Fertility
IVF in transition: 2025 realities and what device manufacturers must do now
FinDBest IVF is a global B2B platform that connects manufacturers of fertility and reproductive health devices with IVF-specialist distributors in over 150 countries. We simplify global expansion, regulatory pathway planning, and distributor onboarding.
Each year, the European Society of Human Reproduction and Embryology (ESHRE) Congress reveals not just clinical updates, but also clear signals about where the IVF market is heading.
In 2025, Circular Communications compiled a focused commercial and product roadmap briefing from the event, kindly shared recently by Dr Georg Griesinger on Linkedin.
What follows is a practical breakdown of their insights—designed for medical device manufacturers and clinical users who need to make fast, evidence-based business and product decisions:
The Six Shifts Reshaping IVF
The IVF landscape in 2025 is not simply evolving—it is undergoing structural change.
Six key forces are reshaping how medical devices are adopted, evaluated, and purchased. Manufacturers who adapt early will find more predictable paths to market.
Those who do not risk falling behind as clinics tighten their criteria.
Cost pressures are now the central constraint
IVF remains financially inaccessible for large segments of the population.
In many countries, patients are still paying out of pocket.
The result is a growing preference for solutions designed around total cost of ownership (TCO).
That means not just upfront purchasing price/cost, but reusability, reliability, throughput, maintenance needs, and training time.
Products that align with capital expenditure (CAPEX) models and flexible subscriptions—especially those matched to clinic cash flow—are more likely to be adopted.
Growth in mature markets has flatlined
In many high-income countries, the number of IVF cycles per capita has plateaued.
For manufacturers, that means growth must now come from share gain or geographic expansion, particularly into fast-growing regions like Southeast Asia, the Middle East and North Africa (MENA), and Latin America.
But entering these markets successfully requires localising value propositions and working with distributors who understand IVF workflows and regulatory constraints.
Legal and ethical oversight is tightening
Questions about embryo selection, long-term storage, and artificial intelligence (AI) in diagnostics are under increased scrutiny.
For manufacturers, this raises the bar on traceability, audit readiness, and labeling compliance.
Products now need to include support for standard operating procedures (SOPs), as well as detailed logging and audit trails.
These are no longer differentiators—they are minimum requirements.
Patient experience has become a key decision factor
Clinics are under pressure to not only deliver outcomes but also reduce the emotional and cognitive burden on patients.
Devices that simplify communication, reduce the number of steps in a procedure, and help patients understand “what’s next” are increasingly favored.
Clear interfaces, intuitive indicators, and minimal user intervention all contribute to better adoption.
Clinic consolidation is shifting how buying decisions are made
Independent clinics are being replaced or absorbed by multi-site groups (Eg. US Fertility or IVIRMA, owned by KKR).
These groups prioritise enterprise-style purchasing: standardised protocols, centralised training, measurable return on investment (ROI), and clear service levels.
Manufacturers that can offer SOP kits, multi-site onboarding, and enterprise-level value metrics will have a distinct advantage.
Technology alone no longer drives differentiation
Automation, AI, microfluidics, smart incubation systems, and digital integration are becoming standard.
The key to winning adoption now lies in reproducibility, data quality, interoperability, and auditability—not just product specifications.
Clinics expect devices that integrate easily with their digital systems and produce consistent results across different settings.
Each of these shifts presents a challenge, but also a roadmap.
Cost, regulation, technology, and buyer behavior are all converging toward a more structured and evidence-driven IVF market.
Manufacturers who address these realities in their design, pricing, and commercial execution will be best positioned to scale.
Clinical and Technological Frontiers Highlighted at ESHRE 2025
Beyond the market dynamics, ESHRE 2025 spotlighted several areas of clinical innovation that are directly shaping device and diagnostics development.
These themes are not theoretical—they are influencing purchasing, adoption, and regulatory expectations now.
Ovarian stimulation protocols are being rethought As clinics aim for personalisation and patient comfort, the need for smarter diagnostics and more flexible drug delivery systems is growing.
Biomarkers that can predict ovarian reserve and treatment response are informing stimulation protocols, making room for devices that adapt to individual profiles.
At the same time, there is a clear trend toward mild stimulation protocols, which create demand for less-invasive monitoring tools and delivery systems that are intuitive, reliable, and easy to train on.
The ongoing refinement of protocols using gonadotropin-releasing hormone (GnRH) antagonists reinforces the need for workflow-agnostic solutions—those that can fit into varying cycles without adding complexity.
Embryo selection is moving well beyond morphology
Objective, evidence-backed methods are replacing subjective scoring.
One major area of interest is AI-supported time-lapse imaging, which offers the potential to assess embryo viability in a more standardised and reproducible way.
However, clinics are demanding validated tools—classified appropriately as software as a medical device (SaMD), with integration capabilities and clean clinical evidence.
In parallel, non-invasive preimplantation genetic testing (niPGT) is gaining momentum.
Media capable of capturing cell-free DNA (cfDNA), paired with ultra-sensitive genetic testing platforms, could redefine embryo selection workflows.
This is not a future trend—it’s a present R&D priority.
Manufacturers need to plan both the evidence and regulatory strategy from the outset.
Metabolomics and biomarker analysis of culture media are also being explored, particularly where kits can offer clear utility and fit easily into existing lab infrastructure.
Implantation remains a key bottleneck
Even with viable embryos, successful transfer remains challenging.
There is growing interest in non-invasive endometrial diagnostics that can assess uterine receptivity without disrupting workflow.
The market demands tools that are specific, reproducible, and easy to use.
Meanwhile, catheter design continues to influence both outcomes and patient experience.
Ergonomics, atraumatic placement, and consistent delivery are still core drivers of successful transfers.
While less discussed in marketing, this area remains a top priority for clinical users and therefore deserves more innovation attention.
Taken together, these frontiers point toward a product development path that favors integration over novelty, reproducibility over experimentation, and real-world usability over theoretical performance.
It is not just what your device does—it is how it fits into the day-to-day life of clinics under pressure.
Regulatory and Market Access: Build It In, Not On
Global regulatory expectations are rising, and shortcuts are closing.
Product teams can no longer afford to treat compliance as a post-development task. It must be embedded from Day 0.
For software and AI-based tools, classification is tightening across the United States, European Union, and China.
This means developers must create full validation plans early, align endpoints with regulatory expectations, and document cybersecurity and data governance practices before launch.
Post-market surveillance and post-market clinical follow-up are not optional; they need to be built into the development process.
Culture media and reagent products are under increased scrutiny from regulations like the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Manufacturers must establish robust quality systems, ensure all labeling is complete and language-appropriate, and be ready to implement unique device identification requirements in every target market.
For connected lab devices, regulatory bodies expect more than just functionality.
They now require detailed documentation of data interoperability, security protocols, and integration capabilities.
Manufacturers should design clean application programming interfaces (APIs) and seamless connectors for hospital and laboratory data systems to make compliance easier—not harder—for clinics.
A practical checklist for manufacturers:
- Confirm software classification and plan validation early for each market.
- Create templates for traceability, labeling, audit logs, and PMS/PMCF.
- Implement cybersecurity and data protection frameworks from Day 0.
- Ensure unique device identification (UDI) compliance for each geography.
- Offer clear integration documents for lab systems (no assumptions).
Strategic Focus Areas for IVF Device and Diagnostics Manufacturers
- Balance cost and innovation
Demonstrate lower total cost of ownership through real-world data. Show how your product reduces maintenance, training time, or consumable use. - Support with evidence, not claims
Build prospective, multi-site clinical studies. Prepare audit-ready documentation: instructions for use, labeling, traceability, and surveillance templates. - Integrate digital and physical
Provide open, secure APIs. Ensure fast and simple onboarding for embryologists and nurses. Focus on reducing clicks, errors, and delays. - Refine embryo selection strategy
Align product claims with validated inputs—whether AI models, cfDNA media, or metabolomic markers. Monitor data drift and revalidate regularly. - Improve uterine receptivity and transfer tools
Support claims with performance data (e.g. time to placement, consistency). Offer quick training modules to accelerate adoption. - Embed regulatory design
Maintain a live matrix of requirements per SKU and market. Don’t delay planning for UDI, cybersecurity, PMS/PMCF. - Sell to enterprise buyers
Offer group-level SOP kits, ROI calculators, and centralised onboarding. Provide remote diagnostics and clear SLAs to reduce downtime. - Speed up market entry through smarter distribution
Use IVF-experienced distributors with proven regulatory capabilities. Shorten time to first order by removing the guesswork.
Key Takeaways
- Total cost of ownership is now the key metric—design around it.
- Patient workflows and clinic processes must be simplified.
- Reproducibility and integration matter more than specs.
- Plan evidence generation around the claims you want to make.
- Prepare for audits with full traceability and post-market tools.
- Offer group-ready commercial packages for multi-site chains.
- Match each market with a localised regulatory strategy.
- Choose distributors who understand both IVF and compliance.
FinDBest IVF: Your Partner in Global Expansion
These insights from ESHRE 2025, as compiled by Circular Communications, offer a compelling glimpse into the future of fertility treatment.
For medical device manufacturers, these trends are direct signals for where to focus R&D, innovation, and market entry efforts.
At FinDBest IVF, we specialise in helping medical device manufacturers navigate the complex global regulatory landscape.
Whether you’re developing cutting-edge AI for embryo selection, next-generation culture media, or advanced cryopreservation devices, we can help you:
- Find regulatory-savvy distributors and license holders.
- Identify partners who understand country-specific timelines and dossier formats.
- Expand globally, faster — with fewer surprises.
Credits
- Original, full report by Circular Communications
- Shared on Linkedin by Georg Griesinger
Article produced in association with London Pregnancy Clinic and Jeen Health
For the majority of couples planning a pregnancy, genetic testing is not something they think about until a problem arises.
Pre-conception genetic carrier screening challenges this approach by identifying risk before pregnancy begins.
As panel sizes have grown and at-home testing options have become widely available, carrier screening is transitioning from a niche clinical referral into a mainstream component of reproductive planning.
What Carrier Screening Tests For
Being a carrier of a genetic condition means carrying one copy of a variant in a gene associated with that condition, without being affected by it.
In most cases, carriers are entirely unaware of their status.
The clinical significance of carrier status emerges when both members of a couple carry a variant in the same gene: in this scenario, each pregnancy carries a one in four chance of resulting in a child who inherits two copies of the variant and is affected by the condition.
The conditions most frequently included in expanded carrier screening panels include cystic fibrosis, spinal muscular atrophy (SMA), fragile X syndrome, sickle cell disease, and a range of metabolic and enzyme deficiency disorders.
The Beacon 787 carrier test, offered by Jeen Health, screens for 787 conditions from a single sample, making it one of the most comprehensive panels currently available to UK families.
Who Is Most Likely to Benefit
Any couple planning a pregnancy can consider carrier screening. It is particularly relevant for:
- Couples with a family history of a known inherited condition
- Those from populations with higher carrier frequencies for specific conditions, including Ashkenazi Jewish, South Asian and African communities
- Couples pursuing fertility treatment, where genetic information informs treatment planning
- Those who wish to have the most complete picture of their reproductive health before conception
Importantly, being a carrier of a condition does not mean a child will be affected. It means there is a defined statistical risk that can be quantified, discussed and planned for with appropriate clinical support.
How the Test Is Performed
Carrier screening is typically carried out on a blood or saliva sample.
For at-home options such as the testing offered by Jeen Health, a cheek swab collection kit is dispatched to the patient, the sample is returned by post, and results are delivered digitally within a defined turnaround period.
In-clinic carrier testing may use a blood draw and provides the advantage of immediate access to a clinical consultation at the point of result delivery.
London Pregnancy Clinic offers genetics counselling through its partnership with Jeen Health, allowing couples to receive and contextualise carrier test results with expert support.
Genetic counselling before and after testing is recommended by Genomics England as a standard component of any genomic testing pathway.
What Happens If Both Partners Are Carriers
If both partners are identified as carriers for the same autosomal recessive condition, they are typically offered further counselling to discuss their options.
These may include proceeding naturally with an awareness of the risk, using prenatal diagnosis (CVS or amniocentesis) during pregnancy to test the fetus, or pursuing preimplantation genetic testing (PGT) in the context of IVF, which allows unaffected embryos to be selected before transfer.
The purpose of identifying carrier status before pregnancy is to give couples time to consider these options without the added pressure of an ongoing pregnancy.
Knowledge of carrier status does not remove reproductive choices; it expands the information available when making them.
The Role of Pre-Conception Services
Carrier screening sits within a broader category of pre-conception care that includes fertility assessments, general health optimisation and, where relevant, management of existing conditions before pregnancy begins.
London Pregnancy Clinic offers pre-conception services encompassing fertility investigations, genetics counselling and carrier testing as part of an integrated 0th trimester approach, allowing couples to address genetic and clinical risk factors before their pregnancy starts rather than after.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment.
Clinical guidance referenced reflects published NHS, NICE and RCOG standards as at March 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article.
This piece was produced in association with London Pregnancy Clinic and Jeen Health, which provided background clinical information for editorial purposes.
Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
A London-based fertility clinic has been shortlisted for a startup award.
Plan Your Baby was shortlisted as a London finalist for Innovative Startup of the Year at the UK StartUp Awards.
Plan Your Baby is a new generation fertility and pregnancy telehealth clinic that provides fertility treatment and and-to-end pregnancy clinical monitoring and psychological support.
The company said on LinkedIn: “Being recognised in a city as competitive as London is meaningful for our team.
“The award is judged by industry experts and reflects the growing need for fertility care that is structured, transparent, and centred around the patient.
“Many people come to us looking for clarity in what can often feel like a complex process.
“Our focus has been to make each step easier to understand and easier to access.”
Plan Your Baby founder Marija Skujina was inspired to launch the company after working at the highest level in private fertility clinics and realising the impact that the traditional approach to fertility treatment was having on clients.
She told Femtech World in a 2023 interview: ““Fertility support is not just a medical procedure, it’s physical, mental, and emotional too.
“That’s why I launched Plan Your Baby: to help parents conceive in a fully supported and holistic manner.”
The UK StartUp Awards aim to ‘recognise the achievements of amazing individuals who have had a great idea, spotted the opportunity and taken the risks to launch a new product or service.’
If selected as the regional winner, Plan Your Baby will go on to the national final at Ideas Fest this September.
Previous winners include Magic AI, makers of a wall-mounted AI fitness mirror that acts as a personal trainer, and EnsiliTech, a medtech startup developing innovative health technology solutions at the intersection of engineering and healthcare.
Future Fertility, a Toronto-based health technology company specialising in AI-powered fertility insights, has entered the Japanese market through a new commercial partnership with Kato Ladies Clinic — a globally recognised leader in IVF research and advancing clinical fertility care.
The collaboration marks Future Fertility’s first partnership in Japan and reflects growing global demand for technologies that bring greater objectivity and personalisation to fertility care.
Kato Ladies Clinic will integrate the company’s AI-powered oocyte (egg) quality assessment tools into its clinical workflows, with the aim of supporting more informed treatment planning and patient counselling across IVF and egg freezing cycles.
“At Kato Ladies Clinic, we are committed to advancing fertility care through innovation while maintaining a strong focus on individualised, patient-centred treatment,” said Keiichi Kato, chief executive officer.
“Partnering with Future Fertility enables us to integrate objective, data-driven insights into our clinical approach and better support our patients in making informed decisions.”
Future Fertility’s platform analyses images of oocytes using artificial intelligence trained and validated on a dataset of more than 650,000 unique oocyte images.
The technology is already in use at more than 300 clinics across more than 35 countries, helping clinicians better understand the developmental potential of individual eggs and provide patients with more personalised insight earlier in their treatment journey.
From Research Collaboration to Clinical Adoption
The partnership between Future Fertility and Kato Ladies Clinic began as a scientific research collaboration in 2024, marking the first use of AI-powered oocyte quality assessment in Japan.
The collaboration not only validated the technology in a new patient population and across diverse clinical protocols — including minimal stimulation cycles —but also resulted in a peer-reviewed publication in Reproductive BioMedicine Online (RBMO) and a poster abstract presentation at ESHRE 2025.
The joint research explored how AI-derived oocyte quality scores relate to early embryonic development and overall treatment outcomes. In a retrospective study conducted at Kato Ladies Clinic, researchers analysed nearly 2,800 mature oocytes across more than 1,300 ICSI cycles, linking image-based assessments of egg quality to key developmental milestones.
The study demonstrated that lower AI scores were associated with reduced fertilization rates, delays, and abnormalities in early embryo development, increased developmental errors, and lower-quality blastocyst formation.
Notably, the researchers also found that cumulative oocyte scores were a stronger predictor of live birth outcomes than the number of eggs retrieved — underscoring the importance of assessing egg quality alongside quantity.
“Our collaboration with Future Fertility has demonstrated how artificial intelligence can uncover meaningful biological differences between oocytes that were previously difficult to quantify,” said Kenji Ezoe, senior scientist.
“Bringing this technology into routine clinical use is an important step toward translating research into improved patient outcomes.”
Future Fertility’s VP of clinical embryology & scientific operations, Jullin Fjeldstad, noted that the findings provide important clinical validation.
“Our joint research with Kato Ladies Clinic has shown how AI-based oocyte assessment can be directly linked to numerous embryo development outcomes, from fertilization through early developmental milestones and blastocyst formation,” she said.
“We are excited to see this work translated into clinical practice.”
Growing Demand for Fertility Care in Japan
The partnership comes at a time when demand for fertility treatment in Japan continues to rise.
The country performs over 450,000 fertility treatment cycles annually, making it one of the largest markets globally. Delayed childbearing and evolving societal trends have also contributed to increasing interest in egg freezing.
As patients seek more clarity and personalization in their care, tools that provide earlier insight into reproductive potential are gaining traction.
“Entering the Japanese market with a partner like Kato Ladies Clinic is a significant step forward for our global commercial strategy,” said Rafael Gonzalez, Future Fertility’s VP of global sales & strategy.
“It reflects the growing demand for technologies that support more transparent, data-driven fertility care across diverse healthcare systems.”
Expanding a Global Footprint
Founded in 1993, Kato Ladies Clinic is known for its pioneering work in natural and minimal stimulation IVF and has long been a leader in clinical innovation in Japan.
For Future Fertility, the partnership represents both a geographic expansion and a continuation of its broader mission to bring AI-driven insights into routine fertility care.
“We are proud to partner with Kato Ladies Clinic, a globally respected leader in IVF and a pioneer in reproductive medicine in Japan,” said Future Fertility’s CEO, Christy Prada.
“This partnership represents an important milestone as we expand into Asia and continue our mission to bring objective, personalised insights into fertility care worldwide.”
Future Fertility develops AI-powered tools designed to generate personalised insights across the fertility journey.
Its flagship oocyte assessment technologies analyse egg images to provide objective, individualised measures of egg quality, supporting treatment planning, patient counselling, and clinical decision-making in egg freezing and IVF, while also enabling more data-driven approaches to donor egg distribution and quality assurance.
As fertility care continues to evolve, collaborations like this one are helping shape a new standard — one that emphasises earlier insight, greater transparency, and more personalised decision-making for patients navigating increasingly complex reproductive journeys.
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