Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030

Overview

I believe that a lot of start-ups have entered the market, however, only a few companies have established their own facilities to manufacture microbiome-based products. This is primarily due to the fact that the cost of establishing an LBP production facility is high, and therefore, requires significant capital investment. As a result, companies have demonstrated preference to outsource manufacturing operations

-Vice President, Sales and Business Development, a US based Small-sized Company

Harnessing the naturally evolved, medicinal functions of gut bacteria in order to achieve desired clinical outcomes / benefits is the core principle behind the rapidly growing field of microbiome therapeutics. In fact, in recent years, promising insights from microbiome focused research has been the cause of much enthusiasm within the medical science community, offering a novel perspective related to personalized medicine. This particular class of products exists at the interface of naturopathic remedies (considering the active substances that are currently used) and clinically validated interventions, having demonstrated the ability to offer legitimate, quantifiable clinical benefits. Around 200 companies, including both private and public stakeholders, claim to be currently engaged in developing microbiome-based therapies for the treatment of a wide range of diseases. Several large pharmaceutical companies have also demonstrated interest in partnering with early-stage innovators in this domain. Having said that, most such initiatives are either still in the preclinical stages or early phase clinical trials. There are a few microbiome-based product candidates in phase II/III trials, which are anticipated to drive the market’s growth in the short-mid term. According to our estimates, the microbiome-based therapeutics market is projected to be worth over USD 2.1 billion by 2030, growing at an annualized rate of over 38%.

Despite the evident increase in interest in this field, manufacturing live microbial therapeutics remains a largely unaddressed area of concern. In fact, experts believe that the lack of sufficient manufacturing capacity is one of the major impediments to the commercialization of such products. Other challenges include absence of the required industry standards related to manufacturing live biotherapeutics, reproducibility (batch-to-batch consistency) related concerns, lack of expertise and infrastructure to handle anaerobic microbial strains, scaling up existing manufacturing protocols, intellectual property related issues (existing patent law prohibits patenting live organisms and naturally occurring materials) and uncertainties related to regulatory review and product approval. Owing to the aforementioned reasons and several others, such as need for specialized facilities, equipment and operational expertise, innovator companies have begun relying on contract manufacturers for their microbiome-related development and production needs. Outsourcing is known to offer several benefits, which include reductions in capital investment, access to larger production capacities, expediting time-to-market, and commercial risk handling and mitigation (to a significant extent). Presently, a number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) claim to offer services for manufacturing microbiome-related products. In fact, some have even developed end-to-end capabilities, starting from drug development to regulatory filings, and commercial scale production, in this field.

Scope of the Report

The “Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Focus on Active Pharmaceutical Ingredients and Finished Dosage Forms, 2020-2030” report features an extensive study of the current landscape and future opportunities related to contract services for microbiome therapeutics. The study features an in-depth analysis, highlighting the capabilities of a diverse set of contract service providers, including CMOs and CDMOs. Amongst other elements, the report includes:

• A detailed review of the overall landscape of companies offering contract services for manufacturing of microbiome therapeutics, including information on 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 drug molecule (small molecules and biologics / live biotherapeutics (LBPs)), type of fermentation (aerobic and anaerobic), type of formulation (solids (tablets / capsules / powders / granules), oral liquids (syrups and solutions), injectables and others), type of primary packaging used (ampoules / vials, blister packing, glass / plastic bottles, pouches / sachets, and others), number and location of manufacturing facilities (country-wise), facility size (if available), as well as their certifications, and company’s contact details.
• A list of companies with in-house manufacturing facilities for microbiome therapeutics along with information on year of establishment, company size, scale of operations (preclinical, clinical and commercial), location of headquarters, and location of manufacturing facilities (country-wise).
• 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 therapeutics at both clinical and commercial scales. Each profile features a brief overview of the company, microbiome-related service portfolio, information on microbiome manufacturing facilities (if available), and recent developments and an informed future outlook.
• An assessment of microbiome contract manufacturing capability in different regions, based on a number of relevant parameters, such as number of CMOs, number of completed / active / planned clinical trials, number of patients enrolled, number of manufacturing facilities, number of companies offering API / FDF manufacturing, number of companies having capabilities for preclinical / clinical / commercial manufacturing, number of companies dedicated to aerobic / anaerobic fermentation, installed manufacturing capacity, and number of in-house players.
• A list of nearly 50 microbiome-focused drug developers that are anticipated to partner with contract manufacturers and have been shortlisted on the basis of parameters, such as developer strength (which takes into account the company’s size and its experience in this field), company’s pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and the availability of in-house manufacturing capabilities.
• A detailed clinical trial analysis of more than 150 completed, ongoing and planned studies of various microbiome therapeutics sponsored by both industry and non-industry players; it highlights prevalent trends across various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, trial recruitment status, study design and trial focus, highlighting leading sponsors (in terms of number of trials conducted), type of organization, popular therapeutic areas, and regional distribution of trials.
• An estimate of the overall, installed capacity for manufacturing of microbiome therapeutics, taking into consideration the capabilities of various stakeholders, based on data gathered via secondary and primary research; it presents the distribution of available capacity in terms of quantity of microbiome therapeutics produced (in liters, per year), across important market segments, such as company size (small-sized, mid-sized and large companies), scale of operation (clinical and commercial), and key geographical regions (North America, Europe and Asia-Pacific and rest of the world).
• An informed estimate of the annual clinical 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 the 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 review of the varied microbiome-focused initiatives of big pharma players (shortlisted from the top 20 pharmaceutical companies as of 2019), 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.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the microbiome therapeutics contract manufacturing market. Based on multiple parameters, such as projected growth of the overall microbiome therapeutics market, cost of goods sold and direct manufacturing costs, we developed informed estimates describing the financial evolution of the market, over the period 2020-2030. The report also provides details on 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, injectables and others), [C] company size (small-sized, mid-sized and large), [D] scale of operation (clinical and commercial), and [E] key geographical regions, covering North America, Europe, Asia-Pacific, and rest of the world. In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in this study was influenced by inputs solicited via a survey and discussions held with multiple senior stakeholders in the industry.

The report features detailed transcripts of discussions held with the following individuals:

• Veronika Oudova (Co-founder and Chief Executive Officer, S-Biomedic)
• Gaurav Kaushik (Chief Executive Officer and Managing Director, Meteoric Biopharmaceuticals)
• Assaf Oron (Chief Business Officer, BiomX)
• Alexander Segal (Vice President, Business Development, Universal Stabilization Technologies)
• Debbie Pinkston (Vice President, Sales and Business Development, List Biological Laboratories)
• JP Benya (Vice President, Business Development, Assembly Biosciences)
• Rob van Dijk (Business Development Manager, Wacker Biotech)
• Alexander Lin (Associate General Manager, Chung Mei Pharmaceutical)

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.

Key Questions Answered

• Who are the leading CMOs offering microbiome contract manufacturing services, across the world?
• 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 biotherapeutic products?
• 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?