Medical Device Reprocessing Market is projected to grow from USD 2.0 billion in 2022 to USD 3.9 billion by 2027, at a CAGR of 13.7% from 2022 to 2027 according to a new report by MarketsandMarkets™. Growth in this market is mainly driven by the rising need to reduce healthcare costs, and the increasing adoption of strategies to reduce medical waste.
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Key Market Players
The prominent players in the medical device reprocessing market are Stryker Corporation (US), Johnson & Johnson (US), Vanguard AG (Germany), Medtronic PLC (Ireland), Steris Healthcare (US), Medline ReNewal (US), Innovative Health (US), Arjo Group (ReNu Medical, Inc.) (Sweden), SteriPro Canada, INC. (Canada), Northeast Scientific, INC. (US), Cardinal Health (Sustainable Technologies) (US), and SureTek Medical(US).
Medical Device Reprocessing Market Dynamics
Drivers: Increasing level of supply chain cost savings in healthcare facilities
Reprocessing of medical devices and equipment has gained a lot of attention in recent years, not just across healthcare facilities for saving millions of dollars annually, but among manufacturers who are seeing it as a means of achieving substantial competitive advantage. According to the Association of the Medical Devices Reprocessors (AMDR, US), on average, reprocessed medical devices are 30% to 50% cheaper than their new counterparts; due to this, medical device reprocessing has become one of the most adopted strategies for supply chain cost reduction among hospitals, surgical centers, and other healthcare facilities. This frees up funds for end users to hire additional staff, upgrade technologies, and enhance healthcare quality, among other improvements.
Restraints: Increasing risk of hospital acquired infections
Hospital-acquired infections (HAIs) are nosocomial infections that occur during a patient’s stay at hospitals and related facilities. HAIs are not observed at admission and are considered a major cause of morbidity and mortality worldwide. Despite the existence of reprocessing guidelines and advances in device reprocessing methods, inadequate reprocessing of medical devices contribute to a significant proportion of hospital-acquired infection, where 22% of all surgical site infections (SSIs), one of the most common types of HAIs cases, are related to equipment reprocessing.
Opportunities: Regulatory changes favoring adoption of medical device reprocessing
Changing dynamics in a number of countries, such as France, Japan, and the Middle East & Africa, are expected to provide significant growth opportunities for medical device reprocessing. According to the AMDR, Japan is the most recent country to take steps to give hospitals access to remanufactured (commercially reprocessed) single-use medical devices. AMDR sees this as a major development for the global remanufacturing medical device industry, as Japan joins the growing number of countries that are adopting a clear regulatory path for remanufactured single-use devices. Thus, the emergence of regulatory guidelines for reprocessing medical devices in these countries provides significant opportunities for the players in this market to increase their geographic presence and garner a larger share in the medical device reprocessing market in the future.
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Challenges: Stringent regulatory procedures for reprocessed medical devices
Reprocessed medical devices should comply with all the standards applicable to a new medical device. The guidelines on reprocessing medical devices do not differentiate between single-use and multi-use medical devices and require the same high standards for both. The safety and performance of the reprocessed device must be equivalent to the original device and must comply with the regulatory standards for medical devices stated in the FDA and EU regulations to receive 510K approval or ISO/CE certifications for marketing in North America and Europe. The pressure to comply with these stringent regulations while reprocessing medical devices serves as a major challenge to the growth of the medical device reprocessing market.
North America holds the largest share of the medical device reprocessing market
North America accounted for the largest share of the pharmacy automation market in 2021. Factors such as favorable US FDA approvals on reprocessing medical devices, growth in the healthcare sector, and the presence of top medical device reprocessing service providers in the US are expected to contribute to the growth of the market in North America.
Recent Developments
- In 2022, Innovative Health, LLC has received clearance to reprocess the Philips Eagle Eye Platinum digital IVUS (intravascular ultrasound) catheter. This clearance effectively marks the company’s entry into the cath lab space, thereby expanding the company’s medical device reprocessing market reach in cardiology applications.
- In 2022, Medline ReNewal opened a new distribution center in Southaven, Mississippi. The facility serves major hospitals, nursing homes, and military facilities in the region. The company invested in expanding its storage and distribution capacity in Mississippi to meet the product needs of its healthcare customers. Over USD 350.0 million in annual orders are expected to be handled from the Southaven facility.
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