Pharmaceutical Contract Manufacturing and Research

Report Highlights

• Worldwide revenue for contract manufacturing and research for the pharmaceutical industry was estimated at $100 billion in 2004 and is expected to rise at an average annual growth rate (AAGR) of 10.8% to $168 billion in 2009.
• Contract manufacturing of prescription drugs for 2004 was estimated at $26.2 billion, and is expected to rise to $43.9 billion by end of 2009.
• Contract manufacturing of OTC and nutritional products is the largest and fastest growing segment, expected to rise at an AAGR of 11.3% to $102 billion by 2009.
• The contract research market is expected to reach $21.9 billion by 2009, rising at an AAGR of 8.6% from $ 14.5 billion in 2004.

INTRODUCTION

Large pharmaceutical companies increasingly turn to contract manufacturing organizations (CMOs) solely to achieve efficiencies in cost, capacity and time-to-market, or to obtain a specific expertise not available in-house. Today, these factors still play a role, but now the most dynamic driver behind the use of CMOs in the pharmaceutical industry rapidly is becoming the unique, innovative, and state-of-the-art process and production technology they offer. More and more pharma companies are leaning towards outsourcing to concentrate on marketing their products, without spending time in drug discovery and process of manufacturing. This applies to those virtual companies that exist by the simple fact they can rely on contract manufacturers and researchers.

This BCC study looks at almost all types of contracting models and contracting companies. The rapid development of technologies and major changes in market behavior justify focusing on this segment. The report provides an overview of contract manufacturing and research in the pharmaceutical and examines contracting models and the history of and need for outsourcing. The contract companies manufacturing and researching pharmaceuticals and biopharmaceuticals are brought to the forefront and described in terms of industry structure and where they are placed in the present scenario.

SCOPE OF STUDY

The report contains:

An overview of the contract in the pharmaceutical industry
Analysis of the quality assurance required, the regulatory environment and technology transfer aspects
An overview of technological issues and trends
Examination of the market's size by specific drug with forecasts through 2009
Revenue analysis by bulk drugs and dosage forms like solids, liquids and semisolids, and separately for OTC and nutritional products
Analysis of the contract research market, with forecasts through 2009
Company profiles and market shares, where available.
METHODOLOGY

A comprehensive literature search was conducted. The literature included technical newsletters and journals, as well as many other sources. The data was collected through interviews and correspondence with various Analytical/Chemical/Pharmaceutical and Contracting experts. Projections were based on estimates such as the current number of end users, potential end users, likely unit prices, rates of consumption and market trends.

INFORMATION SOURCES

BCC surveyed many companies to obtain data for this study. Included were manufacturers and the end users of the pharmaceutical drugs through contract manufacturing/ research. We gathered the data from the industries, also spoke with officials or physicians of this industry, consulted newsletters, company literature, product literature, a host of technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key terminology were done. In addition, we compiled data from current financial and trade information and government sources.

ABOUT THE AUTHOR

Shalini Shahani holds a Masters degree in Pharmaceutical Chemistry. Among the research topics she has covered are Studies on Compounds of Potential Pharmaceutical Interest from Ibuprofen and 2-Naphthyl Acetic Acid. Shahani was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and in the U.S. Some of her other reports with BCC are "Reagents of Chromatography," "Spectroscopy, an Enduring Market" and "Advanced Drug Delivery Systems," "Orthopedic Drugs, Implants and Devices," and "Imaging Reagents."

ABBREVIATIONS USED

ANDA                       Abbreviated New Drug Application