The animal health industry is evolving, driven by scientific advances and regulatory developments. While many of the key themes have been discussed for years, they continue to shape the industry in significant ways. Experts from the Medfiles animal health team have identified several prominent, ongoing and emerging trends that are influencing the animal health industry and discuss them in this blog post. See also our post on the trends in 2026.
Shift from livestock to companion animal health
One very prominent trend seems to be the shift from livestock animal health to companion animal health. The number of pet owners around the world is increasing, with many seeing pets as integral members of the family rather than just animals.
This humanisation of pets is leading to greater investment in their health and well-being. As pet ownership increases, so does the demand for safe and effective veterinary medicines tailored to companion animals. This trend highlights the importance of dedicated pharmacovigilance systems that can accurately monitor and manage adverse events in companion animals, ensuring timely detection and response to any safety concerns.
Sustainability in veterinary medicines and feed
Sustainability is a major driver of innovation in animal health. Companies are investing in research and development to develop new feed additives and veterinary medicines that support more sustainable production. A good example is a recently developed feed additive that traps methane in the rumen. Methane is one of the greenhouse gases that contribute to global warming. Heat also causes significant stress in farm and companion animals. This in turn has spurred efforts to develop new products that improve animal welfare. Companies are also looking at their own production lines and making massive investments to improve sustainability in manufacturing.
As environmental sustainability becomes a global priority, animal health regulatory affairs must adapt. Antimicrobial resistance (AMR), carbon footprint and ecological impact must now be considered in regulatory submissions and variations. The European Union is driving sustainability through new legislation such as the EU Deforestation Regulation (EUDR) and the Corporate Sustainability Due Diligence Directive (CSDDD). EUDR requires companies to check whether their materials were grown or produced on land that was subject to deforestation or forest degradation, and that local laws were applied. CSDDD is to foster sustainable and responsible corporate behavior in companies’ operations.
Regulatory experts are increasingly at the forefront of ensuring that products meet not only safety and efficacy standards, but also environmental expectations.
Antimicrobial resistance and demand for natural products
Antimicrobial resistance is one of the most pressing issues in both human and animal health. Regulatory authorities are placing more stringent requirements on antimicrobial products, including restricting the use of certain antibiotics, requiring stewardship programmes and enforcing stricter regulations. The EMA has stated that the increasing emergence of bacteria resistant to multiple antibiotics is a global public health threat.
In parallel, there is a growing interest in natural products to improve animal health and welfare. Medicinal plants have historically played an important role in veterinary practice. European veterinarians, for example, have been using herbal remedies to treat and prevent animal diseases for decades. However, only a limited number of registered herbal veterinary medicines remain on the European market today.
Regulatory and safety considerations for biologics
The use of biologics such as gene therapies, monoclonal antibodies and biologic vaccines is expanding rapidly in veterinary medicine, particularly in immunology, oncology and chronic disease management. These products offer promising new treatment options but require a more intricate regulatory framework.
Regulatory affairs teams must manage a range of specific data requirements, quality standards, and post-market commitments to ensure the safety and efficacy of biologics. These products often require more extensive clinical trials, detailed manufacturing processes, and rigorous quality control measures compared to traditional small-molecule drugs. Furthermore, there is an increasing emphasis on the long-term monitoring of biologics in the market, necessitating ongoing collaboration with regulatory authorities to ensure compliance throughout the product lifecycle. In addition to regulatory work, pharmacovigilance plays also a critical role while assessing the safety and efficacy of these new therapies. Detailed risk minimisation plans tailored to the specific characteristics of biologics are needed, ensuring that any safety concerns are promptly identified and mitigated.
AI and novel technologies in animal health
New technologies such as digital therapeutics and AI-based diagnostic tools are reshaping the animal health landscape. As these innovations enter the market, regulatory frameworks must evolve to ensure their safety, efficacy and overall suitability for approval.
The increasing use of data management tools and artificial intelligence (AI) is also changing the way regulatory decisions are made. AI and machine learning can analyse large volumes of data, identify patterns in submissions, detect potential issues early and predict outcomes. These insights enable more informed, faster and more accurate decisions.
AI is becoming an increasingly valuable tool in pharmacovigilance, particularly in the detection and analysis of adverse events. By integrating these technologies into regulatory workflows, teams can improve efficiency, strengthen compliance and stay ahead of evolving regulatory requirements.
Regulatory shifts and industry challenges
One of the enduring trends is the constant complaint from animal health companies about regulatory complexity. This challenge is not unique to the EU – despite its reputation for stringent requirements – but is present globally. While there is a strong demand for product safety and efficacy, companies are also asking for greater flexibility and higher speed in the authorities’ evaluations and authorisations. Producing separate products for different markets due to different regulatory requirements is costly.
Regulatory developments are shaping practices in many ways with new guidelines and frameworks. For pharmacovigilance, these changes are to enhance safety monitoring but at the same time they are prompting companies to invest in robust pharmacovigilance systems to comply with the standards. Therefore, the integration of digital technologies in pharmacovigilance processes is a significant and increasing trend. Advanced data analytics and artificial intelligence are being utilized to enhance the detection and analysis of adverse events.
Recent regulatory shifts in the US are also impacting the animal health sector. The FDA has taken over full responsibility for feed ingredient approvals, ending its long-standing collaboration with AAFCO. The future influence of AAFCO is still unclear. Meanwhile, further reforms are being considered, including changes to the GRAS (Generally Recognized as Safe) process, aiming to strengthen oversight and transparency. These developments may have wider implications for the entire feed and food chain.
We hope this blog has provided a valuable insight into current trends in animal health. Sailing the complicated regulatory waters of animal health is our daily business – please do not hesitate to contact us. We’ll help you set your sails in the right direction to reach your target harbour smoothly.
See also
- Meet Medfiles’ dedicated animal health team – experts in CMC, regulatory affairs, pharmacovigilance and animal feed
- Free webinar: EU Veterinary Medicinal Products Regulation from the perspective of variations and the quality part of the pharmacovigilance system
Authors
Mari Eskola, Ph.D.
Senior Regulatory Affairs Expert (food, feed and cosmetics), Team leader of Regulatory Science and Reports
Mari Eskola is a former staff member of the European Food Safety Authority (EFSA) and joined Medfiles in 2021. Since then, she has been involved in several projects on food, feed and cosmetics conducted for Medfiles’ clients.
Mari is a food chemist specialised in analytical chemistry and in 2002, she obtained a PhD degree in food science. Mari has over 25 years of international expertise in the chemical and regulatory safety of food and feed from the European Union and European national organisations as well as from the industry. She has worked for 10 years at the EFSA, carrying out EFSA regulatory risk assessments of contaminants in foods and feeds, where she also worked as acting and deputy head of the EFSA Contaminants Unit.
In addition, Mari has food and feed research and regulatory expertise from various other European institutes, such as the European Commission Joint Research Centre (EC JRC), the European Chemicals Agency (ECHA), Teagasc in Ireland, the Austrian University of Natural Resources and Life Sciences and the former Finnish Food Safety Authority. Mari has international experience in managing projects and people, and she has authored several scientific publications comprising also many scientific EFSA opinions and risk assessments.
Annika Stigell, B.Sc
Regulatory Affairs Expert
Annika has been working at Medfiles since 2017. She started her regulatory career at Fimea (Finnish Medicines Agency), and has worked with pharmaceutical regulatory tasks for more than a decade. She is part of Medfiles’ veterinary and human medicines team, where she handles regulatory tasks related to marketing authorisations (MA), as well as national Scandinavian translations and labelling reviews.
Saana Lamminjoki, M.Sc
Safety Manager
Saana Lamminjoki joined Medfiles Pharmacovigilance team in May 2021 and since then has been working with both human and veterinary PV activities in the EU and UK.
Currently Saana is responsible for operational leading of veterinary pharmacovigilance activities. Her day-to-day responsibilities for veterinary products include, for example, monitoring of published scientific literature, signal detection and management, risk management and evaluation and processing of adverse event reports from the EU, UK and third countries. Saana is actively involved in the maintenance of the Pharmacovigilance System Master File (PSMF) and the Quality Management System, ensuring that all veterinary SOPs and processes are compliant. She has also contributed to the set-up of the veterinary PV system.
With a bachelor’s degree in pharmacy and a master’s degree in general toxicology, Saana brings her knowledge and expertise to her role.
