의약품 임상시험 수탁기관(CRO) 서비스 시장 : 업계 동향과 세계 예측 - 사업 규모별, 대상 치료 영역별, 주요 지역별
Pharma Contract Research Organization Services Market: Industry Trends and Global Forecasts - Distribution by Scale of Operation, Target Therapeutic Area and Key Geographies
상품코드:1762530
리서치사:Roots Analysis
발행일:2025년 07월
페이지 정보:영문 503 Pages
라이선스 & 가격 (부가세 별도)
한글목차
의약품 임상시험 수탁기관(CRO) 서비스 시장 : 개요
세계의 의약품 임상시험 수탁기관(CRO) 서비스 시장 규모는 올해 250억 달러에 달했습니다. 이 시장은 예측 기간 중 10%의 유리한 CAGR로 성장할 것으로 예측됩니다.
시장 세분화에서는 시장 규모와 기회 분석을 다음과 같은 매개 변수로 구분합니다.
사업 규모
탐색 서비스
전임상 서비스
임상 단계 서비스
대상 치료 영역
순환기 질환
피부질환
감염성 질환
염증성 질환
신경질환
종양학 질환
안과 질환
호흡기 질환
기타 질환
주요 지역
북미
유럽
아시아태평양
라틴아메리카
중동 및 북아프리카
기타 지역
의약품 임상시험 수탁기관(CRO) 시장 : 성장과 동향
의약품 개발의 전체 과정은 유망한 약리학적 후보물질을 발굴하는 것부터 시작하여 임상적으로 승인된 제품을 시장에 출시하는 것까지입니다. 이 전체 과정은 약 10-15년에 진행됩니다. 또한 임상 연구와 신약 개발 모두 막대한 자금이 필요하며, 평균 투자 금액은 40억 달러에서 100억 달러에 달할 전망입니다. 따라서 신약개발과 연구개발에는 막대한 자본과 복잡한 인프라가 필요하므로 혁신기업은 제약회사에 대한 의존도가 높아지고 있습니다.
제약 시장에서의 아웃소싱 증가 추세는 CRO가 제공하는 다양한 서비스와 임상 연구 일정을 최적화할 수 있는 능력에 기인합니다. 또한 CRO는 맞춤형 서비스, 비용 절감, 첨단 기술에 대한 접근성 등 여러 가지 이점을 제공하므로 많은 제약회사들이 연구 업무를 아웃소싱하고 있습니다. 또한 새로운 치료제에 대한 수요가 계속 진화하는 가운데, CRO는 맞춤형 서비스 및 맞춤형 의료와 같은 새로운 동향을 주도할 것으로 예측됩니다.
CRO(의약품 임상시험 수탁기관) 서비스 시장 : 주요 인사이트
이 보고서는 세계 CRO(의약품 임상시험 수탁기관) 서비스 시장의 현황을 조사하고, 잠재적인 성장 기회를 파악하고자 작성되었습니다. 이 보고서의 주요 조사 결과는 다음과 같습니다.
현재 여러 업계 진입자들은 다양한 의약품 개입에 필요한 광범위한 위탁 연구 서비스 및 임상시험 지원을 제공하는 데 필요한 역량을 갖추고 있다고 주장하고 있습니다.
시장은 파편화되어 있으며, 여러 치료 영역과 다양한 사업 규모로 연구수탁 서비스를 제공하는 기존 기업과 소규모 기업 모두 존재합니다.
40% 이상의 기업이 2010년 이후 설립되었습니다. Works, Celerion, Concept Life Sciences, Molecular Forecaster, ProRelix Research 등이 있습니다.
대부분의 이해관계자들은 다양한 암, 신경질환, 심혈관질환 치료를 위한 저분자 약리학적 개입의 연구개발 서비스를 제공합니다.
다양한 임상 연구 서비스 중, 회사는 주로 임상시험 관리, 의학 글쓰기, 약물감시 연구, 생물 통계, 데이터 관리 서비스 지원을 제공합니다.
고객 및 이해관계자의 진화하는 임상연구 관련 니즈에 대응하기 위해, 이해관계자들은 전 세계 선진국과 개발도상국 모두에서 입지를 다지고 있습니다.
서비스 프로바이더들은 경쟁 우위를 확보하기 위해 기존 역량을 적극적으로 업그레이드하고 새로운 역량을 추가하여 포트폴리오를 강화하고 기존 벤치마크를 준수하고 있습니다.
이 분야에 대한 이해관계자들의 관심이 높아짐에 따라 파트너십이 증가하고 있으며, 2018년 이후 업계 진입기업은 CRO와 여러 전략적 계약을 체결하고 있습니다.
파트너십 활동은 지정된 기간 중 CAGR 15%로 증가했으며, 대부분의 사례는 기업 인수와 관련이 있었습니다.
과거에는 기존 기업이나 신규 진출기업 모두 암이나 신경질환과 관련하여 여러 전략적 제휴를 맺은 바 있습니다.
북미와 유럽의 기존 기업은 전략적 인수를 통해 시장에서의 입지를 적극적으로 강화하고 있으며, 포트폴리오 및 지역적 확장이 주요 가치 창출 요인 중 하나로 작용하고 있습니다.
현재 바이오의약품 CRO 시장 상황은 전통적 기업 및 전문 서비스 프로바이더들의 서비스가 충실하여 성장의 기회로 작용하고 있습니다.
연구개발 수탁기업의 3분의 2 이상이 북미와 유럽에 기반을 두고 있으며, 대부분 중소기업입니다.
CRO의 약 20%는 임상 및 전임상 규모의 생물제제 연구 서비스를 제공하고 있으며, Alliance Pharma, Covance 등이 그 예입니다.
전체의 약 50%는 임상 서비스만을 제공하고 있으며, 그 중 12%의 CRO는 생물제제 임상연구와 관련된 모든 서비스를 제공합니다.
당사의 독자적인 총소유비용 모델을 통해 20년 동안 다양한 지역에서 개발업무위탁시설을 설립할 때 소요되는 직간접적인 비용을 대략적으로 파악할 수 있습니다.
제약 CRO 시장은 연간 10%의 성장률을 보일 것으로 예상되며, 사업 규모, 치료 분야, 주요 지역별로 그 기회는 충분히 분산되어 있을 것으로 예측됩니다.
의약품 임상시험 수탁기관(CRO) 서비스 시장의 참여 기업 예
Albany Molecular Research(AMRI)
BioDuro
BOC Sciences
Catalent Pharma
Charles River Laboratories
ChemDiv
Covance
Medpace
QPS
Concept Life Sciences
Evotec
ChemPartner
Pharmaron
Syngene
Torrent Pharma
WuXi AppTec
목차
제1장 서문
제2장 개요
제3장 서론
챕터 개요
의약품 개발의 개요
Drug Discovery 프로세스
소분자 발견에 수반하는 과제
Drug Discovery 업무 아웃소싱의 필요성
계약 조사 서비스 프로바이더의 선택에 관한 가이드라인
결론
제4장 의약품 수탁 개발 서비스 프로바이더 : 시장 구도
챕터 개요
의약품 수탁 개발 서비스 프로바이더 : 업계 참여 기업 리스트
제5장 기업 개요
챕터 개요
북미의 의약품 임상시험 수탁기관 서비스 프로바이더
Albany Molecular Research(AMRI)
BioDuro
BOC Sciences
Catalent Pharma
Charles River Laboratories
ChemDiv
Covance
Medpace
QPS
유럽의 의약품 임상시험 수탁기관 서비스 프로바이더
Concept Life Sciences
Evotec
아시아태평양의 의약품 임상시험 수탁기관 서비스 프로바이더
ChemPartner
Pharmaron
Syngene
Torrent Pharma
WuXi AppTec
제6장 기업 경쟁력 분석
챕터 개요
조사 방법
주요 파라미터
기업 경쟁력 분석 : 의약품 수탁 개발 서비스 프로바이더
제7장 파트너십과 협업
챕터 개요
파트너십 모델
의약품 수탁 개발 서비스 프로바이더 : 파트너십 및 협업 리스트
제8장 합병과 인수
제9장 시장 예측과 기회 분석
챕터 개요
예측 조사 방법과 주요 전제조건
세계의 의약품 수탁 개발 서비스 프로바이더 시장(-2035년)
2035년까지의 세계 의약품 수탁 개발 서비스 프로바이더 시장 : 사업 규모별
2035년까지의 세계 의약품 수탁 개발 서비스 프로바이더 시장 : 대상 치료 영역별
2035년까지의 세계 의약품 수탁 개발 서비스 프로바이더 시장 : 지역별
제10장 의약품 수탁 개발 기관에서 총소유 비용
제11장 사례 연구 : 바이오의약품 수탁 개발 서비스 시장
챕터 개요
바이오의약품 CRO : 시장 구도
전임상 바이오의약품 CRO
임상 바이오의약품 CRO
제12장 이그제큐티브 인사이트
제13장 결론
제14장 부록 1 : 표형식 데이터
KSA
영문 목차
영문목차
PHARMA CONTRACT RESEARCH ORGANIZATION (CRO) SERVICES MARKET: OVERVIEW
As per Roots Analysis, the global pharma contract research organization (CRO) services market valued at USD 25 billion in the current year is anticipated to grow at a lucrative CAGR of 10% during the forecast period.
The market sizing and opportunity analysis has been segmented across the following parameters:
Scale of Operation
Discovery Services
Preclinical Services
Clinical Stage Services
Target Therapeutic Area
Cardiovascular Disorders
Dermatological Disorders
Infectious Disorders
Inflammatory Disorders
Neurological Disorders
Oncological Disorders
Ophthalmological Disorders
Respiratory Disorders
Other Disorders
Key Geographies
North America
Europe
Asia- Pacific
Latin America
Middle East and North Africa
Rest of the World
PHARMA CONTRACT RESEARCH ORGANIZATION (CRO) SERVICES MARKET: GROWTH AND TRENDS
The overall drug development process starts from identifying a promising pharmacological candidate to bringing a clinically approved product to market. This entire process spans around 10 to 15 years. Additionally, both clinical research and drug discovery demand substantial financial resources, with average investments ranging from USD 4 to 10 billion. Therefore, owing to the prohibitive capital investments and complex infrastructure requirements for drug discovery and development, the innovators are increasingly relying on the pharmaceutical contract research service providers.
The rising trend of outsourcing in the pharmaceuticals market can be attributed to the variety of services offered by CROs, and their ability to optimize the clinical research timeline. Moreover, CROs provide several benefits including customized services, reduced costs and access to advanced technologies that have prompted a number of pharmaceutical companies to outsource their research operations. Further, as the demand for novel therapeutics continues to evolve, CROs are expected to navigate through the emerging trends, such as customized services and personalized medicine.
PHARMA CONTRACT RESEARCH ORGANIZATION (CRO) SERVICES MARKET: KEY INSIGHTS
The report delves into the current state of the global pharma contract research organization (CRO) services market and identifies potential growth opportunities within industry. Some key findings from the report include:
Presently, several industry players claim to have the necessary capabilities to provide a wide range of contract research services and clinical trial support for a variety of pharmaceutical interventions.
The market is fragmented, featuring the presence of both established players and small firms that offer contract research services, encompassing multiple therapeutic areas and at different scales of operation.
More than 40% of players were established post 2010; examples of such companies include Assay.Works, Celerion, Concept Life Sciences, Molecular Forecaster and ProRelix Research.
Majority of the stakeholders offer services for research and development of small molecule pharmacological interventions for the treatment of various oncological, neurological and cardiovascular disorders.
Amongst the various clinical research services, companies primarily offer support for clinical trial management, medical writing, pharmacovigilance studies, biostatistics and data management services.
To cater to the evolving clinical research-related needs of clients / sponsors, stakeholders have established their presence in both developed and developing regions of the world.
In pursuit of gaining a competitive edge, service providers are actively upgrading their existing capabilities and adding new competencies in order to augment their respective portfolios and comply to existing benchmarks.
The rising interest of stakeholders in this domain is also reflected in the increase in partnerships; since 2018, industry players have entered into multiple strategic agreements with CROs.
The partnership activity has increased at a CAGR of 15% during the given time period; majority of the instances were related to acquisition of companies.
In the past, both established players and new entrants have forged multiple strategic partnerships for oncological and neurological disorders.
Established players in North America and Europe are actively consolidating their presence in the market through strategic acquisitions; portfolio and geographical expansion are amongst the key value drivers.
The current biopharmaceutical CRO market landscape is a growing opportunity area, well served via well-established players and specialty service providers.
More than two-thirds of the contract research service providers are based in North America and Europe; most of these players are small and mid-sized companies.
Close to 20% of the CROs provide research services for biologics at the clinical and preclinical scales; examples include Alliance Pharma, and Covance.
About 50% of the overall players offer only clinical services; of these, 12% CROs provide all the services associated with clinical research of biologics.
Our proprietary total cost of ownership model suggests an informed estimate of direct and indirect expenses while setting up a contract research facility in different regions over a span of 20 years.
The pharmaceutical CROs market is projected to grow at an annualized rate of 10% and the opportunity is expected to be well distributed across different scales of operation, therapeutic areas and key geographies.
Example Players in the Pharma Contract Research Organization (CRO) Services Market
Albany Molecular Research (AMRI)
BioDuro
BOC Sciences
Catalent Pharma
Charles River Laboratories
ChemDiv
Covance
Medpace
QPS
Concept Life Sciences
Evotec
ChemPartner
Pharmaron
Syngene
Torrent Pharma
WuXi AppTec
PHARMA CONTRACT RESEARCH ORGANIZATION (CRO) SERVICES MARKET: RESEARCH COVERAGE
Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the pharma contract research organization (CRO) services market, focusing on key market segments, including [A] scale of operation, [B] target therapeutic area and [C] key geographies.
Market Landscape: A comprehensive evaluation of the companies offering pharmaceutical contract research services, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] scale of operation, [D] location of headquarters, [E] type(s) of services offered, [F] hit identification strategy used, [G] type of business model and [H] target therapeutic area.
Company Profiles: In-depth profiles of the pharma CRO companies offering pharmaceutical related services, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio and [D] recent developments and an informed future outlook.
Company Competitiveness Analysis: A comprehensive competitive analysis of pharma CRO companies, examining factors, such as [A] supplier strength and [B] service strength.
Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the pharma CRO market, based on several parameters, such as [A] year of agreement, [B] type of agreement, [C] scale of operation and [D] target therapeutic area.
Mergers and Acquisitions: An in-depth analysis of the mergers and acquisitions undertaken in this domain, based on relevant parameters, such as [A] year of acquisition, [B] type of collaboration and [C] geographical location of the companies.
Total Cost of Ownership in Pharmaceutical Contract Research Organization: An insightful analysis of the total cost of ownership for a pharmaceutical CRO. It features an informed estimate of direct and indirect costs taking into consideration close to 100 relevant parameters over a span of 20 years.
Case Study: A detailed discussion on current market landscape of biopharmaceutical CROs, including information on the [A] year of establishment, [B] company size, [C] scale of operation and [D] type of services offered.
KEY QUESTIONS ANSWERED IN THIS REPORT
How many companies are currently engaged in this market?
Which are the leading companies in this market?
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.
ADDITIONAL BENEFITS
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TABLE OF CONTENTS
1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.2.1. Research Assumptions
1.2.2. Project Methodology
1.2.3. Forecast Methodology
1.2.4. Robust Quality Control
1.2.5. Key Considerations
1.2.5.1. Demographics
1.2.5.2. Economic Factors
1.2.5.3. Government Regulations
1.2.5.4. Supply Chain
1.2.5.5. COVID Impact / Related Factors
1.2.5.6. Market Access
1.2.5.7. Healthcare Policies
1.2.5.8. Industry Consolidation
1.3 Key Questions Answered
1.4. Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
3.1. Chapter Overview
3.2. Overview of Drug Development
3.3. Drug Discovery Process
3.3.1. Target Identification
3.3.2. Target Discovery and Validation
3.3.3. Hit Generation
3.3.3.1. High-Throughput Screening
3.3.3.2. Fragment-based Screening
3.3.3.3. Virtual Screening
3.3.3.4. DNA-Encoded Libraries Screening
3.3.4. Hit-to-Lead and Lead Generation
3.3.5. Lead Optimization
3.4. Challenges Associated with Small Molecule Discovery
3.5. Need for Outsourcing Drug Discovery Operations
3.6. Guidelines for Selecting a Contract Research Service Provider
3.7. Concluding Remarks
4. PHARMACEUTICAL CONTRACT RESEARCH SERVICE PROVIDERS: MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Pharmaceutical Contract Research Service Providers: List of Industry Players
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Scale of Operation
4.2.4. Analysis by Location of Headquarters
4.2.5. Analysis by Company Size and Scale of Operation
4.2.6. Analysis by Types of Services Offered
4.2.7. Analysis by Location of Headquarters and Types of Services Offered
4.2.8. Analysis by Hit Identification Strategy Used
4.2.9. Analysis by Type of Business Model
4.2.10. Analysis by Target Therapeutic Area
5. COMPANY PROFILES
5.1. Chapter Overview
5.2. Pharmaceutical Contract Research Service Providers in North America
5.2.1. Albany Molecular Research (AMRI)
5.2.1.1. Company Overview
5.2.1.2. Financial Information
5.2.1.3. Service Portfolio
5.2.1.4. Recent Developments and Future Outlook
5.2.2. BioDuro
5.2.2.1. Company Overview
5.2.2.2. Service Portfolio
5.2.2.3. Recent Developments and Future Outlook
5.2.3. BOC Sciences
5.2.3.1. Company Overview
5.2.3.2. Service Portfolio
5.2.3.3. Recent Developments and Future Outlook
5.2.4. Catalent Pharma
5.2.4.1. Company Overview
5.2.4.2. Financial Information
5.2.4.3. Service Portfolio
5.2.4.4. Recent Developments and Future Outlook
5.2.5. Charles River Laboratories
5.2.5.1. Company Overview
5.2.5.2. Financial Information
5.2.5.3. Service Portfolio
5.2.5.4. Recent Developments and Future Outlook
5.2.6. ChemDiv
5.2.6.1. Company Overview
5.2.6.2. Service Portfolio
5.2.6.3. Recent Developments and Future Outlook
5.2.7. Covance
5.2.7.1. Company Overview
5.2.7.2. Financial Information
5.2.7.3. Service Portfolio
5.2.7.4. Recent Developments and Future Outlook
5.2.8. Medpace
5.2.8.1. Company Overview
5.2.8.2. Financial Information
5.2.8.3. Service Portfolio
5.2.8.4. Recent Developments and Future Outlook
5.2.9. QPS
5.2.9.1. Company Overview
5.2.9.2. Service Portfolio
5.2.9.3. Recent Developments and Future Outlook
5.3. Pharmaceutical Contract Research Service Providers in Europe
5.3.1. Concept Life Sciences
5.3.1.1. Company Overview
5.3.1.2. Service Portfolio
5.3.1.3. Recent Developments and Future Outlook
5.3.2. Evotec
5.3.2.1. Company Overview
5.3.2.2. Financial Information
5.3.2.3. Service Portfolio
5.3.2.4. Recent Developments and Future Outlook
5.4. Pharmaceutical Contract Research Service Providers in Asia-Pacific
5.4.1. ChemPartner
5.4.1.1. Company Overview
5.4.1.2. Financial Information
5.4.1.3. Service Portfolio
5.4.1.4. Recent Developments and Future Outlook
5.4.2. Pharmaron
5.4.2.1. Company Overview
5.4.2.2. Service Portfolio
5.4.2.3. Recent Developments and Future Outlook
5.4.3. Syngene
5.4.3.1. Company Overview
5.4.3.2. Financial Information
5.4.3.3. Service Portfolio
5.4.3.4. Recent Developments and Future Outlook
5.4.4. Torrent Pharma
5.4.4.1. Company Overview
5.4.4.2. Financial Information
5.4.4.3. Service Portfolio
5.4.4.4. Recent Developments and Future Outlook
5.4.5. WuXi AppTec
5.4.5.1. Company Overview
5.4.5.2. Financial Information
5.4.5.3. Service Portfolio
5.4.5.4. Recent Developments and Future Outlook
6. COMPANY COMPETITIVENESS ANALYSIS
6.1. Chapter Overview
6.2. Methodology
6.3. Key Parameters
6.4. Company Competitiveness Analysis: Pharmaceutical Contract Research Service Providers
6.4.1. Pharmaceutical Contract Research Service Providers based in North America
6.4.2. Pharmaceutical Contract Research Service Providers based in Europe
6.4.3. Pharmaceutical Contract Research Service Providers based in Asia- Pacific and Rest of the World
7. PARTNERSHIPS AND COLLABORATIONS
7.1. Chapter Overview
7.2. Partnership Models
7.3. Pharmaceutical Contract Research Service Providers: List of Partnerships and Collaborations
7.3.1. Analysis by Year of Partnership
7.3.2. Analysis by Type of Partnership
7.3.3. Analysis by Scale of Operation
7.3.4. Analysis by Target Therapeutic Area
7.3.5. Analysis by Year of Partnership and Type of Partner
7.3.6. Analysis by Type of Partnership and Type of Partner
7.3.7. Most Active Players: Analysis by Number of Partnerships
7.3.8. Regional Analysis
7.3.8.1. Intercontinental and Intracontinental Agreements
8. MERGERS AND ACQUISITIONS
8.1. Chapter Overview
8.2. Merger and Acquisition Models
8.3. Pharmaceutical Contract Research Service Providers: Mergers and Acquisitions
8.3.1. Analysis by Year of Acquisition
8.3.2. Analysis by Geography
8.3.3. Intercontinental and Intracontinental Deals
8.4. Analysis by Key Value Drivers
8.4.1. Mergers and Acquisitions: Analysis by Key Value Drivers
