Market Definition
Surgical instrument tracking systems is a combination of latest scanning technology and application software for inventory management. It provides a solution which allows users to maintain Quality, Compliance and Traceability of Instruments in work place. Starting in 2014, different classes of medical devices are included in UDI program to provide more accurate tracking of medical devices. Moreover, EU acted to adopt UDI in 2017, under the EU MDR.
Market Outlook
The global surgical instrument tracking system market was valued at USD 195.0 million in 2021 and it is anticipated to grow up to USD 764.1 million by 2031, at a CAGR of 14.6% during the forecast period.
Need to meet FDA Unique Device Identification mandates will augment the overall market growth. Manufacturers are required to track surgical instruments—from manufacturing through the distribution chain. The purpose of device tracking is to ensure that manufacturers of instruments establish tracking systems that will enable them to promptly locate devices in commercial distribution. The UDI (Unique Device Identification) regulations proposed by the US FDA (Food and Drug Administration) are expected to drive growth in the surgical instrument tracking systems market. According to the UDI rules, labellers (manufacturers, reprocessors, specification developers, re-packagers, and relabelers) of surgical instruments are expected to implement direct marking at the individual instrument level. Until September 24, 2020, surgical instruments categorized as Class I devices had to comply fully with these FDA requirements. However, the date was then shifted to September 24, 2022. Additionally, labellers need to submit information about each device to the FDA’s GUDID (Global Unique Device Identification Database). This database serves as a reference catalog for all devices. These mandates are expected to be the key factor driving the adoption of surgical instrument tracking systems among end users.
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Research Objectives
• Estimates and forecast the overall market size for the total market, across product, service type, type, end-user, and region
• Detailed information and key takeaways on qualitative and quantitative trends, dynamics, business framework, competitive landscape, and company profiling
• Identify factors influencing market growth and challenges, opportunities, drivers and restraints
• Identify factors that could limit company participation in identified international markets to help properly calibrate market share expectations and growth rates
• Trace and evaluate key development strategies like acquisitions, product launches, mergers, collaborations, business expansions, agreements, partnerships, and R&D activities
• Thoroughly analyze smaller market segments strategically, focusing on their potential, individual patterns of growth, and impact on the overall market
• To thoroughly outline the competitive landscape within the market, including an assessment of business and corporate strategies, aimed at monitoring and dissecting competitive advancements.
• Identify the primary market participants, based on their business objectives, regional footprint, product offerings, and strategic initiatives
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Market Segmentation
Based on product, it is segmented into hardware, software, and services. The hardware product segment accounted for the largest revenue share in 2021. The segment is projected to maintain its dominance during the forecast period. Technological advancements in hardware, such as RFID chips and barcode tags, are a major factor driving the adoption of these systems for inventory as well as surgical instrument management. For instance, Wyss Institute at Harvard University has developed a way to embed RFID chips onto metal surgical instruments using a vapor deposition process and biocompatible sealant. Such a development leads to the positive impact on the market growth.
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Major Players
The key players in the surgical instrument tracking system market are Fortive Corporation (US) , Becton, Dickinson and Company (BD) (US), Haldor Advanced Technologies (US), Getinge AB (Sweden), STERIS (US), STANLEY Healthcare (US), Mobile Aspects (US), Integra LifeSciences Holdings Corporation (US), and B. Braun Melsungen AG (Germany) among others
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Research Scope
• Scope – Highlights, Trends, Insights. Attractiveness, Forecast
• Market Sizing – Product Type, End User, Offering Type, Technology, Region, Country, Others
• Market Dynamics – Market Segmentation, Demand and Supply, Bargaining Power of Buyers and Sellers, Drivers, Restraints, Opportunities, Threat Analysis, Impact Analysis, Porters 5 Forces, Ansoff Analysis, Supply Chain
• Business Framework – Case Studies, Regulatory Landscape, Pricing, Policies and Regulations, New Product Launches. M&As, Recent Developments
• Competitive Landscape – Market Share Analysis, Market Leaders, Emerging Players, Vendor Benchmarking, Developmental Strategy Benchmarking, PESTLE Analysis, Value Chain Analysis
• Company Profiles – Overview, Business Segments, Business Performance, Product Offering, Key Developmental Strategies, SWOT Analysis
• Market Size in 2021 – $195.0 mn
• Market Size in 2031 – $764.1 mn
• CAGR % – 14.6%
• Historic Period – 2015-2022
• Forecast Period – 2024-2033
• Base Year – 2023
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