White House-EMD Serono IVF Deal Signals Regulatory Shift for Fertility Industry

The White House and EMD Serono have reached an agreement to make in vitro fertilization (IVF) more affordable and widely accessible. EMD Serono, the U.S. and Canadian affiliate of Merck KGaA, has agreed to provide its entire portfolio of IVF therapies as a direct-to-consumer (DTC) offering at a significant discount.

With a prescription, patients could see up to 84% savings on IVF therapies, including Gonal-f® (follitropin alfa injection), Ovidrel® (choriogonadotropin alfa injection), and Cetrotide® (cetrorelix acetate for injection). To receive these discounted drugs, patients must purchase them through TrumpRx.gov starting in January 2026.

Following the White House announcement, the U.S. Department of Labor, the Departments of Treasury, and Health and Human Services jointly released new federal guidance that enables employers to offer fertility benefits as standalone coverage options, separate from traditional health insurance. This flexibility could encourage more employers to add fertility benefits without restructuring their entire health plans.

EMD Serono competes with two other large fertility drug manufacturers, Organon and Ferring. EMD Serono’s agreement is notable because it offers all three drugs together, a bundled discount that its competitors may struggle to match without similar government concessions, creating a competitive barrier.

As part of the deal, EMD Serono receives tariff relief in exchange for manufacturing and research investments in the U.S., and may also receive expedited FDA review for launching other fertility drugs to market, thereby gaining a significant competitive advantage.

Typically, IVF cycles cost $12,000 to $30,000. The Centers for Medicare and Medicaid Services estimates women can save up to $2,200 per cycle with these discounts.

Lower out-of-pocket costs for patients could increase demand for IVF and potentially offset revenue concerns. If drug prices fall, patients might expect the overall pricing to fall as well. Clinics might have to reduce the IVF cycle costs by 10–15%. This margin compression could push valuations toward the lower end of the 7–15x EBITDA range, particularly affecting clinics with marked-up medication costs or with lower cycle volumes.

The U.S. fertility market is highly fragmented, with 450 clinics nationwide, but only 135 of them perform over 500 IVF cycles annually. As private equity rapidly consolidates, private equity-backed providers account for 30% of all ART cycles. These private equity-backed networks rely on high-margin services and medication markups, making them vulnerable to pricing pressure and regulatory scrutiny.

Currently, no single governing body oversees the fertility industry. The CDC tracks ART cycles while the FDA oversees devices and drugs, but there is no central regulator. The combination of federal drug pricing intervention, new employer benefit guidance, and the Expanding Access to In Vitro Fertilization executive order signals a new level of federal intervention in fertility care. Investors and fertility networks that have operated under a cash-for-service model may need to adopt traditional healthcare reimbursement structures, insurance contracting, and compliance frameworks in response to this shift toward government involvement, fundamentally altering the industry’s economics.