With the increasing demand for personalized therapeutic solutions, pharmaceuticals have shifted to acknowledge the human gut microbiome modality, as the immune system and microbiome are closely related. Microbiomes refer to the group of microbes that live inside the human body, specifically in the intestine. Multiple studies on microbiota depletion strategies have shown promising results in the treatment of infections particularly associated with the gastrointestinal tract, respiratory tract, nervous system, and hepatic systems. Meanwhile, the gut microbiota has a great impact on human health, including the development of adaptive immunity, and helps in the synthesis of vital nutrients such as Vitamin B.
Microbiomes can resist pathogens and serve as the first line of defense against infection. Considering the essential factors, pharmaceutical industries have shifted to harness the power of gut microbes in the development of microbiome therapies. Microbiomes can be modified to treat diseases, making them an ideal option for the development of advanced therapeutic solutions. Though microbiomes have the potential to treat infectious diseases, there are certain challenges, such as the complexity of the isolation of the microbiome, lack of understanding, and unavailability of standard operational systems to develop live biotherapeutic products. To address those challenges, the microbiome manufacturing market continues to evolve and adapt technology, such as genetic engineering and genome sequencing technologies, to utilize microbiomes for the development of drugs. Driven by the above factors, it is estimated that the microbiome manufacturing marketis anticipated to grow at a CAGR of 22% in the future.
Current Market Landscape Revolves Around Live Biotherapeutic Products
As the healthcare sector is shifting to precision medicine and target-specific therapeutic solutions, several microbiome manufacturing market players are looking forward to isolating and identifying human gut microbes to use them for disease treatment. The primary goals are to translate the raw research data associated with the microbiome’s genome into the finalized consumable products and approval from regulatory bodies.
Metabolic data analytical platforms such as the Internet of Things, Artificial Intelligence, and machine learning allow companies to study and develop site-specific therapeutics for skin, gut, and other body parts. In addition, most of the companies have emphasized the development of live biotherapeutic products (commonly referred to as the administration of gut-friendly live microorganisms to improve the medical conditions of the patients).
The live biotherapeutic products are very similar to the probiotics (a form of food supplement developed with gut microbes). In addition to microbiome therapies for disease treatment, several food companies are also showing keen interest in microbiome research in order to develop probiotics and probiotics solutions. It is worth highlighting that microbiome therapeutics hold a vast future and emerge as a standard solution to treat diseases.
Latest Innovation in Microbiome Industries
Microbiome therapeutics is a groundbreaking innovation to treat infectious diseases, including inflammatory bowel disease (IBD). With technological advancements and ongoing research, researchers are able to bring innovation in microbiome therapeutics, including:
▪ Next Generation Multi-Omics
Multi Omics is an innovative approach where data sets of different genomic groups are combined for analytical studies. Different strategies have been employed, such as proteome, genome, and microbiome, to understand the dynamics of bacterial communities and implement the study to develop live biotherapeutic products and probiotics.
▪ Prediction of Drug Response By Using The Microbiomes
The gut microbes play an essential role in the metabolization of drugs within the body. The study of microbiomes can help in determining the toxicity profile and pharmacokinetics. By understanding the microbiomes, researchers will be able to avoid the adverse impact of drugs and develop personalized therapies for the treatment of diseases.
▪ Engineered Strains to Fight Against Gut Microbiome Disease
The isolated microbial strains from gut microbes have been engineered for the treatment of gut microbiome diseases. For instance, the Lactobacillus strain has been modified using genetic engineering to express bile salt hydrolase (BSH) enzymes for the modulation of bile composition in vivo. The BSH enzymes can directly impact the digestive system function and influence gut microbes composition to treat metabolic diseases.
Recent Developments of Microbiome Therapeutics
The majority of microbiome companies emphasize determining the use of gut microbes to move beyond the treatment of recurrent Clostridium difficile infection in the future. Several types of research are underway on fecal microbiota transplantation and immune-mediated diseases such as ulcerative colitis. The findings are very donor-dependent, with certain donors producing outcomes that are beyond those of biology, while many others provide just placebo-like effects. A more consistently effective microbiome-directed strategy, via the administration of rationally planned, specified consortia or the finding of “super-donors,” could become a game-changer.
▪ In April 2023, the recent approval of VOwst (Seres Therapeutics) and Rebyota (Ferring Pharmaceuticals) for the treatment of C. difficile infection showed a promising future for microbiome therapy. It is worth noting that the FDA approval for microbiome-based therapeutics clears the regulatory pathway for companies to develop more therapies using gut microbes.
▪ In April 2023, MaaT Pharma also announced that the FDA had cleared the application for an investigational new drug to initiate the US Phase III pivotal clinical trial for the evaluation of MaaT013 to treat graft vs host disease. The company has utilized pooling technology that provides higher microbial diversity in a scalable manner.
▪ Within the past few years, many pharmaceutical companies have inked agreements to facilitate human microbiome-linked drug development and therapeutic solutions. It is worth highlighting that in 2020, nearly USD 1.5 billion has been invested in the research and development of microbiome-based therapeutics.
Key Microbiome Manufacturing Market Players
Some of the top live biotherapeutic manufacturing market players who are engaged in the microbiome industry include:
▪ DuPont
▪ Enterome
▪ Ferring Pharmaceuticals
▪ Metabiomics Corporation
▪ Microbiome Therapeutics
▪ Seres Therapeutics
▪ Second Genome
▪ Synlogic
▪ Vedanta Biosciences
A Promising Future of Microbiome Therapies
The bottom line is that the microbiome manufacturing market holds a promising future in the context of next-generation therapeutics for the treatment of diseases. Despite challenges such as lack of identification technology, vast microbiome, and difficulty in finding potential microbes for treatment, market players continue to focus on clinical trials.
Additionally, the paradigm shift to artificial intelligence, natural language processes, and machine learning facilitates the data collection process. The development of organ-on-a-chip has helped clinicians in clinical trials and allows them to study microbiome genomes in real-time. Microbiome holds an immense therapeutic value, and future research will be focused on the development of a microbiome-based solution that helps to treat a wide range of diseases.
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