Key Challenges and Opportunities: Big Pharma and Biotechnology The pharmaceutical industry has demonstrated remarkable structural stability as most of its key players have now been around for almost a century. However, it has been no exception to the unpredictable times of the 21st century as it grapples with a number of challenges. Among the most pressing issues are the termination of manufacturing rights, import risks, pricing issues and the infiltration of counterfeit drugs, despite research and development costs and political and administrative constraints. Most of these challenges have been around for a long time, and the pace at which they are escalating poses a major threat to the industry. Pharmaceutical companies have been the subject of intense political and social criticism due to their extraordinary surpluses and their alleged stake in escalating healthcare. expense. Governments around the world are attempting to cope with ever-increasing production costs as healthcare budgets incorporate a large percentage of government spending. This has made drug costs a major political discussion in America. In the United States, President Clinton initiated a critical evaluation of the healthcare system and proposed federal controls over this sector and price controls on prescription drugs (Bradley and Weber 3). This threat has not materialized, but the likelihood of other restrictive measures targeting pharmaceuticals still prevails. Furthermore, with many companies competing across just a few therapeutic divisions, the industry is highly disintegrated. Cross-border disparities contribute to the plight of the pharmaceutical sector (Bradley and Weber 3). Many countries have government… middle of paper… time to devote to adult vaccines and ways to increase their production. The development of new drugs has been a major challenge as profits from these new drugs are not sufficient to cover research and development costs. To meet the challenge associated with the commercial launch of a new drug, early involvement and a first responder strategy are needed. Works Cited Bradley, Stephen P., and James Weber. "The pharmaceutical industry: challenges in the new century." Pharmacy 70698 (2004): 1-32. Print.Dyer, Geoff, “Trying Times for the Pharmaceutical Industry.” The Financial Times 15 February 2002. 12-15. Print.Federsel, Hans J. “Chemical Process Research and Development in the 21st Century: Challenges, Strategies and Solutions from the Perspective of the Pharmaceutical Industry.” acc. Chemistry. Res. 42.5 (2009): 671–680. Press.