Microbiome Therapeutics Market
Number of pages: 100 | Report Format: PDF | Published date: March 20, 2023
Historical Years – 2021 | Base Year – 2022 | Forecasted Years – 2023-2031
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Report Attribute |
Details |
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Market Size Value in 2022 |
US$ 97.20 million |
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Revenue Forecast in 2031 |
US$ 909.20 million |
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CAGR |
28.2% |
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Base Year for Estimation |
2022 |
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Forecast Period |
2023-2031 |
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Historical Year |
2021 |
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Segments Covered |
Type, Application, and Region |
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Regional Scope |
North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa |
According to the deep-dive market assessment study by Growth Plus Reports, the global microbiome therapeutics market was valued at US$ 97.20 million in 2022 and is expected to register a revenue CAGR of 28.2% to reach US$ 909.20 million by 2031.
Microbiome Therapeutics Market Fundamentals
Microbes are a group of microorganisms living in human bodies, including viruses, bacteria, fungus, and their genes. Fungi, archaic, and protist microbes are abundant in the mouth and gut of the human intestine. This microbiome imbalance may result in weight gain, high blood sugar, and high cholesterol. The microbial population that lives on and in the human body significantly influences human health, influencing everything from metabolism to immunity. To capitalize on the intimate relationships between microorganisms and their hosts, the development of medicines targeting the microbiota has accelerated in recent years. The human microbiome includes all bacteria and associated metabolites/products in and on the human body. The evaluation of the pleiotropic effects of the human gut microbiota in health and illness has become possible because of technological advances. Microorganisms have immense potential to be employed as medicines for disease management due to their broad function in human health. Microbiome treatment shows significant promise for treating any severe medical condition. It serves as a possible source to reach the goal of individualized therapy by overcoming important obstacles, such as interpersonal variability and stability in any environment. The high-resolution data analysis aided in the creation of microbiome engineering modifiers.
The adult gut microbiota is quite robust to modest changes. Over the course of five years, for example, the individual gut microbiome was found to be 60% preserved at the strain level, with members of the phyla bacteroidetes and actinobacteria being the most stable. Its longitudinal stability and the microbiome’s wide interpersonal variety allow about 80% of people to be identified by their unique microbial fingerprint. Despite its strength, significant assaults, such as antibiotic treatment or the start of the illness, can cause profound changes in the makeup of the gut flora. Moreover, host genetics, nutrition, and environment play important roles in community creation.
Conventional medicines are thought to have resulted in antibiotic resistance among microorganisms, chemotherapy resistance, non-responsiveness, and poor specificity. These manifestations pose a major danger to the human population’s health. Microbial treatment overcomes the shortcomings of current medicine. Microbes are natural occupants of the body that boost their therapeutic ability without causing any negative effects. Microbes can also be genetically modified to increase their efficacy and safety. A robust human gut microbiome plays a crucial role in human health maintenance, whereas dysbiosis may result in illness development. Microbes can prevent illness onset by interacting with the host, making them helpful for microbiome therapeutic development.
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Microbiome Therapeutics Market Dynamics
The bulk of therapeutic compounds in the pipeline is in the early phases of development, mainly in Phase I and II. Out of the 23 medicines studied for GI indications, over 13 are for ulcerative colitis. For example, Seres Therapeutics, Inc. announced findings from its Phase 3 ECOSPOR III trial with SER-109 in 2021. The pipeline medicine is being developed as an oral treatment for reoccurring C. difficile infection, with a planned introduction in the first half of 2023. In contrast to the placebo, SER-109 is associated with decreased antimicrobial resistance genes.
Advances in microbiome research are expected to contribute to the identification of improved medicines for infections and other disorders, hence improving medical care results. Companies are decreasing the cost of their goods and making cutting-edge medical care more available to a broader percentage of the public to help adopt microbiome-based therapies. A few nations’ governing bodies are reforming their methods. As a result, market suppliers now have profitable growth opportunities to increase their market share.
Stringent regulatory guidelines, owing to the product’s complexity and the high cost of microbiome treatments, are important factors limiting the market revenue growth. Increased research and manufacturing costs, as well as demanding and lengthy regulatory processes, raise the overall price of the product and, as a result, affect treatment costs. For instance, the out-of-pocket expense of screening a donor might approach USD 3500, but microbiota treatment (FMT) pills cost US$ 2050 per dosage.
Microbiome Therapeutics Market Ecosystem
The global microbiome therapeutics market has been analyzed from three perspectives: type, application, and region.
Microbiome Therapeutics Market Type
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Based on type, the global microbiome therapeutics market has been segmented into fecal microbial transplant and microbiome drugs.
The microbiome therapeutics market was led by the fecal microbiota treatment segment to its widespread usage in treating C. difficile infection. Furthermore, increased R&D focused on advances to identify alternative therapeutic applications of FMT and the market release of capsules are projected to fuel growth. For instance, OpenBiome launched direct testing for SARS-COV-2 in fecal microbiota treatment preparation in February 2021, aiming to improve FMT availability to any scheduled patient for emergency usage without infection transmission risk. Moreover, FMT has shown significant efficacy in treating individuals with recurrent C. difficile infection. As a result, the increasing incidence of the illness is projected to drive up demand for microbiome therapeutics. According to the Therapeutic Advances in Gastroenterology Journal, about 25%-65% of patients in the United States will have recurrent CDI, making treatment more difficult by 2022.
The microbiome drugs segment is predicted to grow at a rapid pace over the forecast period, owing to a healthy pipeline and the development of advanced and new drugs. The bulk of medications is still in the early phases of development. For instance, Blautix, a single-strain biotherapeutic product under investigation for treating IBS-C and IBS-D, is currently in Phase II clinical trials at 4D Pharma plc.
Microbiome Therapeutics Market Application
Based on the application, the global microbiome therapeutics market has been segmented into C. difficle, Crohn’s disease, inflammatory bowel disease, diabetes, and others.
The Clostridium difficile segment is expected to grow at a rapid pace, with the highest revenue CAGR during the forecast period due to the rising usage of FMT in treating C. difficile. According to research released in 2020 by the University of Birmingham, FMT is widely used to treat patients with Clostridium difficile infections. Also, FMT is more effective than antibiotics in treating C difficile, especially in repeated instances.
Microbiome Therapeutics Market Region
Based on region, the global microbiome therapeutics market has been segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
North America dominates the microbiome therapeutics market due to the increased prevalence of lifestyle-related illnesses and autoimmune disorders in the region, as well as a robust medication pipeline. The increased illness burden in the region is also boosting market expansion. According to the American Cancer Society, about 1,918,030 new cancer cases will be recorded in the United States in 2022. Also, according to Globocan 2020 statistics, there are 274,364 new instances of cancer, with 400,564 new cases projected by 2040. Thus, the rising cancer burden will likely boost market expansion since gut microbiota plays a regulatory function in tumor therapy, raising patients’ susceptibility to immunotherapy and lowering chemotherapeutic drug adverse effects. Also, rising research studies and regulatory authority assistance for the inquiry are adding to the region’s market expansion. For instance, 4D Pharma plc gained FDA approval in February 2022 for investigational new drug applications for two Living Biotherapeutics, MRx0005, and MRx0029, for treating Parkinson’s disease. Such approvals are likely to fuel market expansion.
The market in Europe is expected to register significant revenue growth throughout the predicted period. Germany is a developing European market for microbiome treatments. Despite the high cost of microbiome treatments, supporting reimbursement policies are projected to make treatment more accessible in the future years. Startups are also receiving financing to investigate and market microbiome-based goods.
Microbiome Therapeutics Market Competitive Landscape
Leading companies in the global market are conducting substantial research to obtain a competitive edge. Companies are working hard to design and produce goods that will be utilized in treatments. Many treatments are in the early phases of development and are likely to be developed and used in the market. Ferring Pharmaceuticals and Rebiotix, for example, published Phase III results on their candidate RBX2660 to decrease reoccurring C. difficile infection in 2021. The FDA granted the candidate fast track, orphan drug, and breakthrough treatment designations.
The prominent market players in the global microbiome therapeutics market include:
Strategic Developments
Microbes are a group of microorganisms living in human bodies, including viruses, bacteria, fungus, and their genes. Fungi, archaic, and protist microbes are abundant in the mouth and gut of the human intestine. This microbiome imbalance may result in weight gain, high blood sugar, and high cholesterol.
The global microbiome therapeutics market is expected to reach 909.20 million by 2031.
The microbiome therapeutics market is expected to register a revenue CAGR of 28.2% during the forecast period.
Some prominent players in the global microbiome therapeutics market include OpenBiome, Seres Therapeutics Inc., and 4D Pharma plc.
The Clostridium difficile infection application segment leads the global microbiome therapeutics market.
*Insights on financial performance are subject to the availability of information in the public domain