세계의 의료기기 세정 시장 규모는 2023년 51억 4,000만 달러에서 2031년에는 93억 4,000만 달러에 달할 것으로 예측되며, 2024-2031년의 예측 기간에 CAGR로 7.75%의 성장이 전망됩니다. COVID-19 팬데믹 후 소독에 관한 기준의 확립, 혁신적인 제품에 대한 수요의 증가, 초음파 프로브용 소독제의 인기 증가, 산화 에틸렌의 우위성 등의 다양한 요인이 시장을 형성하고 있습니다.
규제 기준은 전 세계 의료기기 세정 시장의 수호자 역할을 하며 모든 제품과 시술이 엄격한 안전 및 품질 요구 사항을 준수하도록 보장합니다. 궁극적으로 의료 환경에서 세척 솔루션 개발의 나침반이 되어 환자와 의료진의 건강과 안전을 보호합니다. 시장에서는 새로운 세척 솔루션과 세척 기술에 대한 수요가 크게 증가하고 있습니다. 이러한 솔루션은 소독의 효과와 효율성을 높이면서 환자의 안전을 최우선으로 고려하고 있습니다. 이러한 수요 증가는 감염 예방과 환자 안전을 위한 보다 진보된 솔루션에 대한 절박한 요구가 직접적인 원인이며, 의료 분야의 소독 수준을 향상시키려는 공통의 노력을 강조하고 있습니다.
초음파 프로브 전용 소독제에 대한 선호도가 높아짐에 따라 시장 수요가 증가하고 있습니다. 이러한 추세는 다양한 의료기기에 적합한 세척 솔루션의 필요성을 강조하고 있습니다. 효과적이고 적응성이 높은 살균제인 에틸렌 옥사이드는 전 세계 의료기기 세정 시장에서 큰 점유율을 차지하고 있습니다. 에틸렌 옥사이드는 의료기기를 효과적으로 멸균할 수 있으므로 의료기기 세정을 위한 최고의 선택이라는 명성을 확고히 하고 있습니다. 에틸렌 옥사이드는 광범위한 재료 호환성으로 인해 의료 산업에서 다양한 용도에 널리 사용되고 있습니다.
규제 기준의 확립이 시장을 형성합니다.
시장은 의료기기 산업에서 환자의 안전과 품질을 보호하는 규제 기준에 의해 크게 형성되고 있습니다. 이러한 지침은 환자의 안전을 보호하고 감염을 방지하기 위해 엄격한 세척 및 소독 절차가 준수되도록 보장합니다. 규제기관이 전 세계에서 이러한 권장 사항을 개선함에 따라 의료 서비스 프로바이더는 혁신적인 세척 솔루션과 기술을 채택해야 합니다. 제조업체와 의료 기관이 이러한 엄격한 규제 요건을 충족시키기 위해 전문 세척 서비스 및 소모품에 대한 수요가 증가하여 궁극적으로 산업의 성장과 발전을 촉진하고 있습니다.
예를 들어 미국 식품의약국(FDA)은 2023년 7월 미국 환경보호청(EPA)이 에틸렌옥사이드(EtO) 사용을 제한하는 규제를 추진하고 있는 가운데, FDA의 의료기기 및 방사선보건센터(Center for Devices and Radiological Health, CDRH)는 의료기기를 멸균하기 위한 저온 기화 과산화수소 사용에 대한 새로운 국제 합의 표준을 승인했다고 발표했습니다.
혁신적인 제품에 대한 수요 증가로 시장 성장 촉진
의료기기의 복잡성 증가와 감염 예방에 대한 관심이 높아짐에 따라 전 세계 의료기기 세정 시장에서 혁신적인 제품에 대한 수요가 크게 증가하고 있습니다. 복잡한 의료기기는 최신 세척 기술로는 충분하지 않을 수 있으며, 보다 진보된 접근 방식이 필요합니다. 또한 COVID-19 팬데믹의 영향으로 엄격한 위생 예방 조치의 필요성이 강조되면서 강력한 세척 솔루션에 대한 수요가 증가하고 있습니다. UV-C 레이저 살균 및 효소 세정제와 같은 혁신적인 기술로 세척 기술이 변화하고 있으며, 감염 위험을 줄이고 환자 안전을 향상시키는 뛰어난 기능을 제공합니다.
예를 들어 미국 식품의약국(FDA)은 2023년 8월에 출시될 3D 프린팅 의료기기를 위한 최초의 멸균 시스템인 V-PRO maX 2 저온 멸균 시스템(V-PRO maX 2 Low-Temperature Sterilization System)을 승인했습니다. 프린팅된 해부학적 모델이나 환자별 맞춤형 수술 가이드와 같은 수술 장비를 멸균할 수 있습니다.
세계의 의료기기 세정 시장에 대해 조사분석했으며, 시장 규모와 예측, 시장 역학, 주요 기업의 상황과 전망 등을 제공하고 있습니다.
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.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.