市場調查報告書
商品編碼
1439915
醫療器材測試服務 - 全球市場考量、競爭格局、市場預測(2030 年)Medical Device Testing Services - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
預計2023年全球醫療器材測試服務市場規模將達到91.5億美元,到2030年將達到121億美元,2024-2030年預測期內複合年增長率為4.82%。 由於各種因素,例如嚴格的政府法規對醫療器材的驗證和確認的需求不斷增加,該市場呈現出積極的增長。 此外,醫療產業的技術進步以及全球越來越多缺乏內部專業知識的小型醫療器材公司也推動了對醫療器材測試服務的需求。 此外,智慧型手機、人工智慧、物聯網服務和醫療設備的整合為市場成長提供了巨大的機會。 因此,預計在 2024 年至 2030 年的預測期內,市場將以顯著的複合年增長率成長。
醫療器材偵測服務市場動態
醫療器材檢測服務市場的主要驅動因素之一是由於患有各種慢性疾病的患者總數的增加而導致醫療器材行業的整體擴張。 此外,小型醫療器材公司和大公司增加投資將在給定的預測期內急劇增加對醫療器材測試服務的需求。
根據世界衛生組織 (WHO) (2022) 的數據,慢性病每年導致近 4,100 萬人死亡,佔全球死亡人數的 74%。 慢性病的主要類型是心臟病和中風等心血管疾病、癌症、慢性阻塞性肺病和氣喘等慢性呼吸道疾病以及糖尿病。 同一份文件也顯示了2020年全球癌症發生率。 最常見的癌症是乳癌(226萬例)、肺癌(221萬例)、大腸癌(193萬例)、攝護腺癌(141萬例)、皮膚癌(120萬例)和胃癌(1.09萬例)。
癌症發生率的上升增加了對用於診斷、治療和管理的醫療器材的需求,進而增加了對醫療器材檢測服務的需求。
此外,政府機構或組織對醫療器材驗證和認證的嚴格規定將迅速增加對醫療器材檢測服務的需求。 此外,隨著人工智慧和物聯網服務融入設備中,對醫療設備測試服務的需求也將增加。 因為人工智慧設備始終面臨網路風險和隱私問題的風險,驗證和確認與這些醫療設備相關的所有風險非常重要。
因此,上述因素共同推動了 2024-2030 年預測期間的整體醫療器材測試服務市場。
然而,醫療器材的高成本以及不同地區存在不同監管機構可能會阻礙全球醫療器材測試服務市場的成長。
由於對口罩、個人防護裝備和呼吸設備等 COVID-19 相關產品的需求增加,COVID-19 大流行對醫療設備測試服務市場產生了積極影響。 由於呼吸器、COVID-19 疫苗和體外診斷藥物 (IVD) 試劑盒用於控制、治療或預防感染,因此它們的需求不斷增加。 上述設備和產品均需要醫療器材檢測服務。 因此,疫情期間各種醫療器材需求的增加,增加了對醫療器材檢測服務的需求,進而提振了整體市場。 此外,隨著醫療器材需求的增加,許多大公司都增加了醫療器材的生產,從而增加了對檢測服務的需求。 此外,醫療設備測試服務市場上的許多主要公司都提供醫療設備的遠距測試,以保持健康和安全合規性的連續性並盡可能避免身體接觸。 因此,上述因素正在增加對醫療器材檢測服務的需求,並且在未來幾年可能仍然如此。
醫療器材檢測服務市場區隔分析
在醫療器材測試服務的服務類型領域,測試服務市場預計將在 2023 年佔據重要的收入佔有率。 這主要是由於對高品質和安全產品的高需求以及監管機構為確保產品安全、品質和效率的強烈建議。
本報告研究和分析了全球醫療器材測試服務市場,提供市場規模和預測、驅動因素和挑戰、公司和產品概況等。
MEDICAL DEVICE TESTING SERVICES MARKET BY SERVICE TYPE (TESTING SERVICE, INSPECTION SERVICE, AND CERTIFICATION SERVICE), BY SOURCING TYPE (IN-HOUSE AND OUTSOURCED), BY DEVICE CLASS (CLASS I, CLASS II, AND CLASS III), BY PRODUCT TYPE (IN-VITRO DIAGNOSTIC MEDICAL DEVICE, ACTIVE IMPLANT MEDICAL DEVICE, VASCULAR MEDICAL DEVICE, OPHTHALMIC MEDICAL DEVICE, AND OTHERS), AND BY GEOGRAPHY IS EXPECTED TO GROW AT A STEADY CAGR FORECAST till 2030 OWING TO AN INCREASING NEED FOR VALIDATION AND VERIFICATION OF MEDICAL DEVICES DUE TO STRICT GOVERNMENT REGULATIONS AND RISING TECHNOLOGICAL DEVELOPMENT IN THE MEDICAL DEVICE INDUSTRY
The global medical device testing services market was valued at USD 9.15 billion in 2023, growing at a CAGR of 4.82% during the forecast period from 2024 to 2030 to reach USD 12.10 billion by 2030. The medical device testing services market is witnessing positive growth owing to various factors such as the growing necessity for validation and verification of medical devices due to strict government regulations. Furthermore, the ongoing technological development in the medical industry and the rise in small medical device firms without in-house expertise across the globe will propel the demand of medical device testing services. Additionally, the integration of smartphones, artificial intelligence, Iot services with the medical devices are offering prominent opportunities for market growth. Therefore, the market for medical device testing services are estimated to grow at a significant CAGR during the forecast period from 2024 to 2030.
MEDICAL DEVICE TESTING SERVICES MARKET DYNAMICS:
One of the main drivers of the medical device testing services market is the increasing overall medical device industry owing to the rise in general patient pool suffering from the various chronic diseases. Moreover, the rising investments by small medical devices firms along with key players will upsurge the demand of medical device testing services in the given forecast period.
According to the World Health Organization (WHO) 2022, chronic diseases kills nearly 41 million people each year, equivalent to 74% of all deaths globally. The main types of chronic diseases are cardiovascular diseases such as heart attacks and stroke, cancers, chronic respiratory diseases such as chronic obstructive pulmonary disease and asthma, diabetes, and others. Also, the source listed the incidence of cancer in 2020, globally. The most common form of cancers were reported was of breast cancer with 2.26 million cases, lung cancer -2.21 million cases, colon and rectum cancer with 1.93 million cases, prostate cancer with 1.41 million cases, skin cancer 1.20 million cases, and stomach cancer with 1.09 million cases, globally.
The increasing incidence of cancers will increase the demand of medical devices in the market used for diagnosis, treatment or management of the disease, ultimately increasing the demand of medical device testing services.
Further, the strict regulations by the government institutes or organizations for validation and verification of medical devices will surge the demand of medical device testing service. Also, the incorporation of artificial intelligence (AI) and IoT services in the device will increase the demand of medical device testing services as the AI devices are always at a risk of cyber risks, and privacy issues so it is very essential to validate and verify all the risks associated with these medical device.
Therefore, the factors stated above collectively will drive the overall medical device testing services market during the forecast period from 2024-2030.
However, high cost of medical devices, presence of different regulatory authorties in different regions, and others, can hamper the global medical device testing services market growth.
The COVID-19 epidemic has positively impacted the medical device testing services market due to the increasing demand for COVID-19-related products such as masks, PPE, respiratory equipment, and others. The demand of the ventilators, COVID-19 vaccines, IVD kits, and other products increases as they were used to either manage or treat or prevent the infection. The medical device testing services is required for the above mentioned devices or products. Thus, the increasing demand of the various medical devices during the pandemic increased the demand of the medical device testing services, ultimately propelling the overall market. Additionally, with the increasing demand of the medical device many key players increased their medical device manufacturing, thereby increasing the demand of testing services. Moreover, many key players working in the market of medical device testing services provided remote inspections of medical equipment to maintain the continuity of health and safety compliance and avoid any possible physical contact. Henceforth, the above factors increased the demand of the medical device testing services and is likely to do the same in the upcoming years.
MEDICAL DEVICE TESTING SERVICES MARKET SEGMENT ANALYSIS:
Medical Device Testing Services Market By Service Type (Testing Service, Inspection Service, and Certification Service), Sourcing Type (In-House and Outsourced), Device Class (Class I, Class II, and Class III), Product Type (In-Vitro Diagnostic Medical Device, Active Implant Medical Device, Vascular Medical Device, Ophthalmic Medical Device, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the service type segment of the medical device testing services, the testing service market is expected to have a significant revenue share in the year 2023. This was primarily owing to the high demand for quality and safe products and due to the strong recommendations from regulatory authorities to ensure the safety, quality, and efficiency of the products.
For instance, examples of testing services are electro medical device testing, biocompatibility testing, clinical research services which help in assessing the final product to investigate the faulty material, and testing the performance of medical devices and the electrical safety of devices.
Further, the testing services are carried out in laboratories and research sites. Also, the testing services assist manufacturers in improving the marketability of their medical devices and in lowering costs in the pre-production phase e.g. R&D, the selection of suppliers, and others.
Moreover, key players in the market are expanding their testing services portfolio. For instance, in June 2020, Intertek, announced the expansion of its personal protective equipment services to include the pre-certification testing of N95 respirators to requirements set by the National Institute for Occupational Safety and Health (NIOSH).
Thus, due to the interplay of all the factors mentioned above, this can result in the rising demand for testing services, which in turn would provide a conducive growth environment for overall medical device testing services market during the market forecast 2024-2030.
NORTH AMERICA IS EXPECTED TO DOMINATE THE OVERALL MEDICAL DEVICE TESTING SERVICES MARKET:
Among all the regions, North America is expected to dominate the global medical device testing services market in the year 2023 and is expected to do the same during the forecast period from 2024-2030. Factors such as strict regulations established by the governments to maintain quality and safety standards in the industry, rising per capita income among the region, growing consumer awareness regarding the importance of certification, and others will increase the demand for medical device testing services in the North America market. Further, the new and replacement sales, rising country demographics, surging disease epidemiology, and import-export tariffs of the medical devices in the region will increase the demand of medical device testing services in the given forecast period.
Also, the increasing prevalence of chronic disorders such as cardiovascular, respiratory, and other disorders will increase the demand of medical devices in the region, ultimately surging the need of medical device testing services. For instance, according to the Centers for Disease Control and Prevention (CDC) 2022, about 20.1 million adults age 20 and older had coronary artery disease in 2020 in the United States. Also, in the United States, every year, about 805,000 people in the United States have a heart attack. Thus, the increasing prevalence of cardiovascular disorders will increase the demand of the medical devices used in diagnosis or treatment or management of the disease.
Further, the increasing complexity in product design and growing efforts toward cost-cutting is one of the factor responsible for driving the market growth. Besides, the presence of stringent regulatory bodies such as the FDA is fueling the market growth in the region. The rapid increase in the manufacturing of medical devices to meet the high demand for efficient healthcare in the region is expected to be one of the major factors that can be attributed to the market growth in North America.
Therefore, the interplay of the aforementioned factors above would provide a conducive growth environment for the North American region in the medical device testing services.
MEDICAL DEVICE TESTING SERVICES MARKET KEY PLAYERS:
Some of the key market players operating in the medical device testing services market include Element Minnetonka, Bioneeds, Charles River Laboratories., A Sotera Health company, North American Science Associates, LLC, Labcorp, SGS Societe Generale de Surveillance SA, Eurofins Scientific, Pace Analytical Services LLC, Intertek Group plc, Bureau Veritas, TUV SUD, DEKRA, Element Materials Technology, Medistri SA, UL LLC, The British Standards Institution, Biomedical Device Labs, NTS, ImpactQA., and others.
RECENT DEVELOPMENTAL ACTIVITIES IN THE MEDICAL DEVICE TESTING SERVICES MARKET:
In April 2022, TUV SUD announced that it had presented itself at Medtec LIVE to exhibit its ability to be a one-stop-shop for medical device testing. The company's services covered testing in the areas of electrical and functional safety, cyber security and software, EMC, and biocompatibility. The experts from TUV SUD featured in the online trade show and congress program with various talks, a live hack and an elevator pitch.
In October 2019, TUV SUD signed a memorandum of understanding (MoU) with the NUS Centre for Additive Manufacturing (AM.NUS) at the National University of Singapore (NUS), to promote R&D activities in the area of 3D printed biomedical implants for clinical trials.
In May 2019, Intertek announced the expansion of its pharmaceutical services laboratory in Melbourne, near Cambridge, through the acquisition of a new 20,000 sq. ft. facility, which will double the footprint of the existing laboratory.
In February 2019, Bureau Veritas and Microsoft, the leader in productivity platforms and services, announced the conclusion of a global technical and business collaboration for the development of laboratory testing services based on artificial intelligence (AI).
KEY TAKEAWAYS FROM THE MEDICAL DEVICE TESTING SERVICES MARKET REPORT STUDY
TARGET AUDIENCE WHO CAN BE BENEFITED FROM THIS MEDICAL DEVICE TESTING SERVICES MARKET REPORT STUDY
FREQUENTLY ASKED QUESTIONS FOR MEDICAL DEVICE TESTING SERVICES MARKET:
Medical device testing is the process of demonstrating that the device will reliably and safely perform in use. In new product development, extensive Design Validation Testing is applied. This includes performance testing, toxicity and chemical analysis, and sometimes human factors or even clinical testing. Ongoing quality assurance testing is generally more limited. This will usually include dimensional checks, some functional tests, and packaging verification
The global medical device testing services market was valued at USD 9.15 billion in 2023, growing at a CAGR of 4.82% during the forecast period from 2024 to 2030 to reach USD 12.10 billion by 2030.
The medical device testing services is witnessing an affirmative market growth due to the factors such as the increasing need for validation and verification of medical devices, ongoing technological development in the medical industry, rise in small medical device firms without in-house expertise, and others.
Some of the key market players operating in the medical device testing services include Element Minnetonka, Bioneeds, Charles River Laboratories., A Sotera Health company, North American Science Associates, LLC, Labcorp, SGS Societe Generale de Surveillance SA, Eurofins Scientific, Pace Analytical Services LLC, Intertek Group plc, Bureau Veritas, TUV SUD, DEKRA, Element Materials Technology, Medistri SA, UL LLC, The British Standards Institution, Biomedical Device Labs, NTS, ImpactQA., and others
North America is expected to dominate the global medical device testing services. Factors contributing to the growth are strict regulations established by the governments to maintain quality and safety standards in the industry, rising per capita income among the region, growing consumer awareness regarding the importance of certification, and others, which are contributing to the growth of the medical device testing services in the North America region.