ライブバイオセラピューティクス市場- 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、2020-2030年

ライブバイオセラピューティクスの世界市場は、2024年には1億1,234万米ドルとなり、2030年には2億4,769万米ドルに達し、CAGR14.06%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に対処するために微生物ベースの治療法への投資を増やしており、市場は力強い成長を遂げています。生きたバイオ治療製品（LBP）-疾患の治療や予防のための生きた微生物を含む生物学的製品と定義される-は、消化器疾患、代謝性疾患、がんなどの症状において有望な用途が示されています。ヒトの健康における腸内マイクロバイオームの役割に関する科学的理解が進むにつれ、研究機関や投資家の関心も高まっています。さらに、米国FDAや欧州医薬品庁（European Medicines Agency）などの規制機関は、LBP開発に関する具体的なガイドラインを導入しており、正当性を高め、この分野でのさらなる技術革新と投資を促しています。

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 世界のライブバイオセラピューティクス市場展望

• 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 北米のライブバイオセラピューティクス市場展望

• 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 欧州のライブバイオセラピューティクス市場展望

• 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ライブバイオセラピューティクス市場展望

• 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 南米のライブバイオセラピューティクス市場展望

• 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・アフリカのライブバイオセラピューティクス市場展望

• 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 混乱：紛争、パンデミック、貿易障壁

第14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15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16章 戦略的提言

第17章 調査会社について・免責事項

The Global Live Biotherapeutics Market was valued at USD 112.34 Million in 2024 and is expected to reach USD 247.69 Million by 2030, growing at a CAGR of 14.06%. The market is witnessing strong growth as pharmaceutical and biotech companies increasingly invest in microbiome-based therapies to address chronic and infectious diseases. Live biotherapeutic products (LBPs)-defined as biological products containing live microorganisms for disease treatment or prevention-are showing promising applications in conditions like gastrointestinal disorders, metabolic diseases, and cancer. As scientific understanding of the gut microbiome's role in human health advances, research institutions and investors are showing increased interest. Additionally, regulatory agencies such as the U.S. FDA and the European Medicines Agency are introducing specific guidelines for LBP development, providing greater legitimacy and encouraging further innovation and investment in the field.

Key Market Drivers

Increasing Prevalence of Chronic Diseases

The rising global burden of chronic diseases is a major driver fueling the growth of the Live Biotherapeutics Market. Chronic conditions such as cardiovascular diseases, cancer, and diabetes are becoming more widespread due to risk factors like poor diet, alcohol use, smoking, and sedentary lifestyles. According to a 2019 report by the Pan American Health Organization (PAHO), ischemic heart disease caused 73.6 deaths per 100,000 population globally, followed by stroke (32.3), other circulatory diseases (14.8), hypertensive heart disease (10.6), and cancer as a leading secondary contributor to mortality. As these chronic diseases persist and increase in incidence, there is a growing need for innovative therapies that can address underlying causes and improve long-term outcomes. Live biotherapeutic products, by modulating the microbiome, offer potential as adjunct or standalone treatments in these chronic health areas, driving continued market expansion.

Key Market Challenges

Regulatory Uncertainty and Evolving Guidelines

One of the primary obstacles facing the Global Live Biotherapeutics Market is the ongoing uncertainty surrounding regulatory frameworks. Live biotherapeutic products involve complex and diverse microbial compositions that challenge traditional regulatory classifications. Agencies like the FDA and EMA are actively developing new guidelines, but the evolving nature of these regulations creates challenges for companies in terms of compliance, product approval, and commercialization timelines. This fluid regulatory environment can lead to increased development costs, extended approval periods, and complex multi-region compliance requirements. Moreover, the lack of harmonization across global regulatory bodies further complicates market entry, particularly for firms aiming to launch products internationally. Companies must constantly adapt to changing requirements, which demands significant time, financial resources, and regulatory expertise-slowing market penetration and increasing operational burden.

Key Market Trends

Rising Interest in Microbiome-Based Therapeutics

The increasing focus on microbiome-based therapeutics is shaping the trajectory of the Global Live Biotherapeutics Market. Scientific discoveries highlighting the microbiome's role in regulating immunity, digestion, metabolism, and disease resistance have positioned it as a key target for drug development. Pharmaceutical and biotech firms are increasingly leveraging this understanding to create targeted therapies that restore microbiome balance, particularly in diseases such as inflammatory bowel disease (IBD), cancer, and autoimmune conditions. As research continues to demonstrate the therapeutic relevance of microbiota modulation, demand for live biotherapeutic products is expanding. This trend is also attracting investment from both public and private sectors, leading to greater innovation and pipeline growth within the LBP segment.

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 Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Live Biotherapeutics Market, By Application:

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

Live Biotherapeutics Market, By Product:

• APIs
• FDFs

Live Biotherapeutics Market, By Type of Formulation:

• Solid Formulations
• Oral Liquids
• Injectables
• Others

Live Biotherapeutics Market, By Scale of Operation:

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

Live Biotherapeutics 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 Market.

Available Customizations:

Global Live Biotherapeutics 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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. Disruptions: Conflicts, Pandemics and Trade Barriers

14. Porters 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. Arrant Bio
  • 15.1.1. Business Overview
  • 15.1.2. Company Snapshot
  • 15.1.3. Products & Services
  • 15.1.4. Financials (As Reported)
  • 15.1.5. Recent Developments
  • 15.1.6. Key Personnel Details
  • 15.1.7. SWOT Analysis
• 15.2. 4D Pharma
• 15.3. Cerbios
• 15.4. Biose Industrie
• 15.5. Assembly Biosciences, Inc.
• 15.6. Wacker Chemie AG
• 15.7. Quay Pharmaceuticals
• 15.8. NIZO
• 15.9. Lonza
• 15.10. Inpac Probiotics

16. Strategic Recommendations

17. About Us & Disclaimer