Regulatory Environment and Impact Analysis- Sterile Packaging Market Analysis & Forecast to 2020


Posted January 18, 2017 by Shirley

Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies – Market Analysis & Forecast to 2020 is a professional and in-depth study.

 
MRRS adds "Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies – Market Analysis & Forecast to 2020" latest studies, published in January 2017. It is a professional and in-depth study.

“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

Table Of Contents
1 INTRODUCTION 15
1.1 OBJECTIVES OF THE STUDY 15
1.2 MARKET DEFINITION 15
1.3 STUDY SCOPE 15
1.3.1 PERIODIZATION CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 15
1.4 CURRENCY CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 15
1.5 UNIT CONSIDERED FOR THE STERILE MEDICAL PACKAGING MARKET 16
1.6 STAKEHOLDERS 16
2 RESEARCH METHODOLOGY 17
2.1 RESEARCH DATA 17
2.1.1 SECONDARY DATA 17
2.1.1.1 Key Data From Secondary Sources 17
2.1.2 PRIMARY DATA 18
2.1.2.1 Key Data From Primary Sources 18
2.1.2.1.1 Breakdown of primaries by company type, designation & region 19
2.2 FACTOR ANALYSIS 19
2.2.1 INTRODUCTION 19
2.2.2 OVERVIEW OF PARENT INDUSTRY 20
2.2.3 DEMAND-SIDE ANALYSIS 20
2.2.3.1 Rising Population 21
2.2.3.1.1 Increase in the middle-class population, 2009–2030 21
2.2.3.2 Increasing Urban population 22
2.2.3.3 Developing Economies: GDP (Purchasing Power Parity) 23
2.2.4 SUPPLY-SIDE ANALYSIS 24
2.2.4.1 Fluctuation in Raw Material Prices 24
2.2.4.2 Increasing Investment in Research & Development to Develop Innovative Technologies 25
2.3 MARKET SIZE ESTIMATION 25
2.4 MARKET BREAKDOWN & DATA TRIANGULATION 27
2.5 RESEARCH ASSUMPTIONS & LIMITATIONS 28
2.5.1 ASSUMPTIONS 28
2.5.2 LIMITATIONS 28

3 EXECUTIVE SUMMARY 29
3.1 INTRODUCTION 29
3.2 REGULATORY SCENARIO 30
3.2.1 REGULATORY FRAMEWORK IN NORTH AMERICA 30
3.2.2 REGULATORY FRAMEWORK IN ASIA-PACIFIC 31
3.2.3 REGULATORY FRAMEWORK IN EUROPE 31
3.2.4 REGULATORY FRAMEWORK IN ROW 31
3.3 MEDICAL DEVICE APPROVAL PROCESS IN KEY COUNTRIES 32
3.4 IMPACT ANALYSIS 38
3.4.1 CASE STUDY: MEDICAL DEVICE RECALL & ITS IMPACT 38
3.4.2 NEED FOR HARMONIZATION OF GLOBAL STANDARDS & REGULATIONS 39
4 MARKET OVERVIEW OF STERILE MEDICAL PACKAGING 40
...

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Last Updated January 18, 2017