Companion Animals: New markets for human pharmaceuticals and agrochemicals

Companion Animals: New markets for human pharmaceuticals and agrochemicals

Products
Strategic Management

It takes 12 years and costs $50-100 million to develop and register a new animal health drug.
Due to the high costs of new product development, the animal health industry is increasingly turning to existing human pharmaceuticals and agricultural pesticides for new leads.

Companion Animals: New markets for human pharmaceuticals and agrochemicals provides you with a detailed examination of the factors fuelling the growth in cross-over products for companion animal use.

The report focuses on eight key therapeutic groups:

anti-inflammatory drugs
cardiovascular treatments
gastrointestinal products
antiparasitics
endocrine treatments
anti-infectives
behaviour-modifying agents
cancer drugs.

For each therapeutic group, the report looks at:

key disease targets and current therapies
product groups utilised by the veterinary profession
recent product developments
potential candidates for future veterinary licensing.

For further information on this report, please contact our Customer Helpdesk on:
Tel: +44 (0)20 8410 2870
Fax: +44 (0)20 8332 8996
E-mail: [email protected]

PUBLISHED: JULY 2000
REFERENCE: SR196E
PAGES: 100
PRICE: �795/$1,670/Y191,000

CONTENTS
LIST OF TABLES
FOREWORD
ABBREVIATIONS
CHAPTER 1 FACTORS DRIVING CROSS-OVER ACTIVITY
1.1 Introduction
1.2 Constraints on the food animal market
1.2.1 Poor livestock market conditions
1.2.2 Social and political pressures
1.2.3 Regulatory pressures
1.3 Drivers of companion animal market growth
1.3.1 Recent market growth
1.3.2 Drug development costs
1.3.3 Regulatory factors
1.3.3.1 The European Union's 'prescribing cascade'
1.3.3.2 The US Animal Medicinal Drug Use Clarification Act (1996)
1.4 Current R&D activity in the companion animal sector

CHAPTER 2 RECENT ACTIVITY AND FUTURE TRENDS
2.1 Introduction
2.2 Inflammatory conditions
2.2.1 Key disease targets and current therapies
2.2.1.1 Equine lameness
2.2.1.2 Osteoarthritis in small animals
2.2.2 Anti-inflammatory product groups
2.2.2.1 Corticosteroids
2.2.2.2 Non-steroidal anti-inflammatory drugs
2.2.3 Recent product developments
2.2.3.1 Meloxicam
2.2.3.2 Carprofen
2.2.3.3 Etodolac
2.2.3.4 Vedaprofen
2.2.4 Potential candidates for veterinary licensing
2.2.4.1 NSAIDs
2.2.4.2 COX-2 inhibitors
2.2.5 Other novel approaches to anti-inflammatory product development
2.3 Cardiovascular conditions
2.3.1 Key disease targets and current therapies
2.3.1.1 Degenerative valve disease
2.3.1.2 Cardiomyopathy
2.3.2 Cardiovascular product groups
2.3.2.1 Diuretics
2.3.2.2 Positive inotropes
2.3.2.3 Beta-blockers
2.3.2.4 ACE inhibitors
2.3.2.5 Calcium antagonists
2.3.3 Recent product developments
2.3.3.1 ACE inhibitors
2.3.3.2 PDE III inhibitors
2.3.4 Potential candidates for veterinary licensing
2.3.4.1 ACE inhibitors
2.3.4.2 Calcium antagonists
2.3.4.3 Angiotensin II antagonists
2.3.4.4 PDE III inhibitors
2.3.5 Other novel approaches to cardiovascular product development
2.4 Gastrointestinal conditions
2.4.1 Key disease targets and current therapies
2.4.1.1 Equine gastric ulcers
2.4.1.2 Small animal gastric ulcers
2.4.1.3 Oesophagitis
2.4.2 Gastrointestinal product groups
2.4.2.1 H2-receptor antagonists
2.4.2.2 Proton pump inhibitors
2.4.2.3 Prokinetic drugs
2.4.3 Recent product developments
2.4.3.1 Omeprazole
2.4.4 Potential candidates for veterinary licensing
2.4.4.1 Proton pump inhibitors
2.4.4.2 H2-receptor antagonists
2.4.4.3 Prokinetic drugs
2.4.5 Other novel approaches to gastrointestinal product development
2.5 Oncology products
2.5.1 Key disease targets and current therapies
2.5.1.1 Cutaneous mast cell tumours
2.5.1.2 Canine lymphosarcoma
2.5.2 Leading anti-cancer products
2.5.2.1 Alkylating agents
2.5.2.2 Antimetabolites
2.5.2.3 Mitotic inhibitors
2.5.2.4 Antibiotics
2.5.2.5 Hormones
2.5.2.6 Others
2.5.3 Potential future candidates for veterinary use
2.5.4 Other novel approaches to oncology product development
2.6 Endocrine conditions
2.6.1 Key disease targets and current therapies
2.6.1.1 Cushing's disease (hyperadrenocorticism)
2.6.1.2 Diabetes mellitus
2.6.2 Endocrine treatment groups
2.6.2.1 Cushing's disease
2.6.2.2 Diabetes mellitus
2.6.3 Recent product developments
2.6.4 Potential candidates for veterinary licensing
2.6.4.1 Diabetes mellitus
2.6.5 Other novel approaches to endocrine product development
2.7 Infectious conditions
2.7.1 Key disease targets and current therapies
2.7.2 Leading anti-infective products
2.7.2.1 Aminoglycosides
2.7.2.2 Penicillins
2.7.2.3 Macrolides
2.7.2.4 Lincosamides
2.7.2.5 Tetracyclines
2.7.2.6 Chloramphenicol
2.7.2.7 Sulphonamides
2.7.2.8 Cephalosporins
2.7.2.9 Fluoroquinolones
2.7.3 Recent product developments
2.7.3.1 Fluoroquinolones
2.7.4 Potential future candidates for veterinary use
2.7.4.1 Fluoroquinolones
2.7.4.2 Others
2.7.5 Other novel approaches to anti-infective product development
2.8 Parasite control
2.8.1 Key parasite targets and current therapies
2.8.1.1 Ctenocephalides felis and flea allergy dermatitis
2.8.1.2 Ixodes spp. and Lyme disease
2.8.2 Ectoparasiticide product groups
2.8.2.1 Organophosphates
2.8.2.2 Carbamates
2.8.2.3 Formamidines
2.8.2.4 Pyrethrins and pyrethroids
2.8.2.5 Insect growth regulators
2.8.2.6 Phenylpyrazoles
2.8.2.7 Chloronicotinyls
2.8.2.8 Avermectins
2.8.3 Recent product developments
2.8.3.1 Insect growth regulators
2.8.3.2 Phenylpyrazoles
2.8.3.3 Chloronicotinyls
2.8.3.4 Avermectins
2.8.4 Potential candidates for veterinary licensing
2.8.4.1 Benzoylurea insecticides
2.8.4.2 Chloronicotinyl insecticides
2.8.4.3 Phenylpyrazole insecticides
2.9 Behavioural conditions
2.9.1 Key problems and current therapies
2.9.1.1 Separation anxiety
2.9.1.2 Other behavioural problems
2.9.2 Behavioural treatment groups
2.9.2.1 Tricyclic antidepressants
2.9.2.2 Selective serotonin reuptake inhibitors
2.9.2.3 Benzodiazepines
2.9.3 Recent product developments
2.9.3.1 Selegiline
2.9.4 Potential candidates for veterinary licensing
2.9.4.1 Tricyclic antidepressants
2.9.4.2 Selective serotonin reuptake inhibitors
2.9.4.3 Anxiolytics

CHAPTER 3 ADAPTING DRUGS FOR VETERINARY USE
3.1 Access to cross-over candidates
3.1.1 Parent company resources
3.1.1.1 Bayer
3.1.1.2 Boehringer Ingelheim Vetmedica
3.1.1.3 Elanco
3.1.1.4 Fort Dodge
3.1.1.5 Intervet
3.1.1.6 Merial
3.1.1.7 Novartis
3.1.1.8 Pfizer
3.1.1.9 Pharmacia
3.1.1.10 Schering-Plough
3.1.2 Product licensing opportunities
3.1.3 Patent issues
3.2 Identifying cross-over candidates
3.3 Development and registration
3.4 Marketing cross-over products
3.4.1 Choice of distribution channel
3.4.2 Marketing resources
3.4.3 Pricing issues

CHAPTER 4 MARKET POTENTIAL
4.1 Companion animal market growth
4.2 Companion animal populations and ownership trends
4.3 Companion animal insurance
4.3.1 Levels of insurance coverage
4.3.2 Recent activity in the UK companion animal insurance market
4.3.3 Recent activity in the US companion animal insurance market
4.3.4 Alternatives to the traditional insurance model
4.3.4.1 Wellness programmes
4.3.4.2 Health maintenance organisations
4.4 The veterinary profession
BIBLIOGRAPHY

AMENDED FOREWORD
The animal health industry has always been dependent on research in the human pharmaceutical and crop protection sectors as sources of new active ingredients with potential applications in veterinary medicine. The synergies that exist between the human pharmaceutical and veterinary product markets have helped to sustain animal health divisions as viable subsidiary businesses of healthcare or life-science groupings, and are a major factor behind the pharmaceutical sector's continued position as the leading parent of animal health industry.

Veterinary drug research has become an increasingly high-risk activity since the mid-1980s thanks to a combination of factors such as stagnating demand for livestock produce, sharp increases in the costs associated with the research process, tougher regulatory demands and the imposition of social and political influences on the regulatory process. All of these factors have affected the ability and willingness of animal health companies to invest large sums in basic research - especially in the livestock product sector, where risks are often at their highest.

At the same time, the industry has experienced a relative boom in demand for companion animal medicines. Responding to these changes in the market environment, many companies have begun to channel an increasing proportion of their research budgets into the development and commercialisation of products for use in companion animals - most notably, dogs, cats and horses. Drugs for use in non-food species are free from some of the more onerous regulatory demands required of livestock products - notably the need to generate detailed residue data profiles in order to ascertain maximum residue limits (MRLs) and appropriate withdrawal periods prior to slaughter.

This report:

Examines the factors driving current cross-over activity in the companion animal sector
Looks at recent developments and future trends in the veterinary application of human drugs and crop protection chemicals
Identifies important factors governing cross-over activity by individual animal health companies
Assesses the future potential of the market for cross-over products

The report focuses mainly on drugs for use in dogs and cats, which dominate the companion animal market in value terms. Equine cross-overs are also addressed, however.

Chapter 2 of the study, which examines recent cross-over activity and future trends in the cross-over market, is the report's main focus. This section looks in detail at eight key therapeutic groups: anti-inflammatory drugs; cardiovascular treatments; gastrointestinal (GI) products; antiparasitics; endocrine treatments; anti-infectives; behaviour-modifying agents; and anticancer drugs. For each therapeutic group, the report looks at key disease targets and current therapies; product groups utilised by the veterinary profession; recent product developments; and potential candidates for future veterinary licensing.

The range of products used by the veterinary profession to treat many disease conditions includes both licensed veterinary medicines and human drugs used on an extra-label basis. Current patterns of extra-label use give significant clues as to which active ingredients may present viable cross-over opportunities in future. Extra-label activity was ascertained by direct communication with the veterinary profession, consulting veterinary manuals and searching veterinary literature.

Potential candidates for future veterinary application have been highlighted in each of the eight key therapeutic fields. Information in these sections was drawn from specialist R&D databases dedicated to tracking developments in both the human pharmaceutical and crop protection sectors. Detailed information on the commercial performance of individual active ingredients already established in the human medicine and agrochemical industries was also collated, using data published by the companies involved.

Veterinary science continues to advance rapidly, and the application of a broad range of increasingly sophisticated drugs is feasible in theory during the early part of the 21st century. The main constraint on rates at which such products are licensed for use in companion animals will be the ability of owners to pay for veterinary treatment. The proportion of the companion animal population covered by health insurance remains relatively low, and owners are the sole payer for the treatment of uninsured animals.

The final chapter of this study assesses recent developments in companion animal health insurance and looks at the possible emergence of alternative third-party payment mechanisms. These may well represent the key that unlocks further significant market potential in the companion animal drug sector.