Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured, Type of Formulation, Type of Primary Packaging Used, Scale of Operation, Company Size and Key Geographical Regions: Industry Trends and Global Forecasts, 2022 - 2035

Given the advancement of several promising microbiome-based live biotherapeutic products through clinical pipeline, this upcoming therapeutic segment is anticipated to become one of the fastest growing markets within the pharmaceutical industry in the coming years. Specifically, in 2020, around 575 IND applications were filed for such therapies, targeting a myriad of diseases indications, including autoimmune, gastrointestinal, infectious, metabolic and oncological disorders, indicating remarkable scientific progress of these breakthrough drug candidates. It is also worth highlighting that SER-109, a microbiome-based therapy developed by Seres Therapeutics, is expected to receive marketing approval from the US Food and Drug Administration (FDA) in 2022; this is further likely to propel the growth in this domain. Further, over 640 patents focused on microbiome therapeutics were granted approval in the year 2020. In addition, during the same time frame, USD 1.5 billion was invested for the development of microbiome-based therapeutics. Although a lot has been achieved in terms of development of live biotherapeutic products, there are certain challenges associated with the complexity of the process. Other key concerns shared by contemporary innovators include limited availability of expertise, lack of specialized infrastructure, requirement for exorbitant capital investment, and constraints associated with ensuring compliance to good manufacturing practices (GMP) and capacity. 

In order to address the technical and operational challenges outlined above, several microbiome developers prefer to rely on contract manufacturing organizations (CMOs). It is worth highlighting that, currently, over 50 players engaged in the manufacturing of microbiome-related products carry out operations either in-house or on contract basis. The current market landscape of microbiome contract manufacturers is highly fragmented, featuring a mix of start-ups, mid-sized firms and established players. Moreover, in recent years, several players engaged in this domain have forged strategic alliances and / or acquired other players, in order to further enhance their respective service offerings and operate as one-stop-shops. As stakeholders strive to mitigate existing challenges and focus on innovation to improve the microbiome production process, we believe that the microbiome manufacturing market is expected to witness significant growth over the next decade.

Scope of the Report

The “Live Biotherapeutic Products and Microbiome Manufacturing Market by Type of Product Manufactured (API and FDF), Type of Formulation (Solids, Oral Liquids and Injectables), Type of Primary Packaging Used (Blister Packs, Glass / Plastic Bottles, Pouches / Sachets and Vials), Scale of Operation (Clinical and Commercial), Company Size (Small, Mid-sized and Large) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022 – 2035” report features an extensive study on the in- house and contract manufacturing organizations within the microbiome industry. The study also includes an elaborate discussion on the future potential of this evolving market. 

Amongst other elements, the report features:

• A detailed overview of the overall landscape of companies offering contract manufacturing services for the development of microbiome therapeutics, along with information on their year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, type of service(s) offered (strain isolation, media / culture development, fermentation, lyophilization, fill / finish, cell banking, and analytical services), type of product manufactured (active pharmaceutical ingredients (API) and finished drug formulations (FDF)), type of fermentation (aerobic and anaerobic), type of formulation (solids, oral liquids and injectables), type of primary packaging used (blister packs, glass / plastic bottles, pouches / sachets, and vials), number and location of manufacturing facilities and bioprocessing capacity. Further, it provides a list of companies with in-house manufacturing facilities for microbiome therapeutics, along with information on their year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities. 
  
• A detailed landscape of the live biotherapeutic products and microbiome manufacturing facilities established across key geographical regions (North America, Europe and Asia-Pacific), highlighting the key manufacturing hubs for microbiomes. 
  
• An in-depth company competitiveness analysis of microbiome manufacturing service providers based on their product portfolio strength (in terms of scale of operation, type of product manufactured, type of formulation, type of primary packaging used and number of manufacturing facilities), service strength (based on its experience) and type of service(s) offered.
  
• Elaborate profiles of key industry players (large and mid-sized companies, established before 2000) based in North America, Europe and Asia-Pacific that offer contract manufacturing services for microbiome-based live biotherapeutics across both clinical and commercial scales of operation. Each profile features a brief overview of the company, details related to its microbiome-related service portfolio, microbiome manufacturing facilities, recent developments, and an informed future outlook.
  
• A list of nearly 70 microbiome-focused drug developers that are likely to partner with manufacturers engaged in this domain. These players have been shortlisted based on several relevant parameters, such as developer strength (which takes into account the company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of in-house manufacturing capabilities.
  
• A review of the various microbiome-focused initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated by the top 10 pharmaceutical companies in 2021), featuring a [A] heat map representation that highlights microbiome therapeutics under development (in partnership with core microbiome-focused entities), along with information on funding, partnership activity, and diversity of product portfolio (in terms of disease indication(s) being treated and focus therapeutic area(s)), and [B] a spider web representation, comparing the initiatives of big pharma players on the basis of multiple relevant parameters.
  
• An analysis of recent developments within the microbiome manufacturing industry, highlighting information on several partnerships and collaborations, mergers and acquisitions, and expansion initiatives that have taken place in this domain, during the period 2016-2021.
  
• An in-depth analysis of completed, ongoing, and planned clinical studies of various microbiome therapeutics, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus, target disease indication and key geographical regions. 
  
• An estimate of the overall, installed capacity for the manufacturing of microbiome-based therapies, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity based on the scale of operation (clinical and commercial), company size (small, mid-sized and large firms) and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).
  
• An informed estimate of the annual clinical and commercial demand for microbiome therapeutics, taking into account the target patient population in ongoing and planned clinical trials of microbiome therapeutics, sponsored by both industry and non-industry players.
  
• A qualitative analysis, highlighting various factors that need to be taken into consideration by microbiome therapeutics developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
  
• A case study on the current market landscape of microbiome contract research organizations and dietary supplement providers, including information on their year of establishment, company size and location of headquarters.
  

One of the key objectives of the report was to evaluate the current opportunity and the future potential of the microbiome manufacturing market, over the next decade. We have developed an informed estimate of the financial evolution of the market, over the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] type of product manufactured (API and FDF), [B] type of formulation (solids, oral liquids and injectables), [C] type of primary packaging used (blister packs, glass / plastic bottles, pouches / sachets and vials) [D] scale of operation (clinical and commercial), [E] company size (small, mid-sized and large) and [F] key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our forecast model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Research Methodology

The data presented in this report has been gathered via secondary and primary research. For all our projects, we have conducted interviews with various experts in this domain (academia, industry, medical practice and other associations) in order to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

• Annual reports
  
• Investor presentations
  
• SEC filings
  
• Industry databases
  
• News releases from company websites
  
• Government policy documents
  
• Industry analysts’ views
  

While the focus has been on forecasting the market till 2035, the report also provides our independent view on technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information. 

Key Questions Answered

• Who are the key players engaged in offering contract manufacturing services for microbiome therapeutics?
  
• What are the key challenges faced by microbiome contract manufacturers?
  
• Who are the most likely partners (microbiome-based live biotherapeutic drug developers) for microbiome contract manufacturers?
  
• What is the annual clinical demand for microbiome-based live biotherapeutics? 
  
• What is the current, installed contract manufacturing capacity for live biotherapeutics?
  
• What are the key factors influencing the make (manufacture in-house) versus buy (outsource) decision in this field?
  
• What are the various initiatives undertaken by big pharma players in this domain? 
  
• What percentage of live biotherapeutics manufacturing operations are outsourced to service providers?
  
• How is the current and future market opportunity likely to be distributed across key market segments?
  
• What are the anticipated future trends related to live biotherapeutics manufacturing?