市場調查報告書
商品編碼
1465962
醫療設備測試市場:按服務類型、測試類型、設備類別、階段、設備類型、採購類型、最終用戶 - 2024-2030 年全球預測Medical Device Testing Market by Service Type, Test Type, Device Class, Phase, Device Type, Sourcing Type, End-Users - Global Forecast 2024-2030 |
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預計2023年醫療設備檢測市場規模為108.3億美元,2024年達116.7億美元,預計2030年將達到184億美元,複合年成長率為7.85%。
醫療設備測試是一個系統性的、受監管的過程,用於評估和檢驗醫療設備的安全性、可靠性和性能。這一廣泛的過程可確保設備能按預期運行,並保護使用者(包括醫療保健專業人員和患者)免受與設備相關的潛在傷害。這個過程包括一系列嚴格的測試,符合國際和國家標準和法規,包括美國食品藥物管理局(FDA) 和歐洲藥品管理局 (EMA) 等組織制定的標準和法規。醫療設備技術的創新、嚴格的監管合規性以及病人安全意識的提高是市場成長的主要推動力。然而,高昂的測試成本是新參與企業的主要障礙,而新醫療設備漫長的核准流程可能會阻礙市場成長。此外,穿戴式醫療設備的日益普及、家庭和遠距患者照護的成長,以及人工智慧、物聯網和其他創新技術在醫療領域的持續應用,都為醫療設備測試市場提供了巨大的機會。
主要市場統計 | |
---|---|
基準年[2023] | 108.3億美元 |
預測年份 [2024] | 116.7億美元 |
預測年份 [2030] | 184億美元 |
複合年成長率(%) | 7.85% |
服務類型:隨著醫療技術變得更加複雜和多樣化,檢測服務的需求不斷增加。
認證服務對於檢驗醫療設備的真實性和可行性至關重要。對於需要醫療設備認證的製造商來說,這些服務對於獲得國際核准和確保病患安全尤其有價值。檢驗服務可確保醫療設備在其整個生命週期內的物理和功能完整性。製造商更喜歡檢查服務,以最大程度地減少缺陷和故障的可能性並確保醫療設備正常運作。測試服務在評估醫療設備性能、安全性和產業標準合規性方面發揮著至關重要的作用。對於想要在將產品投放市場之前確保其產品的功效和安全性的製造商來說,這種產品類型至關重要。
按測試類型:隨著醫療設備先進技術的出現,網路安全測試的新應用
化學測試檢查是否有有害化學物質,物理測試著眼於耐久性等屬性,生物相容性測試確保設備不會與人體組織或體液產生負面交互作用。隨著醫療設備的數位化程度越來越高,網路安全檢查至關重要,檢查是否存在允許未授權存取或駭客攻擊的漏洞。電氣安全檢查確保醫療設備符合觸電防護、電磁相容性和其他評估標準。環境測試評估醫療設備在極端溫度、濕度、振動和跌落衝擊下的功能。機械測試評估醫療設備的性能,例如拉伸強度、硬度和抗疲勞性。
器材類別:III 類醫療設備在上市前需要經過嚴格的 PMA 流程以確保安全性和有效性。
I 類醫療設備風險最低,受到的監管也最少。這包括壓舌板、便盆和彈性繃帶等物品。第二類醫療設備具有中等風險,需要遵守特殊規定以確保安全性和有效性。電動輪椅、輸液幫浦、外科用覆蓋巾等都屬於此類。製造商必須完成 510(k) 流程並證明與領先設備的實質等效性。 III 類醫療設備是維持生命或構成重大風險的醫療器械,並受到最高級別的監管。這包括心律調節器、心臟瓣膜和整形外科植入等。製造商必須經過漫長的上市前核准流程才能證明安全性和有效性。
技術:擴大行動裝置醫療設備測試服務的採用
有源植入式醫療設備(AIMD) 的特點是在人體內持續運作的設備。此類設備包括心臟去顫器、人工電子耳和神經刺激設備。需要進行廣泛的測試來確保安全,重點是電池功能、生物相容性和遠端檢測。主動醫療設備(AMD),例如心律調節器、輸液幫浦和監視器,需要電力才能運作。 AMD 測試重點在於電磁相容性、電氣安全和軟體可靠性等方面,並遵循嚴格的法規要求。體外診斷醫療設備(IVD)用於在人類體外尤其是實驗室中對樣本進行測試,例如血糖值測試和懷孕測試,IVD測試必須確保準確性、再現性和靈敏度。醫療保健中的行動裝置包括智慧型手機、平板電腦和配備醫療應用程式的穿戴式健康監視器。應用程式功能、資料隱私和電池壽命是確保安全有效使用此類裝置的關鍵檢查。無源醫療設備是不需要電力來操作的工具,例如手術刀、縫線和病床。這些設備的檢查重點是機械安全、材料測試和滅菌。用於治療眼部相關疾病的眼科醫療設備包括隱形眼鏡、白內障植入和雷射視力矯正裝置。測試可確保準確的光學和機械性能,並維持獨特的生物相容性要求。整形外科和牙科醫療設備種類繁多,包括人工關節、植入和矯正器具。由於這些設備在人體內長期使用,因此功能、耐用性和生物相容性測試對於這些設備至關重要。血管醫療設備用於治療血管內的疾病,例如支架、導管和人造血管。重要的測試部分是動態血管條件下的設備性能、設備穩健性和生物相容性。
階段:醫療設備測試在臨床階段的顯著普及
臨床階段的特點是對醫療設備在人體中的安全性和有效性進行詳細評估。臨床測試主要由醫療法規以及在確定設備功效的同時確保病患安全的需求所驅動。臨床前階段先於臨床階段,是在實驗室中使用體外技術和動物模型進行的。目的是評估設備在受控條件下的安全性、生物相容性和功能特性。此步驟對於研究人員和醫生來說最重要,以便在設備到達患者手中之前了解該設備的潛在益處和限制。當設備暴露於人體之前需要進行初步安全檢查、識別關鍵風險以及可行性和功效分析時,就會進行臨床前測試。進行臨床測試是為了檢驗現實環境中的發現並符合監管需求。
採購類型:對於高度獨特或高度機密的設備,強烈傾向於內部檢查。
內部測試是在醫療設備製造商的設施中使用自己的員工和資源進行的。因此,雖然可以密切控制和監督檢查過程,但需要在基礎設施和人員方面進行大量投資。對於委託測試,我們利用專門從事醫療設備測試的第三方委託研究組織 (CRO) 和測試實驗室。外包減輕了公司資源的壓力,但隨之而來的是更高的成本以及智慧財產權和商業機密外洩的風險。
最終用戶:醫療設備製造商的需求不斷成長
受託製造廠商(CMO) 在醫療設備醫療設備。此外,CMO 還提供醫療設備測試的專業服務,包括生物相容性測試、性能測試和包裝驗證。 CMO 優先考慮準確性、速度和遵守監管標準。製造商主要專注於製造醫療設備,並嚴重依賴測試服務來確保醫療設備的安全性、有效性以及符合監管標準。製造商喜歡提供快速週轉時間和成本效益的檢驗服務。研究機構更喜歡提供詳細分析和準確結果的測試服務。研究機構重視提供全面測試結果和分析解釋的調查服務。
區域洞察
在美洲,醫療設備測試市場近年來表現出彈性和成長。這是因為 FDA(食品藥物管理局)收緊了該地區的監管標準,增加了對高品質醫療設備的需求。在人口老化加劇以及糖尿病和心血管疾病等慢性病流行等關鍵因素的推動下,醫療保健領域已經做好了創新的準備。歐洲、中東和非洲地區的醫療設備測試市場呈現出良好的成長動能。在技術進步、研究經費增加和高醫療保健支出的推動下,歐洲市場是歐洲、中東和非洲地區醫療設備測試的主要貢獻者。中東和非洲地區雖然市場佔有率相對較低,但由於醫療基礎設施的快速開拓和醫療支出的不斷上升,具有巨大的成長潛力。
另一方面,亞太地區則具有豐富的多樣性,從日本和澳洲等成熟市場到中國和印度等新興市場。該地區的成長是由醫療保健支出增加、人口老化和健康意識增強所推動的。此外,政府鼓勵本地生產的政策也刺激了市場成長。
FPNV定位矩陣
FPNV定位矩陣對於評估醫療設備測試市場至關重要。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。最前線 (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,可以對醫療設備測試市場中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細分市場競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、碎片化主導地位和合併特徵等因素。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:包括新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭力評估與資訊: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:包括對未來技術、研發活動以及突破性產品開發的見解。
1.醫療設備檢測市場的市場規模與預測是多少?
2.在醫療設備測試市場的預測期內,有哪些產品、細分市場、應用程式和細分市場需要考慮投資?
3.醫療設備檢測市場的技術趨勢和法規結構是什麼?
4.醫療設備檢測市場主要廠商的市場佔有率是多少?
5.進入醫療設備檢測市場合適的型態和策略手段是什麼?
[194 Pages Report] The Medical Device Testing Market size was estimated at USD 10.83 billion in 2023 and expected to reach USD 11.67 billion in 2024, at a CAGR 7.85% to reach USD 18.40 billion by 2030.
Medical device testing is the systematic, regulated process of assessing and validating medical devices' safety, reliability, and performance. This extensive process ensures that the device performs as intended and safeguards users, including healthcare professionals and patients, from potential device-related harm. This process often involves a series of rigorous tests adhering to international and national standards and regulations, including those established by organizations such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Innovations in medical device technologies, stringent regulatory compliances, and increasing awareness about patient safety primarily shape market growth. However, the medical device testing market faces challenges owing to high testing costs acting as a significant barrier for new entrants, and the lengthy approval process for new medical devices may hinder market growth. In addition, the increasing adoption of wearable medical devices, growth in home and remote patient care, and the rising application of AI, IoT, and other innovative technologies in the medical field offer tremendous opportunities for the medical device testing market.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 10.83 billion |
Estimated Year [2024] | USD 11.67 billion |
Forecast Year [2030] | USD 18.40 billion |
CAGR (%) | 7.85% |
Service Type: Growing requirement for inspection services driven by the ever-growing complexity and diversity of medical technologies
Certification services are vital to validate the reliability and viability of medical devices. For manufacturers requiring certification for their medical devices, such services are particularly beneficial for gaining international acceptance and ensuring patient safety. Inspection services guarantee medical devices' physical and functional integrity throughout their lifecycle. Inspection services are the preferred choice for manufacturers to ensure their devices work correctly with minimal potential for faults or malfunctions. Testing services play a pivotal role in assessing medical device performance, safety, and compliance with industry standards. This service type is crucial for manufacturers eager to ensure their products' efficacy and safety before entering the market.
Test Type: Emerging applications of cybersecurity testing with advent of advanced technologies in medical devices
Chemical testing checks for harmful chemicals, physical testing examines attributes including durability, and biocompatibility testing confirms devices won't adversely interact with human tissues or fluids. Cybersecurity testing is critical, owing to the increasing digital connectivity of medical devices, which checks for vulnerabilities that could allow unauthorized access or hacking. Electrical safety testing confirms medical devices meet standards for electric shock prevention, electromagnetic compatibility, and other metrics. Environmental testing evaluates medical devices' functions under extreme temperatures, humidity, vibration, or drop impact. Mechanical testing assesses medical device attributes such as tensile strength, hardness, and fatigue resistance.
Device Class: Requirement of rigorous PMA processes for class III devices to ensure safety and effectiveness before reaching the market
Class I medical devices are low-risk devices and are subject to the least regulatory control. These include tongue depressors, bedpans, and elastic bandages, among others. Class II medical devices pose a moderate risk and are subject to special controls to ensure safety and effectiveness. Devices, including powered wheelchairs, infusion pumps, and surgical drapes, fall under this category. Manufacturers must clear a 510(k) process to demonstrate substantial equivalence to a predicate device. Class III medical devices support life or pose a serious risk and are subject to the highest level of regulation. These include devices such as pacemakers, heart valves, and orthopedic implants. Manufacturers must undergo a laborious premarket approval application process to establish safety and effectiveness.
Technology: Escalating adoption of medical device testing services for mobile devices
Active implantable medical devices (AIMDs) are characterized by devices that remain active inside the human body. Such devices include defibrillators, cochlear implants, and neuro-stimulators. Extensive testing is needed to ensure safety, focusing on battery functionality, biocompatibility, and telemetry. Active medical devices (AMDs), such as pacemakers, infusion pumps, and monitors, require a power source for operation. AMD testing ensues rigorous regulatory requirements, focusing on aspects including electromagnetic compatibility, electrical safety, and software reliability. In-vitro diagnostic medical devices (IVDs) are used for testing samples outside the human body, particularly in a laboratory setting, such as blood glucose tests or pregnancy tests, and ensuring their accuracy, reproducibility & sensitivity is required for IVD testing. Mobile devices in healthcare include smartphones & tablets equipped with medical apps or wearable health monitors. Application functionality, data privacy, and battery life are critical testing areas to ensure such devices' safe and effective use. Non-active medical devices consist of tools that do not require power for operation, such as scalpels, sutures, or hospital beds. Testing for these devices focuses on mechanical safety, materials testing, and sterilization. Ophthalmic medical devices used in eye-related ailments include contact lenses, cataract implants, and laser vision correction equipment. Testing ensures precise optical and mechanical performance and maintains unique biocompatibility requirements. Orthopedic and dental medical devices encompass a wide range, such as artificial joints, dental implants, and braces. Functionality, durability, and biocompatibility testing are essential in these devices, given their long-term use inside the human body. Vascular medical devices treat conditions within blood vessels, such as stents, catheters, and vascular grafts. Critical testing areas are device performance under dynamic vascular conditions, the robustness of the device, and biocompatibility.
Phase: Significant penetration of medical devices testing in the clinical phase
A detailed evaluation of the safety and effectiveness of a medical device on human subjects characterizes the clinical phase. Clinical trials are primarily driven by healthcare regulations and the need to ensure patient safety while establishing a device's efficacy. Preceding the clinical phase, the preclinical phase is conducted in laboratories using in-vitro techniques and animal models. The goal is to assess the device's safety profile, biocompatibility, and functional attributes under controlled conditions. This phase is paramount to researchers and physicians for understanding devices' potential benefits and limitations before they reach patients. Preclinical trials are preferred when there's a need for initial safety checks, identifying major risks, feasibility, and efficacy analysis before exposing a device to humans. Clinical trials are performed to validate the findings in real-world settings and comply with regulatory needs.
Sourcing Type: Higher preferences for in-house testing for highly proprietary or sensitive devices
In-house testing is conducted within the medical device company's facilities using their employees and resources, which allows for tight control and oversight over the testing process but requires significant investments in infrastructure and personnel. Outsourced testing leverages third-party contract research organizations (CROs) and test labs specializing in medical device testing. Outsourcing reduces the burden on a company's resources but can be costlier and risk exposing intellectual property or trade secrets.
End-Users: Proliferating need from medical device manufacturers
Contract manufacturing organizations (CMOs) are critical in medical device testing as they provide various services, including device design and development, manufacturing, packaging, sterilization, and testing. In addition, CMO offers specialized medical device testing services, such as biocompatibility testing, performance testing, and packaging validation. CMOs prioritize accuracy, speed, and compliance with regulatory standards. Manufacturers primarily focus on the production of medical devices and rely heavily on testing services to ensure medical devices are safe, effective, and comply with regulatory standards. Manufacturers significantly prefer testing services that offer a quick turnaround time and cost-effectiveness. Research institutions favor testing services that offer detailed analyses and precise results, as these are essential in verifying and validating their research findings. Research institutions emphasize medical device testing services that provide comprehensive test results and analytical interpretations.
Regional Insights
In the Americas, the medical device testing market has exhibited resilience and growth in recent years, attributed to the region's stringent regulatory standards promulgated by the Food and Drug Administration (FDA) and the increasing need for high-quality medical devices. The healthcare sector has been poised for innovation fueled by critical factors such as the increasing aging population and the prevailing chronic diseases, including diabetes and cardiovascular disorders. The EMEA region presents an encouraging growth for the medical device testing market. The European market, driven by technological advancements, increased research funding, and high healthcare expenditure, has contributed heavily to medical device testing in the EMEA region. The Middle East and African regions have comparatively less market share but provide substantial growth potential owing to rapidly developing healthcare infrastructure and increasing healthcare spending.
Meanwhile, the APAC region encapsulates a vast diversity from mature markets, including Japan and Australia, to emerging ones, such as China and India. The increasing healthcare spending, aging population, and surge in health consciousness in the region fuel this growth. In addition, government policies' encouragement of local manufacturing is potentially stimulating market growth.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Medical Device Testing 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 Medical Device Testing 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 Medical Device Testing Market, highlighting leading vendors and their innovative profiles. These include 5D Health Protection Group Ltd., Alliance Technologies, LLC, Almac Group Limited, AMETEK, Inc., Applied Technical Services, LLC, Bioneeds India Pvt. Ltd., Boston Analytical, Bureau Veritas S.A., Cetecom Advanced GmbH, Charles River Laboratories, Inc., Clark Testing, DDL, Inc., DEKRA SE, Device Conformity and Testing, LLC, Element Materials Technology, Eurofins Scientific SE, ImpactQA, Innovatech Labs, LLC, Intertek Group PLC, iuvo BioScience, LLC, Laboratory Corporation of America Holdings, Maven Profcon Services LLP, Measur Oy, MED Institute Inc., Medical Engineering Technologies, Nemko Group, North American Science Associates, LLC, Pace Analytical Services, LLC, Q Laboratories, Inc., Qualitest Group, Qualizeal India LLP, Sanbor Medical Corporation, ScienceSoft Corporation, SGS S.A., STEMart, Sterigenics U.S., LLC by Sotera Health company, STERIS PLC, TA Instruments by Waters Corporation, Tentamus Group GmbH, Test Labs Ltd., The British Standards Institution, The Smithers Group Inc., TUV SUD AG, UL LLC, and WESTPAK, Inc..
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 Medical Device Testing Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Medical Device Testing Market?
3. What are the technology trends and regulatory frameworks in the Medical Device Testing Market?
4. What is the market share of the leading vendors in the Medical Device Testing Market?
5. Which modes and strategic moves are suitable for entering the Medical Device Testing Market?
TABLE 337