活体生物治疗产品和微生物 CDMO 市场－全球产业规模、份额、趋势、机会和预测，按应用、产品、配方类型、营运规模、地区和竞争细分，2020-2030 年

2024 年全球活生物治疗产品和微生物 CDMO 市场价值为 321.2 亿美元，预计到 2030 年将达到 2,184.5 亿美元，预测期内复合年增长率为 37.62%。随着製药和生物技术公司越来越多地采用基于微生物组的疗法来治疗和预防慢性病和传染病，市场正在获得强劲的发展。活生物治疗产品 (LBP) 涉及活微生物作为治疗剂，人们正在探索其治疗胃肠道疾病、癌症、代谢疾病和免疫相关疾病的潜力。对人类微生物组及其与整体健康的关係的科学理解不断增强，引发了医疗保健提供者、投资者和监管机构的兴趣。美国 FDA 和欧洲药品管理局等机构正在积极为 LBP 建立监管途径，这表明市场日趋成熟并吸引了进一步的投资。同时，微生物开发和生产对合约开发和製造组织 (CDMO) 的依赖日益增加，正在重塑外包格局，特别是由于活体生物疗法的技术复杂性。

关键市场驱动因素

慢性病盛行率不断上升

主要市场挑战

监管不确定性和不断发展的指导方针

主要市场趋势

人们对微生物组疗法的兴趣日益浓厚

目录

第 1 章：产品概述

第二章：研究方法

第三章：执行摘要

第四章：顾客之声

第五章：全球活体生物治疗产品与微生物CDMO市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 依应用（艰难梭菌、克隆氏症、肠躁症、糖尿病、其他）
  • 按产品（API、FDF）
  • 依剂型分类（固体剂型、口服液、注射剂、其他）
  • 依营运规模（临床前规模营运、临床规模营运、商业规模营运）
  • 按公司分类（2024）
  • 按地区
• 市场地图

第六章：北美活体生物治疗产品与微生物CDMO市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 美国
  • 墨西哥
  • 加拿大

第七章：欧洲活体生物治疗产品与微生物CDMO市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 法国
  • 德国
  • 英国
  • 义大利
  • 西班牙

第 8 章：亚太地区活体生物治疗产品与微生物 CDMO 市场展望

• 市场规模和预测
• 市场占有率和预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 韩国
  • 日本
  • 澳洲

第九章：南美洲活体生物治疗产品与微生物CDMO市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第 10 章：中东和非洲活体生物治疗产品和微生物 CDMO 市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 合併与收购（如有）
• 产品发布（如有）
• 最新动态

第 13 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 14 章：竞争格局

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

第 15 章：策略建议

第16章调查会社について・免责事项

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