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Palo Alto, CA, United States, 2007/10/15 - New analysis from Frost & Sullivan, U.S. Market for Hemostats & Tissue Sealants, finds that market earned revenues of $485.8 million in 2006 and estimates this to reach $1,031.2 million in 2013.
The desire to improve the effectiveness of surgery, reduce complications, lessen operating room time and increase the feasibility of minimally invasive surgery are likely to drive growth in the U.S. topical hemostats and tissue sealants market during the forecast period.
New analysis from Frost & Sullivan (medicaldevices.frost.com), U.S. Market for Hemostats & Tissue Sealants, finds that market earned revenues of $485.8 million in 2006 and estimates this to reach $1,031.2 million in 2013.
If you are interested in a virtual brochure, which provides manufacturers, end users, and other industry participants an overview of the latest analysis of the U.S. Market for Hemostats & Tissue Sealants, then send an email to Melina Trevino - Corporate Communications at melina.trevino[.]frost.com with the following information: your full name, company name, title, telephone number, email address, city, state, and country. We will send you the information via email upon receipt of the above information.
The shared advantages of some of these products could enable them to be used interchangeably, creating complex issues such as overlaps in product application and positioning.
"This overlap is mainly due to aggressive marketing by suppliers and surgeons' lack of understanding product differentiation and past product experience," explains Frost & Sullivan Research Analyst Sheila Ewing. "Despite the high chances of increased competition, the overlap can be viewed as an opportunity to expand."
However, the prospects of market expansion can be hindered by the stiff regulatory rules imposed by the Food and Drug Administration (FDA). The FDA not only regulates the development of tissue sealants and hemostats, but also its production and sales in the United States.
As most of these products fall under Class III devices, they are required to undergo extensive clinical testing. This long-drawn process involves submission of documentation, engineering, and pre-clinical testing on new products.
Although the FDA has made an effort to streamline portions of its approval process, the lack of standardization of clinical data required for testing by product segment only delays the process further. Such rigid standards not only delay the approval process, but also hold up the certification process by years, depending on the type of product.
These holdups discourage market entrants and also pose a significant hindrance to existing competitors, as manufacturers lose the opportunity to actively promote their products.
"Companies need to understand that the changing business environment demands continuous financial commitment and sustenance capabilities, due to the tedious research, development, and lengthy approval processes," says Ewing. "They must consider strategic mergers and alliances that can assist with balancing costs associated with the approval process to stay competitive."
U.S. Market for Hemostats & Tissue Sealants is part of the Medical Devices Growth Partnership Service program, which also includes research in the following markets: Advanced Wound Dressings including Moist, Antimicrobial and Interactive Wound Dressings. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Interviews with the press are available.
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