세포치료 제조 시장 : 세포치료 유형별, 세포 유래별, 사업 규모별, 제조업체 유형별, 지역별 : 업계 동향과 세계 예측(-2035년)
Cell Therapy Manufacturing Market by Type of Cell Therapy, Source of Cells, Scale of Operation, Type of Manufacturer and Geography : Industry Trends and Global Forecasts, Till 2035
상품코드:1616886
리서치사:Roots Analysis
발행일:2024년 12월
페이지 정보:영문 678 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계의 세포치료 제조 시장 규모는 2035년까지의 예측 기간 중 9.90%의 CAGR로 확대하며, 현재 49억 달러에서 2035년까지 138억 3,000만 달러로 성장할 것으로 예측됩니다.
최근 세포 치료의 발전과 함께 FDA 승인을 받은 몇 가지 세포 치료법은 암, 희귀질환 및 만성질환 치료에 대한 이러한 혁신적 치료의 잠재력을 강조하고 있습니다. 그 결과, 의료계는 이 유망한 치료법을 점점 더 우선순위에 두고 있습니다. 현재 1,930개 이상의 임상시험이 다양한 지역에서 다양한 질병에 대한 세포 치료법을 검토하기 위해 진행 중이라는 점은 주목할 만합니다. 또한 일부 상용화된 세포치료제는 헬스케어 업계에서 가장 많이 팔리는 의약품으로 부상하고 있습니다. 예를 들어 길리어드 사이언스(Gilead Sciences)는 예스카르타(R)의 연간 매출이 15억 달러를 넘어섰다고 보고했습니다. 세포치료의 임상적 이점과 치료 가능성을 지원하는 많은 증거가 있는 가운데, 이해관계자들의 관심은 이제 세포치료제 제조 공정의 최적화에 집중되고 있습니다. 현재 260개 이상의 산업 및 비산업 기업이 세포치료제 제조 산업에 참여하고 있습니다. 주목할 만한 점은 세포치료제 제조 산업의 50% 이상이 미국에 기반을 두고 있다는 점입니다.
다양한 이해관계자들이 제조와 관련된 복잡성을 완화하기 위해 지속적인 노력을 기울이고 있으며, 이러한 치료법의 발전에 중점을 두고 있으므로 세포치료제 제조 시장은 향후 건전한 성장을 이룰 것으로 예상됩니다. 세포치료제의 효능이 상대적으로 높기 때문에 이 시장에 대한 주요 제약사들의 관심과 참여가 증가하고 있습니다. 이는 세포치료제 채택 확대에 중요한 역할을 하고 있습니다.
세계의 세포치료 제조 시장에 대해 조사했으며, 시장의 개요와 세포치료 유형별, 세포 유래별, 사업 규모별, 제조업체 유형별, 지역별 동향 및 시장에 참여하는 기업의 개요 등을 제공하고 있습니다.
목차
제1장 서문
제2장 조사 방법
제3장 경제 및 기타 프로젝트 특유의 고려 사항
제4장 개요
제5장 서론
제6장 세포치료 제조업체(업계 참여 기업) : 시장 구도
제7장 세포치료 제조업체(비명계 참여 기업) : 시장 구도
제8장 규제 상황
제9장 과제 극복을 위한 로드맵
제10장 세포치료 제조 자동화 기술
제11장 기업 개요 : 업계 참여 기업
제12장 기업 개요 : 업계외 기업
제13장 세포치료 제조에서 비영리 단체
제14장 임상시험 분석
제15장 파트너십과 협업
제16장 최근 확장
제17장 대형 제약회사 구상
제18장 용량 분석
제19장 수요 분석
제20장 원가분석
제21장 제조인가 구입인가 의사 의사결정 프레임워크
제22장 세포치료 제조 조직 총소유 비용
제23장 세계의 세포치료 제조 시장
제24장 세포치료 제조 시장(세포치료 유형별)
제25장 세포치료 제조 시장(세포 유래별)
제26장 세포치료 제조 시장(사업 규모별)
제27장 세포치료 제조 시장(제조업체 유형별)
제28장 세포치료 제조 시장(지역별)
제29장 SWOT 분석
제30장 조사 분석
제31장 결론
제32장 이그제큐티브 인사이트
장의 개요
Invetech
John Goldman Centre for Cellular Therapy, Imperial College London
Cellistic
FamiCord
GenCure
Japan Tissue Engineering
Medace
Laboratory For Cell and Gene Medicine, University of Stanford
Sumitomo Pharma
RoslinCT
Discovery Life Sciences
Glycostem Therapeutics
Bio Elpida
Gracell Biotechnologies
Kadimastem
RoslinCT
University of Minnesota
Lion TCR
Center for Commercialization of Cancer Immunotherapy / C3i
Waisman Biomanufacturing
Yposkesi
Cell Therapies
CiMaas
제33장 부록 1 : 표 형식 데이터
제34장 부록 2 : 기업·단체 리스트
KSA
영문 목차
영문목차
CELL THERAPY MANUFACTURING MARKET: OVERVIEW
As per Roots Analysis, the global cell therapy manufacturing market is estimated to grow from USD 4.90 billion in the current year to USD 13.83 billion by 2035, at a CAGR of 9.90% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Cell Therapy
T Cell Therapies
NK Cell Therapies
Dendritic Cell Therapies
Stem Cell Therapies
Source of Cells
Autologous
Allogeneic
Unspecified
Scale of Operation
Clinical
Commercial
Type of Manufacturer
In-house Manufacturing
Contract Manufacturing Organization
Key Geographical Regions
North America
Europe
Asia-Pacific
Rest of the World
CELL THERAPY MANUFACTURING MARKET: GROWTH AND TRENDS
Recent advancements in cellular therapies, along with several FDA-approved cell therapies, highlight the potential of these innovative therapies for treating cancer, rare diseases, and chronic illnesses. As a result, the healthcare sector is increasingly prioritizing this promising therapeutic approach. It is worth noting that more than 1,930 clinical trials are currently underway to investigate cell therapies for the treatment of a wide range of diseases, across different geographies. Moreover, several commercialized cell therapies have emerged as top selling drugs in the healthcare industry. For example, Gilead Sciences reported that Yescarta(R) has achieved annual sales surpassing USD 1.5 billion. Given the substantial evidence supporting the clinical advantages and therapeutic potential of cellular therapies, the focus of stakeholders has now shifted to optimizing the cell therapy manufacturing process. At present, over 260 industry and non-industry players are engaged in the cell therapy manufacturing industry. Notably, over 50% of the organizations in the cell therapy manufacturing industry are based in the US.
Given the continuous efforts of various stakeholders to ease the manufacturing related complexities, and a heightened emphasis on the advancement of such therapies, we anticipate a healthy growth in the cell therapy manufacturing market in the foreseen future. Owing to the relatively high efficacy of cell therapies, there is an increased interest and involvement of the big pharma players in this market. This has played a crucial role in the increasing adoption of cell therapies.
CELL THERAPY MANUFACTURING MARKET: KEY INSIGHTS
The report delves into the current state of the cell therapy manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:
1. Presently, over 265 industry and non-industry stakeholders are engaged in cell therapy manufacturing; more than 70% of these are industry players, with the required capability to manufacture various types of cells.
2. Immune cells and stem cells are the most prominent type of cells being manufactured by stakeholders in this industry; over 60% of the players operate at preclinical, clinical and commercial scales of operation.
3. More than 70 automation technologies are currently available for the manufacturing of cell therapies to minimize manual interventions; this is likely to attract the interest of stakeholders in the cell therapy domain.
4. In the past few years, the number of clinical studies has increased at an annualized rate of nearly 10% across the world; majority of the clinical studies are evaluating cell therapies in phase I studies.
5. The rise in partnership activity in this domain highlights the growing interest of players in the cell therapy manufacturing market; majority of the deals have been inked for the clinical manufacturing of T cell therapies.
6. To gain a competitive edge and establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to cell therapy manufacturing through mergers and acquisitions.
7. 80% of the industry players have expanded their existing capacities and capabilities through the establishment of new facilities; among these more than 40% of facilities are dedicated to the manufacturing of T cells.
8. Nearly 50% of the big pharma initiatives have been undertaken for the purpose of expanding their portfolio and capabilities through partnerships and collaborations; among these, 70% initiatives were undertaken post-2019.
9. More than 70% of the current installed cell therapy manufacturing capacity (in terms of number of cleanrooms) is presently available with industry players; maximum capacity is installed in facilities based in North America.
10. In 2035, more than 45% of the clinical demand for cell therapies is likely to be generated by T cell therapies, including CAR-T, TCR and TIL therapies, for the treatment of patients suffering from various disorders.
11. Owing to the increased disease burden and shift in patient preferences towards tailored cell therapies, the market is poised to witness substantial growth in the next decade.
12. The cell therapy manufacturing domain is poised to grow at a CAGR of 10%; the opportunity is well distributed across different types of cell therapies, sources of cells, scale of operation, type of manufacturer and geography.
CELL THERAPY MANUFACTURING MARKET: KEY SEGMENTS
Currently, T Cell Therapy Holds Maximum Share of the Cell Therapy Manufacturing Market
Based on the type of cell therapy, the market is segmented into T cell therapies, NK cell therapies, dendritic cell therapies and stem cell therapies. It is worth highlighting that the market for dendritic cell therapies is likely to grow at a relatively faster pace (CAGR of 11.1%) in the next decade. This can be attributed to high effectiveness of dendritic cell therapies in treating oncological disorders.
At Present, Autologous Source of Cell Market Segment Captures the Largest Market Share of the Overall Cell Therapy Manufacturing Market
Based on the source of cell, the market is segmented into autologous, allogeneic, and unspecified sources. It is worth highlighting that autologous source of cell is likely to grow at an annualized rate of 9.8% in the next decade. This can be attributed to the fact that more than 90% of the FDA approved cell therapies are derived from the patients.
Cell Therapies Manufactured at Clinical Scale is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period
Based on scale of operation, the market is segmented into clinical and commercial. It is worth highlighting that the cell therapies manufactured at clinical scale capture the larger share of the market and is poised to capture 58% of the revenue share by 2035. This can be attributed to the increasing number of cell therapy pipeline candidates in clinical trial phases.
Contract Manufacturing is Likely to Dominate the Cell Therapy Manufacturing Market During the Forecast Period
Based on type of manufacturer, the market is segmented into contract manufacturing and in-house manufacturing. It is worth highlighting that, currently, contract manufacturing of cell therapies holds the larger share in the cell therapy manufacturing market. This trend is unlikely to change in the coming decade. This can be attributed to the fact that contract manufacturers offer scalability and flexibility, enabling them to quickly adapt to evolving manufacturing needs and accommodate increased production volumes. In addition, by outsourcing cell therapy manufacturing operations, the drug developers can prevent significant capital investments for the establishment of in-house manufacturing facilities
North America Accounts for the Largest Share of the Market
Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.
Example Players in the Cell Therapy Manufacturing Market
AGC Biologics
BioNTech Innovative Manufacturing Services
Cell and Gene Therapy Catapult
Cell Therapies
Center for Cell and Gene Therapy, Baylor College of Medicine
Centre for Cell Manufacturing Ireland, National University of Ireland
Charles River Laboratories
Clinical Cell and Vaccine Production Facility, University of Pennsylvania
FUJIFILM Cellular Dynamics
Guy's and St. Thomas' GMP Facility, Guy's Hospital
KBI Biopharma
Laboratory for Cell and Gene Medicine, Stanford University
Lonza
MEDINET
Minaris Regenerative Medicine
Molecular and Cellular Therapeutics, University of Minnesota
Newcastle Cellular Therapies Facility, Newcastle University
Nikon CeLL Innovation
Rayne Cell Therapy Suite, King's College London
RoslinCT
Scottish National Blood Transfusion Services Cellular Therapy Facility, Scottish Centre for Regenerative Medicine
Sydney Cell and Gene Therapy
Thermo Fisher Scientific
WuXi AppTec
Primary Research Overview
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:
Marketing Manager, Cell Therapy, Invetech
Director, Imperial College London
Marketing Director, Cellistic
Chief Commercial Officer and Executive Vice-President, FamiCord
Senior Director of Sales Advanced Therapies, GenCure
Business Administration Department Manager, Japan Tissue Engineering
Chief Business Officer, Medace
Director of Finance and Facility Operations, Laboratory for Cell and Gene Medicine, University of Stanford
Senior Director, Sumitomo Pharma
Chief Executive Officer, RoslinCT
Chief Technical Officer, Cell and Gene Therapy, Discovery Life Sciences
Chief Executive Officer, Glycostem Therapeutics
General Manager, Bio Elpida
Chief Executive Officer, Gracell Biotechnologies
Executive VP Research and Development, Kadimastem
Ex-Business Development Manager, Roslin CT
Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota
Ex- Co-Founder and Chief Executive Officer, Lion TCR
Ex-Manager, Business Development & Operations-cGMP Manufacturing Unit, C3i Center for Commercialization of Cancer Immunotherapy
Manager of Business Development, Waisman Biomanufacturing
Ex-Department Leader, Cell Therapy Innovation and Development, Yposkesi
Ex-Chief Executive Officer, Cell Therapies
Chief Executive Officer, CiMaas
CELL THERAPY MANUFACTURING MARKET: RESEARCH COVERAGE
The report features an in-depth analysis of the cell therapy manufacturing market, focusing on key market segments, including type of cell therapy, source of cells, scale of operation, type of manufacturer and key geographical regions.
The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.
A comprehensive evaluation of companies involved in cell therapy manufacturing, considering various parameters, such as company size, year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).
Thorough analysis of non-industry players involved in cell therapy manufacturing, detailing information on their year of establishment, location of headquarters, location of manufacturing facilities, type of manufacturer (in-house manufacturers and contract manufacturing organizations), type of cell manufactured (immune cells, stem cells and others), source of cells (autologous and allogeneic), scale of operation (preclinical, clinical and commercial) and additional services offered (research and development, cell culture development, cell banking, documentation, testing, packaging, supply chain management and regulatory support).
A comprehensive discussion on regulations governing cell therapy manufacturing across different regions, specifically North America (with an emphasis on the US), Europe, and Asia (highlighting Japan and China). This analysis includes a review of the various certifications and accreditations granted to manufacturing facilities by key regulatory authorities worldwide.
An overview of the diverse roadmaps released by various global agencies in order to advance the cell therapy manufacturing process.
An in-depth analysis of the impact of technological automation on cell therapy manufacturing aims to enhance existing production methods by utilizing closed and single-use systems. The discussion includes a strategic roadmap outlining the necessary steps for developing automation devices, bolstered by two illustrative case studies. Additionally, it offers a qualitative assessment of the costs associated with manufacturing cell-based therapies through manual versus automated processes. Furthermore, it lists organizations that provide automated technologies for manufacturing operations or assist therapy developers in automating their cell therapy production processes.
In-depth profiles of key industry players in cell therapy manufacturing market, focusing on company overviews, service portfolio, manufacturing capabilities and facilities, recent developments, and an informed future outlook.
In-depth profiles of key non-industry players in cell therapy manufacturing market, focusing on organization overviews, service portfolio and manufacturing facilities.
A comprehensive overview of non-profit organizations engaged in the manufacturing of cell therapies, including a list of organizations actively involved in the development and production of cell-based therapies across various regions. This discussion will also highlight different international and national societies dedicated to disseminating knowledge about advancements in these therapies to the broader community.
Examination of completed, ongoing, and planned clinical studies based on parameters like trial registration year, enrolled patient population, trial status, trial phase, type of sponsor / collaborator, patient segment, study design, most active players (in terms of number of clinical trial conducted) and geographical distribution of trials.
An analysis of partnerships established in this sector, since 2016, based on several relevant parameters, such as the year of partnership, type of partnership, type of cells manufactured, scale of operation, most active players (in terms of number of partnerships) and geographical distribution.
An examination of the different expansion efforts made by service providers in this field to enhance their cell therapy manufacturing capabilities, since 2017. This analysis considers various factors, including the year of expansion, type of expansion, type of cells produced, scale of operations, location of the expanded manufacturing facilities and the most active companies based on the number of expansion initiatives undertaken.
Assessment of the various cell therapy manufacturing focused initiatives undertaken by big pharma players, based on several relevant parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of cell manufactured.
Estimation of global cell-based therapies manufacturing capacity, derived from data provided by various industry and non-industry sources in the public domain. This analysis emphasizes the distribution of the available capacity (in terms of cleanroom area and number of cleanrooms) on the basis of scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific and Rest of the World).
Informed estimates of the annual commercial and clinical demand for cell therapies (in terms of number of patients), based on type of cell therapy and key geographical regions.
An in-depth examination of the various factors that may impact the pricing of cell-based therapies, highlights the different models and strategies used by manufacturers to establish the prices of their proprietary products.
A qualitative analysis that highlights the various factors that need to be taken into consideration by cell therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
A comprehensive total cost of ownership analysis for cell therapy manufacturing organizations, categorized by company size, spanning 20 years.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading CDMOs / CMOs in this market?
What kind of partnership models are commonly adopted by industry stakeholders?
What kinds of expansion initiatives have been undertaken by industry stakeholders?
What are the factors that are likely to influence the evolution of this market?
What is the current and future market size?
What is the CAGR of this market?
How is the current and future market opportunity likely to be distributed across key market segments?
REASONS TO BUY THIS REPORT
The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.
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TABLE OF CONTENTS
1. PREFACE
1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
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 Forecasted 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 Trends 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
5. INTRODUCTION
5.1. Chapter Overview
5.2. Introduction to Cell-based Therapies
5.2.1. Comparison of Cell-based Therapies and Other Biotechnological Products
5.2.2. Classification of Advanced Therapy Medicinal Products (ATMPs)
5.2.3. Current Market Landscape of ATMPs
5.3. Overview of Cell Therapy Manufacturing
5.4. Cell Therapy Manufacturing Models
5.4.1. Centralized Manufacturing
5.4.2. Decentralized Manufacturing
5.5. Scalability of Cell Therapy Manufacturing Processes
5.5.1. Scale-up
5.5.2. Scale-out
5.6. Types of Cell Therapy Manufacturers
5.7. Key Challenges for Manufacturing Cell Therapies
