Live Biotherapeutic Products and Microbiome Manufacturing Market (2nd Edition), 2022-2035

Live Biotherapeutic Products and Microbiome Manufacturing Market (2nd Edition), 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?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the microbiome therapeutics manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to the human microbiome, along with information on the various types of microbiome therapeutics. It also features an elaborate discussion on the functions of the microbiota, emphasizing on the key insights generated from the human microbiome project (HMP). Further, the chapter features the various steps that are involved in the manufacturing of microbiome therapeutics. In addition, it highlights the challenges associated with manufacturing such products and the growing need for outsourcing in this domain. Finally, it provides a list of key factors that need to be considered by innovator companies while selecting a CMO partner.

Chapter 4 provides an overview of the microbiome contract manufacturing landscape. It includes information on over 25 contract manufacturers that claim to offer microbiome therapeutics manufacturing services. In addition, it features an in-depth analysis of these companies, based on a number of parameters, such as 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. It also 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.

Chapter 5 provides a detailed landscape of microbiome manufacturing facilities in key regions (North America, Europe and Asia-Pacific). It includes analysis and map representations based on location of these facilities, highlighting key provinces as the manufacturing hubs.

Chapter 6 features an insightful company competitiveness analysis of microbiome manufacturing service providers based on their product portfolio strength (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.

Chapter 7 includes detailed 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 at both clinical and commercial scales. Each profile features a brief overview of the company, microbiome-related service portfolio, information on microbiome manufacturing facilities, and recent developments and an informed future outlook.

Chapter 8 provides list of nearly 70 microbiome-focused drug developers that are anticipated to partner with manufacturers. 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.

Chapter 9 presents 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.

Chapter 10 presents detailed analysis of the recent developments and initiatives (partnerships and collaborations, mergers and acquisitions and expansions) that have been undertaken in the microbiome manufacturing industry, during the period between 2016 and 2021.

Chapter 11 features 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.

Chapter 12 provides 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 on the basis of 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).

Chapter 13 presents 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.

Chapter 14 provides 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.

Chapter 15 includes a case study on the current market landscape of microbiome contract research organizations and dietary supplement providers, including information on the year of establishment, company size and location of headquarters.

Chapter 16 presents an insightful market forecast analysis, highlighting the future potential of microbiome manufacturing market till 2035. We have segmented the market on the basis of [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).

Chapter 17 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the microbiome contract manufacturing market, based on the research and analysis described in the previous chapters.
Chapter 18 is a collection of transcripts of interviews conducted with various stakeholders in the industry.

Chapter 19 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 20 is an appendix that provides the list of companies and organizations mentioned in the report.

LIST OF COMPANIES AND ORGANIZATIONS
The following companies / institutes / government bodies and organizations have been mentioned in this report.

1. 4D Pharma
2. AbbVie
3. ABCO Laboratories
4. ABH Pharma
5. Adare Pharmaceuticals
6. ADM Biopolis
7. Advanced Enzymes
8. Allianz Biosciences
9. AmpliPhi Biosciences
10. AOBiome Therapeutics
11. Arena Pharmaceuticals
12. Armata Pharmaceuticals
13. Arranta Bio
14. AsiaBiome
15. Assembly Biosciences
16. AstraZeneca
17. Atlantic Essential Products
18. Aumgene Biosciences
19. Axial Therapeutics
20. Azabu University
21. Azitra
22. BacThera
23. Biena
24. Bifodan
25. BIOASTER
26. BioCare
27. Biocodex
28. BioGaia
29. Biomar Microbial Technologies
30. Biomcare
31. Bio-Me
32. Biomica (a subsidary of Evogene)
33. Biomillenia
34. BiomX
35. Biose
36. Biosortia Pharmaceuticals
37. BJP Laboratories
38. Bloom Science
39. Blue Turtle Bio
40. Boehringer Ingelheim
41. Bristol-Myers Squibb
42. C3J Therapeutics
43. Caelus Health
44. Cambridge University Hospitals NHS Foundation Trust
45. Cancer Research UK
46. Capsugel
47. Captozyme
48. Cell Biotech
49. Cerbios-Pharma
50. CHAIN Biotechnology
51. Charles River Laboratories
52. Chr. Hansen
53. Clinical Microbiomics
54. ClostraBio
55. Commense (a subsidiary of PureTech Health)
56. CoreBiome
57. CosmosID
58. Crestovo
59. Custom Probiotics
60. Da Volterra
61. Debiopharm
62. Deerland Probiotics & Enzymes
63. DermBiont
64. Diversigen
65. DuPont
66. EirGenix
67. Emerge Health
68. EMF
69. Emulate
70. Enterin
71. EnteroBiotix
72. Enterome
73. Evelo Biosciences
74. Evologic Technologies
75. EXDEN
76. Exeliom Biosciences
77. Exim Pharma
78. Ferring Pharmaceuticals
79. Finch Therapeutics
80. FUJIFILM Diosynth Biotechnologies
81. Ganeden Biotech
82. GENIBIO (a subsidiary of the LARENA and GB ACTION)
83. Genome & Company
84. GI Innovation
85. Gilead Sciences
86. Ginkgo Bioworks
87. Gustave Roussy
88. Gusto Global
89. Heidelberg University
90. iCarbonX
91. Igen BioLab Group
92. ImmuneBiotech
93. Immuron
94. Infant Bacterial Therapeutics
95. Inpac Probiotics
96. Ion Labs
97. Jeneil Biotech
98. John Theurer Cancer Center
99. Johnson & Johnson
100. JW Nutritional
101. Kaleido Biosciences
102. Karolinska Institutet
103. Karyotica Biologicals
104. Kendy Pharma
105. Kibow Biotech
106. Lallemand
107. Leadiant Biosciences
108. Leiden University Medical Center
109. List Biological Laboratories
110. LNC Therapeutics
111. Locus Biosciences
112. Lonza
113. LUCA Biologics
114. Luina Bio
115. MaaT Pharma
116. Massachusetts General Hospital
117. MatriSys Bioscience
118. Mayo Clinic
119. Medella Naturals
120. Memorial Sloan Kettering Cancer Center
121. Merck
122. MeriCal
123. MetaboGen
124. Meteoric Biopharmaceuticals
125. Microba Life Sciences
126. Microbax
127. Microbiome Insights
128. MicrobiomeDx
129. Microbiotica
130. Microviable Therapeutics
131. Mirna Therapeutics
132. MRM Health
133. MSD
134. MyBiotics
135. Naked Biome
136. Nestlé Health Science
137. New Bellus
138. Nexbiome Therapeutics
139. NIZO
140. Norax Supplements
141. North Zealand University Hospital
142. Novartis
143. Novo Nordisk
144. NuBiyota
145. NutraScience Labs
146. NYU Grossman School of Medicine
147. Osel
148. OxThera
149. Parker Institute for Cancer Immunotherapy
150. Parkinson’s Institute and Clinical Center
151. Pfizer
152. Phi Therapeutics
153. Phylagen
154. Precigen ActoBio
155. Probi
156. ProbioFerm
157. Probiotical
158. Probiotics Australia
159. ProDigest
160. Protexin
161. Qu Biologics
162. Quay Pharma
163. Quorum Innovations
164. Rebiotix
165. The Research Institute of St
166. Resphera Biosciences
167. RIKEN
168. Rise Therapeutics
169. Roche
170. RondinX
171. Roswell Park Comprehensive Cancer Center
172. Sabinsa
173. Sacco
174. S-Biomedic
175. SciBac
176. Scioto Biosciences
177. Second Genome
178. Seres Therapeutics
179. SeylanMED
180. SFA Therapeutics
181. Siolta Therapeutics
182. Sirio Pharma
183. SNIPR Biome
184. Specialty Enzymes & Probiotics
185. Stanford Cancer Institute
186. Stanford University School of Medicine
187. Stellate Therapeutics
188. Symberix
189. Syngen Biotech
190. Synlogic
191. Synthetic Biologics
192. Takeda Pharmaceutical
193. The Medical University of Graz
194. The University of Texas MD Anderson Cancer Center
195. The University of Tokyo
196. Trayer Biotherapeutics
197. UAS Labs
198. Unique Biotech
199. University of Adelaide
200. University of Nottingham
201. University of Oxford
202. University of Pennsylvania
203. University of Reading
204. Vaiomer
205. Vedanta Biosciences
206. VITA-gen Laboratories
207. Vitakem
208. Wacker Biotech
209. Washington University School of Medicine
210. White Rock Capital Partners
211. Winclove Probiotics
212. Xycrobe Therapeutics (a subsidiary of Crown Laboratories)
213. Yakult Honsha
214. Zeta Farmaceutici

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