Excipients in Pharmaceuticals
The chemical compounds used to make excipients are valued at $4.3 billion market value for 2011, up from $3.5 billion in 2006. The dominance of USP water, particularly water for injection, skews the market volume and sets the pace for the anticipated 5.1% average annual market volume growth rate over the next five years.
Formulators will continue to use excipients to give their final drug products the necessary or desired functional use or properties. Vehicles, with an estimated 2011 market volume of 9.6 billion pounds, lead due to the large amount of USP water consumed.
Fillers follow with an estimated 849 million pounds of excipient chemical compounds being used in that functional category in five years. In terms of market value, the situation is reversed. Fillers come out on top, with an estimated 2011 market value of $1.2 billion, and vehicles drop to third place with $781 million, just below emollients at $816 million.
The global market for pharmaceutical ingredients continues to evolve and expand as research seeks to develop and improve relevant processes and technologies. BCC Research was among the first market research companies to undertake an in-depth look at excipients in drug formulations and to publish a multi-client business analysis on the subject. New demands on performance and quality have changed the shape of the pharmaceutical industry, exposing deficiencies in the old assumptions about the worth of excipients in a pharmaceutical formulation. More widespread and precise testing has proven that inert ingredients in drug formulations contribute more than bulk and can even affect the performance of the active (therapeutic) ingredient. As a result, market dynamics with respect to formulated drugs has changed and the supply of the ingredients has broadened internationally. This updated BCC Research technical/marketing study, Excipients in Pharmaceuticals, explores the impact that advancements in the field are expected to have over the next 5 years.
SCOPE OF STUDY
This report contains:
- General information on inert ingredients, the types of technologies used to make them, their uses, and regulatory influences
- Excipients by chemical compounds, functional uses, delivery systems, and finished products
- Market environment, strategies, influences, and shares, international aspects, and other related factors
- Five year market forecasts through 2011 of compounds, delivery systems and finished products
- Company profiles that summarizes the leading industry participants.
METHODOLOGY AND SOURCES
TThe methodology employed to obtain the data found in Excipients in Pharmaceuticals included extensive telephone interviews with key executives of the leading U.S. companies and domestic representatives of foreign companies involved in producing the ingredients. The expert and reasoned comments of the sources, combined with information gleaned from trade journals, patents, company reports, press releases, relevant technical, medical, and product literature, and government documents germane to inert ingredients for drugs, provide the basis for the contents of the report.
The information has been used to formulate average annual growth rates, which are then compounded (CAGR). All market sizes refer to worldwide values and volumes, which are rounded to the nearest million in dollars and pounds. Due to rounding, some CAGRs do not agree exactly with figures in the market tables. Market size is estimated at the level of consumption in actual drug formulations. Where precise information was not available, a consensus was made using a formulation of reasonable assumptions and estimates based on historical data. In this report, the market size for 2005 serves as a base for making estimates for 2006 and projections for 2011.
The author of this report, Norma Corbitt, is a senior analyst with BCC Research, with 21 years of experience with the company. In that time, Ms. Corbitt has written a number of other BCC reports, including Protein Ingredients, Sterilization Technologies Advancing into the 21st Century, The Growing Food Testing Industry, and Engineered and Staple Soy-Containing Foods. She has either assisted or been the editor of a number of the company's monthly newsletters.
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%.