Surgical Instrument Tracking System Market Analysis and Forecast to 2031: By Product (Hardware, Software, Services), By Technology (Barcodes, Radiofrequency Identification (RFID)), By End-use, (Hospitals, Research and Academic Institutes) and Region

Surgical Instrument Tracking System Market Analysis and Forecast to 2031: By Product (Hardware, Software, Services), By Technology (Barcodes, Radiofrequency Identification (RFID)), By End-use, (Hospitals, Research and Academic Institutes) and Region

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.


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 Trends and Drivers

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.

Market Restraints and Challenges

High system costs, long investment cycles, and low ROIs may hampers the market growth. Surgical instrument tracking systems require heavy upfront investments that encompass the costs of application software, hardware, tags, and middleware and the cost of integrating the barcode/RFID framework along with the legacy system, maintenance services, consultancy fees, and staff training. Although the cost of tags and readers has reduced considerably, the implementation cost of automated tracking systems, such as RFID, that require additional servers, databases, and middleware, has been increasing steadily. The overall cost of implementing automated surgical instrument tracking systems using RFID is very high compared to traditional systems such as barcode-based systems. Apart from high implementation costs, most automated surgical instrument tracking systems have very long investment lifecycles.

Global Surgical Instrument Tracking System Market Segmental Overview

The report analyses the global surgical instrument tracking system market based on product, technology, end use, and region.

Global Surgical Instrument Tracking System Market by Product

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.

Global Surgical Instrument Tracking System Market by Technology

Based on technology, it is segmented into barcodes and radiofrequency identification (RFID). The barcode technology segment accounted for the largest revenue share in 2021. Barcode is the most commonly used type of tracking technology and its increased adoption in the medical devices industry is the key element contributing to its high revenue share in the market. 2D barcodes, such as data matrices and QR codes, are more popular in the market due to their advantages, which include low costs, and robust build among others. Thus, propelling the segmental as well as industry growth.

Global Surgical Instrument Tracking System Market by End-use

Based on end-use, it is segmented into hospitals and research and academic institutes. The hospitals segment is likely to dominate the surgical instrument tracking system market during the forecast period is attributed to the rising adoption of surgical device tracking solutions by hospitals for inventory management and tracing of medical instruments during work cycles, such as sterilization procedures and surgery. For instance, St. Joseph’s Hospital and Medical Clinic, in Arizona, uses the IMPRESS instrument management system that allowed it to save more than USD 1.0 million in repair, refurbishment, and instrument purchasing costs, annually. Such scenario boost the segmental growth.

Geographical Analysis of Global Surgical Instrument Tracking System Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America is the largest regional market for surgical instrument tracking systems. The Unique Device Identification (UDI) regulations by the FDA and the need to reduce healthcare expenditures drive the surgical instrument tracking systems market in North America. In addition, the presence of a highly developed healthcare infrastructure and rapid adoption of advanced technologies and products are anticipated to drive the regional market growth.

Major Players in the Global Surgical Instrument Tracking System MarketCOVID-19 Impact

A worldwide emergency has been caused by the COVID-19 pandemic. The impact of COVID-19 on the surgical instrument tracking systems market is lower than other medical devices, timely development and the implementation of contingency plans are extremely critical for business operations. Depending on the impact on economic conditions, there will most likely be threats to vulnerable business models and growing opportunities for development. The factors may play a key role in shaping the growth of the global market including the number of cases of COVID-19 has increased exponentially in the US. This adds to the risk for healthcare workers and patients and has reduced the number of surgeries performed in hospitals. According to the US National Library of Medicine National Institutes of Health, in 2020, all plastic surgeries were postponed. There has been a decline in regular patient visits to hospitals and clinics, which has led to a decline in the number of surgeries conducted. Moreover, shortages in medical supplies and equipment due to the temporary lockdown of manufacturing sites in affected areas or travel restrictions impacting shipments have created hurdles for the market. Beyond transportation-related delays arising from travel restrictions and the shortage of drivers, COVID-19 has not significantly impacted surgical supplies across geographies. Furthermore, players operating in the market are altering their long-term and short-term growth strategies by tapping the consumables market and developing innovative products to combat the pandemic.

Recent Developments

• In July 2022, B. Braun launches Technical Service Center to provide medical equipment repair and maintenance services to support Thailand public health system
• In May 2021, BD launched industry first ready-to-use iodine-based surgical irrigation system to removes wound debris
• In November 2020 STERIS acquired Key Surgical to strengthen, complement, and expand STERIS’s product offerings and global reach
• In July 2020 Vizinex RFID(US) launched Flexible 6012 and Flexible 6027 RFID tags, which offer mounting flexibility, are durable, and are IP67-rated, making them ideal for tracking many types of assets in indoor settings

Frequently Asked Questions

Q1. How big is the surgical instrument tracking system market?Ans. The global Surgical Instrument Tracking System Market size was USD 195.0 million in 2021 and is anticipated to reach USD 764.1 million in 2031, growing at a rate of 14.6% from 2022 to 2031.
Q2. What is the surgical instrument tracking system market growth rate?Ans. The growth rate of the surgical instrument tracking system market is 14.6%.
Q3. Which region holds a major market share for the surgical instrument tracking system market?Ans. North America holds a major market share of the surgical instrument tracking system market in 2021.
Q4. Which segment accounted for the largest surgical instrument tracking system market share?Ans. By end user, the hospitals segment accounted for the largest surgical instrument tracking system market share.
Q5. Who are the key players in the surgical instrument tracking system market?Ans. The global surgical instrument tracking system market report includes players such as Koninklijke Philips N.V. (Netherlands), Getinge AB (Sweden), ResMed (U.S.), Medtronic (Ireland), Fisher & Paykel Healthcare Limited (New Zealand), Avasarala Technologies Limited (India), Shenzhen Mindray Bio-Medical Electronics Co., Ltd, (China), Drägerwerk AG & CO. KGAA (Germany), Nihon Kohden Corporation (Japan), Asahi Kasei Corporation (Japan), Hamilton Medical (Switzerland), Smiths Group plc (U.K), Bio-Med Devices, (U.S.), Hill-Rom Holdings, Inc. (U.S.) and HEYER Medical AG (Germany)among others.
Q6. What are the factors driving the surgical instrument tracking system market growth?Ans. The major factors driving the growth of the market are the growing number of surgical procedures, owing to sports injuries, accidents, and cardiac surgeries, due to the increased frequency of cardiovascular illnesses and other chronic disorders, where surgery is mandatory.
Q7. What are the key growth strategies of surgical instrument tracking system market players?Ans. The key growth strategies of surgical instrument tracking system market players are product launch and product approval.
Q8. Which region will provide more business opportunities for the surgical instrument tracking system market during the forecast period?Ans. The Asia-Pacific region will provide more business opportunities for the surgical instrument tracking system market during the forecast period.

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