라이브 바이오테라퓨틱스 시장 - 세계 산업 규모, 점유율, 동향, 기회, 예측 : 용도별, 제품 유형별, 사업 규모별, 지역별, 경쟁별(2020-2030년)

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