Microbiome Therapeutics Market

Market Overview

The global microbiome therapeutics market size was worth USD 380 million in 2022 and is estimated to reach an expected value of USD 2,400 million by 2031, growing at a CAGR of 24.8% during the forecast period (2023 – 2031).

Microbiome therapeutics have drawn significant attention from the medical community with their potential to address the current unmet need of various clinical conditions. In this digital age, where information is available, the general population has become increasingly aware and conscious of their medical conditions and treatment options. Since available treatment options are majorly chemical compositions and carry some undesired effects, the current population is looking for safer and more natural products that can address their clinical issues and unmet needs. Microbiome therapeutic products, with their route tracing back from 1900 with the isolation of Lactococcus lactis from milk by Joseph Lister, have now made their place in the therapeutics segment.

Microbiome therapeutic products provide a safer alternative with their novel composition and mechanism of action—several indications, such as C. diff. In infection, where recurrence of the disease is a significant issue, microbiome therapeutics have demonstrated promising results in clinical studies and appear to become a treatment of choice. Additionally, researchers have been putting significant efforts into establishing the role of microbiome therapeutics in treating other indications. Indications such as skin disorders and oncology have drawn a lot of attention. Next-Generation Probiotics (NGPs), a new class of microbiome therapeutics, are increasingly becoming popular with their therapeutic role supported by clinical studies.

Market Dynamics

Market Drivers

Growing Strategic Activities in Microbiome Therapeutics Segment

There have been significant strategic activities taking place in the global market. The last three-year data from 2019 to 2021 show 21 financing activities, 22 agreements, and ten regulatory activities have occurred. As the global market evolves with new research outcomes, companies are aligning themselves to efficiently utilize the resources, which can be observed with growing regulatory activities and agreements. Companies such as Finch Therapeutics Group, Inc. and Takeda agreed to develop FIN-524/TAK-524. At the same time, Rebiotix Inc. partnered with Mybiotics to develop live microbiota-based therapeutics for treating bacterial vaginosis for females of reproductive age. Rebiotix Inc. also collaborated with CoreBiome for its products RBX-2660 and RBX-7455. Rebiotix Inc., Second Genome, 4D pharma plc, and YSOPIA Bioscience are active in the microbiome space.

Potential of Microbiome Therapeutics to Address Unmet Needs of Existing Treatment Options

It has been reported from the studies that several bacterial infections become resistant to conventional antibiotic treatment, and C. diff. Infection (CDI) is one of the primary indications where disease recurrence is a common problem. Similarly, for Type 2 diabetes, several treatment alternatives are available, while for Type 1, only Insulin highlights the lack of suitable, more convenient treatment alternatives. With growing evidence supporting its positive role in addressing unmet needs, the microbiome therapeutics segment brings a positive and more effective treatment alternative to the horizon. Microbiome therapeutics, with their novel mechanism of action, is aimed at engineering the gut microbiome using the additive, subtractive, or modulatory mechanism with an application of native or engineered microbes, antibiotics, bacteriophages, and bacteriocins. This approach could overcome the limitation of conventional therapeutics by providing personalized, harmonized, reliable, and sustainable treatment.

Market Restraint

Associated Safety Issues with LBPs

Safety issues associated with LBPs remain a critical challenge compared to conventional treatment options. Although LBPs are not intended to reach systemic circulation and ultimately to distant organs and tissues; however, their interaction with the complex microbiota of the host can lead to undesired effects. The field of microbiome therapeutics faces some significant challenges, such as adequately identifying disease-causing microbial signatures and the need for more consideration of ethical and safety issues.

Market Opportunities

Growing Disease Dimension

There has been a rapid increase in research activities observed in the last ten years, with new indications being explored for the role of microbiome therapeutics. The potential role of the microbiome in addressing cancer and related complications impacting patients' quality of life (QoL) has boosted the market sentiments in favor of microbiome therapeutic products. Several companies are exploring their products in conjunction with immune checkpoint inhibitors to reduce cancer complications also presents opportunities for both consumers and payers. Additionally, the research highlighting the role of microbiome therapeutics in neurological diseases has opened new doors. Although these findings are considered preliminary, the observations reported till now indicate that the gut microbiota can provide the opportunity to identify patients who are more likely to respond to treatment with the ultimate aim of enhancing existing therapeutics and developing novel therapeutic strategies. As more and more indications are being added, the disease dimension is growing, eventually presenting promising treatment alternatives to the target patients and companies involved in their research and development.

Regional Analysis

Asia-Pacific Dominates the Global Market

Based on region, the global microbiome therapeutics market is analyzed across North America, Europe, Asia-Pacific (APAC), and Rest-of-the-World. 

Asia-Pacific is the highest revenue contributor and is estimated to exhibit a CAGR of 24% during the forecast period. The rising prevalence of chronic diseases, the rapidly aging population, and the growing prominence of treatment procedures with minimal after-effects are the leading factors propelling the growth and adoption of novel microbiome therapeutics products. In addition, support from the government and investments by both public and private bodies enhance research activities involving the microbiome. The demographics and the accelerated economic growth in the region are two significant factors that have played a crucial role in establishing the microbiome industry in the area.

Europe is anticipated to grow at a CAGR of 23.1% during the forecast period. Europe is observing the rising commercialization of advanced therapeutic products to treat various indications. Increasing healthcare budget allocation and ongoing research to develop innovative microbiome therapeutic-based products are driving factors contributing to the growth of the global market in Europe. According to a report published by the Microbiome Society, a European Commission analysis of CORDIS and the EU Open Data Portal identified that between 2007 and 2015, the European Commission's FP7 and Horizon 2020 research and innovation programs funded 535 microbiome-related projects at a total cost of USD 1.5 billion. Increasing clinical research activities coupled with product approvals and commercialization in different countries of Europe are expected to boost the growth of the Europe microbiome therapeutics market in the upcoming years.

Europe is at the forefront of the research in microbiome therapeutics, as it promotes the advent of new biotechnology companies developing microbiome-based products. Europe, France, Germany, the U.K, Sweden, Spain, and Italy are among the top countries witnessing high adoption of microbiome therapeutic products. The market dominance in these countries is mainly attributed to the increase in awareness about the therapeutic potential of microbiome therapeutics products and rising investments from both private and public sectors for microbiome therapeutic research.

North America is the third largest region. North America represents one of the most developed healthcare systems in the world. Consisting of countries such as the U.S. and Canada, North America has the world's largest regional economy witnessing substantial investments and funding in the healthcare sector. Diseases such as Inflammatory Bowel Disorder (IBD), colon cancer, and Crohn's Disease, coupled with growing awareness about safer treatment alternatives and improvement in the healthcare infrastructure, screenings, and protocols, are driving the growth of the North American microbiome therapeutics market. Among all the world's geographical regions, North America demonstrates the highest potential for expanding and developing the global market.

Segmental Analysis

The global microbiome therapeutics market is segmented by target therapy area and region. 

By target therapy area, the global market is divided into gastrointestinal and infectious diseases, skin disorders, cancer indications, and other indications.

The gastrointestinal and infectious disease segment dominated the market and is estimated to exhibit a CAGR of 24.7% during the forecast period. As the capacity of microorganisms increases, they are colonized throughout the gastrointestinal tract and coevolve with the help of a symbiotic relationship that can influence an individual's physiology, metabolism, and immune functions. This microbial community has been extensively studied, and its central role in human health has been well documented. With almost 1000 bacterial species and 100-fold more genes (also called the microbiome) than the human genome, this community has been termed the "hidden metabolic organ" within the human body, immensely impacting overall well-being.

With critical information validating the co-evolution of the microbiome with the human genome, it is evident that changes in the population have significant effects- both beneficial and harmful-upon human health. Several therapeutics are being developed to treat irritable bowel syndrome (IBS) subtypes and inflammatory bowel disease (IBD). The global market (gastrointestinal and infectious diseases) is dominated by the field of study in the microbiome space, with many companies (both large-scale and small-scale) targeting the role of the gut microbiome in disease intervention. With many products targeting gastrointestinal and infectious diseases in the pipeline, this segment is expected to dominate the global market.

The skin disorders segment is the second largest region. Most companies are shifting their focus to the skin after gastrointestinal disorders. Several pharmaceutical and probiotic companies are actively developing microbiome therapeutics for skin care. Owing to the significant interest of the associated companies and the potential of microbiome products, this segment is expected to be among the top three indications in 2032, accounting for USD 102.5 million of the global market value. As of 2021, this segment had a value of less than USD 10 million and is expected to register a CAGR of 26.88% during the forecast period 2022-2032, attaining a 102.5 by 2032. This segment dominates the global market due to the number of research activities undertaken by leading companies, such as Evelo Biosciences, Inc., AO Biome, DermBiont, Inc., and Forte Biosciences.

Recent Developments

• February 2023 - A leading provider of microbiome therapeutics, Seres Therapeutics, Inc., announced the publication of data from its Phase 3 ECOSPOR IV trial in the JAMA Network Open that supported earlier findings from the Phase 3 ECOSPOR III study on the investigational microbiome therapeutic SER-109 for the avoidance of recurrent C. difficile infection (rCDI). A primary source of hospital-acquired infections, rCDI has roughly 156,000 cases in the United States and significantly burdens the healthcare system.
• February 2023 - Leading microbiome therapeutics business Seres Therapeutics, Inc. declared enrolment in Cohort 2 of its SER-155 Phase 1b research has begun. In patients receiving allogeneic hematopoietic stem cell transplants, SER-155, an investigational oral microbiome treatment, is intended to lower the frequency of GI infections, bloodstream infections, and graft versus host disease (GvHD) (allo-HSCT)