Risks and Opportunities on the Road to  Further Growth Progress on the 2014 Mid-Term  Management Plan* Therapeutic Area Strategy a leading global position in those categories. The GCL  business model is the most important tool in our drive to  create sustainable growth for Astellas. We are implementing the “value innovation cycle” as a  business cycle that will strengthen our competitive edge in  the pharmaceutical market. We believe that this approach  will enable us to deliver a constant stream of high added  value for people seeking better health.  The risks to our future growth that we must consider are  trends that will remain essentially the same: government  efforts to restrict healthcare spending, increasing difficulties  in new drug development and higher costs once a product  has been launched. We also recognize that we cannot  avoid the risks posed by patent expiry on mainstay prod- ucts. The substance patents on two such products, the  overactive bladder (OAB) treatment Vesicare and the anti- cancer product Tarceva, are due to expire in 2018–2020 in  major countries. We will build a resilient organization and  related systems, along with continuously creating new  drugs so we can overcome the impact of patent expiry  and generate sustained growth. This is a priority task for  us in targeting the next stage of growth. Meanwhile, the business opportunities for the pharma- ceutical industry are broad. There are still many diseases  where unmet medical need exists. Such areas provide  opportunities for Astellas. Moreover, recent scientific and  technical advances are opening vast new possibilities to  create highly innovative drugs at a time when regulatory  authorities worldwide are starting to introduce systems to  recognize innovation. To ensure that we seize these opportunities, we never  miss a chance for in-licensing new products and tech- nologies or M&A deals. Our main aim, however, is not to  expand our operational scale, but rather to acquire products  and innovative technologies that are consistent with our  strategic approach. We will actively look at acquiring  opportunities including alliances in new therapeutic areas  and varied fields with new drug business as our core,   considering our business areas, existing product portfolio  and drug discovery technology. Furthermore, we will con- tinue the never-ending challenge of drug discovery in order  to deliver new value to patients.  Compliance is vital to sustaining and growing our   business and we in management are acutely aware of that.  On the Board of Directors, which is responsible for making  management decisions and overseeing business execution,  outside Directors with a high degree of independence  constitute a majority of four of the seven members. Under  this governance structure, we aim to achieve a level of  transparency and reliability in management that satisfies  the increasing demands of society. When we embarked on the 2014 Mid-Term Management  Plan in fiscal 2010, we faced a significant challenge from  the emergence of generic competition for two of our main- stay products—Prograf, an immunosuppressant, and  Harnal (also known as Flomax in the U.S.), a treatment for  functional symptoms of benign prostatic hyperplasia—  following the expiry of related U.S. patents. Under the plan,  we pursued three growth strategies and an efficiency strat- egy to overcome this situation and engineer a new growth  stage for Astellas. We have made steady progress in   executing each of these strategies. * 2014 Mid-Term Management Plan: Covers the five-year period from fiscal  2010 to fiscal 2014 Under the therapeutic area strategy, we are working to  maintain and reinforce our GCL status in the therapeutic  Astellas Pharma Inc.  _ Annual Report 2014 12 Focus Therapeutic Areas in Research and the Gcl Model Concentrate management resources on the innovative drug business Global category leader (Gcl) current Gcl areas Third Gcl area Focus Therapeutic Areas in Research Urology Transplantation Oncology • Immunology and  Infectious Diseases • Neuroscience • DM Complications  and Kidney Diseases