Unmet Medical Needs

The human-animal bond is stronger than ever before, and we naturally care about keeping animals healthy and safe. Since we share our homes and communities with animals, we must take steps to prevent and treat animal diseases, because illnesses can move between humans and animals. Keeping our pets healthy keeps us healthy.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

DOGS

Dogs Rely On Us To Keep Them Healthy
Sixty-nine percent of households include a dog (American Pet Products Association), making dogs America’s most popular pet. Known for their companionship, dogs enrich our lives, improve our lifestyle, and even boost our mental and physical health. With 85% of dog owners considering their dogs as part of the family (American Veterinary Medical Association), it’s clear that we humans are heavily invested in keeping our dogs happy and healthy.

Unfortunately, dogs can suffer from debilitating or fatal diseases. Many of these diseases are treatable, and therapies are within reach, but the animal health industry needs a regulatory system and funding that lifts barriers to animal medicine innovation.

Unmet Health Needs of Dogs

The current treatment for arthritis is focused on reducing inflammation and decreasing pain. A medication that slows or stops the development of arthritis would significantly improve animals’ long-term quality of life.

Furthermore, developing medicines for animal arthritis could augment research for medicines to treat human arthritis. Research is ongoing to better understand osteoarthritis so that in the future, we can not only treat the ailment but prevent it from developing. Like in human medicine, there is significant interest in exploring biologic and cell therapies.

All dogs are susceptible to heartworms, a parasitic worm spread through mosquito bites. Heartworm disease can cause severe lung disease, heart failure, organ damage or death. Preventing heartworms is considered one of the core components of pet ownership and animal health.

Mosquito species capable of transmitting heartworms can be found in most geographical areas, and due to climate change, the mosquito season is getting longer.  Additionally, data shows the parasites that cause heartworms are becoming increasingly resistant to the medicines that prevent the disease.

Heartworm infections continue to increase in number and geographic distribution, with the greatest number of cases in the southeastern US and the Mississippi River valley.  However, cases are appearing with increasing frequency in traditionally low prevalence areas such as California, Oregon, Washington, and Colorado.

Ear infections can be so painful for pets that they shy away from a good ear scratch.  While bacterial infections are the most common cause of ear infections in dogs, yeast, ear mites, and fungus can all cause your dog’s ears to become infected.

Ear infections can be tricky to treat because successful therapy requires identification and correction of the underlying cause. The underlying cause may be related to grooming, external parasites, allergies, or a combination of several issues. Current treatment focuses on application of topical ointment into the ear canal, which can be challenging for pets with painful ears.

Cancer can affect humans and animals, and in fact, the biology of tumors affecting humans and dogs are similar in many ways. Importantly, cancer treatments that are safe and effective in dogs often work well in people too. Since 2003, the U.S. National Cancer Institute (NCI) has used information from studies of canine cancer to help guide studies of human cancer and vice versa, a field known as comparative oncology. Two NCI efforts, the Comparative Oncology Program (COP) and the Pre-medical Cancer Immunotherapy Network for Canine Trials (PRECINCT), facilitate trials of new therapies for different types of cancer in pet dogs, as well as laboratory studies to more about the basics of canine cancer.

Closing the Gap in Animal Health

Animal health companies are developing innovative therapies to improve dogs’ lives. New vaccines that use mRNA technologies to control parasites could allow more effective vaccines that can be reliably produced. New parasiticides that degrade quickly after use can limit entry into the environment and offer a ‘greener’ product profile.

Regulatory barriers slow the development of innovative drugs for dogs. 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.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

CATS

Caring for Cats the Way they Care for Us
Forty-five percent of households include a cat (American Pet Products Association). Research shows that cats can lower human stress and anxiety as well as reduce feelings of loneliness. Known for their low maintenance companionship, many cat owners chose to have more than one cat.

Unfortunately, cats can suffer from debilitating or fatal diseases. Advanced therapies to improve cats’ quality of life and reduce suffering are within reach, but the animal health industry needs a regulatory system and funding that lifts barriers to animal medicine innovation.

Unmet Health Needs of Cats

Cats try very hard to hide when they are in pain. This is especially true when cats are suffering from chronic long-term pain. The animal health industry is researching new ways to manage pain in our feline friends, including finding ways to prevent or treat diseases that can lead to pain, like arthritis. We are also developing new medicines that can alleviate pain to improve their quality of life.

Cats are susceptible to heartworms, a parasitic worm spread through mosquito bites. Just one or two worms can lead to feline death. Heartworm disease can cause severe lung disease, heart failure, organ damage or death. Preventing heartworms is considered one of the core components of pet ownership and animal health.

Mosquito species capable of transmitting heartworms can be found in most geographical areas, and due to climate change, the mosquito season is getting longer. Additionally, data shows the parasites that cause heartworms are becoming increasingly resistant to the medicines that are currently used to prevent the disease.

Heartworm infections continue to increase in number and geographic distribution, with the greatest number of cases are seen in the southeastern US and the Mississippi River valley. However, cases are appearing with increasing frequency in traditionally low prevalence areas such as California, Oregon, Washington, and Colorado.

Asthma affects up to 5% of cats. Like in people, asthma in cats is caused by an allergic reaction that leads to difficulty breathing and wheezing. The disease varies in intensity, but it can be fatal.

To treat feline asthma, veterinarians usually prescribe corticosteroids to reduce inflammation in the lungs, along with bronchodilators. Drugs approved for human use are often used to treat asthma in cats. Like in people, feline asthma cannot be cured but it can be managed. It’s important pet owners contact their veterinarian if they feel their pet is having trouble breathing.

Closing the Gap in Animal Health

Animal health companies are developing innovative therapies to improve cats’ lives. New vaccines that use mRNA technologies to control parasites could allow more effective vaccines that can be reliably produced. New parasiticides that degrade quickly after use can limit entry into the environment and offer a ‘greener’ product profile.

Regulatory barriers slow the development of innovative drugs. 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.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

HORSES

Protecting the Timeless Bond Between People & Horses
Part companion, part worker, part performer, horses have long been central to American life. Riding horses improves balance, coordination, flexibility, muscle tone, and overall core strength, and horse owners also enjoy strong community and social connections with other horse owners. Owning horses is expensive, elevating the importance of equine care and well-being. Treating diseases and conditions that affect horses can be costly and protracted.

Unmet Health Needs of Horses

Equine Protozoal Myeloencephalitis (EPM) is one of the most commonly diagnosed neurological disorders of horses in the United States. Caused by a parasite passed from opossum to horses, infected animals become uncoordinated and weak, which can be dangerous to people if the horse tips and falls. Affected horses may also suffer from seizures.

There are few treatments for EPM, and existing treatments are expensive because even mildly affected horses can require prolonged therapy. It is common for horses with EPM to be euthanized.

While antiparasitic medications have been developed to kill the parasites that most often cause the disease, damage to the horse’s neurologic systems is often irreversible.  Relapse of the disease occurs in more than 25% of the horses affected once treatment is discontinued.

Current treatments for arthritis are focused on reducing inflammation and decreasing pain. Research is ongoing to better understand osteoarthritis, and in the future we hope to not only treat the ailment but also prevent it from developing.

Like in human medicine, research is focused on biologic therapies that collect and concentrate horse’s natural anti-inflammatory and regenerative proteins or cells then inject them into an area of pathology (disease or damage) in affected horses.

Developing medicines for animal arthritis could augment research for medicines to treat human arthritis.

Few things are scarier to a horse owner than hearing their horse has laminitis. Laminitis occurs when there is swelling and damage of the tissues between the hoof and the coffin bone. The condition causes lameness and diminished quality of life, and it often results in euthanasia.

Currently no treatment targets the root cause of laminitis. Research is looking for new therapies and approaches for identifying the problem earlier, since it is currently difficult to detect until it is quite severe.

Have you ever heard a horse cough? Like people, horses can suffer from asthma, causing coughing, wheezing, and difficulty breathing. Collectively, the disorders affect 25-80 percent of stables horses in the United States (Mazan, 2006).

Historically, equine asthma has been referred to as recurrent airway obstruction or inflammatory airway disease. Environmental modification and avoiding asthma triggers are key components of an asthma control plan in horses. Medication also plays an important role, including corticosteroids and aerosol therapy (nebulization) with a bronchodilator.

Closing the Gap in Animal Health

Animal health companies are developing innovative therapies to improve horses’ lives. New vaccines that use mRNA technologies to control parasites could allow more effective vaccines that can be reliably produced. New parasiticides that degrade quickly after use can limit entry into the environment and offer a ‘greener’ product profile.

Regulatory barriers slow the development of innovative drugs. 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.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

CATTLE, SHEEP, AND GOATS

Meat & Milk: Healthy Cows, Sheep, and Goats are More Productive
From our daily dose of milk to high protein beef, cows provide critical vitamins and nutrition for humans of all ages and socio-economic groups. Cows are also at the heart of the U.S. agricultural industry, with cattle production totaling $391 billion in 2021 and dairy products projected to bring $120.5 billion in 2022.

Furthermore, grazing ruminants such as cows, sheep, and goats on land that is unsuitable for crop production more than doubles the land area in this country that can be used to produce food. When ruminants are healthy, they more reliably produce the protein and nutrient rich foods that fuel our food supply, making grazing ruminants an efficient way to produce food for humans.

These animals are commonly vaccinated to help strengthen their immune system against respiratory and diarrheal diseases. Unfortunately, there are many diseases for which there are no cures.

Unmet Health Needs of Cattle, Sheep, & Goats

Cattle, sheep, and goats infected with Johne’s Disease experience a decreased ability to absorb nutrients in the small intestine. Highly contagious and potentially fatal, animals are typically infected with the bacteria that causes Johne’s Disease early in life but may not show clinical signs or test positive for the bacteria for months or even years.

There is currently not an effective treatment for Johne’s disease, and a 2007 Dairy National Animal Health Monitoring System study found about 68% of U.S. dairy herds have at least one cow that tests positive for the disease. This is projected to cost U.S. dairy producers in excess of $200 million annually. To control spread of the disease in a herd or flock, infected animals are put down.

Development of an effective small molecule chemical or immune stimulant medicine for Johne’s Disease could bring a cost-effective herd health management medicine to market while preventing significant animal and farmer hardship.

Cancer of the eyelid and eye of cattle is a serious condition for which there is no treatment. It accounts for up to 12% of all carcass condemnation during beef processing. At this time, the only treatment is surgery (removal of the eye), other physical treatments (freezing or heating the tumor), or radiation or immunotherapy. These treatments may not spare the carcass from being condemned.

Development of an applied therapy or preventive treatment for squamous cell carcinoma could lead to significant advancements for both human and animal cancer treatment.

Anaplasmosis is caused by the blood-borne parasite Anaplasma marginal, which is spread by tick bites. The infection can lead to pregnancy loss and death of the cow. The cost of a clinical case of anaplasmosis in the U.S. has been conservatively estimated to be over $400 per animal, with the total cost to the beef industry estimated to be over $300 million per year.

In the absence of effective vaccines, control of anaplasmosis in the U.S. is predicated on implementation of biosecurity practices and administration of low doses of tetracycline antimicrobials in feed or mineral supplements. Work is underway to find alternative therapies that could reduce or eliminate the need to administer antibiotics, but antimicrobial therapy coupled with vector control remain the most effect way to reduce the risk of anaplasmosis.

Bovine tuberculosis (Mycobacterium bovis) is zoonotic, meaning it can be transmitted from livestock to humans and other animals. Unless the disease is eradicated from the U.S., it will continue to spread, creating an adverse impact on animal and public health, increasing the cost of animal production and negatively impacting the U.S. trading status. There is no treatment for bovine tuberculosis. The disease is controlled through biosecurity, early detection and culling of affected animals.

Brucellosis is a contagious, costly disease of ruminant animals that also affects humans. Although brucellosis can attack other animals, its main threat is to cattle, bison, and swine. There is no treatment for brucellosis. The disease is controlled through biosecurity, surveillance, certification of brucellosis free herds, and culling of affected animals.

There are approximately 5.2 million head of sheep in the United States, a small number compared to other food-producing species. For this reason, the FDA considers sheep a minor species. Internal parasites are one of the top three nonpredator causes of death for sheep in the United States, accounting for 15.9% of nonpredator deaths in adult sheep and 15.5% death loss in lambs. Protecting lambs from internal parasites requires a multi-pronged approach, including keeping the environment clean and rotating the animals to new pastures. A veterinarian works to diagnose intestinal parasites and recommends appropriate anti-parasite medications.

Currently, there are medicines approved for use in sheep in other countries, like Australia, that are not approved by the U.S. FDA. This means that farmers in the United States are left without some of the tools they need to treat their flocks.  AHI supports initiatives such as the FDA Minor Use, Minor Species (MUMS) program to incentivize the development and approval of new medicines to care for America’s sheep.

Closing the Gap in Animal Health

Digital technologies can keep ruminants healthy, which protects the food supply chain. Advancements in digital monitoring and surveillance can help detect sick animals before they infect the herd, allowing for individual-level treatment and mitigating herd-wide infections.

Regulatory barriers slow adoption of digital technologies. Automation, greater connectivity, and more health data can allow earlier diagnosis and more accurate treatment, but it also requires infrastructure and expertise.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

POULTRY

The Protein in Poultry Keeps People Healthy
Poultry offers affordable lean protein that provides essential nutrients for brain function, muscle development, and bone strength. Furthermore, the companies involved in the production and processing of poultry provide 2,139,617 jobs that pay $121.1 billion in wages to families throughout the country, generate about $576,574,488,100 in annual economic impact, and about $41.9 billion in taxes (U.S. Poultry & Egg Association).

The U.S. poultry industry is the world’s largest producer and second largest exporter of poultry meat and a major egg producer. Chicken meat and eggs are important protein sources for communities around the world.

Unmet Health Needs of Poultry

Blackhead disease is a highly transmissible protozoal disease that can cause 80-100% death loss in turkeys, and mortality and loss of production in breeding chickens. There is not an effective medication to treat or prevent the disease, which occurs in sporadic but high-impact outbreaks.

Development of a safe and effective anti-protozoal to combat Blackhead disease would improve biosecurity on turkey farms, prevent disease losses, and decrease the need for antibiotics to treat potential secondary infections.

The FDA determined that controlling blackhead disease in turkeys qualifies as a “minor use in a major species,” – or MUMS.  This determination, similar to an orphan drug determination in human medicine, opens opportunities for animal health companies to qualify for benefits under the FDA MUMS program. The incentives available through the MUMS program include user fee waivers, grants, exclusive marketing rights and eligibility for conditional approval.

Coccidiosis is a highly contagious intestinal illness caused by a protozoal parasite. The disease leads to production losses and even death, costing over $14 billion per year (Blake et al., 2020).

Farmers have set up extensive monitoring systems to try to detect and control outbreaks of coccidia. Even with tight biosecurity, coccidiosis outbreaks are very common due to the complexity of the disease and the ability of the parasite to survive in the environment. Medication is the best way to control coccidia, and vaccinations exist to further support the fight against coccidia. Research continues to identify additional tools to help veterinarians and farmers keep animals healthy.

New technologies are critical to help the poultry industry reduce the risk of Salmonella and Campylobacter, which are the bacteria often responsible for human foodborne diseases. No single control method is yet known to fully address contamination, and new intervention strategies are required. Technologies such as vaccination and bacteriophages are promising tools to help reduce the presence and shedding of these zoonotic bacteria.

Closing the Gap in Animal Health

Digital technologies can keep poultry healthy, which protects the food supply chain. Advancements in digital monitoring and surveillance are 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.

Regulatory barriers slow adoption of digital technologies. Automation, greater connectivity, and more health data can allow earlier diagnosis and more accurate treatment, but it also requires infrastructure and expertise.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

PIGS

Pork is the Most Widely Consumed Protein in the World
The U.S. produces 12% of the world’s pork, and exports surpassed $8.1 billion in value. (U.S. Foreign Agriculture Service). The U.S. pork industry supports about 550,000 jobs and supports and estimated $22.3 billion of personal income, adding $39 billion to the GDP (National Pork Producers Council).

Pork meat is one of the primary sources of global animal protein, accounting for more than 35% of the global meat intake. Preventing and managing the health needs of pigs not only protects U.S. farms, but also ensures the availability of safe food.

Veterinarians, scientists and farmers work together, using tools like vaccines to reduce the risk animals will get seriously sick. When necessary, veterinarians use medicines like antibiotics to treat infections and return an animal to health.

Unmet Health Needs of Pigs

African swine fever (ASF) is a highly contagious viral disease of domestic and wild pigs, and mortality rate can reach 100%. Rapid outbreaks and the spread of African swine fever across China and other countries have resulted in the huge loss of pig populations and weakened the sustainability of the global food supply chain.

To protect U.S. producers, work is underway within the swine industry and the government to tighten biosecurity and to prepare to respond immediately if the virus spreads to the United States. Concurrently, the animal health industry is racing to develop new vaccines that to protect pigs from infection here and around the world.

Porcine Epidemic Diarrhea Virus (PEDv) is a disease caused by a corona virus. It was first documented in the U.S. swine population in 2013 and sparked a major epidemic. It affects pigs of all ages but is most dangerous in piglets, where it causes significant mortality. While the rate of infection in U.S. swine herds is now lower (prevalence rate less than 10%), the disease remains a threat to animal health. Vaccination against PED is a useful strategy to control the disease.

Closing the Gap in Animal Health

Digital technologies can keep pigs healthy, which protects the food supply chain. Advancements in digital monitoring and surveillance are 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.

Regulatory barriers slow adoption of digital technologies. Automation, greater connectivity, and more health data can allow earlier diagnosis and more accurate treatment, but it also requires infrastructure and expertise.

We need a more flexible, efficient, and productive regulatory review process that includes recognition of data that is submitted to other competent regulatory agencies around the world. The high cost and extended length of time needed to gain approvals and new products prevents development of many animal health therapies.

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.

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