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Market Overview

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The global microbiome therapeutics market, valued at $306 million in 2021, is projected to reach $3,204 million by 2032, with a compound annual growth rate (CAGR) of 24.95% during the forecast period of 2022-2032.

Microbiome therapeutics are a new class of products aimed at restoring the balance of good and bad bacteria in the gut to address various clinical conditions. These therapeutics can be native or engineered microorganisms, bacteriophages, or bacteriocins, and they work by replenishing beneficial microbes, removing disease-causing microbes, or exerting modulatory effects.

The medical community has shown great interest in microbiome therapeutics due to their potential to meet the unmet needs of patients. In today’s digital age, where information is easily accessible, the general population is increasingly aware of their medical conditions and treatment options. As conventional treatment options often come with undesired side effects, people are seeking safer and more natural alternatives to address their clinical issues. Microbiome therapeutics, with their unique composition and mechanisms of action, provide such an alternative. They have shown promising results in clinical studies for indications like C. diff. infection, where recurrence is a major challenge. Researchers are also exploring the role of microbiome therapeutics in treating other conditions such as skin disorders and oncology. Next-Generation Probiotics (NGPs), a novel class of microbiome therapeutics, have gained popularity with their therapeutic potential supported by clinical studies.

The growth of the microbiome therapeutics market is driven by factors such as the increasing elderly population and the adoption of inorganic growth strategies by key market players.

The COVID-19 pandemic had significant consequences for the microbiome therapeutics market. The reduced access to healthcare for non-COVID-19 illnesses impacted the market negatively. Clinical trial activities were interrupted, guidelines were modified to incorporate additional safety measures, and regulatory review and approval timelines were delayed.

Demand for microbiome therapeutics is driven by factors such as the growing strategic activities in the segment, their potential to address unmet needs in existing treatments, and their reputation as a safer alternative to conventional drugs.

However, the market also faces challenges. The lack of standard regulatory guidelines and safety concerns associated with live biotherapeutic products (LBPs) present obstacles to the growth of the global microbiome therapeutics market.

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Market Segmentation

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The market is segmented based on various factors, including target therapy area and region.

Segmentation by Target Therapy Area
Gastrointestinal and Infectious Diseases
Skin Disorders
Cancer Indications
Other Indications

Segmentation by Region
North America
Europe
Asia-Pacific
Rest-of-the-World

Gastrointestinal (GI) and skin disorders dominate the microbiome therapeutics segment and are projected to maintain this dominance throughout the forecast period. Among the advanced-stage microbiome therapeutics, the treatment of C.diff. infection (CDI) holds a prominent position and is expected to be the first to enter the market. The selection of indications for these therapeutics was based on intensive research in specific therapy areas. In 2021, the gastrointestinal and infectious disease segment accounted for 97% of the overall market, followed by skin disorders. This is primarily due to the availability of commercially approved drugs for gastrointestinal and infectious diseases such as diarrhea and gut dysbiosis. However, in the coming years, the segment focused on skin disorders is anticipated to exhibit higher growth compared to gastrointestinal and infectious diseases. According to the latest research estimates, the skin disorders segment, with a market value of $8.3 million in 2021, is expected to reach $102.5 million by 2032, growing at a CAGR of 26.88%.

The Asia-Pacific (APAC) region is poised to dominate the global microbiome therapeutics market during the forecast period of 2022-2032, contributing approximately 40% to the total market size in 2021. This is attributed to increased healthcare spending and government initiatives aimed at promoting the market. APAC’s leadership in the market is further supported by technological advancements in infrastructure and significant investments in the microbiome sector within the healthcare industry. Factors such as a growing geriatric population, rising prevalence of chronic diseases, and the demand for advanced treatment options have driven the growth of the microbiome therapeutics market in APAC. North America also exhibits strong potential for market growth, with the highest expected CAGR of 55.27% during the forecast period. This is mainly due to the entry of multiple microbiome therapeutics in the region.

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Competitive Landscape

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The selection of profiled companies is based on inputs obtained from primary experts, as well as an analysis of their company coverage, product portfolio, and market penetration.

The dominant players in the top segment of the market are Sanofi S.A and Taisho Pharmaceutical Holding, which collectively hold approximately 88% of the market. Sanofi S.A holds a share of 64.31%, while Taisho Pharmaceutical Holdings holds a share of 24.49%.

Key companies profiled in this report include 4D pharma plc, Seres Therapeutics, Inc., Microbiotica, Enterome, Enterome Biosciences, Destiny Pharma plc, Taisho Pharmaceutical Holdings, AOBiome Therapeutics, Inc., Finch Therapeutics Group, Inc., Rebiotix Inc. (A Subsidiary of Ferring Pharmaceuticals), MaaT Pharma, Vedanta Biosciences Inc., OxThera AB, Pendulum Therapeutics, Caelus Health, Quorum Innovations, Sanofi S.A., DermBiont, Inc., EnteroBiotix Ltd, YSOPIA Bioscience, Winclove Probiotics, TargEDys, Evelo Biosciences, Inc., BiomX, Biomica Ltd., Scioto Biosciences, Inc., Lactobio A/S.

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Key Questions Answered

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What do microbiome therapeutics products encompass?

How has microbiome therapeutics evolved since its inception, considering the passage of time?

What are the primary market drivers, challenges, and opportunities in the global microbiome therapeutics market?

Which medical conditions are targeted using microbiome therapeutics products?

What does the pipeline for the market of microbiome therapeutics products look like?

What is the current market size and the future growth potential of microbiome therapeutics products?

How does the clinical trial landscape appear in the global market for microbiome therapeutics products?

What was the impact of COVID-19 on the microbiome therapeutics market?

Which region is anticipated to contribute the highest revenue to the global market for microbiome therapeutics products during the forecast period?

What are the key development strategies implemented by major market players to sustain their position in the competitive market?

How is each segment of the market expected to demonstrate growth throughout the forecast period of 2022-2032?

What is the existing partnership landscape and what are the prevailing regulations for microbiome therapeutics?