Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Rectovaginal Fistula Market size was USD 800 million in 2024 and is estimated to reach USD 1.6 billion by the end of 2037, expanding at a CAGR of 5.8% during the forecast period, i.e., 2025-2037. In 2025, the industry size of rectovaginal fistula is assessed at USD 850 million.
The rectovaginal fistula market is witnessing steadfast growth due to the increasing prevalence of Crohn’s disease. Crohn's disease and, less frequently, ulcerative colitis are the second most frequent causes of rectovaginal fistulas. The tissues lining the digestive tract enlarge and become irritated due to these inflammatory bowel disorders (IBD). According to the National Institutes of Health (NIH), 4.9 million cases of IBD were reported worldwide in 2019. Although having Crohn's disease increases a patient’s risk of developing a rectovaginal fistula, most people with the condition never experience one.
A rare but debilitating indication of Crohn's disease (CD), rectal fistula (RVF) causes severe morbidity and social shame for women who experience it. It is caused by a major anorectal inflammatory process that is severe enough to erode the vaginal wall, generally near the introitus. With 10% of women with CD experiencing RVF, CD is the second most common cause of RVF after obstetrical trauma.
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Rectovaginal Fistula Sector: Growth Drivers and Challenges
Growth Drivers
- Increasing delivery injuries: One of the most frequent causes of recto-vaginal fistulas is injuries sustained during delivery. This includes an episiotomy infection, which is a surgical incision made to expand the perineum during vaginal delivery, or a perineum tear that spreads to the colon. These might happen after a protracted, challenging, or otherwise challenging labor. These fistulas may also involve damage to the anal sphincter, which is a muscle ring at the end of the rectum that helps with holding.
Therefore, the incidence rate of recto-vaginal fistula is expected to rise as a result of an increase in the prevalence of birth injuries. NIH reported that the prevalence of maternal damage with any type of perineal trauma after vaginal delivery ranges from 16.2% to 90.4% globally. Both the incidence of cervical lacerations and the frequency of obstetric anal sphincter injuries are rising rapidly. - Growing prevalence of radiation-induced RVF: The main cause of rectovaginal fistula formation is thought to be pelvic irradiation. All skin layers, as well as the epidermis, dermis, subcutaneous tissue, and arteries, are affected by late radiation-induced skin damage. Vascular sclerosis causes arteriole constriction or obliteration in small arteries, which in turn causes persistent ischemia and inadequate tissue perfusion. Dense, inelastic fibrotic tissue progressively replaces the irradiated dermis and subcutaneous tissues. The patient may get proctitis, anterior rectal wall ulceration, and fistula after radiation therapy.
Therefore, the growing prevalence of cancerous tumors in regions, such as the uterus, rectum, vagina, anal canal, or cervix, led to the development of recto-vaginal fistula. For instance, according to the World Health Organization, with almost 660,000 new cases in 2022, cervical cancer ranks as the fourth most frequent malignancy in women worldwide. Approximately 94% of the 350,000 cervical cancer-related fatalities that year happened in low- and middle-income nations. Moreover, radiation therapy undertaken to treat cancer in these body parts increases the risk of the development of recto-vaginal fistulas. - Advancements in treatment methods: One of the most significant developments in surgery over the past few decades has been using minimally invasive methods, which will likely continue to be popular. To prevent tissue incision, sphincter injury, and intraoperative bleeding, endoscopic clipping is a minimally invasive procedure that entails the transrectal implantation of endo-clips for RVF closure. It is appropriate for minor fistulas and even suggested for high-level fistula repair.
Moreover, advances in tissue engineering and regenerative medicine have led to the development of biomaterials and grafts that can be used to repair and reconstruct damaged tissues. Furthermore, newer surgical approaches, such as the Martius flap procedure and the gracilis muscle interposition, have shown promising results in repairing complex fistulas.
Challenges
- Lack of awareness and social stigma: The most prevalent causes of RVF are trauma from sexual abuse or iatrogenic surgical injuries, female genital mutilation, and obstetric difficulties such as protracted labor or perineal tears. Debilitating health symptoms, social isolation, economic disempowerment, psychological trauma, low self-esteem, and a lack of role fulfillment are all experienced by women who have this illness. One of the biggest obstacles to prompt, safe obstetric care and the treatment of follow-up issues like RVF is a lack of easily available, high-quality, and efficient healthcare. Women are also at risk of developing fistulas due to social, cultural, financial, and systemic hurdles, which often cause delays in seeking and obtaining care. Also, there is a lack of awareness of the condition due to its rarity, impeding the growth of the rectovaginal fistula market.
- High costs of the treatment: Treatment for rectovaginal fistula can be expensive, especially for those without insurance or access to reasonably priced health care. Many patients may require multiple surgeries, which can increase the overall cost of the treatment. Also, the cost of pre and post-operative care, including medications and follow-up appointments may hamper the expansion of the rectovaginal fistula market.
Rectovaginal Fistula Market: Key Insights
Base Year |
2024 |
Forecast Year |
2025-2037 |
CAGR |
5.8% |
Base Year Market Size (2024) |
USD 800 million |
Forecast Year Market Size (2037) |
USD 1.6 billion |
Regional Scope |
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Rectovaginal Fistula Segmentation
Type (High Rectovaginal Fistula, Low Rectovaginal Fistula, Midzone Fistula)
In rectovaginal fistula market, high rectovaginal fistula segment is set to capture revenue share of over 46.7% by 2037. The segment growth can be attributed to the growing prevalence of childbirth injuries, particularly in developing nations. A rectovaginal fistula is classified as high or complex if it exceeds 2.5 cm, is elevated, or arises from inflammatory bowel disease. Additionally, recurrent fistulas, which are often associated with tissue scarring and diminished blood supply, also fall into this category. To enhance the chances of a successful repair, it is crucial to remove any diseased tissue and replace it with healthy, well-vascularized tissue. Addressing high fistulas requires more intricate surgical techniques to ensure effective healing.
Moreover, the increasing geriatric population and associated comorbidities, such as diabetes and obesity, contribute to the development of high recto-vaginal fistula. For instance, WHO reported that in 2022, over half (59%) of persons with diabetes who were 30 years of age or older did not take any medication for their condition.
Treatment (Medication, Surgery)
The surgery segment in rectovaginal fistula market will garner a notable share in the forecast period. The segment growth can be attributed to the higher success rate and ability to provide a permanent solution. Most of the time, rectovaginal fistulas require surgery to seal or repair. The skin and surrounding tissue of the fistula should be clear of inflammation and infection before surgery. A gynecological surgeon, a colorectal surgeon, or a combination of the two may perform surgery to seal a fistula. Non-surgical treatments such as fibrin glue and seton placement, may be effective in some cases because they have a lower success rate and require repeated procedures.
Our in-depth analysis of the global rectovaginal fistula market includes the following segments:
Type |
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End use |
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Indication |
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Treatment |
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Customize this ReportRectovaginal Fistula Industry - Regional Synopsis
North America Market Statistics
In rectovaginal fistula market, North America region is expected to capture over 32.8% revenue share by 2037. The market growth can be attributed to the well-established and high-quality healthcare infrastructure in the region. Moreover, favorable regulatory policies, growing research and development activities, and government funding for life sciences are some of the major factors contributing to the growth of the rectovaginal fistula market.
Moreover, the growing cases of inflammatory bowel diseases in the U.S. such as Crohn’s disease and ulcerative colitis, are accelerating the market growth. According to the U.S. Centers for Disease Control and Prevention, the prevalence of inflammatory bowel disease (IBD) varies by group and is estimated to be between 2.4 and 3.1 million in the U.S. Also, advancements in surgical techniques and the availability of specialized treatment centers are driving the rectovaginal fistula market growth.
Canada’s publicly funded healthcare system also ensures that patients have access to necessary treatments, leading to an increased demand for rectovaginal fistula repair services. For instance, the healthcare system in Canada, known as Medicare, is a collection of provincial and territorial health insurance programs subject to national criteria rather than being a national system in and of itself. This reflects the decentralization of Canadian politics. All eligible Canadians are covered by these tax-based, publicly funded, universal programs, free at the point of care for basic hospital and medical services. Furthermore, the country’s high rate of obstetric injuries is also escalating the growth of the rectovaginal fistula market in the country.
Europe Market Analysis
Europe rectovaginal fistula market will grow significantly in the forecast period. Strong academic and research foundations as well as the availability of research funding in European nations are responsible for the rectovaginal fistula market expansion in this region. Moreover, The European Crohn’s and Colitis Organization’s awareness campaigns and advocacy efforts are driving the growth of the rectovaginal fistula market. By educating patients, healthcare providers, and policymakers about inflammatory bowel diseases (IBD) and their complications, such as rectovaginal fistulas, the organization is helping to reduce stigma, improve diagnosis rates, and increase access to effective treatments.
Furthermore, recent advances in surgical techniques in the UK are gaining momentum worldwide. Researchers in the country are striving to provide a permanent repair for complex rectovaginal fistulas, driving rectovaginal fistula market growth. In 2021, the Royal College of Surgeons of England highlighted the combined transabdominal–transanal technique as a safe alternative to laparoscopic complete mesorectal excision (TME) for mid and low-rectal cancer. This innovative approach provides improved visualization of the surgical planes and margins. The transanal technique allows surgeons to better evaluate the cutting edges, clearly see the plane of the rectal vaginal fistula, and avoid excessive intestinal resection. Moreover, it effectively addresses the challenges posed by the fatty mesorectum, large tumors, and the anatomical constraints of the pelvic bones.
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Companies Dominating the Rectovaginal Fistula Landscape
- Pfizer, Inc.
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- GlaxoSmithKline plc
- Sanofi S.A.
- Johnson & Johnson Services, Inc.
- W.L. Gore & Associates, Inc.
- Mount Sinai Hospital
- St. Mark’s Hospital
- Apollo Hospitals Enterprise Ltd.
- AbbVie Inc
- Bayer AG
The rectovaginal fistula market is well known for its creative strategy, which combines cutting-edge technology with conventional knowledge. Through innovative research, strategic alliances, and ongoing treatment development, the leading businesses control both domestic and foreign markets. Leading manufacturers implement customer needs and changing trends while maintaining regulatory compliance. They frequently keep their competitive edge by making significant R&D investments.
In the News
- In October 2023, Pfizer Inc. received FDA approval for VELSIPITY (etrasimod), a once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for individuals with moderately to severely active ulcerative colitis. The approved recommended dose of VELSIPITY is 2 mg.
- In October 2023, Sanofi and Teva Pharmaceuticals, a United States subsidiary of Teva Pharmaceutical Industries Ltd., announced a collaboration to co-develop and co-commercialize asset TEV'574, which is currently in Phase 2b clinical trials for the treatment of Ulcerative Colitis and Crohn's Disease, two types of inflammatory bowel diseases.
Author Credits: Radhika Pawar
- Report ID: 6946
- Published Date: Jan 08, 2025
- Report Format: PDF, PPT