Jinan Zhuocheng Bio-Tech Co., Ltd.

The veterinary active pharmaceutical ingredient (API) industry is undergoing a significant technological transformation in 2026.

As price competition continues to put pressure on margins for several high-volume veterinary APIs, the traditional growth model based primarily on capacity expansion and scale is facing new challenges. At the same time, technologies including synthetic biology, enzymatic catalysis, fermentation strain engineering, green crystallization, continuous-flow processing and process analytical technology (PAT) are moving from research and development toward industrial application.

These developments are creating new approaches to cost reduction, quality improvement and greener manufacturing across the veterinary API value chain.

From an industry perspective, several major technological directions are emerging. These include using biological technologies to redesign conventional chemical synthesis routes, improving fermentation efficiency through strain engineering, enhancing purity and stability through crystallization engineering, and using continuous manufacturing and digital technologies to strengthen process control.

Synthetic Biology and Enzymatic Processes Are Upgrading Conventional Manufacturing

Synthetic biology and enzymatic catalysis are becoming important approaches for optimizing veterinary API production processes.

In the florfenicol value chain, for example, companies and research institutions are exploring the use of enzymatic and biological manufacturing technologies to replace selected stages of conventional chemical synthesis. Due to the high selectivity of enzymes, these approaches can potentially reduce side reactions, raw-material consumption and certain high-energy or high-emission steps associated with traditional chemical processes.

For the florfenicol intermediate D-ethyl ester, enzymatic processes using L-threonine transaldolase (LTTA) have been explored and are being developed toward larger-scale production. The industrialization of such processes may help reduce pollutant generation while improving the overall cost structure of conventional manufacturing.

Multi-enzyme cascade catalysis is another important area of development. By combining enzymes such as amino acid oxidase, pyruvate decarboxylase and transaminase, multiple sequential reactions can potentially be performed within a single biological system, reducing intermediate isolation and the number of conventional chemical processing steps.

In products such as vitamin D3 metabolites, researchers are also working to improve biocatalytic efficiency by optimizing cytochrome P450 systems and their electron-transfer pathways.

These developments indicate that synthetic biology is gradually moving beyond laboratory research and into veterinary API manufacturing. For established high-volume products, future competitiveness may increasingly depend not only on production capacity, but also on enzyme libraries, microbial strains, process platforms and accumulated biomanufacturing expertise.

Fermentation Strain Engineering Is Becoming a Key Advantage for Macrolide APIs

For fermentation-based veterinary APIs such as tylosin, tylvalosin and tilmicosin, microbial strain performance and fermentation efficiency have a direct impact on production costs and overall competitiveness.

In recent years, genetic engineering and synthetic biology have increasingly been applied to industrial strain development. By optimizing metabolic pathways, improving target-product biosynthesis and reducing unwanted by-products, manufacturers can potentially increase fermentation titers and production efficiency.

Some companies are also combining genetic engineering with high-throughput screening and AI-assisted strain selection to improve the efficiency of strain development.

For macrolide APIs, competitiveness is therefore increasingly determined by a combination of fermentation titer, production efficiency, purification performance and the internal supply of key intermediates.

Companies with long-term experience in strain development and fermentation process optimization may consequently have stronger cost-control capabilities as market conditions change.

Green Crystallization and Impurity Control Are Becoming More Important

The development of companion animal pharmaceuticals and regulated international markets is increasing requirements for API purity, crystal form, stability and impurity control.

For fermentation-derived products with complex compositions, improving fermentation performance alone is not sufficient to ensure final product quality. Downstream separation, purification and crystallization processes can also have a significant impact on the purity and stability of the final API.

Green crystallization and crystal-form control are therefore receiving increasing attention.

For fermentation-derived products such as avermectins and ivermectin, the presence of multiple related components and potential degradation products during storage creates additional challenges. Crystallization methods, solvent systems, crystal morphology and process parameters can all influence the purity and stability of the final product.

At the same time, some veterinary and companion animal APIs are being developed using crystallization and filtration processes as alternatives to conventional column chromatography or preparative liquid chromatography, with the potential to reduce solvent consumption and manufacturing costs.

For products such as diclazuril and selamectin, process-development efforts have included high-purity crystallization, controlled oxidation and recrystallization technologies.

As companion animal pharmaceuticals and export markets place greater emphasis on product quality, high purity, controlled crystal forms and well-defined impurity profiles are becoming increasingly important for selected high-end veterinary APIs.

Continuous-Flow Processing and PAT Are Moving Manufacturing Toward Real-Time Process Control

Conventional API manufacturing has traditionally relied on batch production, with quality testing often performed after production has been completed.

The development of continuous-flow chemistry, continuous bioprocessing and process analytical technology (PAT) is gradually changing this model.

Continuous-flow microreactors can provide more precise control of parameters such as temperature, pressure, flow rate and reaction time. This can improve process stability while reducing certain unwanted side reactions and waste generation.

In selected florfenicol manufacturing processes, continuous-flow technology has been explored to improve reaction efficiency, reduce by-product formation and lower wastewater treatment requirements.

PAT further moves quality control closer to the production process by enabling online or real-time monitoring of critical process parameters and quality attributes. This allows manufacturers to identify process deviations at an earlier stage.

The integration of PAT systems with manufacturing execution systems (MES) is also supporting the digital transformation of API production.

In the future, quality control may increasingly shift from a model based primarily on “testing after production” toward “real-time monitoring during production.” This could improve process consistency, batch-to-batch reproducibility and traceability.

Biomanufacturing Is Expanding the Scope of Veterinary APIs

Technological innovation is not limited to improving the manufacturing processes of established anti-infective APIs. It is also expanding veterinary APIs into areas such as reproductive management, metabolic health and antimicrobial alternatives.

For example, microbial biosynthesis of prostaglandin F2α is being investigated as an alternative to conventional chemical synthesis, potentially providing new manufacturing routes for products used in reproductive management in livestock.

Recombinant veterinary biologics represent another important area of development. Genetic engineering and recombinant protein-expression technologies can be used to develop biologically active proteins for applications such as animal reproduction and disease management.

At the same time, probiotics and other microbiome-based technologies, functional enzymes, bacteriophages and active ingredients derived from traditional Chinese veterinary medicine are continuing to develop.

Together with the global trend toward reducing unnecessary antimicrobial use, improving animal production efficiency and strengthening integrated disease management, these technologies are expanding the scope of the veterinary API industry beyond conventional anti-infective products.

Technology Is Changing the Competitive Landscape

The current technological developments indicate that competition in the veterinary API industry is gradually moving beyond simple capacity and price competition toward technology, process efficiency, quality and overall manufacturing capabilities.

Synthetic biology and enzymatic technologies can address cost and environmental challenges associated with conventional production routes. Fermentation strain engineering directly affects the efficiency of macrolide API manufacturing. Green crystallization and impurity control contribute to higher-quality products, while continuous-flow processing and PAT can improve manufacturing consistency and process control.

Meanwhile, emerging biomanufacturing technologies are creating new opportunities in reproductive management, metabolic health and antimicrobial-alternative applications.

For manufacturers, technological competitiveness is increasingly about more than developing new products. It also involves continuously improving the manufacturing processes of established APIs, enhancing quality consistency, increasing production efficiency and building manufacturing systems capable of meeting different international quality requirements.

The competitive question in veterinary APIs is gradually shifting from “Can the product be manufactured?” to “Can it be manufactured more efficiently, consistently and sustainably?”

As technologies such as synthetic biology, enzyme engineering, fermentation engineering, crystallization engineering, continuous manufacturing and digital quality control continue to mature, technological innovation is expected to become an increasingly important driver of the next stage of development in the veterinary API industry and may further influence the global animal-health supply chain.