Veterinary Active Pharmaceutical Ingredients Manufacturing Market Size Analysis:

The Veterinary Active Pharmaceutical Ingredients Manufacturing Market was valued at USD 6.3 Billion in 2023 and is expected to reach USD 15.16 Billion by 2032, growing at a CAGR of 6.94% over the forecast period 2024-2032.

The Veterinary Active Pharmaceutical Ingredients (API) Manufacturing Market report delivers the key statistics on the current state and developmental trends. It covers important areas where veterinary diseases are common, impacting API demand. Recognising most commonly prescribed drugs and regional trends in veterinary prescription generation. Analysis of the volumes of APIs produced and used breakout trends for manufacturing in the report. It analyzes healthcare expenditures on veterinary drugs, broken down by governmental, insurance, and out-of-pocket spending. In addition, it analyzes the regulatory environment and compliance in a region-wise manner and reviews the R&D investment trends with a focus on biotech-driven and sustainable APIs. These insights offer a comprehensive view of market dynamics, guiding stakeholders in strategic decision-making. The veterinary active pharmaceutical ingredients (APIs) manufacturing market is primarily driven by the rise in pet ownership globally and stringent regulatory standards.

Veterinary Active Pharmaceutical Ingredients Manufacturing Market Dynamics

Drivers:

• The increasing prevalence of zoonotic diseases has heightened the demand for veterinary APIs to control and prevent disease transmission between animals and humans.

The increasing incidence of zoonotic diseases that transmit from animals to humans has led to a significant increase in the demand for Veterinary Active Pharmaceutical Ingredients (APIs). New data emphasize the necessity of working to combat these health threats. In 2023, the European Union (EU) witnessed a significant rise in zoonotic infections. ​Listeriosis cases 2,952 the highest number since 2007. The increase comes as Europe’s population is aging; 21.3% of Europeans are now over the age of 65 and are more vulnerable to severe symptoms. Contaminated, ready-to-eat foods like cold smoked salmon and dairy products were common sources of infection. Furthermore, campylobacteriosis and salmonellosis still ranked among the most reported zoonoses in the EU, with a total of 148,181 and 77,486 cases, respectively. Outside of Europe, other areas have faced serious strains. From May 1, France reported 78 indigenous cases of dengue fever in 2024, compared to 66 in 2023, and could reach 100 cases. This rise is connected to global warming which lengthens the periods and extent to which mosquitoes are active and increases travel from epidemic zones.

Mosquito-borne diseases have also threatened the United States. Mosquito-borne diseases such as Eastern Equine Encephalitis (EEE) and West Nile virus prompted public health alerts in 2024. Variables such as climate change, which permits mosquitoes to reproduce year-round in a wider swath of the population, as well as urbanization, have led to the rising numbers of mosquitoes and greater threat of infection. These statistics indicate the importance of efficient veterinary APIs to control and prevent zoonotic diseases. This upsurge of such diseases warrants the need for pharmaceutical development and ration of targeted medicines to secure both animal and human well-being.

Restraints:

• Stringent regulatory requirements and guidelines governing the production and quality control of veterinary APIs pose significant challenges for manufacturers.

The veterinary active pharmaceutical ingredients (API) manufacturing industry is significantly impacted by rigorous regulatory requirements. In January 2024, the U.S. Food and Drug Administration (FDA) published draft guidance for industry (GFI) #286, Harmonizing Good Manufacturing Practices (GMPs) for Veterinary Active Pharmaceutical Ingredients (APIs), with their global counterpart. This initiative, which is building on the work of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), is focused on harmonising GMP inspections on a global level for API's that must meet required quality and purity standards.

Moreover, many domestic veterinary pharmaceutical companies in India have moved away from manufacturing veterinary APIs owing to the low profit margins and strict regulations. As a result, they have become dependent on imports, mainly from China, to stay profitable. The Technology Information Forecasting and Assessment Council, under India's Department of Science & Technology, has recommended guidelines to reduce dependency on imports and promote self-reliance in API production. While necessary to ensure product safety and efficacy, these regulatory frameworks are not without their challenges for manufacturers. Ensure compliance Costs Compliance entails significant investments in infrastructure, quality control systems, and ongoing monitoring to adhere to evolving standards. Such restrictions can act as high-tech tariffs, dissuading newcomers and stunting the ability of current manufacturers to expand operations, with likely consequences for the availability and price of veterinary APIs.

Opportunities:

• The integration of advanced technologies, such as biotechnology and synthetic biology, in manufacturing processes offers opportunities for improving production efficiency and product quality.

The adoption of advanced technologies, including biotechnology and synthetic biology, offers immense potential for the veterinary API manufacturing industry. These technologies have opened up the potential to innovate biologics and biosimilars, transforming veterinary therapeutics for the treatment of several animal health conditions with more focused and effective therapeutics. Biotechnology facilitates precision medicine, allowing for tailored treatments that enhance efficacy and reduce adverse effects in animals. This personalized approach aligns with the increasing demand for advanced animal health solutions, driven by the rising prevalence of animal diseases and the growing importance of animal welfare.

Synthetic biology adoption in veterinary API manufacturing also aids in the sustainability of the process that leads to the development of "greener" production methods. This fits into a global movement to go green through the implementation of green chemistry and environmentally sound practices, which is a direction many are tirelessly working to achieve to meet the pharmaceutical industry's need for sustainability solutions. Furthermore, the integration of digital technologies, such as big data analytics, enhances disease monitoring and targeted API formulation. This data-driven approach supports the development of more effective veterinary medicines, improving animal health outcomes and meeting the evolving needs of the veterinary sector.

Challenges:

• Supply chain disruptions and raw material shortages can lead to production delays and increased costs in veterinary API manufacturing.

There are serious challenges faced by the Veterinary API manufacturing industry at the moment, majorly due to supply chain disruptions and raw material shortages. Recent geopolitical events and natural disasters have only exacerbated these issues, resulting in increased operational costs and production delays. These issues have been exacerbated by recent geopolitical events and natural disasters, leading to increased operational costs and production delays. In 2024, the Red Sea Crisis, marked by geopolitical tensions and blockades along the Red Sea and Suez Canal key routes for approximately 15% of global trade, resulted in shipping delays averaging 10-14 days. This disruption led to the commencement of freight that led to a bottleneck situation that increased freight by 3 times from the Asia-Pacific region to the U.S. and Europe since January 2024, further increasing API prices of some of the drugs like paracetamol, meropenem, and metformin, which are raised several times. Natural disasters have also put added stress on the supply chain. In the U.S. alone, Hurricane Francine overtook 2.4 million barrels of oil and 4.9 billion cubic feet of gas, pushing up prices for crude oil and the costs of several downstream chemicals that play a vital role in pharmaceutical manufacturing.

The multitude of these compounding challenges has created significant operational disruption. In a 2024 survey, 67% of healthcare providers indicated that their teams spend more than 10 hours per week mitigating supply chain issues and shortages. Of those, nearly 40% said they cancelled or rescheduled cases at least quarterly because of product shortages. In reaction, the industry is starting to invest ever more heavily and rapidly in digital technologies to enable supply chain digital visibility, digital collaboration, and digital resilience. Approximately 43% of providers are leveraging technology and data to monitor supply availability, reflecting an 8% increase from the previous year.

Veterinary Active Pharmaceutical Ingredients Manufacturing Market Segment Analysis

By Synthesis Type

In 2023, the chemical-based API accounted for nearly 70% of the total market. This leads to the continued dominance of chemical compounds due to their cost-effectiveness and established manufacturing processes in veterinary medicine. Since well-tested chemical APIs are subject to regulatory support, they often come up as a preference from the government, where regulatory systems are those of a country. For example, regulatory authorities such as the FDA (U.S. Food and Drug Administration) follow stringent guidelines for the approval of veterinary drugs, which typically require chemical-based APIs. This regulatory support, combined with consumer trust in traditional chemical formulations, has maintained the segment's leading position. The chemical-based API type generates a great deal of revenue and profit for businesses and includes well-characterized compounds such as small molecules. In addition, the growth in the global economy allows more resources to be available to manufacture these APIs, so it further serves to strengthen their position in the global market.

By Animal Type

In 2023, the production animals segment accounted for the largest market share at 58%. This is largely due to the significant economic importance of livestock in many countries. Polices are adopted by governments to safeguard the health and productivity of production animals, driving the demand for veterinary APIs. Such programs aimed at increasing agricultural outputs and decreasing livestock disease prevalence, among others implemented by the governing bodies, have played a strong role in fuelling the demand for veterinary APIs under this segment. Furthermore, the globally rising demand for food products is further driving investment in production animal health.

By Service Type

The in-house segment dominated the market with the largest market share of 61% in 2023. Many pharmaceutical companies choose to manufacture APIs in-house so that they can maintain control of the API quality and production. However, government regulations typically necessitate stringent quality control precautions that are more easily conducted on the premises of a company rather than externally. Moreover, conducting manufacturing processes in-house ensures closer collaboration with ongoing R&D efforts, which facilitates a more responsive approach to innovation and compliance with evolving regulations.

By Therapeutic Category

In 2023, the anti-infective segment retained the highest share at 38%. This is because anti-infectives are vital to preventing and treating diseases in animals. The need for combatting infectious diseases in both pets and livestock has led governments across the globe to lay down hand-in-hand regulations mandating the use of anti-infective APIs, which has in turn further fueled the market. The emergence of diseases that are either zoonotic (zoonosis are diseases caused by microorganisms in animals that can also infect humans) or can be transmitted to humans by animals has added to the need for effective anti-infective treatments. This results in the governing bodies supporting the growth and application of anti-infective APIs to ensure public health and animal welfare.

Veterinary Active Pharmaceutical Ingredients Manufacturing Market Regional Analysis

North America held the largest veterinary API market share, over 36%, in 2023. The establishment of animal healthcare infrastructure and the increasing demand for pet care are responsible for the region being the largest share of the animal healthcare market, with major pharmaceutical players such as Zoetis and Elanco Animal Health. The U.S. FDA's strict regulatory framework ensures the quality and safety of veterinary drugs, contributing to a favorable environment for market growth. Europe also plays a significant role in the market, with countries like Germany and the U.K. contributing to its growth. Due to the stringent quality requirements from the European Medicines Agency, more veterinary APIs imported from Asia-Pacific facilities are acceptable to the EU GMP standard. Veterinary API demand is driven by government initiatives in these regions that improve animal health and welfare.

This growth is led by the Asia-Pacific region, where rapid growth in pet ownership, a burgeoning cattle market, and government efforts to improve veterinary care are making strong impacts. For instance, China has reached an annual production capacity of 185,000 metric tons of veterinary API, and both China and India have invested heavily in veterinary API manufacturing facilities. The increase in living standards and the growing middle class in the region have led to the increased demand for high-quality veterinary APIs in this region.

Veterinary Active Pharmaceutical Ingredients Manufacturing Market Key Players:

Key Service Providers/Manufacturers are

• Zoetis (Ceftiofur Hydrochloride, Maropitant)

• SUANFARMA (Lincomycin Hydrochloride, Enrofloxacin)

• Grupo Indukern S.L. (Clindamycin Hydrochloride, Flunixin Meglumine)

• Sequent Scientific Ltd. (Alivira Animal Health Limited) (Diclazuril, Oxytetracycline)

• Ofichem Group (Tylosin Tartrate, Tiamulin Hydrogen Fumarate)

• Excel Industries Limited (Fenbendazole, Praziquantel)

• NGL Fine-Chem Ltd. (Albendazole, Closantel)

• FIS - Fabbrica Italiana Sintetici S.p.A. (Amprolium, Halofuginone Lactate)

• Sidhiv Pharma (Doramectin, Moxidectin)

• Chempro Pharma Private Limited (Ceftiofur Crystalline Free Acid, Cephapirin Benzathine)

• AMGIS Lifescience Ltd (Gamithromycin, Selamectin)

• Procyon Life Sciences (Oxyclozanide, Delayed Release Pellets)

• Cerata Pharmaceuticals LLP (Albendazole API, Triclabendazole API)

• Orion Corporation (Oxytocin, Isoflurane)

• Naari (High Active Female Hormones, Oxytocin)

• Grindeks (Oxytocin, UDCA)

• Vetter Pharma (Parenteral Drugs, Softgels)

• Dishman Carbogen Amcis (Vitamin D Analogues, Contrast Media)

• Rochem International (Imidacloprid, Milbemycin Oxime)

• Huvepharma (Tylosin Base, Tylvalosin Tartrate)

Recent Developments In the Veterinary Active Pharmaceutical Ingredients Manufacturing Market:

• In January 2024, the U.S. Department of Agriculture announced initiatives to reduce the barriers to access to veterinary care, ultimately driving the demand for veterinary APIs.

• In March 2024, the European Union published new guidelines for the use of veterinary APIs, emphasizing the importance of regulatory compliance and quality control.