The microbiome therapeutics have taken the limelight in addressing chronic diseases worldwide. Apart from focusing on gut-related and gut-originating diseases, these therapeutics are currently being developed for various chronic diseases, including cancers.
Clinical studies on various microbiomes have been significantly growing during the past decade, owing to the considerable reduction in the cost of DNA sequencing, enabling the microbes in their complex mixture to be defined by their genome. Research findings have generated information about the role of the microorganism population in determining human health. The microbiome is found to play a role in inflammatory bowel disease (IBD), allergies, and immune-oncology, among others. Microbiome has become an attractive target for potential therapeutics owing to its extensive role in gastrointestinal and non-gastrointestinal diseases. However, there are challenges associated with microbiome research. Determining the cause-effect relationships and designing microbiome-based therapies that can attain effective results on the human health and microbial community are among such challenges.
The microbiome therapeutics market is projected to grow at a CAGR of 25.64% during the forecast period from 2020 to 2030.With the continuous evolution of data and information being released throughout the tenure of the Human Microbiome Project (HMP), several companies have begun to focus upon the designing and development of drugs that would aim to modulate the human microbiome as a measure to treat a variety of diseases, majorly chronic.
Market Dynamics
The factors propelling the growth of the microbiome therapeutics market are significant external funding for executing research and therapeutic innovation, coupled with the increasing adoption of inorganic growth strategies in the market. Moreover, factors hindering the market growth are payer uncertainty and outcome based pricing, and insufficient application-based research hindering market pull, among other.
Market Drivers
Significant External Funding for Executing Research and Therapeutic Innovation
There lies a significant scope in the growth of the overall microbiome therapeutics market, owing to the significant funding triggered by several government/non-governmental organizations, venture capitalists, and pharmaceutical giants to emerging clinical stage biotechnology companies that are engaged in the clinical development of their proprietary microbiome candidates. A brief description of them is given. The market had recently witnessed a significant increase in the overall research and grant funding, triggered by
various private investment firms and governmental research organizations to accelerate the development of
microbiome therapeutics.
Increasing Adoption of Inorganic Growth Strategies in the Market
Due to the ever-rising incidence of various chronic diseases, the need for drug candidates with minimal side effects is becoming more evident. Several key players are developing their drug candidates by adopting inorganic strategies such as agreements, partnerships, and collaborations. With the ultimate aim of grabbing maximal market share by introducing effective products in the market, several
companies are coming together to provide better products in the domain of microbiome therapeutics to provide the physicians to effectively address various ailments.
Market Restraints
Payer Uncertainty and Outcome-Based Pricing
There is a growing assumption among payers and stakeholders globally that the cost of some drugs is significantly higher than the clinical benefits imparted by them. As a result, outcomes-based and value-based pricing are becoming more eminent in the current drug pricing landscape. The utter goal of this pricing strategy is to match a drug’s price more precisely to its defined value, and by applying this strategy, payers and stakeholders try to achieve cost-cutting while maintaining the higher therapy success rates and ease of access to the eligible patient pool. However, with all of it, the main emphasis is on the simplicity of contracting arrangements with many stakeholders and payers, who demand standard discounts and rebates.
Insufficient Application-Based Research Hindering Market Pull
The innumerable strategies targeting the microbiome indicates the immense potential that many believe this area holds. Although the primary strategy of traditional drug development, includes the development of small molecules, however, in case of the microbiome, this strategy becomes highly complex to include whole live microbial consortia. The includes an entire ecosystem of microbes, potentially trillions of organisms that constitute this environment instead of one molecule.
Even though increasing research programs emulate the potential people hold about the microbiome field, there is hardly any research that significantly quantifies the value these therapeutics bring to major chronic diseases. The market, though being driven by pre-conceived notions regarding the benefits of including probiotics, there is not enough evidence that substantiates the therapeutic potential of the other products that are currently under development.
FMT Manufacturing Issues
The manufacturing process of FMT is quite complex and the associated logistics are a no go compare to live biotherapeutics product suspensions. Furthermore, not every donor is guaranteed to provide the same quality FMT. This further creates issues while developing fecal microbiota transplantation therapies. The selection of donors is a difficult task both because the gut microbiota is a complex entity
making its quality-control challenging, and infectious screening to prevent the transfer of communicable diseases from donor to recipient is limited and costly.
Market Opportunities
Entry of Major Players for the Development of Microbiome Therapeutics
The microbiome therapeutics landscape is gradually blooming with some major players such as Takeda, Genentech and Merck Sharp & Dohme, who are entering into microbiome development programs with emerging key players in the microbiome market. For instance, Takeda had recently expanded the existing collaboration with FINCH Therapeutics in November 2019 for the development of microbiome therapeutics using FINCH’s human first discovery platform. The company, in collaboration with Finch Therapeutics, is currently evaluating a pre-clinical candidate FIN-524 for the treatment of Ulcerative colitis. Apart from Finch Therapeutics, Takeda had also entered into a research agreement with Debio Pharm in June 2020 for the development of novel pre-clinical narrow spectrum microbiome development remodeling program for the treatment of gut dysbiosis. The existing research efforts made by Takeda into the microbiome segment indicates an underlying potential in this field.
Growing Eminence of Microbiome Therapeutics in Cancer Treatment
The potential role of the microbiome in cancer treatment is grabbing significant attention, and there is increasing evidence that suggests the microbiome holds an important part in the way a patient responds to cancer therapies. The above-mentioned fact gets evident support from the results of many research studies, which indicates that the gut microbiome impacts the response to checkpoint inhibitor immunotherapies.
Competitive Landscape
Major players, including 4D Pharma, Enterome, and Finch Therapeutics, led the number of synergistic developments (partnerships and alliances) witnessed by the market. On the basis of region, Asia-Pacific is expected to retain a leading position throughout the forecast period 2020-2030, followed by Europe. This is a result of the presence of leading industry players in this region, coupled up with soaring clinical activities pertaining to the development of microbiome therapeutics.
Key Questions Answered in this Report:
• What is microbiome therapeutics? How have different target therapy area settings for microbiome therapeutics evolved over the centuries?
• What are the major market drivers, challenges, and opportunities in the global microbiome therapeutics market?
• What was the global microbiome therapeutics market size in terms of revenue in 2019? How is the market expected to evolve in the upcoming years? What is the expected market size in 2030?
• How is each segment of the global microbiome therapeutics market expected to grow during the forecast period 2020-2030, and what is the estimated revenue expected to be generated by each of the segments by the end of 2030?
• What are the developmental strategies implemented by the key players to sustain in the competitive market?
• What is the growth potential of the global microbiome therapeutics in several countries globally?
• Which target therapy area segment among the two gastrointestinal and infectious diseases and other therapy areas are offered or being developed by key players such as Taisho Pharmaceuticals, Immuron Limited, Sanofi S.A., and Rebiotix?
• Which target therapy area segment led the market in 2019 and is expected to dominate the market in 2030, and why?
• Which region dominated the global microbiome therapeutics market in 2019, and what are the anticipated trends from each of the regions in the forecast period 2020-2030?
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The report constitutes an in-depth study of the global microbiome therapeutics market, including a thorough analysis of the different types of offerings pertaining to various indications. The study also presents a detailed analysis of market dynamics and estimation of the market size over the forecast period 2020-2030.The scope of this report is focused on the analysis of the global microbiome therapeutics market by target therapy area (gastrointestinal and infectious diseases, and other diseases) and region. The market value may vary from 5-7% as the data has been collected from different sources at the regional and country level.
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