規制環境および影響分析： 無菌包装市場...市場調査レポートについてご紹介

1 Introduction (Page No. – 15)
1.1 Objectives of the Study
1.2 Market Definition
1.3 Study Scope
1.3.1 Periodization Considered for the Sterile Medical Packaging Market
1.4 Currency Considered for the Sterile Medical Packaging Market
1.5 Unit Considered for the Sterile Medical Packaging Market
1.6 Stakeholders

2 Research Methodology (Page No. – 17)
2.1 Research Data
2.1.1 Secondary Data
2.1.1.1 Key Data From Secondary Sources
2.1.2 Primary Data
2.1.2.1 Key Data From Primary Sources
2.1.2.1.1 Breakdown of Primaries By Company Type, Designation & Region
2.2 Factor Analysis
2.2.1 Introduction
2.2.2 Overview of Parent Industry
2.2.3 Demand-Side Analysis
2.2.3.1 Rising Population
2.2.3.1.1 Increase in the Middle-Class Population, 2009–2030
2.2.3.2 Increasing Urban Population
2.2.3.3 Developing Economies: Gdp (Purchasing Power Parity)
2.2.4 Supply-Side Analysis
2.2.4.1 Fluctuation in Raw Material Prices
2.2.4.2 Increasing Investment in Research & Development to Develop Innovative Technologies
2.3 Market Size Estimation
2.4 Market Breakdown & Data Triangulation
2.5 Research Assumptions & Limitations
2.5.1 Assumptions
2.5.2 Limitations

3 Executive Summary (Page No. – 29)
3.1 Introduction
3.2 Regulatory Scenario
3.2.1 Regulatory Framework in North America
3.2.2 Regulatory Framework in Asia-Pacific
3.2.3 Regulatory Framework in Europe
3.2.4 Regulatory Framework in RoW
3.3 Medical Device Approval Process in Key Countries
3.4 Impact Analysis
3.4.1 Case Study: Medical Device Recall & Its Impact
3.4.2 Need for Harmonization of Global Standards & Regulations

4 Market Overview of Sterile Medical Packaging (Page No. – 40)
4.1 Introduction
4.2 Evolution
4.3 Market Dynamics
4.3.1 Drivers
4.3.1.1 Increased Health Awareness
4.3.1.2 Growing Demand From Healthcare Industry
4.3.1.3 Aging Population
4.3.2 Restraints
4.3.2.1 Stringent Regulations
4.3.3 Opportunities
4.3.3.1 New Product Development and Continuous Innovations in Pharmaceuticals
4.3.3.2 Developing New Sustainable Packaging Options
4.3.4 Challenges
4.3.4.1 Maintaining Medical Packaging Integrity
4.3.4.2 Rise in Healthcare Cost
4.4 Sterile Medical Package Development
4.5 Functions of A Sterile Medical Package
4.5.1 Protection
4.5.2 Ease of Use
4.5.3 Identification
4.5.4 Processability
4.5.5 Special Applications

5 International Governing Bodies (Page No. – 49)
5.1 Introduction
5.2 American Society for Testing and Materials (ASTM)
5.2.1 ASTM Committee D10
5.2.1.1 D10.13
5.2.1.2 D10.19
5.2.1.3 D10.27
5.2.1.4 D10.32
5.2.2 ASTM Committee F02
5.2.2.1 F02.10
5.2.2.2 F02.15
5.2.2.3 F02.20
5.2.2.4 F02.40
5.2.2.5 F02.50
5.3 International Organization of Standardization (ISO)
5.3.1 Developing ISO Standards
5.3.1.1 Preliminary Stage
5.3.1.2 Proposal Stage
5.3.1.3 Preparatory Stage
5.3.1.4 Committee Stage
5.3.1.5 Enquiry Stage
5.3.1.6 Approval Stage
5.3.1.7 Publication Stage
5.3.2 Standards Related to Sterile Medical Packaging
5.3.2.1 ISO 16775
5.3.2.2 ISO 11607
5.3.2.2.1 Application
5.3.2.2.2 Limitation
5.3.2.3 ISO 11607-1
5.3.2.4 ISO 11607-2
5.4 U.S. Food and Drug Administration (FDA)
5.5 International Medical Device Regulatory Forum (IMDRF)

6 Regulatory Framework for Sterile Medical Packaging in North America (Page No. – 66)
6.1 North America
6.2 North America: Sterile Medical Packaging Market Size, By Country
6.2.1 U.S.
6.2.2 Key Governing Bodies in the U.S.
6.2.2.1 FDA
6.2.2.1.1 Overview
6.2.2.1.2 Responsibilities
6.2.3 Canada
6.2.4 Key Governing Bodies in Canada
6.2.4.1 Health Canada (HC)
6.2.4.1.1 Overview
6.2.4.1.2 Responsibilities
6.2.5 Mexico
6.2.6 Key Governing Bodies in Mexico
6.2.6.1 Federal Commission for the Protection Against Sanitary Risk (COFEPRIS)
6.2.6.1.1 Overview
6.2.6.1.2 Responsibilities

7 Regulatory Framework for Sterile Medical Packaging in Europe (Page No. – 72)
7.1 Europe
7.2 Europe: Sterile Medical Packaging Market Size, By Country
7.3 Governing Bodies in Europe
7.3.1 European Committee for Standardization (CEN)
7.3.1.1 Overview
7.3.1.2 Standards Developed By CEN
7.3.1.2.1 Harmonization of En 868-1 and ISO 11607
7.3.1.2.2 En 868-2:2009
7.3.1.2.3 En 868-3:2009
7.3.1.2.4 En 868-4:2009
7.3.1.2.5 En 868-5:2009
7.3.1.2.6 En 868-6:2009
7.3.1.2.7 En 868-7:2009
7.3.1.2.8 En 868-8:2009
7.3.1.2.9 En 868-9:2009
7.3.1.2.10 En 868-10:2009
7.3.2 Sterile Barrier Association (SBA)
7.3.2.1 Overview
7.3.2.2 SBA Member Categories
7.3.2.3 Administering Activities
7.4 Medical Device Regulations in Europe
7.4.1 Introduction
7.4.2 Medical Device Directive (93/42/EEC)
7.5 Impact of Medical Device Regulations in Europe
7.5.1 CE Marking- A Gateway to Access European Market
7.5.2 Impact of Harmonization Between En and ISO
7.6 Key Countries in Europe
7.6.1 Germany
7.6.2 Key Governing Bodies in Germany
7.6.2.1 Federal Ministry of Health
7.6.2.1.1 Overview
7.6.2.1.2 Administering Activities
7.6.2.2 German Institute for Standardization (DIN)
7.6.2.2.1 Overview
7.6.2.2.2 Organizational Structure
7.6.2.2.3 Administering Activities
7.6.3 U.K.
7.6.4 Key Governing Bodies in the U.K.
7.6.4.1 Medicines and Healthcare Products Regulatory Agency (MHRA)
7.6.4.1.1 Overview
7.6.4.1.2 Responsibilities
7.6.4.2 Department of Health (DH)
7.6.4.2.1 Overview
7.6.4.2.2 Responsibilities
7.6.4.3 Association of British Healthcare Industries (ABHI)
7.6.4.3.1 Overview
7.6.4.3.2 Responsibilities
7.6.4.4 The British Standards Institution (BSI)
7.6.4.4.1 Overview
7.6.4.4.2 Responsibilities
7.6.5 France
7.6.6 Key Governing Bodies in France
7.6.6.1 National Agency for the Safety of Medicine and Health Products (ANMS)
7.6.6.1.1 Overview
7.6.6.1.2 Responsibilities
7.6.7 Italy
7.6.8 Key Governing Bodies in Italy
7.6.8.1 Ministry of Health (MOH)
7.6.8.1.1 Overview
7.6.8.1.2 Responsibilities
7.6.8.2 Italian Medicines Agency
7.6.8.2.1 Overview
7.6.8.2.2 Responsibilities

8 Regulatory Framework for Sterile Medical Packaging in Asia-Pacific (Page No. – 104)
8.1 Asia-Pacific
8.2 Asia-Pacific: Sterile Medical Packaging Market Size, By Country
8.2.1 China
8.2.2 Key Governing Bodies in China
8.2.2.1 China Food and Drug Administration (CFDA)
8.2.2.1.1 Overview
8.2.2.1.2 Responsibilities
8.2.3 Japan
8.2.4 Key Governing Bodies in Japan
8.2.4.1 Ministry of Health, Labor and Welfare (MHLW)
8.2.4.1.1 Overview
8.2.4.1.2 Responsibilities
8.2.5 India
8.2.6 Key Governing Bodies in India
8.2.6.1 CENtral Drugs Standard Control Organization (CDSCO)
8.2.6.1.1 Overview
8.2.6.1.2 Responsibilities
8.2.7 Australia
8.2.8 Key Governing Bodies in Australia
8.2.8.1 Therapeutic Goods Administration (TGA)
8.2.8.1.1 Overview
8.2.8.1.2 Responsibilities

9 Regulatory Framework for Sterile Medical Packaging in RoW (Page No. – 111)
9.1 RoW
9.2 RoW: Sterile Medical Packaging Market Size, By Country
9.2.1 Brazil
9.2.2 Key Governing Bodies in Brazil
9.2.2.1 National Health Surveillance Agency (ANVISA)
9.2.2.1.1 Overview
9.2.2.1.2 Responsibilities
9.2.3 Argentina
9.2.4 Key Governing Bodies in Argentina
9.2.4.1 National Administration of Drugs, Foodstuffs, and Medical Technology (ANMAT)
9.2.4.1.1 Overview
9.2.4.1.2 Responsibilities
9.2.5 South Africa
9.2.6 Key Governing Bodies in South Africa
9.2.6.1 Medicines Control Council (MCC)
9.2.6.1.1 Overview
9.2.6.1.2 Responsibilities

10 Appendix (Page No. – 116)
10.1 Insights of Industry Experts
10.2 Discussion Guide
10.3 Introducing RT: Real Time Market Intelligence
10.4 Available Customizations
10.5 Related Reports