Live Biotherapeutic Products and Microbiome CDMO Market by Application (C. difficle, Crohn’s Disease, IBS, Diabetes, and Others), and Region (North America, Europe, Asia-Pacific, and LAMEA): Opportunity Analysis and Industry Forecast, 2023-2032

Live Biotherapeutic Products and Microbiome CDMO Overview

The live biotherapeutic products and microbiome CDMO market is an industry focused on the development, production, and commercialization of live biotherapeutic products and microbiome-based therapies. LBPs are biological products containing live organisms that have beneficial effects on human health by modulating the microbiome. They are used to treat conditions like gastrointestinal disorders, metabolic disorders, and infectious diseases. Microbiome-based therapies involve utilizing microbiota communities to influence health and treat diseases. CDMOs, as contract development and manufacturing organizations, provide specialized services to the pharmaceutical and biotechnology sectors.

In the context of LBPs and microbiome-based therapies, CDMOs offer expertise and infrastructure for product development, manufacturing, and testing. They assist biopharmaceutical companies in navigating regulations, conducting clinical trials, scaling up production, and ensuring quality control. The live biotherapeutic products and microbiome CDMO market comprises CROs, CMOs, and other service providers specializing in this field. The market is witnessing growth due to the increasing interest in microbiome research, the potential of LBPs and microbiome-based therapies, and the demand for specialized expertise in their development and production.

Global Live Biotherapeutic Products and Microbiome CDMO Market Analysis

The global live biotherapeutic products and microbiome CDMO market size was $14.33 million in 2022 and is predicted to grow with a CAGR of 41.6%, by generating a revenue of $388.13 million by 2032.

COVID-19 Impact on Global Live Biotherapeutic Products and Microbiome CDMO Market

The COVID-19 pandemic has had several impacts on the live biotherapeutic products and microbiome CDMO market. Firstly, there has been an increased demand for LBPs, such as probiotics and synbiotics, as people seek to support their immune health during the pandemic. However, clinical trials related to LBPs and microbiome-based therapies have faced disruptions, with many being temporarily halted or delayed due to enrollment restrictions and safety concerns. The global supply chain has also been affected, leading to challenges in sourcing raw materials, manufacturing, and distribution of LBPs and microbiome-related products. Regulatory processes have experienced delays or changes in priorities, potentially affecting market access and approval timelines. On a positive note, the pandemic has emphasized the importance of personalized medicine, which may drive future growth in the field of LBPs and microbiome CDMO, as researchers explore the potential of individualized treatments based on unique microbiome compositions.

Increasing Research and Development Activities to Drive the Market Growth

The live biotherapeutic products and microbiome CDMO market is influenced by several factors. First, there is growing interest in LBP and microbiome-based therapeutics, driving further research and development in this area. Many people suffer from chronic diseases such as inflammatory bowel disease (IBD) and obesity, and LBP offers a potential solution, increasing the demand for CDMO services. Regulatory support and advancements have also helped to create guidelines and frameworks for the development and commercialization of these therapies.

Investments and partnerships have grown as pharmaceutical companies and investors recognize the potential of LBP. This has stimulated the market and created collaborations between CDMO providers and industry players. Advances in sequencing and bioinformatics techniques have improved our understanding of human microbiome and facilitated the development of LBPs. This increases the need for his CDMO services to manufacture these products.

Regulatory Challenges to Restrain the Market Growth  

The live biotherapeutic products and microbiome CDMO market faces several impeding factors. The lack of clear guidelines and standardization for manufacturing, quality control, and safety assessment as well as slow approval process and regulatory challenges are major hurdles. Manufacturing complexity further impedes progress as it poses challenges in ensuring the consistency and reproducibility of the biologics used in these therapies. Intellectual property (IP) issues also play a role, as intellectual property protection for LBP and microbiome-related innovations is complex, leading to litigation and uncertainty. Furthermore, clinical validation and efficacy must be demonstrated through rigorous studies, but limited evidence and lack of long-term data prevent widespread adoption. Market awareness and education are required to educate stakeholders about potential benefits, but reimbursement challenges and investment restrictions are barriers to market entry. Finally, manufacturing capacity and infrastructure struggle to keep up with the demand for LBP and microbiome-based therapies, limiting scalability and accessibility.

Increasing Demand for Microbiome-based Therapies to Drive Excellent Opportunities

The live biotherapeutic products and microbiome CDMO market offers multiple opportunities for growth and advancement. With increasing awareness about the role of the microbiome in human health and disease, there is a growing demand for microbiome-based therapies, including LBP. This demand provides CDMOs with an opportunity to offer their expertise in manufacturing and developing these therapies. Continued advancements in microbiome research will further increase market potential. As our understanding of the microbiome grows, new LBPs and microbiome-based therapeutics will be developed, and CDMOs can work with researchers and companies to turn these discoveries into viable products. Regulatory support and guidelines from organizations such as the FDA are also encouraging investment in this area and expanding opportunities for CDMOs to serve. Partnerships and collaborations are key in this complex area, allowing CDMOs to combine skills with academic institutions, biotech companies and pharmaceutical companies. With specialized manufacturing capabilities and bio-handling expertise, CDMOs can establish themselves as a leader in this niche market.

Global Live Biotherapeutic Products and Microbiome CDMO Market Share, by Application, 2022

The c. difficle sub-segment accounted for the highest market share in 2022. Clostridium difficile (C. difficile) has exerted significant dominance over the Live Biotherapeutic Products (LBPs) and Microbiome Contract Development and Manufacturing Organization (CDMO) market. This is primarily due to the rising incidence of C. difficile infections, especially in healthcare settings, driven by prolonged antibiotic use. As the importance of the microbiome in maintaining overall health has been recognized, the disruption of microbial balance caused by C. difficile has prompted the development of microbiome-based therapies. LBPs, live microorganisms that restore a healthy microbiome, have shown promise in combating C. difficile infections. Regulatory support and investment in this field have accelerated the development and commercialization of these therapies, further driving market growth. Additionally, the emergence of specialized CDMOs focusing on microbiome therapeutics has facilitated the manufacturing, formulation, and quality control of LBPs and microbiome-based products.

Global Live Biotherapeutic Products and Microbiome CDMO Market by Region, 2022

The North America live biotherapeutic products and microbiome CDMO market generated the highest revenue in 2022. North America has emerged as a dominant force in the market. This prevalence can be attributed to several important factors. First, the region has a strong research and advancement (R&D) infrastructure, with major academic institutions and biotechnology companies investing heavily in researching the human microbiome and creating imaginative therapeutics. Recently, the regulatory system in North America, particularly the United States, has supported the advancement of microbiome-based therapeutics and encouraged research and investment in this field. Moreover, North America's well-established biotechnology industry brings expertise in process development, production scale-up, and quality control, making it an attractive target for CDMO administrations. In addition, heavy investment and financing in the microbiome and LBP sector, as well as gigantic demand and early presentation of microbiome-based therapeutics, encourage North America's dominance in this market.

Competitive Scenario in the Global Live Biotherapeutic Products and Microbiome CDMO Market

Investment and partnership are common strategies followed by major market players. Some of the leading live biotherapeutic products and microbiome CDMO market players are Arrant Bio, 4D Pharma, Cerbios, Biose Industry, Assembly Biosciences, Inc., Wacker Chemie AG, Quay Pharmaceuticals, NIZO, Lonza, and Inpac Probiotics.