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市場調查報告書
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1643932

全球醫療器材包裝市場 - 2025-2033

Global Medical Device Packaging Market - 2025-2033
出版日期: | 出版商: DataM Intelligence | 英文 166 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

全球醫療器材包裝市場2024年達到395億美元，預計2033年將達到688億美元，2025-2033年預測期間複合年成長率為6.4%。

醫療器材包裝是指用於封裝和保護醫療器材在儲存、搬運和運輸過程中免受污染、損壞和變質的材料、系統和製程。包裝旨在確保設備的安全性、無菌性（如有必要）、完整性和功能性，並保持符合 FDA、ISO 和歐盟法規等組織制定的法規要求。對於需要無菌環境的設備，包裝可確保設備在使用前不受污染。這對於手術器械、植入式設備和診斷工具尤其重要。

在醫療器材技術進步、對病人安全和感染預防的日益重視以及醫療器材需求不斷成長等因素的推動下，全球醫療器材包裝市場正在經歷顯著成長。例如，根據美國食品和藥物管理局的數據，它已通過既定的上市前途徑授權了 1,000 多種人工智慧設備。這些不斷增加的醫療器材核准量增加了對醫療器材包裝的需求。

市場動態：

驅動程式和限制

對永續醫療器材包裝的需求不斷成長

對永續醫療器材包裝的需求不斷成長，極大地推動了醫療器材包裝市場的成長，預計將在預測期內推動市場成長。隨著環境問題的加劇，醫療保健提供者和製造商擴大採用環保包裝解決方案，以減少碳足跡並滿足監管要求。因此，許多市場參與者都專注於永續包裝產品的開發。

例如，2024 年 10 月，Klockner Pentaplast (kp) 推出了 kpNext MDR1，這是一種新型醫療器材包裝薄膜，使 kpNext 品牌超越藥品泡殼膜，進入醫療器材市場。這項創新解決方案旨在滿足醫療保健包裝中對永續包裝選項不斷成長的需求。這種新型 kpNext MDR1 薄膜使醫療保健提供者能夠優先考慮永續性，而不會影響其包裝材料的品質或性能。

此外，由於醫療保健包裝廢物不斷增加，世界各國政府正在實施嚴格的法規，以減少塑膠廢物並促進回收。例如，根據美國醫學協會的數據，美國醫療機構每天產生 14,000 噸廢棄物，其中約 20% 至 25% 是塑膠。然而，91% 的塑膠，包括用於醫療保健的塑膠，都沒有被回收，最終進入垃圾掩埋場或滲入自然棲息地。

嚴格的監管要求

嚴格的監管要求透過實施製造商必須遵守的嚴格標準來顯著影響醫療器材包裝市場，從而影響市場動態。醫療器材包裝的核准過程非常耗時，涉及大量文件、測試和認證。這延遲了新包裝解決方案的推出，可能會阻礙創新和對市場需求的回應。製造商必須準備並提交詳細的檔案，包括技術規格、風險管理文件和臨床測試結果，以獲得必要的批准。

例如，在歐盟，醫療器材必須經過行銷授權流程，以確保其在上市前符合嚴格的要求。此過程包括準備和提交包含特定資訊的檔案，例如設備的一般描述、技術規格和臨床測試結果。

目錄

第1章：市場介紹和範圍

  • 報告的目標
  • 報告範圍和定義
  • 報告範圍

第 2 章：高階主管見解與要點

  • 市場亮點和戰略要點
  • 主要趨勢和未來預測
  • 按產品類型分類的片段
  • 按材料分類
  • 按包裝類型分類的片段
  • 按應用程式片段
  • 最終使用者的片段
  • 按地區分類的片段

第 3 章：動力學

  • 影響因素
    • 促進要素
      • 對永續醫療器材包裝的需求不斷成長
    • 限制
      • 嚴格的監管要求
    • 機會
    • 影響分析

第 4 章：策略洞察與產業展望

  • 市場領導者和先驅
    • 新興先鋒和傑出參與者
    • 擁有最大銷售品牌的知名領導者
    • 擁有成熟產品的市場領導者
  • 新興新創企業和關鍵創新者
  • CXO 觀點
  • 最新進展和突破
  • 案例研究/正在進行的研究
  • 監管和報銷情況
    • 北美洲
    • 歐洲
    • 亞太地區
    • 拉丁美洲
    • 中東和非洲
  • 波特五力分析
  • 供應鏈分析
  • 專利分析
  • SWOT分析
  • 未滿足的需求和差距
  • 市場進入和擴張的推薦策略
  • 情境分析：最佳情況、基本情況和最壞情況預測

第 5 章：醫療器材包裝市場（依產品類型）

  • 托盤
  • 盒子
  • 袋子和袋子
  • 翻蓋式包裝
  • 水泡
  • 電影
  • 其他

第 6 章：醫療器材包裝市場（依材料）

  • 塑膠
  • 金屬
  • 紙和紙板
  • 玻璃
  • 其他

第 7 章：醫療器材包裝市場（依包裝類型）

  • 初級包裝
  • 二次包裝
  • 三級包裝

第 8 章：醫療器材包裝市場（按應用）

  • 無菌包裝
  • 非無菌包裝

第 9 章：醫療器材包裝市場（依最終用戶）

  • 醫療器材製造商
  • 合約製造組織

第 10 章：醫療器材包裝市場，按區域市場分析和成長機會

  • 北美洲
    • 美國
    • 加拿大
    • 墨西哥
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 西班牙
    • 義大利
    • 歐洲其他地區
  • 南美洲
    • 巴西
    • 阿根廷
    • 南美洲其他地區
  • 亞太
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 中東和非洲

第 11 章：競爭格局與市場定位

  • 競爭概況和主要市場參與者
  • 市佔率分析與定位矩陣
  • 策略夥伴關係、併購
  • 產品組合和創新的主要發展
  • 公司基準化分析

第 12 章：公司簡介

  • Amcor plc
    • 公司概況
    • 產品組合和描述
    • 財務概覽
    • 主要進展
    • SWOT分析
  • DuPont
  • Berry Global Inc.
  • WestRock Company
  • 3M
  • Sonoco Products Company
  • Wihuri Group
  • AptarGroup, Inc.
  • Oliver Healthcare Packaging
  • Printpack

第 13 章：假設與研究方法

  • 資料收集方法
  • 數據三角測量
  • 預測技術
  • 數據驗證和確認

第 14 章：附錄

簡介目錄
Product Code: PAC2838

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.

Segment Analysis

The global medical device packaging market is segmented based on product type, material, packaging type, application, end-user and region.

Product Type:

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.

Geographical Analysis

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.

Competitive Landscape

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.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

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

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Market Introduction and Scope

  • 1.1. Objectives of the Report
  • 1.2. Report Coverage & Definitions
  • 1.3. Report Scope

2. Executive Insights and Key Takeaways

  • 2.1. Market Highlights and Strategic Takeaways
  • 2.2. Key Trends and Future Projections
  • 2.3. Snippet by Product Type
  • 2.4. Snippet by Material
  • 2.5. Snippet by Packaging Type
  • 2.6. Snippet by Application
  • 2.7. Snippet by End-User
  • 2.8. Snippet by Region

3. Dynamics

  • 3.1. Impacting Factors
    • 3.1.1. Drivers
      • 3.1.1.1. Rising Demand for Sustainable Medical Device Packaging
    • 3.1.2. Restraints
      • 3.1.2.1. Stringent Regulatory Requirements
    • 3.1.3. Opportunity
    • 3.1.4. Impact Analysis

4. Strategic Insights and Industry Outlook

  • 4.1. Market Leaders and Pioneers
    • 4.1.1. Emerging Pioneers and Prominent Players
    • 4.1.2. Established leaders with largest selling Brand
    • 4.1.3. Market leaders with established Product
  • 4.2. Emerging Startups and Key Innovators
  • 4.3. CXO Perspectives
  • 4.4. Latest Developments and Breakthroughs
  • 4.5. Case Studies/Ongoing Research
  • 4.6. Regulatory and Reimbursement Landscape
    • 4.6.1. North America
    • 4.6.2. Europe
    • 4.6.3. Asia Pacific
    • 4.6.4. Latin America
    • 4.6.5. Middle East & Africa
  • 4.7. Porter's Five Force Analysis
  • 4.8. Supply Chain Analysis
  • 4.9. Patent Analysis
  • 4.10. SWOT Analysis
  • 4.11. Unmet Needs and Gaps
  • 4.12. Recommended Strategies for Market Entry and Expansion
  • 4.13. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts

5. Medical Device Packaging Market, By Product Type

  • 5.1. Introduction
    • 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 5.1.2. Market Attractiveness Index, By Product Type
  • 5.2. Trays*
    • 5.2.1. Introduction
    • 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 5.3. Boxes
  • 5.4. Pouches and Bags
  • 5.5. Clamshell Packs
  • 5.6. Blisters
  • 5.7. Films
  • 5.8. Others

6. Medical Device Packaging Market, By Material

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 6.1.2. Market Attractiveness Index, By Material
  • 6.2. Plastic*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Metal
  • 6.4. Paper and Paperboard
  • 6.5. Glass
  • 6.6. Others

7. Medical Device Packaging Market, By Packaging Type

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 7.1.2. Market Attractiveness Index, By Packaging Type
  • 7.2. Primary Packaging*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Secondary Packaging
  • 7.4. Tertiary Packaging

8. Medical Device Packaging Market, By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Sterile Packaging*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Non-Sterile Packaging

9. Medical Device Packaging Market, By End-User

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 9.1.2. Market Attractiveness Index, By End-User
  • 9.2. Medical Device Manufacturers*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Contract Manufacturing Organizations

10. Medical Device Packaging Market, By Regional Market Analysis and Growth Opportunities

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 10.1.2. Market Attractiveness Index, By Region
  • 10.2. North America
    • 10.2.1. Introduction
    • 10.2.2. Key Region-Specific Dynamics
    • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.2.8.1. U.S.
      • 10.2.8.2. Canada
      • 10.2.8.3. Mexico
  • 10.3. Europe
    • 10.3.1. Introduction
    • 10.3.2. Key Region-Specific Dynamics
    • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.3.8.1. Germany
      • 10.3.8.2. U.K.
      • 10.3.8.3. France
      • 10.3.8.4. Spain
      • 10.3.8.5. Italy
      • 10.3.8.6. Rest of Europe
  • 10.4. South America
    • 10.4.1. Introduction
    • 10.4.2. Key Region-Specific Dynamics
    • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.4.8.1. Brazil
      • 10.4.8.2. Argentina
      • 10.4.8.3. Rest of South America
  • 10.5. Asia-Pacific
    • 10.5.1. Introduction
    • 10.5.2. Key Region-Specific Dynamics
    • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
    • 10.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 10.5.8.1. China
      • 10.5.8.2. India
      • 10.5.8.3. Japan
      • 10.5.8.4. South Korea
      • 10.5.8.5. Rest of Asia-Pacific
  • 10.6. Middle East and Africa
    • 10.6.1. Introduction
    • 10.6.2. Key Region-Specific Dynamics
    • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
    • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Packaging Type
    • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 10.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

11. Competitive Landscape and Market Positioning

  • 11.1. Competitive Overview and Key Market Players
  • 11.2. Market Share Analysis and Positioning Matrix
  • 11.3. Strategic Partnerships, Mergers & Acquisitions
  • 11.4. Key Developments in Product Portfolios and Innovations
  • 11.5. Company Benchmarking

12. Company Profiles

  • 12.1. Amcor plc*
    • 12.1.1. Company Overview
    • 12.1.2. Product Portfolio and Description
    • 12.1.3. Financial Overview
    • 12.1.4. Key Developments
    • 12.1.5. SWOT Analysis
  • 12.2. DuPont
  • 12.3. Berry Global Inc.
  • 12.4. WestRock Company
  • 12.5. 3M
  • 12.6. Sonoco Products Company
  • 12.7. Wihuri Group
  • 12.8. AptarGroup, Inc.
  • 12.9. Oliver Healthcare Packaging
  • 12.10. Printpack

LIST NOT EXHAUSTIVE

13. Assumption and Research Methodology

  • 13.1. Data Collection Methods
  • 13.2. Data Triangulation
  • 13.3. Forecasting Techniques
  • 13.4. Data Verification and Validation

14. Appendix

  • 14.1. About Us and Services
  • 14.2. Contact Us