マイクロバイオーム製造市場、産業動向と世界予測 (～2035年)：製造製品タイプ別、製剤別、使用される一次包装別、事業規模別、企業規模別、地域別、開発企業別

マイクロバイオーム製造の市場規模は、2023年に2,700万米ドルとなりました。同市場は、予測期間の2023年～2035年に17%のCAGRで拡大すると予測されています。

人体はマイクロバイオータと総称される多様な微生物群集を宿しており、これには有益な種と有害な種が含まれます。マイクロバイオームとは、宿主内に存在する微生物の生態系を指し、常在生物、共生生物、病原性生物から構成されます。疾患発症におけるその重要性を考慮し、マイクロバイオームに基づく治療薬への関心が医学界で高まっています。過去20年間で、マイクロバイオーム治療の研究と応用において大きな進展がありました。マイクロバイオーム療法のひとつである生きたバイオ治療製品（LBP）は、細菌、ウイルス、真菌などの生きた微生物を利用して病気を予防・治療するものです。これらの製品は治療目的で綿密に設計されており、多くの国で医薬品または生物製剤として規制されています。一般的には、特定の病態の治療における安全性と有効性を臨床試験で検証し、広範に研究された特定の微生物株が使用されます。さらに、微生物に基づく治療法は、遺伝子配列の決定を通じて患者のマイクロバイオーム構成に基づいて治療法を調整することが期待されています。

臨床パイプラインにおける微生物ベースの生きたバイオ治療製品の出現は、この治療分野が製薬業界の中で急速に成長する市場になることを示唆しています。進歩にもかかわらず、マイクロバイオームの製造、特に生菌療法には課題が残っています。これらの課題には、開発期間の長期化、厳格な温度管理要件、好気性／嫌気性菌株の複雑なエンジニアリング、最終製品の品質属性の不一致などが含まれます。このような課題に対処するため、ヒトマイクロバイオーム療法の開発者は、製造受託機関（CMO）や開発・製造受託機関（CDMO）に製造を委託しています。より広範な生物製剤受託製造市場の一部であるこれらの事業体は、マイクロバイオーム製造プロセスの合理化、生産効率の向上、品質改善のための新技術の統合をますます進めています。この動向はマイクロバイオームとマイクロバイオーム製造の両市場の成長を促進すると予想されます。

当レポートでは、世界のマイクロバイオーム製造市場について調査し、市場の概要とともに、製造製品タイプ別、製剤別、使用される一次包装別、事業規模別、企業規模別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 序文

第2章 調査手法

第3章 経済およびその他のプロジェクト特有の考慮事項

第4章 エグゼクティブサマリー

第5章 イントロダクション

• 章の概要
• ヒト微生物叢とマイクロバイオームの概念
• 腸内フローラの概要
• ヒト・マイクロバイオーム・プロジェクト（HMP）
• マイクロバイオーム療法の概要
• マイクロバイオームに基づく治療薬の製造
• 適切なCMOパートナーを選択する際の重要な考慮事項
• 結論

第6章 市場情勢

• 章の概要
• 生きた生物療法製品およびマイクロバイオーム受託製造業者：市場情勢
• 生きたバイオ医薬品とマイクロバイオームの自社製造業者：市場情勢

第7章 地域能力分析

• 章の概要
• 主要な前提条件とパラメータ
• 北米
• 欧州
• アジア太平洋

第8章 企業の競合分析

• 章の概要
• 主要な前提条件とパラメータ
• 調査手法
• 生きた生物学的製品およびマイクロバイオーム受託製造業者：企業の競合分析：
• トップクラスのマイクロバイオーム受託製造会社の能力ベンチマーク

第9章 企業プロファイル

第10章 可能性の高いパートナーの分析

第11章 大手製薬会社の取り組み

• 章の概要
• 調査手法
• 大手製薬会社による生きた生物学的製品とマイクロバイオーム関連の取り組み

第12章 最近の開発と取り組み

• 章の概要
• パートナーシップとコラボレーション
• 生きたバイオ医薬品とマイクロバイオームの製造：合併と買収
• 生きた生物学的製品とマイクロバイオーム製造：最近の拡大

第13章 臨床試験の分析

• 章の概要
• 範囲と調査手法
• 生きた生物学的製品とマイクロバイオーム製造：臨床試験分析

第14章 容量分析

• 章の概要
• 主な前提条件
• 生きた生物学的製品とマイクロバイオームの受託製造：世界の設備容量

第15章 需要分析

• 章の概要
• 調査手法
• 生きた生物学的製品とマイクロバイオーム製造に対する世界の臨床需要
• 生きた生物学的製品とマイクロバイオーム製造に対する世界の商業需要

第16章 内製か外製かの意思決定の枠組み

第17章 ケーススタディ：生きた生物学的製品とマイクロバイオーム受託製造機関（CRO）および栄養補助食品製造業者

第18章 市場への影響分析：促進要因、抑制要因、機会、課題

• 章の概要
• 市場促進要因
• 市場抑制要因
• 市場の機会
• 市場の課題
• 結論

第19章 生きた生物学的製品とマイクロバイオーム受託製造市場

第20章 生きた生物学的製品およびマイクロバイオーム受託製造市場、製造製品、タイプ別

第21章 生きた生物学的製品およびマイクロバイオーム受託製造市場、製剤別

第22章 生きた生物学的製品およびマイクロバイオーム契約製造市場、使用される一次包装別

第23章 生きた生物学的製品およびマイクロバイオーム契約製造市場、事業規模別

第24章 生きた生物学的製品およびマイクロバイオーム受託製造市場、企業規模別

第25章 生きた生物学的製品およびマイクロバイオーム契約製造市場、主要地域別

第26章 生きた生物学的製品およびマイクロバイオーム療法の主要開発者

第27章 エグゼクティブインサイト

• 章の概要
• Osel
• Unique Biotech
• Meteoric Biopharmaceuticals
• Biomedic
• Siolta Therapeutics
• BiomX
• Vedanta Biosciences
• Universal Stabilization Technologies
• Arranta Bio
• Assembly Biosciences
• List Biological Laboratories
• Luina Bio
• WACKER

第28章 結論

第29章 付録I：表形式のデータ

第30章 付録II：企業および組織のリスト

List of Tables

• Table 5.1 Different Types of Microbiota in the Gastrointestinal Tract
• Table 5.2 Various Food Items Containing Prebiotics
• Table 5.3 Harvey Ball Analysis: Comparison of Key Factors for the Selection of CMOs
• Table 6.1 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers: Market Landscape
• Table 6.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Product Manufactured
• Table 6.3 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Formulation
• Table 6.4 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Primary Packaging Used
• Table 6.5 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Microbe Used
• Table 6.6 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Service Offered
• Table 6.7 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Manufacturing Facilities
• Table 6.8 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Type of Microbial Species Used
• Table 6.9 List of Live Biotherapeutic Products and Microbiome In-House Manufacturers: Market Landscape
• Table 7.1 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
• Table 7.2 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
• Table 7.3 List of Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
• Table 9.1 Capsugel: Company Overview
• Table 9.2. Arranta Bio: Company Overview
• Table 9.3. FUJIFILM Diosynth Biotechnologies: Company Overview
• Table 9.4 List Biological Laboratories: Company Overview
• Table 9.5 ProbioFerm: Company Overview
• Table 9.6 Biose: Company Overview
• Table 9.7 Biose: Recent Developments and Future Outlook
• Table 9.8 Cerbios-Pharma: Company Overview
• Table 9.9 Cerbios Pharma: Recent Developments and Future Outlook
• Table 9.10 Chr. Hansen: Company Overview
• Table 9.11 Chr Hansen: Recent Developments and Future Outlook
• Table 9.12 Inpac Probiotics: Company Overview
• Table 9.13 Inpac Probiotics: Recent Developments and Future Outlook
• Table 9.14 NIZO: Company Overview
• Table 9.15 NIZO: Recent Developments and Future Outlook
• Table 9.16 WACKER: Company Overview
• Table 9.17 WACKER: Recent Developments and Future Outlook
• Table 9.18 Winclove Probiotics: Company Overview
• Table 9.19 Winclove Probiotics: Recent Developments and Future Outlook
• Table 9.20 BacThera: Company Overview
• Table 9.21 Evologic Technologies: Company Overview
• Table 9.22 Probiotical: Company Overview
• Table 9.23 QUAY Pharma: Company Overview
• Table 9.24 BJP Laboratories: Company Overview
• Table 9.25 BJP Laboratories: Recent Developments and Future Outlook
• Table 9.26 Aumgene Biosciences: Company Overview
• Table 9.27 AcuraBio: Company Overview
• Table 9.28 Meteoric Biopharmaceuticals: Company Overview
• Table 9.29 Probiotics Australia: Company Overview

Table 9.30: Unique Biotech: Company Overview

• Table 10.1 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
• Table 10.2 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
• Table 10.3 Likely Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
• Table 12.1 Live Biotherapeutic Products and Microbiome Manufacturing: List of Partnerships and Collaborations, 2016-2023
• Table 12.2 Partnerships and Collaborations: Information on Type of Agreement, 2016-2023
• Table 12.3 Mergers and Acquisitions: Information on Key Value Drivers, 2016-2022
• Table 12.4 Live Biotherapeutic Products and Microbiome Manufacturing: List of Recent Expansions, 2019-2023
• Table 14.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Information on Total Capacity (Sample Data Set)
• Table 14.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Average Capacity by Company Size (Sample Data Set)
• Table 15.1 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Information on Number of Enrolled Patients and Trial Phase
• Table 15.2 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing: List of Microbiome-based Live Biotherapeutic Products
• Table 17.1 List of Live Biotherapeutic Products and Microbiome CROs: Market Landscape
• Table 17.2 Microbiome Dietary Supplement Manufacturers: Market Landscape
• Table 26.1 List of Leading Live Biotherapeutic Product and Microbiome Contract Manufacturing Companies
• Table 27.1 Osel: Company Snapshots
• Table 27.2 Unique Biotech: Company Snapshots
• Table 27.3 Meteoric Biopharmaceuticals: Company Snapshots
• Table 27.4 Biomedic: Company Snapshots
• Table 27.5 Siolta Therapeutics: Company Snapshots
• Table 27.6 BiomX: Company Snapshots
• Table 27.7 Vedanta Biosciences: Company Snapshots
• Table 27.8 Universal Stabilization Technologies: Company Snapshots
• Table 27.9 Arranta Bio: Company Snapshots
• Table 27.10 Assembly Biosciences: Company Snapshots
• Table 27.11 List Biological Laboratories: Company Snapshots
• Table 27.12 Luina Bio: Company Snapshots
• Table 27.13 WACKER: Company Snapshots
• Table 29.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Year of Establishment
• Table 29.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Company Size
• Table 29.3 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Location of Headquarters
• Table 29.4 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation
• Table 29.5 Microbiome Therapeutics Contract Manufacturers: Distribution by Type of Product Manufactured
• Table 29.6 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation
• Table 29.7 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation and Type of Formulation
• Table 29.8 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Primary Packaging Used
• Table 29.9 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation and Type of Primary Packaging Used
• Table 29.10 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used
• Table 29.11 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used and Location of Headquarters
• Table 29.12 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Service Offered
• Table 29.13 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Region)
• Table 29.14 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Country)
• Table 29.15 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbial Species Used
• Table 29.16 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Year of Establishment
• Table 29.17 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Company Size
• Table 29.18 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Headquarters
• Table 29.19 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Scale of Operation
• Table 29.20 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Manufacturing Facilities
• Table 29.21 Partnerships and Collaborations: Distribution by Year of Partnership
• Table 29.22 Partnerships and Collaborations: Distribution by Type of Partnership
• Table 29.23 Partnerships and Collaborations: Distribution by Year and Type of Partnership
• Table 29.24 Partnerships and Collaborations: Distribution by Type of Organization
• Table 29.25 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Organization
• Table 29.26 Partnerships and Collaborations: Distribution by Therapeutic Area
• Table 29.27 Most Active Players: Distribution by Number of Partnerships
• Table 29.28 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
• Table 29.29 Partnerships and Collaborations: Local and International Agreements
• Table 29.30 Mergers and Acquisitions: Year-wise Cumulative Trend, 2016-2023
• Table 29.31 Mergers and Acquisitions: Distribution by Key Value Drivers
• Table 29.32 Mergers and Acquisitions: Distribution by Year of Mergers and Acquisitions and Key Value Drivers
• Table 29.33 Recent Expansions: Distribution by Year of Expansion
• Table 29.34 Recent Expansions: Distribution by Purpose of Expansion
• Table 29.35 Recent Expansions: Distribution by Year and Purpose of Expansion
• Table 29.36 Recent Expansions: Distribution by Scale of Operation
• Table 29.37 Recent Expansions: Distribution by Purpose of Expansion and Scale of Operation
• Table 29.38 Recent Expansions: Distribution by Location of Expanded Facility (Region)
• Table 29.39 Recent Expansions: Distribution by Location of Expanded Facility (Country)
• Table 29.40 Recent Expansions: Distribution by Purpose of Expansion and Location of Expanded Facility (Region)
• Table 29.41 Clinical Trial Analysis: Distribution by Trial Registration Year, Pre-2015-2023
• Table 29.42 Clinical Trial Analysis: Distribution by Trial Status
• Table 29.43 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Status, Pre-2015-2023
• Table 29.44 Clinical Trial Analysis: Distribution by Trial Phase
• Table 29.45 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Phase, Pre-2007-Post-2018
• Table 29.46 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Registration Year, Pre-2015-2023
• Table 29.47 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase
• Table 29.48 Clinical Trial Analysis: Distribution by Type of Sponsor
• Table 29.49 Most Active Players: Distribution by Number of Registered Trials
• Table 29.50 Clinical Trial Analysis: Distribution by Study Design
• Table 29.51 Clinical Trial Analysis: Distribution by Therapeutic Area
• Table 29.52 Clinical Trial Analysis: Distribution of Number of Registered Trials by Geography
• Table 29.53 Clinical Trial Analysis: Distribution of Number of Registered Trials by Trial Status and Geography
• Table 29.54 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
• Table 29.55 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Status and Geography
• Table 29.56 Capacity Analysis: Distribution by Company Size
• Table 29.57 Capacity Analysis: Distribution by Geography
• Table 29.58 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in North America
• Table 29.59 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Europe
• Table 29.60 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Asia-Pacific and Rest of the World
• Table 29.61 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Trials Conducted
• Table 29.62 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Enrolled Patient Population
• Table 29.63 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Distribution by Trial Phase
• Table 29.64 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Distribution by Geography
• Table 29.65 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in North America, 2023-2035
• Table 29.66 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Europe, 2023-2035
• Table 29.67 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Asia-Pacific, 2023-2035
• Table 29.68 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Rest of the World, 2023-2035
• Table 29.69 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Target Patient Population (in Million)
• Table 29.70 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035 (in cfu)
• Table 29.71 Live Biotherapeutic Products and Microbiome CROs: Distribution by Year of Establishment
• Table 29.72 Live Biotherapeutic Products and Microbiome CROs: Distribution by Company Size
• Table 29.73 Live Biotherapeutic Products and Microbiome CROs: Distribution by Location of Headquarters
• Table 29.74 Microbiome Dietary Supplement Manufacturers: Distribution by Year of Establishment
• Table 29.75 Microbiome Dietary Supplement Manufacturers: Distribution by Company Size
• Table 29.76 Microbiome Dietary Supplement Manufacturers: Distribution by Location of Headquarters
• Table 29.77 Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, Conservative, Base and Optimistic Scenarios, 2023-2035 (USD Million)
• Table 29.78 Live Biotherapeutic Products and Microbiome Contract Manufacturing
• Table 29.79 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for APIs: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.80 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDFs: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.81 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Product Formulation, 2023 and 2035 (USD Million)
• Table 29.82 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solid: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.83 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Liquid: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.84 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.85 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Primary Packaging Used, 2023 and 2035 (USD Million)
• Table 29.86 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Blister Packs: Future Estimates (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.87 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Glass / Plastic Bottles: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.88 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Sachets / Pouches: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.89 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Vials: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.90 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Scale of Operation, 2023 and 2035 (USD Million)
• Table 29.91 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.92 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.93 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Company Size, 2023 and 2035 (USD Million)
• Table 29.94 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.95 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.96 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large and Very Large Companies: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.97 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Key Geographical Regions, 2023 and 2035 (USD Million)
• Table 29.98 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.99 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.100 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.101 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Rest of the World: (2023-2035) Conservative, Base and Optimistic (USD Million)
• Table 29.102 Live Biotherapeutic Products and Microbiome Therapeutics Market, Distribution by Leading Developers, 2035

List of Figures

• Figure 2.1 Research Methodology: Project Methodology
• Figure 2.2 Research Methodology: Forecast Methodology
• Figure 2.3 Research Methodology: Robust Quality Control
• Figure 2.4 Research Methodology: Key Market Segmentations
• Figure 4.1 Executive Summary: CMOs Market Landscape
• Figure 4.2 Executive Summary: In-house Manufacturers Market Landscape
• Figure 4.3 Executive Summary: Recent Developments and Initiatives
• Figure 4.4 Executive Summary: Clinical Trial Analysis
• Figure 4.5 Executive Summary: Capacity Analysis
• Figure 4.6 Executive Summary: Demand Analysis
• Figure 4.7 Executive Summary: Market Sizing and Opportunity Analysis
• Figure 5.1 Key Benefits of Human Microbiota
• Figure 5.2 Factors Affecting the Gut Flora
• Figure 5.3 Human Microbiome Project: Key Achievements
• Figure 5.4 Types of Microbiome Therapies
• Figure 5.5 Probiotic Drugs: Overview of Beneficial Bacterial Strains
• Figure 5.6 Microbiome Therapies: Potential Application Areas
• Figure 5.7 Key Steps Involved in Microbiome Therapeutics Supply Chain
• Figure 5.8 Key Steps Involved in Microbiome Therapeutics Manufacturing
• Figure 5.9 Key Challenges in Manufacturing of Microbiome Therapeutics
• Figure 5.10 Key Strategies to Increase Efficiency in Manufacturing Microbiome Therapeutics
• Figure 6.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Year of Establishment
• Figure 6.2 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Company Size
• Figure 6.3 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Location of Headquarters
• Figure 6.4 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation
• Figure 6.5 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Product Manufactured
• Figure 6.6 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation
• Figure 6.7 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Scale of Operation and Type of Formulation
• Figure 6.8 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Primary Packaging Used
• Figure 6.9 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Formulation and Type of Primary Packaging Used
• Figure 6.10 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used
• Figure 6.11 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbe Used and Location of Headquarters
• Figure 6.12 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Service Offered
• Figure 6.13 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Region)
• Figure 6.14 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Number of Manufacturing Facilities (Country)
• Figure 6.15 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Distribution by Type of Microbial Species Used
• Figure 6.16 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Year of Establishment
• Figure 6.17 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Company Size
• Figure 6.18 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Headquarters
• Figure 6.19 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Scale of Operation
• Figure 6.20 Live Biotherapeutic Products and Microbiome In-House Manufacturers: Distribution by Location of Manufacturing Facilities
• Figure 7.1 Regional Capability Analysis: Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
• Figure 7.2 Regional Capability Analysis: Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
• Figure 7.3 Regional Capability Analysis: Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
• Figure 8.1 Live Biotherapeutic Products and Microbiome Contract Manufacturers: Company Competitiveness Analysis
• Figure 8.2 Benchmarking Analysis: Distribution of Top Live Biotherapeutic Products and Microbiome Contract Manufacturers
• Figure 9.1 Capsugel: Service Portfolio
• Figure 9.2 Biose Industrie: Service Portfolio
• Figure 9.3 Cerbios-Pharma: Service Portfolio
• Figure 9.4 Chr. Hansen: Service Portfolio
• Figure 9.5 Inpac Probiotics: Service Portfolio
• Figure 9.6 NIZO: Service Portfolio
• Figure 9.7 WACKER: Service Portfolio
• Figure 9.8 Winclove Probiotics: Service Portfolio
• Figure 9.9 BJP Laboratories: Service Portfolio
• Figure 11.1 Live Biotherapeutic Products and Microbiome Related Initiatives: Spider Web Analysis of Top Big Pharma Players
• Figure 11.2 Big Pharma Players: Distribution by Portfolio Diversity
• Figure 11.3 Big Pharma Players: Distribution by Trial Phase
• Figure 11.4 Big Pharma Players: Distribution by Type of Therapy
• Figure 11.5 Big Pharma Players: Distribution by Type of Molecule
• Figure 11.6 Big Pharma Players: Distribution by Therapeutic Area
• Figure 12.1 Partnerships and Collaborations: Distribution by Year of Partnership
• Figure 12.2 Partnerships and Collaborations: Distribution by Type of Partnership
• Figure 12.3 Partnerships and Collaborations: Distribution by Year and Type of Partnership
• Figure 12.4 Partnerships and Collaborations: Distribution by Type of Organization
• Figure 12.5 Partnerships and Collaborations: Distribution by Type of Partnership and Type of Organization
• Figure 12.6 Partnerships and Collaborations: Distribution by Therapeutic Area
• Figure 12.7 Most Active Players: Distribution by Number of Partnerships
• Figure 12.8 Partnerships and Collaborations: Intracontinental and Intercontinental Agreements
• Figure 12.9 Partnerships and Collaborations: Local and International Agreement
• Figure 12.10 Mergers and Acquisitions: Cumulative Year-wise Trend, 2016-2023
• Figure 12.11 Mergers and Acquisitions: Distribution by Key Value Drivers
• Figure 12.12 Mergers and Acquisitions: Distribution by Year of Mergers and Acquisitions and Key Value Driver
• Figure 12.13 Recent Expansions: Distribution by Year of Expansion
• Figure 12.14 Recent Expansions: Distribution by Purpose of Expansion
• Figure 12.15 Recent Expansions: Distribution by Year and Purpose of Expansion
• Figure 12.16 Recent Expansions: Distribution by Scale of Operation
• Figure 12.17 Recent Expansions: Distribution by Purpose of Expansion and Scale of Operation
• Figure 12.18 Recent Expansions: Distribution by Location of Expanded Facility (Region)
• Figure 12.19 Recent Expansions: Distribution by Location of Expanded Facility (Country)
• Figure 12.20 Recent Expansions: Distribution by Purpose of Expansion and Location of Expanded Facility (Region)
• Figure 13.1 Clinical Trial Analysis: Scope and Methodology
• Figure 13.2 Clinical Trial Analysis: Distribution by Trial Registration Year, Pre-2015-2023
• Figure 13.3 Clinical Trial Analysis: Distribution by Trial Status
• Figure 13.4 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Status, Pre-2015-2023
• Figure 13.5 Clinical Trial Analysis: Distribution by Trial Phase
• Figure 13.6 Clinical Trial Analysis: Distribution by Trial Registration Year and Trial Phase, Pre-2019-2023
• Figure 13.7 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Registration Year, Pre-2015-2023
• Figure 13.8 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Phase
• Figure 13.9 Clinical Trial Analysis: Distribution by Type of Sponsor
• Figure 13.10 Most Active Players: Distribution by Number of Registered Trials
• Figure 13.11 Clinical Trial Analysis: Distribution by Study Design
• Figure 13.12 Clinical Trial Analysis: Distribution by Therapeutic Area
• Figure 13.13 Clinical Trial Analysis: Distribution of Number of Registered Trials by Geography
• Figure 13.14 Clinical Trial Analysis: Distribution of Number of Registered Trials by Trial Status and Geography
• Figure 13.15 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Geography
• Figure 13.16 Clinical Trial Analysis: Distribution of Enrolled Patient Population by Trial Status and Geography
• Figure 14.1 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity: Distribution by Company Size
• Figure 14.2 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity: Distribution by Geography
• Figure 14.3 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in North America
• Figure 14.4 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Europe
• Figure 14.5 Global Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Asia-Pacific and Rest of the World
• Figure 15.1 Global Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Trials Conducted
• Figure 15.2 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Enrolled Patient Population
• Figure 15.3 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Trial Phase
• Figure 15.4 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing: Distribution by Geography
• Figure 15.5 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in North America, 2023-2035
• Figure 15.6 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Europe, 2023-2035
• Figure 15.7 Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing in Asia-Pacific and Rest of the World, 2023-2035
• Figure 15.8 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035: Distribution by Number of Target Patient Population (in Million)
• Figure 15.9 Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing, 2023-2035 (in cfu)
• Figure 16.1 Make versus Buy Decision Making Framework
• Figure 16.2 Make versus Buy Decision Making: Possible Scenario Descriptions
• Figure 17.1 Live Biotherapeutic Products and Microbiome CROs: Distribution by Year of Establishment
• Figure 17.2 Live Biotherapeutic Products and Microbiome CROs: Distribution by Company Size
• Figure 17.3 Live Biotherapeutic Products and Microbiome CROs: Distribution by Location of Headquarters
• Figure 17.4 Microbiome Dietary Supplement Manufacturers: Distribution by Year of Establishment
• Figure 17.5 Microbiome Dietary Supplement Manufacturers: Distribution by Company Size
• Figure 17.6 Microbiome Dietary Supplement Manufacturers: Distribution by Location of Headquarters
• Figure 18.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing: Market Drivers
• Figure 18.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing: Market Restraints
• Figure 18.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing: Market Opportunities
• Figure 18.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing: Market Challenges
• Figure 19.1 Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2023-2035: Base Scenario (USD Million)
• Figure 19.2 Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2023-2035: Conservative Scenario (USD Million)
• Figure 19.3 Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2023-2035: Optimistic Scenario (USD Million)
• Figure 20.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Product Manufactured, 2023 and 2035
• Figure 20.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for API, 2023-2035 (USD Million)
• Figure 20.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDF, 2023-2035 (USD Million)
• Figure 21.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Formulation, 2023 and 2035
• Figure 21.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solids, 2023-2035 (USD Million)
• Figure 21.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Liquids, 2023-2035 (USD Million)
• Figure 21.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others, 2023-2035 (USD Million)
• Figure 22.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Primary Packaging Used, 2023 and 2035
• Figure 22.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Blister Packs, 2023-2035 (USD Million)
• Figure 22.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Glass / Plastic Bottles, 2023-2035 (USD Million)
• Figure 22.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Sachets / Pouches, 2023-2035 (USD Million)
• Figure 22.5 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Vials, 2023-2035 (USD Million)
• Figure 23.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Scale of Operation, 2023 and 2035
• Figure 23.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical, 2023-2035 (USD Million)
• Figure 23.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial, 2023-2035 (USD Million)
• Figure 24.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Company Size, 2023 and 2035
• Figure 24.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies, 2023-2035 (USD Million)
• Figure 24.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies, 2023-2035 (USD Million)
• Figure 24.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large and Very Large Companies, 2023-2035 (USD Million)
• Figure 25.1 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Key Geographical Regions, 2023 and 2035
• Figure 25.2 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America, 2023-2035 (USD Million)
• Figure 25.3 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe, 2023-2035 (USD Million)
• Figure 25.4 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific, 2023-2035 (USD Million)
• Figure 25.5 Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Rest of the World, 2023-2035 (USD Million)
• Figure 26.1 Live Biotherapeutic Products and Microbiome Therapeutics Market, Distribution by Leading Developers, 2035
• Figure 28.1 Concluding Remarks: Overall Market Landscape
• Figure 28.2 Concluding Remarks: Recent Developments and Initiatives
• Figure 28.3 Concluding Remarks: Clinical Trial Analysis
• Figure 28.4 Concluding Remarks: Capacity Analysis
• Figure 28.5 Concluding Remarks: Demand Analysis
• Figure 28.6 Concluding Remarks: Market Sizing and Opportunity Analysis (I/II)
• Figure 28.7 Concluding Remarks: Market Sizing and Opportunity Analysis (II/II)

Microbiome Manufacturing Market (3rd Edition): Distribution by Type of Product Manufactured (API and FDF), Type of Formulation (Solid, Liquid and Others), 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 Very Large), Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World) and Leading Developers: 2023-2035

The microbiome manufacturing market is valued at USD 27 million in 2023 growing at a CAGR of 17% during the forecast period 2023-2035.

The human body hosts diverse microbial communities, collectively known as microbiota, which include beneficial and harmful species. The microbiome refers to the ecological system of microorganisms residing within a host, comprising commensal, symbiotic, and pathogenic organisms. Given their significance in disease development, interest in microbiome-based therapeutics has grown within the medical science community. Over the past two decades, significant progress has been made in microbiome therapy research and applications. Live biotherapeutic products (LBPs), a category of microbiome therapy, utilize live microorganisms like bacteria, viruses, or fungi to prevent or treat diseases. These products are meticulously designed for therapeutic purposes and are regulated as medicinal products or biologics in many countries. They typically involve specific, extensively researched microorganism strains tested through clinical trials for safety and efficacy in treating specific conditions. Furthermore, microbiome-based therapies hold promise in tailoring treatment options based on patient microbiome composition through gene sequencing.

An important milestone occurred in November 2022 when the US Food and Drug Administration (FDA) approved the first microbiome-based therapy, RBX2660 developed by Rebiotix, for recurrent Clostridium difficile infection treatment.

The emergence of microbiome-based live biotherapeutic products in clinical pipelines suggests this therapeutic segment will be a rapidly growing market within the pharmaceutical industry. Despite advancements, challenges persist in microbiome manufacturing, particularly for live bacterial therapies. These challenges include lengthy development timelines, strict temperature control requirements, complex engineering of aerobic/anaerobic strains, and quality attribute inconsistencies in final products. To address these challenges, human microbiome therapy developers are turning to Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) for outsourcing manufacturing. These entities, part of the broader biologics contract manufacturing market, are increasingly integrating novel technologies to streamline microbiome manufacturing processes, enhance production efficiency, and improve quality. This trend is expected to drive growth in both the microbiome and microbiome manufacturing markets.

Key Market Segments

Type of Product Manufactured

API

FDF

Type of Formulation

Solid

Liquid

Others

Type of Primary Packaging Used

Blister Packs

Glass / Plastic Bottles

Pouches / Sachets

Vials

Scale of Operation

Clinical

Commercial

Company Size

Small

Mid-sized

Large and Very Large

Key Geographical Regions

North America

Europe

Asia-Pacific

Rest of the World

Leading Developers

Infant Bacterial Therapeutics

MaaT Pharma

Microbiomik Healthcare

OxThera

Rebiotix

Seres Therapeutics

Research Coverage:

The report studies the microbiome manufacturing market based on type of product manufactured, type of formulation, type of primary packaging used, scale of operation, company size, key geographical regions and leading developers

The report assesses the potential advantages and obstacles within the market for those involved and offers information on the competitive environment for top players in the market.

The report forecasts the revenue of market segments with respect to four major regions

The report offers a comprehensive overview of the human microbiota and microbiome concept, encompassing information on different types of microbiome therapeutics. It delves into the functions of the microbiota, emphasizing key insights from the Human Microbiome Project (HMP). Additionally, the chapter outlines the manufacturing process of microbiome therapeutics, including associated challenges and the increasing trend of outsourcing in this field. Lastly, it presents a list of crucial factors for innovator companies to consider when selecting a Contract Manufacturing Organization (CMO) partner.

Comprehensive analysis of the current landscape of microbiome manufacturing services for the development of microbiome therapeutics considering parameters such as establishment year, company size, headquarters, scale of operation, type of product manufactured, primary packaging used, type of microbe used, type of service offered, number of manufacturing facilities and type of microbial species used. Further, report also features details on in-house manufacturers of live biotherapeutic products and microbiomes.

An in-depth overview of microbiome manufacturing facilities strategically positioned in major geographical regions (North America, Europe, and Asia-Pacific), emphasizing pivotal manufacturing centers for microbiome products.

Detailed company competitiveness evaluation of microbiome manufacturing service providers, considering supplier strength in terms of year of establishment, 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, and number of services offered.

In-depth profiles of companies offering contract manufacturing services for live biotherapeutic products at both clinical and commercial scales of operations, focusing on company overviews, service portfolio, microbiome manufacturing facilities, recent advancements, and informed future prospects.

An evaluation of microbiome-centric endeavors pursued by major pharmaceutical corporations. This assessment includes heat map depictions illustrating these companies' activities, such as partnerships, financial commitments, early-stage and late-stage pipeline development, therapeutic focus areas, and portfolio breadth. Additionally, a spider web analysis is conducted to compare the initiatives of these major pharmaceutical entities across various pertinent parameters.

A comprehensive examination of completed, ongoing, and anticipated clinical trials involving diverse microbiome therapeutics, considering several parameters such as trial registration date, trial status, phase of the trial, patient enrollment demographics, sponsoring entity type, leading industry participants, study methodology, therapeutic focus, and primary geographical regions.

An estimation of the total manufacturing capacity for microbiome-based therapies, derived from data disclosed by industry participants in publicly available sources. This analysis emphasizes the allocation of capacity across different company scales and major geographic regions.

Estimating the annual clinical and commercial demand for microbiome therapeutics involves analyzing the target patient population participating in ongoing and planned clinical trials sponsored by both industry and non-industry entities. This estimation considers factors such as disease prevalence, trial enrollment numbers, and market trends.

A qualitative assessment outlining key considerations for microbiome therapeutics developers when determining whether to internally manufacture their products or outsource to a Contract Manufacturing Organization (CMO).

A case study examining the present market environment of contract research organizations specializing in microbiome studies and providers of dietary supplements, detailing their founding year, organizational size, and headquarters location.

Key Benefits of Buying this Report

The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.

Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.

The report provides stakeholders with a pulse on the microbiome manufacturing market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.

Key Market Companies

Biose

BJP Laboratories

Capsugel

Chr. Hansen

Inpac Probiotics

NIZO

WACKER

Winclove

TABLE OF CONTENTS

1. PREFACE

• 1.1. Live Biotherapeutic Products and Microbiome Manufacturing Market Overview
• 1.2. Key Market Insights
• 1.3. Scope of the Report
• 1.4. Inclusions and Exclusions
• 1.5. Key Questions Answered
• 1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

• 2.1. Chapter Overview
• 2.2. Research Assumptions
• 2.3. Project Methodology
• 2.4. Forecast Methodology
• 2.5. Robust Quality Control
• 2.6. Key Market Segmentations
• 2.7. Key Considerations
  • 2.7.1. Demographics
  • 2.7.2. Economic Factors
  • 2.7.3. Government Regulations
  • 2.7.4. Supply Chain
  • 2.7.5. COVID Impact / Related Factors
  • 2.7.6. Market Access
  • 2.7.7. Healthcare Policies
  • 2.7.8. Industry Consolidation

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

• 3.1. Chapter Overview
• 3.2. Market Dynamics
  • 3.2.1. Time Period
    • 3.2.1.1. Historical Trends
    • 3.2.1.2. Current and Future Estimates
  • 3.2.2. Currency Coverage
    • 3.2.2.1. Overview of Major Currencies Affecting the Market
    • 3.2.2.2. Impact of Currency Fluctuations on the Industry
  • 3.2.3. Foreign Exchange Impact
    • 3.2.3.1. Evaluation of Foreign Exchange Rates and Their Impact on Market
    • 3.2.3.2. Strategies for Mitigating Foreign Exchange Risk
  • 3.2.4. Recession
    • 3.2.4.1. Historical Analysis of Past Recessions and Lessons Learnt
    • 3.2.4.2. Assessment of Current Economic Conditions and Potential Impact on the Market
  • 3.2.5. Inflation
    • 3.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
    • 3.2.5.2. Potential Impact of Inflation on the Market Evolution

4. EXECUTIVE SUMMARY

• 4.1. Chapter Overview

5. INTRODUCTION

• 5.1. Chapter Overview
• 5.2. Concept of Human Microbiota and Microbiome
• 5.3. Overview of Gut Flora
  • 5.3.1. Role of Gut Flora in Healthy Individuals
  • 5.3.2. Factors Affecting Human Gut Flora
• 5.4. The Human Microbiome Project (HMP)
• 5.5. Overview of Microbiome Therapies
  • 5.5.1. Types of Microbiome Therapies
    • 5.5.1.1. Probiotics
    • 5.5.1.2. Prebiotics
  • 5.5.2. Applications of Microbiome Therapies
  • 5.5.3. Microbiome Therapies Supply Chain
• 5.6. Manufacturing of Microbiome-based Therapeutics
  • 5.6.1. Key Steps Involved
  • 5.6.2. Challenges Associated with Manufacturing of Microbiome Therapeutics
  • 5.6.3. Demand for Contract Manufacturing Services
• 5.7. Key Considerations while Selecting a Suitable CMO Partner
• 5.8. Concluding Remarks

6. MARKET LANDSCAPE

• 6.1. Chapter Overview
• 6.2. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Market Landscape
  • 6.2.1. Analysis by Year of Establishment
  • 6.2.2. Analysis by Company Size
  • 6.2.3. Analysis by Location of Headquarters
  • 6.2.4. Analysis by Scale of Operation
  • 6.2.5. Analysis by Type of Product Manufactured
  • 6.2.6. Analysis by Type of Formulation
  • 6.2.7. Analysis by Scale of Operation and Type of Formulation
  • 6.2.8. Analysis by Type of Primary Packaging Used
  • 6.2.9. Analysis by Type of Formulation and Type of Primary Packaging Used
  • 6.2.10. Analysis by Type of Microbe Used
  • 6.2.11. Analysis by Type of Microbe Used and Location of Headquarters
  • 6.2.12. Analysis by Type of Service Offered
  • 6.2.13. Analysis by Number of Manufacturing Facilities (Region)
  • 6.2.14. Analysis by Number of Manufacturing Facilities (Country)
  • 6.2.15. Analysis by Type of Microbial Species Used
• 6.3. Live Biotherapeutic Products and Microbiome In-House Manufacturers: Market Landscape
  • 6.3.1. Analysis by Year of Establishment
  • 6.3.2. Analysis by Company Size
  • 6.3.3. Analysis by Location of Headquarters
  • 6.3.4. Analysis by Scale of Operation
  • 6.3.5. Analysis by Location of Manufacturing Facilities

7. REGIONAL CAPABILITY ANALYSIS

• 7.1. Chapter Overview
• 7.2. Key Assumptions and Parameters
• 7.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
• 7.4. Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
• 7.5. Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific

8. COMPANY COMPETITIVENESS ANALYSIS

• 8.1. Chapter Overview
• 8.2. Key Assumptions and Parameters
• 8.3. Methodology
• 8.4. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Company Competitiveness Analysis:
• 8.5. Capability Benchmarking of Top Microbiome Contract Manufactures

9. COMPANY PROFILES

• 9.1. Chapter Overview
• 9.2. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
  • 9.2.1. Capsugel (Acquired by Lonza)
    • 9.2.1.1. Company Overview
    • 9.2.1.2. Service Portfolio
    • 9.2.1.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.2.1.4. Recent Developments and Future Outlook
• 9.3. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in North America
  • 9.3.1. Arranta Bio
    • 9.3.1.1. Company Overview
    • 9.3.1.2. Service Portfolio
  • 9.3.2. FUJIFILM Diosynth Biotechnologies
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Service Portfolio
  • 9.3.3. List Biological Laboratories
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Service Portfolio
  • 9.3.4. ProbioFerm
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Service Portfolio
• 9.4. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
  • 9.4.1. Biose Industrie
    • 9.4.1.1. Company Overview
    • 9.4.1.2. Service Portfolio
    • 9.4.1.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.1.4. Recent Developments and Future Outlook
  • 9.4.2. Cerbios-Pharma
    • 9.4.2.1. Company Overview
    • 9.4.2.2. Service Portfolio
    • 9.4.2.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.2.4. Recent Developments and Future Outlook
  • 9.4.3. Chr. Hansen
    • 9.4.3.1. Company Overview
    • 9.4.3.2. Financial Information
    • 9.4.3.3. Service Portfolio
    • 9.4.3.4. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.3.5. Recent Developments and Future Outlook
  • 9.4.4. Inpac Probiotics
    • 9.4.4.1. Company Overview
    • 9.4.4.2. Service Portfolio
    • 9.4.4.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.4.4. Recent Developments and Future Outlook
  • 9.4.5. NIZO
    • 9.4.5.1. Company Overview
    • 9.4.5.2. Service Portfolio
    • 9.4.5.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.5.4. Recent Developments and Future Outlook
  • 9.4.6. WACKER
    • 9.4.6.1. Company Overview
    • 9.4.6.2. Service Portfolio
    • 9.4.6.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.6.4. Recent Developments and Future Outlook
  • 9.4.7 Winclove Probiotics
    • 9.4.7.1. Company Overview
    • 9.4.7.2. Service Portfolio
    • 9.4.7.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.4.7.4. Recent Developments and Future Outlook
• 9.5. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in Europe
  • 9.5.1. BacThera
    • 9.5.1.1. Company Overview
    • 9.5.1.2. Service Portfolio
  • 9.5.2. Evologic Technologies
    • 9.5.2.1 Company Overview
    • 9.5.2.2. Service Portfolio
  • 9.5.3. Probiotical
    • 9.5.3.1. Company Overview
    • 9.5.3.2. Service Portfolio
  • 9.5.4. QUAY Pharma
    • 9.5.4.1. Company Overview
    • 9.5.4.2. Service Portfolio
• 9.6. Leading Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
  • 9.6.1. BJP Laboratories
    • 9.6.1.1. Company Overview
    • 9.6.1.2. Service Portfolio
    • 9.6.1.3. Facilities Dedicated to Microbiome Manufacturing
    • 9.6.1.4. Recent Developments and Future Outlook
• 9.7. Other Prominent Live Biotherapeutic Products and Microbiome Contract Manufacturers in Asia-Pacific
  • 9.7.1. Aumgene Biosciences
    • 9.7.1.1 Company Overview
    • 9.7.1.2. Service Portfolio
  • 9.7.2. AcuraBio
    • 9.7.2.1. Company Overview
    • 9.7.2.2. Service Portfolio
  • 9.7.3. Meteoric Biopharmaceuticals
    • 9.7.3.1. Company Overview
    • 9.7.3.2. Service Portfolio
  • 9.7.4. Probiotics Australia
    • 9.7.4.1. Company Overview
    • 9.7.4.2. Service Portfolio
  • 9.7.5. Unique Biotech
    • 9.7.5.1 Company Overview
    • 9.7.5.2. Service Portfolio

10. LIKELY PARTNER ANALYSIS

• 10.1. Chapter Overview
• 10.2. Key Assumptions and Key Parameters
• 10.3. Scope and Methodology
• 10.4. Key Potential Strategic Partners for Live Biotherapeutic Products and Microbiome Contract Manufacturers
  • 10.4.1. Likely Partners in North America
  • 10.4.2. Likely Partners in Europe
  • 10.4.3. Likely Partners in Asia-Pacific

11. BIG PHARMA INITIATIVES

• 11.1. Chapter Overview
• 11.2. Methodology
• 11.3. Live Biotherapeutic Products and Microbiome-related Initiatives of Big Pharmaceutical Players
  • 11.3.1. Analysis by Portfolio Diversity
  • 11.3.2. Analysis by Trial Phase
  • 11.3.3. Analysis by Type of Therapy
  • 11.3.4. Analysis by Type of Molecule
  • 11.3.5. Analysis by Therapeutic Area

12. RECENT DEVELOPMENTS AND INITIATIVES

• 12.1. Chapter Overview
• 12.2. Partnerships and Collaborations
  • 12.2.1. Partnership Models
  • 12.2.2. Live Biotherapeutic Products and Microbiome Manufacturing: List of Partnerships and Collaborations
  • 12.2.3. Analysis by Year of Partnership
  • 12.2.4. Analysis by Type of Partnership
  • 12.2.5. Analysis by Year and Type of Partnership
  • 12.2.6. Analysis by Type of Organization
  • 12.2.7. Analysis by Type of Partnership and Type of Organization
  • 12.2.8. Analysis by Therapeutic Area
  • 12.2.9. Most Active Players: Analysis by Number of Partnerships
  • 12.2.10. Analysis by Geography
    • 12.2.10.1. Intracontinental and Intercontinental Agreements
    • 12.2.10.2. Local and International Agreements
• 12.3. Live Biotherapeutic Products and Microbiome Manufacturing: Mergers and Acquisitions
  • 12.3.1. Cumulative Year-wise Trend of Merger / Acquisition
  • 12.3.2. Analysis by Key Value Drivers
  • 12.3.3. Analysis by Year of Acquisition and Key Value Drivers
• 12.4. Live Biotherapeutic Products and Microbiome Manufacturing: Recent Expansions
  • 12.4.1. Analysis by Year of Expansion
  • 12.4.2. Analysis by Purpose of Expansion
  • 12.4.3. Analysis by Year and Purpose of Expansion
  • 12.4.4. Analysis by Scale of Operation
  • 12.4.5. Analysis by Purpose of Expansion and Scale of Operation
  • 12.4.6. Analysis by Geography
    • 12.4.6.1. Analysis by Location of Expanded Facility (Region)
    • 12.4.6.2. Analysis by Location of Expanded Facility (Country)
  • 12.4.7. Analysis by Purpose of Expansion and Location of Expanded Facility (Region)

13. CLINICAL TRIAL ANALYSIS

• 13.1. Chapter Overview
• 13.2. Scope and Methodology
• 13.3. Live Biotherapeutic Products and Microbiome Manufacturing: Clinical Trial Analysis
  • 13.3.1. Analysis by Trial Registration Year
  • 13.3.2. Analysis by Trial Status
  • 13.3.3. Analysis by Trial Registration Year and Trial Status
  • 13.3.4. Analysis by Trial Phase
  • 13.3.5. Analysis by Trial Registration Year and Trial Phase
  • 13.3.6. Analysis of Enrolled Patient Population by Trial Registration Year
  • 13.3.7. Analysis of Enrolled Patient Population by Trial Phase
  • 13.3.8. Analysis by Type of Sponsor
  • 13.3.9. Most Active Players: Analysis by Number of Registered Trials
  • 13.3.10. Analysis by Study Design
  • 13.3.11. Analysis by Therapeutic Area
  • 13.3.12. Analysis of Number of Registered Trials by Geography
  • 13.3.13. Analysis of Number of Registered Trials by Trial Status and Geography
  • 13.3.14. Analysis of Enrolled Patient Population by Geography
  • 13.3.15. Analysis of Enrolled Patient Population by Trial Status and Geography

14. CAPACITY ANALYSIS

• 14.1. Chapter Overview
• 14.2. Key Assumptions
• 14.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing: Global Installed Capacity
  • 14.3.1. Analysis by Company Size
  • 14.3.2. Analysis by Geography
    • 14.3.2.1. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in North America
    • 14.3.2.2. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity in Europe
    • 14.3.2.3. Analysis of Installed Live Biotherapeutic Products and Microbiome Contract Manufacturing Capacity Asia-Pacific and Rest of the World

15. DEMAND ANALYSIS

• 15.1. Chapter Overview
• 15.2. Methodology
• 15.3. Global Clinical Demand for Live Biotherapeutic Products and Microbiome Manufacturing
  • 15.3.1. Analysis by Number of Trials Conducted
  • 15.3.2. Analysis by Enrolled Patient Population
  • 15.3.3. Analysis by Trial Phase
  • 15.3.4. Analysis by Geography
    • 15.3.4.1. Clinical Demand in North America
    • 15.3.4.2. Clinical Demand in Europe
    • 15.3.4.3. Clinical Demand in Asia-Pacific and Rest of the World
• 15.4. Global Commercial Demand for Live Biotherapeutic Products and Microbiome Manufacturing

16. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

• 16.1. Chapter Overview
• 16.2. Key Assumptions and Parameters
• 16.3. Live Biotherapeutic Products and Microbiome Contract Manufacturers: Make versus Buy Decision Making Framework
  • 16.3.1. Scenario 1
  • 16.3.2. Scenario 2
  • 16.3.3. Scenario 3
  • 16.3.4. Scenario 4
• 16.4. Concluding Remarks

17. CASE STUDY: LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT RESEARCH ORGANIZATIONS (CROs) AND DIETARY SUPPLEMENT MANUFACTURERS

• 17.1 Chapter Overview
• 17.2. Live Biotherapeutic Products and Microbiome CROs
• 17.3. Live Biotherapeutic Products and Microbiome CROs: Market Landscape
  • 17.3.1. Analysis by Year of Establishment
  • 17.3.2. Analysis by Company Size
  • 17.3.3. Analysis by Location of Headquarters
• 17.4. Microbiome Dietary Supplement Manufacturers: Market Landscape
  • 17.4.1. Analysis by Year of Establishment
  • 17.4.2. Analysis by Company Size
  • 17.4.3. Analysis by Location of Headquarters

18. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES

• 18.1. Chapter Overview
• 18.2. Market Drivers
• 18.3. Market Restraints
• 18.4. Market Opportunities
• 18.5. Market Challenges
• 18.6. Conclusion

19. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET

• 19.1. Chapter Overview
• 19.2. Key Assumptions and Methodology
• 19.3. Global Live Biotherapeutic Products and Microbiome Contract Manufacturing Market, 2023-2035
• 19.4. Scenario Analysis
  • 19.4.1. Conservative Scenario
  • 19.4.2. Optimistic Scenario
• 19.5. Key Market Segmentations

20. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRODUCT MANUFACTURED

• 20.1. Chapter Overview
• 20.2. Key Assumptions and Methodology
• 20.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Product Manufactured, 2023 and 2035
  • 20.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for API, 2023-2035
  • 20.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for FDF, 2023-2035
• 20.4. Data Triangulation

21. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF FORMULATION

• 21.1. Chapter Overview
• 21.2. Key Assumptions and Methodology
• 21.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Formulation, 2023 and 2035
  • 21.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Solids, 2023-2035
  • 21.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Liquids, 2023-2035
  • 21.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Others, 2023-2035
• 21.4. Data Triangulation

22. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY TYPE OF PRIMARY PACKAGING USED

• 22.1. Chapter Overview
• 22.2. Key Assumptions and Methodology
• 22.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Type of Primary Packaging Used, 2023 and 2035
  • 22.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Blister Packs, 2023-2035
  • 22.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Glass / Plastic Bottles, 2023-2035
  • 22.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Sachets / Pouches, 2023-2035
  • 22.3.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Vials, 2023-2035
• 22.4. Data Triangulation

23. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION

• 23.1. Chapter Overview
• 23.2. Key Assumptions and Methodology
• 23.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Scale of Operation, 2023 and 2035
  • 23.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Clinical, 2023-2035
  • 23.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Commercial, 2023-2035
• 23.4. Data Triangulation

24. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE

• 24.1. Chapter Overview
• 24.2. Key Assumptions and Methodology
• 24.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Company Size, 2023 and 2035
  • 24.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Small Companies, 2023-2035
  • 24.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Mid-sized Companies, 2023-2035
  • 24.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market for Large and Very Large Companies, 2023-2035
• 24.4. Data Triangulation

25. LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME CONTRACT MANUFACTURING MARKET, BY KEY GEOGRAPHICAL REGIONS

• 25.1. Chapter Overview
• 25.2. Key Assumptions and Methodology
• 25.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market: Distribution by Key Geographical Regions, 2023 and 2035
  • 25.3.1. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in North America, 2023-2035
  • 25.3.2. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Europe, 2023-2035
  • 25.3.3. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Asia-Pacific, 2023-2035
  • 25.3.4. Live Biotherapeutic Products and Microbiome Contract Manufacturing Market in Rest of the World, 2023-2035
• 25.4. Data Triangulation

26. LEADING DEVELOPERS FOR LIVE BIOTHERAPEUTIC PRODUCTS AND MICROBIOME THERAPIES

• 26.1. Chapter Overview
• 26.2. Key Assumptions and Methodology
• 26.3. Live Biotherapeutic Products and Microbiome Therapeutics Market: Distribution by Leading Developers
• 26.4. Data Triangulation

27. EXECUTIVE INSIGHTS

• 27.1. Chapter Overview
• 27.2. Osel
  • 27.2.1. Company Snapshot
  • 27.2.2. Interview Transcript: Peter P. Lee, Founder and Executive Chairman
• 27.3. Unique Biotech
  • 27.3.1. Company Snapshot
  • 27.3.2. Interview Transcript: Ratna Sudha and Jayanthi, Managing Director and Scientific Head
• 27.4. Meteoric Biopharmaceuticals
  • 27.4.1. Company Snapshot
  • 27.4.2. Interview Transcript: Gaurav Kaushik, Managing Director and Chief Executive Officer
• 27.5. Biomedic
  • 27.5.1. Company Snapshot
  • 27.5.2. Interview Transcript: Veronika Oudova, Co- Founder and Chief Executive Officer
• 27.6. Siolta Therapeutics
  • 27.6.1. Company Snapshot
  • 27.6.2. Interview Transcript: Nikole Kimes, Founder and Chief Executive Officer
• 27.7. BiomX
  • 27.7.1. Company Snapshot
  • 27.8.2. Interview Transcript: Assaf Oron, Chief Business Officer
• 27.8. Vedanta Biosciences
  • 27.8.1. Company Snapshot
  • 27.8.2. Interview Transcript: Daniel Couto, Chief Operating Officer
• 27.9. Universal Stabilization Technologies
  • 27.9.1. Company Snapshot
  • 27.9.2. Interview Transcript: Alexander Segal, Former Vice President, Business Development

\27.10. Arranta Bio

• 27.10.1. Company Snapshot
• 27.10.2. Interview Transcript: Traci Kyes, Former Vice President, Commercial Operations
• 27.11. Assembly Biosciences
  • 27.11.1. Company Snapshot
  • 27.11.2. Interview Transcript: JP Benya, Former Vice President, Business Development
• 27.12. List Biological Laboratories
  • 27.12.1. Company Snapshot
  • 27.12.2. Interview Transcript: Debbie Pinkston, Former Vice President. Sales and Business Development
• 27.13. Luina Bio
  • 27.13.1. Company Snapshot
  • 27.13.2. Interview Transcript: Max Rosetto, Head of Business Development
• 27.14. WACKER
  • 27.14.1. Company Snapshot
  • 27.14.2. Interview Transcript: Rob Van Dijk, Business Development Manager

28. CONCLUDING REMARKS

29. APPENDIX I: TABULATED DATA

30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS