Rising prevalence of bacterial vaginosis, and the increased focus on developing novel and targeted therapies are contributing to the growing bacterial vaginosis drug market size. However, the high recurrence rate and treatment adherence challenges hampers the bacterial vaginosis drug market growth. Further, rising inclination toward microbiome therapies and probiotics are expected to bring in new bacterial vaginosis drug market trends in the coming years.
Rising Prevalence of Bacterial Vaginosis to Bring New Trends in Bacterial Vaginosis Drug Market During Forecast Period
Bacterial vaginosis (BV) is a common condition experienced by women of childbearing age, which is generally caused by changes in the normal bacterial flora of the vagina. BV is characterized by a decrease in Lactobacillus species and increase in anaerobic bacteria such as Urea plasma urealyticum, Gardnerella vaginalis, Mobiluncus species, Mycoplasma hominis, and Prevotella species. Activities such as unprotected sexual intercourse and frequent douching further increase the risk of BV. Common symptoms of the condition include abnormal vaginal discharge, odor, and itching. According to the European Journal of Obstetrics & Gynecology and Reproductive Biology article published in ScienceDirect Journal in 2023, the global prevalence of BV ranges from 23% to 29%, and in pregnant women, it ranges from 11% to 49%. According to a report by Medscape in 2024, approximately one-third of adult women, i.e., ~22 million, in the US are affected by BV every year, and 10 million women visit clinics for vaginal discharge. BV poses risks such as preterm labor, miscarriage, and increased susceptibility to HIV and other sexually transmitted infections. The increasing incidence of BV, coupled with potential complications, encourages women to seek medical attention and pharmaceutical interventions, creating significant demand for effective drugs. The high chances of recurrence of BV lead to the development of treatment regimens to prevent relapses. As healthcare access improves globally, especially in emerging markets, a larger number of women are now seeking treatment for BV, driving the growth of the bacterial vaginosis drugs market.
Bacterial Vaginosis Drug Market Report Scope:
The geographic scope of the bacterial vaginosis drug market report covers North America (US, Canada, and Mexico), Europe (Spain, UK, Germany, France, Italy, and Rest of Europe), Asia Pacific (South Korea, China, India, Japan, Australia, and Rest of Asia Pacific), South & Central America (Brazil, Argentina, and Rest of South & Central America), and the Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa). . In terms of revenue, North America dominated the market in 2024. It is estimated to dominate the global market during the forecast period. The US is the largest market for bacterial vaginosis drugs in the world. In the US, the bacterial vaginosis drug market is experiencing significant growth due to the increasing prevalence of BV, rising awareness about women’s health, and ongoing efforts for the development of innovative treatments. BV is one of the most common vaginal infections in women, particularly affecting those of reproductive age. According to a report by Medscape in 2024, approximately one-third of adult women in the US, i.e., ~22 million females, are affected by BV annually, and 10 million women visit clinics for abnormal vaginal discharge. It is often linked to factors such as sexual activity, douching, and hormonal changes; nonetheless, there is uncertainty around the exact causes of BV. The primary therapeutic options available for treating BV include antibiotics approved by the US Food and Drug Administration (FDA), such as metronidazole and clindamycin. Metronidazole, often available in oral and topical forms, is considered the first-line treatment for BV. Clindamycin is also commonly available in both oral and topical formulations. Newer drugs and formulations, such as probiotics and phage therapy, are also emerging to help restore the natural vaginal flora, thereby reducing the recurrence of BV.
Government initiatives in the US play a key role in creating and spreading awareness about vaginosis in the population. The National Institutes of Health (NIH) funds research into the causes, treatment, and prevention of BV. The NIH’s efforts have led to a deeper understanding of the microbiome and its role in causing BV, which is crucial for developing more targeted therapies. Centers for Disease Control and Prevention (CDC) provide guidelines and recommendations to improve the diagnosis and management of BV. These initiatives help standardize care and ensure that patients receive the most effective treatment. Additionally, the National Institute of Child Health and Human Development (NICHD, a federal agency) and NIH are dedicated to understanding BV and educating women about its causes and prevention. NICHD funds and conducts research on the risks associated with BV and methods for its prevention and treatment.
Companies operating in the bacterial vaginosis drugs market constantly focus on strategic developments such as product approvals, collaborations, funding, agreements, and new product launches, which help them improve their sales, increase their geographic reach, and reinforce their capacities to cater to a greater than existing customer base. A few strategic initiatives by key players operating in the bacterial vaginosis drugs market are mentioned below.
• In November 2024, Freya Biosciences received US$ 10.4 million in strategic investment from the Bill & Melinda Gates Foundation, with US$ 1.4 million in additional financing from the current investor—Export and Investment Fund of Denmark (EIFO). The company plans to use these funds to develop microbial immunotherapies for the treatment of BV to address the risk of preterm birth along with other indications potentially affecting maternal and newborn health.
• In March 2022, Organon and Daré Bioscience, Inc. entered into an agreement whereby Organon will license global rights to XACIATO (clindamycin phosphate vaginal gel, 2%). With this, XACIATO received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US Food and Drug Administration (FDA) for the treatment of bacterial vaginosis.
• In February 2022, Lupin Pharmaceuticals Inc. received FDA approval for a supplemental New Drug Application (sNDA) to increase the use of SOLOSEC (secnidazole) for the treatment of BV among female patients aged 12 or older; the approval also entailed the treatment of trichomoniasis among patients from the said age group.
• In December 2021, the FDA approved XACIATO (clindamycin phosphate vaginal gel, 2%) manufactured by Daré Bioscience, Inc. for the treatment of bacterial vaginosis in females of age 12 years or more.
• In February 2021, Rebiotix (Ferring) and MyBiotics collaborated to develop live microbiome-based therapeutics for applications in reproductive medicine and maternal health. This collaboration aims to create live microbiota-based biotherapeutics for bacterial vaginosis among women of childbearing age, which may be associated with the increased risk of miscarriage and complications in pregnancy and fertility.
Therefore, ongoing funding, product launches and approvals, and collaborations are expected to create ample opportunities for the growth of the bacterial vaginosis drugs market in the coming years.
The bacterial vaginosis drug market analysis has been carried out by considering the following segments: type, route of administration, dosage form, and distribution channel, and geography.
• Based on type, the bacterial vaginosis drug market is segmented into prescription drugs and over-the-counter drugs. The prescription drugs segment held a larger share of the market in 2024.
• In terms of route of administration, the bacterial vaginosis drug market is categorized into oral, vaginal, and topical. The oral segment dominated the market in 2024.
• In terms of dosage form, the bacterial vaginosis drug market is categorized into pills, creams, gels, solutions/washes, and others. The pills segment dominated the market in 2024.
• In terms of distribution channel, the bacterial vaginosis drug market is categorized into hospital pharmacies, online pharmacies, and retail pharmacies. The hospital pharmacies segment dominated the market in 2024.
Bacterial Vaginosis Drug Market: Competitive Landscape and Key Developments
Bayer AG, Pfizer Inc, Sanofi SA, Starpharma Holdings Limited, Viatris Inc, Glenmark Pharmaceuticals Ltd, Lupin Ltd, Sun Pharmaceutical Industries Ltd, Organon & Co, Duchesnay Inc., Canada are among the prominent players profiled in the bacterial vaginosis drug market report. In addition, several other players have been studied and analyzed during the study to get a holistic view of the market and its ecosystem. These companies focus on geographic expansions and new product launches to meet the increasing demand from consumers worldwide and diversify their product range in specialty portfolios. Their global presence allows them to serve a large customer base, subsequently facilitating market expansion.