Bacterial Vaginosis (BV) Market
Bacterial vaginosis (BV) is a type of vaginal inflammation caused by the overgrowth of bacteria naturally found in the vagina, which upsets the natural balance. Women in their reproductive years are most likely to get bacterial vaginosis, but it can affect women of any age. Bacterial vaginosis is characterized by the presence of three of the following four criteria:1
- Vaginal pH of >4.5
- Clue cells on saline wet mount
- Release of a fish amine odor
- A characteristic thin, homogenous vaginal discharge
The Nugent score is calculated by assessing for the presence of large gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small gram-variable rods (G. vaginalis morphotypes; scored as 0 to 4), and curved gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) and can range from 0 to 10. A score of 7 to 10 is consistent with BV.2
Throughout the world, BV is the most common vaginal infection. For example, in the United States, an estimated 21 million women aged 14-49 years (approximately 29%) are infected with BV.3 Bacterial vaginosis is not considered to be a sexually transmitted infection, but it is more common in women who are sexually active.3
The majority of BV cases are asymptomatic and are untreated or undertreated. However, a very high proportion of women that are (or become) symptomatic proactively seek Rx and OTC treatments for symptom relief and resolution.4 The current market for the management of BV and associated symptoms is estimated to be in excess of US$150 million in the U.S., with significant areas of unmet need for BV sufferers.5
1Mayo Clinic: https://www.mayoclinic.org/diseases-conditions/bacterial-vaginosis/symptoms-causes/syc-2035227
2Principles and practice of infectious diseases: Bennett, John (2015). Mandell, Douglas, and Bennett's principles and practice of infectious diseases. Philadelphia, PA: Elsevier/Saunders. ISBN 9781455748013; Access provided by the University of Pittsburgh
4Prevalence of Bacterial Vaginosis and Its Association with Risk Factors among Nonpregnant Women: A Hospital Based Study. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5859802/
DARE-BV1 (formerly MP-101)
- Utilizes a proprietary drug delivery platform to deliver 2% clindamycin intravaginally. Designed for efficacy following single administration based on dual release sustained-erosion of clindamycin. Efficacy endpoint met in a proof of principle study: 88% of patients met clinical cure endpoint at Test-of-Cure visit. A 505(b)(2) regulatory pathway enables a concise clinical development plan. A single, successful pivotal study with adequate power and size is expected to be sufficient for marketing approval in the U.S.
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The Global Contraceptive Market
The global market for contraception was over $19 billion in 2015, and is estimated to grow over 6% to $33 billion in 2023 according to a research report by Global Market Insights, Inc. released in February of 2017.
Current contraception options include both long-acting and short-acting varieties, and within these categories are hormonal and non-hormonal options. There is no single form of contraceptive protection that meets the varied needs of all women. In fact, a woman’s preference may change multiple times during the course of her reproductive life based on her circumstances and health status. Hence, development efforts for new contraceptive methods must seek to expand the array of choices to address the differing needs and preferences of as many women as possible.
Two categories of contraceptive options:
Long-acting: Tubal ligation and fallopian tube inserts (permanent sterilization); copper and hormonal intrauterine devices (3-10 years); hormonal implants (3 years).
Short-acting: Non-hormonal condoms, diaphragms, caps, and spermicides used at the time of intercourse; hormonal pills taken daily; hormonal patch worn weekly; intravaginal hormonal ring used monthly.
The attractiveness of long-acting options is that they provide contraceptive protection for multiple years with no intervention on the part of the woman. Intrauterine devices and hormonal implants require a health care provider to both place and remove the device. Because these devices remain in the body and there is no intervention required, these methods have the highest level of contraceptive effectiveness. The attractiveness of short-acting options is that they provide contraceptive protection, but are woman-initiated (so the woman herself can start or stop using the method on demand) and are therefore quickly reversible. In the United States alone, approximately 40 million women are using some form of contraception, and about half of them are using a short-acting, reversible method (www.fda.gov/birthcontrol).
Hormone-based contraceptives remain the most widely embraced short-acting option because of their high rates of effectiveness. However, many women do not tolerate hormones well and experience breast tenderness, bloating, mood swings or other side effects. In other cases, the use of hormone-based contraceptives is contraindicated given health issues. A high body mass index can reduce the effectiveness of hormonal contraception. Some women want to take a break from hormone-based contraceptives. Pill users may find taking a pill every day to be inconvenient and make compliance difficult. And, some women simply want to take a break from hormone-based contraceptives and therefore seek alternative forms of birth control.
Since the early 1960s when oral contraceptive pills and intrauterine devices were first introduced in the United States, many new hormonal contraceptive products have become available including implants, injections, vaginal rings, patches, and hormonal intrauterine systems, as well as non-hormonal methods such as female condoms, new designs of male condoms, spermicides, novel diaphragms, and new methods of female sterilization. Numerous examples exist of successful commercial contraceptive brands including the hormonal vaginal ring, NuvaRing®, from Merck ($777 million in revenue in 2016) and the hormonal intrauterine system, Mirena®, a family of products from Bayer ($1.13 billion in revenue in 2016). Despite numerous product advances over many years, today’s contraceptive method mix still has some gaps.
A gap in the product mix
Development efforts for new contraceptive methods must seek to expand the array of choices to address the differing needs and preferences of as many women as possible.
At Daré, we believe there is a need to improve both convenience and efficacy outcomes of short-acting, non-hormonal options. Market research has shown that most women would prefer a contraceptive method they don’t need to remember to take every day and that does not require action at the time of intercourse. Specifically:
An estimated 67% of women said that a monthly vaginal ring has most of the features they deemed extremely important.
- 85% would prefer a monthly option with a lower hormone dose than the pill.
- An estimated 80% of women currently use a non-coital dependent method.
Non-hormonal options available in the short acting category include condoms, diaphragms, and spermicides, all of which require action at the time of intercourse, and the most commonly used non-hormonal methods, the condom and spermicides, have lower levels of effectiveness than diaphragms or hormones.
Thus, there are two gaps in the short-acting non-hormonal method mix that need to be addressed:
Convenience: a short-acting, non-hormonal method that does not require intervention at the time of intercourse, and
Effectiveness: a non-hormonal method with contraceptive effectiveness approaching the levels of short acting hormonal methods in “typical use” (such as the pill, patch, or vaginal ring).
Thus, while the perfect use effectiveness of short-acting hormonal methods, such as oral contraceptives, is 99%, “typical use” effectiveness is 91%. The most commonly used non-hormonal method, the condom, has “typical use” effectiveness of only 82%. Diaphragms have typical use effectiveness of 88%, in the same range as short acting hormonal methods, but are not widely used due to the lack of convenience and availability.
Therefore, we believe a convenient short-acting, non-hormonal method with “typical use” effectiveness of 88% - 91% would be an attractive new option for women, and has the potential to capture market share across the broad spectrum of short-acting methods.
Female Sexual Arousal Disorder (FSAD) Market
Female sexual arousal disorder (FSAD) is characterized primarily by an inability to attain or maintain sufficient physical sexual arousal that causes distress or interpersonal difficulty.1
As many as thirty-three percent of women in the U.S. (21 to 60 years old) experience symptoms of low or no sexual arousal.2 Up to an estimated ten million women in the U.S. are affected and/or distressed by this condition and seek a solution to improve their condition.3
Currently, there are no approved products in the U.S. that specifically address the symptoms or underlying pathology of FSAD.
1Human Sexuality and Its Problems (Third Edition), 2009
2Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for SST LLC.
316% of women are distressed per Ad Hoc Market Research: FSAD Prevalence Report (Oct 2015) conducted for SST LLC. Based on US Census projections for 2016 this equates to 10 million women.