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Market Research Report

Animal Pharm Generics - New Edition 2017

Published by Animal Pharm Product code 527407
Published Content info 231 Pages
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Animal Pharm Generics - New Edition 2017
Published: April 1, 2017 Content info: 231 Pages
Description

In 2015, the global animal health market was worth an estimated $30bn. This new thoroughly revised and updated Animal Pharm Generics report focuses primarily on the European and North American markets that comprise around 67% of the global market for animal health products. Also fully reviewed are the EU and North American veterinary generics markets, with a specific focus on veterinary pharmaceuticals (such as anti-infectives and parasiticides), as well as medicinal feed additives where appropriate.

The global animal health market is dominated by pharmaceuticals (57% of sales), biologicals (29%) and medicinal feed additives (14%).

While medicated feed is cheap, using primarily established active ingredients (AIs) and often antimicrobials produced in bulk as a commodity product, increasing regulation is making this sector less attractive.

Products based on patented AIs are probably worth just 5% of the market, which reflects a lack of innovation, that many AIs are out of patent, and that pioneer companies frequently retain the controlling share.

Because of the huge costs involved, generic biologicals (or biosimilars) will only be open to large players. The high molecular complexity, multifaceted production methods and stability issues, coupled with smaller returns than for human pharmaceuticals, may prove insurmountable for smaller companies.

PLEASE NOTE: Price is for Single User License only.

Table of Contents
Product Code: 87102

Table of Contents

Contents

Executive Summary

1. Overview

  • 1.1. Focus of the report
  • 1.2. Definition of generics
    • 1.2.1. EU definition
    • 1.2.2. US definition
  • 1.3. Naming conventions
    • 1.3.1. Identifiers
    • 1.3.2. INN
  • 1.4. Counterfeit medicines
  • 1.5. Evolution of human and animal medicine market
  • 1.6. Cost of developing new products
  • 1.7. Emergence of generics
  • 1.8. Innovation impeded
  • 1.9. References

2. Intellectual Property

  • 2.1. Summary
  • 2.2. Introduction
  • 2.3. WIPO
  • 2.4. Patents
    • 2.4.1. Types of patent
    • 2.4.2. Company example
    • 2.4.3. Points of note
  • 2.5. Filing a patent
  • 2.6. PCT
  • 2.7. WTO and TRIPS
  • 2.8. Patent situation in the EU
    • 2.8.1. Overview
    • 2.8.2. Establishment of an EU unitary patent
  • 2.9. Patent situation in the US
  • 2.10. Patent situation in India
    • 2.10.1. Overview
    • 2.10.2. Compulsory licenses
  • 2.11. Patent situation in China
  • 2.12. Extended patent protection
    • 2.12.1. EU - Supplementary Protection Certificates
    • 2.12.2. US - Hatch-Waxman legislation
  • 2.13. Experimental use exceptions ("Bolar" exemptions)
    • 2.13.1. EU
    • 2.13.2. US
  • 2.14. Registration data exclusivity
  • 2.15. Trademarks
    • 2.15.1. Background
    • 2.15.2. Think Outside the Box
    • 2.15.3. Plan Ahead
    • 2.15.4. Select Alternate Names
    • 2.15.5. Trademark Clearance
    • 2.15.6. Invest in Targeted Protection
  • 2.16. References

3. Registration issues

  • 3.1. Summary
  • 3.2. Abridged registration for generics
  • 3.3. US
    • 3.3.1. Veterinary pharmaceuticals approved under the FDA
      • 3.3.1.1. Market exclusivity
      • 3.3.1.2. Registration requirements
      • 3.3.1.3. Suitability Petition
      • 3.3.1.4. Fees
      • 3.3.1.5. Bioequivalence
    • 3.3.2. Ectoparasiticides approved under the EPA
    • 3.3.3. Veterinary biologics approved under the USDA
  • 3.4. EU
    • 3.4.1. Legal background
    • 3.4.2. Abridged applications for generics
      • 3.4.2.1. Directive 2001/82/EC
      • 3.4.2.2. Directive 2004/28/EC
    • 3.4.3. Registration procedures
    • 3.4.4. Proposal for a veterinary medicinal products regulation (revising Directive 2001/82/EC and Directive 2004/28/EC)
      • 3.4.4.1. Overview of Commission proposal
      • 3.4.4.2. Increased data protection proposals
      • 3.4.4.3. EU-wide database
      • 3.4.4.4. ComAgri amendments
      • 3.4.4.5. ComEnvi amendments
      • 3.4.4.6. Proposal for a medicated feed regulation (revising Directive 90/167/EEC)
      • 3.4.4.7. Proposal for a Regulation amending Regulation 726/2004
  • 3.5. References

4. Significance of generics market

  • 4.1. Summary
  • 4.2. Global animal health market
  • 4.3. Global animal health market for generic veterinary pharmaceuticals
  • 4.4. Generics in the pharmaceuticals market
    • 4.4.1. Human pharmaceuticals market
    • 4.4.2. Veterinary pharmaceuticals market
    • 4.4.3. Reasons for differences between the two markets
  • 4.5. Generics in the biologicals market
  • 4.6. Generics in the medicated feed additives market
  • 4.7. Distribution
  • 4.8. Factors favoring generic production
  • 4.9. Regional markets
    • 4.9.1. EU
    • 4.9.2. US
      • 4.9.2.1. Background
      • 4.9.2.2. US FDA approvals
      • 4.9.2.3. Companion animal market
    • 4.9.3. Brazil
    • 4.9.4. China
  • 4.10. Future trends
  • 4.11. References

5. Strategies for R&D companies

  • 5.1. Summary
  • 5.2. Introduction
  • 5.3. Protecting existing IPR
    • 5.3.1. Patents
    • 5.3.2. Trademarks
    • 5.3.3. Data protection
  • 5.4. Developing related patents
    • 5.4.1. Improved manufacturing processes
    • 5.4.2. Improved formulations and delivery methods
      • 5.4.2.1. Background
      • 5.4.2.2. Types of innovative delivery
      • 5.4.2.3. Slow-release bolus delivery
      • 5.4.2.4. Implants
      • 5.4.2.5. Extended/controlled release injections
      • 5.4.2.6. Higher dosing
      • 5.4.2.7. Rapidly disintegrating tablets
      • 5.4.2.8. Lingual spray
      • 5.4.2.9. Pour-on and spot-on delivery products
      • 5.4.2.10. Dermal treatments for companion animals
    • 5.4.3. Combining AIs
  • 5.5. Acquisition
  • 5.6. Marketing strategies
    • 5.6.1. Lifecycle management
    • 5.6.2. Promoting the brand name
    • 5.6.3. Competing on quality
    • 5.6.4. Competing on price
  • 5.7. Distribution issues
  • 5.8. Manufacturing issues
  • 5.9. Parallel trade and its effects on generics
  • 5.10. Focus of R&D companies
  • 5.11. References

6. Strategies for generics companies

  • 6.1. Summary
  • 6.2. Changing image of generics
  • 6.3. Pricing
  • 6.4. Types of generics companies
    • 6.4.1. R&D companies
      • 6.4.1.1. Ivermectin
      • 6.4.1.2. Fipronil
    • 6.4.2. Manufacturers of generic bulk materials
    • 6.4.3. Generic product traders
    • 6.4.4. Generics formulators
    • 6.4.5. Contract manufacturing
    • 6.4.6. Wholesalers and distributors
    • 6.4.7. Generic human pharmaceutical specialists
  • 6.5. Branded generics
  • 6.6. References

7. Company profiles

  • 7.1. Bayer Animal Health
    • 7.1.1. Background
    • 7.1.2. Products
      • 7.1.2.1. Overview
    • 7.1.3. Strategy
      • 7.1.3.1. Imidacloprid
      • 7.1.3.2. Baytril (enrofloxacin)
      • 7.1.3.3. Acquisition of Teva's animal health business
  • 7.2. Bimeda
    • 7.2.1. Background
    • 7.2.2. Products
    • 7.2.3. Strategy
      • 7.2.3.1. Global focus
      • 7.2.3.2. Acquisitions
      • 7.2.3.3. Manufacturing
  • 7.3. Boehringer Ingelheim
    • 7.3.1. Background
    • 7.3.2. Products
    • 7.3.3. Strategy
      • 7.3.3.1. R&D investment
      • 7.3.3.2. Vaccines
      • 7.3.3.3. Pharmaceuticals
      • 7.3.3.4. Product lifecycle management
      • 7.3.3.5. Future direction
  • 7.4. Ceva Sante Animale
    • 7.4.1. Background
    • 7.4.2. Products
      • 7.4.2.1. Background
    • 7.4.3. Strategy
      • 7.4.3.1. Formulations
      • 7.4.3.2. Packaging
      • 7.4.3.3. Applicators
      • 7.4.3.4. Distribution
      • 7.4.3.5. Recent patents
      • 7.4.3.6. US
  • 7.5. Dechra Pharmaceuticals
    • 7.5.1. Background
      • 7.5.1.1. EU Pharmaceuticals
      • 7.5.1.2. North America Pharmaceuticals
    • 7.5.2. Products
      • 7.5.2.1. Overview
      • 7.5.2.2. Putney products
    • 7.5.3. Strategy
      • 7.5.3.1. Expansion plans
      • 7.5.3.2. Company acquisitions
      • 7.5.3.3. Antibiotics
  • 7.6. Elanco
    • 7.6.1. Background
    • 7.6.2. Products
      • 7.6.2.1. Overview
    • 7.6.3. Strategy
      • 7.6.3.1. Research
      • 7.6.3.2. Tylan (tylosin)
      • 7.6.3.3. Acquisitions
  • 7.7. Huvepharma
    • 7.7.1. Background
    • 7.7.2. Products
      • 7.7.2.1. Overview
    • 7.7.3. Strategy
      • 7.7.3.1. Manufacturing
      • 7.7.3.2. Acquisitions
      • 7.7.3.3. US market
  • 7.8. Merck
    • 7.8.1. Background
    • 7.8.2. Products
      • 7.8.2.1. Overview
    • 7.8.3. Strategy
      • 7.8.3.1. R&D focus
      • 7.8.3.2. Acquisition focus
      • 7.8.3.3. Patents
      • 7.8.3.4. Zilmax (zilpaterol hydrochloride)
      • 7.8.3.5. Engagement with veterinarians, livestock producers and consumers
      • 7.8.3.6. Generics competition
  • 7.9. Norbrook
    • 7.9.1. Background
    • 7.9.2. Products
      • 7.9.2.1. Overview
    • 7.9.3. Strategy
      • 7.9.3.1. Innovation
      • 7.9.3.2. Enroflox 100(enrofloxacin)
      • 7.9.3.3. Partnerships
      • 7.9.3.4. Capital investment
  • 7.10. Perrigo
    • 7.10.1. Background
    • 7.10.2. Products
    • 7.10.3. Strategy
      • 7.10.3.1. Product development
      • 7.10.3.2. Product promotion
      • 7.10.3.3. Fipronil and methoprene
  • 7.11. Vetoquinol
    • 7.11.1. Background
    • 7.11.2. Products
      • 7.11.2.1. Overview
    • 7.11.3. Strategy
      • 7.11.3.1. Sales and marketing initiatives geared to reference products
      • 7.11.3.2. Product launches
      • 7.11.3.3. Lifecycle management
      • 7.11.3.4. Acquisitions
      • 7.11.3.5. Agreements with other companies
  • 7.12. Zoetis
    • 7.12.1. Background
    • 7.12.2. Products
      • 7.12.2.1. Overview
      • 7.12.2.2. Antibiotics
      • 7.12.2.3. Competition from generics products
      • 7.12.2.4. Rimadyl (carprofen)
    • 7.12.3. Strategy
      • 7.12.3.1. Intellectual property
      • 7.12.3.2. Product lifecycle management
      • 7.12.3.3. Moving away from low-margin, older products
      • 7.12.3.4. Sales and marketing
      • 7.12.3.5. Moving into new areas
      • 7.12.3.6. Developing selected generics
  • 7.13. References
    • 7.13.1. Bayer
    • 7.13.2. Bimeda
    • 7.13.3. Boehringer Ingelheim
    • 7.13.4. Ceva
    • 7.13.5. Dechra Pharmaceuticals
    • 7.13.6. Elanco
    • 7.13.7. Huvepharma
    • 7.13.8. Merck Animal Health
    • 7.13.9. Norbrook
    • 7.13.10. Perrigo
    • 7.13.11. Vetoquinol
    • 7.13.12. Zoetis

8. Industry associations

  • 8.1. EGGVP
  • 8.2. GADA (US)

9. Abbreviations

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