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IVD CRO 시장 분석과 예측 : 유형, 제품, 서비스, 기술, 구성 요소, 용도, 최종 사용자, 스테이지, 프로세스(-2034년)
IVD Contract Research Organization Market Analysis and Forecast to 2034: Type, Product, Services, Technology, Component, Application, End User, Stage, Process
상품코드 : 1740682
리서치사 : Global Insight Services
발행일 : 2025년 06월
페이지 정보 : 영문 301 Pages
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한글목차

IVD CRO 시장은 2024년 64억 달러로 평가되었고, 2034년에는 129억 달러에 이르고, CAGR 약 7.3%로 성장할 것으로 예측됩니다. 이 조직들은 복잡한 규제 환경을 탐색하고 출시 기간을 단축하는 데 전문 지식을 찾고자 하는 IVD 제조업체를 대상으로 합니다.

시장 개요 :

IVD CRO 시장은 체외 진단용 의약품의 복잡화와 규제 요건 증가로 급속히 발전하고 있습니다. 부문의 이점은 대규모 임상시험 및 검증 연구를 필요로 하는 맞춤형 의료가 중시되고 있기 때문에 분자진단이나 포인트 오브 케어 검사에 있어서의 기술적 진보가 이 부문의 성장을 뒷받침하고 있습니다. 부문으로서는 디지털 병리학이나 바이오인포매틱스 서비스가 있어, 진단 정밀도의 향상이나 데이터 분석의 효율화를 기대할 수 있는 점에서 인기를 모으고 있습니다. 주제를 다루는 혁신적인 솔루션을 제공함으로써 시장에 큰 영향을 미칠 것으로 보입니다.

시장 세분화
유형 임상 화학, 면역 측정, 분자진단, 혈액학, 미생물학, 응고 검사, 소변 검사
제품 시약, 키트, 장비, 소프트웨어, 소모품
서비스 분석 개발, 임상시험 관리, 약사 컨설팅, 생물 통계, 데이터 관리, 실험실 서비스, 품질 보증
기술 PCR, NGS, ELISA, 유동세포계측법, 질량분석, 면역조직화학, 마이크로어레이
구성요소 하드웨어, 소프트웨어, 서비스
용도 암, 감염, 심장병, 내분비, 신경, 유전
최종 사용자 제약기업, 생명공학기업, 학술기관, 병원, 진단연구소
무대 전임상, 단계 I, 단계 II, 단계 III, PMS
프로세스 샘플 준비, 검출, 데이터 분석, 보고

주요 동향과 촉진요인 :

IVD CRO 시장은 맞춤형 의료의 진전과 만성 질환의 만연에 힘입어 강력한 성장을 이루고 있습니다. 이에 따라 포인트 오브 케어 검사에 대한 수요가 급증하고 있습니다. 또한, 규제 준수와 품질 보증에 대한 강조가 점점 더 커지고 있으며, 이는 CRO와 의료 제공자 간의 협력을 촉진하고 있습니다. 이 협력은 엄격한 기준을 준수하도록 보장하여 시장 신뢰도를 높입니다. 원격 의료나 디지털 헬스 플랫폼의 확대도, 원활한 데이터 공유와 분석을 촉진하는 큰 원동력이 되고 있습니다. 보다 비용 효율적인 솔루션을 제공하는 기업은 대규모 시장 점유율을 얻는 태세를 갖추고 있습니다. CRO(IVD Contract Research Organization) 시장은 세계 건강 관리의 역동적인 요구에 적응하면서 성장을 이룰 것입니다.

주요 억제요인과 도전

IVD CRO 시장은 현재 몇 가지 중요한 억제요인과 과제를 안고 있습니다. 게다가, 시장은 치열한 경쟁에 직면하고 있으며, 비용을 관리하면서 지속적인 기술 혁신을 수행하는 조직에 압력을 가하고 있습니다. 하지만 동시에 과제이기도 합니다. 진단 기술의 급속한 진화는 끊임없는 적응과 새로운 기능에 대한 투자를 필요로 합니다. IVD 분야의 숙련된 전문가에 대한 수요가 공급을 앞지르면서 채용 비용 증가와 잠재적인 프로젝트 지연이 발생하고 있습니다.

목차

제1장 IVD CRO 시장 개요

제2장 주요 요약

제3장 시장에 관한 중요 인사이트

제4장 IVD CRO 시장 전망

제5장 IVD CRO 시장 전략

제6장 IVD CRO 시장 규모

제7장 IVD CRO 시장 : 유형별

제8장 IVD CRO 시장 : 제품별

제9장 IVD CRO 시장 : 서비스별

제10장 IVD CRO 시장 : 기술별

제11장 IIVD CRO 시장 : 부품별

제12장 IVD CRO 시장 : 용도별

제13장 IVD CRO 시장 : 최종 사용자별

제14장 IVD CRO 시장 : 무대별

제15장 IVD CRO 시장 : 프로세스별

제16장 IVD CRO 시장 : 지역별

제17장 경쟁 구도

제18장 기업 프로파일

SHW
영문 목차

영문목차

IVD Contract Research Organization Market is anticipated to expand from $6.4 billion in 2024 to $12.9 billion by 2034, growing at a CAGR of approximately 7.3%. The market encompasses entities providing specialized research services for in vitro diagnostics, including assay development, clinical trials, and regulatory support. These organizations cater to IVD manufacturers seeking expertise in navigating complex regulatory landscapes and accelerating time-to-market. Increasing demand for personalized medicine and rapid technological advancements are propelling market growth, necessitating robust partnerships and innovative service offerings.

Market Overview:

The IVD Contract Research Organization (CRO) Market is evolving rapidly, driven by the increasing complexity and regulatory requirements of in vitro diagnostics. The clinical research services segment currently leads the market, propelled by the rising demand for comprehensive testing and validation of diagnostic tools. This segment's dominance is attributed to the growing emphasis on personalized medicine, which necessitates extensive clinical trials and validation studies. Additionally, technological advancements in molecular diagnostics and point-of-care testing are bolstering this segment's growth. Emerging sub-segments include digital pathology and bioinformatics services, which are gaining traction due to their potential to enhance diagnostic accuracy and streamline data analysis. These sub-segments are poised to significantly impact the market by offering innovative solutions that address the challenges of data management and interpretation in IVD research. As the industry continues to embrace digital transformation, these emerging areas are likely to drive future growth and redefine market dynamics.

Market Segmentation
TypeClinical Chemistry, Immunoassay, Molecular Diagnostics, Hematology, Microbiology, Coagulation, Urinalysis
ProductReagents, Kits, Instruments, Software, Consumables
ServicesAssay Development, Clinical Trial Management, Regulatory Consulting, Biostatistics, Data Management, Laboratory Services, Quality Assurance
TechnologyPCR, NGS, ELISA, Flow Cytometry, Mass Spectrometry, Immunohistochemistry, Microarrays
ComponentHardware, Software, Services
ApplicationOncology, Infectious Diseases, Cardiology, Endocrinology, Neurology, Genetics
End UserPharmaceutical Companies, Biotechnology Companies, Academic Institutes, Hospitals, Diagnostic Laboratories
StagePreclinical, Phase I, Phase II, Phase III, Post-Market Surveillance
ProcessSample Preparation, Detection, Data Analysis, Reporting

Geographical Overview:

The In Vitro Diagnostics (IVD) Contract Research Organization (CRO) market exhibits distinct regional dynamics. North America stands at the forefront, propelled by robust healthcare infrastructure and a strong focus on research and innovation. The region's established regulatory framework further supports market growth. Europe follows as a significant player, driven by increasing demand for advanced diagnostic solutions and a supportive regulatory environment. The region's emphasis on quality and technological advancements enhances market prospects. In the Asia Pacific, the IVD CRO market is rapidly expanding. This growth is fueled by rising healthcare expenditures and a burgeoning population demanding improved healthcare services. Governments in the region are investing heavily in healthcare infrastructure, creating lucrative opportunities for market players. Latin America presents emerging prospects, with increasing investments in healthcare and diagnostic research. The region's growing awareness of personalized medicine is also contributing to market expansion. The Middle East & Africa are witnessing gradual growth in the IVD CRO market. This is driven by an increasing focus on healthcare modernization and the adoption of advanced diagnostic technologies. The region's efforts to enhance healthcare accessibility and quality are paving the way for future market opportunities. Each region's unique dynamics offer distinct opportunities for stakeholders in the IVD CRO market, highlighting the importance of tailored strategies to capitalize on regional growth trends.

Recent Developments:

The IVD Contract Research Organization Market has witnessed substantial activity and developments in recent months. Firstly, Eurofins Scientific has announced a strategic acquisition of a prominent IVD CRO in Asia, aiming to expand its global footprint and enhance its service offerings in the diagnostics sector. Secondly, ICON plc entered into a joint venture with a leading biotechnology firm to accelerate the development of novel diagnostic assays, leveraging cutting-edge technologies to meet increasing market demands. Thirdly, Labcorp unveiled a new suite of advanced IVD testing services, focusing on personalized medicine and precision diagnostics, which is expected to significantly enhance patient outcomes. Fourthly, Charles River Laboratories reported a robust financial quarter, attributed to the rising demand for IVD CRO services, and announced plans to further invest in state-of-the-art facilities. Lastly, the FDA has introduced new regulatory guidelines aimed at streamlining the approval process for innovative IVD products, which is anticipated to foster increased innovation and market growth. These developments underscore the dynamic nature of the IVD CRO market and its critical role in advancing diagnostic solutions.

Key Companies:

Charles River Laboratories, Eurofins Scientific, Medpace, ICON plc, Parexel International, Syneos Health, Wu Xi App Tec, PPD, Quintiles, Covance, Bio Agilytix Labs, PRA Health Sciences, Labcorp Drug Development, Toxikon, Envigo, Frontage Laboratories, Pace Analytical, Altasciences, Medelis, QPS

Key Trends and Drivers:

The IVD Contract Research Organization Market is experiencing robust growth, propelled by advancements in personalized medicine and the rising prevalence of chronic diseases. Key trends include the integration of artificial intelligence in diagnostics, enhancing precision and efficiency. The demand for point-of-care testing is surging, driven by the need for rapid and accurate results, especially in remote and underserved areas. Moreover, there is an increasing emphasis on regulatory compliance and quality assurance, which is fostering collaborations between CROs and healthcare providers. This collaboration ensures adherence to stringent standards, thereby boosting market credibility. The expansion of telemedicine and digital health platforms is also a significant driver, facilitating seamless data sharing and analysis. Opportunities abound in emerging markets where healthcare infrastructure is developing rapidly. Companies that offer innovative, cost-effective solutions are poised to capture significant market share. Additionally, the trend towards decentralized clinical trials is gaining traction, providing CROs with new avenues for growth and diversification. With the ongoing evolution of healthcare delivery models, the IVD Contract Research Organization Market is set to thrive, adapting to the dynamic needs of the global healthcare landscape.

Key Restraints and Challenges:

The IVD Contract Research Organization Market is currently navigating several significant restraints and challenges. Regulatory complexities are a primary concern, as varying international standards complicate compliance and increase operational costs. This deters entry and expansion into new markets. Additionally, the market faces intense competition, which pressures organizations to continuously innovate while managing costs. This competition can stifle smaller players who lack the resources to keep pace. Technological advancements, while beneficial, also present challenges. The rapid evolution of diagnostic technologies requires constant adaptation and investment in new capabilities. This can strain financial resources and operational capacity. Furthermore, talent acquisition remains a persistent issue. The demand for skilled professionals in the IVD sector outpaces supply, leading to increased hiring costs and potential project delays. Lastly, economic fluctuations and healthcare budget constraints can influence market growth. Organizations must navigate these financial uncertainties, which can impact investment in research and development initiatives.

Sources:

World Health Organization, U.S. Food and Drug Administration, European Medicines Agency, National Institutes of Health, Centers for Disease Control and Prevention, World Bank - Health Nutrition and Population Statistics, Organization for Economic Co-operation and Development - Health Statistics, International Federation of Clinical Chemistry and Laboratory Medicine, American Association for Clinical Chemistry, Clinical and Laboratory Standards Institute, Global Health Council, Health Level Seven International, International Society for Clinical Laboratory Automation, European Society of Clinical Microbiology and Infectious Diseases, International Conference on Clinical and Medical Case Reports, American Society for Microbiology, International Union of Pure and Applied Chemistry, International Conference on Biomedical and Clinical Research, European Society of Pathology, World Congress on Pathology and Laboratory Medicine

Research Scope:

Our research scope provides comprehensive market data, insights, and analysis across a variety of critical areas. We cover Local Market Analysis, assessing consumer demographics, purchasing behaviors, and market size within specific regions to identify growth opportunities. Our Local Competition Review offers a detailed evaluation of competitors, including their strengths, weaknesses, and market positioning. We also conduct Local Regulatory Reviews to ensure businesses comply with relevant laws and regulations. Industry Analysis provides an in-depth look at market dynamics, key players, and trends. Additionally, we offer Cross-Segmental Analysis to identify synergies between different market segments, as well as Production-Consumption and Demand-Supply Analysis to optimize supply chain efficiency. Our Import-Export Analysis helps businesses navigate global trade environments by evaluating trade flows and policies. These insights empower clients to make informed strategic decisions, mitigate risks, and capitalize on market opportunities.

TABLE OF CONTENTS

1: IVD Contract Research Organization Market Overview

2: Executive Summary

3: Premium Insights on the Market

4: IVD Contract Research Organization Market Outlook

5: IVD Contract Research Organization IVD Contract Research Organization Market Strategy

6: IVD Contract Research Organization Market Size

7: IVD Contract Research Organization Market, by Type

8: IVD Contract Research Organization Market, by Product

9: IVD Contract Research Organization Market, by Services

10: IVD Contract Research Organization Market, by Technology

11: IVD Contract Research Organization Market, by Component

12: IVD Contract Research Organization Market, by Application

13: IVD Contract Research Organization Market, by End User

14: IVD Contract Research Organization Market, by Stage

15: IVD Contract Research Organization Market, by Process

16: IVD Contract Research Organization Market, by Region

17: Competitive Landscape

18: Company Profiles

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