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

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

The management consultant estimates that the global market potential for treating symptoms ranges from $120 billion to $350 billion worldwide.

Menopause occurs when women have gone 12 consecutive months without a menstrual cycle. Although this happens on average around age 51, women can have symptoms years earlier in what is known as perimenopause. Symptoms may continue into the postmenopausal phase.

These symptoms include hot flashes, anxiety, weight gain, vaginal dryness, mood swings, sleep problems, and skin changes. More than 450 million women worldwide are affected by menopausal and perimenopausal symptoms, according to McKinsey.

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

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

Hormone therapy was the standard treatment for menopause for decades. However, it gained notoriety in 2002 after a study by the Women’s Health Initiative found that estrogen plus progestin therapy increased the risk of breast cancer and heart disease in women.

“Many women have given up hormone therapy because of their own fear, or because their doctors were afraid, or some combination of those,” 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 dropped by more than 70%, a 2012 study found.

“It left a lot of women without any guidance,” Faubion said.

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

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

There aren’t many publicly listed companies in the space. The biggest name in the US is Pfizer, which has a number of products in its portfolio. These include Duavee and Premarin, hormone therapy treatment for hot flashes, and osteoporosis prevention.

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

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

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

“It gives you that consistent amount of supply and … there’s no worry about compliance and whether you’re going to remember a day or forget a day,” he said. “Ultimately, it means you feel better.”

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

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

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

Bayer also has a drug in development called elinzanetant. The German company said in January that the therapy reduced the frequency and severity of hot flashes and improved sleep in two late-stage studies. Results from a third phase 3 study are expected in the coming months, Bayer said. It will then be sent for approval.

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

In the non-drug category, fertility benefits manager Progyny recently announced that it is expanding its menopause coverage through a partnership with private companies Gennev and Midi Health.

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

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

“Menopause is inevitable, like death and taxes, and all women will go through it,” Kelemen said. “We just don’t have many public women’s health companies yet, and we hope that will change.”

In 2022, Kelemen arranged a deal for Unified Women’s Healthcare to buy Gennev, Progyny’s partner, which is a digital menopausal care delivery platform. Kelemen did not want to disclose the financial terms.

Midi Health, Progyny’s other partner, which is 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 healthcare has long been underfunded, and menopause only gets a small slice of that pie.

“The dollars don’t match the conversation that’s happening,” Kelemen said. “Even though it’s growing, it’s still growing too slowly and definitely in no way proportional to the potential impact and the needs of the actual population” that needs to be served.

However, Kelemen is optimistic that funding will continue to increase. She is also optimistic about consolidation in the space and the potential for new innovation.

“Because it’s a hormonal change over a period of 10, 15, 20 years, women’s needs will change,” she said. “There is an opportunity for success on multiple platforms.”