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The U.S. and EU Animal Pharmaceutical Industries in the Age of Antibiotic Resistance, ERR-264, U.S

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The U.S. and EU Animal Pharmaceutical Industries in the Age of Antibiotic Resistance, ERR-264, U.S United States Department of Agriculture Economic Research The U.S. and EU Animal Pharmaceutical Service Industries in the Age of Antibiotic Economic Research Report Resistance Number 264 May 2019 Stacy Sneeringer, Maria Bowman, and Matthew Clancy United States Department of Agriculture Economic Research Service www.ers.usda.gov Recommended citation format for this publication: Sneeringer, Stacy, Maria Bowman, and Matthew Clancy. The U.S. and EU Animal Pharmaceutical Industries in the Age of Antibiotic Resistance, ERR-264, U.S. Department of Agriculture, Economic Research Service, May 2019. Cover images: Top photo, USDA; bottom photos, Getty. Use of commercial and trade names does not imply approval or constitute endorsement by USDA. To ensure the quality of its research reports and satisfy governmentwide standards, ERS requires that all research reports with substantively new material be reviewed by qualified technical research peers. This technical peer review process, coordinated by ERS' Peer Review Coordinating Council, allows experts who possess the technical background, perspective, and expertise to provide an objective and meaningful assessment of the output’s substantive content and clarity of communication during the publication’s review. 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Persons with disabilities who require alternative means of communication for program information (e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English. To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at How to File a Program Discrimination Complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992. Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue, SW, Washington, D.C. 20250-9410; (2) fax: (202) 690-7442; or (3) email: [email protected]. USDA is an equal opportunity provider, employer, and lender. United States Department of Agriculture Economic Research The U.S. and EU Animal Pharmaceutical Service Industries in the Age of Antibiotic Economic Research Resistance Report Number 264 May 2019 Stacy Sneeringer, Maria Bowman, and Matthew Clancy Abstract The animal pharmaceutical industry (or “animal pharma”) develops and sells antibiotic drugs and other products used for food and companion animals. However, the use of antibiotics in agriculture is under increasing scrutiny from policymakers and consumers. How animal pharma responds in terms of developing and marketing veterinary products has ramifications for agricultural production and meat prices. This report analyzes trends in sales and develop- ment of veterinary antibiotics. Antibiotics sales for food-animal production in the United States and the European Union (EU) have shown declines, even as demand for food-animal products continues to increase. The number of veterinary drug and biological products brought through regulatory approval in the United States also declined between 1989 and 2015, and antibiotics for food-animal production account for a decreasing share of new drug approvals. Keywords: Antibiotics, veterinary pharmaceuticals, vaccines, livestock, economics, animal pharmaceuticals, innovation, drugs Acknowledgments The authors would like to thank Keith Fuglie, USDA, Economic Research Service (ERS) and Michael Sheats, USDA, Agricultural Marketing Service (AMS) for data. They also thank the following individuals for technical peer reviews: William McBride, USDA, ERS; David Hennessey, Michigan State University; Gregory Graff, Colorado State University; Hyun Lillehoj, USDA, Agricultural Research Service; and two reviewers who requested anonymity. Thanks also to Maria Williams and Cynthia A. Ray, USDA, ERS, for editorial and design services. Contents Summary ..................................................................... iv Introduction .................................................................... 1 Antibiotics and Antibiotic Resistance: A Primer ...................................... 4 What Are Antibiotics? ..........................................................4 How Are Antibiotics Used in Human and Veterinary Medicine? .........................4 What Is Antibiotic Resistance? ...................................................4 The Animal Pharmaceutical Industry: Background ................................... 7 Size and Structure .............................................................7 Connections Between the Human and Animal Pharmaceutical Industries ..................8 Types of Products ..............................................................9 Overlap of Product Types Between Human and Animal Pharmaceuticals .................11 Product Development and Approval Process ........................................12 Patents and Generics ..........................................................13 Costs, Revenues, and Profits Over a Drug’s Lifetime .................................14 Factors Driving Sales of Antibiotics in U.S. and EU Food-Animal Production ..................................................... 16 U.S. and EU Regulations on Use of Antibiotics in Food-Animal Production ...............17 Changes in Consumer Preferences for Meat and Poultry Products “Raised Without Antibiotics” ....................................................18 Changes in Disease Pressure in Livestock Production .................................19 Changing Demand for Meat Means Changing Demand for Antibiotics ...................21 Trends in Sales of Antibiotics for Livestock Production ............................... 25 U.S. Antibiotics Sales Quantities for Use in Food-Animal Production ....................25 Sales of Food-Animal Antibiotics in Select EU Countries .............................27 Impact of Regulations on Antibiotics Sales in Select EU Countries ......................28 Quantity May Not Fully Capture Sales Revenues of Antibiotics .........................31 The Animal Pharmaceutical Industry’s Development of Veterinary Products ............ 32 R&D Spending Increases While New Product Approvals Decline .......................32 Companion Animal Products Constitute an Increasing Share of Veterinary Drug Approvals ..............................................................37 Antibiotics and Vaccines Form the Largest Shares of Animal Drugs and Biologics Approved ...........................................................39 Generics Constitute a Significant Share of New Animal-Drug Approvals .................39 ii The U.S. and EU Animal Pharmaceutical Industries in the Age of Antibiotic Resistance, ERR-264 USDA, Economic Research Service Trends in the Development of New Veterinary Antibiotics ............................ 43 Are Approvals for Veterinary Antibiotics Declining Like Those for Human Antibiotics?. 43 Is the Rise of “Raised without Antibiotics” Poultry Correlated With a Decline in the Number of Poultry Antibiotics Approved? ..........................................44 Are Fewer Medically Important Antibiotics Being Approved for Food-Animal Use? ........45 Effects of Approval Regulation on New Antibiotic Product Development .................46 Summary and Conclusions ...................................................... 49 References ................................................................... .51 Appendix .................................................................... 61 Veterinary Drug Approvals .....................................................61 Veterinary Biologics ...........................................................64 Methods of Characterizing Product Type and Species ................................65 Human Drug Approvals ........................................................66 R&D Spending in Veterinary Pharmaceuticals ......................................67 R&D Spending in Human Pharmaceuticals .........................................67 9-Year Moving Averages .......................................................68 Estimating R&D Spending per Approval in Pharmaceuticals ...........................69 iii The U.S. and EU Animal Pharmaceutical Industries in the Age of Antibiotic Resistance, ERR-264 USDA, Economic Research Service Summary United States Department of Agriculture A report summary from the Economic Research Service May 2019 United States Department of Agriculture Economic Research The U.S. and EU Animal Pharmaceutical
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