細胞療法製造市場：製造される細胞の種類（免疫細胞、幹細胞、その他）、細胞の供給源（自家および同種）、事業規模（前臨床、臨床、商業）、製造目的（自社および受託）、主要地域（北米、欧州、アジア太平洋地域、その他の地域）別：業界動向と世界予測（第5版）、2022-2035年

Cell Therapy Manufacturing Market by Type of Cell Manufactured (Immune Cells, Stem Cells and Others ), Source of Cell (Autologous and Allogeneic), Scale of Operation (Preclinical, Clinical and Commercial), Purpose of Manufacturing (In-house and Contract) and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World): Industry Trends and Global Forecasts (5th Edition), 2022-2035

細胞治療製造市場は、2022年には45億米ドルに達し、2022年から2035年の予測期間中に年平均成長率12％で成長すると予測されている。細胞療法は、希少疾患の治療において有望な可能性を秘めているため、ヘルス... もっと見る

出版社	出版年月	電子版価格	ページ数	言語
Roots Analysis ルーツアナリシス	2023年1月1日	US$4,799 シングルユーザライセンスライセンス・価格情報・注文方法はこちら	553	英語

サマリー

細胞治療製造市場は、2022年には45億米ドルに達し、2022年から2035年の予測期間中に年平均成長率12％で成長すると予測されている。

細胞療法は、希少疾患の治療において有望な可能性を秘めているため、ヘルスケア分野で大きな注目を集めている。特に、これらの療法に焦点を当てた1,035以上の臨床研究が2019年以降開始されている。Kymriah®などの一部の商業化された細胞療法は、2018年の発売以来、15億米ドルを超える大きな売上を達成している。これらの生物学的製剤の臨床的有用性がますます検証されるにつれて、細胞療法の製造プロセスを洗練させることに重点が置かれている。このような複雑な治療製品に関連する製造コストの削減を目指し、GMP-In-A Boxという新たなコンセプトのような高度な自動化ツールの開発に向けた取り組みが行われている。しかし、細胞治療の製造は複雑であるため、完全な自動化には課題がある。さらに、この分野の専門的なインフラや専門知識の不足が、進歩の妨げとなっている。

現在の細胞治療製造の市場環境は多様で、自社製造業者と受託サービス業者が存在する。この分野のイノベーター企業の多くは、リソースの利用を最適化し、さらなる収益を生み出すために、自社内の能力と並行して受託サービスを提供している。細胞治療の需要拡大に対応するため、業界各社は能力を拡大しており、2020年以降、細胞治療分野での提携や事業拡大が顕著になる。大手製薬会社の関与は、これらの治療法の採用を大幅に後押ししている。大手製薬会社は、細胞治療の製造能力を強化するため、戦略的パートナーシップや拡張プロジェクトを開始した。関係者は製造上の課題を克服するためにたゆまぬ努力を続けており、これらの治療法の進歩に焦点が当てられていることから、細胞治療製造市場は予測される将来において大幅な成長を遂げるものと思われる。

レポート範囲
 本レポートでは、生産される細胞の種類、細胞の供給源、事業規模、製造目的、主要地域に焦点を当て、細胞治療製造市場を調査している。
 市場成長に影響を与える要因（促進要因、阻害要因、機会、課題など）を評価しています。
 当レポートでは、市場内の潜在的な利点と障害の両方を評価し、トップ市場プレイヤーの競争環境に関する洞察を提供しています。
 主要4地域に関する市場セグメントの収益予測を提供しています。
 包括的なレビューでは、細胞治療製造の多面的な側面をカバーしており、市場内の課題と影響因子を包含する概要から始まります。また、製造プロセスを強化する自動化ツールや技術についても、将来展望とともに解説しています。
 市場概況の広範な分析では、細胞ベースの治療薬製造に携わる主要企業の調査を行う。これには、製造される細胞の種類（免疫細胞、幹細胞など）、細胞の供給源（自家、同種）、事業規模（前臨床、臨床、商業）、目的（自社、受託サービス）、提供される能力／サービス（研究開発、品質検査など）、グローバル本社および製造施設などの詳細が含まれる。
 議論は様々な地域（米国を中心とする北米、欧州、日本と中国を中心とするアジア）の細胞治療製造規制にまで及び、規制機関による様々な認証を網羅している。
 概要には、細胞治療製造プロセスの進歩を目指す世界的機関のロードマップも含まれている。技術自動化の役割を掘り下げ、手作業と自動化プロセスのコストを比較している。
 臨床および商業規模で細胞治療製造サービスを提供する業界プレイヤーの詳細なプロフィールが紹介されている。これには、サービス・ポートフォリオ、能力、施設、最近のパートナーシップ、将来の展望などが含まれる。同様に、この領域における非業界プレイヤーのプロフィールも概説している。
 さまざまな地域における細胞ベースの治療開発における非営利組織の役割と、関連知識を広める国際的／全国的な学会を検討。
 治験のフェーズ、スポンサー、治療領域、業界/非業界の関係者などのパラメータを網羅し、完了済み、進行中、計画中の臨床試験の分析を提示。細胞治療製造における最近のパートナーシップ（2016-2022年）、コラボレーション、同期間にサービスプロバイダーが実施した拡大イニシアチブについて調査しています。
 大手製薬企業による細胞治療製造への取り組み、設備容量の推定、年間需要予測、価格設定に影響する要因、自社製造とCMOの関与の検討事項、細胞治療メーカーの分布の包括的表現（3Dグリッド分析、ロゴランドスケープ、世界地図）などが含まれる。
 本調査は、収集した情報から導き出された重要な洞察をまとめ、各大陸の細胞治療製造プロバイダーの詳細を強調している。
 さらに、関連するトレンド、主要な推進要因、課題、業界への影響をSWOTフレームワークを用いて分析し、ハーベイボール分析を通じてそれらの相対的な影響を示している。
 細胞ベースの治療開発および製造に携わる専門家からのインプットを収集した市場全体の調査から得られた洞察が統合されている。

主要市場企業
 AGC Biologics
 チャールズ・リバー・ラボラトリーズ
 KBI バイオファーマ
 サーモフィッシャーサイエンティフィック
 BioNTech Innovative Manufacturing Services
 細胞・遺伝子治療カタパルト
 ロンザ
 RoslinCT
 セルセラピー
 富士フイルムセルラーダイナミクス
 ミナリス再生医療
 メディネット
 ニコンCeLLイノベーション
 呉西AppTec

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1. PREFACE
1.1. Scope of the Report
1.2. Market Segmentations
1.3. Research Methodology
1.4. Key Questions Answered
1.5. Chapter Outlines
2. EXECUTIVE SUMMARY
2.1. Chapter Overview
3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Cell-based Therapies
3.2.1. Comparison of Cell-based Therapies and Other Biotechnological Products
3.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)
3.2.3. Current Market Landscape of ATMPs
3.3. Overview of Cell Therapy Manufacturing
3.4. Cell Therapy Manufacturing Models
3.4.1. Centralized Manufacturing
3.4.2. Decentralized Manufacturing
3.5. Scalability of Cell Therapy Manufacturing Processes
3.5.1. Scale-up
3.5.2. Scale-out
3.6. Types of Cell Therapy Manufacturers
3.7. Key Challenges for Manufacturing Cell Therapies
3.8. Key Factors Influencing Cell Therapy Manufacturing
3.8.1. Characterization
3.8.2. Cost of Goods
3.9. Automation of Cell Therapy Manufacturing Processes
3.10. Cell Therapy Manufacturing Supply Chain
3.11. Future Perspectives
4. MARKET OVERVIEW
4.1. Chapter Overview
4.2. Cell Therapy Manufacturing (Industry Players): Overall Market Landscape
4.2.1. Analysis by Company Size
4.2.2. Analysis by Year of Establishment
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Company Size and Location of Headquarters
4.2.5. Analysis by Year of Establishment and Location of Headquarters
4.2.6. Analysis by Location of Manufacturing Facility
4.2.7. Analysis by Type of Manufacturer
4.2.8. Analysis by Location of Headquarters and Type of Manufacturer
4.2.9. Analysis by Type of Cell Manufactured
4.2.10. Analysis by Company Size and Type of Cell Manufactured
4.2.11. Analysis by Location of Headquarters and Type of Cell Manufactured
4.2.12. Analysis by Source of Cells
4.2.13. Analysis by Type of Cell Manufactured and Source of Cells
4.2.14. Analysis by Scale of Operation
4.2.15. Analysis by Manufacturing Capabilities / Services Offered
4.2.16. Analysis by Company Size and Services Offered
4.2.17. Analysis by Year of Establishment, Location of Headquarters and Services Offered
4.3. Cell Therapy Manufacturing (Non-Industry Players): Overall Market Landscape
4.3.1. Analysis by Organization Size
4.3.2. Analysis by Year of Establishment
4.3.3. Analysis by Location of Headquarters
4.3.4. Analysis by Organization Size and Location of Headquarters
4.3.5. Analysis by Year of Establishment and Location of Headquarters
4.3.6. Analysis by Location of Manufacturing Facility
4.3.7. Analysis by Type of Manufacturer
4.3.8. Analysis by Location of Headquarters and Type of Manufacturer
4.3.9. Analysis by Type of Cell Manufactured
4.3.10. Analysis by Organization Size and Type of Cell Manufactured
4.3.11. Analysis by Location of Headquarters and Type of Cell Manufactured
4.3.12. Analysis by Source of Cells
4.3.13. Analysis by Type of Cell Manufactured and Source of Cells
4.3.14. Analysis by Scale of Operation
4.3.15. Analysis by Manufacturing Capabilities / Services Offered
4.3.16. Analysis by Organization Size and Services Offered
4.3.17. Analysis by Year of Establishment, Location of Headquarters and Services Offered
5. REGULATORY LANDSCAPE
5.1. Chapter Overview
5.2. Current Scenario
5.2.1. Regulatory Guidelines in North America
5.2.2. Regulatory Guidelines in Europe
5.2.3. Regulatory Guidelines in Japan
5.2.4. Regulatory Guidelines in China
5.2.5. Conditional Approvals
5.3. Regulatory Accreditations for Cell Therapy Manufacturing
5.3.1. Facilities Approved by Regulators to Manufacture Cell Therapies
5.4. Summary of Guidelines for Clinical-Stage Manufacturing of Cell Therapies
5.5. Existing Challenges to Clinical-Stage Manufacturing of Cell Therapies
5.5.1. Variability in Regulatory Guidelines across Different Geographies
6. ROADMAPS FOR OVERCOMING CHALLENGES
6.1. Chapter Overview
6.2. Roadmap for the US
6.2.1. Cell Processing
6.2.2. Cell Preservation, Distribution and Handling
6.2.3. Process Automation and Data Analytics
6.2.4. Process Monitoring and Quality Control
6.2.5. Standardization and Regulatory Support
6.2.6. Workforce Development
6.2.7. Supply Chain and Logistics
6.3. Roadmaps for Other Geographies
6.3.1. Europe
6.3.2. Asia Pacific
7. AUTOMATION TECHNOLOGIES FOR CELL THERAPY MANUFACTURING
7.1. Chapter Overview
7.2. Automation of Cell Therapy Manufacturing Processes
7.2.1. Closed Systems
7.2.2. Single-use Systems
7.2.3. Modular Systems
7.3. Growth Drivers and Roadblocks
7.4. Case Studies
7.4.1. Roadmap to Develop an Automated Cell Manufacturing / Processing Device
7.4.2. Automating the Cell Therapy Manufacturing Process
7.5. GMP-in-a-Box
7.6. List of Automated and Closed Cell Therapy Processing Systems
7.7. Comparative Analysis of Manual and Automated Processes
8. PROFILES: INDUSTRY PLAYERS
8.1. Chapter Overview
8.2. Service Providers in North America
8.2.1 AGC Biologics
8.2.1.1. Company Overview
8.2.1.2. Service Portfolio
8.2.1.3. Manufacturing Facilities and Capabilities
8.2.1.4. Recent Developments and Future Outlook
8.2.2. Charles River Laboratories
8.2.2.1. Company Overview
8.2.2.2. Service Portfolio
8.2.2.3. Manufacturing Facilities and Capabilities
8.2.2.4. Recent Developments and Future Outlook
8.2.3. KBI Biopharma
8.2.3.1. Company Overview
8.2.3.2. Service Portfolio
8.2.3.3. Manufacturing Facilities and Capabilities
8.2.3.4. Recent Developments and Future Outlook
8.2.4. Thermo Fisher Scientific
8.2.4.1. Company Overview
8.2.4.2. Service Portfolio
8.2.4.3. Manufacturing Facilities and Capabilities
8.2.4.4. Recent Developments and Future Outlook
8.3. Service Providers in Europe
8.3.1. BioNTech Innovative Manufacturing Services
8.3.1.1. Company Overview
8.3.1.2. Service Portfolio
8.3.1.3. Manufacturing Facilities and Capabilities
8.3.1.4. Recent Developments and Future Outlook
8.3.2. Cell and Gene Therapy Catapult
8.3.2.1. Company Overview
8.3.2.2. Service Portfolio
8.3.2.3. Manufacturing Facilities and Capabilities
8.3.2.4. Recent Developments and Future Outlook
8.3.3. Lonza
8.3.3.1. Company Overview
8.3.3.2. Service Portfolio
8.3.3.3. Manufacturing Facilities and Capabilities
8.3.3.4. Recent Developments and Future Outlook
8.3.4. RoslinCT
8.3.4.1. Company Overview
8.3.4.2. Service Portfolio
8.3.4.3. Manufacturing Facilities and Capabilities
8.3.4.4. Recent Developments and Future Outlook
8.4. Service Providers in Asia Pacific
8.4.1. Cell Therapies
8.4.1.1. Company Overview
8.4.1.2. Service Portfolio
8.4.1.3. Manufacturing Facilities and Capabilities
8.4.1.4. Recent Developments and Future Outlook
8.4.2. FUJIFILM Cellular Dynamics
8.4.2.1. Company Overview
8.4.2.2. Service Portfolio
8.4.2.3. Manufacturing Facilities and Capabilities
8.4.2.4. Recent Developments and Future Outlook
8.4.3. Minaris Regenerative Medicine
8.4.3.1. Company Overview
8.4.3.2. Service Portfolio
8.4.3.3. Manufacturing Facilities and Capabilities
8.4.3.4. Recent Developments and Future Outlook
8.4.4. MEDINET
8.4.4.1. Company Overview
8.4.4.2. Service Portfolio
8.4.4.3. Manufacturing Facilities and Capabilities
8.4.4.4. Recent Developments and Future Outlook
8.4.5. Nikon CeLL Innovation
8.4.5.1. Company Overview
8.4.5.2. Service Portfolio
8.4.5.3. Manufacturing Facilities and Capabilities
8.4.5.4. Recent Developments and Future Outlook
8.4.6. WuXi AppTec
8.4.6.1. Company Overview
8.4.6.2. Service Portfolio
8.4.6.3. Manufacturing Facilities and Capabilities
8.4.6.4. Recent Developments and Future Outlook
9. PROFILES: NON-INDUSTRY PLAYERS
9.1. Chapter Overview
9.2. Center for Cell and Gene Therapy, Baylor College of Medicine
9.2.1. Overview
9.2.2. Operating Segments
9.2.3. Service Portfolio
9.2.4. Manufacturing Facilities and Capabilities
9.3. Centre for Cell Manufacturing Ireland, National University of Ireland
9.3.1. Overview
9.3.2. Service Portfolio
9.3.3. Manufacturing Facilities and Capabilities
9.4. Clinical Cell and Vaccine Production Facility, University of Pennsylvania
9.4.1. Overview
9.4.2. Service Portfolio
9.4.3. Manufacturing Facilities and Capabilities
9.5. Guy’s and St. Thomas’ GMP Facility, Guy’s Hospital
9.5.1. Overview
9.5.2. Service Portfolio
9.5.3. Manufacturing Facilities and Capabilities
9.6. Laboratory for Cell and Gene Medicine, Stanford University
9.6.1. Overview
9.6.2. Service Portfolio
9.6.3. Manufacturing Facilities and Capabilities
9.7. Molecular and Cellular Therapeutics, University of Minnesota
9.7.1. Overview
9.7.2. Service Portfolio
9.7.3. Manufacturing Facilities and Capabilities
9.8. Newcastle Cellular Therapies Facility, Newcastle University
9.8.1. Overview
9.8.2. Service Portfolio
9.8.3. Manufacturing Facilities and Capabilities
9.9. Rayne Cell Therapy Suite, King’s College London
9.9.1. Overview
9.9.2. Manufacturing Facilities and Capabilities
9.10. Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
9.10.1. Overview
9.10.2. Manufacturing Facilities and Capabilities
9.11. Sydney Cell and Gene Therapy
9.11.1. Overview
9.11.2. Manufacturing Facilities and Capabilities
10. ROLE OF NON-PROFIT ORGANIZATIONS
10.1. Chapter Overview
10.2. Cell Therapy Manufacturing: Non-Profit Organizations
10.2.1. CellCAN
10.2.2. Cell Therapy Manufacturing Cooperative Research Center
10.2.3. National Cell Manufacturing Consortium (NCMC)
10.2.4. California Institute of Regenerative Medicine (CIRM)
10.3. Cell Therapy Manufacturing: International Societies
11. CLINICAL TRIAL ANALYSIS
11.1. Chapter Overview
11.2. Scope and Methodology
11.3. Cell Therapies: Clinical Trial Analysis
11.3.1. Analysis by Trial Registration Year
11.3.2. Analysis of Enrolled Patient Population by Trial Registration Year
11.3.3. Analysis by Trial Status
11.3.4. Analysis by Trial Registration Year and Trial Status
11.4.5. Analysis by Trial Phase
11.4.6. Analysis of Enrolled Patient Population Trial Phase
11.4.7. Analysis by Type of Sponsor / Collaborator
11.4.8. Analysis by Patient Segment
11.4.9. Analysis by Study Design
11.4.10. Most Active Players: Analysis by Number of Registered Trials
11.4.11. Analysis by Number of Trials and Geography
11.4.12. Analysis by Number of Trials, Trial Status and Geography
11.4.13. Analysis by Enrolled Patient Population, Trial Status and Geography
12. PARTNERSHIPS AND COLLABORATIONS
12.1. Chapter Overview
12.2. Partnership Models
12.3. Cell Therapy Manufacturing: List of Partnerships
12.3.1. Analysis by Year of Partnership
12.3.2. Analysis by Type of Partnership
12.3.3. Analysis by Year and Type of Partnership
12.4. Analysis by Type of Cell Manufactured
12.5. Analysis by Scale of Operation
12.6. Analysis by Region
12.6.1. Continent-wise Distribution
12.6.2. Country-wise Distribution
12.7. Most Active Players: Analysis by Number of Partnerships
12.8. Cell Therapy Manufacturing: List of Mergers and Acquisitions
12.8.1. Analysis by Year of Agreement
12.8.2. Analysis by Type of Agreement
12.8.3. Analysis by Year of Acquisition and Type of Cell Manufactured
12.8.4. Analysis by Region
12.8.4.1. Continent-wise Distribution
12.8.4.2. Country-wise Distribution
12.8.4.3. Intercontinental and Intracontinental Deals
12.8.5. Ownership Change Matrix
13. RECENT EXPANSIONS
13.1. Chapter Overview
13.2. Cell Therapy Manufacturing: List of Expansions
13.2.1. Cumulative Year-wise Distribution
13.2.2. Analysis by Type of Expansion
13.2.3. Analysis by Types of Cells Manufactured
13.2.4. Analysis by Scale of Operation
13.2.5. Analysis by Location of Manufacturing Facility
13.2.6. Analysis by Type of Expansion and Location of Manufacturing Facility
13.2.7. Most Active Players: Analysis by Number of Expansions
13.2.8. Most Active Players: Analysis by Area of Expansion
13.2.9. Analysis by Year and Location of Manufacturing Facility
14. BIG PHARMA INITIATIVES
14.1. Chapter Overview
14.2. Big Pharma Players: List of Cell Therapy Manufacturing Focused Initiatives, 2017-2022
14.2.1. Analysis by Number of Initiatives
14.2.2. Analysis by Year of Initiative
14.2.3. Analysis by Type of Initiative
14.2.3.1. Analysis by Type of Partnership
14.2.3.2. Analysis by Type of Expansion
14.2.4. Analysis by Types of Cells Manufactured
14.2.5. Analysis by Scale of Operation
14.2.6. Analysis of Big Pharma Players by Year of Initiative
14.2.7. Analysis by Year and Type of Initiative
14.2.8. Analysis of Big Pharma Players by Types of Cells Manufactured
14.2.9. Analysis of Big Pharma Players by Scale of Operation
14.3. Competitive Benchmarking of Big Pharmaceutical Players
14.3.1. Harvey Ball Analysis: Big Pharma Initiatives Summary
14.3.2. Spider Web Analysis: Big Pharmaceutical Players
15. CAPACITY ANALYSIS
15.1. Chapter Overview
15.2. Key Assumptions and Methodology (Industry Players)
15.2.1 Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)
15.2.1.1. Analysis by Company Size
15.2.1.2. Analysis by Scale of Operation
15.2.1.3. Analysis by Location of Manufacturing Facility
15.2.1.4. Analysis by Company Size and Location of Manufacturing Facility
15.2.1.5. Analysis by Scale of Operation and Location of Manufacturing Facility
15.2.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)
15.2.2.1. Analysis by Company Size
15.2.2.2. Analysis by Scale of Operation
15.2.2.3. Analysis by Location of Manufacturing Facility
15.2.2.4. Analysis by Company Size and Location of Manufacturing Facility
15.2.2.5. Analysis by Scale of Operation and Location of Manufacturing Facility
15.3. Key Assumptions and Methodology (Non-Industry Players)
15.3.1. Cell Therapy Manufacturing: Installed Global Capacity (Number of Cleanrooms)
15.3.1.1. Analysis by Scale of Operation
15.3.1.2. Analysis by Location of Manufacturing Facility
15.3.2. Cell Therapy Manufacturing: Installed Global Capacity (Cleanroom Area)
15.3.2.1. Analysis by Scale of Operation
15.3.2.2. Analysis by Location of Manufacturing Facility
15.4 Concluding Remarks
16. DEMAND ANALYSIS
16.1 Chapter Overview
16.2 Scope and Methodology
16.3 Global Demand for Cell Therapy Manufacturing
16.4 Global Clinical Demand for Cell Therapy Manufacturing
16.4.1. Analysis by Type of Cell Therapy
16.4.2. Analysis by Geography
16.5. Global Commercial Demand for Cell Therapy Manufacturing
16.5.1. Analysis by Type of Cell Therapy
16.5.2. Analysis by Geography
17. COST PRICE ANALYSIS
17.1. Chapter Overview
17.2. Factors Contributing to the High Price of Cell Therapies
17.3. Pricing Models for Cell Therapies
17.3.1. Based on Associated Costs for T-Cell Therapies
17.3.2. Based on Associated Costs for Stem Cell Therapies
17.3.3. Based on Availability of Competing Products
17.3.4. Based on Target Patient Segment
17.3.5. Based on the Opinions of Industry Experts
17.4. Cell Therapy Cost Optimization
17.4.1. Role of Cost of Goods Sold
17.4.2. Role of Automation
17.5. Role of Cell Therapy Contract Manufacturing Organizations
17.6. Reimbursement-related Considerations for Cell Therapies
17.6.1. Case Study: The National Institute for Health and Care Excellence’s (NICE) Appraisal of CAR-T Therapies
18. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
18.1. Chapter Overview
18.2. Assumptions and Key Parameters
18.3. Cell Therapy Manufacturing: Make versus Buy Decision Making
18.3.1. Scenario 1
18.3.2. Scenario 2
18.3.3. Scenario 3
18.3.4. Scenario 4
18.4. Concluding Remarks
19. TOTAL COST OF OWNERSHIP FOR CELL THERAPY MANUFACTURING ORGANIZATIONS
19.1. Chapter Overview
19.2. Key Parameters
19.3. Assumptions and Methodology
19.4. Sample Dataset for the Estimation of Total Cost of Ownership
19.5. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations, Y0-Y20
19.6 Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by CAPEX and OPEX, Y0 and Y20
19.6.1. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by CAPEX, Y0
19.6. Total Cost of Ownership for Mid-sized Cell Therapy Manufacturing Organizations: Analysis by OPEX, Y1-Y20
20. MARKET SIZING AND OPPORTUNITY ANALYSIS
20.1. Chapter Overview
20.2. Scope of the Forecast
20.3. Input Data and Key Assumptions
20.4. Forecast Methodology
20.5. Global Cell Therapy Manufacturing Market, 2022-2035
20.5.1. Cell Therapy Manufacturing Market: Analysis by Type of Cell Therapy, 2022-2035
20.5.2. Cell Therapy Manufacturing Market: Analysis by Source of Cells, 2022-2035
20.5.3. Cell Therapy Manufacturing Market: Analysis by Scale of Operation, 2022-2035
20.5.4. Cell Therapy Manufacturing Market: Analysis by Purpose of Manufacturing, 2022-2035
20.5.5. Cell Therapy Manufacturing Market: Analysis by Region, 2022-2035
20.6. Cell Therapy Manufacturing Market for Commercial Scale Manufacturing
20.6.1. Global Commercial Scale Manufacturing Market for T-cell Therapies, 2022-2035
20.6.1.1. Commercial Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Type of Therapy
20.6.1.2. Commercial Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Source of Cells
20.6.1.3. Commercial Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Region
20.6.2. Global Commercial Scale Manufacturing Market for NK Cell Therapies, 2022-2035
20.6.2.1. Commercial Scale Manufacturing Market for NK Cell Therapies, 2022-2035: Analysis by Source of Cells
20.6.2.2. Commercial Scale Manufacturing Market for NK Cell Therapies, 2022-2035: Analysis by Region
20.6.3. Global Commercial Scale Manufacturing Market for Dendritic Cell Therapies, 2022-2035
20.6.3.1. Commercial Scale Manufacturing Market for Dendritic Cell Therapies, 2022-2035: Analysis by Region
20.6.4. Global Commercial Scale Manufacturing Market for Stem Cell Therapies, 2022-2035
20.6.4.1. Commercial Scale Manufacturing Market for Stem Cell Therapies, 2022-2035: Analysis by Source of Cells
20.6.4.2. Commercial Scale Manufacturing Market for Stem Cell Therapies, 2022-2035: Analysis by Region
20.7. Cell Therapy Manufacturing Market for Clinical Scale Manufacturing
20.7.1. Global Clinical Scale Manufacturing Market for T-cell Therapies, 2022-2035
20.7.1.1. Clinical Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Type of Therapy
20.7.1.2. Clinical Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Source of Cells
20.7.1.3. Clinical Scale Manufacturing Market for T-cell Therapies, 2022-2035: Analysis by Region
20.7.2. Global Clinical Scale Manufacturing Market for Dendritic Cell Therapies, 2022-2035
20.7.2.1. Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, 2022-2035: Analysis by Source of Cells
20.7.2.2. Clinical Scale Manufacturing Market for Dendritic Cell and Tumor Cell Therapies, 2022-2035: Analysis by Region
20.7.3. Global Clinical Scale Manufacturing Market for NK Cell Therapies, 2022-2035
20.7.3.1. Clinical Scale Manufacturing Market for NK Cell Therapies, 2022-2035: Analysis by Source of Cells
20.7.3.2. Clinical Scale Manufacturing Market for NK Cell Therapies, 2022-2035: Analysis by Region
20.7.4. Global Clinical Scale Manufacturing Market for Stem Cell Therapies, 2022-2035
20.7.4.1. Clinical Scale Manufacturing Market for Stem Cell Therapies, 2022-2035: Analysis by Source of Cells
20.7.4.2. Clinical Scale Manufacturing Market for Stem Cell Therapies, 2022-2035: Analysis by Region
21. KEY INSIGHTS
21.1. Chapter Overview
21.2. Cell Therapy Manufacturing: Grid Analysis
21.3. Cell Therapy Manufacturing: Logo Landscape
21.3.1. Immune Cell Therapy Manufacturing: Logo Landscape
21.3.2. Stem Cell Therapy Manufacturing: Logo Landscape
21.4. Cell Therapy Manufacturing: World Map Representation based on Location of Manufacturing Facilities
21.4.1. Industry Players
21.4.2. Non-Industry Players
22. SWOT ANALYSIS
22.1. Chapter Overview
22.2. Strengths
22.3. Weaknesses
22.4. Opportunities
22.5. Threats
22.6. Comparison of SWOT Factors
23. CONCLUDING REMARKS
23.1. Chapter Overview
24. SURVEY ANALYSIS
24.1. Chapter Overview
24.2. Analysis by Designation of Respondents
24.3. Analysis by Type of Cell Therapy
24.4. Analysis by Scale of Operation
24.5. Analysis by Source of Cells
24.6. Analysis by Type of Cell Culture System Used
24.7. Analysis by Availability of Fill / Finish Services
25. INTERVIEW TRANSCRIPTS
25.1. Chapter Overview
25.2. RoslinCT
25.2.1. Company Overview
25.2.2. Interview Transcript: Peter Coleman, Chief Executive Officer
25.3. Discovery Life Sciences
25.3.1. Company Overview
25.3.2. Interview Transcript: Dominic Clarke, Chief Technical Officer, Cell and Gene Therapy
25.4. Glycostem Therapeutics
25.4.1. Company Overview
25.4.2. Interview Transcript: Troels Jordansen, Chief Executive Officer
25.5. Bio Elpida
25.5.1. Company Overview
25.5.2. Interview Transcript: Gilles Devillers, President
25.6. Gracell Biotechnologies
25.6.1. Company Overview
25.6.2. Interview Transcript: Wei (William) Cao, Chief Executive Officer
25.7. Kadimastem
25.7.1. Company Overview
25.7.2. Interview Transcript: Arik Hasson, Executive VP Research and Development
25.8. RoslinCT
25.8.1. Company Overview
25.8.2. Interview Transcript: Fiona Bellot, Ex-Business Development Manager
25.9. University of Minnesota
25.9.1. Company Overview
25.9.2. Interview Transcript: David Mckenna, Professor and American Red Cross Chair in Transfusion Medicine
25.10. Lion TCR
25.10.1. Company Overview
25.10.2. Interview Transcript: Victor Lietao Li, Ex- Co-Founder and Chief Executive Officer
25.11. Center for Commercialization of Cancer Immunotherapy / C3i
25.11.1. Company Overview
25.11.2. Interview Transcript: Arnaud Deladeriere, Ex-Manager, Business Development & Operations-cGMP Manufacturing Unit
25.12. Waisman Biomanufacturing
25.12.1. Company Overview
25.12.2. Interview Transcript: Brian Dattilo, Manager of Business Development
25.13. Yposkesi
25.13.1. Company Overview
25.13.2. Interview Transcript: Mathilde Girard, Ex-Department Leader, Cell Therapy Innovation and Development
25.14. Cell Therapies
25.14.1. Company Overview
25.14.2. Interview Transcript: Tim Oldham, Ex-Chief Executive Officer
25.15. CiMaas
25.15.1. Company Overview
25.15.2. Interview Transcript: Gerard MJ Bos, Chief Executive Officer
26. APPENDIX 1: TABULATED DATA27. APPENDIX
27: LIST OF COMPANIES AND ORGANIZATIONS

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Table of Contents

Summary

The cell therapy manufacturing market is expected to reach USD 4.5 billion in 2022 anticipated to grow at a CAGR of 12% during the forecast period 2022-2035.

Cellular therapies have garnered considerable attention in the healthcare sphere due to their promising potential in treating rare disorders. Notably, more than 1,035 clinical studies focusing on these therapies have commenced since 2019. Certain commercialized cell therapies, such as Kymriah®, have achieved significant sales exceeding USD 1.5 billion since their launch in 2018. As the clinical benefits of these biologic drugs are increasingly validated, there is a heightened emphasis on refining the cell therapy manufacturing process. Efforts have been directed towards developing advanced automation tools, such as the emerging concept of GMP-In-A Box, aimed at reducing manufacturing costs associated with these intricate therapeutic products. However, the complexity of cell therapy manufacturing poses challenges to complete automation. Additionally, the lack of specialized infrastructure and expertise in this field hampers progress.

The current market landscape for cell therapy manufacturing is diverse, encompassing in-house manufacturers and contract service providers. Many innovator companies in this domain offer contract services alongside their in-house capabilities to optimize resource utilization and generate additional revenue. To meet the growing demand for cell therapies, industry players are expanding their capacities, leading to a noticeable surge in partnerships and expansions within the cell therapy domain starting in 2020. The involvement of major pharmaceutical companies has significantly bolstered the adoption of these therapies. Big pharma players have initiated strategic partnerships and expansion projects to strengthen their cell therapy manufacturing capabilities. With stakeholders persistently striving to overcome manufacturing challenges and a heightened focus on advancing these therapies, the cell therapy manufacturing market is poised for substantial growth in the forecasted future.

Report Coverage
 The report conducts an examination of the cell therapy manufacturing market, focusing on the types of cells produced, cell sources, operational scales, manufacturing purposes, and key geographical regions.
 It evaluates the factors—such as drivers, restraints, opportunities, and challenges—that impact market growth.
 The report assesses both the potential advantages and obstacles within the market, providing insights into the competitive landscape for top market players.
 Revenue forecasts for market segments are provided concerning four major regions.
 A comprehensive review covers multiple aspects of cell therapy manufacturing, commencing with an overview that encompasses challenges and influencers within the market. It also explores automation tools and technologies enhancing manufacturing processes, along with future prospects.
 Extensive analysis of the market landscape involves examining key players engaged in manufacturing cell-based therapies. This includes details on cell types produced (immune cells, stem cells, etc.), cell sources (autologous, allogeneic), operational scales (preclinical, clinical, commercial), purposes (in-house, contract services), offered capabilities/services (R&D, quality testing, etc.), and global headquarters and manufacturing facilities.
 Discussion extends to cell therapy manufacturing regulations across various regions (North America focusing on the US, Europe, Asia with emphasis on Japan and China), encompassing diverse certifications from regulatory bodies.
 The overview includes global agencies' roadmaps aiming to advance cell therapy manufacturing processes. It delves into the role of technology automation, comparing costs between manual and automated processes.
 Detailed profiles of industry players providing cell therapy manufacturing services at clinical and commercial scales are presented. This includes their service portfolios, capabilities, facilities, recent partnerships, and future prospects. Similarly, profiles of non-industry players in this domain are outlined.
 Examination of non-profit organizations' roles in cell-based therapy development across different regions, along with international/national societies disseminating related knowledge.
 Analysis of completed, ongoing, and planned clinical trials is presented, covering parameters like trial phases, sponsors, therapeutic areas, and industry/non-industry players involved. Recent partnerships in cell therapy manufacturing (2016-2022), collaborations, and expansion initiatives undertaken by service providers during the same period are explored.
 Initiatives by big pharma in cell therapy manufacturing, installed capacity estimates, annual demand projections, factors influencing pricing, considerations for in-house manufacturing versus CMO engagement, and comprehensive representations (3D grid analysis, logo landscapes, world maps) of cell therapy manufacturers' distribution are included.
 The study concludes by summarizing key insights derived from the gathered information, emphasizing details of cell therapy manufacturing providers across continents.
 Furthermore, affiliated trends, key drivers, challenges, and industry impacts are analyzed using a SWOT framework, showcasing their relative effects through a Harvey ball analysis.
 Insights derived from a market-wide survey, capturing inputs from experts involved in cell-based therapy development and manufacturing, are synthesized.

Key Market Companies
 AGC Biologics
 Charles River Laboratories
 KBI Biopharma
 Thermo Fisher Scientific
 BioNTech Innovative Manufacturing Services
 Cell and Gene Therapy Catapult
 Lonza
 RoslinCT
 Cell Therapies
 FUJIFILM Cellular Dynamics
 Minaris Regenerative Medicine
 MEDINET
 Nikon CeLL Innovation
 WuXi AppTec

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