The Global Surgical Instrument Tracking Systems Market size is expected to reach $731.9 million by 2032, rising to a market growth of 13.7% CAGR during the forecast period.
The barcode element is evolving as healthcare systems become more digitally integrated. The transition from 1D to 2D barcodes, like DataMatrix and QR codes, is a notable trend. Instead of just using trays or kits, these codes may store a lot more data in a smaller space, allowing you to keep track of every instrument. The use of barcode-based traceability solutions is being encouraged by regulatory bodies such as the European Union and the U.S. FDA, which require adherence to Unique Device Identification (UDI).
The barcode element is evolving as healthcare systems become more digitally integrated. The transition from 1D to 2D barcodes, like DataMatrix and QR codes, is a notable trend. Instead of just using trays or kits, these codes may store a lot more data in a smaller space, allowing you to keep track of every instrument. The use of barcode-based traceability solutions is being encouraged by regulatory bodies such as the European Union and the U.S. FDA, which require adherence to Unique Device Identification (UDI).
COVID-19 Impact Analysis
The global supply chain for surgical instrument tracking systems experienced significant issues because of the COVID-19 pandemic. Important components like RFID tags, barcode labels, scanners, and software modules were produced and delivered more slowly because of lockdowns and other restrictions in manufacturing hubs. This slowed market growth by making it more difficult to promptly install and use tracking systems in surgical centres and hospitals. To concentrate on urgent COVID-19 cases and reduce the risk of virus transmission, hospitals worldwide postpone elective surgeries. As a result, the demand for surgical instruments and the systems that monitor them fell precipitously. Instead of investing in new tracking technologies, healthcare providers now fund respiratory care equipment and emergency supplies. Thus, the COVID-19 pandemic had a negative impact on the market.Driving and Restraining Factors
Drivers
- Rising Incidence Of Surgical Procedures And Hospital-Acquired Infections (Hais)
- Regulatory And Accreditation Mandates For Traceability And Accountability
- Workflow Optimization And Operational Cost Reduction
- Technological Advancements In RFID, Iot, And Data Analytics
Restraints
- Lack Of Tangibility And Physical Inspection
- Concerns Around Authenticity, Fraud, And Provenance
- Pricing Transparency And Market Volatility
Opportunities
- Growing Demand For Data-Driven Surgical Performance And Analytics
- Expansion In Emerging Healthcare Markets And Infrastructure Modernization
- Integration With Sterilization Automation And Robotics In Smart Hospitals
Challenges
- Fragmentation Of Surgical Workflows And Lack Of Standardization
- Interoperability Barriers With Legacy IT Infrastructure
- Ensuring Data Accuracy And Preventing Workflow Disruptions
Market Growth Factors
Rising Incidence of Surgical Procedures and Hospital-Acquired Infections (HAIs)
The world is seeing a significant increase in operations due to the aging population, the rise in chronic illnesses, and the advancements in minimally invasive surgery. As per the International Society of Aesthetic Plastic Surgery, total surgical and non-surgical procedures increased by 3.4% in 2023, up to 34.9 million. The pressure on hospitals and surgical facilities to increase operational efficiency while maintaining patient safety and standards compliance is growing. Hospital-Acquired Infections (HAIs), which can occur when surgical instruments are not used or cleaned appropriately, are one of the primary challenges in these environments. As a result, there is an increasing demand for surgical tool monitoring systems worldwide. This is due to an increasing number of surgeries and the pressing need to prevent hospital-acquired infections.Regulatory And Accreditation Mandates For Traceability And Accountability
Governments and regulatory bodies around the world are making it more difficult to monitor and hold medical devices accountable. Every piece of medical equipment, including surgical instruments, must have a Unique Device Identification (UDI) number issued by the US Food and Drug Administration (FDA). Surgical instruments must also be tracked and documented in an orderly manner, according to the European Union's Medical Device Regulation (EU MDR). Because of the increasing pressure from regulatory and certification frameworks to ensure traceability and accountability, healthcare institutions are implementing surgical tool tracking systems much more quickly.Market Restraining Factors
High Initial Capital Investment and Cost of Ownership
The hardware (such as barcode scanners, RFID readers, and surgical tray tracking tools) and software that monitor and track surgical equipment from inventory and sterilisation to use in the operating room comprise surgical instrument tracking systems. Long-term advantages of these systems include facilitating surgeries, improving patient safety, and reducing the number of lost instruments. However, the initial cost of setting it up is a major obstacle.Technology Outlook
Based on technology, the surgical instrument tracking systems market is characterized into barcodes and RFID. The RFID segment procured 24% revenue share in the surgical instrument tracking systems market in 2024. The RFID market is quickly gaining popularity, delivering increased capabilities for real-time tracking and better automation. You don't have to scan RFID tags directly in line of sight, which makes it faster to handle a lot of instruments. This technology makes things go more smoothly, assists with keeping track of supplies, and lowers the number of mistakes individuals make when getting ready for surgery and putting things back together after surgery.End Use Outlook
By end use, the surgical instrument tracking systems market is divided into hospitals and others. The others segment garnered 23% revenue share in the surgical instrument tracking systems market in 2024. Ambulatory surgical centres (ASCs), speciality clinics, dental surgery units, and educational institutions or research groups are all included in the "others" category. Although these facilities typically treat fewer patients than hospitals, safety, accuracy, and traceability are still crucial. Barcode-based systems are widely used by small businesses due to their low cost and ease of setup.
Product Outlook
On the basis of product, the surgical instrument tracking systems market is classified into hardware, software, and services. The software segment recorded 39% revenue share in the surgical instrument tracking systems market in 2024. A significant component of the intelligent system that monitors surgical instruments is the software. These platforms give you the digital tools and data management systems you need to monitor the location, frequency, and maintenance of your tools. Sophisticated software helps with regulatory reporting, automatically tracks inventories, and connects to hospital IT systems.Regional Outlook
Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment recorded 36% revenue share in the surgical instrument tracking systems market in 2024. Due to its extensive surgical procedures, strict regulations, and advanced healthcare system, North America leads the market. In the United States and Canada, hospitals and surgical centres are spending a lot of money on tracking systems to reduce errors, make procedures safer, and comply with FDA and Joint Commission standards. Because there are strong IT networks and skilled personnel in this area, there are many RFID and integrated software systems.Recent Strategies Deployed in the Market
- Oct-2024: Becton, Dickinson, and Company teamed up with ten23 Health to enhance aseptic manufacturing using RFID-enabled prefillable syringes. This innovation boosts traceability, efficiency, and quality control. The signals broader potential applications of RFID in healthcare, including surgical instrument tracking, by reinforcing secure, data-driven inventory and asset management systems in clinical environments.
- Jun-2024: Getinge AB unveiled Poladus 150, an innovative washer-disinfector designed for high-efficiency sterile reprocessing. With user-centric features and advanced automation, it improves workflow traceability, cleanliness, and regulatory compliance - key to surgical instrument tracking systems and infection prevention in healthcare facilities.
- Oct-2023: Getinge AB announced the acquisition of Healthmark Industries, a U.S.-based provider of products for instrument care, cleaning verification, and sterile processing. This acquisition enhances Getinge’s surgical instrument tracking capabilities by expanding its sterile processing portfolio and boosting compliance with global surgical safety standards.
- Mar-2023: Getinge AB announced the acquisition of Ultra Clean Systems, a U.S. company specializing in ultrasonic cleaning equipment for surgical instruments. The acquisition strengthens Getinge’s offering in surgical instrument tracking by integrating high-performance cleaning solutions that support infection control and process validation in sterile services.
- Jan-2023: Becton, Dickinson, and Company unveiled a fully automated robotic track system for microbiology labs, designed to streamline specimen processing and improve efficiency. This innovation aligns with broader trends in lab automation and traceability, offering potential insights and applications for surgical instrument tracking systems by enhancing workflow accuracy and reducing human intervention.
- Sep-2022: B. Braun Melsungen AG announced the acquisition of Clik-FIX catheter securement devices from Starboard Medical, enhancing its portfolio in patient safety and device management. This strategic move supports innovation in medical device tracking and control, aligning with the growing demand for effective surgical instrument tracking systems to improve clinical workflow and reduce procedural risks.
- Sep-2021: Xerafy Singapore Pte Ltd. unveiled XENSE, a new generation of RAIN RFID sensors designed for industrial IoT applications, including healthcare. These sensors enable precise real-time tracking of surgical instruments, improving operational efficiency, asset utilization, and patient safety in hospitals, thereby contributing significantly to advancements in the Surgical Instrument Tracking Systems Market.
List of Key Companies Profiled
- Fortive Corporation
- Becton, Dickinson and Company
- Xerafy Singapore Pte Ltd.
- Ternio Group, LLC
- Getinge AB
- Steris PLC
- Censis Technologies, Inc.
- ScanCARE Pty Ltd
- B.Braun Melsungen AG
- Integra Lifesciences Holdings Corporation
Market Report Segmentation
By Technology
- Barcodes
- RFID
By End Use
- Hospitals
- Other End Use
By Product
- Hardware
- Software
- Services
By Geography
- North America
- US
- Canada
- Mexico
- Rest of North America
- Europe
- Germany
- UK
- France
- Russia
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- Singapore
- Malaysia
- Rest of Asia Pacific
- LAMEA
- Brazil
- Argentina
- UAE
- Saudi Arabia
- South Africa
- Nigeria
- Rest of LAMEA
Table of Contents
Chapter 1. Market Scope & Methodology
Chapter 2. Market at a Glance
Chapter 3. Market Overview
Chapter 6. Value Chain Analysis of Surgical Instrument Tracking Systems Market
Chapter 7. Global Surgical Instrument Tracking Systems Market by Technology
Chapter 8. Global Surgical Instrument Tracking Systems Market by End Use
Chapter 9. Global Surgical Instrument Tracking Systems Market by Product
Chapter 10. Global Surgical Instrument Tracking Systems Market by Region
Chapter 11. Company Profiles
Companies Mentioned
- Fortive Corporation
- Becton, Dickinson and Company
- Xerafy Singapore Pte Ltd.
- Ternio Group, LLC
- Getinge AB
- Steris PLC
- Censis Technologies, Inc.
- ScanCARE Pty Ltd
- B. Braun Melsungen AG
- Integra Lifesciences Holdings Corporation
