Global Medical Device Testing Services Market - 2021-2028
発行: DataM Intelligence
ページ情報: 英文 180 Pages
世界の医療機器検査サービス市場の主な促進要因として、医療機器の妥当性の確認・検証ニーズの増大などが挙げられます。他方、過度の規制により医療機器開発・製造のローカル化が制約されることが、市場成長の妨げとなる可能性もあります。サービス分野別では微生物・滅菌検査セグメントが、フェーズ別 (相別) では前臨床検査が最大のシェアを占めています。地域別ではアジア太平洋が最大の市場で、今後もその地位を維持する見通しです。
The global medical device testing services market size was valued US$ XX billion in 2020 and is estimated to reach US$ XX billion by 2028, growing at a CAGR of XX % during the forecast period (2021-2028).
Medical device testing is a significant step in transforming an innovative design into a solid and marketable product. Moreover, testing puts the product through a comprehensive medical devices industry assessment and helps to show compliance with standards and regulations worldwide.
Increasing demand for validation and verification of medical devices is expected to drive the market's growth.
The companies manufacturing across the globe are planning to invest more in automation post-COVID-19. Moreover, the need for automated quality assurance has increased as industries have realized its importance in manufacturing processes. In addition, this need is further raised due to the COVID-19 outbreak due to less interference by humans required in the process. It has resulted in the widespread approval of machine vision as an integral part of long-term automation development processes. Hence, from the above statements medical device testing market is expected to drive growth.
Limitations to the local development of medical devices is expected to hamper the market's growth.
According to the Medical Journal, while the advancement of standards and control of medical devices is essential, excessive regulations, particularly in domestic circumstances, can also be a barrier to local innovation. Moreover, it can potentially hinder domestic innovation by subjecting new technologies to a lengthy and expensive licensing procedure after increasing the cost and the time that local manufacturers spend. The production cost of the medical equipment and few products, which are of significant value to low-income countries, may be extracted from the market due to the observed risks compared with their use. Hence Barriers to the local development of medical devices are expected to hamper the market's growth.
COVID-19 Impact Analysis
The COVID-19 pandemic has affected the healthcare systems globally. Also, it has a notable impact on the market, and this has happened in several businesses closing down their manufacturing plants and halting most of their operations. During this pandemic, the main objective of companies was to run the business by safety and to continue the operations to get their revenues. Moreover, the pandemic has increased the demand for TIC services in the medical sector. For instance, the COVID-19 outbreak has led to increased demand for hygienic masks. In few countries such as France, Spain, and Mexico, have published appropriate standards and specifications, i.e., the UNE 0065, UNE 0064-1, UNE 0064-2, and AFNOR-SPEC-S76 standards, which is met before a mask is sold.
Additionally, TIC market players who provide services to the medical industry have begun inspections of medical equipment to keep the continuity of health and safety compliance and avoid any possible physical contact.
Microbiology & Sterility Testing segment is expected to hold the largest market share in this market segment.
The microbiology and sterility testing segment commanded the medical device testing services market and accounted for the largest revenue share in 2020. According to the Journal, A sterile medical device is free from viable microorganisms. Medical devices produced under approved manufacturing conditions under the requirements for Quality Management Systems (QMS) may have microorganisms present and within them before sterilization (non-sterile products). Moreover, sterilization aims to inactivate the microbiological contaminants to modify the devices from non-sterilized to sterilized. Sterility testing of medical devices is needed during the sterilization validation process, and routine release testing as sterility assurance is very crucial for medical devices. Failure to conduct such tests might delay the regulatory process for devices. Hence, the microbiology & sterility testing segment is expected to hold the largest market share.
Preclinical Segment is expected to hold the largest market share in this segment
The preclinical phase has accounted for the largest revenue share of the medical device testing services market in 2020. Preclinical studies determine a starting, safe dose for the first-in-human study and evaluate the potential toxicity of the product, including new medical devices, prescription drugs, and diagnostics. According to the Journal(CBSET), they profile the safety and efficacy of implanted devices and combination products and develop novel testing and assessment procedures with multiple regulatory compliances. For instance, Full histology suite for all phases of embedding, sectioning, staining and imaging, Customizable mechanical testing of biomaterials and biological tissues. Hence, the medical device companies must follow the testing and verification & validation practices to ensure the quality & reliability of medical devices. Therefore, from the above statements, the preclinical segment is expected to hold the largest market share.
Asia Pacific region holds the largest market share in the global medical device testing services market
The Asia Pacific held a maximum share in the medical device testing services market in 2020 because of the increasing per capita income among the middle class. Moreover, there is increasing consumer awareness about the importance of certification, the growing interest of international players in the China and India market, stringent product approval in countries such as China, and advancements in healthcare infrastructure. Additionally, China is the leading exporter for many companies worldwide, which has appeared to increase medical device testing services in the country to have agreement with international standards. Thus, there is a vast potential for the medical device testing services market during the forecast period.
For instance, WuXi PharmaTech (Cayman) Inc., on October 23, 2015, a leading R&D capability and technology platform company assisting the pharmaceutical, biotechnology, and medical device industries, announced its Laboratory Testing Division (LTD) had launched preclinical medical device testing services in China. Moreover, these services are being offered for Chinese and international clients for their product registration with the China Food and Drug Administration (CFDA) and Chinese clients for product registration in global markets.
The medical device testing services market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market Sterigenics International LLC, Charles River Laboratories International, Inc., Pace Analytical Services LLC, Intertek Group Plc , Wuxi AppTec, SGS SA, Eurofins, North American Science Associates Inc., Toxikon, Element Materials Technology and Adico Inspection Service LTD. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Medical Device Testing Services market globally.
Key Companies to Watch
Eurofins Advinus is an R&D services company that supports the discovery and development of compounds for different industries, including Pharmaceuticals, Biologicals, Agrochemicals, Nutraceuticals and Cosmetics. Moreover, it is part of Eurofins Scientific, a EUR 4.5 Billion leading international group of laboratories that provides a unique range of analytical testing services to the pharmaceutical, food, environmental and consumer products industries and governments.
Additionally, for the pharma/biotech industries, the company offers end-to-end services in preclinical toxicology testing, chemical process development, analytical R&D, drug metabolism and pharmacokinetics for IND submission.
Besides, the company is also one of the pioneers in drug discovery services in India, with a track record that is well explained by its path-breaking collaborations with Takeda, Merck, J&J, Novartis, Celgene and DNDi.
Biocompatibility Testing (Cytotoxicity Testing, Sensitization Testing, Irritation Testing)
Material Mediated Pyrogenicity Testing (Systemic Toxicity Testing, Implantation Testing, Hemocompatibility testing) and includes other tests.
In June 2020, Intertek announced expanding its protective equipment services to include the pre-certification testing of N95 respirators to conditions set by the National Institute for Occupational Safety and Health (NIOSH). Intertek also expanded upon its solutions and resources to support customers and the global community during the COVID-19 pandemic with these new services.
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 improve R&D projects in the area of 3D printed biomedical implants for clinical trials.
The global medical device testing services market report would provide an access to an approx. 50market data table, 41 figures and 200pages.
Global Medical Device Testing Services Market- By Service
Pyrogen & Endotoxin Testing
Sterility Test & Validation
Antimicrobial Activity Testing
Global Medical Device Testing Services Market - By Phase
Global Medical Device Testing Services Market - By Region
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