市場調查報告書
商品編碼
1466557
中心實驗室市場:按服務類型、階段、治療領域和最終用途分類 - 全球預測 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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預計2023年中心實驗室市場規模為31.1億美元,預計2024年將達33.8億美元,2030年將達57.8億美元,複合年成長率為9.25%。
中心實驗室作為卓越中心,為世界各地的各種臨床試驗設施提供高品質、標準化的檢測服務。這些實驗室在確保資料完整性、一致性和可靠性方面發揮著至關重要的作用,這是有效臨床研究和開發的先決條件。由於對專業檢測服務的需求不斷成長、全球臨床試驗的激增以及製藥行業對外包以提高效率和專注於核心能力的重視,對中心實驗室的需求也在不斷成長。然而,製藥業面臨營運成本高、監管複雜、全球營運標準化等挑戰。中央實驗室透過利用技術進步、建立策略合作夥伴關係和加強其地理影響力來解決這些限制,以提供本地服務,同時保持國際標準。生物標記服務的擴展、個人化醫療以及預測分析人工智慧的整合標誌著 Central Lab 在不斷發展的臨床研究領域的發展軌跡。
主要市場統計 | |
---|---|
基準年[2023] | 31.1億美元 |
預測年份 [2024] | 33.8億美元 |
預測年份 [2030] | 57.8億美元 |
複合年成長率(%) | 9.25% |
服務類型 優先選擇中央實驗室,在受控條件下長期儲存生物樣本以進行特定管理
解剖病理學和組織學服務包括檢查身體組織以發現疾病。這些服務對於診斷各種類型的癌症和慢性病至關重要。生物標記服務可辨識組織、血液和其他體液中的生物標記,以診斷疾病、監測疾病進展並預測治療效果。遺傳服務提供基於 DNA 的檢測,包括序列測定和基因分型,以識別遺傳疾病、易感性和疾病攜帶者狀態。微生物學服務對於識別和表徵微生物以預防和治療感染疾病至關重要。中心實驗室確保這些程序的安全性並遵守全球衛生法規。專業化學服務進行複雜的生化分析,以檢測荷爾蒙失衡、營養缺乏和有害物質。檢體管理和儲存服務確保用於研究和診斷的生物樣本的完整性。中心實驗室提供專業化學服務和用於檢體管理的安全檢體儲存解決方案。
中心實驗室在整個臨床試驗過程中的關鍵作用
中心實驗室在臨床試驗各個階段的成功和管理中發揮著至關重要的作用。實驗室的參與可確保測試結果的準確性、可靠性和標準化,這對於監管核准流程和整個臨床開發計劃的成功至關重要。第一階段的重點在於評估藥物的安全性,中心實驗室利用生物樣本評估藥物的藥物動力學(PK)、動態(PD),並監測不利事件的收集和分析。中心實驗室的標準化流程以最高精度評估藥物的初始安全性,並促進無縫過渡到下一階段。在第二階段,中心實驗室將繼續評估藥物的安全性,同時開始評估對更多患有相關疾病或病症的患者群體的療效。為了衡量藥物的有效性並更好地了解其作用機制,通常會進行更複雜的分析,包括多種生物標記和專門測試。中心實驗室現階段所獲得的資料對於規劃3期試驗至關重要。第三階段涉及大規模試驗,以證明該藥物的有效性並監測不同人群的副作用。中央實驗室管理在多個國際站點創建的大量資料。儘管分佈廣泛,中央實驗室的全球網路和嚴格的品管通訊協定確保了結果的一致性和標準化。這種一致性對於監管提交至關重要。此外,中心實驗室在長期藥物監測、評估現實世界的療效和安全性方面發揮著重要作用。進行專門的試驗並收集可以識別罕見副作用和益處的資料可以導致標籤的變化和臨床實踐指南的調整。
最終用途:必須促進無縫臨床試驗並確保製藥公司的資料完整性和卓越營運。
學術研究機構主要利用研究服務來推廣科學研究和實現教育目標。他們的主要目的是利用先進的分析能力和技術,而這些能力和技術通常在經濟上無法在內部維護。這些實驗室優先考慮高品質、準確的結果和技術主導的解決方案,以支持從生物醫學研究到環境調查的各種研究項目。病理學和診斷實驗室經常利用中心實驗室進行高級測試,由於設備成本和專業知識的需要,這些測試很難在內部進行。與中央實驗室的合作使診斷病理學實驗室能夠透過提供高通量測試技術並確保測試品質和可靠性來滿足快速週轉時間的需求。生技公司,尤其是處於早期和開發階段的生技公司,希望中央實驗室能夠擴大其研發能力,而無需對自己的設施進行大量投資。對於這些公司來說,不同司法管轄區的周轉時間、擴充性和監管合規性方面的專業知識至關重要。他們通常需要專業服務,例如生物標記開發、細胞/基因治療評估和個人化醫療支援。製藥公司在整個藥物開發週期(從藥物發現到上市後監督)廣泛使用中央實驗室服務。關鍵考慮因素包括全球企業發展、物流能力、資料管理能力以及監管合規記錄。 Central Lab Pharmaceuticals 專注於支援多中心、全球臨床試驗的端到端解決方案。
癌症和感染疾病治療領域的綜合診斷和預後測試
中心實驗室檢測服務透過促進臨床試驗各階段的準確和標準化檢測,在推進和支持治療領域方面發揮著至關重要的作用。中心實驗室口語服務在多個關鍵領域發揮著重要作用,顯著影響治療方法和推進醫學知識。這些實驗室為自體免疫疾病提供準確診斷和疾病管理的基本服務,包括自體抗體分析和細胞激素分析。在對抗心血管疾病的過程中,評估心血管生物標記物,例如脂質譜和心肌損傷標記物,有助於早期發現和最佳化患者照護。中心實驗室的能力對於感染疾病控制也至關重要,它提供了控制疫情和評估治療性介入所需的先進診斷和監測工具。對於神經系統疾病,生物標記特異性測試可以深入了解阿茲海默症和帕金森氏症等疾病,支持早期診斷和新治療方法。此外,在腫瘤學領域,中心實驗室提供腫瘤標記分析、基因組分析等全面的診斷和預後檢測,推動個人化醫療的進步。中心實驗室的標準化和先進服務是改善病患治療效果和加速這些關鍵治療領域的醫學研究的基礎。
區域洞察
在美洲,在臨床試驗激增和強大的研發基礎設施的推動下,中心實驗室市場呈現強勁成長。先進診斷和生物標記開發的重要性日益增加,正在加速對美洲中心實驗室的投資。在醫療保健投資增加、對監管合規性的日益關注以及促進技術轉移和能力建設的全球戰略合作夥伴關係的推動下,亞太地區以其快速擴張而脫穎而出。向精準醫學的轉變為亞太地區充滿活力且相互關聯的全球中心實驗室生態系統奠定了基礎。歐洲、中東和非洲是一個發達的市場,擁有嚴格的監管架構和高度統一的檢驗實踐。該地區受益於藥物研究的歷史、高技能的勞動力和創新,特別是在個人化醫療方面。
FPNV定位矩陣
FPNV定位矩陣對於評估Central Lab市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對中央實驗室市場供應商的現狀進行深入而詳細的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1. 中心實驗室市場的市場規模與預測是多少?
2.在中心實驗室市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3. 中心實驗室市場的技術趨勢和法規結構是什麼?
4.中心實驗室市場主要廠商的市場佔有率是多少?
5. 進入中心實驗室市場的適當型態和策略手段是什麼?
[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?