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