TOC - Global Microbiome Therapeutics Market.pdf

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res
Focus on Target Therapies, Region (10
Countries), and Competitive Landscape
Analysis and Forecast: 2022-2032
June 2022
Global
Microbiome
Therapeutics
Market-
A Global and
Regional Analysis
Table of Content

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BIS Research is a leading market intelligence and technology research company. BIS Research publishes in-
depth market intelligence reports focusing on the market estimations, technology analysis, emerging high-
growth applications, deeply segmented granular country-level market data and other important market
parameters useful in the strategic decision making for senior management. BIS Research provides multi-client
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Copyright © 2022 BIS Research Inc.
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or organization concerned. It may not be accessed by or offered, whether for sale or otherwise, to any third
party.

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Table of Content
Executive Summary ..........................................................................20
1. Market Definition .......................................................................24
1.1 Inclusion and Exclusion Criteria ....................................................................24
2. Research Scope ........................................................................25
2.1 Target Audience...............................................................................................26
2.2 Key Questions Answered in the Report.........................................................27
3. Research Methodology ..............................................................28
3.1 Global Microbiome Therapeutics: Research Methodology..........................28
3.2 Primary Data Sources .....................................................................................29
3.3 Secondary Data Sources ................................................................................29
3.4 Market Estimation Model.................................................................................30
3.5 Criteria for Company Profiling........................................................................32
4. Market Overview........................................................................33
4.1 Market Size and Future Growth Potential......................................................33
4.2 Historical Trends .............................................................................................34
5. Industry Insights ........................................................................35
5.1 Regulatory Landscape ....................................................................................35
5.1.1 Regulatory Requirements for Live Biotherapeutic Products (LBPs)......35
5.1.2 Quality Check of LBPs................................................................................35
5.1.3 FDA Approved Fecal Microbiota Transplantation (FMT) Quality
Check Procedure.........................................................................................36
5.2 Patent Landscape............................................................................................37
5.2.1 Patent Filing Analysis .................................................................................37
5.2.2 Key Players Patent Portfolio ......................................................................38
5.2.3 Key Players Patent Expiration Analysis....................................................40
5.3 Partnership Landscape ...................................................................................41
5.4 Government Initiatives ....................................................................................42
5.5 Impact of COVID-19 on the Global Microbiome Therapeutics Market.........44
5.5.1 Clinical Trial Disruptions and Resumptions .............................................44

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6. Market Dynamics .......................................................................46
6.1 Market Drivers..................................................................................................46
6.1.1 Growing Strategic Activities in Microbiome Therapeutics Segment ......46
6.1.2 Potential of Microbiome Therapeutics to Address Unmet Needs of
Existing Treatment Options........................................................................47
6.1.3 Microbiome Therapeutic Products as a Safer Alternative to
Conventional Drug Treatments ..................................................................47
6.2 Market Restraints.............................................................................................48
6.2.1 Lack of Uniformed Standardized Regulatory Guidelines.........................48
6.2.2 Associated Safety Issues with LBPs .........................................................48
6.2.3 Storage Issues with Live Micro-Organisms ..............................................48
6.2.4 Challenges Associated with Manufacturing of LBPs...............................48
6.3 Market Opportunities.......................................................................................49
6.3.1 Need for Current Good Manufacturing Practice (cGMP) Certified
Contract Manufacturing Facilities..............................................................49
6.3.2 Growing Disease Dimension ......................................................................49
6.3.3 Entry of Major Players.................................................................................49
7. Clinical Trial Landscape.............................................................50
7.1 Microbiome Therapeutics Pipeline Landscape.............................................50
7.1.1 Competitive Landscaping...........................................................................50
7.1.2 Pipeline Analysis.........................................................................................54
7.1.2.1 By Development Phase ..................................................................................... 54
7.1.2.2 By Route of Administration ................................................................................ 55
7.1.2.3 By Type of Microbiome Strategy........................................................................ 56
7.1.2.4 By Indication ...................................................................................................... 57
7.1.3 Emerging Microbiome Therapeutics Products .........................................58
7.2 Probable Potential First Entrants to Global Microbiome Therapeutics
Market/ Microbiome Therapeutics Clinical Trial Design...............................62
7.2.1 CP-101 (Finch Therapeutics Group, Inc.) ..................................................63
7.2.1.1 CP-101: Product Profile..................................................................................... 63
7.2.2 SER-109 (Seres Therapeutics, Inc.) ...........................................................65

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7.2.2.1 SER-109: Product Profile................................................................................... 65
7.2.3 RBX-2660 (Rebiotix Inc.).............................................................................68
7.2.3.1 RBX-2660: Product Profile................................................................................. 68
7.2.4 CH-106 (Caelus Health)...............................................................................71
7.2.4.1 CH-106: Product Profile..................................................................................... 71
7.2.5 LACTIN-V (Osel Inc.) ...................................................................................73
7.2.5.1 LACTIN-V: Product Profile................................................................................. 73
7.2.6 MaaT013 (MaaT Pharma).............................................................................73
7.2.6.1 MaaT013: Product Profile.................................................................................. 73
8. Competitive Insights ..................................................................74
8.1 Key Strategies and Developments.................................................................74
8.2 Synergistic Activities ......................................................................................74
8.3 Product Launch and Regulatory Approvals..................................................75
8.4 Funding and Investment .................................................................................76
8.5 Mergers and Acquisitions...............................................................................77
8.6 Market Share Analysis ....................................................................................78
8.7 Growth-Share Analysis (Opportunity Mapping)............................................79
8.7.1 By Region.....................................................................................................79
8.7.2 By Company ................................................................................................80
9. Global Microbiome Therapeutics Market (by Target Therapy
Area) .........................................................................................82
9.1 Overview...........................................................................................................82
9.2 Gastrointestinal and Infectious Diseases......................................................83
9.3 Skin Disorders .................................................................................................85
9.4 Cancer Indications...........................................................................................87
9.5 Other Indications .............................................................................................88
10. Global Microbiome Therapeutics Market (by Region) .................89
10.1.1 Overview ......................................................................................................89
10.2 North America..................................................................................................90
10.2.1 Overview ......................................................................................................90

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10.2.2 U.S. ...............................................................................................................93
10.2.3 Canada .........................................................................................................94
10.3 Europe ..............................................................................................................95
10.3.1 Overview ......................................................................................................95
10.3.2 France...........................................................................................................98
10.3.3 Germany.......................................................................................................99
10.3.4 Sweden.......................................................................................................100
10.3.5 U.K. .............................................................................................................101
10.3.6 Italy .............................................................................................................102
10.3.7 Spain...........................................................................................................102
10.3.8 Rest-of-Europe...........................................................................................103
10.4 Asia-Pacific (APAC).......................................................................................104
10.4.1 Overview ....................................................................................................104
10.4.2 Japan..........................................................................................................106
10.4.3 Australia.....................................................................................................107
10.4.4 China ..........................................................................................................109
10.4.5 India............................................................................................................110
10.4.6 Rest-of-Asia-Pacific...................................................................................111
10.5 Rest-of-the-World ..........................................................................................112
10.5.1 Overview ....................................................................................................112
11. Competitive Benchmarking and Company Profiles ...................113
11.1 4D pharma plc................................................................................................113
11.1.1 Company Overview ...................................................................................113
11.1.2 Role of 4D pharma plc in the Global Microbiome Therapeutics
Market.........................................................................................................113
11.1.3 Key Competitors of the Company............................................................114
11.1.4 Financials...................................................................................................115
11.1.5 Recent Developments...............................................................................116
11.1.6 Analyst’s Perspective ...............................................................................116
11.2 Seres Therapeutics, Inc. ...............................................................................118

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11.2.2 Role of Seres Therapeutics, Inc. in the Global Microbiome
Therapeutics Market..................................................................................118
11.2.4 Financials...................................................................................................119
11.2.6 Analyst Perspective ..................................................................................121
11.3 Microbiotica....................................................................................................122
11.3.2 Role of Microbiotica in the Global Microbiome Therapeutics Market
..............................................................................................................122
11.4 Enterome ........................................................................................................124
11.4.2 Role of Enterome in the Global Microbiome Therapeutics Market .......124
11.5 Destiny Pharma plc .......................................................................................126
11.5.2 Role of Destiny Pharma plc in the Global Microbiome Therapeutics
Market.........................................................................................................126
11.5.4 Financials...................................................................................................127
11.6 Taisho Pharmaceutical Holdings .................................................................130

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11.6.2 Role of Taisho Pharmaceutical Holdings in the Global Microbiome
11.6.4 Financials...................................................................................................131
11.7 AOBiome Therapeutics, Inc..........................................................................135
11.7.2 Role of AOBiome Therapeutics, Inc. in the Global Microbiome
11.8 Finch Therapeutics Group, Inc.....................................................................137
11.8.2 Role of Finch Therapeutics Group, Inc. in the Global Microbiome
11.8.4 Financials...................................................................................................138
11.9 Ferring Pharmaceuticals...............................................................................141
11.10 Rebiotix Inc. (A Subsidiary of Ferring Pharmaceuticals) ...........................141
11.10.1 Company Overview.............................................................................141
11.10.2 Role of Rebiotix Inc. in the Global Microbiome Therapeutics
Market.........................................................................................................141
11.10.3 Key Competitors of the Company .....................................................142
11.10.4 Recent Developments.........................................................................142
11.10.5 Analyst’s Perspective.........................................................................143
11.11 MaaT Pharma .................................................................................................144

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11.11.2 Role of MaaT Pharma in the Global Microbiome Therapeutics
Market.........................................................................................................144
11.11.4 Financials ............................................................................................145
11.12 Vedanta Biosciences Inc...............................................................................147
11.12.2 Role of Vedanta Biosciences Inc. in the Global Microbiome
11.13 OxThera AB....................................................................................................149
11.13.2 Role of OxThera AB in the Global Microbiome Therapeutics
Market.........................................................................................................149
11.14 Pendulum Therapeutics ................................................................................151
11.14.2 Role of Pendulum Therapeutics in the Global Microbiome
11.15 Caelus Health.................................................................................................153

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11.15.2 Role of Caelus Health in the Global Microbiome Therapeutics
Market.........................................................................................................153
11.16 Quorum Innovations......................................................................................156
11.16.2 Role of Quorum Innovations in the Global Microbiome
11.17 Sanofi S.A.......................................................................................................158
11.17.2 Role of Sanofi S.A. in the Global Microbiome Therapeutics
Market.........................................................................................................158
11.17.4 Financials ............................................................................................159
11.18 DermBiont, Inc. ..............................................................................................163
11.18.2 Role of DermBiont, Inc. in the Global Microbiome Therapeutics
Market.........................................................................................................163
11.19 EnteroBiotix Ltd.............................................................................................166
11.19.2 Role of EnteroBiotix Ltd in the Global Microbiome Therapeutics
Market.........................................................................................................166

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11.20 YSOPIA Bioscience .......................................................................................168
11.20.2 Role of YSOPIA Bioscience in the Global Microbiome
11.21 Winclove Probiotics ......................................................................................171
11.21.2 Role of Winclove Probiotics in the Global Microbiome
11.22 TargEDys........................................................................................................174
11.22.2 Role of TargEDys in the Global Microbiome Therapeutics
Market.........................................................................................................174
11.23 Evelo Biosciences, Inc. .................................................................................176
11.23.2 Role of Evelo Biosciences, Inc. in the Global Microbiome
11.23.4 Financials ............................................................................................178

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11.24 BiomX .............................................................................................................180
11.24.2 Role of BiomX in the Global Microbiome Therapeutics Market ......180
11.24.4 Financials ............................................................................................181
11.25 Biomica Ltd. ...................................................................................................184
11.25.2 Role of Biomica Ltd. in the Global Microbiome Therapeutics
Market.........................................................................................................184
11.26 Scioto Biosciences, Inc.................................................................................186
11.26.2 Role of Scioto Biosciences, Inc. in the Global Microbiome
11.27 Lactobio A/S...................................................................................................189
11.27.2 Role of Lactobio A/S in the Global Microbiome Therapeutics
Market.........................................................................................................189
12. Appendix .................................................................................192

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List of Figures
Figure 1: Global Microbiome Therapeutics Market Share (by Target Therapy Area), $Million, 2021
Figure 2: Global Microbiome Therapeutics Market Share (by Region), $Million, 2021 and 2032
Figure 3: Growth-Share Analysis (by Region), 2020-2021
Figure 4: Global Microbiome Therapeutics Market Segmentation
Figure 5: Global Microbiome Therapeutics Market Methodology
Figure 6: Primary Research Methodology
Figure 7: Bottom-Up Approach (Segment Wise Analysis)
Figure 8: Top-Down Approach (Segment-Wise Analysis)
Figure 9: Global Microbiome Therapeutics Market, $Million, 2021-2032
Figure 10: Historical Evolution of Microbiome Therapeutics
Figure 11: Chemistry, Manufacturing, and Control (CMC) Information of LBPs by FDA
Figure 12: Patent Landscape of the Microbiome Therapeutics Market (by Region), 2019-2021
Figure 13: COVID-19 Impact on the Global Microbiome Therapeutics Market
Figure 14: Number of Strategic Activities in the Global Microbiome Therapeutics Market, 2019-2021
Figure 15: Number of Agreements for Leading Companies
Figure 16: Share of Microbiome Therapeutics Products in Global Clinical Trials (by Development Phase)
Figure 17: Share of Microbiome Therapeutics Pipeline Candidates (by Route of Administration)
Figure 18: Share of Microbiome Therapeutics Products (by Type of Microbiome Strategy)
Figure 19: Number of Microbiome Therapeutic Products in Global Clinical Trials (by Indication)
Figure 20: CP-101: Phase II Clinical Design for Recurrent C. diff. Infection (CDI)
Figure 21: CP-101 Phase III Clinical Design for Recurrent C. diff. Infection (CDI)
Figure 22: SER-109: Mechanism of Action
Figure 23: SER-109: Clinical Trial Details for Recurrent C. diff. Infection (CDI)
Figure 24: RBX-2660: Key Regulatory Milestones
Figure 25: RBX-2660: Clinical Progress for Recurrent C. Diff Infection (CDI)
Figure 26: RBX-2660: Clinical Trial Details for Recurrent C. diff. Infection (CDI)
Figure 27: CH-106: Clinical Design for Metabolic Syndrome/Prediabetes
Figure 28: Share of Key Developments and Strategies, January 2019–October 2021
Figure 29: Share of Synergistic Activities (by Company), January 2019-October 2021
Figure 30: Share of Product Launch and Regulatory Approvals (by Company), January 2019-October
2021

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Figure 31: Share of Funding and Investment (by Company), January 2019-October 2021
Figure 32: Share of Mergers and Acquisitions (by Company), January 2019-October 2021
Figure 33: Market Share Analysis for the Global Microbiome Therapeutics Market, $Million, 2020 and
2021
Figure 34: Growth-Share Analysis (by Region), 2020-2021
Figure 35: Growth-Share Analysis (by Company), 2020-2021
Figure 36: Global Microbiome Therapeutics Market (by Target Therapy Area), $Million, 2021 and 2032
Figure 37: Number of Pipeline Candidates for Gastrointestinal and Infectious Diseases
Figure 38: Global Microbiome Therapeutics Market (Gastrointestinal and Infectious Diseases), $Million,
2021-2032
Figure 39: Number of Pipeline Products for Skin Disorders
Figure 40: Global Microbiome Therapeutics Market (Skin Disorders), $Million, 2021-2032
Figure 41: Number of Pipeline Products for Cancer Indications
Figure 42: Number of Pipeline Products for Other Indications
Figure 43: Global Microbiome Therapeutics Market (by Region), 2022-2032
Figure 44: Global Microbiome Therapeutics Market Share (by Region), $Million, 2021-2032
Figure 45: North America Microbiome Therapeutics Market, $Million, 2021-2032
Figure 46: North America: Market Dynamics
Figure 47: North America Microbiome Therapeutics Market Share (by Country), $Million, 2021 and 2032
Figure 48: U.S. Microbiome Therapeutics Market, $Million, 2021-2032
Figure 49: Canada Microbiome Therapeutics Market, $Million, 2021-2032
Figure 50: Europe Microbiome Therapeutics Market, $Million, 2021-2032
Figure 51: Europe: Market Dynamics
Figure 52: Europe Microbiome Therapeutics Market Share (by Country), $Million, 2021 and 2032
Figure 53: France Microbiome Therapeutics Market, $Million, 2021-2032
Figure 54: Germany Microbiome Therapeutics Market, $Million, 2021-2032
Figure 55: Sweden Microbiome Therapeutics Market, $Million, 2021-2032
Figure 56: U.K Microbiome Therapeutics Market, $Million, 2021-2032
Figure 57: Italy Microbiome Therapeutics Market, $Million, 2021-2032
Figure 58: Spain Microbiome Therapeutics Market, $Million, 2021-2032
Figure 59: Rest-of-Europe Microbiome Therapeutics Market, $Million, 2021-2032
Figure 60: Asia-Pacific Microbiome Therapeutics Market, $Million, 2021-2032
Figure 61: Asia-Pacific: Market Dynamics

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Figure 62: Asia-Pacific Microbiome Therapeutics Market Share (by Country), $Million, 2021-2032
Figure 63: Japan Microbiome Therapeutics Market, $Million, 2021-2032
Figure 64: Australia Microbiome Therapeutics Market, $Million, 2021-2032
Figure 65: China Microbiome Therapeutics Market, $Million, 2021-2032
Figure 66: India Microbiome Therapeutics Market, $Million, 2021-2032
Figure 67: Rest-of-Asia-Pacific Microbiome Therapeutics Market, $Million, 2021-2032
Figure 68: Rest-of-the-World Microbiome Therapeutics Market, $Million, 2021-2032
Figure 69: 4D pharma plc: Product Portfolio
Figure 70: 4D pharma plc: Overall Financials, $Million, 2019-2021
Figure 71: 4D pharma plc: R&D Expenditure, $Million, 2019-2021
Figure 72: Seres Therapeutics, Inc.: Product Portfolio
Figure 73: Seres Therapeutics, Inc.: Overall Financials, $Million, 2019-2021
Figure 74: Seres Therapeutics, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 75: Microbiotica: Product Portfolio
Figure 76: Enterome: Product Portfolio
Figure 77: Destiny Pharma plc: Product Portfolio
Figure 78: Destiny Pharma plc: Overall Financials, $Million, 2019-2021
Figure 79: Destiny Pharma plc: R&D Expenditure, $Million, 2019-2021
Figure 80: Taisho Pharmaceutical Holdings: Product Portfolio
Figure 81: Taisho Pharmaceutical Holdings: Overall Financials, $Million, 2019-2021
Figure 82: Taisho Pharmaceutical Holdings: Net Revenue (by Segment), $Million, 2019-2021
Figure 83: Taisho Pharmaceutical Holdings: Net Revenue (by Region), $Million, 2019-2021
Figure 84: Taisho Pharmaceutical Holdings: R&D Expenditure, $Million, 2019-2021
Figure 85: AOBiome Therapeutics, Inc.: Product Portfolio
Figure 86: Finch Therapeutics Group, Inc.: Product Portfolio
Figure 87: Finch Therapeutics Group, Inc.: Overall Financials, $Million, 2019-2021
Figure 88: Finch Therapeutics Group, Inc.: R&D Expenditure, $Million, 2020-2021
Figure 89: Rebiotix Inc.: Product Portfolio
Figure 90: MaaT Pharma: Product Portfolio
Figure 91: MaaT Pharma: Overall Financials, $Million, 2020-2021
Figure 92: MaaT Pharma: R&D Expenditure, $Million, 2020-2021
Figure 93: Vedanta Biosciences Inc.: Product Portfolio
Figure 94: OxThera AB: Product Portfolio

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Figure 95: Pendulum Therapeutics: Product Portfolio
Figure 96: Caelus Health: Product Portfolio
Figure 97: Quorum Innovations: Product Portfolio
Figure 98: Sanofi S.A.: Product Portfolio
Figure 99: Sanofi S.A.: Overall Financials, $Million, 2019-2021
Figure 100: Sanofi S.A.: Net Revenue (by Segment), $Million, 2019-2021
Figure 101: Sanofi S.A.: Net Revenue by Region), $Million, 2019-2021
Figure 102: Sanofi S.A.: R&D Expenditure, $Million, 2019-2021
Figure 103: DermBiont, Inc.: Product Portfolio
Figure 104: EnteroBiotix Ltd: Product Portfolio
Figure 105: YSOPIA Bioscience: Product Portfolio
Figure 106: Winclove Probiotics: Product Portfolio
Figure 107: TargEDys: Product Portfolio
Figure 108: Evelo Biosciences, Inc.: Product Portfolio
Figure 109: Evelo Biosciences, Inc.: Pipeline Products
Figure 110: Evelo Biosciences, Inc.: Overall Financials, $Million, 2019-2021
Figure 111: Evelo Biosciences, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 112: BiomX: Product Portfolio
Figure 113: BiomX: Pipeline Products
Figure 114: BiomX: Overall Financials, $Million, 2019-2021
Figure 115: BiomX: R&D Expenditure, $Million, 2019-2021
Figure 116: Biomica Ltd.: Pipeline Product
Figure 117: Scioto Biosciences, Inc.: Product Portfolio
Figure 118: Scioto Biosciences, Inc.: Pipeline Product
Figure 119: Lactobio A/S: Product Portfolio
Figure 120: Lactobio A/S: Pipeline Product

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List of Tables
Table 1: Global Microbiome Therapeutics Market: Key Players Patent Portfolio
Table 2: Patent Expiration Analysis
Table 3: Partnership Landscaping
Table 4: Government Initiatives in Microbiome Therapeutics
Table 5: Impact of COVID-19 on Microbiome Therapeutics Developing Companies
Table 6: Key Players/Investors Portfolio
Table 7: Emerging Microbiome Therapeutics Products Pipeline
Table 8: Probable Potential First Entrants to Global Microbiome Therapeutics Market
Table 9: 4D pharma plc: Key Competitors
Table 10: Seres Therapeutics, Inc.: Key Competitors
Table 11: Microbiotica: Key Competitors
Table 12: Enterome: Key Competitors
Table 13: Destiny Pharma plc: Key Competitors
Table 14: Taisho Pharmaceutical Holdings: Key Competitors
Table 15: AOBiome Therapeutics, Inc.: Key Competitors
Table 16: Finch Therapeutics Group, Inc.: Key Competitors
Table 17: Rebiotix Inc.: Key Competitors
Table 18: MaaT Pharma: Key Competitors
Table 19: Vedanta Biosciences Inc.: Key Competitors
Table 20: Pendulum Therapeutics: Key Competitors
Table 21: Caelus Health: Key Competitors
Table 22: Quorum Innovations: Key Competitors
Table 23: Sanofi S.A.: Key Competitors
Table 24: DermBiont Inc.: Key Competitors
Table 25: EnteroBiotix Ltd: Key Competitors
Table 26: YSOPIA Bioscience: Key Competitors
Table 27: Winclove Probiotics: Key Competitors
Table 28: TargEDys: Key Competitors
Table 29: Evelo Biosciences, Inc.: Key Competitors
Table 30: BiomX: Key Competitors
Table 31: Biomica Ltd.: Key Competitors

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Table 32: Scioto Biosciences, Inc.: Key Competitors
Table 33: Lactobio A/S: Key Competitors

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