Not a bunch of empty vessels
Excipients are a curious topic. These majorly inert carries of active pharmaceutical ingredients in a medicine are responsible for the physical attributes of the tablet/capsule but are often neglected in term of the role they play in the medication. Innovating sophisticated medicine customized to genomic traits (read precision medicine) without concentrating on suitable excipients is analogous to fixing a Ferrari engine in old and dusted lemon. It may be good, but it won’t be the best. After all, what good is an efficient medicine if it can’t reach its full potential.
Many people think that just because excipients are inert, they are nothing but empty vessels but it has demonstrated to be wrong in many cases. One of the more famous ones include, Sandoz vs Novartis where, the latter relaunched an already existing product in the market with new micro-emulsifying technology which proved to be a game changer in the case. Similarly, when Pfizer are searching for a IV formulation for their anti-fungal drug voriconazole, they turned towards Cydex’s Captisol which addressed their problem of low solubility.
Downfall of blockbuster boom
As mentioned, every drug needs a suitable excipient to unlock its full potential and make it into a blockbuster. With many blockbusters like Merck’s Zetia, Teva’s Nuvigil, AstraZeneca’s Crestor among others, set to expire their patents by the year end, generic drugs will flood the market seeking to replace them as a cost effective replacements.
Yet, the reluctance or lack of interest of key players to invest in excipients when its needed most is baffling many industry experts. One reason that can be cited is the stringent regulations of FDA and other regulating agencies around the world. It became a sort of pharmaceutical quandary since the agencies won’t approve new excipients unless they are paired with existing drugs and no company would look to develop new excipients with existing drugs without getting regulatory approval. Set the fact aside, development pipelines for new excipients are too costly and time-taking adding to the fact that they must be developed in tandem with the main drug.
Innovate or Imitate
As discussed earlier, Pfizer took a big risk, but they had an overwhelmingly technical issue for which they have literally found the solution in captisol. Unfortunately, scenarios like these rarely come by hand. As generic drugs are taking over the market the only avenue that remained seems to be imitating rather than innovating. The manufacturing of co-processed excipients seems to be the solution in this case. Here, two existing novel excipient technologies are combined to give rise to a new product which can be approve easily, since it has all the relevant safety data in the form of its predecessors. Besides that, often many of the Pharmaceutical seek alternative ways of administering a drug, just so that they can counter the patent expiry laws and extend their market exclusivity on the drug sales. The age old laws can be blamed in this case. Many companies seem to have the capacity to innovate in the field but considering the ease of manipulating the rules and consequent benefits brought the progress in the field to a standstill.
A New Hope
Despite the hurdles, organizations like International Pharmaceutical Excipients Council (IPEC) and European Medical Agency (EMA) are trying to bring order to the chaos by establishing a standard set of guidelines for maintaining the quality manufacturing and usage of excipients and drug administering systems.
Though the organizations themselves are old, they have been gaining a lot of traction in the recent years. IPEC has been invited as member of International council for harmonization (ICH) in an observational capacity which makes its voice heard with regulatory bodies overall. EMA also follows suit to IPEC by publishing Good manufacturing practice (GMP) and good distribution practice (GDP) for the European Economic Area (EEA)
While western countries are taking a stand on the regulatory policies, the lack thereof seems to be positive points in developing countries like BRICS nations. Whatever progress seemed to remain the market is due to activity in these regions but true potential and sustainability can only be achieved when the governing bodies realize the importance of innovations in the field and updating the laws accordingly.
Analysts at Market Data Forecast have evaluated all the above factors and much more and predicted the excipients market to grow at 6.1% to reach $7.64 billion by 2020. For more revealing insights about the excipients market and healthcare in general be sure to visit our comprehensive research reports section. Don’t forget to subscribe to our newsletters and blog updates to stay updated with relevant industry news.