AI Testing, Inspection and Certification (TIC) Services in Healthcare Market - By Service (Testing, Inspection, Certification), By Type (In-house, Outsourced), By Application & Forecast, 2024 - 2032

AI TIC Services in Healthcare Market Size

AI TIC Services in Healthcare Market was valued at USD 1.8 billion in 2023 and is estimated to register a CAGR of over 15% between 2024 and 2032. The growth of the market can be attributed to the growing adoption of digital health solutions such telemedicine, wearable devices, and health information systems. These solutions require accurate testing and certification to ensure their reliability, security, and compliance with healthcare standards.
 

For instance, in February 2024, a group of 14 healthcare and consumer trade associations including the American Telemedicine Association (ATA), American Medical Association (AMA), AARP, AHIP, the Consumer Technology Association, the Digital Medicine Society, the National Committee for Quality Assurance, and the Digital Therapeutics Alliance formed the Digital Health Collaborative to speed up digital health research and adoption. The collaboration supports evidence-based research and programs to increase awareness and confidence in adopting digital health technologies.  
 

The healthcare industry is highly regulated, with stringent standards and regulations governing the development, deployment, and use of medical devices, digital health solutions, and AI algorithms. As AI continues to revolutionize healthcare with applications in diagnostics, personalized medicine, drug discovery, and patient management, the need for specialized TIC services to validate AI algorithms and systems has become important. TIC services ensure that AI technologies are accurate, reliable, and safe for clinical use, which is essential for getting regulatory approval and gaining trust from healthcare providers.
 

Developing and implementing AI TIC services requires high upfront investment in technology, talent, and infrastructure. Also, the return on investment (ROI) can be uncertain, especially in the early stages of adoption. High initial costs and unclear ROI can discourage healthcare organizations from adopting AI TIC services. Ensuring these services demonstrate clear and measurable benefits is crucial for widespread adoption and market growth. Furthermore, the complex regulatory environment poses a significant challenge for TIC providers across the globe.
 

AI TIC Services in Healthcare Market Trends

The growing integration of AI in drug discovery and development is enabling faster identification of drug candidates, predicting drug efficacy and enhancing clinical trials. Companies are launching AI-based software to integrate drug discovery. For instance, in December 2023, Merck, a science and technology company launched AIDDISON, drug discovery software, a software-as-a-service platform to close the gap between virtual molecule design and real-world manufacturability through Synthia retrosynthesis software API integration. The integration of AI in drug discovery needs accurate testing and certification to ensure AI models are reliable. AI TIC services are important for verifying AI-driven drug discovery processes and checking if they meet regulatory standards.
 

Also, regulatory bodies in various countries are updating their regulations for AI-driven medical devices.  For instance, in May 2024, The FDA (Food and Drug Administration) in the United States has announced updated guidelines for the regulation of AI-driven medical devices. The new guidelines emphasize the importance of rigorous testing and validation of AI algorithms used in healthcare to ensure safety, efficacy, and compliance with regulatory standards. This update reflects ongoing efforts to streamline the approval process for AI technologies while maintaining patient safety.
 

AI TIC Services in Healthcare Market Analysis

Based on type, the market is categorized into in-house and outsourced. In 2023, the outsourced held over 55% of the market share and is expected to cross over USD 3.5 billion by 2032. Outsourcing AI TIC services allows healthcare companies to access specialized expertise and skills that may not be available in-house. This includes expertise in AI algorithm validation, regulatory compliance, data analytics, and cybersecurity specific to healthcare applications. Furthermore, outsourcing ensures that testing and certification processes are conducted by professionals with high domain knowledge and experience. Healthcare organizations benefit from flexible service agreements that scale with their testing and certification needs, avoiding fixed overhead costs associated with maintaining internal testing capabilities.
 

Based on service, the AI TIC services in healthcare market is divided into testing, inspection, certification and others. The testing segment is expected to hold around 53% of the revenue share by 2032. The growing need to verify the accuracy and performance of AI algorithms used in healthcare applications including diagnostic tools and predictive analytics is driving the demand for testing procedures. Also, as AI algorithms in healthcare become more complex, there is increasing demand for specialized testing services that can assess algorithm performance, accuracy, reliability, and safety across different clinical scenarios and patient populations. Furthermore, testing services help healthcare companies navigate regulatory complexities by conducting comprehensive assessments to demonstrate compliance with standards such as those set by the FDA (in the US) or the EMA (in Europe). This ensures that AI systems meet safety, efficacy, and quality standards before entering the market.
 

North America dominated the global TIC services in the healthcare industry with a market share of around 40% in 2023. The region is at the forefront of technological advancements in AI, particularly in healthcare applications. Countries such as U.S. and Canada benefit from a strong ecosystem of AI research institutions, startups, and established companies developing modern healthcare solutions. This drives demand for specialized TIC services to verify AI algorithms, ensuring they meet regulatory standards and deliver reliable clinical outcomes.
 

Patient safety and quality of care are major priorities in the U.S. healthcare system. This is driven by the regulatory mandates and patient expectations in the country. Furthermore, the country faces high healthcare costs pushing the need for more efficient and cost-effective healthcare delivery systems. AI TIC services reduce costs by increasing the efficiency and accuracy of TIC processes. By automating and upgrading these processes, healthcare organizations get better resource utilization and reduced operational expenses.
 

Europe has a presence of stringent regulatory framework for medical devices and digital health technologies, including AI applications in healthcare. Growth in TIC services is driven by the stringent requirements set by regulatory bodies such as the European Medicines Agency (EMA) and the Medical Devices Regulation (MDR). TIC providers in Europe have high expertise in conducting testing and certification to ensure AI technologies meet the safety, efficacy, and data protection standards.
 

The Asia Pacific region is experiencing rising adoption of digital health technologies, including AI-powered solutions for diagnostics, telemedicine, remote patient monitoring, and personalized medicine. This growth of the market in the region can be attributed to the increasing healthcare expenditures, aging populations, and efforts to improve healthcare access and quality across diverse economies. TIC providers in Asia-Pacific are offering localized testing and certification services tailored to specific regulatory environments and cultural nuances.
 

AI TIC Services in Healthcare Market Share

SGS Group and Bureau Veritas dominate the AI TIC services in the healthcare market holding high market share over 15%. SGS Group invests heavily in A and other advanced technologies to improve its TIC services. The company develops AI-driven solutions for quality control, compliance and risk management.
 

Bureau Veritas focuses on customer needs and offering tailored solutions to address the specific challenges faced for healthcare clients. Also, the company invests heavily in training and development of their workforce to ensure that the team has the skills and knowledge to leverage AI technologies effectively.
 

AI TIC Services in Healthcare Market Companies

Major players operating in the AI TIC Services in healthcare industry are:

• Bureau Veritas
• DEKRA
• DNV GL
• Emitech Group
• Eurofins Scientific
• Intertek Group
• SGS Group
• TUV Rheinland
• TUV SUD
• UL (Underwriters Laboratories)

AI TIC Services in Healthcare Industry News

• In April 2024, Bureau Veritas SA announced a partnership with a leading healthcare technology firm to develop AI-based certification processes for medical devices. This collaboration aims to streamline the certification workflow and improve the reliability of medical device approvals.
   
• In April 2024, RetiSpec and Topcon Healthcare have collaborated to bring an AI-based eye diagnostic tool to the market. This technology focuses on predicting biomarkers of Alzheimer’s disease through eye diagnostics, integrating with Topcon Harmony, a cloud-based clinical data management platform.
   

The AI TIC services in healthcare market research report includes in-depth coverage of the industry with estimates & forecasts in terms of revenue (USD Billion) from 2021 to 2032, for the following segments:

Click here to Buy Section of this Report

Market, By Service

• Testing
• Inspection
• Certification
• Others

Market, By Type

• In-house
• Outsourced

Market, By Application

• Pharmaceuticals & biotechnology
• Clinical laboratories and diagnostics
• Hospitals & healthcare facilities
• Medical devices

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Nordics
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • ANZ
  • Southeast Asia
  • Rest of Asia Pacific 
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• MEA
  • UAE
  • Saudi Arabia
  • South Africa
  • Rest of MEA