Do these questions keep you up at night: What does the future of the vein market look like? How will it impact my practice? What challenges and risks will we face in the years to come? Where is there opportunity for growth? I’m sure these are just some of questions you ask yourself each year as you plan for the future in your practice. Here are a few highlights to consider from a recent Millennium Research Group report on the U.S. varicose vein market published in March 2013. These insights came from a diverse phlebology field ranging from vascular surgeons, interventional radiologists, dermatologists
and phlebologists across the United States.
• The U.S. varicose vein market was estimated to reach $200 million in 2014 with steady growth to reach $250 million by 2018 (page 43).
• The overall market will continue to expand despite failing reimbursement and endovenous ablations that slow procedure and market growth.
• Phlebectomy will grow in procedures in the first half of the 2011-2021 forecast period, giving way to increasing competition from foam sclerotherapy with the introduction of BTG’s Varithena®.
• Despite widespread use, compounding pharmacies are starting to lose ground in part to the negative press they received due to the meningitis outbreak in northeastern United States in October 2012.
• The sclerotherapy market will benefit from a shift away from compounding pharmacies toward FDA-approved sclerosants.
Exposure for the Vein Industry
The good news is that public awareness and comfort of varicose and spider vein treatments are growing thanks to popular TV programs and increasing number of vein centers opening to meet demand. The total sclerotherapy agent market is expected to grow to $30 million by end of 2015, fueled by the declining compounding market, Varithena launch and an increase in the number of procedures.
Branded, FDA-approved sclerosing agents compete mainly with compounding pharmacies based on price, but safety/efficacy/overall value continues to be an important topic discussed across the industry from both a legal and risk perspective.
The need for FDA testing
According to Kenneth J. McKenna, Esq. , “The simple fact that compounded products have not been subjected to FDA testing to determine safety and effectiveness places those physicians who chose to use these products at significant risk of legal liability in the event of an adverse outcome (Vein Magazine, Winter 2008, page 13)." Since this article, further studies have been published that bring into question the accuracy and efficacy of compounded solutions.
A 2011 study by Weiss, Voigts, Howell published in Dermatologic Surgery states that the compounded solutions did not deliver the claimed concentration five of six times and the gas chromatography mass spectrometry (GC/MS) analysis showed impurities in all six compounded solutions. In October 2012, compounding pharmacies received negative press due to a meningitis outbreak in northeastern part of the United States. The outbreak was traced to an anesthetic being sold by a compounding pharmacy in New England (Newsweek, “The Killer Pharmacy: Inside a Medical Mass Murder Case,” April 24, 2015).
This incident renewed discussions of increasing regulations surrounding compounded drugs and promoted greater awareness of the risks physicians assume when using products from these pharmacies.
Creating stronger, more sustainable vein industry growth
In light of the expected industry growth and issues facing the vein industry, Merz has begun to increase its collaboration with key opinion leaders and industry partners such as the American College of Phlebology and the American Venous Forum in hopes to make an even more meaningful impact on health care providers in the venous disease space.
According to Skip Allen, Associate Director Merz Portfolio Solutions, ASCLERA®, one of the most exciting new developments in the year ahead is Merz’s enhanced focus on education, teaching institutions and residency programs that span the multi-disciplinary field of phlebology. Merz has a long and successful heritage in aesthetics and with the acquisitions of NeoCutis skin care line and energy-based Ultherapy® from Ulthera, we are building an aesthetic portfolio with a wide range of treatment options that will allow physicians across the vein industry to utilize FDA-approved Merz technologies to treat a broader range of patients to help navigate this ever changing market in the years to come.
For all of us working in the Vein industry, the future, while not totally devoid of challenges and risk, is certainly bright and is full of opportunities for practice growth, and that should help all of us sleep well at night.
Jim Hartman is Vice President of Merz Aesthetics, a division of Merz North America. Merz North America, Inc. is a specialty healthcare company that develops and commercializes innovative treatment solutions in aesthetics, dermatology and neurosciences. The company is based in Raleigh, North Carolina.
