Generic Injectables 2020

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 248 distinct APIs for which there is at least one approved generic injectable ANDA. These 248 APIs account for 1,223 approved ANDAs. Including all approved doses, the current universe of generic injectables consists of 1,746 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.

 
 

What You Will Learn

~ Provides detailed analysis of generic drugs supplied as injectables and assesses key market segments, market dynamics and potential product opportunities
~ Presents the competitive picture for generic injectables in two dozen drug classes
~ Evaluates the importance of ANDA filing strategies and indirect ANDA acquisition on participant growth prospects
~ Analyzes the impact of patents, exclusivity and litigation on participant market sector prospects
~ Assesses the market presence and product position of the top twenty-four generic injectables suppliers
Evaluates the impact of economic, technology, and regulatory factors

Summary of Contents

Executive Summary

The Market Opportunity

The Economics of Injectable Drugs

Growth in Injectables

Generic Injectables – Growth Factors

Patents and Exclusivity

Litigation and First-to-File ANDA Strategies

Buying and Selling ANDAs

Generic Injectables – Product Considerations

As-supplied Container

Lyophilization/Reconstitution

Formulation Factors

Generic Injectables Market Analysis

Drug Class Analysis

Adrenergic Agents    
Anabolic Agents    
Antibiotics    
Anesthetics    
Antiarrhythmics    
Anticoagulants    
Anticonvulsants    
Antiemetics    
Anti-inflammatory    
Antihypertensives    
Antineoplastics         
Antivirals

Bone Resorption  Inhibitors    
Diuretics    
Folic Acid Metabolites    
Growth Hormone    
Inhibitors    
Muscle Relaxants    
Narcotic Analgesics    
Neurotransmitter    
Opioid Antagonist    
Sedatives    
Vasodilators  

Therapeutic Class Analysis

Cardiology

Hematology

Neurology

Pain Management

Other Key Classes

Market Factors

Regulatory Issues

Litigation Issues

Evolving ANDA Filing Strategies

The Role of CMOs

Healthcare Economics