|Status : Published||Published On : Oct, 2021||Report Code : VRSME9073||Industry : Semiconductor & Electronics||Available Format :||Page : 250|
The testing, inspection, and certification market in the medical devices industry was USD 11 billion in 2020, registering a CAGR of 6.2% during the forecast period 2021-2027. Testing is done on manufactured products, individual components, and multi-component systems required for specific purposes. Inspection and testing include the operating parts of quality control which are essential for any manufacturing company. The testing, inspection, and certification market report offers cost-effective conformity assessment which leads to a high level of compliance., and TIC agencies provide services from audit, inspection, testing, verification, quality assurance, and certification.
The medical device industry is a diverse, innovative, and dynamic sector. The global market for medical devices is massive and will continue to grow substantially in the future. The increased globalization has standardized the product and developed technologies have led to dominance in different industries like pharmaceutical & biotech, medical devices, automotive industries, etc., which has led to growth in the TIC market. The growing urbanization, stringent safety regulations, rise in the illicit trade of counterfeit and pirated products, advances in networking and communication technology, the rising propensity of outsourcing testing, inspection, and certification services, favorable government initiatives have bolstered the growth of the TIC market in medical devices industry. Also, TIC provides various benefits with regard to credibility and image, compliance with legal and regulatory requirements, lower employee turnover, and improvement in cost control. Quality, assurance, and transparency are significant for manufacturers in the medical devices industry.
TIC services are offered by various industrial verticals and applications like pharmaceutical & biotechnology companies, diagnostic centers, medical devices, clinical research, and digital health applications in the medical sector to curb the spread of coronavirus. Pharmaceutical companies are developing drugs, antidotes, and vaccines to battle against the coronavirus. Countries are spending huge amounts on R&D vaccines, increasing their budget towards the healthcare industry, and have to work closely with regulators and policymakers resulting in the growth of TIC services in the medical devices industry.
Insight by Sourcing Type
Based on sourcing type, the TIC market for the medical devices industry is bifurcated into in-house and outsourced. Of the two segments, the in-house segment will witness dominance in the TIC market for the medical devices industry over the projected period 2021-2027. In-house testing and inspection will provide companies to have complete control over technology, skilled personnel, full-service laboratories, and testing and measurement equipment. Moreover, it provides help to the manufacturers of the TIC market for the medical devices industry in decreasing in-house compliance costs and quickly respond to global market demands. Therefore, the medical devices industry chose in-house services over outsourced services due to the criticality of applications.
Insight by Service Type
Based on service type, the TIC market for the medical devices industry is segmented into testing, inspection, and certification. Among these segments, the testing segment dominates the market in 2020 owing to the diverse product standards, stringent regulations, increasing need for improved safety, effectiveness, and growing industrialization, rising demand for verification and validation of medical devices, and a need to protect the brand. Testing in the medical devices industry should be on biocompatibility (ISO 10933 series, ISO 18652), electro-medical devices (IEC 60601 SERIES, IEC 61010 series) implantable medical devices, medical PPE, sterilization, surgical tools, syringes, medical needles, etc.
Insight by Industry Vertical
Based on industry vertical, the TIC market for the medical devices industry is divided into In-Vitro Diagnostics, Dental Equipment, Ophthalmic Devices, Diagnostic Equipment, Hospital Supplies, Cardiovascular Devices, Surgical Equipment, Patient Monitoring Devices, Orthopedic Devices, Diabetes Care Devices, Nephrology And Urology Devices, ENT Devices, Anesthesia And Respiratory Devices, Neurology Devices, Wound Care Devices, implantable devices, batteries and medical components, home healthcare devices, and others. The in-vitro diagnostic segment dominates the medical device TIC market owing to the rising demand for rapid testing kits and other diagnostic devices in various regions. The implantable device segment is anticipated to have a high CAGR during the forecast period owing to the mandatory and strict regulations to ensure that implantable medical devices suit the human body.
The TIC market for the medical devices industry is influenced by several trends like rising investment in AR and VR, data analytics, automation, connected devices and cloud-based technology, rising mergers, and acquisitions by the market players, expansion of medical technologies such as wearables and contactless monitoring and sustained consolidation of suppliers leading to globalization.
The mandatory regulatory and industry standards, the requirement of certification, massive penalties for non-compliance are projected to drive the demand for TIC in the medical devices industry. Moreover, manufacturing companies are focused on providing quality products to increase customer retention, rise in demand for IoT, urbanization, increase in global trade and emerging digital platforms will bolster the growth of the TIC market in the medical devices industry. Furthermore, the sudden emergence of severe infections such as coronavirus and rising demand for hospital supplies, in-vitro diagnostic devices, and respiratory care devices have substantially increased resulting in the growth of TIC services in the medical devices industry.
The TIC market is faced with a challenge of growth fluctuations, trade wars, increase cost of TIC due to different standards and regulations globally, insufficient testing facilities, and lack of skilled personnel. Furthermore, medical devices industry have to comply with various regulatory changes resulting in a rising cost to new product development and service offered to patients which may restrict the growth of the medical devices industry.
Testing, inspection, and certification offer various opportunities in AI, robotics, drones, big data analytics, next-generation automation, and cloud and cybersecurity.
Geographically, APAC is expected to have a high CAGR in the TIC market for medical devices industry over the forecast period due to the increasing investment in research and development, growing urbanization, large manufacturing capabilities and exports, enhanced lifestyles, and the rise in consumer awareness regarding the significance of certification. Moreover, the increasing dependence of European and American countries on Asia-Pacific companies for medical devices, PPE kits, pharmaceuticals, and other necessary equipment, will result in bolstering the growth of the TIC market in the medical devices industry.
Key players are improving technologies to enhance their product portfolio by producing medical supplies having high demand such as PPE kits, hand sanitizers, masks, ventilators, etc., and generate high revenues. The industry players are taking the COVID-19 crisis as a promising opportunity to rethink their existing strategies, provide new services and delivery models to understand the rising demand for automation, remote service execution, and improved digitization.
German technical services provider TUV Rheinland’s Indian subsidiary has partnered with Andhra Pradesh MedTech Zone (AMTZ) to create an infrastructure for Electro-Magnetic Interference (EMI/EMC) at an investment of Rs 85 crore over four to five years. The public-private partnership is aimed at reducing the medical devices imports and production cost and to help deliver quality medical devices to the local market.
Some of the key players operating in the TIC market in the medical devices industry: Intertek Group plc, Bureau Veritas, UL LLC, SGS SA, Eurofins Scientific, The British Standards Institution, TUV Rheinland, DEKRA SE, Element Materials Technology, and TUV SUD.