Inert Ingredients for Drugs

Report Highlights

• In 2001, the global market for pharmaceutical (drug) inert ingredients was an estimated 7.25 billion pounds, of which water, accounted for about 77% of the total.
• Overall growth of all drug inert ingredients is the order of 5% per year.
• Injectables, essentially all Rx, constitute the single largest dosage form of excipients used in 2001 with almost 1.9 billion Kgs.
• Nonaqueous biological use will grow to 563 million Kgs by 2007, an average annual growth rate (AAGR) of 4.5%.

INTRODUCTION

A typical pharmaceutical formulation, whether it be a tablet, capsule, lotion or inhaler contains two primary types of ingredients: (1) the active, therapeutic agent or agents, and (2) all the other ingredients that comprise the formulated product. Since the amount of active agent(s) usually is small (with the exception of many OTC tablets), the bulk of the formulation comprises inert ingredients, usually up to 95% or even more of the total product makeup.

BCC throws light on this little studied area. It quantifies the volumes (that is, the weight) of inert ingredients in drug formulations used worldwide, a difficult task since inerts are some of the most “hidden” subjects. It also articulates issues that drive the inert ingredients . These include questions of purity, safety, and the internationalization of quality, purity standards, etc. The goal here is to help suppliers and users of inert ingredients understand what they must deal with to move their forward. The report identifies the major producers and distributors of inert ingredients for drugs; that is, the companies that actually manufacture these materials and some that stock and sell them. Suppliers that interact directly with drug product formulators at the last step of the supply chain may or may not be readily identifiable, but true bulk manufacturers can be even more opaque, particularly on a global scale.

BCC was the first ever to publish a multiclient analysis of inert ingredients. In this update we add new developments and products in the field, refine the data and bring our knowledge up to the beginning of the 21st century.

This analysis is intended to assist CEOs, presidents, marketers, developers, directors of research and strategic planners in drug ingredients supply and finished drug formulations es.

SCOPE OF STUDY

This study covers in depth many of the most important technological, economic, environmental, political and other considerations relating to pharmaceutical inert ingredients, and is global in its analysis. It includes:

• An overview of the industry

• A discussion of formulated drug sales and their inert ingredients, prescription (Rx) and over-the-counter (OTC) markets, labeling, and trends, issues and regulations

• Product and market analysis of inert ingredients covering materials, functionality, dosage form, and Rx vs. OTC markets

• Industry structure, regulatory and international aspects of the inert ingredients markets

• Profiles of inert ingredients supplier companies.

METHODOLOGY AND INFORMATION SOURCES

Extensive searches were made of relevant technical and medical literature, and on the Internet. These included many leading trade publications and technical government and private compendia, and information from trade and other associations. Much of the product and market information, or at least good leads for getting it, was obtained from principals in the industries. Corporate profile information was obtained primarily from the individual companies, especially the larger publicly owned firms. Other information sources included BCC's previously published studies of the medical field (the recent BCC study, B-108R, on bulk pharmaceutical actives was particularly helpful), textbooks, directories, articles and industry Websites.

ANALYST CREDENTIALS

This is the fifth revision of BCC's pioneering work in this field. J. Charles Forman, author of 25 BCC reports, is a chemical engineer with a strong background in chemistry. For the past 15 years, he has been an independent technical writer and analyst. He has over 20 years of experience in the pharmaceutical and fine chemicals manufacturing industries, including Abbott Laboratories. Dr. Forman holds a B.S. from MIT and a Ph.D. from Northwestern University.