Summary

Market Overview
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:
o C. difficile
o Crohn’s Disease
o IBS
o Diabetes
o Others
• Live Biotherapeutics Market, By Product:
o APIs
o FDFs
• Live Biotherapeutics Market, By Type of Formulation:
o Solid Formulations
o Oral Liquids
o Injectables
o Others
• Live Biotherapeutics Market, By Scale of Operation:
o Preclinical Scale Operations
o Clinical Scale Operations
o Commercial Scale Operations
• Live Biotherapeutics Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o 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).

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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