A Field in Transition - Animal Microbiome & Biotics

In 2013, a year after finishing my PhD in veterinary microbiology, I sat in a government meeting explaining to regulators why a bottle of bacteria was not a pathogen but a probiotic feed additive. Three months later, I registered the first animal probiotic feed additive -with over ten strains- for the country. And within seven months, four probiotic products were registered and imported, successfully.

The animal microbiome is not a marketing trend. It is not a label decoration, It is a scientific responsibility. And right now, we are commercializing complexity faster than we are understanding it. Someone in this space needs to say it clearly.

So here it is.
 

Where We Came From

Let me take you back to 2012.

I was a new graduate with a Ph.D. in Veterinary Microbiology and had been a Doctor of Veterinary Medicine for six years. I was excited, curious, and enthusiastic enough to believe that the information I had consumed day and night during twelve years of higher education could change the world. Well... at least mine! When I look back at those days now, I was both right and wrong.

I was right because I had already seen that what we knew about microorganisms was just a leaf on a centuries-old tree. During the nights I stayed at the lab, sleeping on a green military camp bed, waiting for PCR electrophoresis times for my avian tuberculosis trials, I had already realized that the next twenty years would be surprisingly big for microbiology and biotechnology.

After my graduation in 2012, I immediately met probiotics in the industry. But first!... I met two cousins from jewelry and construction backgrounds who had never heard the word "probiotic" yet had bought a couple of *tons* of animal probiotic products from the USA during a business trip. They thought, after a successful sales presentation, that "there is a future in this area," and signed an agreement with payment on the table to bring the products from North America and South Africa to Turkey. These two cousins found me, offered a nice salary, and said: "We know nothing about probiotics but need to import the product here, then start manufacturing as soon as possible. We only have a couple of sample products and these papers in English."

Picture a girl in her late twenties, sitting in a luxury office next to an old computer screen. Tens of folders on her desk -not about probiotics (there was not nearly enough information back then), just construction projects. I remember that first day, looking at the empty screen and thinking: *Lots of scientific experience with microorganisms, but not so much about probiotics. Not enough data for the business.* The actual learning was starting for me right at that point. And it was not a microorganism staining or a cat surgery. It was import process. Tariff codes. Customs. Lot numbers.

I had two options: like it and stay, or go back to the lab and the pathogens I knew. That night I spent hours searching for these probiotic products. Each hour brought me more passion. The next day, I went back to the office, asked for a clean desk and a notebook (received a construction company agenda which I am still keeping it), and started working.

And I was not just learning for myself.
 

What I Learned on the Ground

I had to attend meetings at the municipality to convince officials that the microorganisms in these bottles were not pathogenic. I had to spend

hours on the phone with government laboratory employees explaining why they needed to use different testing methods — otherwise the product looked like just a bottle of microbes. Turkey did not yet have a clear regulatory pathway for probiotic microorganisms used in animal feed. So instead of simply filling out forms, I found myself sitting in meetings at the Ministry of Agriculture explaining what these organisms actually were (the products were a combination of over ten strains) and how other parts of the world were regulating them. I brought the European regulatory framework to those discussions. I walked through how microbial feed additives were evaluated in the EU and other markets, what safety documentation looked like, how strains were identified, and how products were categorized.

In the spring and summer of 2013, I registered four probiotic feed additives for animals — one for livestock, one for dogs, one for silage premix, and one for horses — in April, May, and July of that year. Then I imported all of the pre-ordered products, activated the manufacturing facility, led marketing, sales, and R&D teams, and hired over 20 employees. I was twenty-eight years old, a fresh microbiologist who was excited and curious about the global probiotics business.

I did not fully appreciate what we were building. Now, looking back, I realize it was something else as well: one of the early steps in building the regulatory foundation for animal probiotics in that country. After that, the Ministry began actively building out the regulatory infrastructure for animal probiotics.

On the other hand, the science and the industry were also improving. Learning, discussing, generating... However:

• It was not easy to explain to doctors, veterinarians, and pharmacists what probiotics actually are.

• It was not easy to prove the benefits of a product in a bottle — even to mention them without proper scientific evidence.

• It was not easy to convince people to participate in in-vivo product trials and studies.

• And it was not easy to keep up with constantly evolving legislation while your product was already labelled and marketed under the previous rules.

Years passed. I started working for the main company of the same brand and had more opportunity to travel to other countries, train distributors on other continents, and teach them how to manufacture probiotics and use them properly. But still -the word "probiotic" meant almost nothing to most veterinarians, physicians, or pharmacists around me. Not because they weren't smart. When they were kind enough to listen, they gave great reactions. But the truth was clear: the science hadn't reached them yet. There was no infrastructure for it. No courses. No clinical guidance.

And that was normal, in a way. During my entire DVM and PhD education in microbiology, no less probiotics and the microbiome were barely mentioned. At my department, there was only one master's thesis on probiotics. One. In an entire microbiology department.

That was a little over a decade ago.

Now? The global animal microbiome market is projected to reach $13 billion by the early 2030s, growing at roughly 9% annually. Probiotics, prebiotics, postbiotics, phage therapies, microbiome diagnostics — these are no longer fringe ideas. They are the center of a commercial explosion. They are in pet owners' social media posts. They are showing up at conferences and in big pharma brand formulations. I liked how many booths were available at this year's VMX in Orlando with different microbiome products, ideas, and projects… It was different, even compared to last year's VMX.

But that is both the good news and the problem.

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What Changed and Why It Matters

Several things converged to create the market we see today.

First, antimicrobial resistance became impossible to ignore. The European Union banned all antibiotics as growth promoters in animal feed in 2006. Sweden had done it as early as 1986. Finally, the FDA followed with its own phased approach beginning in 2013. Suddenly, the industry needed alternatives — and probiotics were positioned as the answer.

Second, pet ownership grew worldwide. People started treating their animals more like family members. Spending on animal health products surged, and consumers began demanding cleaner, more natural options for gut health, immunity, and chronic conditions.

Third, the science itself accelerated. Next-generation sequencing made it possible to map microbial communities in ways we never could before. The research output doubled, then tripled. Animal microbiome became a legitimate field — not just an extension of human microbiome science.

To put that in perspective: in 2012, when I began my probiotic journey, the term "animal microbiome" returned just 57 papers on Google Scholar. Today, in 2026, it returns 4,080. Still modest compared to the 1,690,000 results for "microbiome" — but that is 71 times the growth in just over a decade.

All good so far. But here is where I start to get uncomfortable.

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The Real Problem: Probiotic Quality and Label Accuracy

Knowledge without education is wasted.

Although there is a beautiful increase on the scientific side of animal microbiome, the biotics market is growing faster than the science. Products hit shelves before mechanisms were understood. Marketing teams outpaced research teams. Labels promised what clinical data couldn't yet support, even what the regulatory bodies don't want to see.

Studies have shown that the contents of commercial animal probiotics are frequently inaccurate. Research published in peer-reviewed journals found that only about one in four veterinary probiotic products actually met or exceeded their label claims for viable organisms. Some contained none of the stated bacteria at all. Others misspelled the species names on the label — including, remarkably, labeling non-spore-forming Lactobacillus species as spore-formers. These are not minor errors. These are fundamental gaps in manufacturing integrity and scientific literacy.

I have lost count of how many companies I have contacted over the years just to correct errors on their own labels, as if it were my company. But someone had to.

And because probiotics in animal health are largely classified as "direct-fed microbials" or feed additives — not pharmaceuticals — the regulatory bar for market entry remains low. In the U.S., the FDA Center for Veterinary Medicine and AAFCO have listed species considered safe, but there is no requirement to demonstrate efficacy before selling. In most markets around the world, the situation is similar or weaker. This means that the person buying a probiotic for their dog, or the veterinarian recommending one to a client, often has no reliable way to know if the product contains what it says, does what it claims, or has been tested at the dose that would actually matter.

And that is not responsible biotics.

The revolution began over a decade ago. The education must begin today - we are already late!

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Responsible Biotics Means​:

• Mechanism comes before marketing. If you don't know how a strain works through what pathway, in which species, at what dose, you are not ready to sell it. A CFU number on a label is not a mechanism. A marketing story is not a mechanism.

• Data collection before claims. Clinical evidence in the target species, under realistic conditions, with appropriate controls. Not extrapolations from human studies. Not in vitro results dressed up as proof of efficacy. Not testimonials.

• Precision first, then speed. Strain-level identity matters. Host specificity matters. Shelf stability matters. Regulatory compliance across different markets matters. Cutting corners to get to market six months faster is not innovation but negligence wearing a lab coat. It is an approaching big loss.
   

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Why Education Is Part of the Solution

Here is something that doesn't get enough attention: the education system hasn't caught up either.

Most veterinary programs around the world still do not offer dedicated microbiome or biotics curricula. Veterinarians graduate without meaningful training in microbial ecology, probiotic pharmacology, or the regulatory landscape for these products. Then they are expected to advise clients who walk in with a bag of probiotic supplements they bought online.

This was true when I started my career. And while some progress has been made, the gap between what veterinarians need to know and what they are taught remains enormous. Since I have worked in human and agriculture probiotics businesses as well, I believe the same is true for those areas. Maybe another manifesto's topic.

This is not a criticism of individual veterinarians. We all know they are overworked, generally underpaid, and drowning in new information from every direction. The system is what failed... and the same system is what we need to fix. That is why I now place teaching at the heart of my work. Because knowledge is the only thing that changes outcomes. We urgently need targeted, practical educational programs for the people who care for animals and make business decisions every day: veterinarians, feed and nutrition teams, livestock and aquaculture managers, pet health companies, and pharma and biotech developers.

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The Field We Could Build

I am not against commercialization or innovation. I have spent almost two decades helping companies develop, formulate, register, and launch microbiome-based products across continents. I have written the regulatory dossiers, designed the clinical protocols, and sat across from the regulators. I want this field to succeed.

But I want it to succeed on the right foundation.

I want to see an industry where a probiotic label is a scientific promise, not a marketing dilemma. Where the veterinarian who recommends a product knows exactly what it contains and why they chose specifically that bottle, that strain, that brand. Where the company that invests in proper strain characterization and clinical trials is rewarded — not undercut by a competitor selling fairy dust in a capsule.

We are at an inflection point. The science is there. The market demand is there.
The regulatory conversations are happening... The only question is whether we build this field responsibly — or whether we let the gold rush bury the science.

I know which side I'm on.​

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Dr. Nihan
Founder, Sigma BioVet Sciences

If you are building something in animal microbiome or biotics and want to do it responsibly; I'd like to hear about it.
 

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