IVF Drug markets are small in size and expensive to enter; commitment and collaboration can help drive the momentum needed for new drugs.
Novel drug approvals in reproductive health have been at a standstill since 2004, leaving U.S. providers with a narrow set of options while other therapeutic fields advance rapidly. Despite the demand for improved infertility treatments, investment and innovation remain constrained by modest market sizes, expensive development programs, and a strong incumbency.
$1.3B Fertility Drug Market vs. $252B Oncology Drug Market
The U.S. infertility drug market is valued at just $1.3 billion, compared with $252 billion in oncology. With only 500 IVF clinics and fewer than 1,250 reproductive endocrinologists, the US market has failed to attract sustained pharmaceutical investment from longtime market leaders. Core drugs in use today: gonadotropins, GnRH analogs, and progesterone were all developed decades ago, highlighting the sector’s stagnant pipeline.
NIH Funding Down, Trial Burdens Up
NIH funding for women’s health research has declined, shrinking early-stage discovery. Meanwhile, reproductive health trials face heightened liability and cost: studies with mandated clinical endpoints (pregnancy/live birth) require extended duration and expanded cohorts. European regulators often approve based on oocyte counts, but the U.S. typically requires live birth or clinical pregnancy data. In 2020, the FDA reclassified gonadotropins as biologics, adding additional complexity to an already lengthy approval process.
$4.9B in Unmet Opportunity Signals Revival Potential
The Amboy Street Ventures Ghost Market Report estimates $4.9 billion in untapped women’s health opportunity, underscoring both the commercial and clinical space for renewal.
12-Year Path to Reversing the Innovation Drought
Bringing a new drug to market still takes 12–13 years, with only one or two of every 10,000 compounds surviving the process. One organization helping advance this effort is Granata Bio, which is conducting three Phase 3 trials in reproductive health. The company emphasizes research partnerships and reinvests revenue from established products to fund ongoing development.
Progress in reproductive health depends on collective commitment—developers investing in discovery, investors recognizing value, and companies willing to hazard the risk, time, and money to introduce new therapies to what is today, a modestly sized market. To justify the investment, companies like Granata Bio are betting that the market will continue to grow and that translational innovation that improves outcomes for patients will be rewarded.
INNOVATION DOESN’T STAND STILL, AND NEITHER DO WE.
We’re putting progress back into reproductive pharmaceuticals with a focused mission to expand access, affordability, and choice.
Here’s how we’re doing it:
Advancing three active Phase 3 trials in reproductive health
Reinvesting established revenue streams directly into new R&D
Building partnerships across industry to reignite innovation
Learn More Now - see how Granata Bio is unlocking new possibilities for patients and care teams.
This article was not sponsored by the article subject and indicates no relationship between the article subject and the sponsor.