A vital part of health care, pharmaceuticals are at the forefront of innovation and deliver life altering medicines to millions across the world. However, there are many challenges behind the mask of progress and breakthroughs. The sector is undergoing an increasingly complex environment, from strict regulation to a constant threat of counterfeiting. In this blog, we'll look at the broad range of challenges facing the pharmaceutical industry and try to find a solution.
A number of stringent regulations are imposed on the pharmaceuticals sector by various regulatory bodies across the world. In order to ensure the safety and efficacy of medicines, all authorities shall lay down rules on their development, manufacturing and marketing. However, undertakings have a major challenge in complying with these regulations and are required to make substantial investments of time and resources. Moreover, market access is even more difficult as a result of the complexity of dealing with an extensive range of legal frameworks in different countries.
Solution: Regulatory processes can be simplified, the compliance and efficiency enhanced through adoption of digital technologies such as artificial intelligence digitalization or Blockchain. More efficient operations may also be facilitated by cooperation with regulatory authorities on transparent communication and the harmonization of standards.
The development of a new medicinal product is an expensive and difficult process. It can take more than a decade, and up to the final approval it could cost billions of dollars from initial discovery through clinical trials. In addition, there is a high rate of failure in the development of medicinal products and just a few candidates have made it to market. Increased R&D costs, with lower returns, are the main challenge facing drug companies, particularly small ones.
Solution: Combining resources and expertise between industry stakeholders, academia as well as research and development institutions can help to reduce R&D costs. Innovative approaches, e.g. computational modelling and virtual trials, can also be adopted to accelerate the development process and decrease costs.
The main means to protect the intellectual property rights of healthcare companies is patenting their products, which gives them sole marketing authorization. However, patents are only valid for a short period of time and the market is open to generic competitors that will significantly reduce their market shares and profits when they cease to be valid. The impact of this phenomenon, which has been referred to as a "patent cliff," is significant for the pharmaceuticals industry and they need strategies in order to maintain profit margins.
Solution: Diversification of product portfolios with investments in innovative therapies and biotechnologies could mitigate the effects of patent expiry. Moreover, by exploring niche markets and geographical expansion, it is possible to generate new revenue streams in order to mitigate the effects of generic competition.
A key source of information for the pharmaceutical sector is the Chemxpert database. For identifying chemicals, discovering drugs, assessing their pharmacokinetics, safety or patent related information, Chemxpert is administered to researchers, scientists and pharmaceutical professionals. It provides detailed information on the properties, interactions, toxicology profiles and intellectual property so that decision making and effective drug development can be informed.
The pharmaceutical sector faces a number of complicated problems, such as regulation, counterfeiting and price pressures. Innovation, collaboration and a patient centered approach to healthcare are at the heart of it. Stakeholders need to work together towards a thriving ecosystem if they are to succeed.