EMD Serono Deal Shakes Up Everything. New Players Emerge Where Incumbents Have Remained Stagnant
TrumpRx Forces Price Reset in IVF Medications
Federal drug pricing intervention reached fertility care in October 2025 when the Trump administration announced a government-backed IVF medication discount under its broader TrumpRx initiative. The agreement centered on discounted fertility drugs supplied by EMD Serono, marking the first time IVF medications were explicitly included in a national prescription program tied to federal policy.
The impact was immediate. EMD Serono’s participation effectively established a public reference price for cash-pay IVF medications, a category that represents a substantial share of U.S. cycles. Once a government-endorsed discount exists, manufacturers with higher list prices face increasing resistance from clinics, specialty pharmacies, and patients—particularly in a market where medication costs sometimes account for 30–40% of total IVF spend.
With overlapping stimulation portfolios and similar clinical use cases, Organon now competes against a benchmark that did not previously exist. Matching EMD Serono’s discounts may no longer be optional if the company intends to protect market share, which had been increasing against EMD Serono’s Gonal-F prior to the Trump-EMD Serono deal, according to Dr. Ravi Gada..
Ferring Layoffs and Organon CEO Exit Hit Companies, But Not Their Fertility Divisions
Disruption across drug manufacturers have thus far not shown signs of impacting their fertility operations. In September 2025, Ferring Pharmaceuticals announced layoffs affecting roughly 500 employees, but spared their fertility team. In 2026, however, Ferring’s fertility division is expected to see intensified competition to Menopur from EMD Serono’s pending Pergovaris.
Weeks later, Reuters reported in October 2025 that CEO Kevin Ali resigned after an internal investigation into wholesaler sales practices. So far, there have been no signs of disruption to the fertility division as a consequence.
Fertility Drug R&D Has Lagged for Decades, Until Now…Finally
Despite rising IVF volumes, fertility drug development has seen limited investment in new ovarian stimulation approaches. As a result, the field has remained heavily reliant on long-established drug classes, with few meaningful advances in how these therapies work.
Granata Bio was founded in 2018 to address that gap. Rather than incremental reformulations, the company built its strategy around identifying biological limitations in existing therapies and advancing targeted development programs. Its portfolio now spans commercialized products and early-stage assets across multiple IVF drug classes, supported by U.S. regulatory strategy, clinical development expertise, and strategic partnerships.
Recent moves underscore that focus. Granata partnered with Gedeon Richter to bring recombinant FSH (BEMFOLA®) to the U.S. market and acquired Oviva Therapeutics, gaining access to first-in-class programs focused on ovarian aging. The company is also advancing hypoglycosylated FSH, designed to more closely reflect reproductive-age biology rather than menopausal hormone profiles—an approach supported by preclinical findings showing stronger intracellular signaling and improved granulosa cell function.
IVF Drug Costs Remained High Without Generics. That’s Changing
“Perhaps I could be enlightened,” Dr. Brian Kaplan, a retired REI physician, wrote in a LinkedIn comment prior to the announcement of Trump Rx. “If drug costs are 30–40% [of IVF costs] (often more in older patients)… in order to reduce total costs to patients by 50% wouldn’t one need to reduce ‘clinical’ expenses by 60–80%?”
Dr. Kaplan’s framing underscored a central constraint in fertility care: without lower medication costs, downstream efficiencies have limited impact on patient affordability. For years, the fertility space lacked viable generics and biosimilars as biologics accounted for nearly 40% of total drug spending . The imbalance pushed greater attention toward lower-cost biosimilars in 2025
Chicago-based Meitheal has taken the lead on closing that gap by expanding access to generic fertility medications such as ganirelix and cetrorelix, while advancing an FSH biosimilar pipeline aimed at one of IVF’s largest cost drivers. The company has also introduced a multi-dose ganirelix pen designed to simplify administration and reduce dosing errors during stimulation, addressing operational friction alongside cost.
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