More and more drug makers are turning to reformulation to prolong the lifecycle of their top sellers and protect precious revenue from generic copies, as well as supplement dwindling pipelines.
The fact that 39 per cent of the total product launches from the 50 top manufacturers between 2002 and 2005 were reformulations is a clear indication of the presence of this trend.
Central nervous system (CNS), alimentary and metabolic therapies are the most frequently targeted for reformulation, according to a new research report by Datamonitor.
Within the CNS market, reformulated products are predominantly antipsychotics, antidepressants, and ADHD and pain therapies. Reformulated stomach ulcer and insulin therapies make up the bulk of alimentary and metabolic reformulations, while respiratory, anti-infective and genito-urinary and sex hormone therapies have also experienced frequent reformulation, the report says.
"This reflects the large patient populations within the major indications of these therapy areas, the high commercial value of many of the products and the highly competitive nature of the markets," said Alistair Sinclair, Datamonitor pharmaceutical markets analyst and report author.
"All of which drive companies to be more active in gaining a competitive advantage within the respective markets, but most of all; with product development pipelines looking increasingly barren, on top of spiraling R&D costs, pharmaceutical companies must ensure they maximize revenues of existing brands."
Reformulations within these categories include soluble tablets, chewable tablets, extended release tablets, oral liquids and suspensions, pre-filled syringes, transdermal patches, and a variety of gels and creams. Converting injectable drugs into non-injectable forms of delivery is proving particularly popular.
However, for all the strategy and planning involved, the success of a reformulation is heavily dependent on the manufacturer's ability to develop an improved version of the original drug, said the report, titled: "Reformulation Strategies - Comparisons of Past and Future Reformulation Strategies."
"The key to a successful reformulation is to provide clear therapeutic benefits over their predecessor", said Sinclair.
"First and foremost, manufacturers need to ensure there is a market need for their reformulated products, and then ensure the drug displays sufficient differentiation from the original, particularly in terms of efficacy and side effects; launch timing is also of key importance."
For many firms this is a daunting task, as they may not have sufficient in-house resources or expertise to rise to the challenge.
Therefore, this reformulation trend is good news for the drug formulation industry, which has seen a 38 per cent growth in the past five years and is expected to continue to boom, as drug companies wishing to reformulate are outsourcing the function to specialist formulation companies.
Reformulation is still quite a niche field and there are relatively few companies in the world that specialise in individual reformulation areas. Firms that do are now finding themselves inundated with new business.
For example, UK form Medpharm said it has been experiencing a growing business demand for topical formulations of drugs, in which it specialises.
According to the firm, there is only one other company in the US that specialises in topical drug formulation and provides the full range of services, from mathematical modelling of a drug profile, through to formulation development and optimisation and manufacturing.