Surgical Instrument Tracking Systems Market Anticipated to Hit $875.7 Billion By 2033, Expanding at 14.2% CAGR: Persistence Market Research

Hospitals are increasingly turning to surgical instrument tracking systems to streamline workflows, meet regulatory requirements, and ultimately improve patient care. This demand is driving the significant growth of the market

New York, Jan. 11, 2024 (GLOBE NEWSWIRE) -- A recent report from Persistence Market Research tells us that the global sales of Surgical Instrument Tracking Systems reached $208.6 million in 2022. The market is expected to grow at a rate of 14.2% annually from 2023 to 2033, reaching a total value of $875.7 million by 2033. The main contributor to this growth is projected to be the hardware used for tracking surgical instruments, with an expected annual growth rate of over 15.5% during the same period.

Looking ahead from 2023 to 2033, the study by Persistence Market Research, a firm specializing in market research, shows that the Surgical Instrument Tracking System market grew at a rate of 12.1% from 2018 to 2022.

The introduction of the Unique Device Identification (UDI) is set to revolutionize the way we detect medical devices globally. This method is becoming widely accepted and will lead to the availability of better, more functional, and error-free medical devices for healthcare providers.

UDI eliminates uncertainty in the healthcare industry, making tasks easier for many lives. It ensures more accurate reporting, quicker recall management, and reduces medical mistakes, benefitting both healthcare institutions and patients. In the United States, there are over 160,000 suspected adverse health occurrences each year linked to patient or test sample misidentification. Barcodes are identified as a powerful solution to reduce labeling mistakes, ensuring that the right patient receives the correct analysis. Combining scanning technologies with instrument tracking systems like RFID or barcode scanning, along with software for inventory management, shows great potential for the development of surgical instrument tracking systems.

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Market Scope:

 Report Coverage Details
 Market Revenue 2022 US$ 6.4 Million
 Estimated Revenue 2033 US$ 10.9 Million
 Growth Rate - CAGR 5.5% 
 Forecast Period 2023-2033
 No. of Pages 250 Pages
 Market Segmentation  By Type, By Material, By Application, By Region
 Regions Covered North America, Latin America, Europe, South Asia & Pacific, East Asia, The Middle East & Africa
 Key Companies Profiled
  • Raphas Co. Ltd.
  • Becton Dickinson and Company
  • NanoPass Technologies Limited
  • 3M
  • Zosano Pharma Corporation
  • Corium International Inc.
  • Valeritas Inc.
  • Nitto Denko Corporation
  • Microdermics Inc

Surgical Instrument Tracking System Market Dynamics:


Manufacturers need to trace surgical instruments from production to distribution to comply with the FDA's Unique Device Identification (UDI) regulations. The aim is to ensure that manufacturers have effective tracking systems to quickly locate devices in commercial distribution.

The UDI regulations proposed by the US FDA are expected to boost the growth of the surgical instrument tracking systems market. According to these rules, those labeling surgical instruments must directly mark each instrument, following the individual instrument level, as outlined by the FDA.

The deadline for Class I devices to comply with these FDA requirements was initially set for September 24, 2020, but it was later extended to September 24, 2022. Labelers are also required to submit device information to the FDA's Global Unique Device Identification Database (GUDID), serving as a comprehensive catalog for all devices. These regulations are anticipated to be the primary factor encouraging the adoption of surgical instrument tracking systems among end users.

Restraints/ Challenges

Implementing surgical instrument tracking systems involves substantial upfront investments covering application software, hardware, tags, and middleware. Costs also include integrating barcode and RFID frameworks with existing systems, along with maintenance services, consulting fees, and staff training. While tag and reader costs have reduced, the implementation cost of automated systems like RFID remains high, requiring additional servers, databases, and middleware. The overall expense of implementing RFID-based systems is considerably higher than traditional barcode-based systems. Additionally, these systems often have extended investment lifecycles.

Understanding the cost-benefit analysis and return on investment (ROI) for tracking systems poses a challenge for hospitals. This is due to a lack of awareness regarding the importance of these systems and their high acquisition costs. Regulatory clearance from government bodies is another hurdle for new entrants in the industry, further restraining market growth.

Both RFID and barcode technologies for instrument tracking have notable limitations. RFID tags often malfunction, cannot withstand certain conditions, and may face interference. Barcode scanning is error-sensitive and labor-intensive, with labels prone to damage during autoclaving. Technological limitations pose challenges in maintaining the effectiveness of these tracking systems.


Growing economies like India, China, and countries in the Middle East, Latin America, and Southeast Asia present significant growth opportunities for the surgical instrument tracking systems market. Increased healthcare spending and improved infrastructure in these regions offer favourable conditions for market players.

Governments in the Middle East, such as Saudi Arabia, are allocating substantial budgets to enhance healthcare services. In China, the National Health Service System Plan aims to expand the hospital sector. India's healthcare sector is also witnessing rapid growth, with significant revenue contributions from hospitals. Other Asia-Pacific (APAC) economies offer attractive investment prospects, leading to market expansion by various players.

In a nutshell, the Persistence Market Research report is a must-read for start-ups, industry players, investors, researchers, consultants, business strategists, and all those who are looking to understand this industry. Get a glance at the report at -

Competitive Overview

The market for surgical instrument tracking systems is characterized by fragmentation, with leading companies employing various strategies to enhance their presence. These strategies include introducing new products, expanding operations, entering agreements, forming joint ventures, establishing partnerships, and making acquisitions.

Some recent developments by key providers of surgical instrument tracking systems include:

In November 2020, STERIS acquired Key Surgical, aiming to broaden and enhance its product line while expanding its global reach.

In May 2020, CISCO and STANLEY Healthcare collaborated. The AeroScout Real-time Location System platform from STANLEY is now fully integrated and certified with CISCO DNA Spaces. This integration is expected to offer healthcare organizations a comprehensive view of the location and status of assets and individuals.

In November 2019, Fortive Corporation announced the acquisition of Censis Technologies to expand its Software-as-a-Service (SaaS)-based solutions for surgical equipment tracking and workflow.

Market Segmentation:

Why Surgical Instrument Hardware Demand Is Expected to Grow?

The need for surgical instrument hardware is predicted to increase significantly, with a growth rate of more than 15.5% between 2023 and 2033. Upgrades in hardware, like RFID chips and barcode tags, are speeding up the adoption of systems to manage surgical instruments.

Pfizer advocated for using RFID in all its bottles, not just a few in the United States. Although only one distributor was ready to start labeling, the progress has been positive. Pfizer continues to benefit from RFID technology, reducing counterfeiting significantly, leading to better organization.

The majority of hardware surgeries happen in hospitals, clinics, and cardiac centers. Surgical instrument tracking systems are present in intensive care units, critical care units, and emergency departments.

ICDs and external surgical instrument tracking systems are commonly used in institutions. While manual tracking systems are preferred and widely used in hospitals, the use of automated external surgical instrument tracking systems (AEDs) is expanding in medical settings.

Using its Orpheus technology, Intuitive Surgical's teams in Israel and the United States developed the Intuitive Hub. This single hardware and software platform allows teams to collect, modify, and share video footage from clinical operations and collaborate digitally.

Intuitive Surgical recently introduced an updated interface for da Vinci systems, enabling automated video collection with integrated process annotation for crucial occurrences, simplifying video storage and viewing during events.

Which Surgical Instrument Tracking Technology Is Expected to Grow?

Barcodes are anticipated to generate significant revenue with a CAGR of over 14.3% during the forecast period. It is the most commonly used tracking technology, contributing a substantial portion of revenue from the medical device industry. 2D barcodes, data matrix, and QR codes are becoming widely marketable due to their advantages, such as low cost, durable construction, and 360-degree readability.

The "5 rights" of medicine administration, including the right patient, proper medication, right dose, right time, and correct distribution channel, can be ensured through barcode medication validation at the bedside. Barcodes have been shown to save around 90,000 prominent medical mistakes annually, reducing death rates by 20%. Across the five units tested, the use of barcodes decreased medicine delivery mistakes by 82% from pre-implementation to post-implementation, according to an analysis.

Which Region Provides the Best Opportunity for Surgical Instrument Tracking Systems?

Currently, North America holds a big part of the worldwide market. The introduction of the UDI method by the United States Food and Drug Administration (FDA) for efficient detection of health equipment is a key reason for the region's significant share. Additionally, the region's excellent healthcare facilities and increasing acceptance of new materials and services are expected to boost the market.

Reed Technology and Information Services Inc., a well-known provider of data reporting and analytics solutions for the biomedical industry, has teamed up with Schlafender Hase, a leading provider of intelligent, automated proofreading applications and services for regulated markets.

As part of this growing partnership, both companies' current and future clients can enjoy special benefits. Pharmaceutical labelers facing US FDA regulatory deadlines can benefit from Reed Tech's expert conversion and submission systems. At the same time, Schlafender Hase's Text Verification Tool (TVT) ensures lower risk and improved accuracy in proofreading drug labels and related documentation. The expected increase in the use of advanced software and hardware solutions is likely to enhance the adoption of surgical instrument monitoring systems in the near future.

Top 5 Key Trends Transforming the Surgical Instrument Tracking Market:

The surgical instrument tracking system market is undergoing a dynamic transformation, driven by technological advancements, evolving regulations, and a relentless focus on patient safety and efficiency. Here are some key trends shaping this landscape:

1. Precision Tracking Takes Center Stage:

Gone are the days of manual inventory checks and frantic instrument hunts. RFID, barcode, and real-time location systems (RTLS) are now integrating seamlessly into surgical workflows. These technologies provide precise, real-time data on instrument location, status, and usage, streamlining procedures and minimizing delays. Imagine surgeons accessing a dashboard that pinpoints the exact location of any instrument within seconds, eliminating the frantic scrambling for crucial tools.

2. Regulatory Landscape Drives Adoption:

Stringent regulations like the FDA's Unique Device Identification (UDI) program are mandating stricter instrument traceability. Tracking systems ensure compliance by providing detailed records of instrument usage, history, and maintenance, safeguarding patient safety and simplifying recall processes. This regulatory push, coupled with the inherent benefits of improved tracking, is fueling rapid market adoption.

3. AI and Data Analytics Take the Helm:

The integration of artificial intelligence (AI) and machine learning (ML) is adding a new layer of intelligence to surgical instrument tracking systems. These technologies can analyze data to predict instrument needs for specific procedures, automate restocking processes, and even identify potential instrument failures before they occur.

4. Cloud-Based Solutions Gain Traction:

The cloud is revolutionizing data accessibility and scalability in healthcare. Cloud-based surgical instrument tracking systems offer hospitals real-time access to instrument data from anywhere, anytime. This facilitates centralized monitoring, remote management, and collaboration across different departments, enhancing overall operational efficiency.

5. Focus on Patient-Centric Outcomes:

Ultimately, the surgical instrument tracking market is driven by a desire to improve patient outcomes. By ensuring the right tools are readily available, minimizing surgical delays, and enhancing instrument traceability, these systems contribute to a safer, more efficient surgical environment. This translates to reduced surgical site infections, improved post-operative recovery, and better overall patient satisfaction.

Key Questions Answered in the Report:

  1. What factors contribute to the growth trends in the market?
  2. What is the present market size, and how is it anticipated to change in the forthcoming years?
  3. What key elements are influencing the market?
  4. How is the Industrial Lighting market divided, considering types, fuels, applications, or other relevant factors?
  5. Who are the primary participants in the Surgical Instrument Tracking Systems market?
  6. What strategies are these players employing to establish a competitive edge?
  7. What factors are driving the expansion of the Surgical Instrument Tracking Systems market?
  8. Which regions are expected to experience notable growth, and what are the reasons behind it?
  9. What recent technological advancements are impacting the Surgical Instrument Tracking Systems industry?

About Persistence Market Research:

Business intelligence is the foundation of every business model employed by Persistence Market Research. Multi-dimensional sources are being put to work, which include big data, customer experience analytics, and real-time data collection. Thus, working on “micros” by Persistence Market Research helps companies overcome their “macro” business challenges.

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