The global anal fistula therapeutics market is estimated to grow at a CAGR of nearly 4.0% during the forecast period. Rising incidences of inflammatory bowel disease (IBD) is the major factor encouraging the demand for anal fistula therapeutics. As per the Centers for Disease Control and Prevention (CDC), in 2015, nearly 1.3% of the US adults (3 million) were reported being diagnosed with IBD (either ulcerative colitis or Crohn’s disease). This was a substantial increase from 1999 (0.9% or 2 million adults). As many as 70,000 new incidences of IBD are diagnosed in the US annually. IBD is the major risk factor of developing anal fistula.
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There is a possibility of developing fistulas when an organ becomes injured or inflamed, which is a common complication of IBD, occurs more often in Crohn’s disease compared to ulcerative colitis. 35% of the patients with Crohn's disease develop at least one fistula episode over the course of the condition. Fistula is most commonly located around the anus that is referred to as perianal fistulas. More than half of fistulas form in this location. Fistulas can also form in the perianal region or digestive tract after traumatic injury, surgery, or radiation therapy for cancer. Some conditions and infections can cause fistulas, including sexually transmitted disease and diverticulitis.
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Fistulas treatment includes medication, surgery and other non-surgical treatments, such as fibrin glue and stem cell therapy. Surgery can be risky; therefore, most health care providers firstly tries to treat perianal fistula with medication. However, several patients with perianal fistulas ultimately require surgery. Many surgical procedures are used to treat anal fistula, which includes fistulotomy, seton techniques, ligation of the intersphincteric fistula tract (LIFT) procedure, and endoscopic ablation. Fistulotomy is the most common and effective form of surgery for several anal fistulas, which involves cutting along the total length of the fistula for opening it up that allows its healing as a flat scar.
Medtronic plc, Signum Surgical Ltd., and Karl Storz SE & Co. KG is the major companies offering medical devices for anal fistula procedures. Signum Surgical developed the BioHealx device, which is an intuitive single-use technology which improves upon current advanced devices and surgical procedures to fulfill all identified essential clinical requirements for reliable healing of heal anal fistulas. In April 2019, Signum Surgical received funding of $4 million through two grant funding awards, which include $2.6 million from the EU Horizon 2020 SME (Small and Medium Enterprise) Instrument, and $1.4 million from Ireland’s Disruptive Technologies Innovation Fund (DTIF). These grants will enable clinical and regulatory programs engaged in the commercialization of the BioHealx device.
Global Anal Fistula Therapeutics Market Segmentation
Global Anal Fistula Therapeutics Market by Treatment
• Surgical
• Non-Surgical
Global Anal Fistula Therapeutics Market by Application
• Intersphincteric Fistula
• Transsphincteric Fistula
• Suprasphincteric Fistula
• Others
Global Anal Fistula Therapeutics Market by End-User
• Hospitals
• Ambulatory Surgical Centers
• Others
Global Anal Fistula Therapeutics Market – Segment by Region
North America
• United States
• Canada
Europe
• Germany
• United Kingdom
• France
• Spain
• Italy
• Rest of Europe
Asia-Pacific
• China
• Japan
• India
• Rest of Asia-Pacific
Rest of the World
• Latin America
• Middle East and Africa
Company Profiles
• Medtronic plc
• Cook Group Inc.
• Takeda Pharmaceutical Co. Ltd.
• Karl Storz SE & Co. KG
• Biolitec AG
• Pfizer Inc.
• Becton, Dickinson and Co.
• GEM S.r.l.
• TiGenix NV
• W. L. Gore & Associates, Inc.
• AstraZeneca plc
• Agency for Medical Innovations (A.M.I.) GmbH
• Signum Surgical Ltd.
• Novartis International AG
• Assembly Biosciences, Inc.
• Ovesco Endoscopy AG
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