To meet the medical needs of patients, SymBio takes full advantage of its 'search engine' to identify and develop only the most promising drug candidates from a late stage in clinical development, thereby shortening development timelines to NDA filing.
Drug development is not an industry for the fainthearted, requiring the commitment of staggering research and development costs over an undefined period, entailing countless risks to human life along the way, and with no guarantee of final marketing approval: gambling in the purest sense of the word.
Under growing financial pressures and inherent risks associated with development, pharmaceutical companies have begun to step up activities for mergers and acquisitions over the past few years, and the industry is now heading down the path of so-called "Megapharma." This shift in the industry and reliance on 'economies of scale' has left behind a number of underserved therapeutic areas, areas which SymBio intends to address.
With the trend in "economies of scale" and increasing competition, pharmaceutical companies are now in the process of integrating more cutting-edge technologies into pipeline portfolios (e.g. gene/bio-therapies).
The impending expiration of several global "blockbusters" within the next five years has forced drug companies to re-evaluate their dependence on existing drug development technologies, and to develop novel and more cost-effective therapies; the ultimate goal is to offset this trend in sliding revenues, and eventually regain profitability.
Due to the substantial long-term investment required to bring a drug from the research stage to market (estimated to be an investment of 170 billion JPY over 10 years) and a decreasing success rate for new drug candidates, pharmaceutical companies are now under growing pressure to implement cost containment measures in drug development.
The probability that a compound with some physiological activity will ultimately become a drug is reportedly "1 in 5,000 to 1 in 10,000", an extremely low success rate given the investment of time and money required by pharmaceutical companies: recent data suggests that this downward spiral in the success rate of drug candidates from the preclinical to clinical stage is accelerating.
Giant pharmaceutical companies, or so-called "Megapharma" operating outside of Japan, have now successfully penetrated the pharmaceutical market in Japan, a market estimated to be worth more than 7(*) trillion JPY, and the second largest in the world. This significant increase in market competition by foreign drug companies has necessitated the reconsolidation of the Japanese pharmaceutical industry, and led to the current trend in "economies of scale": an overriding belief by major pharmaceutical companies that "bigger must be better."
(*)research by Fuji Keizai
The upward trend in national healthcare costs due changing demographics in Japan, with an aging population and expensive advances in medical care, exceeded 34 trillion JPY in fiscal 2008, straining the purse strings of healthcare services. The implementation of policies by the Japanese government to contain drug costs and curb expenditures has begun to have a negative impact on profits generated by pharmaceutical companies, reducing reinvestment into R & D activities.