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市場調査レポート
商品コード
1635932
シングルユース医療機器再処理市場レポート:機器タイプ、用途、最終用途、地域別、2025~2033年Single-use Medical Device Reprocessing Market Report by Device Type, Application, End User, and Region 2025-2033 |
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シングルユース医療機器再処理市場レポート:機器タイプ、用途、最終用途、地域別、2025~2033年 |
出版日: 2025年01月10日
発行: IMARC
ページ情報: 英文 129 Pages
納期: 2~3営業日
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シングルユース医療機器再処理市場の世界市場規模は2024年に9億660万米ドルに達しました。今後、IMARC Groupは、市場は2033年までに25億3,360万米ドルに達し、2025年から2033年の間に12.1%の成長率(CAGR)を示すと予測しています。慢性疾患の有病率の上昇、外科手術の増加、品質管理方法、持続可能性と医療廃棄物の削減への関心の高まりなどが、市場を推進している主な要因の一部です。
シングルユース医療機器再処理は、単回使用用に設計されラベルが貼られた医療機器を回収、洗浄、消毒、再生することにより、コストを軽減し、環境廃棄物を削減することを目的としたヘルスケア業界内の慣行です。これらの医療機器は、適切な処理が施された後、再び医療現場に導入され、患者に使用されます。この方法は、医療機器の調達にかかる費用を削減できる可能性がある一方で、使い捨て医療器具が環境に与える影響に関する懸念にも対処できるため、注目されています。このプロセスには通常、再処理された機器の安全性と有効性を確保するための厳格なステップが含まれます。機器は回収され、再処理に適しているかどうかに基づいて選別されます。その後、洗浄、消毒、検査、試験、滅菌などの一連の入念な手順が行われます。
慢性疾患の有病率の上昇と外科手術の増加が、世界市場を牽引しています。さらに、持続可能性と医療廃棄物の削減への関心の高まりが、使い捨て器具の再処理への関心を高めています。再処理は、埋立地や焼却炉で処理される医療廃棄物の量を減らすことで、ヘルスケアの環境への影響を最小限に抑えるのに役立ちます。さらに、各国の規制機関は、特定の単回使用医療機器の安全な再処理のためのガイドラインと承認を提供しています。これらの規制は、再処理された器具が厳しい安全基準と品質基準を満たすことを保証することで、再処理市場の成長を支えています。リプロセシング技術と技法の継続的な進歩により、プロセスの有効性と安全性が向上しています。これらの進歩には、より優れた洗浄、滅菌、品質管理方法が含まれ、リプロセス機器は臨床使用においてより信頼できるものとなっています。また、シングルユース機器の再処理に関する基準や規制の確立も、市場の成長に寄与しています。明確なガイドラインは、ヘルスケア施設にリプロセスデバイスの安全性と有効性に対する信頼を提供しています。
コスト抑制と予算圧力
ヘルスケア支出の増大と財政的制約の中で、病院やクリニックは、患者のケアを損なうことなくリソースを最大限に活用する革新的な方法を模索しています。単回使用の医療機器は、患者が1回使用しただけで廃棄されることが多く、交換のために多額の経常費用が発生します。このような医療機器を再加工することで、大幅なコスト削減が可能になります。再加工された医療機器は、新品の数分の一のコストで臨床に導入することができるからです。この戦略は、調達費用を削減するだけでなく、頻繁な供給補充の必要性を抑制することで、業務効率にも貢献します。再処理によって節約された資金を、患者ケアやインフラ強化の他の重要な分野に再配分することで、ヘルスケア機関は高水準の医療サービス提供を維持しながら、財政的圧力を軽減することができます。
環境維持と廃棄物削減
ヘルスケア分野では大量の医療廃棄物が発生し、その多くは使い捨て医療機器から生じます。これらの廃棄物は、埋立地に非生分解性物質を蓄積させ、環境に悪影響を及ぼす可能性があります。再処理は、徹底的な洗浄、消毒、滅菌によってこれらの機器の寿命を延ばすことで、この懸念に対する解決策を提供します。再処理された器具を再利用することで、ヘルスケア施設は医療廃棄物の発生量を大幅に減少させることができ、より環境に配慮した医療へのアプローチを促進することができます。これは、環境に配慮した実践を目指す社会全体のシフトと一致し、ヘルスケア機関は、患者の健康と環境の両方に対する責任ある管理者として位置づけられます。規制機関や患者がますます持続可能性を優先するようになる中、シングルユース医療機器再処理を採用することは、エコロジカル・フットプリントの削減を目指すヘルスケア提供者にとって論理的な選択肢となります。
規制当局のサポートと技術の進歩
規制機関は、厳格な品質管理で実施された場合の再処理の潜在的な利点を認識し、患者の安全を確保するためのガイドラインと基準を確立しています。再処理された器具の有効性を保証するためにこれらの規制が進化するにつれて、ヘルスケア施設は再処理を診療に取り入れる傾向が強まり、市場の成長を増大させています。さらに、技術の進歩はリプロセシングの状況を一変させました。洗浄剤、消毒方法、滅菌技術における革新は、汚染物質をより効果的に除去することを可能にし、リプロセス器具を新品と同等の安全性と信頼性を持つものにしています。これらの進歩はまた、品質保証の強化にも貢献し、有害事象の可能性を減らしています。規制当局のサポートと技術の進歩が組み合わさることで、シングルユース医療機器再処理の信頼性が高まり、ヘルスケア提供者の信頼が醸成され、より広範な導入が促進されます。
The global single-use medical device reprocessing market size reached USD 906.6 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 2,533.6 Million by 2033, exhibiting a growth rate (CAGR) of 12.1% during 2025-2033. The rising prevalence of chronic disorders, along with the increasing number of surgical procedures, and quality control methods, and the growing focus on sustainability and reducing medical waste are some of the major factors propelling the market.
Single-use medical device reprocessing is a practice within the healthcare industry aimed at mitigating costs and reducing environmental waste by collecting, cleaning, disinfecting, and refurbishing medical devices that are designed and labeled for single-use. These devices, after appropriate processing, are then reintroduced into the medical setting for subsequent patient use. This approach has gained attention due to its potential to lower expenses associated with medical equipment procurement while also addressing concerns regarding the ecological impact of disposable medical items. The process typically involves rigorous steps to ensure the safety and efficacy of reprocessed devices. Devices are collected and sorted based on their suitability for reprocessing. They then undergo a series of meticulous procedures, including cleaning, disinfection, inspection, testing, and sterilization.
The rising prevalence of chronic disorders, along with the increasing number of surgical procedures, is driving the global market. Moreover, the growing focus on sustainability and reducing medical waste has led to increased interest in reprocessing single-use devices. Reprocessing helps minimize the environmental impact of healthcare by reducing the volume of medical waste that ends up in landfills or incinerators. Furthermore, regulatory agencies in various countries have provided guidelines and approvals for the safe reprocessing of certain single-use medical devices. These regulations support the growth of the reprocessing market by ensuring that reprocessed devices meet stringent safety and quality standards. Ongoing advancements in reprocessing technologies and techniques have improved the effectiveness and safety of the process. These advancements include better cleaning, sterilization, and quality control methods, making reprocessed devices more reliable for clinical use. Also, the establishment of standards and regulations for reprocessing single-use devices has contributed to the growth of the market. Clear guidelines provide healthcare facilities with confidence in the safety and effectiveness of reprocessed devices.
Cost Containment and Budget Pressures
In an environment of rising healthcare expenditures and financial constraints, hospitals and clinics are seeking innovative ways to maximize resource utilization without compromising patient care. Single-use medical devices are often discarded after a single patient use, leading to significant recurring expenses for replacements. Reprocessing these devices provides an avenue for substantial cost savings, as the refurbished devices can be reintroduced into the clinical setting at a fraction of the cost of new ones. This strategy not only reduces procurement expenses but also contributes to operational efficiency by curtailing the need for frequent supply replenishment. By reallocating funds saved through reprocessing to other critical areas of patient care and infrastructure enhancement, healthcare institutions can alleviate financial pressures while maintaining high standards of medical service delivery.
Environmental Sustainability and Waste Reduction
The healthcare sector generates a significant amount of medical waste, much of which comes from single-use medical devices. These disposables contribute to the accumulation of non-biodegradable materials in landfills, potentially causing environmental harm. Reprocessing offers a solution to this concern by extending the lifespan of these devices through thorough cleaning, disinfection, and sterilization. By reusing reprocessed devices, healthcare facilities can significantly decrease the volume of medical waste generated, promoting a more ecologically responsible approach to medical care. This aligns with the broader societal shift towards environmentally conscious practices and positions healthcare institutions as responsible stewards of both patient health and the environment. As regulatory bodies and patient populations increasingly prioritize sustainability, the adoption of single-use medical device reprocessing becomes a logical choice for healthcare providers looking to reduce their ecological footprint.
Regulatory Support and Technological Advancements
Regulatory agencies, recognizing the potential benefits of reprocessing when conducted with stringent quality controls, have established guidelines and standards to ensure patient safety. As these regulations evolve to ensure the efficacy of reprocessed devices, healthcare facilities are more inclined to incorporate reprocessing into their practices, augmenting the market growth. Moreover, technological advancements have transformed the reprocessing landscape. Innovations in cleaning agents, disinfection methods, and sterilization technologies have enabled more effective removal of contaminants, rendering reprocessed devices comparably safe and reliable as new ones. These advancements also contribute to enhanced quality assurance, reducing the likelihood of adverse events. The marriage of regulatory support and technological progress enhances the credibility of single-use medical device reprocessing, fostering trust among healthcare providers and encouraging broader adoption.
Class I Devices
Laparoscopic Graspers
Scalpels
Tourniquet Cuffs
Other Class I Devices
Class II Devices
Pulse Oximeter Sensors
Sequential Compression Sleeves
Catheters and Guidewires
Other Class II Devices
Class II devices dominate the market
Class II devices encompass a diverse range of medical instruments that pose a moderate to high risk to patients. These devices often require a more complex reprocessing process due to their intricate designs, various components, and critical functionalities. Class II devices are widely utilized across multiple medical specialties, including cardiology, orthopedics, and gastroenterology. This broad usage translates into a higher volume of devices that can be targeted for reprocessing. Furthermore, the cost implications of Class II devices play a pivotal role. Several devices are expensive to procure, and their disposability contributes significantly to healthcare expenditures. As healthcare providers face mounting pressure to optimize budget allocation, the potential for cost savings through reprocessing becomes particularly attractive. The reprocessing of Class II devices offers a practical solution to mitigate financial burdens while still adhering to stringent quality and safety standards.
General Surgery
Anesthesia
Arthroscopy and Orthopaedic Surgery
Cardiology
Gastroenterology
Gynaecology
Urology
Others
General surgery encompasses a wide array of procedures that address a range of conditions, from routine to complex. This diversity in surgical interventions contributes to the substantial size of the general surgery application segment within the reprocessing market. Single-use devices utilized in general surgery procedures, such as endoscopic tools, laparoscopic instruments, and trocars, are often costly, driving up healthcare expenditures. As hospitals and surgical centers face mounting financial pressures, reprocessing these devices becomes an attractive strategy to control costs without compromising patient safety.
On the other hand, cardiology procedures, ranging from diagnostic angiography to complex interventions, such as angioplasty and stent placement, heavily rely on a variety of single-use medical devices. These devices, often intricate and specialized, contribute to the substantial size of the cardiology application segment. The utilization of reprocessed devices in cardiology not only addresses the financial burden of procuring expensive single-use instruments but also aligns with the industry's shift towards sustainability.
Hospitals
Ambulatory Surgical Centers
Others
Hospitals dominate the market
Hospitals are at the forefront of sustainability efforts within the healthcare sector. With increased global awareness of environmental concerns, hospitals are under pressure to reduce their ecological footprint. Reprocessing single-use devices aligns perfectly with this sustainability objective by reducing the volume of medical waste generated. By reprocessing devices instead of disposing of them after a single use, hospitals contribute to waste reduction and minimize their impact on the environment. The adoption of reprocessed devices by hospitals also benefits from advancements in reprocessing technologies and the growing support from regulatory agencies. These factors collectively impel the credibility and safety of reprocessed devices, assuaging concerns about their efficacy. As hospitals focus to provide the best possible care to their patients, the assurance of regulatory compliance and technological sophistication plays a pivotal role in their decision to adopt reprocessed devices.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America exhibits a clear dominance, accounting for the largest single-use medical device reprocessing market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada), Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others), Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others), Latin America (Brazil, Mexico, and others), and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America boasts an advanced and well-established healthcare infrastructure. The region is home to a plethora of world-renowned medical institutions, cutting-edge research centers, and innovative healthcare providers. This robust healthcare ecosystem naturally lends itself to the adoption of progressive medical practices, including the reprocessing of single-use devices. As a result, the market experiences a substantial influx of both demand and supply for reprocessed medical devices. Moreover, the stringent regulatory framework in North America serves as a catalyst for the adoption of safe and compliant reprocessing practices. Furthermore, the culture of innovation and technology adoption in North America contributes to the region's leadership in the market. Technological advancements in reprocessing techniques, sterilization methods, and quality control mechanisms are embraced more readily in this environment. Financial considerations also play a significant role in North America's dominance. The high costs associated with healthcare delivery, including the procurement of new medical devices, motivate healthcare institutions to explore cost-effective alternatives.
Companies are heavily investing in research and development to improve reprocessing techniques. This includes advancements in cleaning, disinfection, and sterilization methods to ensure that reprocessed devices meet or exceed regulatory requirements and maintain their safety and efficacy. Companies are also working closely with regulatory authorities to ensure that their reprocessed devices adhere to the necessary safety and quality standards. They engage in rigorous testing, validation, and documentation to demonstrate that reprocessed devices are equivalent to new ones in terms of performance and safety. Additionally, several companies are expanding their portfolios of reprocessed medical devices. Initially, the focus might have been on common devices, but as the market matures, companies are diversifying into more complex and specialized instruments used in various medical specialties. Moreover, companies are actively involved in educating healthcare professionals about the benefits and safety of reprocessed devices. This involves providing training sessions, workshops, webinars, and educational materials to ensure that healthcare providers have a clear understanding of the reprocessing process and the quality assurances in place.
Arjo Inc.
Innovative Health
Johnson & Johnson
Medline Industries LP
NEScientific Inc.
Steripro Canada
Stryker Corporation
SureTek Medical
Vanguard AG