市場調查報告書
商品編碼
1466401
臨床試驗設備和輔助解決方案市場:按產品類型、階段、最終用途、適應症分類 - 全球預測 2024-2030Clinical Trial Equipment & Ancillary Solutions Market by Product (Equipment, Services, Systems), Type (Biologic Drugs, Medical Devices, Small Molecules), Phase, End-Use, Indication - Global Forecast 2024-2030 |
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預計2023年臨床試驗設備和輔助解決方案市場規模為42.1億美元,2024年達45.8億美元,預計2030年將達到76.2億美元,複合年成長率為8.81%。
臨床試驗設備和輔助解決方案是臨床試驗過程中使用的專業醫療設備和服務,用於準確有效地評估治療方法、藥物和設備。該設備包括患者監護儀、成像系統、實驗室設備、自動資料收集系統等。它還包括臨床試驗管理和監管支援等輔助服務。臨床試驗設備和支援解決方案是成功臨床試驗的重要組成部分,提供確保參與者安全和試驗結果準確性所需的工具和資源。臨床試驗設備輔助解決方案包括用於支援完成臨床試驗的任何工具、服務和產品。增加對臨床試驗設備和輔助解決方案的研發活動的投資將促進創新,提高資料質量,擴大產品範圍,確保合規性,並透過吸引新的市場參與企業來滿足不斷變化的臨床試驗需求。外包臨床試驗業務可提高成本效率、獲得專業知識、擴大影響範圍、簡化業務、遵守法律規章、擴充性,並進一步增加臨床試驗設備和輔助解決方案的使用。與雲端基礎的臨床試驗解決方案相關的資料安全風險,例如未授權存取和資料洩露,引起了人們對保密、法規遵循、資料完整性和網路安全的擔憂,阻礙了臨床試驗設備和輔助解決方案市場的成長。此外,越來越多的臨床試驗設備監管核准和政府支持正在推動測試活動的活性化、先進技術的採用、技術創新和監管流程的簡化,從而在預測期內創造市場機會。
主要市場統計 | |
---|---|
基準年[2023] | 42.1億美元 |
預測年份 [2024] | 45.8億美元 |
預測年份 [2030] | 76.2億美元 |
複合年成長率(%) | 8.81% |
擴大在產品設備租賃和租賃服務中使用輔助採購服務
在臨床試驗中,輔助設備是指臨床試驗過程、操作和系統所需的專用工具、裝置和設備。輔助器具允許醫務人員在測試過程中準確測量資料點,從而為臨床試驗提供重要的好處。臨床試驗中使用的實驗室設備包括用於精確樣本分析的離心機、高壓釜、培養箱、低溫冷凍和光強度。診斷影像設備包括X光設備、超音波設備、MRI掃描儀、CT掃描儀、肺計量計、臨床實驗室分析儀等。臨床試驗中所使用的診斷設備是指在試驗過程中用於診斷、評估和監測受試者健康狀況的設備和裝置。
輔助採購服務包括設備租賃和租賃服務、採購、供應和物流。供應和物流是由臨床試驗設備和輔助解決方案供應商提供的服務,專注於識別、評估和採購支援成功臨床試驗所需的材料。供應與物流的輔助採購服務提供市場研究和分析支持,幫助臨床試驗申辦者為其臨床試驗確定最佳輔助解決方案。臨床試驗資料管理和分析服務系統性地收集、儲存和分析與臨床試驗相關的資料。臨床試驗中的維護和校準服務對於確保所獲得結果的安全性和準確性至關重要,並涉及設備的定期測試、維護和校準。臨床試驗監管和合規服務是幫助確保遵守管理機構制定的規則、法規和標準的服務和解決方案。臨床實驗試驗中心監測和支援服務是在整個臨床實驗過程中從臨床實驗臨床試驗贊助者到臨床試驗中心提供持續支援、監測和監督的服務。我們的臨床試驗培訓和諮詢服務為研究人員和臨床實驗提供有關最佳實踐、安全程序和法規遵循的教育。此外,臨床試驗管理系統對於有效規劃、管理和追蹤您的臨床試驗組合至關重要。電子資料擷取 (EDC) 系統是一種軟體應用程式,可簡化臨床試驗資料的收集、儲存和保護。
擴大臨床試驗設備在型生物製藥生產過程中的使用
醫療設備臨床試驗是為了評估用於治療、預防和診斷人類疾病的醫療設備的安全性和性能而進行的測試。在醫療設備臨床試驗中,患者監護儀、影像系統、診斷工具、資料管理系統和設備校準設備等設備和輔助解決方案有助於確保準確的評估和成功的測試。生物製藥製造過程中使用的臨床試驗設備具有許多好處,包括提高效率和精確度。在生物製藥中,臨床試驗設備可以實現更高品質的資料收集和分析,從而提高藥物製造的整體效率和準確性。小分子臨床試驗中常用的設備包括高效液相層析(HPLC)、超高效液相層析(UHPLC)、氣相層析法(GC)、溶出度測試設備、自動移液系統、離心機等。臨床試驗領域使用的輔助解決方案包括樣本處理、收集、儲存、資料分析系統、用於患者記錄監控和追蹤的軟體解決方案以及樣本安全性和合規性。
適應症在消化器官系統疾病分析中越來越偏好臨床試驗儀器
臨床試驗儀器透過提供電腦化和高度專業化的血液分析儀來分析血液樣本中的紅血球、白血球、血紅蛋白和血小板,從而增強了血液疾病臨床研究的工作流程。代謝和消化器官系統疾病臨床試驗中優選使用顯微鏡、胃鏡、十二指腸鏡等臨床試驗儀器進行分析,以改善臨床研究過程中的臨床結果。儀器和輔助解決方案可用於急性骨髓性白血病、貧血性癌症和慢性骨髓性白血病病症的腫瘤學臨床試驗。在心血管疾病、中樞神經系統和精神疾病、感染疾病、代謝性疾病的臨床試驗中,根據適應症採用醫學影像設備和智慧穿戴設備,有效進行臨床試驗。
擴大臨床試驗設備和輔助解決方案在第二期臨床試驗的使用,以評估第二期藥物的療效
一期臨床試驗主要著重於評估新藥和治療方法的安全性和劑量。 I 期臨床試驗中使用的設備和輔助解決方案包括劑量管理、病患監測和安全評估工具。在開發過程的第一階段,將在最多 100 人的研究小組中進行藥物動力學和耐受性評估,包括初始單劑量研究、劑量遞增研究和健康志願者的重複劑量研究。 II 期試驗評估藥物或治療方法在 100 至 500 名患者的較大人群中的有效性。該試驗旨在發現該產品的初步功效和副作用。 III 期試驗涉及約 3,000 人的更多患者群體,並將新藥或治療方法與現有護理標準進行比較。 III期試驗需要很長時間來研究藥物。
最終用途:擴大臨床試驗設備在生物技術和製藥公司的使用
臨床試驗儀器和輔助解決方案用於在藥物開發、委外研發機構(CRO)、製藥公司和生物技術公司進行的臨床試驗期間監測患者的進展。臨床試驗設備和輔助解決方案可提高方案合規性並確保符合醫療設備公司的監管標準。學術和研究機構為參與者和工作人員提供教育支持,以實現臨床試驗的最佳表現。
區域洞察
由於政府對藥物發現和開發的支持投資和舉措,以及該地區臨床試驗活動的顯著成長,美洲臨床試驗設備和輔助解決方案市場高度發展。亞太地區因其龐大且多樣化的患者群體以及低成本因素而成為臨床試驗設備和輔助解決方案不斷成長的市場,這是開展臨床試驗的主要優勢。此外,在歐洲、中東和非洲地區,為確保臨床試驗設備和輔助解決方案的安全性和有效性而製定的嚴格政府法規正在推動市場競爭和標準化。包括歐洲藥品管理局 (EMA)、臨床試驗法規 536/2014 (EU-CTR) 和區域框架在內的各種政府框架負責監控和規範該地區臨床試驗設備和輔助解決方案的使用。
FPNV定位矩陣
FPNV定位矩陣對於評估臨床試驗設備和輔助解決方案市場至關重要。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,可以對臨床試驗設備和輔助解決方案市場供應商的現狀進行深入而深入的研究。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.競爭評估及資訊: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、製造能力等進行綜合評估。
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.臨床試驗設備及輔助解決方案市場的市場規模與預測為何?
2.臨床試驗設備和輔助解決方案市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3.臨床試驗設備和輔助解決方案市場的技術趨勢和法規結構是什麼?
4.臨床試驗設備及輔助解決方案市場主要廠商的市場佔有率如何?
5. 進入臨床試驗設備及輔助解決方案市場的合適型態和策略手段是什麼?
[189 Pages Report] The Clinical Trial Equipment & Ancillary Solutions Market size was estimated at USD 4.21 billion in 2023 and expected to reach USD 4.58 billion in 2024, at a CAGR 8.81% to reach USD 7.62 billion by 2030.
Clinical trial equipment & ancillary solutions are specialized medical equipment and services used during clinical trials to accurately and effectively evaluate treatments, drugs, and devices. This equipment includes patient monitors, imaging systems, laboratory instruments, and automated data collection systems. It also includes ancillary services such as clinical trial management and regulatory support. Clinical trial equipment & ancillary solutions are essential components of any successful clinical trial as they provide the necessary tools and resources to ensure participants' safety and the trial results' accuracy. An ancillary solution for clinical trial equipment includes any tools, services, or products used to assist in completing a clinical trial. Rising investment in R&D activities for clinical trial equipment and ancillary solutions drives market growth by fueling innovation, improving data quality, expanding product offerings, ensuring regulatory compliance, addressing evolving trial needs, and attracting new market participants. Outsourcing clinical trial activities provides cost-effectiveness, access to expertise, expanded reach, streamlined operations, regulatory compliance, and scalability, further increasing the use of clinical trial equipment & ancillary solutions. Data security risks associated with cloud-based clinical trial solutions, such as unauthorized access and data breaches, create concerns about confidentiality, regulatory compliance, data integrity, and cybersecurity, hampering the clinical trial equipment & ancillary solutions market growth. Moreover, rising regulatory approvals for clinical trial equipment and government support, which increased trial activity, adoption of advanced technologies, innovation, and streamlined regulatory processes, have created market opportunities in the forecasted period.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 4.21 billion |
Estimated Year [2024] | USD 4.58 billion |
Forecast Year [2030] | USD 7.62 billion |
CAGR (%) | 8.81% |
Product: Growing utilization of ancillary sourcing services for equipment leasing & rental services
In clinical trials, ancillary supplies equipment refers to the specialized tools, devices, and instruments necessary for the clinical trials processes, operations, or system. Ancillary supplies provide essential advantages to clinical trials by enabling medical staff to accurately measure data points during a test. Laboratory equipment used in clinical trials includes centrifuges, autoclaves, incubators, cryogenic freezers, and spectrophotometers used to ensure accurate sample analysis. Imaging & diagnostics equipment includes X-ray machines, sonography machines, MRI scanners, CT scanners, spirometers, and laboratory analyzers. Diagnostic equipment used in clinical trials refers to the instruments and devices employed to diagnose, assess, and monitor participants' health status during the test.
Ancillary sourcing services include equipment leasing & rental services, procurement, and supply & logistics, a service provided by clinical trial equipment and ancillary solutions providers that focuses on identifying, evaluating, and procuring the materials needed to support the success of a clinical trial. Supply & logistics ancillary sourcing services provide market research and analytical support to help clinical trial sponsors identify the optimal ancillary solutions for their trials. Data management & analysis services in clinical trials offer an organized way to collect, store, and analyze data related to the trial. Maintenance & calibration services in clinical trials are vital in ensuring the safety and accuracy of results achieved, which involve regular inspections, maintenance, and equipment calibration. Regulatory & compliance services in clinical trials are services and solutions that help ensure organizations comply with the rules, regulations, and standards established by a governing body. Site monitoring & support services in clinical trials involve providing ongoing support, monitoring, and oversight for research sites from the trial sponsor throughout the clinical trial process. Training & consulting services in clinical trials educate research staff and investigators on matters concerning best practices, safety procedures, and regulatory compliance. Moreover, a clinical trial management system is essential to effectively plan, manage, and track clinical study portfolios. An electronic data capture (EDC) system is a software application that helps streamline collecting, storing, and securing data from clinical studies.
Type: Increasing application of clinical trial equipment in the manufacturing process of biological drugs
Medical device clinical trials are examinations undertaken to assess a medical device's safety or performance in terms of its use in treating, preventing, or diagnosing diseases in human subjects. In medical device clinical trials, equipment and ancillary solutions such as patient monitors, imaging systems, diagnostic tools, data management systems, and device calibration equipment ensure accurate evaluation and successful trial outcomes. Clinical trial equipment used in the manufacturing process of biological drugs offers numerous benefits, including increased efficiency and accuracy. In biological drugs, clinical trial equipment results in higher-quality data collection and analysis, which can increase overall efficiency and accuracy in drug production. The commonly used equipment in small molecule clinical trials include high-performance liquid chromatography (HPLC), ultra-high performance liquid chromatography (UHPLC), gas chromatography (GC), dissolution testing apparatus, automated dispensing systems, and centrifuges. Ancillary solutions utilized in the clinical trials space include sample handling, collection, storage, data analysis systems, software solutions for monitoring and tracking patient records, and sample safety and compliance.
Indication: Rising preferences for clinical trial equipment to analyze digestive disorders
Clinical trial equipment enhances the workflow of clinical investigation of blood disorders by providing computerized, highly specialized hematology analyzers for analyzing red and white blood cells, hemoglobin, and blood platelets in a blood sample. Clinical trial equipment such as the microscope, gastroscope, and duodenoscope is preferred in analyzing metabolic disorders and digestive disorders clinical trials to enhance the clinical outcomes during clinical investigation. Equipment and ancillary solutions are available for acute myelogenous leukemia, anemic cancer, and chronic myeloid leukemia disease conditions for oncology clinical studies. Medical imaging equipment and smart wearable devices are employed in the clinical trials of cardiovascular diseases, central nervous system (CNS) & mental disorders, infectious diseases, and metabolic disorders depending upon the indication to organize clinical trials effectively.
Phase: Growing usage of clinical trial equipments & ancillary solutions in phase II to assess effectiveness of drug
Phase I clinical trials primarily focus on assessing the security and dosage of a new drug or treatment. Equipment and ancillary solutions used in phase I trials include tools for dose administration, patient monitoring, and safety assessments. During phase I of the development process, pharmacokinetics and tolerance evaluations occur in a trial group comprising 100 people or less, including initial single-dose studies, dose-escalation, and repeated-dose studies in healthy volunteers. Phase II trials assess the effectiveness of a drug or therapy in a larger group of patients, between 100 and 500. The trial aims to discover the product's preliminary efficacy and side effect profile. Phase III trials involve a larger patient population, around 3,000, and compare the new drug or treatment against existing standard therapies. Phase III trial takes an extended period to study the drug.
End-Use: Expanding application of clinical trial equipment in biotechnology & pharmaceutical companies
Clinical trial equipment and ancillary solutions are utilized in drug development, monitoring patient progress during a clinical trial executed by contract research organizations (CROs), pharmaceutical companies, and biotechnology companies. Clinical trial equipment and ancillary solutions improve protocol adherence and ensure compliance with medical device companies' regulatory standards. Academic & research institutes provide educational support to participants and staff for optimum performance in clinical trials.
Regional Insights
The clinical trials equipment & ancillary solutions market in the Americas is highly developing due to supportive governmental investments and initiatives for drug discovery and development and significant growth of clinical trial activities in the region. The Asia-Pacific region is an evolving market for clinical trial equipment & ancillary solutions owing to factors such as a large and diverse patient base and low costs that provide significant advantages for conducting clinical trials. Moreover, the stringent government norms in the EMEA region for ensuring the safety and efficacy of clinical trial equipment & ancillary solutions are making the market more competitive and standardized. The various government frameworks, including the European Medicines Agency (EMA), Clinical Trial Regulation 536/2014 (EU-CTR), and regional frameworks, monitor and regulate the use of clinical trial equipment & ancillary solutions in the region.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Clinical Trial Equipment & Ancillary Solutions 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 Clinical Trial Equipment & Ancillary Solutions 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 Clinical Trial Equipment & Ancillary Solutions Market, highlighting leading vendors and their innovative profiles. These include Almac Group Limited, Ancillare, LP, Avantor, Inc., Axelerist, B. Braun SE, Bio-Rad Laboratories, Inc., Charles River Laboratories International, Inc., Dassault Systemes SE, Emsere B.V., Eppendorf SE, Eurofins Scientific SE, Global Vision Technologies, Inc., Hitachi, Ltd., IQVIA Holdings Inc., Lonza Group Ltd., MedNet Solutions, Inc., Myonex, Inc., Navitas Inc., Oracle Corporation, Parexel International Corporation, Quanticate International Limited, Quipment SAS, Royal Philips, Thermo Fisher Scientific, Inc., United Parcel Service, Inc., Veeva Systems Inc., Yokogawa Electric Corporation, and Zifo Technologies Private Limited.
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 Clinical Trial Equipment & Ancillary Solutions Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Clinical Trial Equipment & Ancillary Solutions Market?
3. What are the technology trends and regulatory frameworks in the Clinical Trial Equipment & Ancillary Solutions Market?
4. What is the market share of the leading vendors in the Clinical Trial Equipment & Ancillary Solutions Market?
5. Which modes and strategic moves are suitable for entering the Clinical Trial Equipment & Ancillary Solutions Market?