HOME › Research Insight › Regulatory Environment and Impact Analysis- Sterile Packaging Market Plays a Crucial Role as it is used for Packing Pharmaceutical and Medical Device Products
Regulatory Environment and Impact Analysis- Sterile Packaging Market Plays a Crucial Role as it is used for Packing Pharmaceutical and Medical Device Products
MarketsandMarkets projects the global market for sterile medical packaging to grow from USD 26.55 Billion in 2015 to USD 35.07 Billion by 2020, at a CAGR of 5.72% from 2015 to 2020. As the application of sterile packaging in the pharmaceutical & biological industry is growing day by day, the market for sterile medical packaging is also growing. Sterile medical packaging is used in thermoform trays, sterile bottles & containers, blister & clamshells, vials & ampoules, bags & pouches, pre-filled syringes, pre-fillable inhalers, wraps, sterile closures, and others such as strip packs. The growth in sterile medical packaging has also impacted the regulatory framework of the sterile medical packaging industry.
Sterile packaging plays a crucial role as it is used for packing pharmaceutical and medical device products. The slightest negligence in the packaging may result into serious health consequences or even the death of a patient. Such concerns have resulted into a stringent regulatory framework in the global sterile medical packaging industry. The regulatory framework in the sterile packaging market is complex and varies region to region. However, in order to avoid confusion among manufacturers and ease the trade barrier, continuous efforts are made to harmonize the multiple standards and regulations to form global standards.
In Europe, healthcare facilities are reducing the amount spent on the sterile medical equipment, medical devices, and medical packaging due to lack of availability of funds from the central government. However, at the same time, the introduction of European regulations has become more stringent and requires stronger and more effective sterile barrier than earlier. In order to overcome this challenge, a Europe-wide packaging material group named Sterile Barrier Association acts as a voice for all the relevant matters related to the sterile barrier industry. The report includes various governing bodies and associations in different countries.
The European Union has particular requirements for all medical products entering its communities which the manufacturers have to adhere to while placing its products in the market. It has specific regulations related to the sterile medical packaging which the product manufacturer has to comply. The requirements in the sterile packaging are related to various aspects such as packaging material specifications as well as its performance, sterile package integrity, and quality management of the package.
EU has the second largest medical device market, worldwide. Several factors such as faster approval process, shorter time-to-market, and less stringent regulatory directives as compared to other countries such as the U.S. has attracted the medical device manufacturer in the EU market.
Regulatory Environment and Impact Analysis- Sterile Packaging Market Standards & Regulations, Regional & National Regulatory Bodies - Market Analysis & Forecast to 2020
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