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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
The government and NHS England should work with pharmacies to show how the sector can help women experiencing menopause symptoms, according to a joint statement released by several pharmacy bodies.
A consensus statement endorsed by the Royal College of Pharmacy warned there remains significant unmet need for clear, evidence-based guidance and advice on the condition.
The statement, ‘Menopause, unmissed’, published on 24 April 2026, was endorsed by bodies including the Royal College of Pharmacy, the Company Chemists’ Association and the National Pharmacy Association.
Amandeep Doll, director for England at the Royal College of Pharmacy, said: “Pharmacy teams are highly accessible and already support people experiencing menopause with advice, self-care and signposting to other services.
“We endorsed this statement because improving access to clear information and joined-up care is essential, particularly for those facing inequalities.”
According to the NHS, around 75 per cent of women experience some symptoms during perimenopause and menopause, while 25 per cent report that their symptoms are severe.
In the joint statement, the pharmacy bodies welcomed increased awareness of menopause in recent years but warned this had also led to a sea of misinformation and that there remains significant unmet need, particularly for clear, evidence-based and accessible information and guidance.
The document set out eight recommendations to improve menopause care, including a public awareness campaign on menopause symptoms and opportunities for self-care, alongside guidance on how pharmacies can support women with menopause.
It also recommended that integrated care boards and women’s health hubs should report progress on implementing the upcoming equity framework in menopause care.
In its renewed women’s health strategy for England, published on 15 April 2026, the Department of Health and Social Care set out plans to publish an equity good practice guide to help integrated care boards better understand and reduce inequalities in heavy periods and menopause.
The joint statement asked that the Department of Health and Social Care and NHS England work with champions in minority communities to ensure menopause materials reflect a diverse range of experiences.
It added that women living in areas of high deprivation and those from Black, Asian and minority ethnic communities can experience menopause differently and are more likely to face health inequalities in their care.
Doll said: “With the right support, training and commissioning, community pharmacy can play a greater role in delivering timely, convenient menopause care closer to home, working as part of neighbourhood health teams and in partnership with women’s health hubs.”
Article produced in association with Spital Clinic
The UK’s fertility rate has fallen for a third consecutive year to the lowest level ever recorded. That headline gets written every year, and it is easy to read it as a purely demographic story.
For anyone currently trying for a baby, the figure is something more practical: the conditions that produced the statistic are the same conditions shaping your own chances.
The decline has a clear pattern, and it is mostly not about couples being unable to conceive.
The change sits in when people start trying, and in what happens to fertility during the years by which most are now ready to have children.
What the numbers actually show
Figures from the ONS put the total fertility rate in England and Wales at 1.41 children per woman in 2024, down from 1.42 in 2023. The rate has been in overall decline since 2010 and has now recorded its lowest value three years running.
The figure sounds abstract until you compare it with the replacement level of 2.1 – the rate required for a population to sustain itself without net migration.
The UK has been below that line since the early 1970s, but the gap is now wider than at any point on record.
The data also shows where the decline is happening. Age-specific fertility rates for women in their twenties are the lowest of any generation since 1920. Rates for women in their thirties are holding up, and in some parts of the country rising.
Mothers are having babies later, not necessarily in smaller numbers. The average age of a first-time mother in England and Wales is now 31.0, up from 30.9 the year before. Regional variation matters too: London sits at 1.35, the West Midlands at 1.59.
Why the rate is falling
None of this is new. Every decade since the 1970s has seen the same trend, and it has accelerated in recent years. What has changed is the pace.
The shift is primarily social: delayed partnership formation, high housing costs, expensive childcare, and careers structured around full-time work through the exact years fertility is easiest.
The same pattern shows up across the EU, where the total fertility rate sat at 1.5 in 2022.
These forces compound. People meet later, partner later, feel financially ready later, and start trying later.
For many couples, first attempts happen in the early thirties, by which point fertility has begun its slow and uneven decline. A low national TFR is the population-level consequence of millions of individual timing decisions made under real-world constraints.
What this means for individuals trying now
Around one in seven couples in the UK will struggle to conceive naturally.
That figure has been stable for decades; the population of people seeking help, however, has grown – not because fertility itself has worsened, but because more people are trying during the window where it becomes harder.
UK fertility treatment data from the HFEA shows around 52,400 patients had over 77,500 IVF cycles in 2023, making 1 in every 32 UK births IVF-conceived.
The average age of a first-time IVF patient in the UK is now just over 35 – nearly six years older than the average first-time mother in the population overall.
NHS-funded IVF cycles have fallen from 40 per cent of the total in 2012 to 27 per cent in 2022, and to 24 per cent in England in 2023. The private sector has absorbed the rest.
When to get checked – and what it involves
Current NHS advice is to see a GP after a year of regular unprotected sex without a pregnancy, or sooner if you are 36 or older.
That threshold reflects the fact that every additional six months of trying is more clinically informative in the years when fertility is starting to shift.
The first set of investigations is usually straightforward.
For women, this typically covers hormone testing (AMH, FSH, LH, TSH and prolactin), rubella immunity, chlamydia screening, a mid-luteal progesterone and a transvaginal ultrasound.
For men, a semen analysis is the first step.
A private trying-to-conceive screening covers the same ground without the NHS waiting list, with the advantage that results can be reviewed in a single consultation.
The purpose of early screening is not to diagnose infertility – most couples conceive naturally within a year or two – but to identify specific, treatable issues before more time passes.
The fertility window is narrower than most people think
The uncomfortable truth behind the falling TFR is that the biological fertility window has not changed. The subtle decline begins around age 32, and accelerates from the late thirties.
The chance of natural conception in any given month is substantially lower at 40 than at 30, and falls sharply through the early forties.
IVF success rates track the same curve.
For patients aged 18 to 34, the average birth rate per embryo transferred was around 35 per cent in 2022; for those aged 40 to 42, around 10 per cent using their own eggs.
This is why the growth areas in UK fertility care are now pre-conception screening and elective egg freezing – HFEA data shows egg storage cycles rose from 4,700 in 2022 to 6,900 in 2023, one of the fastest-growing treatments in the sector.
A focused fertility consultation earlier in the timeline – in the late twenties or very early thirties, before there is a known problem – tends to produce better decisions than a consultation triggered by a year of trying without success.
The wider picture
The UK’s falling fertility rate is the product of a society that has reorganised when people have children, not one in which couples have become less capable of conceiving.
There is no need for alarm in that finding. The practical takeaway is that the old default of ‘wait and see’ assumes a timeline no longer matching the one most people now live.
For anyone currently trying, or planning to try soon, the single most useful move is to understand your own numbers earlier than previous generations did.
The national trend is not going to reverse quickly.
A clear picture of your own fertility window – and the information to use it well – is within reach in a way the headline statistics are not.
If you are trying to conceive or thinking about starting, a structured pre-conception review is a reasonable first step.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment. Clinical guidance referenced reflects published NHS, ONS and HFEA data as at April 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 Spital Clinic, 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.
The women’s digital health market is set to reach US$5.28bn in 2026, up from US$4.36bn in 2025, according to a new report.
That would represent annual growth of 20.9 per cent, driven by factors including greater smartphone use among women, wider uptake of telehealth and a stronger focus on preventive care.
The report said the market could reach US$11.47bn by 2030, with projected annual growth of 21.4 per cent over the forecast period.
It also pointed to rising awareness of gender-specific health needs, expansion among digital health start-ups, growing demand for personalised healthcare, investment in femtech innovation and the spread of AI-enabled diagnostics.
Wearables linked to health apps and wider use of remote monitoring tools are also expected to play a larger role, as companies focus on more preventive and joined-up care.
Smartphone use was highlighted as a major driver because mobile apps are increasingly being used for women’s health services, from menstrual cycle tracking to pregnancy support.
The report cited Eurostat data showing that in 2023, 89 per cent of EU residents aged 16 to 74 in urban areas accessed the internet via smartphones.
The report also said companies in the sector are developing new technology aimed at improving access to more personalised healthcare.
One example it gave was a 2024 collaboration between Algorand and the Self-Employed Women’s Association to launch a digital health passport for women in India’s informal economy using blockchain technology.
Recent mergers and acquisitions were also noted. In March 2023, Maven Clinic acquired Naytal to expand its services in the UK and Europe.
North America was identified as the largest market in 2025, while Asia-Pacific is expected to be the fastest-growing region.
Companies named as key players included Flo Health Inc, Natural Cycles, Elvie, Bellabeat, Clue by Biowink, MobileODT Ltd., Glow, Veera Health, Biowink GmbH, Ava AG, Hims & Hers Health, Inc., The Women’s Wellness Centre, Elara Health, myGynaeDoc, Maven Clinic, Kindbody, Allara Health, Tia and Hera Med Ltd.
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