The generic injectable drug segment is a rapidly evolving and highly unpredictable environment that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. There are 235 distinct APIs for which there is at least one approved generic injectable ANDA. These 235 APIs account for 1,167 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,699 unique injectable products. These products are marketed and supplied by slightly less than one hundred companies. Competition among the various drug and therapeutic classes is uneven, with the top ten segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.

1. Generic Injectables Products, Markets, Players
and Outlook
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2. ABSTRACT
The generic injectable drug segment is a rapidly evolving and highly unpredictable environment
that lacks a true data compass to assist decision makers in mapping strategies for success in this
segment. There are 235 distinct APIs for which there is at least one approved generic injectable
ANDA. These 235 APIs account for 1,167 approved ANDAs. Including all approved doses, the
current universe of generic injectables consists of 1,699 unique injectable products. These
products are marketed and supplied by slightly less than one hundred companies. Competition
among the various drug and therapeutic classes is uneven, with the top ten segments accounting
for a disproportionate level of activity and revenue. Understanding the underlying factors
affecting business performance is key to attaining financial targets.
‘This report is a comprehensive evaluation and analysis of the products and participants in this
evolving segment of the injectable drug sector. It is designed to provide drug product decision
makers, healthcare marketers, and supply chain participants with a detailed understanding of the
economics, disease segments, and commercial opportunities for generic injectables. Provider
organization business managers, healthcare administrators and investors will also benefit from
this study.’

3. ABSTRACT
Market-driven Product Strategies
A longer life span is expected to translate to a growing number of patients diagnosed with
chronic conditions. To counteract the financial and medical infrastructure implications of this
trend, pressure from the public sector and managed care organizations will place a premium on
therapeutic self-administration, an expectation that is creating an increased interest in routes of
administration that are patient-friendly and cost-effective. Pharma company decision makers
have come to the realization that for many products, success no longer only depends on the
medication itself but also on achieving a consumer-compatible form of packaging and application.

4. Length Publisher Published Date
173 Pages Greystone Research April 1st, 2016
Table of Contents
1. Executive Summary
2. The Market Opportunity
3. The Economics of Injectable Drugs
4. Growth in Injectables
5. Demand Drivers
6. Competitive Landscape
7. Generic Injectables - Growth Factors
8. Patents and Exclusivity
9. Litigation and First-to-File ANDA Strategies
10. Buying and Selling ANDAs
11. Generic Injectables – Product Considerations
12. As-supplied Container
13. Lyophilization/Reconstitution
14. Formulation Factors
15. Etc.
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5. ABOUT THE PUBLISHER
Greystone Research Associates is a medical technology consulting firm focused on the areas
of medical market strategy, product commercialization, venture development, and market
research. We assist medical and healthcare market participants in achieving their business
objectives through the creation of detailed development strategies, product
commercialization programs, and comprehensive market and technology research and
analysis. Our market research publications are designed, researched and written to provide
timely and insightful information and data on focused market segments, with the aim of
providing market participants with the essential knowledge to refine and execute their
marketing plans and reach their financial targets.
View more reports from this publisher
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