The human microbiome is characterized by microbial communities that consist of beneficial bacteria, also known as microbiota. The microbiome creates a dynamic ecosystem inside the digestive system, contributing to the overall health of an individual.
This human microbiome helps to prevent pathogenesis and target various disease indications such as autoimmune, gastrointestinal infection, and metabolic diseases. With a growing understanding of the significant role of the microbiome in disease and health management, several microbiome manufacturing market players focus on the concept of live biotherapeutics.
Live biotherapeutics is a class of microbiome therapy that aims to prevent diseases in humans. It is worth highlighting here that in 2023, Ser-109 (VOWST™), developed by Seres Therapeutics, received approval from the FDA.
- Amid ongoing research for the development of live therapeutics, the microbiome manufacturing market is estimated to be worth USD 27 million in 2023, according to the Roots Analysis report.
- The market is expected is anticipated to reach USD 187 million by 2035.
- The growing prevalence of gut-microbiota-based therapeutics is driving the market at a CAGR of 17% from 2023-2035.
Microbiome Manufacturing Market Landscape
According to the recently published report of Roots Analysis, the microbiome manufacturing market consists of start-ups, mid-sized firms, and well-established players. Overall, the market also features various contract manufacturing organizations that are currently offering technical expertise across different scales of operation, namely, preclinical, clinical, and commercial.
It is interesting to note here that 50% of the contract manufacturers provide services for both API (Active Pharmaceutical Ingredients) and FDF (Fixed Dosage Formulation) manufacturing. Some notable examples of the top market players offering contract manufacturing services include Seres Therapeutics and MaaT Pharma. As the demand for live therapeutics increases, the microbiome manufacturing market is expected to witness substantial growth from 2023-2035.
Top 4 Drivers of the Microbiome Manufacturing Market
In recent years, pharmaceutical companies have begun to focus on omics and microbiomes to understand the underlying cause of diseases. The ongoing study of microbiome science has fueled the development of live therapeutics for the treatment of diseases. As the research on microbiome manufacturing continues to explore more therapeutic applications based on microbiota, the microbiome manufacturing market will expand at an exponential rate.
- Advancements in Microbiome Technologies: The microbiome manufacturing market benefits from ongoing technological advancements such as metabolomics, DNA sequencing, gene sequencing, and bioinformatics. These technologies enable researchers to foster a better understanding of the microbiome and enable comprehensive analysis. This facilitates the development of targeted microbiome-based interventions that allow healthcare experts to treat various disease indications.
- Growing Prevalence of Chronic Disease: The growing prevalence of chronic diseases across the globe, such as inflammatory bowel disease, obesity, diabetes, and autoimmune disorders, has further heightened the interest of researchers in the microbiome. Researchers are continually exploring ideologies and strategies to manipulate the microbiome to target particular diseases. The ongoing research and rising risk of chronic disease is further fueling the demand for microbiome-based therapeutics.
- Trends Towards Personalized Medicine: With the increasing incidence of chronic disorders, healthcare professionals have begun to focus on personalized treatment plans that help to target specific disease indications based on individual molecular profiles. Microbiome-based therapies can be easily tailored according to the individual's microbiome profile, thereby facilitating the treatment of various disease indications. The growing shift towards personalized medicine has surged the requirement for microbiome-based therapies, which is anticipated to drive the market from 2023-2035.
- Regulatory Support and Collaboration Initiatives: The growing understanding of microbiomes and their therapeutic benefits has driven the attention of regulatory bodies and several key players to develop tailored therapies. Regulatory authorities and government bodies are offering funding support as well as providing flexibility in the regulatory framework to drive innovation in the field. Therefore, growing support from regulatory authorities will propel the market in the coming years.
Additional Factors Propelling Microbiome Therapeutics
Collaborations and partnerships remain at the forefront of the evolution of microbiome therapeutics. In the upcoming years, the microbiome manufacturing market will witness several partnerships that aim to enhance the production of tailored microbiota-based therapeutics for the treatment of a wide range of diseases.
Examples of the key milestones that have taken place between key market players are listed below:
In March 2023, MBiomics, a leading microbiome company established in Germany, raised USD 13 million in a series A round held by MIG Capital. The company will use these funds for the development of their proprietary platform to accelerate the identification of leading drug candidates and boost research towards clinical validation of the drugs.
In April 2023, SER-109, the first oral therapy-based microbiome developed by Seres Therapeutics for the prevention of recurrent Clostridium difficile infection, received FDA approval.
It is worth highlighting here that microbiome manufacturing market players have entered strategic partnerships. These ongoing activities and partnerships enable pharmaceutical companies to share expertise, infrastructure, and facilities to encourage the development of microbiome therapeutics. As research proceeds in the field, the microbiome manufacturing market will witness steady growth in the upcoming years.
For more information, please read the full report by Roots Analysis on the Microbiome Manufacturing Market, which details this market’s unique dynamics, providing insights into the historical period (2023-2024) and forecasting trends for 2023-2035.
About Author
Simran Kaur is a senior analyst who has been working as an integral part of the Roots Analysis team since 2020. Holding a master's and bachelor's degree in pharmacy from a prestigious institution, she embarked on her professional journey with a strong academic foundation and an interest in the life sciences domain. Her keenness to learn more about emerging trends, regulatory dynamics, and technological advancements enables her to provide comprehensive analyses.
About Roots Analysis
Roots Analysis is a global leader in pharma and biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists, and strategic investors for more than a decade, Roots Analysis offers a highly analytical and data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by this firm are structured in a way that enables the reader to develop a thorough perspective on the given subject.