Regulatory Environment and Impact Analysis- Sterile Packaging Market

The report "Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies - Market Analysis & Forecast to 2020", The market for sterile medical packaging is projected to grow from USD 26.55 Billion in 2015 to USD 35.07 Billion by 2020, at an estimated CAGR of 5.72%.

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The market for sterile medical packaging is growing due to increasing applications of sterile packaging in the pharmaceutical & biological sectors, aging population, and rising chronic diseases. Growing demand from the healthcare industry also provides an opportunity to the market to grow further, especially in the emerging Asia-Pacific and Latin American regions. However, maintaining medical packaging integrity can act as a challenge to the growth of the market for sterile medical packaging.

North America dominated the market for sterile medical packaging in 2014 and has the most organized regulatory framework for sterile medical packaging

On the basis of key regions, the market for sterile medical packaging is segmented into North America, Europe, Asia-Pacific, and Rest of the World (RoW). The North American region held the largest share among all the regions in 2014. This is mainly due to rising healthcare awareness and continuous innovation & technological developments in both pharmaceutical & medical industries which is transforming the healthcare packaging industry further, thereby driving the growth of the sterile medical packaging market.

Further, the regulatory framework in North America is organized, effective, strong, and transparent. Factors such as timelines for the medical device approval process, cost for placing the product in the market, and ease of doing business have been considered for defining the structure of the sterile medical device regulatory framework. Countries such as the U.S., Canada, and Mexico have been considered for the study. In North America, the regulations implemented by governing bodies such as U.S. FDA and ASTM have been followed as international standards and regulations by different countries across the region. While in Asia-Pacific, factors such as longer timelines for approving the medical devices in Australia, red tapism in India, and higher cost for approval of the medical device make the regulatory framework in the region complex as compared to the regulatory environment in North America and Europe.

The scope of the report covers detailed information regarding the major factors influencing the growth of the market for sterile medical packaging such as drivers, restraints, challenges, and opportunities. This report studies and covers sterile medical packaging regulations and legislations in North America, Europe, Asia-Pacific, and RoW. The regions have been further studied based on laws prevalent in the top countries. The report also includes key governing bodies and the medical device approval process is mentioned for the key countries.

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