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.

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.

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.

Market Segmentation

The global anal fistula therapeutics market is classified based on treatment, application, and end-user. Based on treatment, the market is classified into surgical and non-surgical. Based on application, the market is classified into intersphincteric fistula, transsphincteric fistula, suprasphincteric fistula, and others. Based on end-user, the market is classified into hospitals, ambulatory surgical centers, and others. 

Hospitals Contribute for a Significant Share in the End-User Segment

In 2019, hospitals held the major share in the market owing to the rising number of multi-specialty hospitals and significant presence of skilled healthcare professionals in hospitals. Increasing medical tourism is further leading the demand for anal fistula therapeutics in hospitals. The major hospitals that are gaining the attention of medical tourists include Asklepios Kliniken GmbH (Germany), Clemenceau Medical Center (CMC) (Middle East), Fortis Hospital (India), and Raffles Hospital (Singapore). A significant number of private hospitals in Singapore, especially those hospitals who offer high standards of care and involved in medical tourism, only treat international patients covered by a health insurance plan. Owing to the high quality of healthcare service, Singapore hospitals are gaining huge importance in medical tourism for the treatment of multiple diseases. This, in turn, is contributing to the largest share of hospitals for anal fistula therapeutics.

Global Anal Fistula Therapeutics Market Share by End-User, 2019 (%)

Regional Outlook

Geographically, in 2019, North America is expected to hold the largest share in the market owing to the rising prevalence of IBD and better healthcare coverage in the region. Significant awareness regarding health problems is also a major cause for the rising number of patients receiving treatment for anal fistula in the region. Asia-Pacific is estimated to witness potential growth during the forecast period owing to the rising medical tourism and improving healthcare infrastructure in the region. Emerging adoption of minimally invasive procedures is expected to offer an opportunity for market growth in the region. 

Global Anal Fistula Therapeutics Market Growth, by Region 2020-2026

Market Players Outlook 

The major players in the market include Medtronic plc, Karl Storz SE & Co. KG, Cook Group Inc., Takeda Pharmaceutical Co. Ltd., and Signum Surgical Ltd. Product launches, partnerships and collaborations, and mergers and acquisitions are considered as crucial strategies adopted by the market players to expand market share and gain a competitive advantage. For instance, in March 2018, TiGenix NV and Takeda Pharmaceutical Co. Ltd. declared that the European Commission (EC) has approved Alofisel (darvadstrocel), to treat complex perianal fistulas in adult patients suffering from nonactive/mildly active luminal Crohn’s disease, when fistulas have shown an insufficient response to at least one traditional or biologic therapy. It is the first allogeneic stem cell therapy that received central marketing authorization approval in Europe.

The Report Covers

• Market value data analysis of 2019 and forecast to 2026.
• Annualized market revenues ($ million) for each market segment.
• Country-wise analysis of major geographical regions.
• Key companies operating in the global anal fistula therapeutics market. Based on the availability of data, information related to pipeline products, and relevant news is also available in the report.
• Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
• Analysis of market-entry and market expansion strategies.
• Competitive strategies by identifying ‘who-stands-where’ in the market.