生菌製剤（LBP）と微生物CDMO市場- 世界の産業規模、シェア、動向、機会、予測、用途別、製品タイプ別、事業規模別、地域別、競合別セグメント、2020-2030F

生菌製剤（LBP）と微生物CDMOの世界市場は、2024年に321億2,000万米ドルと評価され、2030年には2,184億5,000万米ドルに達し、予測期間中のCAGRは37.62％で成長すると予測されています。

製薬会社やバイオテクノロジー企業が、慢性疾患や感染症の治療や予防のために微生物を利用した治療法を採用するケースが増えていることから、同市場は力強い牽引力となっています。生きた微生物を治療薬として使用する生菌製剤（LBP）は、消化器疾患、がん、代謝性疾患、免疫関連疾患への対処の可能性が模索されています。ヒトマイクロバイオームとその健康全般との関連性についての科学的理解が深まったことで、ヘルスケアプロバイダー、投資家、規制機関からの関心が急上昇しています。米国FDAや欧州医薬品庁（European Medicines Agency）のような機関は、LBPに対する規制の道筋を積極的に確立しており、市場の成熟を示し、さらなる投資を引き寄せています。同時に、微生物開発・製造のための開発・製造受託機関（CDMO）への依存の高まりは、特に生きたバイオ医薬品の技術的複雑性のために、アウトソーシングの状況を再構築しています。

市場促進要因

慢性疾患の増加

主な市場課題

規制の不確実性とガイドラインの進化

主要市場動向

微生物ベースの治療薬への関心の高まり

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • 用途別（クロストリジウム・ディフィシル、クローン病、過敏性腸症候群、糖尿病、その他）
  • 製品別（API、FDF）
  • 製剤の種類別（固形製剤、経口液剤、注射剤、その他）
  • 事業規模別（前臨床規模の事業、臨床規模の事業、商業規模の事業）
  • 企業別（2024）
  • 地域別
• 市場マップ

第6章 北米の生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第7章 欧州の生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • 英国
  • イタリア
  • スペイン

第8章 アジア太平洋地域の生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • 韓国
  • 日本
  • オーストラリア

第9章 南米の生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの生菌製剤（LBP）と微生物CDMO市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 合併と買収
• 製品上市
• 最近の動向

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第14章 競合情勢

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

第15章 戦略的提言

第16章 調査会社について・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