市场调查报告书
商品编码
1466557
中心实验室市场:按服务类型、阶段、治疗领域和最终用途分类 - 全球预测 2024-2030Central Lab Market by Service Type (Anatomic Pathology/Histology, Biomarker Services, Genetic Services), Phase (Phase 1, Phase 2, Phase 3), Therapeutic Area, End-use - Global Forecast 2024-2030 |
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预计2023年中心实验室市场规模为31.1亿美元,预计2024年将达33.8亿美元,2030年将达57.8亿美元,复合年增长率为9.25%。
中心实验室作为卓越中心,为世界各地的各种临床试验设施提供高品质、标准化的检测服务。这些实验室在确保资料完整性、一致性和可靠性方面发挥着至关重要的作用,这是有效临床研究和开发的先决条件。由于对专业检测服务的需求不断增长、全球临床试验的激增以及製药行业对外包以提高效率和专注于核心能力的重视,对中心实验室的需求也在不断增长。然而,製药业面临营运成本高、监管复杂、全球营运标准化等挑战。中央实验室透过利用技术进步、建立策略合作伙伴关係和加强其地理影响力来解决这些限制,以提供本地服务,同时保持国际标准。生物标记服务的扩展、个人化医疗以及预测分析人工智慧的整合标誌着 Central Lab 在不断发展的临床研究领域的发展轨迹。
主要市场统计 | |
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基准年[2023] | 31.1亿美元 |
预测年份 [2024] | 33.8亿美元 |
预测年份 [2030] | 57.8亿美元 |
复合年增长率(%) | 9.25% |
服务类型 优先选择中央实验室,在受控条件下长期储存生物样本以进行特定管理
解剖病理学和组织学服务包括检查身体组织以发现疾病。这些服务对于诊断各种类型的癌症和慢性病至关重要。生物标记服务可辨识组织、血液和其他体液中的生物标记,以诊断疾病、监测疾病进展并预测治疗效果。遗传服务提供基于 DNA 的检测,包括序列测定和基因分型,以识别遗传疾病、易感性和疾病携带者状态。微生物学服务对于识别和表征微生物以预防和治疗感染疾病至关重要。中心实验室确保这些程序的安全性并遵守全球卫生法规。专业化学服务进行复杂的生化分析,以检测荷尔蒙失衡、营养缺乏和有害物质。检体管理和储存服务确保用于研究和诊断的生物样本的完整性。中心实验室提供专业化学服务和用于检体管理的安全检体储存解决方案。
中心实验室在整个临床试验过程中的关键作用
中心实验室在临床试验各个阶段的成功和管理中发挥着至关重要的作用。实验室的参与可确保测试结果的准确性、可靠性和标准化,这对于监管核准流程和整个临床开发计划的成功至关重要。第一阶段的重点在于评估药物的安全性,中心实验室利用生物样本评估药物的药物动力学(PK)、动态(PD),并监测不利事件的收集和分析。中心实验室的标准化流程以最高精度评估药物的初始安全性,并促进无缝过渡到下一阶段。在第二阶段,中心实验室将继续评估药物的安全性,同时开始评估对更多患有相关疾病或病症的患者群体的疗效。为了衡量药物的有效性并更好地了解其作用机制,通常会进行更复杂的分析,包括多种生物标记和专门测试。中心实验室现阶段所获得的资料对于规划3期试验至关重要。第三阶段涉及大规模试验,以证明该药物的有效性并监测不同人群的副作用。中央实验室管理在多个国际站点创建的大量资料。儘管分布广泛,中央实验室的全球网路和严格的品管通讯协定确保了结果的一致性和标准化。这种一致性对于监管提交至关重要。此外,中心实验室在长期药物监测、评估现实世界的疗效和安全性方面发挥着重要作用。进行专门的试验并收集可以识别罕见副作用和益处的资料可以导致标籤的变化和临床实践指南的调整。
最终用途:必须促进无缝临床试验并确保製药公司的资料完整性和卓越营运。
学术研究机构主要利用研究服务来推广科学研究和实现教育目标。他们的主要目的是利用先进的分析能力和技术,而这些能力和技术通常在经济上无法在内部维护。这些实验室优先考虑高品质、准确的结果和技术主导的解决方案,以支持从生物医学研究到环境调查的各种研究项目。病理学和诊断实验室经常利用中心实验室进行高级测试,由于设备成本和专业知识的需要,这些测试很难在内部进行。与中央实验室的合作使诊断病理学实验室能够透过提供高通量测试技术并确保测试品质和可靠性来满足快速週转时间的需求。生技公司,尤其是处于早期和开发阶段的生技公司,希望中央实验室能够扩大其研发能力,而无需对自己的设施进行大量投资。对于这些公司来说,不同司法管辖区的周转时间、扩充性和监管合规性方面的专业知识至关重要。他们通常需要专业服务,例如生物标记开发、细胞/基因治疗评估和个人化医疗支援。製药公司在整个药物开发週期(从药物发现到上市后监督)广泛使用中央实验室服务。关键考虑因素包括全球企业发展、物流能力、资料管理能力以及监管合规记录。 Central Lab Pharmaceuticals 专注于支援多中心、全球临床试验的端到端解决方案。
癌症和感染疾病治疗领域的综合诊断和预后测试
中心实验室检测服务透过促进临床试验各阶段的准确和标准化检测,在推进和支持治疗领域方面发挥着至关重要的作用。中心实验室口语服务在多个关键领域发挥着重要作用,显着影响治疗方法和推进医学知识。这些实验室为自体免疫疾病提供准确诊断和疾病管理的基本服务,包括自体抗体分析和细胞激素分析。在对抗心血管疾病的过程中,评估心血管生物标记物,例如脂质谱和心肌损伤标记物,有助于早期发现和优化患者照护。中心实验室的能力对于感染疾病控制也至关重要,它提供了控制疫情和评估治疗性介入所需的先进诊断和监测工具。对于神经系统疾病,生物标记特异性测试可以深入了解阿兹海默症和帕金森氏症等疾病,支持早期诊断和新治疗方法。此外,在肿瘤学领域,中心实验室提供肿瘤标记分析、基因组分析等全面的诊断和预后检测,推动个人化医疗的进步。中心实验室的标准化和先进服务是改善病患治疗效果和加速这些关键治疗领域的医学研究的基础。
区域洞察
在美洲,在临床试验激增和强大的研发基础设施的推动下,中心实验室市场呈现强劲成长。先进诊断和生物标记开发的重要性日益增加,正在加速对美洲中心实验室的投资。在医疗保健投资增加、对监管合规性的日益关注以及促进技术转移和能力建设的全球战略合作伙伴关係的推动下,亚太地区以其快速扩张而脱颖而出。向精准医学的转变为亚太地区充满活力且相互关联的全球中心实验室生态系统奠定了基础。欧洲、中东和非洲是一个发达的市场,拥有严格的监管架构和高度统一的检验实践。该地区受益于药物研究的历史、高技能的劳动力和创新,特别是在个人化医疗方面。
FPNV定位矩阵
FPNV定位矩阵对于评估Central Lab市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对中央实验室市场供应商的现状进行深入而详细的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1. 中心实验室市场的市场规模与预测是多少?
2.在中心实验室市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3. 中心实验室市场的技术趋势和法规结构是什么?
4.中心实验室市场主要厂商的市场占有率是多少?
5. 进入中心实验室市场的适当型态和策略手段是什么?
[182 Pages Report] The Central Lab Market size was estimated at USD 3.11 billion in 2023 and expected to reach USD 3.38 billion in 2024, at a CAGR 9.25% to reach USD 5.78 billion by 2030.
A central lab operates as a core facility providing high-quality and standardized testing services across various clinical trial sites globally. These labs are pivotal for ensuring data integrity, consistency, and reliability, a prerequisite for effective clinical research and development. The increasing need for specialized testing services, the surge in clinical trials worldwide, and the pharmaceutical industry's emphasis on outsourcing to enhance efficiency and focus on core competencies are expanding the need for central labs. However, the sector faces restraints such as high operational costs, regulatory complexities, and the challenge of maintaining standardization across global operations. Central labs leverage technological advancements, establish strategic partnerships, and enhance their geographical presence to provide localized services while maintaining international standards to address these restraints. The expansion of biomarker services, personalized medicine, and the integration of artificial intelligence for predictive analysis are setting a trajectory for central labs in the evolving clinical research landscape.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 3.11 billion |
Estimated Year [2024] | USD 3.38 billion |
Forecast Year [2030] | USD 5.78 billion |
CAGR (%) | 9.25% |
Services Type: Preference for central labs for long-term storage of biological samples under controlled conditions for specific management
Anatomic pathology and histology services encompass examining bodily tissues to detect diseases. These services are vital for diagnosing various types of cancers and chronic diseases. Biomarker services focus on identifying biological markers in tissues, blood, and other body fluids to diagnose diseases, monitor disease progression, and predict treatment response. Genetic services provide DNA-based testing, including sequencing and genotyping, to identify genetic disorders, predispositions, and carrier statuses for diseases. Microbiology services are essential for identifying and characterizing microorganisms to prevent and treat infections. Central labs ensure the safety and compliance of these procedures with health regulations stated worldwide. Special chemistry services involve complex biochemical analyses to detect hormonal imbalances, nutritional deficiencies, and toxic substances. Specimen management and storage services ensure the integrity of biological samples for research and diagnostics. Central labs offer secure sample storage solutions for specialty chemical services and specimen management.
Phase: Integral role of the central labs for the execution of the entire clinical trial process
Central laboratories play a pivotal role in the successful execution and management of clinical trials across all phases. Their involvement ensures the accuracy, reliability, and standardization of laboratory results, which are essential for the regulatory approval process and the overall success of the clinical development program. In Phase I, the primary focus is on assessing a drug's safety, where central labs collect and analyze biological samples to evaluate the drug's pharmacokinetics (PK), pharmacodynamics (PD), and monitor adverse events. Their standardized processes ensure that the early safety profile of the drug is assessed with the highest accuracy, facilitating a seamless transition to the subsequent phase. During Phase 2, central labs continue to assess the drug's safety while beginning to evaluate its efficacy in a larger patient population with the targeted disease or condition. They perform more complex analyses, often involving multiple biomarkers and specialized tests to measure the drug's effect and further understand its mechanism of action. The data generated by central labs at this stage are critical for planning Phase 3 studies. Phase 3 involves large-scale testing to conclusively demonstrate the drug's efficacy and monitor its side effects in diverse populations. Central labs manage a vast amount of data generated across multiple international sites. Despite the geographical spread, they ensure consistency and standardization of results through their global network and stringent quality control protocols. This uniformity is crucial for regulatory submissions. Moreover, central labs play a vital role in long-term drug surveillance, assessing its real-world effectiveness and safety profile. They conduct specialized tests and gather data that can identify rare side effects or benefits, which may result in label changes or adjustments in clinical practice guidelines.
End-use: Need to facilitate seamless clinical trials, ensuring data integrity and operational excellence for pharmaceutical companies
Academic and research institutes predominantly engage central lab services to advance scientific research and fulfill their educational objectives. The primary focus lies in getting access to advanced analytical capabilities and technologies, which often are not financially feasible to maintain in-house. These institutes prioritize high-quality, accurate results and technology-driven solutions to support various research programs ranging from biomedical research to environmental studies. Pathology and diagnostic labs often leverage central labs for advanced tests that are not feasible to conduct in-house due to the cost of equipment or the need for specialized expertise. Collaborating with central labs allows pathology and diagnostic labs to meet the demand for rapid turnaround times by providing access to high-throughput testing technologies, ensuring the quality and reliability of the tests. Biotechnology companies, especially those in the early and developmental stages, look to central laboratories to extend their R&D capabilities without substantial investment in in-house facilities. For these entities, turnaround time, scalability, and expertise in regulatory compliance across different jurisdictions are vital. They often require specialized services such as biomarker development, cell and gene therapy assessments, and personalized medicine support. Pharmaceutical companies utilize central laboratory services extensively across the drug development cycle, from discovery through post-market surveillance. Their key considerations include global footprint, logistical prowess, data management capabilities, and a proven track record in regulatory compliance. The central lab pharmaceutical companies emphasize end-to-end solutions that can support multi-centric, global clinical trials.
Therapeutic Area: Comprehensive diagnostic and prognostic testing for oncology and infectious diseases therapeutic areas
Central laboratory services play a pivotal role in advancing and supporting therapeutic areas, facilitating precise and standardized testing across various stages of clinical trials. The central laboratory services play an indispensable role across various key areas, significantly influencing treatment modalities and advancing medical knowledge. These labs provide essential services for autoimmune diseases, such as autoantibody profiling and cytokine analysis, which are critical for accurate diagnosis and disease management. In tackling cardiovascular diseases, assessing cardiovascular biomarkers, including lipid profiles and cardiac injury markers, facilitates early detection and patient care optimization. Central labs' capabilities are also pivotal in infectious disease management, offering advanced diagnostic and monitoring tools essential for controlling outbreaks and evaluating therapeutic interventions. When examining neurological conditions, specialized testing for biomarkers offers insights into diseases such as Alzheimer's and Parkinson's, supporting early diagnosis and the path to novel treatments. Moreover, in oncology, central labs deliver comprehensive diagnostic and prognostic testing, such as tumor marker analysis and genomic profiling, driving the progression of personalized medicine. Central laboratories' standardized, advanced services are foundational to improving patient outcomes and accelerating medical research across these crucial therapeutic areas.
Regional Insights
In the Americas, the central lab market demonstrates robust growth, fueled by a surge in clinical trial activities and a robust infrastructure for research and development. The rising importance of advanced diagnostics and biomarker development has accelerated the investment for central labs in the Americas. The APAC region stands out for its rapid expansion, driven by increasing investments in healthcare, a growing focus on regulatory compliance, and strategic global partnerships facilitating technology transfer and capability enhancements. A shift toward precision medicine lays the foundation for a dynamic and interconnected global central lab ecosystem for APAC. EMEA showcases an advanced market with stringent regulatory frameworks and a high degree of harmonization in laboratory practices. This region benefits from a history of pharmaceutical research, a highly skilled workforce, and a focus on innovation, particularly in personalized medicine.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Central Lab Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Central Lab Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Central Lab Market, highlighting leading vendors and their innovative profiles. These include ACM Medical Laboratory, Inc., Almac Group, Cerba HealthCare, CROMSOURCE by ClinChoice, Cryoport, Inc., Eurofins Scientific SE, Exagen Inc., Frontage Laboratories, Inc., GBA Group, GCCL Co., Ltd., ICON PLC, InterlabCorp, Intertek Group PLC, IQVIA Inc., LabConnect, Inc., Laboratory Corporation of America Holdings, Lambda Therapeutic Research Ltd., Lotus Labs Pvt. Ltd. by Teva Pharmaceutical Industries Ltd., MDS Pharma Services, Medicover AB, Medpace, Inc., MLM Medical Labs GmbH, Novotech Health Holdings, Pace Analytical Services, LLC, Precision Medicine Group, LLC, Quest Diagnostics Incorporated, REPROCELL Inc., SGS S.A., Shanghai Clinical Research Center, SMS Pharmaceuticals Ltd., Sonic Healthcare International, Syngene International Limited, Thermo Fisher Scientific Inc., Unilabs AB, Versiti, Inc., and WuXi AppTec.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Central Lab Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Central Lab Market?
3. What are the technology trends and regulatory frameworks in the Central Lab Market?
4. What is the market share of the leading vendors in the Central Lab Market?
5. Which modes and strategic moves are suitable for entering the Central Lab Market?