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Medical Device Reprocessing Market

Medical Device Reprocessing Market

Medical Device Reprocessing Market Analysis By Product & Service (Reprocessing Support & Services, Reprocessing Medical Devices), By Device (Catheters, Laparoscopy Instruments, Biopsy Instruments, Endoscopy Instruments), By Application - Global Insights to 2031

Medical Device Reprocessing Market
  • Sep-2021
  • List of Tables : 84
  • List of Figures : 112
  • 170 Pages
  • Healthcare

Market Outlook for Medical Device Reprocessing

As per the latest industry analysis on medical device reprocessing, the market was valued at US$ 1.4 Bn in 2020, and is expected to accelerate at a CAGR of 16% to top US$ 3 Bn by 2031. Demand for reprocessing support and services to surge at a CAGR of 15% across the assessment period of 2021 to 2031.

Key Points Covered in Medical Device Reprocessing Industry Survey:

  • Market Estimates and Forecasts (2016-2031)
  • Key Drivers and Restraints Shaping Market Growth
  • Segment-wise, Country-wise and Region-wise Analysis
  • Competition Mapping and Benchmarking
  • Market Share Analysis
  • COVID-19 Impact on Demand for Medical Device Reprocessing and How to Navigate
  • Recommendation on Key Winning Strategies

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Revenue Analysis of Medical Device Reprocessing from 2016 to 2020 Vs Demand Outlook for 2021 to 2031

As per Fact.MR – a market research and competitive intelligence provider, the global medical device reprocessing market expanded 1.75X over the past 5 years to reach a valuation of US$ 1.4 Bn in 2020.

 Key factors driving growth of this market include low prices of reprocessed devices as compared to new ones and pressure to reduce the volume of medical waste generated.

Reprocessed medical devices offer reliable patient care, with additional savings in hospital expenditure as well as advantages to environment. As several hospitals globally find ways to reduce healthcare expenditure, there are several third-party firms, distributors as well as product manufacturers, providing reprocessing programs suited for some medical devices. This network is strengthening in developing economies as they provide more opportunities for reprocessed medical devices businesses due to high unmet needs.

Cost of reprocessed devices can be nearly half that of new devices, and, as such, opting for reprocessed devices can result in huge cost savings. The healthcare industry is anticipated to save billions of dollars yearly through reprocessing.

Hence, demand for medical device reprocessing has fairly increased over the past few years and is expected to maintain the upward trend across the assessment period surging at a CAGR of 16%.

How Will Patient Preference Towards Reprocessed Medical Devices Create Growth Opportunities for Market Players?

Increasing number of hospitals with well-equipped medical devices and surgical equipment, especially in developed countries, will boost market expansion.

Availability of advanced healthcare infrastructure along with presence of skilled professionals in hospital settings will further augment the overall market revenue. Also, rising demand for reprocessed medical devices for conducting cost-efficient medical procedures to benefit patients with low-income will propel market growth.

Many patients with low-income prefer reprocessed medical devices over single use devices as this reduces overall hospital expenditure to almost half the original amount.

An Adaptive Approach to Modern-day Research Needs

Which Region is Expected to Offer the Most Lucrative Opportunities to Medical Device Reprocessing Service Providers?

North America holds 42% share of the global market for medical device reprocessing.

Rising preference among healthcare professionals regarding improvised reprocessed medical devices is boosting market growth. Surging cases of cancer and other chronic disorders in the region is expected to raise demand for reprocessed medical devices.

The European region is also expected to witness high demand for reprocessed medical devices during the forecast period. This is on the back of rising prevalence of chronic diseases, increasing geriatric population, rising healthcare expenditure, increasing number of surgical procedures, and growing awareness about the usage of reprocessed medical devices.

medical device reprocessing marketby FactMR

Country-wise Analysis

Will FDA Regulations for Medical Device Reprocessing in the U.S. Aid Regional Market Growth?

In the U.S., the market for medical device reprocessing reached a valuation of US$ 323 Mn in 2020. The U.S. Food and Drug Administration (FDA) requires third-party reprocessors to meet the same standards as originally manufactured single-use devices.

Reprocessing is a common practice in the U.S. where hospitals prefer to reprocess single-use devices. Around 45% of hospitals have agreements with third-party reprocessing companies in the U.S. for reprocessing of medical devices. Thus, making treatment of chronic diseases more affordable for the low-income patients.

How is Changing Regulatory Scenario Favouring Medical Device Reprocessing in Different Economies?

Reprocessing practices are regulated by various regional regulatory authorities. Changing regulatory scenario favouring medical device reprocessing in a number of countries such as France and Japan is expected to propel growth of this market.

For example, till 2016, outsourcing of medical device reprocessing was prohibited in France; however, the European Union (EU) Regulations (Article 17), released on April 5, 2017, mandated the use of third-party reprocessing services by all French hospitals. These regulations are expected to be implemented in France for 2021 and beyond.

Similarly, Japan does not currently have any regulations for the reprocessing of single-use medical devices. Therefore, regulatory authorities, such as the Ministry of Health, Labor and Welfare (MHLW) (Japan), in collaboration with the FDA (U.S.), are focusing on generating new medical device reprocessing guidelines for Japan. This will favour and regulate the reprocessing of medical devices in the country.

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Category-wise Analysis

Why are Reprocessed Medical Devices Extensively used in Cardiovascular Surgeries?

Revenue from cardiovascular reprocessed medical devices accounts for more than 52% market share. Introduction of cardiovascular reprocessed medical devices at low-cost have resulted in high adoption across the globe.

Also, the surging geriatric population base that is susceptible to cardiovascular disorders will fuel product demand. Low-income groups are inclined towards reprocessed medical devices given their affordable cost, which, in turn, is acting as an accelerant for market growth.

How Has COVID-19 Impacted Demand for Medical Device Reprocessing?

With the outbreak of COVID-19, physicians and patients became more concerned about their safety, hence, raising concerns about the reuse of medical devices. This negatively impacted demand for reprocessed medical devices.

To overcome these safety concerns, reassuring steps such as sterilization and microbial testing of reprocessed medical devices were made mandatory by various regulatory authorities.

Competitive Landscape

Major companies are focusing on strategies such as investments in research & development, new market initiatives, expansion of production sites and facilities, new product launches, product approvals, and patents.

  • In May 2019, Medtronic announced U.S. FDA approval and launch of the Select Site C304-HIS deflectable catheter system. This system is used in processes involving His-bundle pacing (HBP). This strategic move helped the company in generating extra revenue and strengthened its position in the industry.
  • In April 2019, 3M announced that it added 3M extended wear medical transfer adhesive, 4075 to its line-up of advanced adhesives for medical devices. This has enabled the company expand its product portfolio.
  • In September 2018, Vanguard announced the acquisition of Pioneer Medical Devices AG to enhance reprocessing services for medical devices. This strategy assisted the company in enhancing its product portfolio in global market.

Medical Device Reprocessing Market Report Scope



Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value & ‘000 Units for Volume
Key Regions Covered
  • North America
  • Europe
  • Asia Pacific
  • Central & South America
  • Middle East & Africa

Key Market Segments Covered

  • USA
  • Canada
  • Germany
  • France
  • the UK
  • Russia
  • Italy
  • China
  • Japan
  • South Korea
  • India
  • Australia
  •  Middle East
  • Latin America
Key Market Segments Covered
  • Product & Service
  • Device
  • Application
  • Region

Key Companies Profiled


  • Stryker Corporation
  • Johnson & Johnson
  • Vanguard AG
  • Medline ReNewal
  • Medtronic plc
  • SteriPro
  • Pioneer Medical Devices AG
  • Vascular Solutions
  • HYGIA Health Services
  • ReNu Medical
  • SureTek Medical
  • Centurion Medical Products Corporation.

Available upon Request

Key Segments Covered in Medical Device Reprocessing Industry Research

  • By Product & Service

    • Reprocessing Support & Services
    • Reprocessing Medical Devices
  • By Device

    • Catheters
    • Laparoscopy Instruments
    • Biopsy Instruments
    • Endoscopy Instruments
    • Cables, Columns, Curves and Cutters
  • By Application

    • Medical Device Reprocessing for Cardiology
    • Medical Device Reprocessing for Gastroenterology, Urology, and Gynaecology
    • Medical Device Reprocessing for Arthroscopy and Orthopaedic Surgery
    • Medical Device Reprocessing for General Surgery and Anaesthesia

- FAQs -

The global medical device reprocessing market is currently worth more than US$ 1.4 Bn.

The market for medical device reprocessing is expected to accelerate at a CAGR of 16% across the forecast period.

Trend of adoption of low-priced reprocessed medical devices and elevated efforts for reducing regulated medical waste (RMW) are driving market growth.

Major players in the industry are Stryker Corporation, Johnson & Johnson, Vanguard AG, Medline ReNewal, Medtronic plc, SteriPro Inc., and Pioneer Medical Devices AG.

North America holds 42% of the global revenue share in this market.

Cardiovascular reprocessed medical devices account for around 52% of the total market share.

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