A note to conscientious readers:
While I use the term “women” in this article for simplicity, I refer to all individuals with uterus and ovaries that may want to use birth control to avoid pregnancies, including some transgender men, non-binary people, intersex people or people with variations in sex characteristics.
Additionally, I will highlight innovative birth control options with the efficacy percentages presented by their manufacturers. Should you need more information on these options (for instance, indications for use), please refer to the web links. This article shall not be interpreted in any manner as a medical prescription or medical advertising.
A massive use of modern family planning…
842M women used birth control in 2019.
According to the CDC, family planning is one of the 10 great public health achievements of the 20th century. The ability of individuals to determine their family size and the timing of their children has resulted in significant improvements in health, social and economic well-being.
In 2019, 1.1 billion women of reproductive age (15-49 years) in the world had a need for family planning. Among them, 842 million were users of modern methods of contraception.
What are the most commonly used contraceptive methods among women?
The 2015–2017 National Survey of Family Growth in the U.S. assessed that among the 64.9% women aged 15-49 using contraception, the top 4 were female sterilization (18.6%), oral contraceptive pill (12.6%), long-acting reversible contraceptives (LARCs) (10.3%), and male condom (8.7%).
The availability of contraceptive methods may vary from one country to another due to local regulations. For instance “the NEXPLANON® contraceptive implant became available in May 2020 in Canada, several years after other countries following a due diligence from Health Canada” explained Dallas Barnes, Founder & CEO of Reya Health.
… but women’s contraceptive journeys remain complex
Precision medicine is needed to fit each unique lifestyle and biology.
With more than 200 hormonal and non-hormonal options, finding the right birth control can sometimes seem overwhelming, especially as each comes with potential side effects and different levels of efficacy.
“Before launching Reya Health, our market research found that 75% of Canadian persons with ovaries using birth control in the 18-35 age group described their contraceptive experience as negative. It took them on average 2 years to find the right birth control” detailed Dallas.
3 aspects may complicate the whole journey:
First, each metabolism being unique, body reactions can highly vary among women. Some women may be perfectly fine with hormonal therapies while others will encounter side effects like mood swings, weight gain or diminished libido.
Second, lifestyle implications can play an important role: one-time intervention? in-the-moment solution? daily ritual?…several test & learn phases may be needed to find the right fit.
Third, even when the right solution is found, access and affordability can remain problematic for persons living in medical deserts or with limited health coverage.
3 innovative trends filling the gaps
Facilitating birth control selection, access and non-hormonal alternatives address unmet needs.
We scanned more than 20 start-ups worldwide and decided to highlight 14 companies in North America (64%) and Europe and the UK (36%).
3 promising trends:
Trend N°1: facilitating birth control selection using AI and biological testing
3 start-ups develop AI-powered platforms for contraceptive counseling to help women navigate the numerous hormonal and non-hormonal options. Their goal is to leverage precision medicine to save them time, expenses and unwanted side effects.
Various data are collected from the individual using a questionnaire, from medical background to lifestyle preferences. Biological parameters can be added through at-home hormone tests, as is the case for the Adyn’s Birth Control Test (see picture above).
Following this assessment, a personal plan based on scientific research is provided to the individual with unique birth control recommendations.
Results can be reviewed, approved and discussed with a physician during a telehealth encounter, as offers UK-based Tuune. Upon a user’s approval, a written prescription can be sent to a pharmacy.
Once selected, Reya Health encourages users to track side effects to make sure their new contraceptive is right for their health. “For both hormonal and non-hormonal methods, we support individuals in monitoring their body and mental changes: libido, periods, skin, weight, relationships…In the traditional counseling process, there are rarely these kinds of follow-ups”.
On an epidemiologic level, these platforms could provide real-life data to identify the pragmatic needs of birth control among given populations and track side effects. This could represent interesting insights for medical prescribers and the biopharma industry.
Trend N°2: improving access and adherence to hormonal therapies
For persons living in medical deserts, lacking access to transportation or experiencing busy schedules, access to birth control might be problematic.
U.S. start-ups Favor, Pandia Health and Twentyeight deliver telehealth services that include birth control prescriptions by physicians and straight-to-door delivery. Emergency contraception is also available.
“This really made it easy to renew my prescription in a few clicks. I received my pill at home and didn’t even have to pick it up at the pharmacy” pointed out one customer on the Twentyeight website.
Once prescribed and received, adherence to contraception might be crucial to avoid unintended pregnancies. According to Emme“up to 80% of women on the pill miss at least one per month”, showing the difficulty of a perfect routine.
Along with Aavia, these two U.S. companies commercialize a smart case that tracks the pill and sends reminders until it’s taken.
Emme claims that their solution “reduces missed pills by 80%”. Individuals can also track pill-related symptoms in the app to discuss them with their physician.
This innovation could be particularly interesting for younger women who are new to daily hormonal intake.
Trend N°3: developing non-hormonal alternatives
Non-hormonal options may appeal to different patients:
Some women may not be able to use hormonal therapies for medical and / or lifestyle reasons
Others might wish to stop during specific phases of their lives: pregnancy planning, child breastfeeding…
Last, some individuals are just trending in favor of more natural solutions as part of the organic movement
2 types of non-hormonal innovations caught our attention in this market study:
On-demand vaginal gels
Digital contraceptives
Shall you need more information on their indication of use, please refer to the web links. It is important to note that none of these innovations protect against STDs (sexually transmitted diseases), which rates have been increasing in the last years.
On-demand vaginal gels:
For persons looking for non-hormonal, in-the-moment solutions beyond condoms, two biopharmaceutical companies are developing vaginal gels that could (one day) be available in Europe:
Evofem Biosciences launched FDA-approved Phexxi® in 2020 in the U.S.
This prescription contraceptive vaginal gel can be applied “0-60 minutes before each act of intercourse” and works to “keep vaginal pH in the baseline range of 3.5 to 4.5 which reduces sperm mobility, lowering the chance of sperm reaching the egg”.
According to Evofem, Phexxi® is 86% effective with typical use (vs 93% for the contraceptive pill and 87% for the male condom based on the World Health Organization data).
As a new player in the biopharma scene, one difficulty might be to get the word to medical prescribers. How do you reach thousands of obstetricians and gynecologists in the U.S.?
What I found really interesting with Evofem is their go-to-market strategy. Not only did they hire “more than 70 sales representatives to prospect OBGYNs” according to their CEO Saundra Pelletier. They also created “an education platform for doctors” to present Phexxi®. Lastly, their telehealth platform makes it easy for patients to check their eligibility with a physician, access prescriptions and receive at-home deliveries.
“More than 55,000 women made the Phexxi choice in 2021 and our refill rate continues to rise” announced the company in January 2022. Out of the estimated 47 million women using contraception in the U.S., it will be interesting to check how their market share evolves.
Copenhagen-based Cirqle Biomedical is currently developing OUI, a vaginal gel that releases small biopolymers reinforcing the barrier properties of the cervical mucus.
The cervical mucus is then made impenetrable for sperm, which prevents sperm cells from traveling through the cervix and fertilizing an egg.
Digital contraceptives:
European start-ups Natural Cycles (Sweden) and Clue (Germany) received FDA clearance for over-the-counter digital birth control in the U.S.
As fertility awareness methods, they predict “high risk days” (Clue) or “fertile days” (Natural Cycles) when users could become pregnant if they don’t use barrier methods or abstinence. The collection of patient’s biometric data, algorithm and indications of use vary between the two apps. With typical use, Natural Cycles and Clue Birth Control respectively claim to be 93% and 92% effective at preventing pregnancy.
Interestingly enough, these 2 applications are based on ancestral methods that already existed before the launch of hormonal therapies. Their added-value is that they make it easy for users to track their cycle patterns through smartphone applications.
FDA-cleared and CE-marked, Natural Cycles already claims “2 million registered users worldwide”.
Looking at Google Play reviews, the app (combined with a thermometer) seems to appeal to individuals willing to go hormone-free and skip side effects. Some customers additionally highlight the minimal impact on the environment that such a digital alternative offers versus more energy-intensive options. As we collectively realize that health and the environment are related, this could become a growing selection criteria among patients.
With already 12 million users worldwide tracking their periods with Clue, once available, Clue Birth Control could also become a largely adopted digital contraceptive.
The company plans a specific on-boarding experience to make sure that only eligible users will access this feature as it is regulated to be used. “There is a very detailed assessment process as soon as you try to sign up for Clue Birth Control” shared Audrey Tsang, Clue’s Co-CEO, in a TechCrunch interview. Already FDA-cleared, CE certification in Europe is underway.
Conclusion
When I discussed these innovations with friends and my gynecologist, I realized that there was quite some enthusiasm around them. Mostly available in North America or under clinical development, we could expect a future international spread.
What if a fourth trend could also emerge in the perspective of male contraception?
We learned recently that the first male birth control pill could begin human testing before the end of the year.
Demand seems to be coming. In France, a 2021 study found out that 37 % of men aged 18-30 would be ready to take a reimbursed contraceptive pill, even if it generated side effects similar to the female one.
Alternatively, start-ups like Coso in Germany are working on other reversible male contraceptive solutions.
The road to market access will probably take years and require massive clinical investments. I (personally) believe the market is huge for male-centered reversible options as heterosexual couples seek more balanced relationships and shared mental loads.
What’s your opinion on these trends? How likely will they come to your country?
Please share your thoughts in the comments!
Thanks to Dallas Barnes, Founder & CEO of Reya Health (Canada) for contributing to this article.
Shall you want more insights on the birth control space or FemTech trends in general, I will gladly connect via email: charlotte@femtechnow.eu or Linkedin message.
Charlotte Puechmaille from FemTech Now
This article was initially published on the FemTech Now Linkedin page on March 29, 2022.