| Historically pharmaceutical companies did all their own | | | | synthesis. A number operate as 'one-stop shops' and |
| research and development in house. Over the last | | | | provide the whole range of chemistry services that |
| few years however, while the cost of discovering | | | | the chemistry department of a traditional |
| and developing a new drug has rocketed to almost | | | | pharmaceutical company might have once provided. |
| $1 billion the number of new drugs approved has | | | | These cover the diverse range from drug discovery |
| dropped considerably, to almost half of the level in | | | | to manufacture of commercial drug substances. |
| the nineties. Many blockbuster pharmaceuticals are | | | | The outsourcing companies can ensure that prices |
| coming off patent in the near future. In addition, | | | | are kept competitive. A pharmaceutical company |
| newer technologies are resulting in the growth of the | | | | does not now have to maintain a large R&D |
| number of candidate drugs that need to be tested. | | | | workforce. Specialist outsource providers become |
| These pressures are combining to change the | | | | expert in their particular areas and the pharmaceutical |
| historical models operated by pharmaceutical | | | | companies benefit from this expertise. This is |
| companies. | | | | particularly relevant in the custom synthesis and lead |
| One of the changes is that pharmaceutical companies | | | | optimisation areas where suppliers can develop special |
| are increasingly turning to specialist outsourcing | | | | expertise. Timely process development is essential as |
| providers to cover both peaks in demand and to | | | | it is often on the critical path to new drug |
| concentrate on core capabilities, which are usually | | | | development. So is GMP synthesis when clinical trials |
| research and marketing. | | | | have been committed to. Time lines are minimised |
| Chemistry services loom large in those services | | | | using this model. This ensures the maximum period of |
| outsourced including custom synthesis, process | | | | patent protection is achieved before generic suppliers |
| development, scale-up, GMP synthesis from lead | | | | enter the market and depress prices and profit |
| optimisation to clinical phase III. | | | | margins. A diverse supplier database has developed in |
| Specialist chemistry providers carve out niches for | | | | recent years and ensures that new drugs will |
| themselves and generally offer one or two specific | | | | continue to be developed and benefit mankind in the |
| services, typically custom synthesis [ and lead | | | | future. |
| optimisation or process development and GMP | | | | |