑戰。生物製藥生產的複雜性要求嚴格的品管和低溫運輸物流，這導致最終價格較高，並限制了新興經濟體患者的用藥途徑。為了因應這些經濟障礙，美國藥品研究與製造商協會（PhRMA）報告稱，到2025年，美國將核准70多種生物相似藥上市，這表明人們越來越重視克服與成本相關的市場擴張障礙。

市場促進因素

慢性病和代謝性疾病的日益普遍是全球蛋白質療法市場的主要驅動力。隨著癌症和糖尿病等疾病的蔓延，人們對蛋白質藥物所提供的高度特異性治療方法的需求也日益成長。不斷擴大的患者群體與單株抗體和替代療法的廣泛應用密切相關，尤其是在診斷率不斷上升的已開發地區。美國癌症協會發布的《2025年癌症事實與數據》報告強調了這一緊迫性，預測到2025年美國將新增超過200萬例癌症病例。

同時，有利的法規環境和加速的核准流程正顯著加快新型治療方法的市場准入。監管機構正在推動簡化生物製藥的審查流程，以滿足未被滿足的醫療需求，從而縮短研發週期並促進創新。監管事務專業人員協會 (RAPS) 的報告也印證了這一效率，該報告指出，美國食品藥物管理局(FDA) 在 2024 年核准了50 種新的分子實體。這種監管支持轉化為商業性成功，諾和諾德公司 2025 年的報告便證明了這一點，該報告指出，其基於 GLP-1 的糖尿病治療產品在 2024 年的銷售額將達到 1491 億丹麥克朗。

市場挑戰

全球蛋白質療法市場面臨一個重大障礙：產品研發和生產需要巨額資本投入。與小分子藥物不同，蛋白質療法是體積龐大、結構複雜的生物製藥，需要高度專業的生產設施和嚴格的品質保證通訊協定。這種技術複雜性要求前期投資大量資金，不僅提高了新參與企業的進入門檻，也加劇了現有生產商的資源壓力。因此，企業不得不提高產品價格以收回投資，這往往會限制其目標患者群體。

這種經濟負擔直接阻礙了市場擴張，尤其是在醫療預算緊張、對成本高度敏感的地區。對先進低溫運輸物流的需求進一步增加了營運成本，使得世界各地許多人難以負擔這些救命療法。歐洲製藥工業協會聯合會（EFPIA）估計，到2024年，歐洲以研發為基礎的製藥業將在研發方面投入550億歐元，如此龐大的投入導致單位成本持續高企，阻礙了整體市場成長，凸顯了該產業的資本密集特徵。

市場趨勢

將人工智慧 (AI) 應用於蛋白質設計，能夠開發出具有最佳化特性的新型療法，從根本上改變了藥物發現流程。與傳統篩檢方法不同，生成式 AI 模型可以高精度地預測蛋白質結構和結合親和性，從而顯著縮短先導化合物的最佳化週期。這項技術進步正吸引大量投資。根據 BioSpace 2024 年 4 月的報告顯示，Xaira Therapeutics 已籌集超過 10 億美元的資金籌措，並啟動運營，致力於開發一個用於功能分子設計的 AI 驅動平台。

此外，抗體藥物複合體（ADC）的加速發展代表著癌症治療領域的重大變革，其技術已從簡單的單株抗體發展到高效、強大的載體。現代ADC採用先進的連接子技術，使其細胞毒性有效載荷僅在癌細胞內釋放，從而最大限度地提高療效，同時最大限度地降低全身毒性。這種潛力正在推動策略整合，例如強生公司於2024年3月宣布以約20億美元收購Ambrx Biopharma，旨在整合其專有的合成生物學平台，用於設計下一代ADC。

目錄

第1章概述

第2章調查方法

第3章執行摘要

第4章：客戶評價

第5章 全球蛋白質療法市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依蛋白質功能分類（酵素/調節功能、蛋白質診斷、疫苗）
    • 依產品類型（血液凝固因子、促紅血球生成素、促卵泡激素、濾泡刺激素、胰島素、干擾素、單株抗體）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美蛋白質療法市場展望

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

7. 歐洲蛋白質療法市場展望

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

8. 亞太地區蛋白質療法市場展望

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

9. 中東和非洲蛋白質療法市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東和非洲：國家分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

10. 南美洲蛋白質療法市場展望

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

第11章 市場動態

  • 促進要素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 最新進展

第13章 全球蛋白質療法市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的可能性
  • 供應商電力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Amgen Inc.
  • Eli Lilly and Company.
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services, Inc
  • Merck KGaA
  • Pfizer Inc.
  • AstraZeneca Plc.
  • Teva Pharmaceutical Industries Ltd
  • Bristol-Myers Squibb Company
  • AbbVie Inc.

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 17277

The Global Protein Therapeutics Market is projected to expand from USD 301.19 Billion in 2025 to USD 447.46 Billion by 2031, achieving a CAGR of 6.82%. These therapeutics consist of pharmacologically active substances derived from living organisms, such as monoclonal antibodies and recombinant hormones, which are engineered to replace deficient proteins or target specific disease markers. Market growth is primarily driven by the increasing global prevalence of chronic conditions like oncology and autoimmune disorders that require potent interventions, alongside advancements in bioengineering that enable the synthesis of complex molecules with enhanced efficacy profiles.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 301.19 Billion
Market Size 2031USD 447.46 Billion
CAGR 2026-20316.82%
Fastest Growing SegmentErythropoietin
Largest MarketNorth America

Conversely, the sector faces significant challenges due to the high costs associated with development and manufacturing. The complex nature of biologic production demands strict quality control and cold chain logistics, which raises final prices and limits patient access in emerging economies. Reflecting the industry's effort to address these economic barriers, the Pharmaceutical Research and Manufacturers of America reported that there were over 70 approved biosimilars in the United States in 2025, signaling a strong focus on overcoming cost-related impediments to market expansion.

Market Driver

The rising prevalence of chronic diseases and metabolic disorders serves as a major catalyst for the Global Protein Therapeutics Market. As conditions like cancer and diabetes become more widespread, the demand for highly specific interventions provided by protein-based drugs intensifies. This expanding patient pool correlates with a higher utilization of monoclonal antibodies and replacement therapies, particularly in developed regions where diagnosis rates are increasing. Highlighting this urgent need, the American Cancer Society's 'Cancer Facts & Figures 2025' report projected that over 2 million new cancer cases would be diagnosed in the United States in 2025.

Simultaneously, a supportive regulatory environment and accelerated approval pathways are significantly speeding up market entry for new treatments. Regulatory agencies are increasingly adopting streamlined review processes for biologics that address unmet medical needs, reducing development timelines and fostering innovation. This efficiency is evidenced by the Regulatory Affairs Professionals Society's report that the U.S. FDA approved 50 new molecular entities in 2024. Such regulatory support translates into commercial success, as seen in Novo Nordisk's 2025 report, which stated that sales of its GLP-1 based diabetes products reached DKK 149.1 billion in 2024.

Market Challenge

The Global Protein Therapeutics Market confronts a major obstacle regarding the immense capital expenditure needed for product development and manufacturing. Unlike small-molecule drugs, protein therapeutics are large, complex biologics requiring highly specialized production facilities and rigorous quality assurance protocols. This technical complexity demands a massive upfront financial commitment, creating a high barrier to entry for new competitors and straining the resources of existing manufacturers, often forcing companies to set premium prices to recover their investments, which limits the addressable patient population.

This economic strain directly impedes market expansion, especially in cost-sensitive regions with constrained healthcare budgets. The requirement for sophisticated cold chain logistics further increases operational costs, making these life-saving treatments unaffordable for many people globally. The financial intensity of the sector is underscored by the European Federation of Pharmaceutical Industries and Associations, which estimated that the research-based pharmaceutical industry invested €55 billion in research and development in Europe in 2024, an expenditure level that sustains high unit costs and hinders broader market growth.

Market Trends

The integration of Artificial Intelligence into protein design is fundamentally transforming discovery pipelines by allowing for the de novo generation of therapeutics with optimized properties. Unlike traditional screening methods, generative AI models can predict protein structures and binding affinities with high accuracy, significantly shortening lead optimization timelines. This technological advancement has attracted substantial investment, as evidenced by BioSpace's April 2024 report stating that Xaira Therapeutics launched with over $1 billion in committed capital to advance an AI-driven platform for designing functional molecules.

Furthermore, the acceleration of Antibody-Drug Conjugate (ADC) development marks a critical evolution in oncology, progressing from simple monoclonal antibodies to highly potent armed constructs. Modern ADCs employ sophisticated linker technologies to release cytotoxic payloads exclusively within tumor cells, maximizing efficacy while minimizing systemic toxicity. This potential has driven strategic consolidation, exemplified by Johnson & Johnson's March 2024 announcement that it completed the acquisition of Ambrx Biopharma for approximately $2 billion to integrate its proprietary synthetic biology platform for next-generation ADC design.

Key Market Players

  • Amgen Inc.
  • Eli Lilly and Company.
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services, Inc
  • Merck KGaA
  • Pfizer Inc.
  • AstraZeneca Plc.
  • Teva Pharmaceutical Industries Ltd
  • Bristol-Myers Squibb Company
  • AbbVie Inc.

Report Scope

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

Protein Therapeutics Market, By Protein Function

  • Enzymatic & Regulatory
  • Protein Diagnostics
  • Vaccines

Protein Therapeutics Market, By Product Type

  • Blood Clotting Factor
  • Erythropoietin
  • Follicle Stimulating Hormone
  • G-CSF
  • Insulin
  • Interferons
  • Monoclonal Antibodies

Protein Therapeutics 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 Protein Therapeutics Market.

Available Customizations:

Global Protein Therapeutics 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 Protein Therapeutics Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Protein Function (Enzymatic & Regulatory, Protein Diagnostics, Vaccines)
    • 5.2.2. By Product Type (Blood Clotting Factor, Erythropoietin, Follicle Stimulating Hormone, G-CSF, Insulin, Interferons, Monoclonal Antibodies)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Protein Therapeutics Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Protein Function
    • 6.2.2. By Product Type
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Protein Therapeutics 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 Protein Function
        • 6.3.1.2.2. By Product Type
    • 6.3.2. Canada Protein Therapeutics 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 Protein Function
        • 6.3.2.2.2. By Product Type
    • 6.3.3. Mexico Protein Therapeutics 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 Protein Function
        • 6.3.3.2.2. By Product Type

7. Europe Protein Therapeutics Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Protein Function
    • 7.2.2. By Product Type
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Protein Therapeutics 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 Protein Function
        • 7.3.1.2.2. By Product Type
    • 7.3.2. France Protein Therapeutics 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 Protein Function
        • 7.3.2.2.2. By Product Type
    • 7.3.3. United Kingdom Protein Therapeutics 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 Protein Function
        • 7.3.3.2.2. By Product Type
    • 7.3.4. Italy Protein Therapeutics 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 Protein Function
        • 7.3.4.2.2. By Product Type
    • 7.3.5. Spain Protein Therapeutics 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 Protein Function
        • 7.3.5.2.2. By Product Type

8. Asia Pacific Protein Therapeutics Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Protein Function
    • 8.2.2. By Product Type
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Protein Therapeutics 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 Protein Function
        • 8.3.1.2.2. By Product Type
    • 8.3.2. India Protein Therapeutics 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 Protein Function
        • 8.3.2.2.2. By Product Type
    • 8.3.3. Japan Protein Therapeutics 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 Protein Function
        • 8.3.3.2.2. By Product Type
    • 8.3.4. South Korea Protein Therapeutics 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 Protein Function
        • 8.3.4.2.2. By Product Type
    • 8.3.5. Australia Protein Therapeutics 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 Protein Function
        • 8.3.5.2.2. By Product Type

9. Middle East & Africa Protein Therapeutics Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Protein Function
    • 9.2.2. By Product Type
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Protein Therapeutics 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 Protein Function
        • 9.3.1.2.2. By Product Type
    • 9.3.2. UAE Protein Therapeutics 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 Protein Function
        • 9.3.2.2.2. By Product Type
    • 9.3.3. South Africa Protein Therapeutics 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 Protein Function
        • 9.3.3.2.2. By Product Type

10. South America Protein Therapeutics Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Protein Function
    • 10.2.2. By Product Type
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Protein Therapeutics 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 Protein Function
        • 10.3.1.2.2. By Product Type
    • 10.3.2. Colombia Protein Therapeutics 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 Protein Function
        • 10.3.2.2.2. By Product Type
    • 10.3.3. Argentina Protein Therapeutics 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 Protein Function
        • 10.3.3.2.2. By Product 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 Protein Therapeutics 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. Amgen 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. Eli Lilly and Company.
  • 15.3. F. Hoffmann-La Roche Ltd.
  • 15.4. Johnson & Johnson Services, Inc
  • 15.5. Merck KGaA
  • 15.6. Pfizer Inc.
  • 15.7. AstraZeneca Plc.
  • 15.8. Teva Pharmaceutical Industries Ltd
  • 15.9. Bristol-Myers Squibb Company
  • 15.10. AbbVie Inc.

16. Strategic Recommendations

17. About Us & Disclaimer