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市场调查报告书
商品编码
1643932
全球医疗器材包装市场 - 2025-2033Global Medical Device Packaging Market - 2025-2033 |
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全球医疗器材包装市场2024年达到395亿美元,预计2033年将达到688亿美元,2025-2033年预测期间复合年增长率为6.4%。
医疗器材包装是指用于封装和保护医疗器材在储存、搬运和运输过程中免受污染、损坏和变质的材料、系统和製程。包装旨在确保设备的安全性、无菌性(如有必要)、完整性和功能性,并保持符合 FDA、ISO 和欧盟法规等组织制定的法规要求。对于需要无菌环境的设备,包装可确保设备在使用前不受污染。这对于手术器械、植入式设备和诊断工具尤其重要。
在医疗器材技术进步、对病人安全和感染预防的日益重视以及医疗器材需求不断增长等因素的推动下,全球医疗器材包装市场正在经历显着增长。例如,根据美国食品和药物管理局的数据,它已通过既定的上市前途径授权了 1,000 多种人工智慧设备。这些不断增加的医疗器材核准量增加了对医疗器材包装的需求。
驱动程式和限制
对永续医疗器材包装的需求不断增长
对永续医疗器材包装的需求不断增长,极大地推动了医疗器材包装市场的成长,预计将在预测期内推动市场成长。随着环境问题的加剧,医疗保健提供者和製造商越来越多地采用环保包装解决方案,以减少碳足迹并满足监管要求。因此,许多市场参与者都专注于永续包装产品的开发。
例如,2024 年 10 月,Klockner Pentaplast (kp) 推出了 kpNext MDR1,这是一种新型医疗器材包装薄膜,使 kpNext 品牌超越药品泡罩膜,进入医疗器材市场。这项创新解决方案旨在满足医疗保健包装中对永续包装选项不断增长的需求。这种新型 kpNext MDR1 薄膜使医疗保健提供者能够优先考虑永续性,而不会影响其包装材料的品质或性能。
此外,由于医疗保健包装废物不断增加,世界各国政府正在实施严格的法规,以减少塑胶废物并促进回收。例如,根据美国医学协会的数据,美国医疗机构每天产生 14,000 吨废弃物,其中约 20% 至 25% 是塑胶。然而,91% 的塑料,包括用于医疗保健的塑料,都没有被回收,最终进入垃圾掩埋场或渗入自然栖息地。
严格的监管要求
严格的监管要求透过实施製造商必须遵守的严格标准来显着影响医疗器材包装市场,从而影响市场动态。医疗器材包装的审批过程非常耗时,涉及大量文件、测试和认证。这延迟了新包装解决方案的推出,可能会阻碍创新和对市场需求的回应。製造商必须准备并提交详细的檔案,包括技术规格、风险管理文件和临床测试结果,以获得必要的批准。
例如,在欧盟,医疗器材必须经过行销授权流程,以确保其在上市前符合严格的要求。此过程包括准备和提交包含特定资讯的檔案,例如设备的一般描述、技术规格和临床测试结果。
The global medical device packaging market reached US$ 39.5 billion in 2024 and is expected to reach US$ 68.8 billion by 2033, growing at a CAGR of 6.4% during the forecast period 2025-2033.
Medical device packaging refers to the materials, systems, and processes used to enclose and protect medical devices from contamination, damage and deterioration during storage, handling, and transportation. The packaging is designed to ensure the device's safety, sterility (if necessary), integrity and functionality maintaining compliance with regulatory requirements set by organizations such as the FDA, ISO and EU regulations. For devices that require a sterile environment, packaging ensures that the device remains free from contaminants until it is used. This is particularly important for surgical instruments, implantable devices, and diagnostic tools.
The global medical device packaging market is experiencing significant growth, driven by factors such as technological advancements in medical devices, a rising emphasis on patient safety and infection prevention and rising demand for medical devices. For instance, according to the U.S. Food & Drug Administration, it has authorized more than 1,000 AI-enabled devices by the established premarket pathways. These rising medical device approvals boosting the demand for medical device packaging.
Market Dynamics: Drivers & Restraints
Rising demand for sustainable medical device packaging
The rising demand for sustainable medical device packaging is significantly driving the growth of the Medical Device Packaging market and is expected to drive the market over the forecast period. As environmental concerns intensify, healthcare providers and manufacturers are increasingly adopting eco-friendly packaging solutions to reduce their carbon footprint and meet regulatory requirements. Thus, many market players are focussing on the development of sustainable packaging products.
For instance, in October 2024, Klockner Pentaplast (kp) introduced kpNext MDR1, a new medical device packaging film that takes the kpNext brand beyond pharmaceutical blister films and into the medical device market. This innovative solution is intended to fulfill the growing demand for sustainable packaging options in healthcare packaging. This new kpNext MDR1 film allows healthcare providers to prioritize sustainability, without compromising on the quality or performance of their packaging materials.
Additionally, governments worldwide are implementing stringent regulations to reduce plastic waste and promote recycling due to rising healthcare packaging waste. For instance, according to the American Medical Association, of the 14,000 tons of waste created daily in US healthcare facilities, around 20% to 25% is plastic. However, 91% of plastics, including those used in health care, are not recycled and end up in landfills or have penetrated natural habitats.
Stringent regulatory requirements
Stringent regulatory requirements significantly impact the medical device packaging market by imposing rigorous standards that manufacturers must adhere to, thereby influencing market dynamics. The approval process for medical device packaging is time-consuming, involving extensive documentation, testing, and certification. This delays the introduction of new packaging solutions, potentially hindering innovation and responsiveness to market demands. Manufacturers must prepare and submit detailed dossiers, including technical specifications, risk management documentation, and clinical test results, to obtain necessary approvals.
For instance, in the European Union, medical devices must undergo a marketing authorization process to ensure they meet stringent requirements before being marketed. This process includes preparing and submitting a dossier containing specific information, such as the device's general description, technical specifications, and clinical test results.
The global medical device packaging market is segmented based on product type, material, packaging type, application, end-user and region.
The films segment is expected to dominate the medical device packaging market share
Films offer a wide range of properties, including moisture, oxygen, and light barriers, essential for preserving the integrity of medical devices. They can be tailored to specific requirements, such as sterilization compatibility and mechanical strength. Thus, many market players are focussing on the development of films for medical device packaging.
For instance, in November 2023, Coveris, a flexible packaging provider, created a recyclable thermoforming film designed for medical device applications. Formpeel P joins Coveris' portfolio of sustainable materials, which also includes Formpeel T, Flexopeel T, and Cleerpeel. It offers the same performance and safety as traditional materials while reducing packaging and product waste, according to the business.
Films are generally more affordable compared to other packaging materials like rigid containers, making them a preferred choice for manufacturers aiming to balance quality and cost. Films can be engineered to meet stringent regulatory standards, ensuring safety and efficacy in medical device packaging leading to market dominance.
North America is expected to hold a significant position in the medical device packaging market share
North America especially in the United States boasts a well-developed healthcare system, leading to a high demand for advanced medical devices and, consequently, sophisticated packaging solutions. North America is home to numerous prominent and emerging medical device manufacturers and packaging companies, fostering innovation and competition within the market. Key players in the region include Amcor plc, DuPont, and Berry Global, among others.
The region is at the forefront of adopting new technologies in medical device packaging, such as smart packaging solutions and sustainable materials, enhancing the quality, sterility, functionality and appeal of packaging products. For instance, in April 2024, STEMart launched its packaging solutions for the pharmaceutical and medical device industries to meet the unique needs of the medical device industries. These services are designed to ensure the quality, sterility, and regulatory compliance of medical devices throughout their lifecycle.
Asia-Pacific is growing at the fastest pace in the medical device packaging market
Rising healthcare investments in countries like China, India, and Japan are fueling the growth of the medical device market, which in turn drives demand for packaging solutions. As disposable incomes rise, people are increasingly seeking better healthcare services, which translates to higher consumption of medical devices and their packaging. For instance, the healthcare sector in China and India is rapidly expanding, and both are predicted to lead in the adoption of advanced medical device packaging solutions.
Regulatory agencies in countries like China and India have become stricter in terms of product safety and packaging standards. The imposition of these standards is pushing medical device manufacturers to adopt high-quality and reliable packaging solutions to comply with regulations. The adoption of global standards like ISO and GMP (Good Manufacturing Practices) is also contributing to the growth of the market.
The major global players in the medical device packaging market include Amcor plc, DuPont, Berry Global Inc., WestRock Company, 3M, Sonoco Products Company, Wihuri Group, AptarGroup, Inc., Oliver Healthcare Packaging, Printpack and among others.
The global Medical Device Packaging market report delivers a detailed analysis with 78 key tables, more than 76 visually impactful figures, and 166 pages of expert insights, providing a complete view of the market landscape.
Target Audience 2024
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