Live Biotherapeutics & Microbiome Contract Manufacturing Market Set for Takeoff- 2024-2031 Forecasts

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Live Biotherapeutic Products And Microbiome Contract Manufacturing Market Size, Share & Trends Analysis Report By Type of Services (Development Services, Manufacturing Services, and Others (Regulatory expertise and support, Quality Control and Assurance)), By Scale of operations (Preclinical Scale Operations, Clinical Scale Operations, Commercial Scale Operations) By Application (C. difficle, Crohn's disease, IBS, Diabetes, Others) - Market Outlook And Industry Analysis 2031"

The Global Live Biotherapeutic Products And Microbiome Contract Manufacturing Market is valued at US$ 141.52 Mn in 2023, and it is expected to reach US$ 993.81 Mn by 2031, with a CAGR of 23.19% during the forecast period of 2024-2031.

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Live Biotherapeutic Products (LBPs) are a category of biological products that contain live microorganisms, such as bacteria or yeast, which are used to prevent, treat, or cure diseases in humans. These products are distinct from traditional probiotics in that they are intended for specific therapeutic purposes and are subject to regulatory approval by agencies like the FDA. LBPs are used in various medical fields, including gastroenterology, immunology, and dermatology, to modulate the human microbiome and treat conditions such as inflammatory bowel disease, Clostridium difficile infection, and other microbiome-associated disorders.

LBPs for IBS focus on strains that can improve gut motility, reduce bloating, and alleviate pain. Research and development efforts identify strains with these properties. LBPs are tested in clinical trials to determine their effectiveness in preventing and treating CDI. This includes evaluating their ability to reduce recurrence rates and restore healthy gut flora. Ensuring the safety of LBPs is paramount, particularly for immunocompromised patients. Clinical trials assess the safety profile of the product, monitoring for adverse effects. Contract manufacturers provide support for regulatory submissions, including compiling data on product safety, efficacy, and manufacturing processes.

The global nature of modern clinical trials requires efficient logistics and standardized biospecimen handling across multiple sites. Contract research services offer the necessary infrastructure and expertise to manage biospecimens on a global scale.

List of Prominent Players in the Live Biotherapeutic Products And Microbiome Contract Manufacturing Market

• Quay Pharmaceuticals,
• Cerbios-Pharma SA,
• List Biological Labs, Inc.,
• Arranta Bio (Acquired by Recipharm),
• BacThera,
• Biose Industrie
• Wacker Biotech,
• Other prominent players

Market Dynamics:

Drivers-

Rising incidence of chronic diseases such as inflammatory bowel disease (IBD), diabetes, and obesity has spurred interest in microbiome-based therapies. LBPs offer potential solutions by modulating the gut microbiota to improve health outcomes. Innovations in bioprocessing technologies, such as improved fermentation techniques and bioreactor design, have enhanced the scalability and cost-effectiveness of producing LBPs. This has enabled contract manufacturers to meet the growing demand for these specialized products. The shift towards personalized medicine has highlighted the potential of LBPs to provide targeted therapies based on individual microbiome profiles. This approach promises more effective treatments with fewer side effects, driving adoption in clinical practice.

Challenges:

Ensuring consistency and quality across batches of LBPs poses a challenge. Variability in microbial growth conditions, fermentation processes, and formulation techniques can impact the efficacy and safety of the final product.

Regional Trends:

North America dominates the market. Many clinical trials for microbiome-based therapies, including LBPs, are conducted in North America. Research institutions and biotech companies collaborate extensively to advance novel treatments for gastrointestinal disorders, metabolic diseases, and other conditions. Asia pacific is a rapidly growing due to Increasing investment from local biotech firms, multinational companies, and government initiatives supports innovation in microbiome research and contract manufacturing capabilities.

Recent Developments:

• In April 2023, Arranta Bio, a contract to develop a continuous production technique for mRNA therapies has been inked with MIT. One of the biggest awards from the FDA's CBER office, the contract is a part of the agency's plan to establish a fully integrated, continuous manufacturing production line for mRNA vaccines. The deal is being funded by MIT. Enabling quick production capability will enable quicker response and preparedness for emerging pandemic risks.

• In March 2023, Biose Industrie, declared their intention to open a laboratory later this year in the center of Boston, Massachusetts. Following Biose Industries' remarkable global success in the development and production of LBP processes, the company will open a new plant to further solidify its position in the US market.

Segmentation of Live Biotherapeutic Products And Microbiome Contract Manufacturing Market-

By Type of Services

• Development Services
• Manufacturing Services
• Others (Regulatory expertise and support, Quality Control and Assurance)

By Scale of Operation

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

By Application

• difficle
• Crohn's disease
• IBS
• Diabetes
• Others

By Region-

North America-

• The US
• Canada
• Mexico

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Rest of Latin America

 Middle East & Africa-

• GCC Countries
• South Africa
• Rest of Middle East and Africa