As 2025 draws to a close, I would like to take a moment to reflect on the key events and trends shaping our industry — and how they position us for the year ahead.
Despite a continued challenging economic environment across biotech, the past 12 months have brought meaningful progress for the microbiome field. We have seen encouraging developments in microbiome therapeutics, alongside impressive resilience from companies committed to addressing unmet medical needs for patients.
At the same time, new patterns are emerging with the rapid development of — and growing demand for — Next-Generation Probiotics.
Here at Biose Industrie, I am proud of how our teams navigated these dynamics while delivering strong results. In 2025, we onboarded more than 200 new client strains across our U.S. and EU facilities, produced 450 certified active-substance batches, and delivered 250 certified finished-product batches.
With early signs of renewed investor interest and new European public-funding initiatives building momentum into 2026, I am optimistic that our industry is preparing for a new wave of opportunity — not only next year, but well beyond.
Clinical and Regulatory Milestones
If there is one feature that has truly defined 2025 for the microbiome field, it is the strength of the Phase II and III therapeutic readouts.
MaaT Pharma’s Xervyteg® (MaaT013) demonstrated a three-fold increase in one-year survival among patients with GI-aGvHD in the pivotal ARES Phase III trial creating waves for the microbiome field and making headlines globally. These results supported submission to the EMA under an MAA — positioning Xervyteg® as potentially the first microbiota therapeutic in hemato-oncology.
Siolta Therapeutics announced positive topline results from the Phase 2 ADORED study of STMC-103H, its lead oral microbial therapy. Infants completing one year of treatment showed a clinically meaningful reduction in the risk of developing atopic dermatitis and food allergy, including a 77% reduction in physician-diagnosed food allergy, with consistent benefits across secondary endpoints.
In the metabolic space, Bloom Science reported that BL-001, an investigational oral therapy, achieved statistically significant placebo-adjusted weight loss at 28 days in a Phase 1 study.
We also saw compelling long-term data published in Nature Communications. In a cohort of adolescents originally enrolled in an FMT study eight years earlier, participants in the treatment arm were, on average, 11 kg lighter than placebo recipients four years post-intervention.
Looking ahead, 2026 is poised to be a milestone year, with anticipated topline data from Vedanta’s Phase 3 RESTORATiVE-303 study, potential EMA marketing authorization for Xervyteg®, and possible FDA accelerated approval for Infant Bacterial Therapeutics’ IBP-9414 in the United States.
In addition, the EMA’s positive Pediatric Investigation Plan decision for AOB Pharma’s B244 in atopic dermatitis and pruritus enables AOBiome to move toward an initial MAA submission following completion of its pivotal and extension studies.
Finally, Exeliom Biosciences continues advancing multiple Phase 2 programs evaluating a Faecalibacterium prausnitzii-derived LBP to prevent post-surgical recurrence in Crohn’s disease and as an adjuvant across several oncology indications with data expected in early 2027.
Promising Financial Indicators
2025 also brought encouraging financial signals for the microbiome and next-generation probiotics sector:
MRM Health successfully closed a €55M Series B round — a landmark raise that drew widespread attention across the European biotech ecosystem. SNIPR Biome likewise completed its Series B at $35M, bringing its total funding to more than $90M to continue advancing its pipeline.
The acquisition of The Akkermansia Company by Danone in July marked a significant inflection point for the next-generation probiotics market, underscoring growing strategic interest from major consumer health players.
Beyond these transactions, we observed several early-stage financings as well as two announcements with important implications for the years ahead:
- Novo Nordisk and Novonesis entered into a partnership to explore the role of the gut microbiome in metabolic health — with the dual aim of informing product development and identifying predictive biomarkers for obesity prevention.
- Wellcome Leap launched the FORM (Foundations of a Resilient Microbiome) program — a $50M initiative designed to investigate the causal link between early-life microbiome dysfunction and neurodevelopmental conditions such as autism.
Together, these developments reinforce gr owing investor confidence and highlight the strategic relevance of microbiome science across pharma and consumer health.
The EU Biotech Sector
As the CEO of a company with facilities in France and the US and Treasurer of the European Microbiome Innovation for Health, I have been well-positioned over the past years to monitor both the EU and US markets closely.
The EU has traditionally controlled the biotech market through tighter regulations and reduced market exclusivity periods, a strategy that inadvertently signalled a ‘hostile’ environment for R&D and drove significant capital migration to the United States. This ‘production drain’ was starkly validated by the recent Draghi report, which identified the chronic investment gap as a primary threat to European stability within the biotech industry.
However, it is great to see important steps being taken that will greatly increase the EU’s competitive position moving in to 2026 with the announcement of The Biotech Act and the €10 billion BioTechEU initiative. By introducing regulatory sandboxes, simplifying clinical trials, and creating a massive capital injection, the European Commission aims to strengthen the EU biotech sector with the objective to restore a regulatory and industrial environment capable of sustaining innovation within Europe.
The Consolidation of Live Biotherapeutics Products & Next Generation Probiotics
To properly understand the current microbiome landscape, it’s essential to understand how it now spans two converging and increasingly interconnected sectors:
Live Biotherapeutic Products (LBPs) are fully regulated biological medicines developed under stringent GMP conditions and supported by advanced CMC packages, and multi-phase clinical trials.
Next-Generation Probiotics (NGPs) by contrast, are positioned within the Consumer-health space but are increasingly underpinned by strain-specific clinical data, multi-omics characterisation, and precision formulation strategies. Companies such as Pendulum, Design for Health, Verb Biotics, and Clostra Bio are generating robust real-world datasets feeding therapeutic discovery.
Increasingly, microbiome companies are considering a dual strategy, leveraging their expertise in LBPs to launch NGPs. This approach allows companies to generate early revenue and gather solid scientific evidence while navigating the lengthy pathway for biological drugs.
Despite distinct regulatory frameworks, both LBPs and NGPs rely on shared biology and industrial foundations such as fermentation and formulation technologies, analytical methods, manufacturing infrastructure, supply-chain management, and downstream quality and data systems. This convergence is giving rise to a unified industrial ecosystem, and ample market opportunities for Biose. making NGPs a primary focus area for our company’s strategy moving forward.
It’s all about the Science
Albeit I am writing this letter as Biose’s CEO, I am a scientist at heart and especially excited to see recent advances in both basic and population-level research.
What were once viewed largely as associative “gut–organ” links are now increasingly supported by mechanistic evidence, moving the field from correlation toward causality.
Studies published this year have shown that specific gut-derived metabolites do not merely circulate through the body, but actively influence immune function in peripheral tissues such as the skin and lungs, effectively acting as systemic signalling molecules.
At the same time, researchers are beginning to characterise microbial communities in biological sites that were long considered sterile or biologically marginal. Emerging data indicate that low-biomass environments — including intratumoral niches and the ocular surface harbor distinct microbial signatures capable of modulating disease progression and influencing responses to existing therapies.
As research increasingly moves beyond the gut, women’s health has emerged as one of the most compelling areas where microbiome science is now delivering robust, mechanistic insights.
Over the past years, several academic groups and industrials— including work conducted by Seed Health, Freya Biosciences, Biocodex, and teams at Massachusetts General Hospital — have significantly contributed to elevating vaginal microbiome research to the level of global health priorities, with initiatives that have reached major institutional stakeholders such as the Gates Foundation.
Recent publications have moved the field beyond descriptive abundance profiling, demonstrating how Lactobacillus crispatus–dominated ecosystems form structured, protective biofilms that actively reinforce epithelial integrity and limit pathogen invasion. These findings provide a mechanistic framework explaining why L. crispatus–rich microbiota is consistently associated not only with protection against bacterial vaginosis, but also with improved reproductive and gestational outcomes.
In parallel, growing clinical and translational evidence continues to strengthen the rationale for strain-specific approaches in women’s health. Recent peer-reviewed studies published in 2024–2025 have further documented the functional properties of Lacticaseibacillus rhamnosus Lcr35, including its capacity to modulate host–microbe interactions across multiple indications, from mucosal protection to systemic metabolic and inflammatory pathways, moving away from generic probiotic concepts toward well-characterized, clinically validated strains.
Conclusion
The microbiome field is coming out of a transition period, being defined by in-human data, industrial maturity, and clear regulatory pathways. With some important milestones expected and signs of a recovering financing landscape I remain bullish entering 2026.
At Biose we look forward to another year of continuing to support leading microbiome companies around the world with their mission of developing the next generation of microbiome products for patients with unmet medical needs.
Supporting our clients with this mission is the very foundation of our business and as such, I’d like to close this year’s wrap-up with the words of Adam Wilkinson, Vice President of Pre-Clinical Development at Microbiotica:
“Working in partnership with the Biose team, we are delighted to have successfully navigated the challenges of process development and scale-up of two LBPs in parallel. Manufacturing of biologics can be challenging at the best of times, but the development of multiple processes to be scaled up to cGMP standard poses significant challenges, and seamless open collaboration between our project teams has been essential to success”
Wishing everyone a very Happy New Year filled with joy and success.
Yours Sincerely,
Adrien Nivoliez
Chief Executive Officer, Biose Industrie
