Oral delivery is the preferred route of drug administration, and there have been many advances in the technologies used for controlling a drug’s release rate and bioavailability. Oral delivery of small molecule drugs can be achieved by various methods, although the oral delivery of peptides, proteins and vaccines pose challenges to pharma companies. There is a need to develop novel technologies that can be used to deliver a larger variety of drugs by the oral route. New oral delivery technologies can improve the efficacy of a drug even when same quantity is taken, and this and other advances decrease the cost of manufacturing and therefore decrease the cost of therapy to the patient. These technologies are thus beneficial to both pharma companies and patients. This is especially pertinent due to the potential for this research to allow a company to extend its patent protection by applying a new delivery technology to an existing drug. Pharma companies can also extend their patent protection, patient compliance and drug efficacy by reformulating their products based on their physical and chemical properties. These benefits lead to increased market share and reduced manufacturing costs for the drugmakers.
Increasing patient compliance is important for pharma companies. Many patients do not adhere to a regime of prescription drugs because of difficulty in administration or the taste of a drug. So it is vital for pharma companies to ensure the convenient administration of drug. A study by the New England Healthcare Institute (NEHI) has shown that the cost of non-compliance to medicines is $290 billion in the U.S. This implies that by increasing the compliance rate, there will be a corresponding increase in the revenues of pharma companies.
Drugs for Infectious Diseases
Small molecules constitute the largest segment of marketed drugs, as they are easier to manufacture when compared to protein or peptide drugs or vaccines. Small molecule drugs are generally more stable than protein or peptide drugs, and there is no commercial biologic drug currently delivered orally.
Figure 1: Oral Drug Delivery Market, Marketed Oral Small Molecules by Therapy Area, %, 2011
Small molecule drugs for infectious diseases constitute the largest segment of marketed small molecule oral drugs, with a 21.7% share of the total small molecule drugs market. The three next largest shares of this market are held by drugs for the Central Nervous System (CNS), with 17.5%, and cardiovascular and respiratory disorders, with 11.9% and 8.2% respectively.
The FDA Approves More Reformulations Than NCEs each Year
The FDA approved 75 reformulations and 26 New Chemical Entities (NCEs) in 2009. The larger number of reformulation approvals provides an opportunity for pharma companies to extend the exclusivity period of a drug, and the R&D cost for reformulating a drug is generally lower than for developing NCEs. These two factors have led to pharma companies taking a keen interest in reformulating their drugs. This process has been a key part of large pharma companies’ lifecycle management protocols for more than a decade; innovative pharma companies can expect reformulation to sustain the market value of their leading products.
Oral Drug Delivery is Forecast To Increase Due to Demand
The oral drug delivery market was valued at $49 billion in 2010, and is forecast to grow at a CAGR of 10.3% until reaching $97 billion by 2017. The market is expected to show this increase due to continuing upswing in demand for innovative oral drugs. The implementation of different technologies for oral drug delivery is changing the market scenario — this area has been receiving high levels of attention from pharmaceutical companies due to the advantages that research can provide, such as reformulations, which can reposition drugs and delay patent expiry.
Figure 2: Oral Drug Delivery Market, Revenue Forecasts, ($bn), 2010–2017
Repositioning of Marketed Drugs
Drug repositioning is a term that has recently been coined by the pharmaceutical industry to describe the process of finding new uses for failed drugs, such as those abandoned for lack of efficacy after Phase II trials, or marketed drugs for which new uses will extend patent life and, therefore, profitability.
- There are many examples of repositioned drugs, including Lilly’s Evista (raloxifene), which began clinical trials for breast cancer but was developed for osteoporosis, Celegene’s Thalomid (halidomide), which began as a treatment for nausea in pregnant women and is now on the market for the treatment of leprosy, and Pfizer/Nektar’s Exubera, reformulated inhaled insulin. Many of these treatments are highly profitable, earning billions of dollars for the innovative companies that have found new uses for them.
- The pharmaceutical industry is facing ever-growing R&D expenditure and fewer new drug approvals as a result of increasing regulation, a failure to predict safety problems or a lack of efficacy early in a drug’s development, and high investment in new technologies to improve the speed and accuracy of drug development. In addition to these challenges to the industry’s operators, many leading drugs are due to come off-patent, creating a need to fill revenue gaps.
In order to remain profitable, the industry is looking to low-risk strategies to refuel its product pipelines. Drug repositioning, which presents a lower risk and can offer shorter drug delivery times, is a possible solution to the problems facing companies in the current market scenario.
GBI Research, a provider of business intelligence reports, offering actionable data and forecasts based on the insights of key industry leaders, compiled this report based on the research of its pharmaceuticals analysis team. The company can be reached at firstname.lastname@example.org and www.gbiresearch.com.