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## Business Environment and Growth Opportunities 

The business environment for the pharmaceutical industry is changing with unprecedented speed. Governments around the world are strengthening measures to rein in healthcare costs, including reductions in drug prices and promotion of generics. Another change is the increasing burden associated with meeting the requirements for developing and marketing new drugs. On the other hand, the global market for pharmaceuticals is projected to keep growing, and we have seen a steady level of new drug approvals in developed countries in recent years. 

There remain numerous diseases where medical needs are largely unmet and Astellas is targeting these in its R&D activities. Moreover, recent scientific and technological advances are opening up vast new possibilities to create highly innovative drugs at a time when regulatory authori- ties worldwide are starting to introduce systems to recog- nize innovation. Going forward, we will continue to focus on new drugs, seeking to take advantage of growth opportunities for Astellas through the development of high-value-added pharmaceuticals. 

## Business Risks 

Business activities are subject to many risks and uncer- tainties, both known and unknown, that have the potential to impact operating and financial performance significantly. 

<img src='content_image/294245.jpg'>

Source: EvaluatePharma 

These risks include factors relating to R&D or marketing activities, intellectual property, side effects and other safety aspects, the impact of regulatory actions, environmental issues, litigation and foreign exchange rate movements. (For further details, please refer to page 102.) Each busi- ness division of Astellas has the basic responsibility for managing its own risks, and works to mitigate them and ensure appropriate responses. 

In particular, one inherent risk that pharmaceutical companies face relates to the advent of tough competi- tion from generic drugs after the expiry of patents on mainstay products. Minimizing the fluctuation of sales revenue and ensuring sustained growth over the medium and long term are critical management issues. 

## Towards the Next Growth Stage 

Having overcome the “patent cliff” that we faced with earlier growth drivers Prograf, an immunosuppressant, and Harnal, a treatment for functional symptoms of benign prostatic hyperplasia, we have made steady prog- ress since fiscal 2010 in implementing growth and effi- ciency strategies that will support Astellas’ sustainable growth into the future. To support swift and flexible responses to a rapidly changing business environment and to ensure continued growth, we are focusing on three strategic initiatives: maximize the value of new products; enhance innovation; and pursue operational excellence. 

## Strategic initiatives for Sustainable Growth 

Continue to pursue three strategic initiatives to respond smoothly to environmental changes and achieve sustainable growth 

Maximize the value of new products 

Growth strategy 

Enhance innovation 

Efficiency strategy 

Pursue operational excellence 

