Live Biotherapeutics Products and Microbe CDMO Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application, By Product, By Type of Formulation, By Scale of Operation, By Region and Competition, 2020-2030F

Description

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.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 32.12 Billion
Market Size 2030	USD 218.45 Billion
CAGR 2025-2030	37.62%
Fastest Growing Segment	Clinical Scale Operations
Largest Market	North America

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:

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