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Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies - Market Analysis & Forecast to 2020

Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies - Market Analysis & Forecast to 2020

“Growing demand from the healthcare industry to drive the market for sterile medical packaging”
The global market for sterile medical packaging is projected to grow from USD 26.55 billion in 2015 to reach USD 35.07 billion by 2020, at an estimated CAGR of 5.72%. The market for sterile medical packaging is driven by the growing demand from the healthcare industry due to increase in health awareness.

“Need for harmonization between the global standards and regulations in the sterile medical packaging market”
In line with the global applicable standards, each country may have its own specific set of applications and environments in which the product needs to perform. Having multiple standards may create confusion and trade barriers for manufacturers. Hence, in order to avoid this as well as to easily understand and implement packaging requirements, harmonization between the standards is necessary.

“Asia-Pacific projected to grow during the forecast period”
Asia-Pacific is projected to be the fastest-growing region in the sterile medical packaging market in the next five years. However, factors such as longer timelines for approving the medical devices in Australia, red tapism in India, and higher cost for the approval of medical devices make the regulatory framework in the region more complex.

Breakdown of Primaries:
Primary interviews were conducted with a number of industry experts in order to collect data related to different aspects of sterile medical packaging. Estimates reached after analyzing secondary sources were validated through these interviews. Primary sources include professionals such as sterile packaging manufacturers, distributors, and academic professionals. Distribution of primary interviews is as follows:
By Company Type: Tier 1 – 38%, Tier 2 – 38%, and Tier 3 – 24%
By Designation: C-level – 38%, Manager Level – 34%, and Others* – 28%
By Region: North America – 32%, Europe – 28%, Asia-Pacific – 25%, and RoW – 15%
The tier of the companies is defined on the basis of their total revenue, as of 2014: Tier 1: Revenue >USD 500 million, Tier 2: Revenue USD 100 to USD 500 million, and Tier 3: Revenue <USD 100 million
*Others include sales managers, marketing managers, and product managers.

Reasons to buy the report
The report will help the market leaders/new entrants in this market in the following ways:
1. This report segments the market for sterile medical packaging comprehensively and provides the closest approximations of the revenue numbers for the overall market across different regions.
2. The report helps stakeholders to understand the market and related regulations further providing them information on key market drivers, restraints, challenges, and opportunities.
3. The report helps to understand the regulatory aspects of the sterile medical packaging industry for the top key countries and regions.


  • INTRODUCTION
    • OBJECTIVES OF THE STUDY
    • MARKET DEFINITION
    • STUDY SCOPE
      • PERIODIZATION CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET
    • CURRENCY CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET
    • UNIT CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET
    • STAKEHOLDERS
  • RESEARCH METHODOLOGY
    • RESEARCH DATA
      • SECONDARY DATA
      • PRIMARY DATA
    • FACTOR ANALYSIS
      • INTRODUCTION
      • OVERVIEW OF PARENT INDUSTRY
      • DEMAND-SIDE ANALYSIS
        • Table ASIA-PACIFIC: URBANIZATION PROSPECTS
      • SUPPLY-SIDE ANALYSIS
    • MARKET SIZE ESTIMATION
    • MARKET BREAKDOWN & DATA TRIANGULATION
    • RESEARCH ASSUMPTIONS & LIMITATIONS
      • ASSUMPTIONS
      • LIMITATIONS
  • EXECUTIVE SUMMARY
    • INTRODUCTION
    • REGULATORY SCENARIO
      • REGULATORY FRAMEWORK IN NORTH AMERICA
      • REGULATORY FRAMEWORK IN ASIA-PACIFIC
      • REGULATORY FRAMEWORK IN EUROPE
      • REGULATORY FRAMEWORK IN ROW
    • MEDICAL DEVICE APPROVAL PROCESS IN KEY COUNTRIES
    • IMPACT ANALYSIS
      • CASE STUDY: MEDICAL DEVICE RECALL & ITS IMPACT
      • NEED FOR HARMONIZATION OF GLOBAL STANDARDS & REGULATIONS
  • MARKET OVERVIEW OF STERILE MEDICAL PACKAGING
    • INTRODUCTION
    • EVOLUTION
    • MARKET DYNAMICS
      • DRIVERS
      • RESTRAINTS
      • OPPORTUNITIES
      • CHALLENGES
    • STERILE MEDICAL PACKAGE DEVELOPMENT
    • FUNCTIONS OF A STERILE MEDICAL PACKAGE
      • PROTECTION
      • EASE OF USE
      • IDENTIFICATION
      • PROCESSABILITY
      • SPECIAL APPLICATIONS
  • INTERNATIONAL GOVERNING BODIES
    • INTRODUCTION
      • AMERICAN SOCIETY FOR TESTING AND MATERIALS (ASTM)
      • ASTM COMMITTEE D10
        • Table TECHNICAL SUBCOMMITTEES
      • ASTM COMMITTEE F02
        • Table TECHNICAL SUBCOMMITTEES
    • INTERNATIONAL ORGANIZATION OF STANDARDIZATION (ISO)
      • DEVELOPING ISO STANDARDS
      • STANDARDS RELATED TO STERILE MEDICAL PACKAGING
        • Table ANNEX
        • Table ISO 11607-1
        • Table ISO 11607-2
    • U.S. FOOD AND DRUG ADMINISTRATION (FDA)
    • INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM (IMDRF)
  • REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN NORTH AMERICA
    • NORTH AMERICA
    • NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY
      • Table NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (USD MILLION)
      • Table NORTH AMERICA: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (MILLION UNITS)
      • U.S.
      • KEY GOVERNING BODIES IN THE U.S.
      • CANADA
      • KEY GOVERNING BODIES IN CANADA
      • MEXICO
      • KEY GOVERNING BODIES IN MEXICO
  • REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN EUROPE
    • EUROPE
    • EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY
      • Table EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (USD MILLION)
      • Table EUROPE: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (MILLION UNITS)
    • GOVERNING BODIES IN EUROPE
      • EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)
        • Table EN 868-2:2009
        • Table IMPLEMENTATION OF EN 868-2:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-3:2009
        • Table IMPLEMENTATION OF EN 868-3:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-4:2009
        • Table IMPLEMENTATION OF EN 868-4:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-5:2009
        • Table IMPLEMENTATION OF EN 868-5:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-6:2009
        • Table IMPLEMENTATION OF EN 868-6:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-7:2009
        • Table IMPLEMENTATION OF EN 868-7:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-8:2009
        • Table IMPLEMENTATION OF EN 868-8:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-9:2009
        • Table IMPLEMENTATION OF EN 868-9:2009 IN EUROPEAN COUNTRIES
        • Table EN 868-10:2009
        • Table IMPLEMENTATION OF EN 868-10:2009 IN EUROPEAN COUNTRIES
      • STERILE BARRIER ASSOCIATION (SBA)
    • MEDICAL DEVICE REGULATIONS IN EUROPE
      • INTRODUCTION
      • MEDICAL DEVICE DIRECTIVE (93/42/EEC)
    • IMPACT OF MEDICAL DEVICE REGULATIONS IN EUROPE
      • CE MARKING- A GATEWAY TO ACCESS EUROPEAN MARKET
      • IMPACT OF HARMONIZATION BETWEEN EN AND ISO
    • KEY COUNTRIES IN EUROPE
      • GERMANY
      • KEY GOVERNING BODIES IN GERMANY
        • Table STANDARDS PUBLISHED BY NA 063-04-04 AA
      • U.K.
      • KEY GOVERNING BODIES IN THE U.K.
      • FRANCE
      • KEY GOVERNING BODIES IN FRANCE
      • ITALY
      • KEY GOVERNING BODIES IN ITALY
  • REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN ASIA-PACIFIC
    • ASIA-PACIFIC
    • ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY
      • Table ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (USD MILLION)
      • Table ASIA-PACIFIC: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (MILLION UNITS)
      • CHINA
      • KEY GOVERNING BODIES IN CHINA
      • JAPAN
      • KEY GOVERNING BODIES IN JAPAN
      • INDIA
      • KEY GOVERNING BODIES IN INDIA
      • AUSTRALIA
      • KEY GOVERNING BODIES IN AUSTRALIA
  • REGULATORY FRAMEWORK FOR STERILE MEDICAL PACKAGING IN ROW
    • ROW
    • ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY
      • Table ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (USD MILLION)
      • Table ROW: STERILE MEDICAL PACKAGING MARKET SIZE, BY COUNTRY, 2013-2020 (MILLION UNITS)
      • BRAZIL
      • KEY GOVERNING BODIES IN BRAZIL
      • ARGENTINA
      • KEY GOVERNING BODIES IN ARGENTINA
      • SOUTH AFRICA
      • KEY GOVERNING BODIES IN SOUTH AFRICA
  • APPENDIX
    • INSIGHTS OF INDUSTRY EXPERTS
    • DISCUSSION GUIDE
    • INTRODUCING RT: REAL TIME MARKET INTELLIGENCE
    • AVAILABLE CUSTOMIZATIONS
    • RELATED REPORTS

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