Among advanced solubility enhancement technologies, the most important are solid dispersions and lipid solubilisation
The trend towards low solubility is expected to see the market for solubility enhancement excipients grow at a compound annual growth rate of nearly 13% from 2014 to 2024, according to a recent report from market research company Kline & Company.
The Solubility Enhancement in Pharmaceutical Oral Solid Dosage Forms: Global Market Analysis and Opportunities study says various techniques are being used to achieve increased solubility of drug compounds depending on the characteristics of the active pharmaceutical ingredients (API), capabilities of the formulator, and relative cost-effectiveness of the strategies in use. Many solubilisation techniques currently co-exist, and even if some can be considered as preferred routes; when developing drugs, the technology to be used is decided on a case-by-case basis.
Among advanced solubility enhancement technologies, the most important are solid dispersions and lipid solubilisation, finds the report. While these two techniques imply the use of specific excipients, several techniques, such as chemical modification and hydrotropy, do not use excipients for solubility enhancement.
Lipid excipients are the largest category of solubility enhancement excipients because of their high levels of use in drug formulations and their ability to increase the solubility of lipophilic active ingredients. Polymers come in second due to the increasing use of solid dispersion technologies.
The report says the competitive landscape is constantly evolving, and future technology choices on potential blockbusters may bring significant additional changes. Currently, the market for solubility enhancement excipients is dominated by the top five suppliers controlling nearly 70% of the market. BASF is the market leader, followed by Abitec and Gattefossé.
Nikola Matic, Industry Manager of Kline's Chemicals & Materials Practice, said: 'Solubility enhancement excipients are a niche and specific application-oriented market in the pharmaceutical industry. However, there are a large number of advanced technology and excipient suppliers that could potentially gain prominence in the short term.
'Understanding the drivers affecting the solubility enhancement market is vital for suppliers of excipients to best position their business in order to leverage the promising growth of what is today a niche market, but will become a key segment of the pharmaceutical excipients industry tomorrow.'