02 July 2012 | News | By BioSpectrum Bureau
HIV generics to take over antivirals market
Loss of patent exclusivity will push growth of HIV generics
Singapore: Generics are predicted to take over the antiviral drugs market, especially in the case of HIV medication, as a series of patent expiries will open opportunities for ambitious companies to seize huge revenue, according to a new report by healthcare experts GBI Research.
The new report states that an increase in the patient population and reforms in government policies will work together to encourage the rise of generic pharmaceutical powers.
Government policies include the need for prior authorization in order to dispense branded drugs that have generic alternatives, while further incentives are available from Pharmacy Benefit Managers (PBM) for dispensing generic drugs. These kinds of regulatory changes and financial benefits could act as significant drivers of the market during the forecast period. (Read India announces new biosimilar regulatory guidelines)
While it is estimated that, in 2010, generics accounted for 18.9 percent of the market share in the global antivirals market, this market share is forecast to grow to reach 29.2 percent by 2018. This is largely due to a series of patent expiries expected to hit the antiviral market, which will act to raise the value of generic antiviral drugs to over $9 billion by 2018.
Generics in the HIV market in particular accounted for an estimated majority market share of 46 percent in the total generic antivirals market during 2010. HIV generics are expected to create a boom in the market, due to a loss of patent exclusivity for key antiviral drugs.
The generic market is currently dominated by products such as zidovudine, didanosine, stavudine and lamivudine. However, many major patent expiries are expected during the forecast period, including Sustiva (efavirenz) and Kaletra (lopinavir + ritonavir) in 2013, Prezista (darunavir ethanolate) in 2014, and major Nucleoside Reverse Transcriptase Inhibitors (NRTIs) such as Trizivir (abacavir sulphate/lamivudine/zidovudine), Epzicom (lamivudine and abacavir) and Emtriva (emtricitabine) in 2016.
By 2018, billions of dollars worth of industry revenue will be lost from the expiry of these brand name products, and the race will be on for generics manufacturers to create new superstar drugs to make the most of this unmet need in the market. Generics within the antiviral market are forecast to grow at a CAGR of 10.5% during 2010-2018.
In December 2011, Teva launched generic Combivir in the US market as a combination tablet containing lamivudine and zidovudine, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Combivir had annual sales of approximately $556m in 2010, based on the annual report.