活體生物治療產品和微生物 CDMO 市場－全球產業規模、佔有率、趨勢、機會和預測，按應用、產品、配方類型、營運規模、地區和競爭細分，2020-2030 年

2024 年全球活生物治療產品和微生物 CDMO 市場價值為 321.2 億美元，預計到 2030 年將達到 2,184.5 億美元，預測期內複合年成長率為 37.62%。隨著製藥和生物技術公司擴大採用基於微生物組的療法來治療和預防慢性病和傳染病，市場正在獲得強勁的發展。活生物治療產品 (LBP) 涉及活微生物作為治療劑，人們正在探索其治療胃腸道疾病、癌症、代謝疾病和免疫相關疾病的潛力。對人類微生物組及其與整體健康的關係的科學理解不斷增強，引發了醫療保健提供者、投資者和監管機構的興趣。美國 FDA 和歐洲藥品管理局等機構正在積極為 LBP 建立監管途徑，這表明市場日趨成熟並吸引了進一步的投資。同時，微生物開發和生產對合約開發和製造組織 (CDMO) 的依賴日益增加，正在重塑外包格局，特別是由於活體生物療法的技術複雜性。

關鍵市場促進因素

慢性病盛行率不斷上升

主要市場挑戰

監管不確定性和不斷發展的指導方針

主要市場趨勢

人們對微生物組療法的興趣日益濃厚

目錄

第 1 章：產品概述

第2章：研究方法

第3章：執行摘要

第4章：顧客之聲

第5章：全球活體生物治療產品與微生物CDMO市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 依應用（艱難梭菌、克隆氏症、腸躁症、糖尿病、其他）
  • 按產品（API、FDF）
  • 依劑型分類（固體劑型、口服液、注射劑、其他）
  • 依營運規模（臨床前規模營運、臨床規模營運、商業規模營運）
  • 按公司分類（2024）
  • 按地區
• 市場地圖

第6章：北美活體生物治療產品與微生物CDMO市場展望

• 市場規模和預測
• 市場佔有率和預測
• 北美：國家分析
  • 美國
  • 墨西哥
  • 加拿大

第7章：歐洲活體生物治療產品與微生物CDMO市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 法國
  • 德國
  • 英國
  • 義大利
  • 西班牙

第 8 章：亞太地區活體生物治療產品與微生物 CDMO 市場展望

• 市場規模和預測
• 市場佔有率和預測
• 亞太地區：國家分析
  • 中國
  • 印度
  • 韓國
  • 日本
  • 澳洲

第9章：南美洲活體生物治療產品與微生物CDMO市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 巴西
  • 阿根廷
  • 哥倫比亞

第 10 章：中東和非洲活體生物治療產品和微生物 CDMO 市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第 11 章：市場動態

• 驅動程式
• 挑戰

第 12 章：市場趨勢與發展

• 合併與收購（如有）
• 產品發布（如有）
• 最新動態

第 13 章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的力量
• 顧客的力量
• 替代產品的威脅

第 14 章：競爭格局

• Arrant Bio
• 4D Pharma
• Cerbios
• Biose Industrie
• Assembly Biosciences, Inc.
• Wacker Chemie AG
• Quay Pharmaceuticals
• NIZO
• Lonza
• Inpac Probiotics

第 15 章：策略建議

第16章調查會社について,免責事項

The Global Live Biotherapeutics Products and Microbe CDMO Market was valued at USD 32.12 Billion in 2024 and is projected to reach USD 218.45 Billion by 2030, growing at a CAGR of 37.62% during the forecast period. The market is gaining strong traction as pharmaceutical and biotechnology companies increasingly embrace microbiome-based therapies for the treatment and prevention of chronic and infectious diseases. Live Biotherapeutic Products (LBPs), which involve live microorganisms as therapeutic agents, are being explored for their potential to address gastrointestinal disorders, cancer, metabolic conditions, and immune-related diseases. Enhanced scientific understanding of the human microbiome and its connection to overall health has triggered a surge in interest from healthcare providers, investors, and regulatory bodies. Agencies like the U.S. FDA and European Medicines Agency are actively establishing regulatory pathways for LBPs, signaling a maturing market and drawing further investment. Simultaneously, the growing reliance on Contract Development and Manufacturing Organizations (CDMOs) for microbial development and production is reshaping the outsourcing landscape, particularly due to the technical complexity of live biotherapeutics.

Key Market Drivers

Increasing Prevalence of Chronic Diseases

The rising global burden of chronic diseases is a major factor fueling growth in the Live Biotherapeutics Products and Microbe CDMO Market. Non-communicable diseases such as cardiovascular disorders, cancer, and diabetes are among the leading causes of mortality worldwide. Contributing factors include poor diet, sedentary lifestyles, smoking, and alcohol use. According to the Pan American Health Organization (2019), ischemic heart disease alone accounted for 73.6 deaths per 100,000 globally, with stroke and other circulatory diseases also contributing significantly to mortality. Similarly, the World Health Organization (2022) reported lung cancer as the deadliest cancer worldwide, causing 1.8 million deaths, followed by colorectal, liver, stomach, and breast cancers. Live biotherapeutic products, which aim to regulate the gut microbiome-a key modulator of immunity and metabolic function-are gaining recognition for their potential to prevent or manage chronic conditions. Microbe-focused CDMOs offer tailored development, manufacturing, and scale-up services to support clinical research and commercialization of such therapies. As the incidence of chronic illness increases, demand for microbiome-driven solutions is expected to accelerate, supporting market expansion.

Key Market Challenges

Regulatory Uncertainty and Evolving Guidelines

One of the core challenges confronting the Live Biotherapeutics Products and Microbe CDMO Market is the evolving regulatory landscape. LBPs are biologically complex and often composed of novel microbial strains, which do not conform easily to conventional pharmaceutical classification systems. Regulatory agencies such as the FDA and EMA are still developing dedicated frameworks for assessing the safety, efficacy, and quality of LBPs. This regulatory ambiguity can cause delays in product approvals, increased development costs, and uncertainty in commercial planning. Additionally, navigating varied global regulatory requirements complicates efforts to launch products in multiple markets, adding operational and compliance burdens. The absence of harmonized international guidelines creates further complications for companies with global ambitions, particularly smaller firms that lack dedicated regulatory teams. Ongoing monitoring, documentation updates, and real-time compliance with changing regulations are resource-intensive and may slow down product pipelines, creating a significant barrier for innovation and commercialization.

Key Market Trends

Rising Interest in Microbiome-Based Therapeutics

There is a growing emphasis on microbiome-based therapies, significantly influencing the direction of the global Live Biotherapeutics Products and Microbe CDMO Market. As scientific research increasingly links the gut microbiota to immune regulation, metabolic health, and chronic disease development, pharmaceutical companies are intensifying efforts to develop live biotherapeutic products targeting the microbiome. Innovations in sequencing technologies and microbial identification have accelerated the discovery of beneficial strains, while AI integration is enabling faster optimization of formulations and development pathways. Clinical trials in this space are on the rise, and regulatory support is gradually evolving to accommodate these novel products. Personalized microbiome therapies tailored to individual microbial profiles are also gaining momentum, offering a promising frontier for precision medicine. These advancements are creating new opportunities for CDMOs with specialized capabilities in anaerobic fermentation, formulation, and encapsulation. As industry focus shifts from conventional small molecules to microbiome-centered strategies, the demand for microbial CDMO services is expected to surge.

Key Market Players

• Arrant Bio
• 4D Pharma
• Cerbios
• Biose Industrie
• Assembly Biosciences, Inc.
• Wacker Chemie AG
• Quay Pharmaceuticals
• NIZO
• Lonza
• Inpac Probiotics

Report Scope

In this report, the Global Live Biotherapeutics Products and Microbe CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Live Biotherapeutics Products and Microbe CDMO Market, By Application:

• C. difficile
• Crohn's Disease
• IBS
• Diabetes
• Others

Live Biotherapeutics Products and Microbe CDMO Market, By Product:

• APIs
• FDFs

Live Biotherapeutics Products and Microbe CDMO Market, By Type of Formulation:

• Solid Formulations
• Oral Liquids
• Injectables
• Others

Live Biotherapeutics Products and Microbe CDMO Market, By Scale of Operation:

• Preclinical Scale Operations
• Clinical Scale Operations
• Commercial Scale Operations

Live Biotherapeutics Products and Microbe CDMO 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 Live Biotherapeutics Products and Microbe CDMO Market.

Available Customizations

Global Live Biotherapeutics Products and Microbe CDMO 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, and Trends

4. Voice of Customer

5. Global Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Application (C.difficle, Crohns disease, IBS, Diabetes, Others)
  • 5.2.2. By Product (APIs, FDFs)
  • 5.2.3. By Type of Formulation (Solid Formulations, Oral Liquids, Injectables, Others)
  • 5.2.4. By Scale of Operation (Preclinical Scale Operations, Clinical Scale Operations, Commercial Scale Operations)
  • 5.2.5. By Company (2024)
  • 5.2.6. By Region
• 5.3. Market Map

6. North America Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Application
  • 6.2.2. By Product
  • 6.2.3. By Type of Formulation
  • 6.2.4. By Scale of Operation
  • 6.2.5. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 6.3.1.2.2. By Product
      • 6.3.1.2.3. By Type of Formulation
      • 6.3.1.2.4. By Scale of Operation
  • 6.3.2. Mexico Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 6.3.2.2.2. By Product
      • 6.3.2.2.3. By Type of Formulation
      • 6.3.2.2.4. By Scale of Operation
  • 6.3.3. Canada Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 6.3.3.2.2. By Product
      • 6.3.3.2.3. By Type of Formulation
      • 6.3.3.2.4. By Scale of Operation

7. Europe Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Application
  • 7.2.2. By Product
  • 7.2.3. By Type of Formulation
  • 7.2.4. By Scale of Operation
  • 7.2.5. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 7.3.1.2.2. By Product
      • 7.3.1.2.3. By Type of Formulation
      • 7.3.1.2.4. By Scale of Operation
  • 7.3.2. Germany Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 7.3.2.2.2. By Product
      • 7.3.2.2.3. By Type of Formulation
      • 7.3.2.2.4. By Scale of Operation
  • 7.3.3. United Kingdom Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 7.3.3.2.2. By Product
      • 7.3.3.2.3. By Type of Formulation
      • 7.3.3.2.4. By Scale of Operation
  • 7.3.4. Italy Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 7.3.4.2.2. By Product
      • 7.3.4.2.3. By Type of Formulation
      • 7.3.4.2.4. By Scale of Operation
  • 7.3.5. Spain Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 7.3.5.2.2. By Product
      • 7.3.5.2.3. By Type of Formulation
      • 7.3.5.2.4. By Scale of Operation

8. Asia-Pacific Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Application
  • 8.2.2. By Product
  • 8.2.3. By Type of Formulation
  • 8.2.4. By Scale of Operation
  • 8.2.5. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 8.3.1.2.2. By Product
      • 8.3.1.2.3. By Type of Formulation
      • 8.3.1.2.4. By Scale of Operation
  • 8.3.2. India Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 8.3.2.2.2. By Product
      • 8.3.2.2.3. By Type of Formulation
      • 8.3.2.2.4. By Scale of Operation
  • 8.3.3. South Korea Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 8.3.3.2.2. By Product
      • 8.3.3.2.3. By Type of Formulation
      • 8.3.3.2.4. By Scale of Operation
  • 8.3.4. Japan Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 8.3.4.2.2. By Product
      • 8.3.4.2.3. By Type of Formulation
      • 8.3.4.2.4. By Scale of Operation
  • 8.3.5. Australia Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 8.3.5.2.2. By Product
      • 8.3.5.2.3. By Type of Formulation
      • 8.3.5.2.4. By Scale of Operation

9. South America Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Application
  • 9.2.2. By Product
  • 9.2.3. By Type of Formulation
  • 9.2.4. By Scale of Operation
  • 9.2.5. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 9.3.1.2.2. By Product
      • 9.3.1.2.3. By Type of Formulation
      • 9.3.1.2.4. By Scale of Operation
  • 9.3.2. Argentina Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 9.3.2.2.2. By Product
      • 9.3.2.2.3. By Type of Formulation
      • 9.3.2.2.4. By Scale of Operation
  • 9.3.3. Colombia Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 9.3.3.2.2. By Product
      • 9.3.3.2.3. By Type of Formulation
      • 9.3.3.2.4. By Scale of Operation

10. Middle East and Africa Live Biotherapeutics Products and Microbe CDMO Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Application
  • 10.2.2. By Product
  • 10.2.3. By Type of Formulation
  • 10.2.4. By Scale of Operation
  • 10.2.5. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 10.3.1.2.2. By Product
      • 10.3.1.2.3. By Type of Formulation
      • 10.3.1.2.4. By Scale of Operation
  • 10.3.2. Saudi Arabia Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 10.3.2.2.2. By Product
      • 10.3.2.2.3. By Type of Formulation
      • 10.3.2.2.4. By Scale of Operation
  • 10.3.3. UAE Live Biotherapeutics Products and Microbe CDMO 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 Application
      • 10.3.3.2.2. By Product
      • 10.3.3.2.3. By Type of Formulation
      • 10.3.3.2.4. By Scale of Operation

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. Porters Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Arrant Bio
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. 4D Pharma
• 14.3. Cerbios
• 14.4. Biose Industrie
• 14.5. Assembly Biosciences, Inc.
• 14.6. Wacker Chemie AG
• 14.7. Quay Pharmaceuticals
• 14.8. NIZO
• 14.9. Lonza
• 14.10. Inpac Probiotics

15. Strategic Recommendations

16. About Us & Disclaimer