Commercial Insight: Antibacterials - Regulations, Resistance & Generics

Overview

Introduction

Antibacterial players are currently facing significant hurdles in terms of increasing and maintaining product revenue. These include growing resistance across classes, greater restrictions relating to the use of antibacterials and an expected increase in generic competition following the expiry of a number of key patents in the next 2-3 years.

• In-depth analysis of country-specific environmental factors that affect the performance of antibacterial products
• Review of recent and expected product specific events and other aspects that will impact sales of leading products
• Country-specific sales forecasts to 2014 of leading brands and classes, for each for the seven major markets
• Detailed case-study analysis of life-cycle management strategies such as follow-up products and reformulations

Increased regulatory scrutiny, drug resistance and generic competition have placed greater pressure on antibacterial profit margins. This explains the lack of significant activity in the current antibacterial pipeline. Datamonitor predicts that, by 2014, pipeline compounds will only account for 10.9% of total antibacterial revenue.

Regulatory scrutiny and pharmacovigilance responsibilities are becoming ever more intense. Key players should support initiatives aimed at easing product approval processes and should also tighten compliance practices throughout their businesses in order to reduce the risk of heavy fines and reductions to ROI.

Novel formulations can allow access to additional market segments while even minor clinical advantages can drive uptake of follow-ups, provided they are accompanied by improvements in cost-efficiency. Datamonitor believes that key players will need to increase their focus on such activities in order to maintain their market position.

• Quantify future size and scope of the antibacterial market and potential for new products
• Understand key drivers and predict the future performance of key compounds
• Evaluate a range of lifecycle-management strategies to combat the threat of generic incursion