세포 및 유전자 치료 CRO 시장 : 세포치료 유형별, 유전자재조합 유형별, 개발 단계별, 치료 영역별, 최종사용자별, 지역별 : 업계 동향과 세계 예측(-2035년)
Cell and Gene Therapy CRO Market by Type of Cell Therapy, Type of Genetic Modification, Stage of Development, Therapeutic Area, End-Users and Key Geographical Regions : Industry Trends and Global Forecasts, Till 2035
상품코드:1616880
리서치사:Roots Analysis
발행일:2024년 12월
페이지 정보:영문 343 Pages
라이선스 & 가격 (부가세 별도)
한글목차
세계의 세포·유전자 치료 CRO 시장 규모는 2035년까지의 예측 기간 중 7.1%의 CAGR로 확대하며, 현재 17억 달러에서 2035년까지 35억 달러로 성장할 것으로 예측됩니다.
세포·유전자 치료 영역에서의 지속적인 발전은 FDA 승인을 받은 몇 가지 치료법과 함께 현재 효과적인 치료법이 없는 다양한 질환(희귀질환 및 복합질환 포함)의 치료에서 이러한 혁신적 치료법의 가능성을 보여주고 있습니다. 그 결과, 이 유망한 치료법은 투자자들뿐만 아니라 의약품 개발자들의 관심을 끌고 있습니다. 현재 전 세계에서 90개 이상의 세포 및 유전자 치료제가 승인되었습니다는 점은 주목할 만합니다. 최근 승인된 대표적인 치료제로는 Sarepta Therapeutics의 Elvediys(Duchenne muscular dystrophy 치료제), IASO Bio의 Fucaso(다발성골수종 치료제), Krystal Biotech의 Vyjuvek( 위축성 표피수포증 치료제) 등이 있습니다. 또한 현재 16개 치료 분야에서 3,500개 이상의 세포 및 유전자 치료제 임상시험이 진행 중입니다. 이는 이 분야의 이해관계자들이 광범위한 개발 노력을 기울이고 있음을 보여줍니다. 세포 및 유전자 치료 분야가 빠르게 발전함에 따라 CRO는 임상시험 설계 최적화, 복잡한 규제 프레임워크 관리, 전임상에서 임상으로의 원활한 전환에 있으며, 귀중한 전문지식을 제공합니다. 현재 105개 이상의 업계 진입자들이 다양한 규모의 위탁 서비스를 제공하는 데 필요한 역량을 보유하고 있다고 주장하고 있습니다.
세계의 세포·유전자 치료 CRO 시장에 대해 조사했으며, 시장의 개요와 세포치료 유형별, 유전자재조합 유형별, 개발 단계별, 치료 영역별, 최종사용자별, 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 아웃소싱 가이드
제7장 시장 구도
제8장 기업 개요
장의 개요
Aixial
Altasciences
CMIC
ICON
Labcorp
Linical
Medpace
Novotech
PPD
Precision for Medicine
QPS
Syneos Health
제9장 벤치마킹 분석
제10장 파트너십과 협업
제11장 합병과 인수
제12장 주요인수 대상
제13장 임상시험 분석
제14장 총소유 비용
제15장 SWOT 분석
제16장 세계의 세포·유전자 치료 CRO 시장
제17장 세포·유전자 치료 CRO 시장, 세포치료 유형별
제18장 세포·유전자 치료 CRO 시장, 유전자재조합 유형별
제19장 세포·유전자 치료 CRO 시장, 카이하츠 단계별
제20장 세포·유전자 치료 CRO 시장, 치료 영역별
제21장 세포·유전자 치료 CRO 시장, 최종사용자별
제22장 세포·유전자 치료 CRO 시장, 주요 지역별
제23장 이그제큐티브 인사이트
제24장 결론
제25장 부록 I : 표 형식 데이터
제26장 부록 II : 기업 및 단체 리스트
KSA
영문 목차
영문목차
CELL AND GENE THERAPY CRO MARKET: OVERVIEW
As per Roots Analysis, the global cell and gene therapy CRO market is estimated to grow from USD 1.7 billion in the current year to USD 3.5 billion by 2035, at a CAGR of 7.1% during the forecast period, till 2035.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Cell Therapy
CAR-NK
CAR-T
TCR-T
Others
Type of Genetic Modification
Ex vivo
In vivo
Stage of Development
Discovery
Preclinical
Clinical
Therapeutic Area
Blood Disorders
Cardiovascular Disorders
Dermatological Disorders
Immunological Disorders
Infectious Diseases
Metabolic Disorders
Musculoskeletal Disorders
Neurological Disorders
Oncological Disorders
Rare Diseases
Other Disorders
End Users
Industry Players
Non- Industry Players
Key Geographical Regions
North America
Europe
Asia-Pacific
Rest of the World
CELL AND GENE THERAPY CRO MARKET: GROWTH AND TRENDS
The ongoing advancements in cell and gene therapies domain, along with several FDA-approved therapies, demonstrate the potential of these innovative therapies in treating a wide range of diseases (including rare and complex diseases) for which no effective treatment is currently available. As a result, this promising therapeutic modality has garnered the interest of both investors and drug developers alike. It is worth highlighting that, at present, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include Elvediys (for the treatment of duchenne muscular dystrophy) developed by Sarepta Therapeutics, Fucaso (for the treatment of multiple myeloma) developed by IASO Bio and Vyjuvek (for the treatment of dystrophic epidermolysis bullosa) developed by Krystal Biotech. In addition, more than 3,500 clinical trials are currently underway to investigate cell and gene therapies across 16 therapeutic areas. This demonstrates the extensive development efforts being undertaken by stakeholders in this domain. As the cell and gene therapy field rapidly evolves, CROs offer valuable expertise in optimizing study designs, managing complex regulatory frameworks and seamless transition from preclinical to clinical success. At present, over 105 industry players claim to have the necessary capabilities to offer contract research services across different scales of operations.
CELL AND GENE THERAPY CRO MARKET: KEY INSIGHTS
The report delves into the current state of the cell and gene therapy CRO market and identifies potential growth opportunities within the industry. Some key findings from the report include:
1. Presently, over 105 players (established as well as start ups) claim to have the necessary capabilities to offer contract research services; majority of these firms are based in North America.
2. Stakeholders offer contract research services for cell and gene therapies across different scales of operations; close to 20% of the players offer all types of clinical services.
3. More than 65 deals have been inked between various stakeholders involved in this domain; acquisitions emerged as the most common type of partnership model.
4. The rising interest of players is reflected by the number of mergers and acquisitions reported in the last few years; 58% of such initiatives were signed to incorporate additional capabilities to their existing portfolio offerings.
5. Since 2019, more than 3,000 clinical trials have been registered for cell therapies; over 70% of the trials recently initiated are currently recruiting patients.
6. Close to 500 clinical trials (with over 48,000 enrolled patients) have been registered to investigate gene therapies, across different geographies.
7. In order to meet the rising demand for cell and gene therapies, stakeholders are striving to upgrade / expand their capabilities to enhance their respective service portfolios.
8. Total cost of ownership model offers an informed estimate of capital and operational expenses associated with the establishment and maintenance of a contract research facility, over a span of 20 years.
9. Driven by the increasing number of chronic indications (requiring novel personalized therapies), and ongoing research on cell and gene therapies, this market is anticipated to grow at a CAGR of 7.1%, till 2035.
10. About 25% of the market is expected to be captured by revenues generated from cell and gene therapies for oncological disorders; it is also worth highlighting that the CRO market in China is likely to grow at a faster pace.
CELL AND GENE THERAPY CRO MARKET: KEY SEGMENTS
Currently, the CAR-T Cell Therapy Market Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market
Based on the type of cell therapy, the market is segmented into CAR-NK, CAR-T, TCR-T, and others. It is worth highlighting that the CAR-T cell therapies segment is likely to dominate the market in the coming decade. This can be attributed to the proven efficacy of CAR-T cell therapies in treating CD19-positive haematological malignancies, acute lymphoblastic leukemia and multiple myeloma.
Ex Vivo Segment Holds the Maximum Share within the Cell and Gene Therapy CRO Market
Based on the type of genetic modification, the market is segmented into ex vivo and in vivo. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the ex vivo segment and this trend is likely to remain the same in the forthcoming years. This can be attributed to the fact that ex vivo techniques utilize viral vectors, which are effective in delivering and integrating modified genetic material into cells.
Currently, the Clinical Segment Occupies the Largest Share of the Cell and Gene Therapy CRO Market
Based on the stage of development, the market is segmented into discovery, preclinical and clinical. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the clinical segment and this trend is likely to remain the same in the forthcoming years. This can be primarily attributed to the rigorous clinical testing that these therapies undergo in order to meet the regulatory standards before commercialization.
Oncological Disorders Segment is Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period
Based on therapeutic areas, the market is segmented into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the oncological disorders segment and this trend is likely to remain the same in the forthcoming years.
Industry Players are Likely to Dominate the Cell and Gene Therapy CRO Market During the Forecast Period
Based on end user, the market is segmented into industry and non-industry players. It is worth highlighting that majority of the current cell and gene therapy CRO market is captured by the industry players and this trend is likely to remain the same in the forthcoming years.
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. Majority share is expected to be captured by CROs based in North America. It is worth highlighting that, over the years, the market for Asia-Pacific is expected to grow at a higher CAGR.
Example Players in the Cell and Gene Therapy CRO Market
Altasciences
Allucent
CMIC
Labcorp
Linical
Medpace
PPD
Precision for Medicine
QPS
Syneos Health
CMED
ICON
Pharmalex
Novotech
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:
Business Development Executive, Aixial
Clinical Trial Manager, Gsap
Former Director, Marketing and Sales, CATO SMS
CELL AND GENE THERAPY CRO MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the cell and gene therapy CRO market, focusing on key market segments, including [A] type of cell therapy, [B] type of genetic modification, [C] stage of development, [D] therapeutic area, [E] end users and [F] key geographical regions.
Market Landscape: A comprehensive evaluation of contract research service providers engaged in cell and gene therapy market, considering various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] area of expertise (cell therapy and gene therapy), [E] scale of operation (discovery, preclinical, clinical and commercial), [F] type of preclinical services offered (toxicology studies, in-vivo testing, safety studies, PK / ADME studies, bioanalytical studies, and other preclinical services), [G] type of clinical services offered (clinical trial management / clinical project management, clinical research monitoring, data management, safety and pharmacovigilance, and other clinical services), [H] type of regulatory services offered (legal representation, GAP analysis, Technical Dossier Submission, and IND Preparation) and [I] type of general support services offered (consulting, training, biostatistics, post-market assessment, and re-imbursement).
Company Profiles: In-depth profiles of key cell and gene therapy contract research service providers based in North America, Europe and Asia-Pacific, focusing on [A] company overviews, [B] service portfolio, [C] insightful recent developments and [D] an informed future outlook.
Benchmark Analysis: A detailed benchmark analysis of the various players involved in this domain. It highlights the capabilities of the companies (in terms of their expertise across various services related to the development of cell and gene therapies). The analysis allows companies to compare their existing capabilities within and beyond their peer groups and identify opportunities to become more competitive in the industry.
Total Cost of Ownership: A thorough examination of the total cost of ownership for large and very large contract research organizations (CROs) specializing in cell and gene therapy, highlighting the costs associated in both the establishment and ongoing maintenance of a CRO facility over the short and long term. This chapter includes insights derived from an in-depth analysis of the total cost of ownership for cell and gene therapy CROs during the period from Y0-Y20.
Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2015, based on several parameters, [A] year of partnership, [B] type of partnership, [C] area of expertise, [D] most active players (in terms of number of partnerships inked) and [E] regional distribution of partnership activity.
Merger and Acquisitions: A comprehensive examination of the various mergers and acquisitions, focusing on multiple relevant parameters, including [A] year of agreement, [B] type of agreement, [C] key value drivers of the deal, [D] most active players (in terms of number of agreements signed) and [E] geographical location of companies. Furthermore, this chapter provides details on the financial aspects of these deals (where available) to calculate deal multiples based on the annual revenues of the acquired companies at the time of acquisition and their years of experience in the industry.
Key Acquisition Targets: A detailed analysis of acquisitions that have taken place in the cell and gene therapy domain, taking into consideration the historical trend of the activity of players that have acquired other firms since 2015, and offering a means for other industry stakeholders to identify potential acquisition targets. The primary purpose of this analysis was to develop a better understanding of the overall potential and capabilities of companies involved in this domain, that are likely to be acquired in the recent future.
Clinical Trial Analysis: Examination of completed, ongoing, and planned clinical studies of various cell and gene therapies, based on several parameters, such as [A] trial registration year, [B] trial status, [C] trial phase, [D ]enrolled patient population, [E] type of sponsor, [F] most active industry players (in terms of number of registered trials), [G] study design, [H] therapeutic area and [I] key geographical regions.
Business Model Analysis: A detailed discussion of the business models that are commonly adopted by the biopharmaceutical industry for outsourcing cell and gene therapies. In addition, it includes information on various factors that drive sponsors towards outsourcing and key parameters that sponsors must consider while choosing CROs at each phase of drug development process.
SWOT Analysis: A SWOT analysis of cell and gene therapy CRO services focuses on identifying industry-specific trends, key market drivers and challenges faced by companies providing these services.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading CROs in this market?
What kind of partnership models are commonly adopted by industry stakeholders?
What factors 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
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 and Foreign Exchange Rates
3.2.2.1. Major Currencies Affecting the Market
3.2.2.2. Factors Affecting Currency Fluctuations and Foreign Exchange Rates
3.2.2.3. Impact of Foreign Exchange Rate Volatility on the Market
3.2.2.4. Strategies for Mitigating Foreign Exchange Risk
3.2.3. Trade Policies
3.2.3.1. Impact of Trade Barriers on the Market
3.2.3.2. Strategies for Mitigating the Risks Associated with Trade Barriers
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
5. INTRODUCTION
5.1. Chapter Overview
5.2. Overview of Contract Research Organizations (CROs)
5.3. Classification of CROs
5.4. Evolution of CROs
5.5. Modern CROs and Prevalent Outsourcing Trends
5.6. Type of Services Offered by CROs
5.7. Role of CROs in Development of Advanced Therapy Medicinal Products (ATMPs)
5.8. Advantages of Outsourcing Operations to CROs
5.9. Risks Associated with Outsourcing to CROs
5.10. Future Perspectives
6. GUIDE TO OUTSOURCING
6.1. Chapter Overview
6.2. Cell and Gene Therapy Research: Need for Outsourcing
6.3. Outsourcing Models
6.3.1. Transactional Outsourcing Model
6.3.2. Performance-based Business Model
6.3.3. Outcome-based Business Model
6.3.4. Staff Augmentation Model
6.3.5. Phase-Dependent Outsourcing Model
6.4. Selecting an Appropriate Outsourcing Model
6.5. Selecting a CRO Partner
6.6. Role of CROs in Drug Development
6.6.1. Discovery and Preclinical Research
6.6.2. Early Clinical Research
6.6.3. Clinical Research and Laboratory Services
6.6.4. Key Considerations for Outsourcing Cell and Gene Therapy Operations
6.7. Concluding Remarks
7. MARKET LANDSCAPE
7.1. Chapter Overview
7.2. Cell and Gene Therapy CROs: Overall Market Landscape
7.2.1. Analysis by Year of Establishment
7.2.2. Analysis by Company Size
7.2.3. Analysis by Location of Headquarters
7.2.4. Analysis by Area of Expertise
7.2.5. Analysis by Type of Cell Therapy
7.2.6. Analysis by Scale of Operation
7.2.7. Analysis by Type of Preclinical Services Offered
7.2.8. Analysis by Type of Clinical Services Offered
7.2.9. Analysis by Type of Regulatory Services Offered
7.2.10. Analysis by Type of General Support Services Offered
8. COMPANY PROFILES
8.1. Chapter Overview
8.2. Aixial
8.2.1. Company Overview
8.2.2. Service Portfolio
8.2.3. Recent Developments and Future Outlook
8.3. Altasciences
8.3.1. Company Overview
8.3.2. Service Portfolio
8.3.3. Recent Developments and Future Outlook
8.4. CMIC
8.4.1. Company Overview
8.4.2. Financial Information
8.4.3. Service Portfolio
8.4.4. Recent Developments and Future Outlook
8.5. ICON
8.5.1. Company Overview
8.5.2. Service Portfolio
8.5.3. Recent Developments and Future Outlook
8.6. Labcorp
8.6.1. Company Overview
8.6.2. Financial Information
8.6.3. Service Portfolio
8.6.4. Recent Developments and Future Outlook
8.7. Linical
8.7.1. Company Overview
8.7.2. Financial Information
8.7.3. Service Portfolio
8.7.4. Recent Developments and Future Outlook
8.8. Medpace
8.8.1. Company Overview
8.8.2. Financial Information
8.8.3. Service Portfolio
8.8.4. Recent Developments and Future Outlook
8.9. Novotech
8.9.1. Company Overview
8.9.2. Service Portfolio
8.9.3. Recent Developments and Future Outlook
8.10. PPD
8.10.1. Company Overview
8.10.2. Service Portfolio
8.10.3. Recent Developments and Future Outlook
8.11. Precision for Medicine
8.11.1. Company Overview
8.11.2. Service Portfolio
8.11.3. Recent Developments and Future Outlook
8.12. QPS
8.12.1. Company Overview
8.12.2. Service Portfolio
8.12.3. Recent Developments and Future Outlook
8.13. Syneos Health
8.13.1. Company Overview
8.13.2. Financial Information
8.13.3. Service Portfolio
8.13.4. Recent Developments and Future Outlook
9. BENCHMARKING ANALYSIS
9.1. Chapter Overview
9.2. Key Assumptions and Methodology
9.3. Cell and Gene Therapy CROs: Benchmark Analysis
9.3.1. Benchmarking Analysis of Small Players based in North America (Peer Group I)
9.3.2. Benchmarking Analysis of Mid-sized Players based in North America (Peer Group II)
9.3.3. Benchmarking Analysis of Large and Very Large Players based in North America (Peer Group III)
9.3.4. Benchmarking Analysis of Small Players based in Europe (Peer Group IV)
9.3.5. Benchmarking Analysis of Mid-sized Players based in Europe (Peer Group V)
9.3.6. Benchmarking Analysis of Large and Very Large Players based in Europe (Peer Group VI)
9.3.7. Benchmarking Analysis of Small, Mid-sized, Large and Very Large Players based in Asia-Pacific (Peer Group VII)
9.3.8. Benchmarking Analysis of Small and Mid-sized Players based in Rest of the World (Peer Group VIII)
9.4. Concluding Remarks
10. PARTNERSHIPS AND COLLABORATIONS
10.1. Chapter Overview
10.2. Partnership Models
10.3. Cell and Gene Therapy Contract Research Organizations: Partnerships and Collaborations
10.3.1. Analysis by Year of Partnership
10.3.2. Analysis by Type of Partnership
10.3.3. Analysis by Year and Type of Partnership
10.3.4. Analysis by Area of Expertise
10.3.5. Most Active Players: Analysis by Number of Partnerships
10.3.6. Analysis by Geography
10.3.6.1. Intracontinental and Intercontinental Agreements
10.3.6.2. Local and International Agreements
11. MERGERS AND ACQUISITIONS
11.1. Chapter Overview
11.2. Merger and Acquisition Models
11.3. Cell and Gene Therapy CROs: Mergers and Acquisitions
11.3.1. Cumulative Year-wise Trend of Mergers and Acquisitions
11.3.2. Analysis by Type of Agreement
11.3.3. Analysis by Key Value Drivers
11.3.4. Analysis by Year of Agreement and Key Value Drivers
11.3.5. Most Active Acquirers: Analysis by Number of Acquisitions
11.3.6. Analysis by Geography
11.3.6.1. Local and International Mergers and Acquisitions
11.3.6.2. Intracontinental and Intercontinental Mergers and Acquisitions
11.3.7. Key Acquisitions: Deal Multiples
12. KEY ACQUISITION TARGETS
12.1. Chapter Overview
12.2. Key Assumptions and Parameters
12.3. Scope and Methodology
12.4. Potential Strategic Acquisition Targets Amongst Small Players
