This overlooked corner of women’s health could be a $350 billion market opportunity

In fact, menopause is among the female health conditions with the highest unmet need and has “enormous potential for innovative treatments,” according to a recent McKinsey report.

The management consultant estimates the global market potential to treat symptoms ranges from $120 billion to as much as $350 billion globally.

Menopause occurs when women have gone 12 consecutive months without a menstrual period. While that happens, on average, at around age 51, women can have symptoms for years beforehand in what’s known as perimenopause. Symptoms can also continue in the postmenopausal phase.

Those symptoms include hot flashes, anxiety, weight gain, vaginal dryness, mood changes, sleep problems and changes in skin conditions. More than 450 million women worldwide are affected by menopause and perimenopause symptoms, according to McKinsey.

There is also a big unmet demand for menopause products and services, said Anna Pione, a partner at McKinsey who leads the firm’s research on the future of wellness.

Menopause is “underserved, underfunded, underpaid attention to,” she said. “That would apply to women’s health in general, and then specifically and acutely to menopause in particular.”

Hormone therapy was the typical menopause treatment for decades. However, it got a bad rap in 2002 after a Women’s Health Initiative study found estrogen plus progestin therapy increased a woman’s risk of breast cancer and heart disease.

“A lot of women bailed off hormone therapy for their own fear, or because their doctors were afraid, or some combination thereof,” said Dr. Stephanie Faubion, director of the Mayo Clinic Center for Women’s Health and medical director of the nonprofit Menopause Society.

From 2002 to 2009, hormone therapy claims were reduced by more than 70%, a 2012 study showed.

“It left a lot of women without any management at all,” Faubion said.

However, research now shows that the benefits may outweigh the risks for women under age 60, or less than 10 years out of their menopause diagnosis.

“Our knowledge has changed,” said Dr. Karen Adams, a Stanford University professor and director of the school’s menopause and healthy aging program. “It is really very exciting, but women are left shaking the trees trying to find someone who can help them.”

There are not many publicly-listed companies in the space. The largest U.S. name is Pfizer, which has a number of products in its portfolio. They include Duavee and Premarin, hormone therapy treatments for hot flashes and the prevention of osteoporosis.

Then, there is tiny Biote, which has a market cap just north of $400 million. The company, which went public in May 2022 through a SPAC deal, makes customized bioidentical hormone pellets to address hormone imbalances.

Hormone treatment in general is an area of focus that is “really bubbling up to the surface,” said Jefferies analyst Kaumil Gajrawala, who has a buy rating on Biote.

Menopause is the largest part of its market, he said. Biote uses blood tests to customize its hormone pellets, which are inserted into the body subcutaneously.

“It gives you that consistent amount of delivery, and … there’s no concern about compliance and if you’ll remember a day or forget a day,” he said. “What it means in the end is that you feel better.”

Meanwhile, Dare Bioscience, which has an even smaller market cap of about $47 million, has a hormone therapy in the pipeline. The clinical-stage biopharmaceutical company, which focuses on women’s health, has an intravaginal ring hormone therapy that is set to progress to a single Phase 3 study.

There is also a race to find non-hormone treatments.

Last May, the Food and Drug Administration approved Tokyo-based Astellas Pharma’s Veozah, also known as fezolinetant, to treat hot flashes.

Bayer also has a drug in its pipeline called elinzanetant. The German company said in January that therapy reduced the frequency and severity of hot flashes and improved sleep in two late-stage trials. The results of a third phase 3 study is expected in coming months, Bayer said. It will then submit for approval.

In addition, late-clinical-stage biopharmaceutical company Vistagen Therapeutics, with a market cap of about $100 million, has a trial underway for a hormone-free nasal spray to treat hot flashes.

In the non-drug category, fertility benefits manager Progyny recently announced it was expanding into menopause coverage by partnering with private companies Gennev and Midi Health.

“The fact that they are focusing on menopause as one of the next legs of the stool is an indicator of the potential opportunity there,” said Sasha Kelemen, the head of women’s health investment banking at Leerink Partners.

Still, much of the innovation in menopause is happening in the private space.

“Menopause is inevitable, like death and taxes, and all women will go through this,” Kelemen said. “We just don’t have a lot of public women’s health companies yet, and hopefully that will change.”

In 2022, Kelemen orchestrated a deal for Unified Women’s Healthcare to buy Gennev, the Progyny partner that’s a digital menopause care delivery platform. Kelemen would not disclose the financial terms.

Midi Health, the other Progyny partner that’s a virtual care clinic specializing in perimenopause and menopause, is another company attracting investor dollars. In September, Alphabet‘s venture capital arm, Google Ventures, led a $25 million Series A funding round for the company, bringing its total funding to $40 million.

Still, women’s health has long been underfunded, and menopause is getting just a small slice of that pie.

“The dollars don’t match the conversation that’s happening,” Kelemen said. “While it’s growing, it’s still growing too slowly and definitely not in any way proportionate to the potential impact and the need of the actual population” that needs to be served.

That said, Kelemen is optimistic funding will continue to increase. She’s also bullish on consolidation in the space and the potential for new innovations.

“Because it is a hormonal change for a 10-, 15-, 20-year period, the needs of women will change,” she said. “There’s opportunity for multiple platforms to succeed.”