Doubled over the past decade, while new drug approvals have dropped down to a third. With the R&D cost now at more than US $1.2 billion per drug approved, only one in five drugs approved is able to pay for the cost of its own development.
As health agencies become increasingly risk averse with respect to safety, drug approvals have become progressively more difficult as larger studies and more data, both pre- and post-approval, Asian Biopharmaceuticals: are being mandated. Furthermore, regulatory approval is no longer the last hurdle in major markets, The Challenge to Globalize but success depends increasingly on whether a new drug will receive reimbursement based on (continued) favorable health economic assessments. Biotechnology companies in all
And in this increasingly challenging landscape of rising costs and falling approval rates of new emerging countries should learn drugs, the pharmaceutical industry is rapidly moving towards an impending “patent cliff” with an from the Japanese experience. estimated $128 billion of branded revenues losing patent protection between 2009 and 2014 Success in the parent country is a (Figure 2). Reflecting this gloomy outlook, pharmaceutical stock values have fallen far behind the very long way from global broad stock market indices (Figure 3). commercial success. A biopharma company may have an excellent