"Designing Growth Strategies is in our DNA"

Medical Device Reprocessing Market Size, Share & Industry Analysis By Product (Reusable and Single Use), By Service Type (Cleaning & Decontamination, Disinfection & Sterilization, and Storage & Distribution), By Device Type (Critical Devices, Semi-critical Devices and Non critical Devices), By Application (Cardiology, Gastroenterology, Gynecology, General Surgery, and Others), By End User (Hospitals & ASCs, Specialty Clinics, and Others), and Regional Forecast, 2026-2034

Last Updated: January 28, 2026 | Format: PDF | Report ID: FBI115312

 

KEY MARKET INSIGHTS

Play Audio Listen to Audio Version

The global medical device reprocessing market size was valued at USD 4.50 billion in 2025 and is projected to grow from USD 4.84 billion in 2026 to USD 7.80 billion by 2034, exhibiting a CAGR of 6.1% during the forecast period.

Medical device reprocessing is a systematic process that includes cleaning, disinfection, sterilization, preparation and testing of used medical devices with an aim to reuse these devices in healthcare settings. The increasing surgical and diagnostic procedure volume along with high healthcare cost containment pressure resulting in growing preference toward the adoption of reused medical devices. The increasing geriatric population and growing patients with chronic disorders further increase the demand for surgical procedures among patients, thereby boosting the adoption rate of these products in the market.

  • For instance, according to the 2020 statistics published by National Center for Biotechnology Information (NCBI), about 310 million major surgical procedures are performed each year globally.

Additionally, growing adoption of advanced methods for the reprocessing of these devices is further supporting the investments in medical device reprocessing among the key players such as Stryker, Johnson & Johnson Services, Inc., among others, further contributing to the demand for these products in the market.

Medical Device Reprocessing Market Trends

Preferential Shift toward Reprocessing of Single Use Devices is a Significant Market Trend

There is an increasing focus toward the reprocessing of single use medical devices owing to benefits such as cost savings, sustainability and others. The prominent players are focusing on technologically advanced reprocessing techniques, which is increasing the collection, disinfection and sterilization of single use devices including catheters, compression sleeves and others globally.

These trends are promoting the adoption of reprocessed medical devices in the healthcare settings such as hospitals, specialty clinics and others. Furthermore, adoption of these devices also improves environmental sustainability, regulatory compliance and others, thereby supporting the demand of these products in the market.

  • According to 2020 statistics published by NS Medical Devices, about 80% of hospitals use reprocessed single use devices in Spain.

Other Prominent Trends

  • Third-party reprocessing services prefer certified external providers.

Download Free sample to learn more about this report.

Market Dynamics

Market Drivers

Increasing Volume of Surgical & Diagnostic Procedure to Drive Market Growth

The increasing prevalence of chronic disorders such as cardiovascular disorders, neurological disorders and others is resulting in the growing number of diagnostic and surgical procedures among the patient population. It is subsequently driving the demand for medical devices  such as catheters, imaging devices, and others in the market.

  • For instance, according to 2024 statistics published by the Center for Disease Control & Prevention, it was reported that about 1 in 20 adults have coronary artery disease in the U.S.

The growth in procedure volumes encourages the healthcare providers to adopt efficient device management methods including reprocessing of medical devices. Therefore, the factors above, along with the growing focus of key companies on the introducing novel techniques, are anticipated to fuel the adoption rate of these products, thereby contributing to the global market size.

Market Restraints

High Capital Investment for In-house Reprocessing to Limit Market Growth

There is an increasing demand for reprocessing medical devices such as imaging devices, and others for various applications. However, the high upfront cost of in-house medical device reprocessing infrastructure is expected to limit the adoption rate for these devices, especially in developing countries, such as India, Brazil, and others.

Furthermore, the significant upfront capital cost includes costs of sterile processing equipment, dedicated space, compliance-grade monitor controls, among others makes it challenging for smaller clinical facilities especially in low- and middle income countries to adopt these advanced techniques. Additionally, stringent regulatory standards, among others, further adds to the overall financial burden.

  • For instance, according to data published by the Boston Scientific Corporation, it was reported that the cost of reprocessing one endoscope ranges from USD 114.07 to USD 280.71.

Market Opportunities

Untapped Potential in Emerging Nations Boost Market Growth

There is a rapid expansion of healthcare systems in emerging markets such as China, Mexico and others. The increasing surgical volumes, expansion of hospital infrastructure, growing participation of private companies subsequently increasing adoption of reprocessed imaging and other medical systems in the healthcare settings. Moreover, improving reimbursement framework, increasing per capita healthcare spending, and inorganic growth strategies among governmental organizations to promote diagnostic procedures are anticipated to contribute to the adoption rate of these products in the market.

  • According to 2025 data published by the International Trade Administration (ITA), the healthcare spending of Brazil is USD 135.0 billion.

Market Challenges

Stringent and Complex Regulatory Policies to Hamper Market Growth

There is a growing demand for innovative reprocessing techniques for single use and reusable medical devices globally. The reprocessed devices are required to meet the stringent quality standards which further increases extensive validation, ongoing compliance, and documentation. The regulatory organizations mandate detailed evidence regarding efficacy, material integrity, sterilization validation, functional performance, and others. These requirements increase time-to-market, compliance costs, and operational complexity, thereby limiting penetration among smaller companies further limiting the adoption rate globally.

Furthermore, limited expertise among professionals, especially in emerging countries, are some of the additional factors resulting in limited access to clinical settings among the patient population.

  • For instance, the FDA regulates reprocessed single use devices under the same framework as new devices, which requires 510(k) clearance or PMA approval, coupled with compliance to quality system regulations (21 CFR Part 820).

SEGMENTATION ANALYSIS

By Product

Increasing Adoption of Reusable Medical Device Reprocessing Led to Segment Dominance

Based on the product, the market is classified into reusable and single use.

The reusable segment held the largest revenue share in 2025. The growth is due to the increasing prevalence of chronic conditions among patients, resulting in a growing number of surgical and diagnostic procedures globally. This, along with the increasing number of healthcare settings such as hospitals maintaining in-house sterile processing capabilities, is further expected to contribute to the global medical device reprocessing market growth.

  • According to various articles, about 85% of tertiary and secondary hospitals maintain in-house sterile processing capabilities specifically designed for reusable devices globally.

The single use segment is expected to grow at a CAGR of 5.9% over the forecast period.

To know how our report can help streamline your business, Speak to Analyst

By Service Type

The Increasing Prevalence of Healthcare Associated Infections Led to Dominance of Disinfection & Sterilization Segment

Based on service type, the market is segmented into cleaning & decontamination, disinfection & sterilization, and storage & distribution.

The disinfection & sterilization segment dominated the global market in 2025. By application, the disinfection & sterilization segment held the share of 50.6% in 2025. The growth is due to the increasing prevalence of healthcare associated infections, resulting in a growing demand for advanced disinfection & sterilization services for these reused medical devices, thereby supporting the adoption rate of these devices in the market.

  • For instance, according to the 2024 data published by Center for Disease Control & Prevention (CDC), it was reported that about one in 31 hospital patients has at least one healthcare-associated infection on any given day.

The segment of storage & distribution is set to flourish with a growth rate of 7.1% across the forecast period.

By Device Type

Increasing Number of Surgical Procedures Led to Critical Devices Segmental Dominance

Based on device type, the market is segmented into critical devices, semi-critical devices, and non-critical devices.

The critical devices segment dominated the market in 2025. One of the major factors is the growing number of surgical procedures for various chronic disorders among the patients resulting in the growing demand for reprocessed critical devices, thereby favoring the growth of the segment. Furthermore, the segment is set to hold a 53.8% share in 2026.

  • For instance, according to 2024 statistics published by Science Direct, more than 1 million cardiac surgical procedures are estimated to occur yearly worldwide.

The segment of non-critical devices is set to flourish with a growth rate of 7.2% across the forecast period.

By Application

Increasing Number of General Surgery Procedures Led to Dominance of Segment

Based on application, the market is segmented into cardiology, gastroenterology, gynecology, general surgery, and others.

The general surgery segment dominated the global market in 2025. By application, the general surgery segment held the share of 30.0% in 2025. The growth is due to the increasing prevalence of chronic conditions such as cardiovascular diseases, among others, resulting in a growing number of surgical procedures, thereby supporting the adoption rate of reprocessed medical devices in the market.

  • For instance, according to the 2020 data published by National Center for Biotechnology Information (NCBI), about 18.3% procedures were for general surgery in 9,284 surgical procedures performed in 88,273 people in India.

The segment of gastroenterology is set to flourish with a growth rate of 7.0% across the forecast period.

By End-user

Increasing Number of Hospitals & ASCs Led to Segmental Dominance

Based on end user, the market is classified into hospitals & ASCs, specialty clinics, and others.

The hospitals & ASCs segment dominated the market in 2025. The growing prevalence of chronic disorders, growing surgical procedures volumes in hospitals, rising number of hospitals, among others are some of prominent factors supporting the growth of the segment in the market. Furthermore, the segment is set to hold a 87.7% share in 2026.

  • For instance, according to a 2025 data published by American Hospital Association (AHA), it was reported there are about 6,093 hospitals in the U.S.

In addition, specialty clinics’ end users are projected to grow at a 7.1% CAGR during the forecast period.

Medical Device Reprocessing Market Regional Outlook

Based on region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

North America Medical Device Reprocessing Market Size, 2025 (USD Billion)

To get more information on the regional analysis of this market, Download Free sample

The North America market held the dominant share in 2024, valued at USD 1.89 billion, and also took the leading share in 2025 with USD 2.01 billion. The increasing prevalence of chronic disorders, strong reimbursement frameworks supporting devices adoption, widespread hospital adoption, strong regulatory oversight, strong medical device reprocessing industry, among others are some of the factors supporting the growth of the segment in the market.

  • For instance, according to a 2024 data published by the Center for Disease Control & Prevention (CDC), it was reported that the prevalence of inflammatory bowel disease (IBD) is estimated between 2.4 and 3.1 million among patients in the U.S.

U.S. Medical Device Reprocessing Market

Based on North America’s strong contribution and the U.S. dominance within the region, the U.S. market can be analytically approximated at around USD 1.98 billion in 2025, accounting for roughly 40.9% of global medical device reprocessing sales.

Europe

Europe is projected to record a growth rate of 5.3% in the coming years, which is the second highest among all regions, and reach a valuation of USD 1.42 billion by 2025. The region’s increasing geriatric population and diagnostic and surgical volumes are supporting the demand of these devices.

U.K Medical Device Reprocessing Market

The U.K. market in 2026 is estimated at around USD 0.28 billion, representing roughly 5.7% of global medical device reprocessing revenues.

Germany Medical Device Reprocessing Market

Germany’s market is projected to reach approximately USD 0.31 million in 2026, equivalent to around 6.4% of global medical device reprocessing sales.

Asia Pacific

Asia Pacific is estimated to reach USD 0.83 billion in 2026 and secure the position of the third-largest region in the market. The expanding healthcare infrastructure and rising procedure volumes in China, Japan, and South Korea and introduction of innovative reprocessing methods. In the region, India and China are both estimated to reach USD 0.12 billion and USD 0.26 billion, respectively in 2026.

Japan Medical Device Reprocessing Market

The Japan market in 2026 is estimated at around USD 0.17 billion, accounting for roughly 3.5% of global revenues. Japan has historically reported a relatively high prevalence of chronic conditions, with a strong number of surgical and diagnostic volumes.

China Medical Device Reprocessing Market

China’s market is projected to be one of the largest worldwide, with 2026 revenues estimated at around USD 0.26 billion, representing roughly 5.4% of global sales.

India Medical Device Reprocessing Market

The India market size in 2026 is estimated at around USD 0.12 billion, accounting for roughly 2.5% of global revenues.

Latin America and Middle East & Africa

The Latin America and the Middle East & Africa regions are expected to witness moderate growth in this market space during the forecast period. The Latin America market is set to reach a valuation of USD 0.27 billion in 2026.  The growth is owing to gradual expansion of diagnostic infrastructure in these regions. In the Middle East & Africa, the GCC is set to reach a value of USD 0.10 billion in 2026.

South Africa Medical Device Reprocessing Market

The South Africa market is projected to reach around USD 0.05 billion in 2026, representing roughly 1.0% of global revenues.

Competitive Landscape

Key Industry Players

Increasing Number of Reprocessed Medical Devices to Support Their Dominance

A significant services portfolio, along with a strong brand presence worldwide, is one of the prominent factors supporting the dominance of these players in the market. Stryker and Johnson & Johnson Services, Inc., are major companies in the market in 2025. Additionally, the growing focus of prominent companies on the reprocessing of medical devices to strengthen their presence is mostly to support the global medical device reprocessing market share.

  • For instance, in June 2024, Stryker’ Sustainability Solutions (SSS) announced that the company has reprocessed 145.2 million single-use medical devices.

Other key players, including STERIS and others, are also growing in the market, primarily due to their increasing focus on R&D initiatives to strengthen their presence in the market.

List of Key Medical Device Reprocessing Companies Profiled

KEY INDUSTRY DEVELOPMENTS

  • November 2025: SteriPro International Inc., partnered with Getinge U.S. Sales, LLC that aims to reinforce safer workflows and deliver a scalable model for the future of surgical services within sterile processing departments across North America.
  • September 2025: Stryker established a new R&D facility with an aim to strengthen its presence in India.
  • May 2025: Cardinal Health is investing in a sustainable initiative by opening a new Sustainable Technologies medical device remanufacturing facility, located in Beresfield, Newcastle.
  • January 2025: Denmark will legalize the reprocessing of medical devices, marking a significant step toward more sustainable healthcare practices.
  • January 2025: Netherlands announced another step toward a more sustainable healthcare system. The single-use medical devices can also be reprocessed with CS reprocessing, in addition to CE reprocessing.

REPORT COVERAGE

The market report provides a detailed global medical device reprocessing market analysis. Further, it focuses on key aspects such as leading companies and market segmentation including product, service type, device type, application, and end user. Besides this, the global report offers insights into the market growth trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth and advancement of the market over recent years.

Request for Customization   to gain extensive market insights.

Report Scope & Segmentation

ATTRIBUTE

DETAILS

Study Period

2021-2034

Base Year

2025

Estimated Year

2026

Forecast Period

2026-2034

Historical Period

2021-2024

Growth Rate

CAGR of 6.1% from 2026-2034

Unit

Value (USD Billion)

Segmentation

By Product, Service Type, Device Type, Application, End User, and Region

By Product

·         Reusable

·         Single Use

By Service Type

·         Cleaning & Decontamination

·         Disinfection & Sterilization

·         Storage & Distribution

By Device Type

·         Critical Devices

·         Semi-critical Devices

·         Non Critical Devices

By Application

·         Cardiology

·         Gastroenterology

·         Gynecology

·         General Surgery

·         Others

By End User

·         Hospitals & ASCs

·         Specialty Clinics

·         Others

By Region

·         North America (By Product, By Service Type, By Device Type, By Application, By End User, and by Country)

o   U.S. (By Product)

o   Canada (By Product)

·         Europe (By Product, By Service Type, By Device Type, By Application, By End User, and by Country/Sub-region)

o   U.K. (By Product)

o   Germany (By Product)

o   France (By Product)

o   Italy (By Product)

o   Spain (By Product)

o   Scandinavia (By Product)

o   Rest of Europe (By Product)

·         Asia Pacific (By Product, By Service Type, By Device Type, By Application, By End User, and by Country/Sub-region)

o   China (By Product)

o   Japan (By Product)

o   India (By Product)

o   Australia (By Product)

o   Southeast Asia (By Product)

o   Rest of Asia Pacific (By Product)

·         Latin America (By Product, By Service Type, By Device Type, By Application, By End User, and by Country/Sub-region)

o   Brazil (By Product)

o   Mexico (By Product)

o   Rest of Latin America (By Product)

·         Middle East & Africa (By Product, By Service Type, By Device Type, By Application, By End User, and by Country/Sub-region)

o   GCC (By Product)

o   South Africa (By Product)

o   Rest of the Middle East & Africa (By Product)



Frequently Asked Questions

Fortune Business Insights says that the global market size was USD 4.50 billion in 2025 and is projected to reach USD 7.80 billion by 2034.

In 2025, the North America regional market value stood at USD 2.01 billion.

Growing at a CAGR of 6.1%, the market will exhibit steady growth over the forecast period.

By product, the reusable segment is the leading segment in this market.

The introduction of novel medical device reprocessing techniques is one of the major factors driving the market's growth.

Stryker and Johnson & Johnson Services, Inc., are the major players in the global market.

North America dominated the market share in 2025.

The growing prevalence of chronic disorders, the increasing number of reprocessing techniques, among others, are some of the vital factors expected to boost the adoption of these products worldwide.

Seeking Comprehensive Intelligence on Different Markets?Get in Touch with Our Experts Speak to an Expert
  • 2021-2034
  • 2025
  • 2021-2024
  • 261
Download Free Sample

    man icon
    Mail icon
Growth Advisory Services
    How can we help you uncover new opportunities and scale faster?
Healthcare Clients
3M
Toshiba
Fresenius
Johnson
Siemens
Abbot
Allergan
American Medical Association
Becton, Dickinson and Company
Bristol-Myers Squibb Company
Henry Schein
Mckesson
Mindray
National Institutes of Health (NIH)
Nihon Kohden
Olympus
Quest Diagnostics
Sanofi
Smith & Nephew
Straumann

Related Reports