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

After years of being ignored, menopause has entered the general public dialog.

Celebrities from Drew Barrymore to Naomi Watts have opened up about signs and promoted merchandise. But regardless of the elevated chatter, there’s a lengthy method to go relating to treating signs — and a variety of alternatives for firms to step in to fill the hole.

The truth is, menopause is among the many feminine well being situations with the best unmet want and has “huge potential for revolutionary therapies,” based on a latest McKinsey report.

The administration marketing consultant estimates the worldwide market potential to deal with signs ranges from $120 billion to as a lot as $350 billion globally.

Menopause happens when ladies have gone 12 consecutive months with out a menstrual interval. Whereas that occurs, on common, at round age 51, ladies can have signs for years beforehand in what’s referred to as perimenopause. Signs may also proceed within the postmenopausal section.

These signs embrace sizzling flashes, nervousness, weight achieve, vaginal dryness, temper adjustments, sleep issues and adjustments in pores and skin situations. Greater than 450 million ladies worldwide are affected by menopause and perimenopause signs, based on McKinsey.

There may be additionally a giant unmet demand for menopause services, mentioned Anna Pione, a associate at McKinsey who leads the agency’s analysis on the way forward for wellness.

Menopause is “underserved, underfunded, underpaid consideration to,” she mentioned. “That will apply to ladies’s well being usually, after which particularly and acutely to menopause particularly.”

Hormone remedy was the everyday menopause remedy for many years. Nonetheless, it received a foul rap in 2002 after a Girls’s Well being Initiative examine discovered estrogen plus progestin remedy elevated a lady’s danger of breast most cancers and coronary heart illness.

“Lots of ladies bailed off hormone remedy for their very own worry, or as a result of their medical doctors had been afraid, or some mixture thereof,” mentioned Dr. Stephanie Faubion, director of the Mayo Clinic Heart for Girls’s Well being and medical director of the nonprofit Menopause Society.

From 2002 to 2009, hormone remedy claims had been lowered by greater than 70%, a 2012 examine confirmed.

“It left a variety of ladies with none administration in any respect,” Faubion mentioned.

Nonetheless, analysis now reveals that the advantages could outweigh the dangers for ladies below age 60, or lower than 10 years out of their menopause analysis.

“Our information has modified,” mentioned Dr. Karen Adams, a Stanford College professor and director of the college’s menopause and wholesome growing old program. “It’s actually very thrilling, however ladies are left shaking the bushes looking for somebody who can assist them.”

There should not many publicly-listed firms within the house. The biggest U.S. identify is Pfizer, which has quite a lot of merchandise in its portfolio. They embrace Duavee and Premarin, hormone remedy therapies for warm flashes and the prevention of osteoporosis.

Then, there’s tiny Biote, which has a market cap simply north of $400 million. The corporate, which went public in Could 2022 by way of a SPAC deal, makes custom-made bioidentical hormone pellets to handle hormone imbalances.

Hormone remedy usually is an space of focus that’s “actually effervescent as much as the floor,” mentioned Jefferies analyst Kaumil Gajrawala, who has a purchase score on Biote.

Menopause is the biggest a part of its market, he mentioned. Biote makes use of blood assessments to customise its hormone pellets, that are inserted into the physique subcutaneously.

“It provides you that constant quantity of supply, and … there is no concern about compliance and if you happen to’ll bear in mind a day or neglect a day,” he mentioned. “What it means ultimately is that you simply really feel higher.”

In the meantime, Dare Bioscience, which has a good smaller market cap of about $47 million, has a hormone remedy within the pipeline. The clinical-stage biopharmaceutical firm, which focuses on ladies’s well being, has an intravaginal ring hormone remedy that’s set to progress to a single Part 3 examine.

There may be additionally a race to seek out non-hormone therapies.

Final Could, the Meals and Drug Administration authorised Tokyo-based Astellas Pharma’s Veozah, also called fezolinetant, to deal with sizzling flashes.

Bayer additionally has a drug in its pipeline known as elinzanetant. The German firm mentioned in January that remedy lowered the frequency and severity of sizzling flashes and improved sleep in two late-stage trials. The outcomes of a 3rd section 3 examine is predicted in coming months, Bayer mentioned. It’ll then submit for approval.

As well as, late-clinical-stage biopharmaceutical firm Vistagen Therapeutics, with a market cap of about $100 million, has a trial underway for a hormone-free nasal spray to deal with sizzling flashes.

Within the non-drug class, fertility advantages supervisor Progyny just lately introduced it was increasing into menopause protection by partnering with personal firms Gennev and Midi Well being.

“The truth that they’re specializing in menopause as one of many subsequent legs of the stool is an indicator of the potential alternative there,” mentioned Sasha Kelemen, the top of girls’s well being funding banking at Leerink Companions.

Nonetheless, a lot of the innovation in menopause is occurring within the personal house.

“Menopause is inevitable, like loss of life and taxes, and all ladies will undergo this,” Kelemen mentioned. “We simply do not have a variety of public ladies’s well being firms but, and hopefully that may change.”

In 2022, Kelemen orchestrated a deal for Unified Girls’s Healthcare to purchase Gennev, the Progyny associate that is a digital menopause care supply platform. Kelemen wouldn’t disclose the monetary phrases.

Midi Well being, the opposite Progyny associate that is a digital care clinic specializing in perimenopause and menopause, is one other firm attracting investor {dollars}. In September, Alphabet‘s enterprise capital arm, Google Ventures, led a $25 million Collection A funding spherical for the corporate, bringing its whole funding to $40 million.

Nonetheless, ladies’s well being has lengthy been underfunded, and menopause is getting only a small slice of that pie.

“The {dollars} do not match the dialog that is taking place,” Kelemen mentioned. “Whereas it is rising, it is nonetheless rising too slowly and positively not in any method proportionate to the potential impression and the necessity of the particular inhabitants” that must be served.

That mentioned, Kelemen is optimistic funding will proceed to extend. She’s additionally bullish on consolidation within the house and the potential for brand spanking new improvements.

“As a result of it’s a hormonal change for a 10-, 15-, 20-year interval, the wants of girls will change,” she mentioned. “There’s alternative for a number of platforms to succeed.”