세계의 의료기기 세정 시장 평가 : 프로세스별, EPA 분류별, 기기별, 유형별, 방법별, 용도별, 최종사용자별, 지역별, 기회, 예측(2017-2031년)

Global medical device cleaning market is projected to witness a CAGR of 7.75% during the forecast period 2024-2031F, growing from USD 5.14 billion in 2023 to USD 9.34 billion in 2031F. Various factors are shaping the market, including establishing standards related to disinfection post-COVID-19 pandemic, rising demand for innovative products, increasing popularity of disinfectants for ultrasound probes, and the dominance of ethylene oxide.

Regulatory standards act as guardians of the global medical device cleaning market, ensuring that all goods and procedures follow stringent safety and quality requirements. In the end, they safeguard the health and safety of patients and medical staff by serving as a compass for developing cleaning solutions in healthcare environments. There is a significant increase in demand for novel cleaning solutions and techniques in the global medical device cleaning market. These solutions prioritize patient safety while enhancing disinfection's effectiveness and efficiency. This rising demand directly results from the pressing need for more advanced solutions to prevent infections and protect patient safety, highlighting a shared commitment to raise the bar for healthcare disinfection.

The increasing preference towards disinfectants specifically designed for ultrasound probes indicates a growing demand in the global medical device cleaning market. This trend highlights the need for tailored cleaning solutions for different medical equipment. An effective and adaptable sterilizing agent, ethylene oxide has established a significant share in the global medical device cleaning market. Its reputation as the best option for medical device cleaning procedures has been solidified because it can sterilize medical devices with high efficacy. Ethylene oxide is a popular choice for a variety of applications in the healthcare industry due to its broad range of material compatibility.

The establishment of Regulatory Standards is Shaping the Market

The global medical device cleaning market is significantly shaped by regulatory standards, which protect patient safety and quality in the medical device industry. These guidelines guarantee that strict cleaning and disinfection procedures are followed in order to protect patient safety and avoid infections. Healthcare providers must adopt innovative cleaning solutions and technologies as regulatory organizations globally refine these recommendations. As manufacturers and healthcare institutions work to meet these strict regulatory requirements, there is an increasing demand for specialized cleaning services and supplies, ultimately promoting growth and advancement within the industry.

For example, the Food and Drug Administration (FDA) announced in July 2023 that its Center for Devices and Radiological Health (CDRH) recognized a new international consensus standard on the use of low-temperature vaporized hydrogen peroxide to sterilize medical devices, amid a regulatory effort by the US Environmental Protection Agency (EPA) to limit the use of ethylene oxide (EtO).

Rising Demand for Innovative Products are Driving Market Growth

The need for innovative products in the global medical device cleaning market is rising significantly due to the advancements in medical devices becoming more complicated and the growing emphasis on infection prevention. Modern cleaning techniques may not be sufficient for complex medical equipment, necessitating more sophisticated approaches. Furthermore, the COVID-19 pandemic's effects have highlighted the need for strict hygiene precautions, which have increased the demand for powerful cleaning solutions. Cleaning techniques are being revolutionized by innovations like UV-C laser sterilization and enzyme-based detergents, which offer enhanced capabilities that reduce infection risks and improve patient safety.

For example, the Food and Drug Administration approved the first sterilization system for 3D-printed medical equipment to be marketed in August 2023. With its specialized cycle, the V-PRO maX 2 Low-Temperature Sterilization System can sterilize surgical equipment like anatomical models printed using 3D printing technology and surgical guides customized for each patient that is meant to be used just once during an operation.

Increasing Popularity of Disinfectants for Ultrasound Probes Boosting Market Size

The use of specialty disinfectants made especially for ultrasound probes is growing significantly in the global medical device cleaning market. Since these devices come into close contact with patients' bodies, there is a growing awareness of the significance of maintaining good standards of hygiene, which is driving this development. Since ultrasound probes are used so often and in so many different medical settings, wrong disinfection techniques or inadequate disinfection increases the potential for cross-contamination and infection transmission. Consequently, there is an increased need for efficient, quick-acting disinfectants that can guarantee patient security without endangering delicate equipment. As a result, producers are creating specialty disinfectants that work well with the components of ultrasonic probes and have strong antibacterial properties to limit the spread of infection.

In June 2023, US Food and Drug Administration (FDA) announced clearance for Tristel ULT, a disinfecting foam manufactured by Parker Laboratories Inc., a global leader in ultrasound supplies and accessories. The foam is made up of chlorine dioxide and is used for disinfecting probes that are used for skin-surface transducers and inside the body cavities.

Ethylene Oxide is Dominating the Market

The demand for ethylene oxide is increasing in the global market for medical device cleaning because of its ability to sterilize medical devices that are prone to moisture and heat. This chemical compound is known for its capacity to permeate deeply into complex electronics, guaranteeing complete sterilization while protecting fragile components. Ethylene oxide is an essential tool in healthcare facilities because of its broad range of antibacterial capabilities, which successfully eradicate bacteria, viruses, fungi, and spores. However, there are issues with the safety of the environment and human health while using Ethylene Oxide, which has prompted regulatory scrutiny and the search for better alternatives.

For example, PAMA Manufacturing and Sterilization announced in January 2023 the launch of a new ethylene oxide (EO) sterilization solution that is intended to preserve the sterility outcomes of the conventional system while being safe, affordable, and environmentally friendly. The system is ISO 11135 certified and also prevents the release of EO directly into the environment.

North America Dominating the Global Medical Device Cleaning Market

North America accounts for a significant portion of the global medical device cleaning market due to its advanced healthcare system, stringent laws, and emphasis on infection control procedures. Due to the availability of many hospitals and clinics, huge healthcare spending, and strict laws and regulations related to disinfection, the United States is the major region responsible for key business activities related to medical device cleaning. The need for advanced and efficient medical equipment cleaning solutions is being influenced by these variables. Additionally, North America's position in the global medical device cleaning market is strengthened by the existence of major manufacturers who continuously invest in the research and development of new technologies, ensuring its supremacy and promoting improvements in medical device cleanliness and safety standards.

For example, in July 2023, STEMart Inc., a US-based provider of comprehensive services for all stages of medical device development, launched a new ethylene oxide sterilant residual testing service. By identifying acceptable residual levels, the new services will assist manufacturers and healthcare providers in guaranteeing the security of EO-sterilized medical devices.

Future Market Scenario (2024-2031F)

The global medical device cleaning market is moving toward sustainable and environmentally friendly cleaning products. Healthcare facilities and equipment makers are actively searching for environmentally friendly cleaning solutions as they grow more conscious of the negative consequences of disposing of chemicals in the environment.

Specialized cleaning solutions made especially for disposable devices are becoming more and more common as healthcare institutions use more disposable devices to reduce the danger of cross-contamination and streamline cleaning procedures, propelling the growth of the global medical device cleaning market.

Automation and robotics are being preferred to clean medical devices boosting the growth of the global medical device cleaning market. When it comes to cleaning and sterilizing medical equipment, automated cleaning solutions offer effectiveness, consistency, and reduce human errors.

Key Players Landscape and Outlook

Prominent companies operating in the global medical device cleaning market are progressively forming partnerships as a means of leveraging each other's advantages. These businesses may more effectively and efficiently promote innovation by combining their technological know-how, R&D capacities, and market presence through partnerships. The development of superior cleaning and sterilization solutions is made possible by this cooperative approach, which facilitates the sharing of best practices in production and quality assurance. These kinds of partnerships frequently lead to improved products, more avenues for distribution, and higher standards of customer service. In the end, these collaborations promote growth and sustainability in the global medical device cleaning market by increasing competition, and innovation, and meeting the changing needs of healthcare providers.

In November 2023, AdaptivEndo and Plasmapp announced their collaboration to assess the potential applications of low-temperature hydrogen peroxide gas plasma for flexible endoscopy. AdaptivEndo was actively looking for partnerships to evaluate different opportunities in gas plasma for flexible endoscopy.

Table of Contents

1. Research Methodology

2. Project Scope and Definitions

3. Executive Summary

4. Global Medical Device Cleaning Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Process
  • 4.2.1. Precleaning
  • 4.2.2. Manual Cleaning
  • 4.2.3. Automatic Cleaning
• 4.3. By EPA Classification
  • 4.3.1. High Level
  • 4.3.2. Intermediate Level
  • 4.3.3. Low Level
• 4.4. By Device
  • 4.4.1. Non-Critical
  • 4.4.2. Semi-Critical
  • 4.4.3. Critical
• 4.5. By Type
  • 4.5.1. Enzymatic
  • 4.5.2. Non-Enzymatic
• 4.6. By Technique
  • 4.6.1. Cleaning
  • 4.6.2. Disinfection
• 4.7. By Application
  • 4.7.1. Endoscopes
  • 4.7.2. Ultrasound Probes
  • 4.7.3. Dental Instruments
  • 4.7.4. Surgical Instruments
  • 4.7.5. Others
• 4.8. By End-user
  • 4.8.1. Hospitals and Clinics
  • 4.8.2. Diagnostic Centers
  • 4.8.3. Dental Clinics
  • 4.8.4. Others
• 4.9. By Region
  • 4.9.1. North America
  • 4.9.2. Europe
  • 4.9.3. Asia-Pacific
  • 4.9.4. South America
  • 4.9.5. Middle East and Africa
• 4.10. By Company Market Share (%), 2023

5. Global Medical Device Cleaning Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Process
    • 5.1.2.1. Precleaning
    • 5.1.2.2. Manual Cleaning
    • 5.1.2.3. Automatic Cleaning
  • 5.1.3. By EPA Classification
    • 5.1.3.1. High Level
    • 5.1.3.2. Intermediate Level
    • 5.1.3.3. Low Level
  • 5.1.4. By Device
    • 5.1.4.1. Non-critical
    • 5.1.4.2. Semi-critical
    • 5.1.4.3. Critical
  • 5.1.5. By Type
    • 5.1.5.1. Enzymatic
    • 5.1.5.2. Non-Enzymatic
  • 5.1.6. By Technique
    • 5.1.6.1. Cleaning
    • 5.1.6.2. Disinfection
  • 5.1.7. By Application
    • 5.1.7.1. Endoscopes
    • 5.1.7.2. Ultrasound Probes
    • 5.1.7.3. Dental Instruments
    • 5.1.7.4. Surgical Instruments
    • 5.1.7.5. Others
  • 5.1.8. By End-user
    • 5.1.8.1. Hospitals and Clinics
    • 5.1.8.2. Diagnostic Centers
    • 5.1.8.3. Dental Clinics
    • 5.1.8.4. Others
  • 5.1.9. United States*
    • 5.1.9.1. Market Size & Forecast
      • 5.1.9.1.1. By Value
      • 5.1.9.1.2. By Volume
    • 5.1.9.2. By Process
      • 5.1.9.2.1. Precleaning
      • 5.1.9.2.2. Manual Cleaning
      • 5.1.9.2.3. Automatic Cleaning
    • 5.1.9.3. By EPA Classification
      • 5.1.9.3.1. High Level
      • 5.1.9.3.2. Intermediate Level
      • 5.1.9.3.3. Low Level
    • 5.1.9.4. By Device
      • 5.1.9.4.1. Non-Critical
      • 5.1.9.4.2. Semi-Critical
      • 5.1.9.4.3. Critical
    • 5.1.9.5. By Type
      • 5.1.9.5.1. Enzymatic
      • 5.1.9.5.2. Non-Enzymatic
    • 5.1.9.6. By Technique
      • 5.1.9.6.1. Cleaning
      • 5.1.9.6.2. Disinfection
    • 5.1.9.7. By Application
      • 5.1.9.7.1. Endoscopes
      • 5.1.9.7.2. Ultrasound Probes
      • 5.1.9.7.3. Dental Instruments
      • 5.1.9.7.4. Surgical Instruments
      • 5.1.9.7.5. Others
    • 5.1.9.8. By End-user
      • 5.1.9.8.1. Hospitals and Clinics
      • 5.1.9.8.2. Diagnostic Centers
      • 5.1.9.8.3. Dental Clinics
      • 5.1.9.8.4. Others
  • 5.1.10. Canada
  • 5.1.11. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East and Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Process
• 6.2. By EPA Classification
• 6.3. By Device
• 6.4. By Type
• 6.5. By Technique
• 6.6. By Application
• 6.7. By End-user
• 6.8. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat From New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Key Players Landscape

• 9.1. Competition Matrix of Top Five Market Leaders
• 9.2. Market Revenue Analysis of Top Five Market Leaders (By Value, 2023)
• 9.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 9.4. SWOT Analysis (For Five Market Players)
• 9.5. Patent Analysis (If Applicable)

10. Pricing Analysis

11. Case Studies

12. Key Players Outlook

• 12.1. Waters Corporation
  • 12.1.1. Company Details
  • 12.1.2. Key Management Personnel
  • 12.1.3. Products and Services
  • 12.1.4. Financials (As Reported)
  • 12.1.5. Key Market Focus and Geographical Presence
  • 12.1.6. Recent Developments
• 12.2. 3M Company
• 12.3. Integra LifeSciences Corporation
• 12.4. Steris Plc
• 12.5. Ecolab Inc.
• 12.6. Revvity Inc
• 12.7. Advanced Sterilization Products Services Inc
• 12.8. Thermo Fisher Scientific, Inc.
• 12.9. Agilent Technologies, Inc.
• 12.10. Cantel Medical Corporation

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

13. Strategic Recommendations

14. About Us & Disclaimer