Live Biotherapeutics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Application (C.difficle, Crohns disease, IBS, Diabetes, Others), By Product (APIs, FDFs), By Type of Formulation (Solid Formulations, Oral Liquids, Injectables, Others), By Scale of Operation (Preclinical Scale Operations, Clinical Scale Operations, Commercial Scale Operations), By Region and Competition, 2020-2030F

Market Overview

Global Live Biotherapeutics Market was valued at USD 112.34 Million in 2024 and is expected to reach USD 247.69 Million by 2030 with a CAGR of 14.06%. The Global Live Biotherapeutics Market is gaining momentum as pharmaceutical and biotech companies increasingly explore microbiome-based therapies for a wide range of chronic and infectious diseases. Live biotherapeutic products (LBPs), defined as biological products containing live organisms applicable to disease prevention or treatment, are showing promise in areas such as gastrointestinal disorders, cancer, and metabolic diseases. The growing understanding of the gut microbiome's influence on health has spurred interest from research institutions, investors, and healthcare providers. Furthermore, regulatory authorities such as the U.S. FDA and European Medicines Agency have started framing guidelines for the development of LBPs, lending credibility and encouraging further investment in this area.

A significant trend driving the market is the increasing outsourcing of complex microbiome-related development and manufacturing to specialized Contract Development and Manufacturing Organizations (CDMOs). Developing LBPs involves unique challenges related to stability, viability, and controlled fermentation, all of which require advanced infrastructure and technical expertise. As a result, pharmaceutical companies are turning to CDMOs that offer specialized capabilities for microbial fermentation, anaerobic processing, and encapsulation. The market is also seeing a rise in partnerships and collaborations between biopharma companies and academic institutions to co-develop novel strains and delivery systems. The integration of artificial intelligence in strain identification and process optimization is further advancing development timelines and reducing costs.

The market faces several challenges that could hinder its pace of growth. Live biotherapeutics require stringent cold-chain logistics and present stability concerns during manufacturing and transportation. Regulatory complexity is another barrier, with evolving standards for safety, efficacy, and classification differing across regions. High development costs and long clinical validation timelines, especially for novel microbial strains, also create entry barriers for smaller firms. However, increasing awareness about microbiome health, rising incidence of lifestyle diseases, and continuous technological improvements in fermentation and preservation offer a positive outlook for the Live Biotherapeutics Market in the coming years.

Key Market Drivers

Increasing Prevalence of Chronic Diseases

Chronic diseases are defined broadly as conditions that progress slowly and persist over an extended period. Some of the major risk factors which lead to the development of chronic illness inside human body include intake of unbalanced diet, consumption of alcohol, smoking cigarettes, physical inactivity, and others. Cardiovascular diseases, Cancer, and diabetes are three most prevailing chronic diseases in the world which are thereby increasing the mortality of every country in the forecast period. According to the report published by Pan American Health Organization (PAHO) in 2019, Ischemic heart disease accounted for 73.6 deaths per 100,000 population in the world, followed by stroke with 32.3 deaths, other circulatory diseases with 14.8 deaths, hypersensitive heart disease with 10.6 deaths, cardiomyopathy, myocarditis, and endocarditis with 5.1 deaths and rheumatic heart disease with 0.7 deaths of total population across the world.  After cardiovascular diseases, cancer has been reported as second major reason behind the growing mortality rate of various developing countries across the world.

As per the report published by World Health Organization (WHO) in 2022, it has been observed that lung cancer has been the most prominent type of cancer prevailing across the world accounting for 1.80 million deaths, followed by 9,16,000 deaths caused by colon and rectum cancer, 8,30,000 deaths due to liver cancer, 7,69,000 deaths by stomach cancer and 6,85,000 deaths caused by breast cancer. Live biotherapeutic products are designed to modulate the gut microbiome which plays a major role in maintaining a healthy immune system and preventing chronic diseases. Moreover, microbe CDMOs provide customized solutions for the development, manufacturing, and scale-up of microbial products for clinical trials and commercial use. Other health problems which can affect the human body along with prevalence of chronic diseases are expected to propel the growth of global biotherapeutics market in the forecast period.

Rising Clinical Focus on the Human Microbiome

​The growing clinical focus on the human microbiome is a key driver for the Global Live Biotherapeutics Market. As research into the microbiome advances, its role in maintaining health and influencing disease outcomes becomes increasingly evident. The microbiome, consisting of trillions of microorganisms living in and on the human body, is now recognized for its significant impact on a wide range of health conditions, including autoimmune diseases, gastrointestinal disorders, metabolic disorders, and even neurological conditions. This growing understanding has accelerated the demand for live biotherapeutic products that leverage the microbiome to restore balance and promote health.​

Pharmaceutical companies and biotechnological firms are heavily investing in microbiome-based therapeutics, focusing on the development of live biotherapeutic products (LBPs) that utilize live bacteria to treat or prevent diseases. The clinical focus on microbiome therapy has led to an increase in the number of clinical trials aimed at demonstrating the efficacy of these treatments. As a result, there is an increased need for contract development and manufacturing organizations (CDMOs) to support the production and scale-up of microbiome-based products. The demand for specialized manufacturing expertise, including fermentation, purification, and formulation of live organisms, is growing, driving the need for CDMOs capable of supporting these complex processes.​

As the human microbiome market expands, the clinical focus on these therapies is expected to continue to intensify, creating significant opportunities for CDMOs with expertise in live biotherapeutics. This focus on clinical applications of microbiome therapies is expected to significantly contribute to the growth of the Global Live Biotherapeutics Market in the coming years.

Advances in Synthetic Biology and Strain Engineering

Advances in synthetic biology and strain engineering are significantly driving the growth of the Global Live Biotherapeutics Market. These innovations enable the precise design and optimization of microbial strains to enhance their therapeutic efficacy and safety profiles. The ability to engineer microorganisms at the genetic and molecular level has revolutionized the development of live biotherapeutics, allowing for the creation of more potent, stable, and targeted therapies. This has opened new avenues for the treatment of a range of diseases, particularly those related to the microbiome, such as gastrointestinal disorders, autoimmune diseases, and metabolic conditions.

Synthetic biology tools, such as CRISPR and gene editing technologies, empower scientists to modify microbial genomes more efficiently and with greater precision. Strain engineering enhances the production capabilities of microbes, enabling higher yields of therapeutic compounds with reduced costs. These technological advancements allow for a faster and more cost-effective development process, which is crucial for the commercial success of live biotherapeutic products. The ability to manipulate microbial strains also accelerates the transition from research to clinical application, facilitating the rapid testing and optimization of new therapies. As a result, synthetic biology and strain engineering are pivotal in expanding the scope and potential of live biotherapeutics, thereby driving market growth in the coming years.

Recent data underscores the growing significance of synthetic biology in the biomanufacturing sector. In 2023, combined private and public investment in synthetic biology totaled approximately USD 16.35 billion, with projections indicating the market could reach USD 148 billion by 2033. This surge in investment reflects the increasing confidence in synthetic biology's potential to revolutionize therapeutic development and manufacturing processes. Additionally, the U.S. bioeconomy, encompassing synthetic biology applications, is estimated to be worth nearly USD 1 trillion, highlighting the substantial economic impact of these advancements. These figures demonstrate the critical role of synthetic biology in shaping the future of live biotherapeutics and underscore the importance of continued investment and innovation in this field.

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Key Market Challenges

Regulatory Uncertainty and Evolving Guidelines

Regulatory uncertainty remains one of the major challenges for the Global Live Biotherapeutics Market. As live biotherapeutic products (LBPs) involve novel and diverse microbial strains, regulators are faced with challenges in establishing clear guidelines. The evolving nature of these regulations can create significant obstacles for manufacturers, as compliance requirements may change or remain unclear, leading to delays in product approvals. Regulatory bodies such as the FDA, EMA, and other global authorities are still developing frameworks to address the unique characteristics of live biotherapeutics, which often do not fit within traditional pharmaceutical regulations. These evolving guidelines can result in extended approval timelines and increased costs for companies attempting to bring innovative therapies to market. Additionally, the global nature of the market requires adherence to multiple regulatory standards, complicating the approval process for manufacturers who wish to introduce their products in various regions. The lack of harmonization between different regulatory bodies adds a layer of complexity for businesses, leading to higher operational costs and uncertain market entry strategies. Companies must continually monitor regulatory changes and adapt their strategies accordingly, which can be resource-intensive and slow down market growth.

High Complexity in Strain Cultivation and Manufacturing

The complexity of strain cultivation and manufacturing presents another significant challenge for the Global Live Biotherapeutics Market. Manufacturing live biotherapeutic products involves growing a wide variety of microbial strains, each with its own unique cultivation requirements. These strains often require highly controlled environments to maintain their stability and viability, which necessitates specialized facilities and expertise. The complexity of optimizing growth conditions for different strains can lead to higher costs and inefficiencies in production. Scaling up the production process to meet commercial demand while maintaining the quality and consistency of live biotherapeutic products is particularly challenging. These products must be manufactured under stringent Good Manufacturing Practices (GMP) standards, which are difficult to achieve due to the need for precise environmental control and the complexity of microbial strain handling. Inconsistent strain performance, potential contamination issues, and difficulties in preserving the integrity of live microbes throughout the production process all pose risks to the success of the product. These challenges create barriers for smaller companies without the resources or infrastructure to handle large-scale, complex production processes, limiting the potential for innovation and growth in the sector.

Key Market Trends

Rising Interest in Microbiome-Based Therapeutics

The growing interest in microbiome-based therapeutics is significantly impacting the Global Live Biotherapeutics Market. Researchers and pharmaceutical companies have increasingly turned their attention to the human microbiome for its therapeutic potential, recognizing its role in numerous physiological processes, including immune response, metabolism, and disease prevention. As the understanding of the microbiome’s influence on health deepens, it is becoming a focal point for the development of innovative treatments for a wide range of diseases, including autoimmune disorders, gastrointestinal diseases, and even cancer. This shift in focus is driving the demand for live biotherapeutic products that are designed to modulate or restore the balance of microbiota.

The increasing number of microbiome-related clinical trials further highlights this trend. Regulatory bodies, such as the FDA and EMA, are establishing frameworks for approving microbiome-based therapies, making it more feasible for companies to bring their microbiome-related products to market. As the field continues to evolve, there is growing interest in the development of personalized microbiome therapies, tailored to individuals’ unique microbiota profiles. This level of personalization is enhancing the market’s potential by opening avenues for more effective treatments. The rising interest in microbiome-based therapeutics is also being bolstered by advancements in sequencing technology, which allows for more precise identification of beneficial microorganisms that can be used for therapeutic purposes. This trend is expected to continue expanding the market for live biotherapeutics and microbial contract development and manufacturing organizations (CDMOs).

Shift Toward Next-Generation Engineered Microbes

Next-generation engineered microbes are becoming a key trend in the Global Live Biotherapeutics Market, as advancements in synthetic biology and genetic engineering have opened new possibilities in therapeutic applications. Traditional approaches to microbial therapy often focused on using naturally occurring microbes, but now, companies are moving toward the engineering of microorganisms to improve their functionality, targeting precision, and overall therapeutic potential. By modifying the genetic structure of these microbes, researchers can enhance their ability to produce therapeutic molecules or deliver specific treatments, significantly increasing their effectiveness and safety.

These engineered microbes are being developed for a variety of applications, including targeted drug delivery, treatment of chronic diseases, and even as tools for cancer immunotherapy. The shift to next-generation microbes also aligns with the increasing interest in precision medicine, where therapies are tailored to the individual’s specific genetic makeup and disease characteristics. This trend is leading to the creation of highly specialized microbial products, optimized to address specific health conditions. As the demand for more precise and efficient treatments rises, engineered microbes will play a pivotal role in advancing the development of live biotherapeutic products.

The growing capability to design and manipulate microbial genomes using CRISPR and other gene-editing technologies has enabled the creation of novel strains with improved capabilities. These innovations are driving the demand for CDMOs with the expertise to handle the complex processes involved in producing such advanced therapies. As the biotechnology industry continues to advance, the shift towards engineered microbes will likely expand the market, offering new opportunities for companies specializing in the development and manufacturing of microbial-based therapies.

Segmental Insights

Application Insights

Based on the Application, C.difficle emerged as the dominant segment in the Global Live Biotherapeutics Market in 2024. Clostridium difficile (C. difficile) infection has become a major focus in the Global Live Biotherapeutics Market, emerging as the dominant application in 2024. C. difficile infections, which cause severe gastrointestinal symptoms, are often linked to antibiotic overuse and can lead to life-threatening complications. The rising prevalence of C. difficile infections, particularly in healthcare settings, has driven the demand for therapeutic solutions, especially those leveraging live biotherapeutics. These therapies aim to restore the balance of the gut microbiome and provide an alternative to traditional antibiotic treatments. Live biotherapeutics, particularly fecal microbiota transplants (FMT) and engineered probiotics, have shown promising results in treating recurrent C. difficile infections, providing a significant improvement over conventional method. As a result, pharmaceutical companies and CDMOs are increasingly focusing on developing and manufacturing live biotherapeutics specifically targeted at C. difficile infections. The potential to address unmet medical needs and reduce the frequency of recurrence has made this application a priority in the market. This trend is expected to drive continued growth in the C. difficile segment, as the therapeutic options expand, with more personalized and effective treatments on the horizon.

Product Insights

Based on the Product, APIs emerged as the dominant segment in the Global Live Biotherapeutics Market in 2024. Active Pharmaceutical Ingredients (APIs) emerged as the dominant product segment in the Global Live Biotherapeutics Market in 2024. APIs, being the core substance in any pharmaceutical formulation, play a vital role in the production of live biotherapeutics. In the context of live biotherapeutics, APIs are essential for ensuring the correct functioning of microorganisms engineered for therapeutic purposes. These biotherapeutic APIs, derived from live microbes, help in modulating the microbiome and delivering therapeutic effects for various conditions, such as gastrointestinal disorders, metabolic diseases, and immune system regulation. As the biotherapeutic landscape continues to expand, particularly in areas like microbiome-based therapies and engineered probiotics, the demand for APIs is growing rapidly. These APIs enable more precise targeting of specific health conditions and allow for the development of personalized treatments, improving both efficacy and safety.

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Regional Insights

North America emerged as the dominant region in the Global Live Biotherapeutics Market in 2024. This is driven by a strong ecosystem of research, development, and manufacturing capabilities. The United States has been at the forefront of microbiome-based therapeutic research, with numerous biotechnology companies focusing on live biotherapeutics. The region benefits from a well-established healthcare infrastructure, significant funding for biotech research, and a regulatory environment that supports the development and approval of innovative therapies. The demand for live biotherapeutics is rapidly increasing in North America, with rising awareness about microbiome-based treatments for diseases such as C. difficile infections, metabolic disorders, and autoimmune conditions. Major pharmaceutical companies and biotechs in the region are investing heavily in microbiome research and clinical trials, further propelling the market growth.

Asia-Pacific emerged as the fastest growing region in the Global Live Biotherapeutics Market during the forecast period. This is driven by several factors that position the region as a critical player in the biotherapeutic space. The rapid growth of healthcare infrastructure, coupled with increased investment in biotechnology and pharmaceutical sectors, is fostering a conducive environment for the development of live biotherapeutics. The region has witnessed substantial advancements in microbial-based therapeutics, with several biotechnology startups and established players in countries like China, Japan, India, and South Korea focusing on the growing demand for microbiome-based therapies. This surge in biotech innovation is supported by government initiatives and favorable policies that encourage research and development in microbial therapies, alongside enhanced regulatory frameworks. As a result, companies in Asia-Pacific are increasingly engaging in clinical trials and collaborations aimed at harnessing the potential of live biotherapeutics, particularly in addressing conditions such as gastrointestinal disorders, autoimmune diseases, and metabolic conditions.

Recent Developments

• In November 2024, SEKISUI Diagnostics announced the completion of a USD 20.7 Million cGMP capacity expansion at its UK site, enhancing its microbial CDMO business for clinical-grade drug substance manufacturing. This expansion will improve manufacturing capabilities for enzymes, proteins, antibody fragment therapies, plasmids, and advanced gene therapy products, once necessary licenses are obtained. The new Grade C microbial fermentation and purification facilities will support production scales of up to 1,000L. SEKISUI Diagnostics' BioProduction division specializes in microbial process development and downstream purification, offering contract manufacturing services (CDMO) to biopharma companies.
• In September 2024, Vironexis Biotherapeutics received FDA clearance for its investigational new drug (IND) application for VNX-101, an AAV vector-based gene therapy. This approval paves the way for a Phase 1/2 clinical trial targeting CD19+ acute lymphoblastic leukemia. VNX-101 is designed to transduce liver cells to express a bispecific T-cell engager that targets CD19 on tumor cells and CD3 on T-cells, enabling targeted cancer cell destruction by the body's immune system. The therapy is based on the company’s TransJoin platform, which is also being explored for other cancers through additional investigational candidates in preclinical stages. This announcement follows a USD 26 million seed financing round and marks the company's exit from stealth mode.
• In August 2024, Fujifilm Diosynth Biotechnologies, a leading contract development and manufacturing organization (CDMO), launched a new microbial fermentation facility in Billingham. The facility enhances microbial production capacity, tripling existing throughput with the addition of a new production line featuring two 4,000 L fermenters, a primary separations suite, and a modular purification suite. Designed with flexibility in mind, the expansion accommodates future projects and strengthens supply chain resilience. This facility will also support a major pharmaceutical partner focused on developing a specialized ophthalmic therapeutic for wet age-related macular degeneration (AMD).
• In March 2024, Siolta Therapeutics, a clinical-stage biotech company, completed a USD 12 million Series C financing round. The round was co-led by SymBiosis and Khosla Ventures, with participation from existing investors such as TIME Ventures, Seventure, and Global Brain. The funds will support the clinical development of Siolta's lead product, STMC-103H, a Live Biotherapeutic Product (LBP) aimed at preventing atopic diseases in newborns. This financing is crucial as Siolta explores the potential of microbiome-based treatments for maternal and infant health.

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.difficle

o   Crohns 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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