APRIL 2026 • PharmaTimes Magazine • 26-27
// REPRODUCTION //
Notes from the frontline of the ‘Age of the Oocyte’
For decades, progress in IVF has been driven by improvements in process efficiency rather than advances in biology.
Clinics have become better at retrieving eggs, culturing embryos and selecting those most likely to implant, improving efficiency and expanding access to fertility care.
Yet IVF success rates remain constrained by a biological reality: egg quality. For many patients, particularly those in their late thirties and early forties, IVF success rates remain at a frustrating plateau.
This is driven not by laboratory conditions or clinical technique, but by oocyte level biology. By the early thirties, around half of a woman’s eggs are no longer chromosomally viable. By the early forties, that figure exceeds 95%.
No amount of optimisation downstream can fully compensate for errors that arise upstream during egg maturation.
After forty years spent refining the lab, reproductive medicine is now confronting a harder truth: if outcomes are to improve meaningfully, the biology of the egg has to be addressed directly.
This shift in focus marks the beginning of what many in the field now recognise as the ‘Age of the Oocyte’.
My own background sits at the intersection of medicine, translational science and biotech formation, with a focus on bringing novel reproductive therapeutics into the clinic.
That perspective has shaped how I view the fertility landscape and the biological problems that IVF innovation has, until very recently, focused on working around rather than resolving.
Historically, reproductive medicine has prioritised optimisation of the IVF process itself. Improvements in stimulation protocols, lab conditions, embryo culture and selection have expanded access and improved efficiency, but they have not addressed the fundamental biological constraint imposed by declining egg quality.
U-Ploid is one example of a new generation of teams attempting to intervene at the level of the oocyte itself.
Importantly, this is not about a single company or approach, but about a broader reorientation across the field towards the biology that ultimately determines success.
When many of today’s reproductive biotech companies were founded, the therapeutic landscape was strikingly sparse. Reproductive medicine had become highly procedural, while drug development largely bypassed the field.
Innovation concentrated on improving IVF workflows rather than altering the biological drivers of success. Egg quality, particularly age-related decline, remained essentially unchanged despite decades of procedural refinement.
For patients, this often translated into repeated cycles, escalating costs and significant emotional burden, with little change in underlying odds.
From a drug development perspective, reproductive health was effectively a desert. Despite the size and rapid growth of the global IVF market, true reproductive therapeutics remained under-prioritised relative to the scale of unmet need.
While overall investment in women’s health has increased in recent years, only a third of that has flowed into biopharma and an even smaller share into egg level or fertility therapeutics.
This has led to a widening gap: a growing population of patients facing biologically driven infertility, but very few therapies designed to act at the root cause.
Working in reproductive therapeutics quickly exposes how unusual this space is. Reproductive biology sits at the intersection of drug regulation, device frameworks and embryo governance, with no established development pathways.
Companies are helping to define an entirely new therapeutic category, and this comes with complexity and challenges.
Building the scientific, clinical and regulatory infrastructure in parallel with developing the therapy itself adds time, increases uncertainty and pushes meaningful inflection points further out than investors might expect from more established therapeutic areas.
This explains why reproductive therapeutics often need patient, specialist capital and why progress in the field has historically been slower than the scale of the unmet need would suggest.
But the complexity becomes particularly apparent in clinical development. Fertility patients are, in most cases, not patients with life-threatening disease.
They are usually healthy individuals, operating under intense time pressure and making deeply personal decisions. Trial endpoints, recruitment strategies and ethical considerations therefore look very different from those with chronic or life-threatening disease.
This is why early partnership with fertility clinics is essential. Translational insight lives in clinical settings, not in preclinical models alone. A thorough understanding of patient flow, clinic workflows and real-world constraints must shape everything from trial design to regulatory strategy.
Importantly, in this space, regulatory thinking has to be built alongside the science from the outset rather than retrofitted once data emerges.
‘If outcomes are to improve meaningfully, the biology of the egg has to be addressed directly’
Over the past decade, that landscape has begun to shift. Advances in cell biology, protein engineering and reproductive science are enabling genuinely new approaches in reproductive health therapeutics that were not previously feasible.
The refocusing of attention onto the egg itself has emerged alongside a surge in demand for fertility services.
At the same time, collaboration between biotech companies and fertility clinics is becoming more common, signalling the emergence of a real ecosystem. Scientific, clinical and regulatory thinking are beginning to converge rather than operate in parallel.
Taken together, these changes suggest that the first wave of true reproductive therapeutics, interventions designed to act directly on egg level biology, will enter clinics within this decade.
Although scientific progress is the critical driver, for reproductive therapeutics to deliver on their promise of improved health and fertility outcomes, accessibility has to be factored in from the start.
Efficacy without access is not progress. The field also needs purpose-built clinical trial frameworks rather than adaptations of models developed for unrelated diseases. Fertility care requires rigour, but it also demands pragmatism.
Speed and standards are often framed as being in tension, yet they need not be, provided the right infrastructure exists.
Regulatory clarity, thoughtful trial design and early engagement with clinics will allow innovation to move quickly without compromising safety or ethics.
The challenge now is not proving that egg level biology matters, but building systems capable of translating that insight responsibly and at scale.
The Age of the Oocyte reflects a simple reality: meaningful improvements in fertility outcomes will depend on addressing the biology of the egg itself.
For those building in reproductive biotech, the lessons are these: invest early in partnerships and regulatory expertise. Spend time in clinics, not just at conferences. Share early data and be prepared for development paths that differ from conventional biotech in timeline, capital structure and regulatory logic.
Above all, design trials around patient reality. Recruitment and retention in reproductive medicine depend on genuine clinical partnerships and trust, and on recognising that translational insight ultimately lives with clinicians and patients.
For decades IVF has worked around the biology of the egg. The next decade of progress will depend on finally addressing it.
Jordan Abdi is Co‑founder and CEO of U‑Ploid Biotechnologies