The Value of Innovation

Animal diseases never rest – they constantly evolve and trigger a ripple effect that impacts animal welfare, human health, and the economy. Disease outbreaks among livestock can threaten food security and trade, and increased pet ownership and companion animal bonding inspires the need for improved pet care solutions.

The animal health industry is investing in exciting innovations that will have a profound impact on animal health and welfare; see the comprehensive report on animal health innovation here.

Between 2000 and 2016, almost 360 animal disease outbreaks were recorded across 116 countries, causing enormous economic losses, impacting trade, and affecting global food security. Of these outbreaks, two-thirds were caused by just five diseases, including Avian Influenza, Foot and Mouth Disease, and African Swine Fever (ASF), highlighting the opportunities available to better target and manage livestock disease.

At the same time, pet ownership has skyrocketed across the globe. Over 50% of households in major markets currently own a pet, and in the U.S. pet ownership sits at 67% This has led to more veterinarian visits, which offers the opportunity for improved care to allow pets to thrive.

Scientific advances and emerging technologies provide greater opportunities to predict, prevent, diagnose, and treat animal illness more quickly, accurately, and safely. Artificial intelligence, stem cell therapy, and new generations of vaccines will all play a crucial role in how we care for and treat animals. Veterinary researchers and developers continue to break new ground in reducing disease spread and its impact. The result is untold potential to improve animal welfare, protect livelihoods, raising livestock more sustainably, and offer longer, healthier lives for pets in our home.

Cost of Innovation

While human drugs are developed for a single species, animal medicines are developed for seven major species plus dozens of other minor and exotic species.

Research is complex and rigorous, and the policy and regulatory environment that governs animal medicine presents challenges that can hinder the development of therapies to keep animals healthy.

The animal health industry works with policy makers and regulators to identify and execute approaches to address roadblocks to animal health innovation.

Animal medicines and health products are necessary to prevent, diagnose and treat disease across over fifty different animal species. Developing innovations that are effective across this diverse landscape is a significant challenge, which is why a policy and regulatory environment that recognizes the unique characteristics of the animal health sector is essential. A new medicine or product can take anywhere from five to 15 years from first discovery until it is available to treat an animal. Animal health in general has less intellectual property protection, meaning the opportunity to recoup this investment is time-limited.

In the United States this problem is even more acute.  In Europe, companies have 10 years data protection once a new product receives a “market approval.” In the U.S., data protection lasts just five years, much of which can be absorbed by the global standard-setting process. For example, establishing Maximum Residue Levels (MRLs) for trade is necessary before a product can be used by producers who wish to export. This means that by the time a product can be widely used, it may have already lost this exclusivity protection and faces generic competition before the innovator can obtain a return on investment.

Furthermore, once a product receives a market approval, Good Manufacturing Practices (GMP) that are tailored to human health are often applied to the animal health sector. Without adapted GMP, an animal health product can face unnecessary requirements that may make it financially unfeasible to manufacture. Altogether, this has contributed to a downward trend in the number of new approvals in some markets. In the early 1970s, U.S. approval rates for new animal products were on par with those for human medicine. While the rate of approval for human medicines skyrocketed to a peak of more than 400 by the mid-1990s, approvals in animal health have dwindled below 50.

New Vaccines

Vaccines are among the most powerful tools in the veterinary toolbox, preventing disease to protect animals from needing later treatment and reducing losses. New vaccines and delivery methods provide opportunities to prevent more disease and protect more animals, offering a cost-effective way of safeguarding animal health and livelihoods. Vaccine development can be hampered by repetitive regulatory requirements that drive up costs and prolong the time needed for vaccines to reach market. Streamlining regulatory approval and assessment could inspire more and quicker vaccine development.

Innovations in vaccine development can lead to new vaccines against previously deadly and costly diseases, as well as new ways to expand existing vaccinations to more regions and species. New vaccine innovations include:

mRNA Vaccines. These new therapies work by giving cells in the body a blueprint for how to fight off infectious disease. Learn more…

Precision Systems for Vaccine Delivery. New vaccine platforms can improve the efficiency and precision of mass vaccination. Learn more…

Heat-resistant Vaccines. When vaccines must be kept at cold, sometimes subzero, temperatures until they are administered to remain effective, it can limit their use in tropical and temperate climates. Learn more…

‘Custom’ Vaccines. Autogenous vaccines offer farmers protection tailored specifically to their animals and situation. Learn more…

Rigid processes and needless regulatory barriers compromise speed and agility, which can delay or discourage developing and updating vaccines to respond to evolving disease threats. Identified barriers include:

Repetitive approvals & non-substantive changes. In the US, manufacturers submit data packages to regulators for evaluation of vaccines’ efficacy and safety. When new strains of diseases are encountered and minor changes to the vaccine’s design or delivery are required, this often means repeating large portions of the approval process. This can be extremely time consuming when applied across a range of products and extended to vaccine components such as raw materials, adjuvants, and preservatives with known safety profiles.

Inflexible field trials. Testing a vaccine on animals relies on the continued presence of the disease. If a disease is seasonal or is no longer present, field trials can be delayed, holding up the approval process. By accepting new alternative testing methods and allowing for submission of international data as a part of the approval process, regulators could streamline this process.

Lack of farmer incentive. It is difficult to generate a positive return on investment for vaccines that offer positive societal value, such as protection against zoonotic illness or reduction in carbon emissions, but little financial benefit to producers. This ultimately disincentivizes research into vaccines that could benefit sustainability efforts.

Vaccine and delivery platform development could be accelerated with greater regulatory flexibility. Identified opportunities include:

Vaccine antigen master file. Increasing acceptance for a master dossier would allow for the singular approval of a basic vaccine technology, meaning subsequent assessments could focus on the novel or specific aspects of each vaccine submission.

Multi-strain dossier. Encouraging companies to submit a single dossier for a vaccine covering multiple strains would help increase the agility and flexibility to deal with different disease threats in different regions.

Acceptance of alternative testing. By developing standards for new testing methodologies such as in vitro testing and eliminating unnecessary batch safety testing, regulators could increase the opportunities to demonstrate efficacy and safety while reducing the number of research animals needed. In the US, this has been long sought after by the veterinary biologics industry but regulatory hurdles remain.

Producer incentives. Incentives for producer adoption of vaccines that benefit society could provide a greater pull for research into innovative fields such as emissions reductions.

Platform vaccines. In the US, there is a greater push among vaccine manufacturers for the use of “platform” vaccine technology to easily change the strain/target of a vaccine without changing the majority of product components. Such flexibility allows for rapid development of new vaccines that can quickly be developed and deployed to fight a foreign animal disease outbreak, should one occur.

Alternatives to Antibiotics

Antibiotics are the cornerstone of modern medicine and public health protection against infectious disease, and there are currently no alternatives to effectively treat bacterial infections. Antimicrobial resistance is a significant global threat to human and animal health. New compounds that offer a novel way to target bacteria without using antibiotics are among the most valuable potential innovations. Competition between human and animal health and a poor return on investment hold back innovation toward developing alternatives to antibiotics.

True alternatives to antibiotics are products that target bacteria in a similar way and cure bacterial infection. Other innovations that reduce infection risk also reduce the need for antibiotics but cannot truly be called an alternative because they cannot treat a bacterial infection. Currently, antibiotics remain the only way to treat a bacterial infection. The animal health sector has taken significant action in recent years to improve responsible use while researching potential alternatives. Innovative alternatives to antibiotics include:

Bacteriophages. Literally defined as “bacteria eaters,” bacteriophages are a type of virus that infects bacteria and destroys the host cells. Learn more…

Ambient Cold Plasmas. Ongoing research into cold and ambient plasmas – or ionised gases – has shown that these substances can destroy harmful pathogens without leaving residues. Learn more…

Antimicrobial Peptides. Also known as AMPs, these broad-spectrum antimicrobial molecules are produced in almost all animals as part of the immune system. Learn more…

Nanotechnology Treatments. Using nanotechnology, or tiny particles, to treat antibiotic-resistant bacteria is in development and test trials. Learn more…

Immunotherapies. Treatments that direct the immune system response could harness an animal’s natural defenses against a bacterial infection. Learn more…

Obstacles holding back new antibiotic alternatives can be significant. Identified barriers include:

Limited Possibilities.  New antimicrobial treatments that are efficacious in people are considered “critically important” and are reserved for human use only. This limits the pool of potential molecules for animal health research.

Inflexible Regulations. Antibiotic alternatives are typically assessed as conventional antibiotics because regulatory processes have not adapted to assess new and emerging categories of products.

xBroken Market. It can take years and significant R&D to develop a new antibiotic, yet if a new treatment does succeed, it may be treated as a drug of last resort and used sparingly to minimize resistance risk. Many companies are reluctant to invest in this process as it is near impossible to see a return.

Limited Patent Protection. Once companies patent a new molecule and are granted protection over this intellectual property, they are likely to spend much of this period bringing it to market. After this, there may be little time remaining to recoup the investment before the patent protection expires.

Non-tariff Trade Barriers. Some existing antibiotics have approvals but lack internationally accepted Maximum Residue Levels (MRLs) that enable use. As a result, some companies are concerned that it may be difficult to secure MRLs for novel antibiotics alternatives, which will limit farmers ability to use them and disincentivizes companies from investing.

It is in the interests of the whole public health sector that human and veterinary medicine unite to address the issue of antibiotic resistance and the need for alternatives. This can be supported through:

Expanded IP Protection. An opportunity to support innovation in antibiotic alternatives lies with legislators, which could extend data exclusivity protection for these products.

New Market Paradigms. While longer protection periods can offer greater financial incentives, government-run schemes could also be considered to secure future developments by guaranteeing a return on investment on new developments with limited market potential.

More Public Investment. Significant public resources have been invested in developing new treatments for bacterial infections in people to combat resistance. Animal health faces similar pressure but receives a small fraction of the public investment seen in human health. Greater parity could help generate new alternatives to using antibiotics in animals and better understandings of AMR transfer pathways.

Product Label Claims. Considering reduction of antibiotic use as a clinical endpoint or efficacy measure as an allowable claim on product labels could help more innovations reach the market. This is not allowed under current guidelines and may sideline valuable products.

Digital Technologies

Digital technology offers opportunities for veterinary medicine to become more efficient and precise, enabling individualized veterinary care to large groups of animals. Automation, greater connectivity, and more health data can allow earlier diagnosis and more accurate treatment, but it also requires infrastructure and expertise. Greater levels of data also raise issues of confidentiality, ownership, and capacity for adequate analysis. Regulators and governments can support the digital health revolution by working with developers to streamline regulations and considering appropriate incentives.

Advancements in digital monitoring and surveillance are rapidly transforming the animal health landscape, bringing improvements in speed and efficiency that enable individual-level treatment even in groups of hundreds or thousands of animals. Digital technology innovations include:

Sensors and Smart Tags. New technology can allow farmers and veterinarians to treat herds at an individual level at a scale that is near impossible when relying solely on farm staff. Learn more…

Remote Monitoring Surveillance. Cameras, microphones, and sensors can produce accurate, real-time data demonstrating animals’ wellbeing, productivity and performance. Learn more…

Building Design. The smart design of animal accommodation such as pens and barns can improve animal health and incorporate monitoring and surveillance. Many US facilities are already designed to automatically adjust environmental controls and determine optimum air circulation for a given herd/flock. Learn more…

Digital tools have the potential to revolutionize animal agriculture if barriers can be lifted or overcome, including:

Limited Capacity to Act Upon New Levels of Data. More information is only useful if it can be acted upon. While digital tools have the potential to generate large amounts of data, farmers also need support to be able to aggregate, analyze and identify how to respond. In many parts of the world, the agricultural staff required to leverage the potential of new technology can be hard to find and retain, while rural connectivity is often a restricting factor for digital innovations.

Lack of Acceptance for Probability. Powerful data-backed algorithms make it increasingly possible to make veterinary decisions based on probability rather than a clinical diagnosis. This can help producers, veterinarians and animal care, but regulators have not accepted this as a valid method for justifying treatment. This reinforces the need to insist that regulators adopt a risk-based approach when creating & applying animal health regulations rather than a hazard-based approach.

Data Storage and Confidentiality Requirements. National policies that require data be processed and/or stored in servers within the country make it difficult for digital services to be delivered at scale in a competitive, efficient manner. In addition, data confidentiality and ownership requirements remain unclear in some markets.

Unclear Regulatory Situation or Limited Regulator Capabilities. There are often no clear indications of how such products should be assessed. In addition, traditionally animal health regulators often lack the background to assess such products.

Digital technologies constitute new territory to many stakeholders in the agricultural ecosystem, which brings its own set of challenges. But there are also vast opportunities to accelerate the transition to digital health:

Effective Data Protection. For data-driven solutions to reach their full potential, it is crucial that regulators ensure fair and effective data protection for all stakeholders in the industry. This means making sure that animal caretakers are protected, while simultaneously not stifling the potential of digital solutions.

Rural Connectivity. Limited connectivity in many parts rural America is a major barrier to digital advancements. Improving access to telecommunications and internet in rural areas would help accelerate the uptake of digital innovations.

Incentive Schemes. If regulators, governments, and the private sector can provide financial incentives to accelerate digital development and support infrastructure, the collective benefits can compound at a faster rate.

Adapting Regulations. If regulatory systems include improvements in well-being as a recognized claim for products, not just health improvements, this could allow for more products to reach market that support better welfare.

Diagnostics

Accurate diagnostics curb the severity of animal disease by enabling more effective treatments and reducing the need for antibiotics. A large share of diagnostic innovation is happening in the digital sphere, where artificial intelligence and user-friendly tools are potential game-changers for the animal health industry. The development of diagnostic tools is stifled by limited veterinary infrastructure in rural areas, which hampers adoption and the incentive for innovation. Strategic financial and regulatory support for technology can help increase the pace of innovation and strengthen the digital ecosystem.

Diagnostic innovations include:

Artificial Intelligence. AI has the ability to improve diagnostics by enabling more predictable, rapid analysis of samples that can quickly and effectively identify disease. Learn more…

Microfluidics. These devices are tiny chips that can conduct analyses on extremely small volumes of fluids, such as blood. Learn more…

Molecular Diagnostics. This refers to a collection of techniques for analyzing biological markers in the genetic code and proteins of an organism. Learn more…

Limited infrastructure and the high cost of adoption are some of the major barriers to innovation of diagnostics, such as:

High Barriers to Entry. New diagnostic tools need to be affordable and suitable to the end-user. Even if novel solutions help reduce costs in the long run, they must be appropriately priced and well-designed to attract early adopters.

Limited Connectivity. Digital tools require connectivity that is not available in many rural areas, which limits adoption and innovation.

Shortage of Veterinarians. While technology enables practitioners to connect from across great distances, a shortage of staff makes it challenging to create thriving digital ecosystems.

Lack of Regulatory Clarity. Advanced technologies applied to diagnostic methods and materials suffer from a lack of exposure/understanding on the part of regulatory officials in many cases.

Innovation in diagnostics could be accelerated through improved infrastructure and regulatory flexibility; for example:

Infrastructure Improvements. By strengthening rural infrastructure and increasing internet connectivity, more people will be able to use new tools as they reach the market and ultimately help create a strong digital community.

Financial Support. Without investment there is no innovation. Private or public financial support mechanisms that help attract investment into diagnostic tools – or subsidize their use – could play a major role in driving innovation.

Prediction-based Diagnostics. Artificial intelligence will allow animal health practitioners to diagnose animals based on probability. Factoring this into regulations will enable treatment in lieu of a clinical diagnosis.

Promoting Innovation via Regulation. If animal health authorities developed a mindset and institutional culture of promoting wide-spread and rapid advancement of new diagnostic technologies, manufacturers would be much more inclined to pursue potential “game-changing” advances in this arena.

Parasite Control

Parasites are spreading to new regions as climate change allows them to survive in warmer temperatures, which poses a significant threat to global livestock. New methods of control, administration, and stewardship are improving parasite control while also managing the challenge of resistance. Regulation must keep pace with innovation and distinguish between human and animal health challenges to allow new products to reach the market.

Warming temperatures due to climate change are allowing parasites to thrive in new regions, increasing the urgency to discover new parasiticides and other methods of parasite control. Parasite control innovation includes:

mRNA Parasite Vaccines. New vaccines that use mRNA technologies to control parasites could allow for more effective vaccines that can be reliably produced. Learn more…

Oral Parasiticides. Flea and tick control products that can be administered orally are a growing segment of the pet market and will likely expand to livestock in the future. Learn more…

‘Green’ Parasiticides. Parasiticides that degrade quickly after use can limit entry into the environment and offer a ‘greener’ product profile. Learn more…

Novel and emerging technologies are often regulated according to the standards set for their predecessors, which can complicate or delay the development and regulatory process by:

Conflating Human & Animal Health Needs. Parasiticide resistance is often treated as a public health threat comparable to antibiotic resistance, despite mainly affecting animals. This can lead to unnecessary requirements to meet public health standards that are not wholly relevant. Parasiticides can face additional scrutiny from food safety agencies in markets where they may also be categorized as pesticides.

Repetitive Safety Requirements. Regulators increasingly require evidence of a threat from all relevant parasites when assessing a new combination of active ingredients. This can delay the development of a treatment that requires multiple active ingredients if it cannot be demonstrated that all relevant parasites are a threat.

Recent developments have relieved some issues facing paraciticides, but EPA regulators can further stimulate innovation by:

Applying Reviews Consistently. Better cooperation between reviewers and internal alignment on policy (along with greater transparency) ensures shorter review times and delivers innovative products to market sooner.

Ensuring Continuity of Service. Government shutdowns occurring more often means regulators should have standard procedures in place to ensure funds and personnel remain available to process new applications, avoiding backlogs and prolonged review times.

Ensuring Timely Updates to PPLS. The Pesticide Product Label System ensures transparency of the most up-to-date label information, ensuring accuracy of label claims and content. This system needs more frequent updating and monitoring to ensure the proper information is displayed.

Streamlining Safety Assessments. Aligning the regulatory review of products like parasiticides across medical and food safety regulators will streamline the approval process, saving time, money, and resources.

Recognizing Zoonoses Control. Allowing parasiticides to include zoonotic disease control claims, after demonstrating efficacy through modeling, can strengthen development of products that directly improve public health.

Nutrition

Managing immunity and gut microbiome through nutrition offers enormous untapped potential for improving overall health. Products are already making an impact by reducing the need for antibiotics, however more research into gut health is needed to better understand this emerging area. Regulatory requirements are not always adapted to nutritional products, as it is a new area of innovation with novel technologies.

Growing knowledge about the role of nutrition, gut health and natural immunity to disease is opening up new opportunities for improved animal health and welfare. Nutritional innovation includes:

Probiotics. Pre- and pro-biotic molecules added to animal feed can prevent disease and target specific health challenges. Learn more…

Phytogenic Feed Additives. Phytogenic, or plant-based, substances with anti-bacterial properties are increasingly being identified, combined and added to animal feed to alter the gut microbiome, improve immunity, and protect against specific diseases. Learn more…

Novel Feeds. Alternative animal feeds such as insect-based protein and seaweeds are opening opportunities for precision nutrition. Learn more…

Novel and emerging technologies are often regulated according to the standards set for their predecessors, which can complicate or delay the development and regulatory process by:

Disincentivizing the Most Advanced Technology. Developing a combination of synthetic compounds to manage specific diseases will be subject to more rigorous, costly, and resource-intensive safety assessment than substances known to be safe but with generic health benefits. This discourages manufacturers from developing the most targeted, cutting edge products.

Untapped Potential. Gut health is an emerging area in animal health research that has grown rapidly in recent years. However, much like in human health, our understanding of the microbiome is still in early stages.

Disparate Regulations. Requirements for registering a novel nutritional product can widely differ across various markets. This makes it difficult for a company, especially smaller ones, to generate the data required to enter enough markets for product viability.

Addressing roadblocks to nutrition innovation could be achieved through:

Increased Basic Research. Greater investments in nutrition research by public institutions could accelerate knowledge about gut health and lead to new breakthroughs that can strengthen animal health, reduce the need for antibiotics, improve sustainability.

Updating Regulatory Requirements to Align With Innovation. Existing regulatory requirements are not always suitable for assessing novel nutrition technologies because not all criteria are relevant or applicable.

Safe Development

New animal medicines and products must be proven to be safe and effective before being approved, which relies on an extensive process of testing on live animals. In-vitro testing, stem cell technology, and biomarkers are among the innovations that allow researchers to demonstrate safety and efficacy while reducing the need for animal testing. However, alternative testing methods must be shown to meet the same clinical standards as animal testing or risk being rejected. Developing new clinical standards for alternatives to animal testing could accelerate research and development.

Rigorous testing of new medical products on live animals raises concerns about animal welfare. Developing safer, quicker, and less expensive alternatives for demonstrating safety and efficacy can reduce the cost of product development and limit the need for live animals. Innovation around safer development includes:

Biomarkers. Biomarkers have the potential to demonstrate drug or treatment efficacy more quickly and accurately in both people and animals by measuring biological processes associated with specific diseases. Learn more…

In-vitro Testing and Stem Cell Technology. Testing a new product on cells or tissue in a lab (in-vitro) is an emerging alternative to animal testing. Learn more…

While technology for alternative testing is developing quickly, regulatory requirements maintain the same clinical indicators to demonstrate the effectiveness and safety of a product. This means companies must demonstrate that their alternative method of testing is as reliable as animal testing.

There is also a discrepancy between the standards of validation for biomarkers in pivotal studies, compared to those used as diagnostic tests by veterinarians.

Animal testing remains a requirement for many countries, including the U.S.,  so manufacturers must continue to use animal testing for any product intended to be marketed globally instead of alternative methods.

Regulators and health agencies can facilitate more innovation in alternative testing methodology and safer product development through:

Increasing Public Funding. Investing in more research into animal-free testing can help meet public health goals and consumer needs.

Responsive Regulation. Developing new methodologies and clinical standards for alternative testing can foster more innovation in this field and move toward validating new, quicker, and more accurate processes and reduce the need for research animals.

Greater Focus on 3Rs. The 3Rs framework seeks to reduce animal testing through ‘replacement, reductions and refinement’ of existing procedures. However, requirements such as unnecessary batch safety testing still exist in certain markets. Increased focus on implementing the 3Rs could help alternative methods emerge and reduce animal testing.

Applying Pharmacovigilance Data. Well designed and properly maintained pharmacovigilance (PV) reporting systems allow for accumulation of “real world” data on the safety and efficacy of animal health products. When combined with other new development technologies, this can greatly reduce the need for animal testing of new products in existing drug/vaccine classes.

About Animal Health Institute

The Animal Health Institute (AHI) represents the companies that develop and produce animal medicines. Our industry is a global leader whose products improve the health of nearly 10 billion companion and food-producing animals in the U.S., which results in significant economic and social benefits for Americans.