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2030 年醫療設備測試市場預測：按產品、服務類型、採購類型、設備類別、最終用戶和地區進行的全球分析

市場調查報告書

商品編碼

1383459

2030 年醫療設備測試市場預測：按產品、服務類型、採購類型、設備類別、最終用戶和地區進行的全球分析

Medical Device Testing Market Forecasts to 2030 - Global Analysis By Product, By Service Type, By Sourcing Type, By Device Class, By End User and By Geography

出版日期: 2023年11月01日 | 出版商:

Stratistics Market Research Consulting | 英文 200+ Pages | 商品交期: 2-3個工作天內

價格

簡介目錄圖表

根據Stratistics MRC預測，2023年全球醫療設備測試市場規模將達到109億美元，預計2030年將達到173億美元，預測期內年複合成長率為6.9%。

醫療設備檢測是指對醫療設備進行嚴格的評估和評估，以確保其安全性、有效性並符合法規標準。這包括在產品開拓和製造以及上市後監督期間進行的一系列測試、檢查和試驗。醫療設備測試對於確保醫療設備符合品質標準、按預期發揮作用以及對患者造成的風險降到最低至關重要。

根據醫療保險和醫療補助服務中心的數據，2018 年美國醫療保健支出增加了 4.6%，達到 3.6 兆美元，即人均 11,172 美元。

高齡化進展

隨著世界人口高齡化，醫療保健需求也隨之增加。老年人通常需要各種醫療設備，從整形外科植入到心臟裝置和行動輔助設備。嚴格的測試對於確保這些設備的安全性和有效性至關重要。此外，老年患者可能更容易受到與設備相關的潛在併發症，因此徹底檢查更加重要。針對人口特徵的醫療設備不斷成長的需求凸顯了穩健的測試流程對於應對高齡化帶來的獨特醫療保健挑戰的重要性。

醫療設備變得越來越複雜

隨著醫療技術的進步，醫療設備變得越來越複雜，融合了尖端材料、電子設備和軟體。檢測此類先進設備需要專業知識、先進設備和先進技術，這會顯著增加檢測成本和檢測時間。此外，這些設備的複雜性為確保其安全性和有效性帶來了挑戰，因此開發和應用同樣複雜的測試程序非常重要。這種複雜性增加了法規負擔，阻礙創新和市場進入，並影響醫療設備測試過程的整體效率和競爭。

醫療保健支出增加

醫療保健預算的增加導致醫療設備研究、開發和製造的投資增加。因此，對全面測試服務的需求不斷成長，以確保醫療設備符合嚴格的品質和安全標準。隨著醫療保健系統將更多資源分配給技術進步和設備創新，透過嚴格的測試來檢驗這些設備的功能和安全性變得至關重要。對醫療保健基礎設施和醫療技術不斷成長的財政投入為專門從事醫療設備測試的公司提供了廣闊的前景，為市場擴張和創新創造了機會。

獲得熟練人員的機會有限

該行業需要具有各種科學和技術領域專業知識的高度專業人才，包括臨床研究、品質保證、資料分析和監管事務。缺乏合格的專業人員可能會阻礙試驗和臨床實驗的高效和準確進行，並導致產品開發和市場進入的延遲。此外，它還可能導致營運成本增加和品管挑戰，最終影響醫療設備測試公司的競爭力和信譽。

COVID-19 的影響：

COVID-19 的疫情對醫療設備測試市場產生了積極影響。人們對醫療保健的日益關注以及對診斷和治療設備的迫切需求導致對高效、可靠的測試解決方案的需求激增。醫療設備測試在確保人工呼吸器、診斷套件和個人防護裝備等產品的安全性和有效性方面發揮關鍵作用。此外，疫情加速了新醫療設備的開發和法規核准，導致對檢測服務的需求增加。這場意想不到的全球健康危機凸顯了嚴格測試和品質保證的重要性，導致醫療設備測試市場的擴大。

有源植入醫療設備領域預計在預測期內將成長至最高水平

有源植入醫療設備領域預計將出現良好的成長。這些設備，例如心臟節律器、神經刺激設備和植入式心臟整流去顫器，需要進行徹底的測試，以檢驗安全性、功能性以及與人體的兼容性。測試包括電子系統、電池性能、生物相容性和電磁相容性的評估。確保這些植入設備的可靠性和長期安全性至關重要，因為它直接影響患者的健康。

預計消費者/患者細分市場在預測期內將經歷最高的年複合成長率

預計消費者和患者細分市場在預測期內將出現最快的年複合成長率。隨著病患安全越來越受到關注，消費者和病患對他們使用的醫療設備越來越資訊和辨別。這種意識的增強推動了對嚴格測試的需求，以確保設備的安全性和有效性。此外，直接面對消費者的醫療設備和家庭保健設備的興起進一步強調了需要進行可靠的測試以建立最終用戶的信心。隨著醫療保健消費者賦權趨勢的持續發展，消費者和患者的趨勢有望顯著成長。

比最大的地區

在預測期內，北美佔據市場的主要佔有率。該地區擁有成熟的醫療保健行業、先進的研究基礎設施和嚴格的法律規範。北美國家，尤其美國，擁有大量醫療設備製造商和研究機構，對測試服務的需求不斷成長，以確保產品符合法規標準。該市場受益於由認可實驗室、臨床試驗設施和法規專家組成的強大生態系統，對尋求嚴格可靠的測試、認證和驗證服務的國內外醫療設備公司具有吸引力，已成為熱門目的地。

複合年複合成長率最高的地區：

預計亞太地區在預測期內年複合成長率最高。該地區不斷擴大的醫療保健行業、增加的研發投資以及不斷成長的醫療設備需求都推動了對全面檢測服務的需求。隨著醫療保健品質和安全意識的不斷增強，亞太國家正在收緊法規和品質標準，增加了確保產品合規性和安全性的測試需求。此外，熟練的勞動力、具有成本效益的臨床試驗和多樣化的患者群體的存在，使亞太地區成為尋求進行臨床試驗和測試的醫療設備製造商的一個有吸引力的地區。

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公司簡介
- 其他市場公司的綜合分析（最多 3 家公司）
- 主要企業SWOT分析（最多3家企業）
區域分割
- 根據客戶興趣對主要國家的市場估計、預測和年複合成長率（註：基於可行性檢查）
競爭基準化分析
- 根據產品系列、地理分佈和策略聯盟對主要企業基準化分析

北美洲
- 美國
- 加拿大
- 墨西哥
歐洲
- 德國
- 英國
- 義大利
- 法國
- 西班牙
- 歐洲其他地區
亞太地區
- 日本
- 中國
- 印度
- 澳洲
- 紐西蘭
- 韓國
- 其他亞太地區
南美洲
- 阿根廷
- 巴西
- 智利
- 南美洲其他地區
中東/非洲
- 沙烏地阿拉伯
- 阿拉伯聯合大公國
- 卡達
- 南非
- 其他中東/非洲

第11章進展

合約、夥伴關係、協作和合資企業
收購和合併
新產品發布
業務擴展
其他關鍵策略

第12章公司簡介

Avomeen
BSI Group
Bureau Veritas
Dekra Testing and Certification GmbH
Element Materials Technology
Eurofins Scientific
Gateway Analytical LLC
Intertek Group PLC
Medistri SA
Pace Analytical Services LLC
SGS SA
TUV Rheinland
WuXi AppTec

簡介目錄圖表

Product Code: SMRC24307

According to Stratistics MRC, the Global Medical Device Testing Market is accounted for $10.9 billion in 2023 and is expected to reach $17.3 billion by 2030 growing at a CAGR of 6.9% during the forecast period. Medical device testing refers to the rigorous evaluation and assessment of medical devices to ensure their safety, efficacy and compliance with regulatory standards. It involves a series of tests, inspections and trials conducted during product development and manufacturing, as well as post-market surveillance. Medical device testing is essential to verify that devices meet quality standards, perform as intended and pose minimal risk to patients.

According to the Center for Medicare & Medicaid Services, the United States healthcare spending grew by 4.6% in 2018, reaching USD 3.6 trillion or USD 11,172 per person.

Market Dynamics:

Driver:

Growing aging population

As the global demographic landscape skews older, there is a parallel increase in healthcare needs. Elderly individuals often require a wide range of medical devices, from orthopedic implants to cardiac devices and mobility aids. To ensure the safety and efficacy of these devices, rigorous testing is essential. Moreover, older patients may be more vulnerable to potential device-related complications, making thorough testing even more critical. The rising demand for medical devices tailored to this demographic underscores the importance of robust testing processes to meet the unique healthcare challenges posed by an aging population.

Restraint:

Increasing complexity of medical devices

As medical technology advances, devices are becoming more intricate, incorporating cutting-edge materials, electronics, and software. Testing these sophisticated devices demands specialized expertise, sophisticated equipment, and advanced methodologies, which can substantially drive up testing costs and duration. Furthermore, the intricacy of these devices poses challenges in ensuring their safety and efficacy, making it critical to develop and apply equally complex testing procedures. This complexity adds to the regulatory burden and can hinder innovation and market entry, impacting the overall efficiency and competitiveness of the medical device testing process.

Opportunity:

Rising healthcare expenditure

Increased healthcare budgets result in higher investments in medical device research, development, and manufacturing. This, in turn, fuels the demand for comprehensive testing services to ensure that these devices meet stringent quality and safety standards. As healthcare systems allocate more resources to technological advancements and device innovation, the need for rigorous testing to verify the functionality and safety of these devices becomes paramount. This growing financial commitment to healthcare infrastructure and medical technology offers a promising landscape for companies specializing in medical device testing, creating opportunities for expansion and innovation in the market.

Threat:

Limited access to skilled personnel

The industry demands a highly specialized workforce with expertise in various scientific and technical disciplines, including clinical research, quality assurance, data analysis, and regulatory affairs. The shortage of qualified professionals can hinder the efficient and accurate execution of tests and trials, potentially leading to delays in product development and market entry. Furthermore, it can result in increased operational costs and quality control challenges, ultimately affecting the competitiveness and credibility of medical device testing companies.

COVID-19 Impact:

The COVID-19 pandemic has had a positive impact on the medical device testing market. With a heightened focus on healthcare and the urgent need for diagnostic and therapeutic devices, the demand for efficient and reliable testing solutions surged. Medical device testing played a crucial role in ensuring the safety and effectiveness of products like ventilators, diagnostic kits, and PPE. Additionally, the pandemic accelerated the development and regulatory approval of new medical devices, leading to increased demand for testing services. This unforeseen global health crisis underscored the importance of rigorous testing and quality assurance, resulting in a growing market for medical device testing.

The active implant medical devices segment is expected to be the largest during the forecast period

The active implant medical devices segment is expected to have lucrative growth. These devices, such as cardiac pacemakers, neurostimulators, and implantable defibrillators, require meticulous testing to validate their safety, functionality, and compatibility with the human body. Testing encompasses assessments of electronic systems, battery performance, biocompatibility, and electromagnetic compatibility. Ensuring the reliability and long-term safety of these implantable devices is paramount as they directly affect patient well-being.

The consumers and patients segment is expected to have the highest CAGR during the forecast period

The consumers and patients segment is anticipated to witness the fastest CAGR growth during the forecast period. With the growing focus on patient safety, consumers, and patients are becoming more informed and discerning about the medical devices they use. This increased awareness is driving demand for stringent testing to ensure the safety and efficacy of devices. Additionally, the rise in direct-to-consumer medical devices and home healthcare equipment further emphasizes the need for robust testing to build trust among end-users. As the empowered healthcare consumer trend continues to gain momentum, the Consumers and Patients segment is poised for substantial growth.

Region with largest share:

North America holds a significant share in the market over the forecast period. The region boasts a well-established healthcare industry, advanced research infrastructure, and stringent regulatory frameworks. North American countries, particularly the United States, host a plethora of medical device manufacturers and research organizations, fueling the demand for testing services to ensure product compliance with regulatory standards. The market benefits from a robust ecosystem of accredited testing laboratories, clinical trial facilities, and regulatory experts, making it an attractive destination for both domestic and international medical device companies seeking rigorous and reliable testing, certification, and validation services.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period. The region's expanding healthcare sector, increasing investments in research and development, and growing demand for medical devices have fuelled the need for comprehensive testing services. With the rising awareness of healthcare quality and safety, Asia Pacific countries are enhancing their regulatory and quality standards, driving the demand for testing to ensure product compliance and safety. Additionally, the availability of a skilled workforce, cost-effective clinical trials, and a diverse patient population make Asia Pacific an attractive destination for medical device manufacturers looking to conduct clinical studies and tests.

Key players in the market

Some of the key players in Medical Device Testing market include: Avomeen, BSI Group, Bureau Veritas, Dekra Testing and Certification GmbH, Element Materials Technology, Eurofins Scientific, Gateway Analytical LLC, Intertek Group PLC, Medistri SA, Pace Analytical Services LLC, SGS SA, TUV Rheinland and WuXi AppTec.

Key Developments:

In June 2023, TUV SUD has opened a laboratory in New Brighton, Minnesota, accredited to ISO 17025 for biological and chemical testing of medical devices. Staffed by experienced scientists and technicians, the lab will cater to both domestic and international medical device companies, aiding in research and development through microbiology, reusable device testing, chemistry, biocompatibility, and packaging testing services.

In September 2022, Bureau Veritas has acquired Galbraith Laboratories Inc., known for advanced analytical solutions in healthcare. This acquisition amplifies Bureau Veritas' presence in Consumer Healthcare and Industrial Chemicals supply chains, bolstering support for research, development, and product testing. Galbraith Laboratories' expertise will enhance Bureau Veritas' service portfolio, particularly in medical device testing, expanding its reach and influence in the US.

Products Covered:

Active Implant Medical Devices
Non-active Medical Devices
In Vitro Diagnostic (IVD) Medical Devices
Ophthalmic Medical Devices
Orthopedic Medical Devices
Vascular Medical Devices
Other Products

Service Types Covered:

Testing Services
Inspection Services
Certification Services
Other Service Types

Sourcing Types Covered:

In-house
Outsourced

Device Classes Covered:

Class I
Class II
Class III
Other Device Classes

End Users Covered:

Academic and Research Institutions
Consumers and Patients
Healthcare Professionals
Other End Users

Regions Covered:

North America
- US
- Canada
- Mexico
Europe
- Germany
- UK
- Italy
- France
- Spain
- Rest of Europe
Asia Pacific
- Japan
- China
- India
- Australia
- New Zealand
- South Korea
- Rest of Asia Pacific
South America
- Argentina
- Brazil
- Chile
- Rest of South America
Middle East & Africa
- Saudi Arabia
- UAE
- Qatar
- South Africa
- Rest of Middle East & Africa

What our report offers:

Market share assessments for the regional and country-level segments
Strategic recommendations for the new entrants
Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
Strategic recommendations in key business segments based on the market estimations
Competitive landscaping mapping the key common trends
Company profiling with detailed strategies, financials, and recent developments
Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

Company Profiling
- Comprehensive profiling of additional market players (up to 3)
- SWOT Analysis of key players (up to 3)
Regional Segmentation
- Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
Competitive Benchmarking
- Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

1 Executive Summary

2 Preface

2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
- 2.4.1 Data Mining
- 2.4.2 Data Analysis
- 2.4.3 Data Validation
- 2.4.4 Research Approach
2.5 Research Sources
- 2.5.1 Primary Research Sources
- 2.5.2 Secondary Research Sources
- 2.5.3 Assumptions

3 Market Trend Analysis

3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 End User Analysis
3.8 Emerging Markets
3.9 Impact of Covid-19

4 Porters Five Force Analysis

4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry

5 Global Medical Device Testing Market, By Product

5.1 Introduction
5.2 Active Implant Medical Devices
5.3 Non-active Medical Devices
5.4 In Vitro Diagnostic (IVD) Medical Devices
5.5 Ophthalmic Medical Devices
5.6 Orthopedic Medical Devices
5.7 Vascular Medical Devices
5.8 Other Products

6 Global Medical Device Testing Market, By Service Type

6.1 Introduction
6.2 Testing Services
6.3 Inspection Services
6.4 Certification Services
6.5 Other Service Types

7 Global Medical Device Testing Market, By Sourcing Type

7.1 Introduction
7.2 In-house
7.3 Outsourced

8 Global Medical Device Testing Market, By Device Class

8.1 Introduction
8.2 Class I
8.3 Class II
8.4 Class III
8.5 Other Device Classes

9 Global Medical Device Testing Market, By End User

9.1 Introduction
9.2 Academic and Research Institutions
9.3 Consumers and Patients
9.4 Healthcare Professionals
9.5 Other End Users

10 Global Medical Device Testing Market, By Geography

10.1 Introduction
10.2 North America
- 10.2.1 US
- 10.2.2 Canada
- 10.2.3 Mexico
10.3 Europe
- 10.3.1 Germany
- 10.3.2 UK
- 10.3.3 Italy
- 10.3.4 France
- 10.3.5 Spain
- 10.3.6 Rest of Europe
10.4 Asia Pacific
- 10.4.1 Japan
- 10.4.2 China
- 10.4.3 India
- 10.4.4 Australia
- 10.4.5 New Zealand
- 10.4.6 South Korea
- 10.4.7 Rest of Asia Pacific
10.5 South America
- 10.5.1 Argentina
- 10.5.2 Brazil
- 10.5.3 Chile
- 10.5.4 Rest of South America
10.6 Middle East & Africa
- 10.6.1 Saudi Arabia
- 10.6.2 UAE
- 10.6.3 Qatar
- 10.6.4 South Africa
- 10.6.5 Rest of Middle East & Africa

11 Key Developments

11.1 Agreements, Partnerships, Collaborations and Joint Ventures
11.2 Acquisitions & Mergers
11.3 New Product Launch
11.4 Expansions
11.5 Other Key Strategies

12 Company Profiling

12.1 Avomeen
12.2 BSI Group
12.3 Bureau Veritas
12.4 Dekra Testing and Certification GmbH
12.5 Element Materials Technology
12.6 Eurofins Scientific
12.7 Gateway Analytical LLC
12.8 Intertek Group PLC
12.9 Medistri SA
12.10 Pace Analytical Services LLC
12.11 SGS SA
12.12 TUV Rheinland
12.13 WuXi AppTec

簡介目錄圖表

List of Tables

Table 1 Global Medical Device Testing Market Outlook, By Region (2021-2030) ($MN)
Table 2 Global Medical Device Testing Market Outlook, By Product (2021-2030) ($MN)
Table 3 Global Medical Device Testing Market Outlook, By Active Implant Medical Devices (2021-2030) ($MN)
Table 4 Global Medical Device Testing Market Outlook, By Non-active Medical Devices (2021-2030) ($MN)
Table 5 Global Medical Device Testing Market Outlook, By In Vitro Diagnostic (IVD) Medical Devices (2021-2030) ($MN)
Table 6 Global Medical Device Testing Market Outlook, By Ophthalmic Medical Devices (2021-2030) ($MN)
Table 7 Global Medical Device Testing Market Outlook, By Orthopedic Medical Devices (2021-2030) ($MN)
Table 8 Global Medical Device Testing Market Outlook, By Vascular Medical Devices (2021-2030) ($MN)
Table 9 Global Medical Device Testing Market Outlook, By Other Products (2021-2030) ($MN)
Table 10 Global Medical Device Testing Market Outlook, By Service Type (2021-2030) ($MN)
Table 11 Global Medical Device Testing Market Outlook, By Testing Services (2021-2030) ($MN)
Table 12 Global Medical Device Testing Market Outlook, By Inspection Services (2021-2030) ($MN)
Table 13 Global Medical Device Testing Market Outlook, By Certification Services (2021-2030) ($MN)
Table 14 Global Medical Device Testing Market Outlook, By Other Service Types (2021-2030) ($MN)
Table 15 Global Medical Device Testing Market Outlook, By Sourcing Type (2021-2030) ($MN)
Table 16 Global Medical Device Testing Market Outlook, By In-house (2021-2030) ($MN)
Table 17 Global Medical Device Testing Market Outlook, By Outsourced (2021-2030) ($MN)
Table 18 Global Medical Device Testing Market Outlook, By Device Class (2021-2030) ($MN)
Table 19 Global Medical Device Testing Market Outlook, By Class I (2021-2030) ($MN)
Table 20 Global Medical Device Testing Market Outlook, By Class II (2021-2030) ($MN)
Table 21 Global Medical Device Testing Market Outlook, By Class III (2021-2030) ($MN)
Table 22 Global Medical Device Testing Market Outlook, By Other Device Classes (2021-2030) ($MN)
Table 23 Global Medical Device Testing Market Outlook, By End User (2021-2030) ($MN)
Table 24 Global Medical Device Testing Market Outlook, By Academic and Research Institutions (2021-2030) ($MN)
Table 25 Global Medical Device Testing Market Outlook, By Consumers and Patients (2021-2030) ($MN)
Table 26 Global Medical Device Testing Market Outlook, By Healthcare Professionals (2021-2030) ($MN)
Table 27 Global Medical Device Testing Market Outlook, By Other End Users (2021-2030) ($MN)