subject: The Global Active Pharmaceutical Ingredients (api) Market [print this page] Active pharmaceutical ingredients (APIs), also known as bulk drug substances, are defined by the US Food and Drugs Administration (FDA) as any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product.
Companies use APIs at a number of stages of pharmaceutical development, including in stability sample testing, general analytical testing and method development, as GMP (Good Manufacturing Practice) APIs in clinical trials, and as source materials for manufacturing marketed drugs.
Sourcing APIs from low-cost suppliers is a key strategy for pharmaceutical companies pressured by the emerging patent cliff . The model of vertical integration that dominated the pharmaceutical industry in the past century, characterized by tight control over all factions of the pharmaceutical manufacturing and development process is now being broken up. For example, UK-based AstraZeneca has stated that it is looking to outsource its entire API production between 2014 and 2019. There have been suggestions that this will be to China and India, although according to the company in November 2009, it has not yet made final decisions on outsourcing locations.
Key features of this report
Forecasts to 2014 for the global APIs market, including forecasts for biotechnology-based APIs and third-party generic APIs (APIs sold to other companies as opposed to consumed in-house).
Evaluation and analysis of the key drivers and restraints impacting the global APIs market
Analysis of the competitive landscape including company profiles for 19 API companies
Analysis of the latest regulatory developments impacting the APIs market
Scope of this report
Understand the size the global APIs market and what the forecasted growth is between 2010-2014
Evaluate which market areas in the API industry have the most promise
Evaluate what new technology areas are driving the APIs market.
Understand the competitive landscape and the key strategies undertaken by the leading APIs companies
Key Market Issues
Outsourcing the production of APIs, or if already outsourced, finding a cheaper supplier, is a key way of saving money at the API manufacturing stage, whether it is for APIs for preclinical or clinical trials, or for the production of finished drugs.
Growth in the overall pharmaceutical market has slowed, as a result of patent expiries, generic encroachment, and price erosion, but growth is expected to revive from 2010, driven by increased demand for healthcare. Growth in the pharmaceutical market in-turn will drive expansion in the API market.
API producers in Europe and the US have the advantages of offering high levels of regulatory compliance, and having advanced technological capabilities. However, the major disadvantage of using these companies is higher costs. API producers from the Asia Pacific region are gaining similar advantages by acquiring facilities in Europe and the USA.
Key findings from this report
The overall growth rate for pharmaceuticals has slowed in the 2001-2008 period. Growth will accelerate from 2010 onwards, as the global economy begins to recover, although it will not hit pre-crisis levels.
Going forward an overall growth rate of around 7.3% is projected for the global APIs market, which is higher than the growth rate expected in the overall drug market.
The upcoming patent cliff is resulting in a surge in sales for generic APIs, which should comfortably outpace growth for innovator APIs over the next five years
In 2008, China was the largest API-producing country in the world. By 2010, India is predicted to be the second-largest market, growing from 6.5% of the global API market to around 10.5% by 2010.
Key questions answered
What is the size and growth rate of the global pharmaceutical market?
What are the main trends driving the growth of the APIs market?
How is the patent cliff impacting API sales?
What impact is the growth in biotechnology and also the emerging biosimilars market having on the APIs sector?
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