The following Restructuring & Insolvency practice note produced in partnership with Alexandra Pygall and Naomi Leach of Stephenson Harwood LLP provides comprehensive and up to date legal information covering:
The life sciences industry is made up of a diverse range of players and interested parties from small biotech companies spun out of university teams focused on one invention through to huge, multinational ‘Big Pharma’ companies commercialising their blockbuster drugs. Within that spectrum of players you'll also find, among others, contract research organisations, contract manufacturing organisations, specialist logistics and distribution suppliers and wholesale and retail pharmacies. There are a huge number of businesses involved in the life cycle of a pharmaceutical product—a life cycle that can be fraught with challenges and risks.
It is estimated to take between 12 and 15 years to bring a medicinal product to market with a high risk of failure along the way; only a tiny proportion of products that enter pre-clinical testing will obtain regulatory approval for use in humans.
In addition to the incredibly high costs of bringing a product to market, the sector continues to be challenged by increasing pricing pressures from the ‘payers’ in the industry to demonstrate not just the safety and efficacy of a product, but also good value for money through outcome-based pricing. Companies are also still struggling with patent expiries (estimated to be a US$194bn risk for sales in 2022). Some of the largest drug developers also continue to be challenged with entrance onto the
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