REPORT SCOPE
INTRODUCTION
OBJECTIVES AND GOALS OF STUDY
The objectives of this study are to:
- examine the pharmaceutical actives (bulk pharmaceuticals) market
- quantify the bulk production of pharmaceutical actives
- identify producers as opposed to formulators of finished dosage forms
- describe and detail the manufacturing processes for production of pharmaceutical actives
- examine the directions and dynamics of new developments in this marketplace.
The ultimate goal of this endeavor is to provide strategic information that can be useful for planning purposes.
REASONS FOR STUDY AND ITS CONTRIBUTION
The U.S. pharmaceutical industry and the total health care delivery system have seen numerous changes since BCC last looked at this market in 1997. Many of these changes are market driven. With the stronger presence of health maintenance organizations (HMOs) in the U.S. health care delivery marketplace, the end-market dynamics of pharmaceutical sales have been impacted dramatically. Consolidation and major technological breakthroughs also have modified the pharmaceutical industry.
Although new bulk actives used in pharmaceutical-formulated drugs have accounted for major sales increases, the escalating cost of many drugs has caused strong pressure to be exerted in an effort to control rising health care costs. The future is very optimistic because of new therapeutic interventions expected from the success of defining the genetic code and advances in receptor and enzyme research.
This study explores issues driving the development and commercialization of pharmaceutical bulk actives. It sheds light on bulk production and relevant manufacturing methods. It also discusses the likely impact of new technologies on the development of new drug entities. In particular, we stress the quantitative aspects of all matters discussed, and analyze bulk pharmaceutical volume.
SCOPE AND CONTENT OF STUDY
The scope of this study is worldwide. It is about bulk pharmaceutical active ingredients, their producers and the aggregated quantities produced or consumed. The strategic orientation of the study is to explain the forces for change in bulk pharmaceutical requirements along with changes in the bulk pharmaceutical industry itself. Included within the scope of this study are bulk actives for prescription and OTC drugs. Our discussion and analysis of the prescription market includes both branded (ethical) and generic subcategories.
The study focuses only on bulk actives for human therapeutic use. While formulated products have relevance to the subject, this study offers very little discussion or analysis on formulated (finished) drug sales. Other BCC reports can provide this information.
This study is not an audit data report of the kind offered by pharmaceutical tracking services. Rather, it offers aggregated estimates of specific pharmaceuticals or pharmaceutical groups by all providers combined.
Excluded from this study are any discussions or volume measures pertaining to veterinary drugs, animal feed, food, cosmetics, research or other products, applications and markets. Where substances have both human therapeutic and other markets, we quantify only the human therapeutic aspect. This report's Table of Contents contains our specific inclusions.
AUDIENCE FOR THE STUDY
This study should be of importance to those who have an interest in the drug industry. In particular, it should serve manufacturers of bulk pharmaceutical actives, suppliers of intermediates and other supportive materials, formulators and marketers of pharmaceutical preparations, and any others who track the drug industry.
STUDY METHODOLOGY AND INFORMATION SOURCES
Data for this study were collected using both primary and secondary research techniques. A literature search of BCC's extensive library, as well as pharmaceutical and libraries was conducted. We made numerous contacts with suppliers of bulk pharmaceutical actives, both producers and distributors. Other interviews were conducted with industry personnel, professional and trade organizations, government agency personnel, observers, scientists and industry professionals.
Dollar estimates are the work of BCC and are forecasted in 2000 constant dollars. Volume estimates also are the work of BCC. All data collected refer to worldwide figures, unless otherwise indicated. All volumes are expressed in kilograms (kg).
Because the market for bulk pharmaceutical actives has changed since BCC last looked at this segment, we have converted data presentation to both dollar volume and kgs (where feasible). In the previous report, volumes of a drug produced were used exclusively to measure the significance of the drug within the industry. Today, manufacturers of bulk pharmaceutical actives have reevaluated their operations according to a recent article in Chemical Market Reporter (CMR).
A representative of a leading manufacturer is quoted as saying that in the past "...(we) focused primarily on the larger volume indications that require tons of material, but have now broadened our focus to also include smaller volume ." He went on to state that this is a function of the company installing new equipment capable of producing smaller volumes, coupled with the fact that certain therapeutic categories have very low-volume requirements. Consequently, the more important market index is dollar volume sales rather than volume of a specific entity and we have adjusted our presentation accordingly.
These data were analyzed by BCC personnel for specific findings and forecasts (in constant dollars through 2005.) Once these forecasts were obtained, they were validated with industry experts. Therefore, all estimates provided in this report represent a consensus opinion of BCC personnel, industry participants and industry observers.
All analyses were made independently, without the bias of vested interests. Mentions of products or companies is not an endorsement, and omissions, if any, are not intentional.
RELATED WORK CREDENTIALS
The BCC analyst serving as project director on this report has both medical technology and advanced marketing degrees, along with extensive experience in the medical device industry, pharmaceutical industry and in other high-technology markets. Among the other BCC studies published by this analyst are reports on the U.S. blood supply, microorganism testing systems, gene probe markets, medical diagnostic equipment, biocompatible materials, bioengineered protein drugs, new drug delivery systems, the dental marketplace and the laser industry and skin, wound and hair care products.
