市場調査レポート

商品コード

1660679

医療機器試験市場レポート：サービス別、タイプ別、検査タイプ別、デバイスクラス別、デバイスタイプ別、地域別、2025年～2033年

Medical Device Testing Market Report by Service, Type, Testing Type, Device Class, Device Type, and Region 2025-2033

出版日: 2025年02月10日
発行: IMARC
ページ情報: 英文 133 Pages
納期: 2～3営業日

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全表示
概要
図表
目次

概要

サンプル依頼リストに入れる

医療機器試験の世界市場規模は2024年に133億米ドルに達しました。今後、IMARC Groupは、市場は2033年までに220億米ドルに達し、2025-2033年の成長率（CAGR）は5.47％になると予測しています。厳しい規制要件の賦課、大幅な技術進歩、患者の安全性重視の高まり、医療機器メーカーの新興市場への浸透、医療機器の複雑化、継続的な競合圧力などが、市場を推進する主な要因となっています。

医療機器試験とは、様々な能動・非能動医療機器の設計や生産効率を検査するプロセスを指します。これには、プロトタイプ、生体適合性、化学、微生物学、無菌性試験、パッケージバリデーション、電気的、機械的、機能的安全性評価、ソフトウェア試験が含まれます。これらの試験は、心臓血管、神経、整形外科用機器、歯科用インプラント、材料部品に対して実施されます。サービス・プロバイダーはまた、消費者に対して、社内または外注による試験、検査、認証サービスを提供しています。これらのサービスにより、機器の信頼性と、臨床や緊急時の使用における安全性が保証されます。その結果、医療機器試験は病院、クリニック、その他のヘルスケアおよび診断センターで幅広く利用されています。

医療機器メーカーが新興市場に浸透しつつあることが、複数の管轄区域にまたがる多様な規制環境に準拠するための試験需要を促進しています。さらに、複雑な試験プロトコルを必要とするマルチコンポーネント・システムやソフトウェア一体型デバイスなど、デバイスの複雑性が増していることも成長を促す要因となっています。さらに、競合他社との差別化を図るために認証や規格の取得を求める競争圧力が高まっていることも、市場の成長を後押ししています。このほか、機器の誤動作や故障に起因する高額な訴訟費用の支払いから企業を守るための積極的なリスク管理戦略として試験が広く採用されていることも、市場の成長を後押ししています。さらに、世界のヘルスケア支出の急増は、品質が保証された医療機器に対する需要を増大させており、市場成長にプラスの影響を与えています。

医療機器試験市場動向/促進要因：

規制要件の厳格化

規制状況の進化は、市場成長を促進する顕著な要因です。世界中の組織は、医療機器の安全性と有効性を維持するために厳しい基準を定めています。さらに、このような基準や規制を遵守することは、単なる管理上の義務ではなく、公衆衛生に直接影響を与える厳格な措置です。さらに、これらの要件は、いかなる医療機器も、その安全性、有効性、および全体的な品質を検証する一連の厳格な試験を通過することなく市場に出回ることがないようにするのに役立っています。これとは別に、これらの要件を満たさない場合、金銭的な罰則、法的な影響、製造業者の評判への取り返しのつかない損害が生じる可能性があります。その結果、医療機器分野のどの企業にとっても、規制遵守は重要な焦点となり、テストに多大なリソースを割くことになります。

著しい技術進歩

医療機器業界における技術進歩の著しいペースは、市場成長の顕著な要因です。デバイスはより複雑になり、リアルタイムのモニタリングから人工知能（AI）主導の診断まで、さまざまな機能を包含するようになっています。この複雑さが、有効性、安全性、信頼性を保証する専門的な検査サービスへの需要を促進しています。さらに、ウェアラブル技術、遠隔医療、個別化医療の出現は、複雑なアルゴリズム、データ保存機能、さらにはユーザー・インターフェース・コンポーネントを組み込んでおり、堅牢性と信頼性を確保するための特定の検査セットに対する需要を煽っています。さらに、新たな技術の複雑さに対応できる新たな調査手法の開発も、成長を促す要因となっています。

患者安全の重視の高まり

患者の安全性は、医療機器試験市場の重要な推進力となっています。ヘルスケア機関や消費者は、医療機器の不具合がもたらす影響についてますます認識するようになっています。医療機器の欠陥がもたらす影響は、誤った診断から生命を脅かす可能性のある合併症に至るまで、壊滅的なものになる可能性があります。医療機器試験は、患者の安全性を確保する上で重要な役割を果たしています。さらに、患者の安全性に関して政府や規制機関が厳しい規制を課しているため、医療機器試験の重要性が高まっており、市場の成長を支えています。これに加えて、患者自身がより多くの情報を得るようになり、より高い水準の医療を求め始めています。その結果、医療機器メーカーは、厳格で広範な試験プロトコルに投資する必要性に迫られています。

北米
- 米国
- カナダ
アジア太平洋地域
- 中国
- 日本
- インド
- 韓国
- オーストラリア
- インドネシア
- その他
欧州
- ドイツ
- フランス
- 英国
- イタリア
- スペイン
- ロシア
- その他
ラテンアメリカ
- ブラジル
- メキシコ
- その他
中東・アフリカ
- 市場動向
- 市場内訳：国別
- 市場予測

第12章 SWOT分析

概要
強み
弱み
機会
脅威

第13章バリューチェーン分析

第14章ポーターのファイブフォース分析

概要
買い手の交渉力
供給企業の交渉力
競合の程度
新規参入業者の脅威
代替品の脅威

第15章価格分析

第16章競合情勢

市場構造
主要企業
主要企業のプロファイル
- American Preclinical Services LLC
- Charles River Laboratories International Inc.
- Element Materials Technology
- Eurofins Scientific LLC
- Intertek Group Plc
- North American Science Associates Inc.
- Pace Analytical Services LLC（LAB Holdings Inc.）
- SGS SA
- Sterigenics U.S. LLC（Sotera Health LLC）
- Toxikon Corporation
- TUV Rheinland Aktiengesellschaft
- TUV SUD Aktiengesellschaft
- WuXi AppTec

図表

List of Figures

Figure 1: Global: Medical Device Testing Market: Major Drivers and Challenges
Figure 2: Global: Medical Device Testing Market: Sales Value (in Billion USD), 2019-2024
Figure 3: Global: Medical Device Testing Market Forecast: Sales Value (in Billion USD), 2025-2033
Figure 4: Global: Medical Device Testing Market: Breakup by Service (in %), 2024
Figure 5: Global: Medical Device Testing Market: Breakup by Type (in %), 2024
Figure 6: Global: Medical Device Testing Market: Breakup by Testing Type (in %), 2024
Figure 7: Global: Medical Device Testing Market: Breakup by Device Class (in %), 2024
Figure 8: Global: Medical Device Testing Market: Breakup by Device Type (in %), 2024
Figure 9: Global: Medical Device Testing Market: Breakup by Region (in %), 2024
Figure 10: Global: Medical Device Testing (Testing Services) Market: Sales Value (in Million USD), 2019 & 2024
Figure 11: Global: Medical Device Testing (Testing Services) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 12: Global: Medical Device Testing (Inspection Services) Market: Sales Value (in Million USD), 2019 & 2024
Figure 13: Global: Medical Device Testing (Inspection Services) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 14: Global: Medical Device Testing (Others) Market: Sales Value (in Million USD), 2019 & 2024
Figure 15: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 16: Global: Medical Device Testing (In-House) Market: Sales Value (in Million USD), 2019 & 2024
Figure 17: Global: Medical Device Testing (In-House) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 18: Global: Medical Device Testing (Outsourced) Market: Sales Value (in Million USD), 2019 & 2024
Figure 19: Global: Medical Device Testing (Outsourced) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 20: Global: Medical Device Testing (Biocompatibility Testing) Market: Sales Value (in Million USD), 2019 & 2024
Figure 21: Global: Medical Device Testing (Biocompatibility Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 22: Global: Medical Device Testing (Chemistry Testing) Market: Sales Value (in Million USD), 2019 & 2024
Figure 23: Global: Medical Device Testing (Chemistry Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 24: Global: Medical Device Testing (Bio-Burden Determination) Market: Sales Value (in Million USD), 2019 & 2024
Figure 25: Global: Medical Device Testing (Bio-Burden Determination) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 26: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market: Sales Value (in Million USD), 2019 & 2024
Figure 27: Global: Medical Device Testing (Anti-Microbial Activity and Sterility Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 28: Global: Medical Device Testing (Others) Market: Sales Value (in Million USD), 2019 & 2024
Figure 29: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 30: Global: Medical Device Testing (Class I) Market: Sales Value (in Million USD), 2019 & 2024
Figure 31: Global: Medical Device Testing (Class I) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 32: Global: Medical Device Testing (Class II) Market: Sales Value (in Million USD), 2019 & 2024
Figure 33: Global: Medical Device Testing (Class II) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 34: Global: Medical Device Testing (Class III) Market: Sales Value (in Million USD), 2019 & 2024
Figure 35: Global: Medical Device Testing (Class III) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 36: Global: Medical Device Testing (Implantable Medical Devices) Market: Sales Value (in Million USD), 2019 & 2024
Figure 37: Global: Medical Device Testing (Implantable Medical Devices) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 38: Global: Medical Device Testing (Non-Active Medical Devices) Market: Sales Value (in Million USD), 2019 & 2024
Figure 39: Global: Medical Device Testing (Non-Active Medical Devices) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 40: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market: Sales Value (in Million USD), 2019 & 2024
Figure 41: Global: Medical Device Testing (In-Vitro Diagnostic Medical Devices) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 42: Global: Medical Device Testing (Ophthalmic Medical Devices) Market: Sales Value (in Million USD), 2019 & 2024
Figure 43: Global: Medical Device Testing (Ophthalmic Medical Devices) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 44: Global: Medical Device Testing (Others) Market: Sales Value (in Million USD), 2019 & 2024
Figure 45: Global: Medical Device Testing (Others) Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 46: North America: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 47: North America: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 48: United States: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 49: United States: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 50: Canada: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 51: Canada: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 52: Asia-Pacific: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 53: Asia-Pacific: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 54: China: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 55: China: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 56: Japan: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 57: Japan: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 58: India: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 59: India: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 60: South Korea: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 61: South Korea: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 62: Australia: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 63: Australia: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 64: Indonesia: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 65: Indonesia: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 66: Others: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 67: Others: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 68: Europe: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 69: Europe: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 70: Germany: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 71: Germany: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 72: France: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 73: France: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 74: United Kingdom: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 75: United Kingdom: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 76: Italy: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 77: Italy: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 78: Spain: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 79: Spain: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 80: Russia: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 81: Russia: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 82: Others: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 83: Others: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 84: Latin America: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 85: Latin America: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 86: Brazil: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 87: Brazil: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 88: Mexico: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 89: Mexico: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 90: Others: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 91: Others: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 92: Middle East and Africa: Medical Device Testing Market: Sales Value (in Million USD), 2019 & 2024
Figure 93: Middle East and Africa: Medical Device Testing Market Forecast: Sales Value (in Million USD), 2025-2033
Figure 94: Middle East and Africa: Medical Device Testing Market: Breakup by Country (in %), 2024
Figure 95: Global: Medical Device Testing Industry: SWOT Analysis
Figure 96: Global: Medical Device Testing Industry: Value Chain Analysis
Figure 97: Global: Medical Device Testing Industry: Porter's Five Forces Analysis

List of Tables

Table 1: Global: Medical Device Testing Market: Key Industry Highlights, 2024 and 2033
Table 2: Global: Medical Device Testing Market Forecast: Breakup by Service (in Million USD), 2025-2033
Table 3: Global: Medical Device Testing Market Forecast: Breakup by Type (in Million USD), 2025-2033
Table 4: Global: Medical Device Testing Market Forecast: Breakup by Testing Type (in Million USD), 2025-2033
Table 5: Global: Medical Device Testing Market Forecast: Breakup by Device Class (in Million USD), 2025-2033
Table 6: Global: Medical Device Testing Market Forecast: Breakup by Device Type (in Million USD), 2025-2033
Table 7: Global: Medical Device Testing Market Forecast: Breakup by Region (in Million USD), 2025-2033
Table 8: Global: Medical Device Testing Market: Competitive Structure
Table 9: Global: Medical Device Testing Market: Key Players

Product Code: SR112025A3343

The global medical device testing market size reached USD 13.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 22.0 Billion by 2033, exhibiting a growth rate (CAGR) of 5.47% during 2025-2033. The imposition of strict regulatory requirements, significant technological advancements, growing emphasis on patient safety, increasing penetration of medical device manufacturer into emerging markets, rising complexity of medical devices, and ongoing competitive pressure are some of the major factors propelling the market.

Medical device testing refers to the process of inspecting the design and production efficiency of various active and non-active medical equipment. It involves prototype, biocompatibility, chemistry, microbiology and sterility testing, package validation, electrical, mechanical and functional safety assessments and software testing. These tests are conducted for cardiovascular, neuro and orthopedic devices, dental implants and material components. The service providers also offer in-house or outsourced testing, inspection and certification services to the consumers. These services ensure that the device is reliable and safe to use in clinical or emergency settings. As a result, medical device testing finds extensive applications across hospitals, clinics and other healthcare and diagnostic centers.

The increasing penetration of emerging markets by medical device manufacturers is facilitating the testing demand to comply with a diverse array of regulatory environments across multiple jurisdictions. Additionally, the rising complexity of devices, including multi-component systems and software-integrated devices, which calls for intricate testing protocols, is acting as another growth-inducing factor. Furthermore, the ongoing competitive pressure, which drives companies to achieve certifications and standards that distinguish them from competitors, is favoring the market growth. Besides this, the widespread testing adoption as a proactive risk management strategy to safeguard companies from paying high litigation costs arising from device malfunction or failures is supporting the market growth. Moreover, the surge in global healthcare expenditure, which amplifies the demand for quality-assured medical devices, is positively influencing the market growth.

Medical Device Testing Market Trends/Drivers:

The imposition of strict regulatory requirements

The evolving landscape of regulatory requirements is a prominent factor driving the market growth. Organizations across the globe have set forth stringent standards to maintain the safety and efficacy of medical devices. Furthermore, complying with such standards and regulations is not merely an administrative obligation but a strict measure that directly impacts public health. In addition, these requirements help to ensure that no device reaches the market without passing through a rigorous series of tests that verify its safety, effectiveness, and overall quality. Apart from this, the failure to meet these requirements can result in financial penalties, legal repercussions, and irreversible damage to the manufacturer's reputation. As a result, regulatory compliance is a significant focus for any company in the medical device sector, leading them to allocate substantial resources to testing.

The significant technological advancements

The significant pace of technological advancements in the medical device industry is a prominent factor contributing to the market growth. Devices are becoming more intricate, encompassing a variety of functionalities from real-time monitoring to artificial intelligence (AI)-driven diagnostics. This complexity is facilitating the demand for specialized testing services that ensure its efficacy, safety, and reliability. Furthermore, the advent of wearable technology, telemedicine, and personalized medicine, which incorporates complex algorithms, data storage capabilities, and even user interface components, is fueling the demand for a specific set of tests to ensure their robustness and reliability. Additionally, the development of novel testing methodologies that can keep pace with the complexity of emerging technologies is acting as another growth-inducing factor.

The growing emphasis on patient safety

Patient safety serves as a critical driver for the medical device testing market. Healthcare institutions and consumers are becoming increasingly aware of the implications of device malfunctions. The impact of a defective medical device can be devastating, ranging from incorrect diagnosis to potentially life-threatening complications. Medical device testing plays a critical role in ensuring patient safety as it provides an added layer of assurance, reducing the likelihood of device-related incidents. Furthermore, the heightened importance of medical device testing due to the imposition of strict regulation by governments and regulatory bodies regarding patient safety is supporting the market growth. Besides this, patients themselves are becoming more informed and are beginning to demand higher standards of care. As a result, medical device producers are facing increasing pressure to invest in rigorous and extensive testing protocols.

Medical Device Testing Industry Segmentation:

Breakup by Service:

Testing Services
Inspection Services
Others

Testing services dominates the market

Testing services are dominating the market as medical device manufacturers must adhere to rigorous standards set by regulatory agencies, which necessitates comprehensive testing services to ensure compliance. Additionally, the increasing complexity of medical device design, integrating hardware, software, and sometimes bio-components, requires a broad range of specialized testing services. Furthermore, comprehensive testing is essential for mitigating risks associated with device malfunctions, which could lead to patient harm and legal consequences for manufacturers. Besides this, possessing a thoroughly tested product can serve as a competitive advantage, allowing manufacturers to differentiate themselves in a crowded market based on quality and reliability.

Breakup by Type:

In-House
Outsourced

In-house holds the largest share in the market

In-house testing allows manufacturers to maintain strict control over their intellectual property, reducing the risk of information leaks that could occur when outsourcing to third-party services. Additionally, manufacturers have the flexibility to develop customized testing protocols that are tailored specifically to their devices, enabling more precise and relevant evaluations. Besides this, conducting tests in-house often results in quicker turnaround times, allowing for faster iterations and shorter time-to-market for new products. Moreover, possessing an in-house testing facility provides greater control over the quality of testing procedures and equipment, ensuring consistency and reliability in results. Apart from this, in-house testing allows for easier integration of testing data with other internal systems, such as design and manufacturing, facilitating a more cohesive product development process.

Breakup by Testing Type:

Biocompatibility Testing
Chemistry Testing
Bio-Burden Determination
Anti-Microbial Activity and Sterility Testing
Others

Anti-microbial activity and sterility testing holds the largest share in the market

Anti-microbial activity and sterility testing are dominating the market as it is a non-negotiable aspect of medical devices that come into contact with the human body. Any microbial contamination could lead to severe infections, making anti-microbial and sterility testing critical for patient safety. Furthermore, the imposition of stringent guidelines for sterility and anti-microbial properties by regulatory bodies is acting as another growth-inducing factor. Besides this, all categories of medical devices, from surgical instruments to implantable devices, require sterility. Hence, the applicability of this testing type is vast, driving its dominance in the market. Moreover, the rising demand for sterility and anti-microbial testing owing to the heightened awareness and concern about healthcare-associated infections (HAIs) is contributing to the market growth.

Breakup by Device Class:

Class I
Class II
Class III

Class II hold the largest share in the market

Class II devices make up a large proportion of the medical devices produced and used. Their sheer volume drives a higher demand for testing services. Furthermore, they are often more complex than Class I devices, which necessitates a broad range of testing services, such as mechanical, electrical, and biocompatibility tests. Additionally, Class II devices carry moderate risks and, therefore, require more comprehensive testing compared to low-risk Class I devices, thus increasing the demand for specialized testing services. Besides this, the class II segment is a hotbed for technological innovation, which continually introduces new types of devices or updates to existing ones. Moreover, they have prolonged contact with patients, which imposes additional requirements for safety and effectiveness testing.

Breakup by Device Type:

Implantable Medical Devices
Non-Active Medical Devices
In-Vitro Diagnostic Medical Devices
Ophthalmic Medical Devices
Others

Implantable medical devices often fall under the highest risk classification in regulatory frameworks due to their critical role in patient health. This necessitates rigorous and extensive testing to ensure safety and efficacy. Furthermore, the complexity of implantable devices, which often feature electronic components, biocompatible materials, and even software, requires a broader range of testing services. Moreover, implantable medical devices are designed to function over extended periods, sometimes for a lifetime. This long-term application requires exhaustive durability and reliability testing.

Non-active medical devices, such as surgical instruments, catheters, and syringes, are produced in higher volumes, which drives a substantial need for testing. Furthermore, they are used across various healthcare settings, including hospitals, clinics, and home care, making their market considerably large and diverse. The wide range of applications calls for versatile testing protocols. Additionally, non-active medical devices are subject to stringent regulatory guidelines concerning material safety, sterility, and mechanical reliability, which necessitates comprehensive testing.

Breakup by Region:

North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia-Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

North America has one of the most stringent regulatory environments that are pushing companies to invest heavily in comprehensive evaluation processes. This regulatory stringency naturally elevates the demand for advanced testing services. Furthermore, the region is a hub for technological innovation, housing numerous high-tech companies, research institutions, and startups focusing on medical devices. The fast-paced development of new technologies necessitates equally advanced testing services, creating a thriving market. Additionally, North America accounts for a significant proportion of global healthcare spending. The substantial investment in healthcare infrastructure and medical technology feeds into the need for extensive and specialized medical device testing.

Asia-Pacific is experiencing rapid economic growth, which translates into increased healthcare expenditure. This surge in healthcare spending fuels the need for a diverse array of medical devices and, consequently, their testing. Furthermore, the region is undergoing significant expansion in healthcare infrastructure, including hospitals and clinics, which creates a burgeoning demand for certified medical devices and testing services. Additionally, the imposition of various policies by regional governments to strengthen medical device regulations is propelling the market growth.

Competitive Landscape:

Top market players are developing cutting-edge testing technologies, such as automation and artificial intelligence (AI) algorithms, that increase testing efficiency and reliability. Furthermore, they are establishing new testing facilities or forming partnerships with local entities to broaden their geographical reach. Additionally, leading companies are working closely with regulatory agencies to ensure that their testing protocols meet or exceed current standards. Apart from this, they are offering specialized testing services, such as biocompatibility testing, electrical safety testing, and mechanical testing, to cater to the diverse needs of clients. Moreover, major players are obtaining international certifications and accreditations to enhance their credibility and build trust among consumers. Along with this, they are adopting a more customer-focused approach, offering tailored solutions that meet the specific needs of individual clients, including after-service support and consultancy.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

American Preclinical Services LLC
Charles River Laboratories International Inc.
Element Materials Technology
Eurofins Scientific LLC
Intertek Group Plc
North American Science Associates Inc.
Pace Analytical Services LLC (LAB Holdings Inc.)
SGS SA
Sterigenics U.S. LLC (Sotera Health LLC)
Toxikon Corporation
TUV Rheinland Aktiengesellschaft
TUV SUD Aktiengesellschaft
WuXi AppTec.

Key Questions Answered in This Report

1.What was the size of the global medical device testing market in 2024?
2.What is the expected growth rate of the global medical device testing market during 2025-2033?
3.What are the key factors driving the global medical device testing market?
4.What has been the impact of COVID-19 on the global medical device testing market?
5.What is the breakup of the global medical device testing market based on the service?
6.What is the breakup of the global medical device testing market based on the type?
7.What is the breakup of the global medical device testing market based on the testing type?
8.What is the breakup of the global medical device testing market based on the device class?
9.What are the key regions in the global medical device testing market?
10.Who are the key players/companies in the global medical device testing market?

1 Preface

2 Scope and Methodology

2.1 Objectives of the Study
2.2 Stakeholders
2.3 Data Sources
- 2.3.1 Primary Sources
- 2.3.2 Secondary Sources
2.4 Market Estimation
- 2.4.1 Bottom-Up Approach
- 2.4.2 Top-Down Approach
2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

4.1 Overview
4.2 Key Industry Trends

5 Global Medical Device Testing Market

5.1 Market Overview
5.2 Market Performance
5.3 Impact of COVID-19
5.4 Market Forecast

6 Market Breakup by Service

6.1 Testing Services
- 6.1.1 Market Trends
- 6.1.2 Market Forecast
6.2 Inspection Services
- 6.2.1 Market Trends
- 6.2.2 Market Forecast
6.3 Others
- 6.3.1 Market Trends
- 6.3.2 Market Forecast

7 Market Breakup by Type

7.1 In-House
- 7.1.1 Market Trends
- 7.1.2 Market Forecast
7.2 Outsourced
- 7.2.1 Market Trends
- 7.2.2 Market Forecast

8 Market Breakup by Testing Type

8.1 Biocompatibility Testing
- 8.1.1 Market Trends
- 8.1.2 Market Forecast
8.2 Chemistry Testing
- 8.2.1 Market Trends
- 8.2.2 Market Forecast
8.3 Bio-Burden Determination
- 8.3.1 Market Trends
- 8.3.2 Market Forecast
8.4 Anti-Microbial Activity and Sterility Testing
- 8.4.1 Market Trends
- 8.4.2 Market Forecast
8.5 Others
- 8.5.1 Market Trends
- 8.5.2 Market Forecast

9 Market Breakup by Device Class

9.1 Class I
- 9.1.1 Market Trends
- 9.1.2 Market Forecast
9.2 Class II
- 9.2.1 Market Trends
- 9.2.2 Market Forecast
9.3 Class III
- 9.3.1 Market Trends
- 9.3.2 Market Forecast

10 Market Breakup by Device Type

10.1 Implantable Medical Devices
- 10.1.1 Market Trends
- 10.1.2 Market Forecast
10.2 Non-Active Medical Devices
- 10.2.1 Market Trends
- 10.2.2 Market Forecast
10.3 In-Vitro Diagnostic Medical Devices
- 10.3.1 Market Trends
- 10.3.2 Market Forecast
10.4 Ophthalmic Medical Devices
- 10.4.1 Market Trends
- 10.4.2 Market Forecast
10.5 Others
- 10.5.1 Market Trends
- 10.5.2 Market Forecast

11 Market Breakup by Region

11.1 North America
- 11.1.1 United States
  - 11.1.1.1 Market Trends
  - 11.1.1.2 Market Forecast
- 11.1.2 Canada
  - 11.1.2.1 Market Trends
  - 11.1.2.2 Market Forecast
11.2 Asia-Pacific
- 11.2.1 China
  - 11.2.1.1 Market Trends
  - 11.2.1.2 Market Forecast
- 11.2.2 Japan
  - 11.2.2.1 Market Trends
  - 11.2.2.2 Market Forecast
- 11.2.3 India
  - 11.2.3.1 Market Trends
  - 11.2.3.2 Market Forecast
- 11.2.4 South Korea
  - 11.2.4.1 Market Trends
  - 11.2.4.2 Market Forecast
- 11.2.5 Australia
  - 11.2.5.1 Market Trends
  - 11.2.5.2 Market Forecast
- 11.2.6 Indonesia
  - 11.2.6.1 Market Trends
  - 11.2.6.2 Market Forecast
- 11.2.7 Others
  - 11.2.7.1 Market Trends
  - 11.2.7.2 Market Forecast
11.3 Europe
- 11.3.1 Germany
  - 11.3.1.1 Market Trends
  - 11.3.1.2 Market Forecast
- 11.3.2 France
  - 11.3.2.1 Market Trends
  - 11.3.2.2 Market Forecast
- 11.3.3 United Kingdom
  - 11.3.3.1 Market Trends
  - 11.3.3.2 Market Forecast
- 11.3.4 Italy
  - 11.3.4.1 Market Trends
  - 11.3.4.2 Market Forecast
- 11.3.5 Spain
  - 11.3.5.1 Market Trends
  - 11.3.5.2 Market Forecast
- 11.3.6 Russia
  - 11.3.6.1 Market Trends
  - 11.3.6.2 Market Forecast
- 11.3.7 Others
  - 11.3.7.1 Market Trends
  - 11.3.7.2 Market Forecast
11.4 Latin America
- 11.4.1 Brazil
  - 11.4.1.1 Market Trends
  - 11.4.1.2 Market Forecast
- 11.4.2 Mexico
  - 11.4.2.1 Market Trends
  - 11.4.2.2 Market Forecast
- 11.4.3 Others
  - 11.4.3.1 Market Trends
  - 11.4.3.2 Market Forecast
11.5 Middle East and Africa
- 11.5.1 Market Trends
- 11.5.2 Market Breakup by Country
- 11.5.3 Market Forecast

12 SWOT Analysis

12.1 Overview
12.2 Strengths
12.3 Weaknesses
12.4 Opportunities
12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

14.1 Overview
14.2 Bargaining Power of Buyers
14.3 Bargaining Power of Suppliers
14.4 Degree of Competition
14.5 Threat of New Entrants
14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

16.1 Market Structure
16.2 Key Players
16.3 Profiles of Key Players
- 16.3.1 American Preclinical Services LLC
  - 16.3.1.1 Company Overview
  - 16.3.1.2 Product Portfolio
- 16.3.2 Charles River Laboratories International Inc.
  - 16.3.2.1 Company Overview
  - 16.3.2.2 Product Portfolio
  - 16.3.2.3 Financials
  - 16.3.2.4 SWOT Analysis
- 16.3.3 Element Materials Technology
  - 16.3.3.1 Company Overview
  - 16.3.3.2 Product Portfolio
  - 16.3.3.3 Financials
- 16.3.4 Eurofins Scientific LLC
  - 16.3.4.1 Company Overview
  - 16.3.4.2 Product Portfolio
- 16.3.5 Intertek Group Plc
  - 16.3.5.1 Company Overview
  - 16.3.5.2 Product Portfolio
  - 16.3.5.3 Financials
  - 16.3.5.4 SWOT Analysis
- 16.3.6 North American Science Associates Inc.
  - 16.3.6.1 Company Overview
  - 16.3.6.2 Product Portfolio
- 16.3.7 Pace Analytical Services LLC (LAB Holdings Inc.)
  - 16.3.7.1 Company Overview
  - 16.3.7.2 Product Portfolio
- 16.3.8 SGS SA
  - 16.3.8.1 Company Overview
  - 16.3.8.2 Product Portfolio
  - 16.3.8.3 Financials
- 16.3.9 Sterigenics U.S. LLC (Sotera Health LLC)
  - 16.3.9.1 Company Overview
  - 16.3.9.2 Product Portfolio
- 16.3.10 Toxikon Corporation
  - 16.3.10.1 Company Overview
  - 16.3.10.2 Product Portfolio
- 16.3.11 TUV Rheinland Aktiengesellschaft
  - 16.3.11.1 Company Overview
  - 16.3.11.2 Product Portfolio
  - 16.3.11.3 Financials
- 16.3.12 TUV SUD Aktiengesellschaft
  - 16.3.12.1 Company Overview
  - 16.3.12.2 Product Portfolio
  - 16.3.12.3 Financials
- 16.3.13 WuXi AppTec
  - 16.3.13.1 Company Overview
  - 16.3.13.2 Product Portfolio
  - 16.3.13.3 Financials

医療機器試験市場レポート：サービス別、タイプ別、検査タイプ別、デバイスクラス別、デバイスタイプ別、地域別、2025年～2033年

Medical Device Testing Market Report by Service, Type, Testing Type, Device Class, Device Type, and Region 2025-2033

医療機器試験市場動向/促進要因：

目次

第1章 序文

第2章 調査範囲と調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

第5章 世界の医療機器試験市場

第6章 市場内訳：サービス別

第7章 市場内訳：タイプ別

第8章 市場内訳：検査種別

第9章 市場内訳：デバイスクラス別

第10章 市場内訳：デバイスタイプ別

第11章 市場内訳：地域別

第12章 SWOT分析

第13章 バリューチェーン分析

第14章 ポーターのファイブフォース分析

第15章 価格分析

第16章 競合情勢