헬스케어 시험, 검사 및 인증(TIC) 시장 규모는 2024-2030년의 예측기간 동안 CAGR 8.1%를 나타낼 것으로 예측됩니다.
TIC 서비스에 대한 현저한 수요의 급증은 제품 리콜 증가로 인한 것입니다. 디지털 헬스와 의료기기의 채용 확대도 시장 확대를 더욱 뒷받침하고 있습니다. 또한 제약회사 및 의료기기 제조업체에 의한 신약 및 의료기기 개발을 위한 R&D 활동 및 투자 증가로 제품 승인 취득을 위한 엄격한 TIC이 필요합니다. 이러한 역학은 예측 기간 동안 시장의 견조한 성장 예측에 기여합니다.
제품 위험 평가, 품질 테스트 및 인증 서비스는 제약 기업 및 의료기기 기업에게 제품 리콜을 줄이는 데 매우 중요합니다. 헬스케어 TIC 서비스는 제약·의료기기 기업이 잠재적인 제품의 결함이나 제조 공정의 불일치를 확인할 수 있도록 지원합니다. 예를 들어 미국 식품의약국(USFDA)이 2023년 6월에 발표한 State of Pharmaceutical Quality Report 2022에 따르면 2022년에는 166개 사업소가 912건의 리콜을 보고해 지난 5년간 최고가 되었습니다. CGMP 문제, 보관 온도 편차, 부형제 오염이 이러한 리콜의 주된 이유였습니다. Healthcare TIC는 제품 품질을 유지하고 제품 회수 가능성을 최소화하기 위해 이러한 문제를 핀포인트에서 파악하는 데 중요한 역할을 합니다.
2022년 세계보건기구(WHO)가 발표한 데이터에 따르면, 세계에는 200만 유형 이상의 의료기기가 존재하며, 이들은 7,000개 이상의 범용기기 그룹으로 분류되어 있습니다. 의료기기의 이러한 증가는 질병의 진단, 치료 및 예방을 위한 의료기기의 사용 증가에 기인합니다. 의료기기의 TIC서비스는 운용상의 문제를 특정·시정하고, 규제기준에 준거를 확보하는데 중요한 역할을 하고, 시장의 성장을 가속하고 있습니다.
이 보고서는 세계 건강 관리 시험, 검사 및 인증(TIC) 시장을 조사했으며, 시장 개요, 시장 영향요인 및 시장 기회 분석, 법규제 환경, 시장 규모 추이 및 예측, 각종 구분 및 지역/주요 국가별 상세 분석, 경쟁 구도, 주요 기업 프로파일 등을 정리했습니다.
Healthcare Testing, Inspection, and Certification (TIC) Market by Sourcing Type (In House, Outsourced), Service Type (Testing, Inspection, Certification), End-Users (Pharma and Biotechnology Companies, Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2030 owing to the surge in demand for medical devices testing and growing adoption of digital health & medical devices
The Healthcare Testing, Inspection, and Certification (TIC) market is estimated to grow at a CAGR of 8.1% during the forecast period from 2024 to 2030. The healthcare testing, inspection, and certification (TIC) market is poised for significant growth from 2024 to 2030, driven by several key factors. A notable surge in demand for TIC services stems from the increasing number of product recalls. The expanding adoption of digital health and medical devices further fuels market expansion. Additionally, rising R&D activities and investments by pharmaceutical and MedTech companies in developing novel drugs and devices necessitate rigorous testing, inspection, and certification to achieve product approval. These dynamics collectively contribute to the robust growth forecast for the healthcare TIC market during the forecast period.
Healthcare Testing, Inspection, And Certification (TIC) Market Dynamics:
Product risk assessment, quality testing, and certification services are crucial for pharmaceutical and medical device companies in reducing product recalls. Healthcare testing, inspection, and certification (TIC) services assist pharmaceutical and medical device firms in identifying potential product defects and inconsistencies in manufacturing processes. For example, according to the State of Pharmaceutical Quality Report 2022 published by the United States Food and Drug Administration (USFDA) in June 2023, a total of 166 sites reported 912 recalls in fiscal year 2022, the highest in five years. Consistently, CGMP issues, storage temperature deviations, and excipient contaminations were the primary reasons for these recalls. Healthcare TIC plays a vital role in pinpointing these issues to uphold product quality and minimize the likelihood of product recalls.
According to data published by the World Health Organization (WHO) in 2022, it was estimated that there were more than two million different types of medical devices in the world which were categorized in more than 7000 generic device groups. This growth in medical devices is attributed to the growing use of medical devices for diagnoses, treatment, and prevention of diseases. Testing, inspection, and certification services in medical devices play a crucial role in identifying and rectifying operational issues to ensure compliance with regulatory standards, thereby stimulating market growth.
According to data published by the Office of the National Coordinator for Health Information Technology in April 2022, approximately 78% of office-based physicians and 96% of non-federal acute care hospitals had implemented certified Electronic Health Records (EHRs), in 2021, which a part of digital health tools. This represents a significant advancement over the past decade, as compared to 2011 when only 34% of physicians and 28% of hospitals had adopted EHR systems. Therefore, the rising adoption of digital health solutions such as HER is estimated to propel the growth of the healthcare TIC market.
The pharmaceutical industry report published by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in 2023 revealed significant investment trends. In 2020, the industry invested USD 42,779.87 million (EUR 39,442 million), followed by USD 46,132.45 million (EUR 42,533 million) in 2021. By 2022, this investment had risen to USD 48,264.82 million (EUR 44,500 million), indicating a steady increase over the years. Due to increased R&D activities and investments, there is a growing demand for drug quality testing, inspection, and certification services, which is consequently contributing to the expansion of the market.
However, the high cost associated with TIC service, and the stringent regulatory standards and guidelines, among others are some of the key constraints that may limit the growth of the healthcare testing, inspection, and certification (TIC) market.
Healthcare Testing, Inspection, And Certification (TIC) Market Segment Analysis:
Healthcare Testing, Inspection, and Certification (TIC) Market by Sourcing Type (In House, Outsourced), Service Type (Testing, Inspection, Certification), End-Users (Pharma and Biotechnology Companies, Medical Technology Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the service type segment of the healthcare testing, inspection, and certification (TIC) market, the testing category was estimated to amass the largest revenue share in 2023. Medical device testing offers numerous advantages, including enhancing patient safety, ensuring compliance with legal and regulatory standards, safeguarding device and patient data against breaches, and optimizing cost management. For manufacturers in the medical device industry, maintaining quality, assurance, and transparency is paramount. These are the factors contributing to the growth of the segment in the healthcare testing, inspection, and certification (TIC) market.
In December 2023, TUV SUD, a prominent Germany-based certification, testing, auditing, inspection, and training company, inaugurated its state-of-the-art testing and inspection laboratory in Bangalore. This facility offers comprehensive testing services for active medical devices, in vitro diagnostic devices, non-active medical devices, and other electrical components. These testing services are performed to assess medical device biocompatibility testing, toxicity assessment, and microbiology testing.
In pharmaceutical drug development, rigorous testing is essential across all phases of research, development, and manufacturing. It's imperative to optimize new formulations for stability and bioavailability to ensure effective drug delivery and treatment outcomes. Precise measurements of lead APIs, excipients, and impurities are conducted, and manufacturing processes are meticulously designed to adhere to rigorous quality control standards.
In March 2024, Element Materials Technology, a United Kingdom-based TIC company launched an innovative Rapid Response Pharmaceutical Testing Service from its Manchester Life Sciences laboratory. This innovative offering will support the pharmaceutical industry by delivering expedited and comprehensive testing solutions to pharma companies globally, meeting the demands of regulatory requirements for fast product approval.
Further, testing service supports product compliance, interaction between drugs and excipients, compatibility of medical devices, and meeting regulatory guidelines for products in development are the key benefits associated with testing service. Therefore, the various applications provided by the testing service for pharmaceuticals and medical devices are expected to foster segment growth, thereby driving the growth of the healthcare testing, inspection, and certification (TIC) market during the forecast period.
North America Is Expected To Dominate The Overall Healthcare Testing, Inspection, And Certification (TIC) Market:
North America was estimated to account for the largest market share of the healthcare testing, inspection, and certification (TIC) market in 2023. This is due to the presence of major market players engaged in drug and medical device development which requires testing, inspection, and certification, contributing to the growth of the market. Additionally, growing healthcare spending and developed healthcare infrastructure in the region are some of the key factors driving the growth of the healthcare testing, inspection, and certification (TIC) market in North America.
The escalating healthcare expenditure is driving the need for advanced medical devices tailored for patients grappling with chronic diseases. This increasing demand necessitates thorough testing and inspection of devices to meet regulatory standards, consequently fostering market growth in the region. In June 2021, according to a report published by the Advanced Medical Technology Association, a United States-based medical device trade association, expenditures on medical and in-vitro diagnostics amounted to $199.1 billion, comprising 5.2 percent of total national health expenditures in 2019. In 2021, according to the Centers for Medicare and Medicaid Services, a United States-based federal agency, anticipate that annual healthcare spending on medical devices in the United States is expected to rise from approximately $300 billion in 2021 to $400 billion by 2030. This represents around 5-6% of the projected $6.8 trillion total healthcare expenditure.
In 2021, TUV SUD, a Germany-based testing and certification company, has recently been admitted to the U.S. Food and Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program. This program focuses on ensuring the safety and performance testing of medical devices. With its accreditation, TUV SUD's North American labs are now authorized to conduct premarket testing for device manufacturers aiming to enter the U.S. market.
Moreover, significant players in the region are strategically focusing on maintaining their market presence by acquiring smaller entities. For instance, in 2021, NAMSA, a company based in the United States, announced the successful acquisition of American Preclinical Services (APS) for an undisclosed amount. This acquisition enhances NAMSA's position in the medical device testing sector, leveraging APS's expertise in medical device development and preclinical research.
Healthcare Testing, Inspection, And Certification (TIC) Market Key Players:
Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) market include SGS Societe Generale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TUV SUD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.
Recent Developmental Activities In The Healthcare Testing, Inspection, And Certification (TIC) Market:
Key Takeaways From The Healthcare Testing, Inspection, And Certification (TIC) Market Report Study
Target Audience Who Can Be Benefited From This Healthcare Testing, Inspection, And Certification (TIC) Market Report Study
Frequently Asked Questions For The Healthcare Testing, Inspection, And Certification (TIC) Market:
Healthcare Testing, Inspection, And Certification (TIC) Market ensures pharmaceuticals and medical devices meet safety, efficacy, and regulatory standards. It involves thorough evaluation through chemical, physical, biological, and microbiological analyses to assess quality and performance. Inspection verifies manufacturing compliance, while certification confirms adherence to standards and regulations.
The Healthcare Testing, Inspection, and Certification (TIC) market is estimated to grow at a CAGR of 8.1% during the forecast period from 2024 to 2030.
The healthcare testing, inspection, and certification (TIC) market is poised for significant growth from 2024 to 2030, driven by several key factors. A notable surge in demand for TIC services stems from the increasing number of product recalls. The expanding adoption of digital health and medical devices further fuels market expansion. Additionally, rising R&D activities and investments by pharmaceutical and MedTech companies in developing novel drugs and devices necessitate rigorous testing, inspection, and certification to achieve product approval. These dynamics collectively contribute to the robust growth forecast for the healthcare TIC market during the forecast period.
Some of the key market players operating in the healthcare testing, inspection, and certification (TIC) include SGS Societe Generale de Surveillance SA, DEKRA, Intertek Group plc, Nemko, Smithers, Eurofins Scientific, UL LLC, TUV SUD, Element Materials Technology, CSA Group Testing & Certification Inc., ALS, Applus+, Bureau Veritas, DeviceLab Inc., DNV GL, EdgeOne Medical Inc., F2 Labs, North American Science Associates, LLC, UX Firm, Neva Analytics, and others.
North America was estimated to account for the largest market share of the healthcare testing, inspection, and certification (TIC) market in 2023. This is due to the presence of major market players engaged in drug and medical device development which requires testing, inspection, and certification, contributing to the growth of the market. Additionally, growing healthcare spending and developed healthcare infrastructure in the region are some of the key factors driving the growth of the healthcare testing, inspection, and certification (TIC) market in North America.