Market Challenges And Opportunities

Antimicrobial Wound Dressing Market Restraints

Challenges in classification of antimicrobial wound dressing into the FDA’s existing medical device classification is expected to create further complications in the marketing and gaining the regulatory product approval for antimicrobial wound products. In September 2016, U.S. Food and Drug Administration (FDA) assembled the advisory panel to receive recommendations regarding the appropriate regulatory classification for wound dressings containing drugs.

Antimicrobial wound dressings product are historically approved to market through the 510(k) process under product code FRO as unclassified and pre-amendments devices. Moreover, there are different opinions on whether classify antimicrobial wound dressings in Class II or Class III. However, medical device manufacturers will be affected with the FDA’s decision to regulate wound dressings containing drugs, as FDA’s Class II is appropriate for antimicrobial dressings and allows manufacturers to easily demonstrate their effectiveness and safety, while upregulating to Class III will makes manufacturers to undergo strict regulatory guidelines regarding higher safety and effectiveness of antimicrobial wound dressing to gain product approval. These change in the classification, could impact market players to increase the price of antimicrobial wound dressings, and may require larger time period to launch the product in the market, limiting the future growth of antimicrobial wound dressing market over the forecast period.

Antimicrobial Wound Dressing Market Drivers

Conventional wound dressings take longer time for wound healing as compared to advanced wound dressing products such as antimicrobial and anti-infective wound dressings, which are widely used in post-operation to prevent risk of any Hospital Acquired Infections (HAIs). Antimicrobial wound dressings are rapidly replacing conventional wound dressings due to their high functional efficiency and effectiveness.

Increasing incidence of burns, trauma wounds and injuries, and diabetic ulcers are expected to drive growth of the global antimicrobial wound dressings market over the forecast period. For instance, in January 2017, according to the World Health Organization (WHO) data published in African Journal of Emergency Medicines, burn cases accounted for around 18 million disability cases and more than 2,50,000 deaths annually, out of which over 90% deaths were reported in low- and middle-income economies. The U.S. fire department responded to around 1.3 million fire incidences in 2016, out of which 3,280 civilian deaths and 15,700 civilian injuries were reported by National Fire Protection Association (NFPA).

Chronic wounds have a significant impact on the health and quality of life and their families, causing pain, emotional stress, restriction of daily activities and stress, depression, distress, and anxiety, with prolonged hospital stay, and chronic morbidity. For instance, according to the data published by Agency for Healthcare Research & Quality (AHRQ), in October 2014, over 2.5 million individuals in the U.S. develop pressure ulcers annually, which costs the U.S. health care system around US$ 9.1 billion to US$ 11.6 billion annually.

Furthermore, increasing adoption of antimicrobial wound dressings for providing antimicrobial protection in chronic and acute wound treatment is expected to boost the antimicrobial wound dressing market size. According to the data published in the Journal of Arthroplasty in June 2014, Aquacel surgical dressings from ConvaTec Inc. significantly reduced the rate of acute periprosthetic joint infection (PJI), following total joint arthroplasty.