The Brazilian government is investing in the development of biopharmaceuticals through partnerships with innovative multinationals, local pharma companies and public research and development institutions, as Gabriela Salerno and Rana Gosain of Daniel Advogados report.
In 2001, the worldwide revenue of the pharmaceutical market was around $390 billion. Ten years later, this number increased to almost $1 trillion, with biopharmaceuticals accounting for approximately 15.7%. Forecasts show that this percentage is expected to exceed 20% by 2016. The key regions for the global biologics market are the US, Europe, Japan and Brazil, Russia, India and China, which together accounted for 83% of this market in 2014.
Based on these statistics, the research, development and innovation process of the pharma industry has been gradually changing due to the so-called modern biotechnology revolution, which represents a whole new world of possibilities for the treatment of autoimmune diseases, cancer and others.
However, several important differences between synthetic drugs and biopharmaceuticals must be taken into consideration. The former are usually small stable molecules which can be easily manipulated and obtained by a controlled process. On the other hand, biological drugs are quite complex and unstable molecules which can have their structures completely changed when subjected to minor variations.
Because of their complexity, identical copies of biopharmaceuticals are extremely difficult to produce and the processes for producing them play a critical role in maintaining their safety and efficacy. Large-scale biotech manufacturing facilities are at least five times more expensive to build compared with synthetic molecule facilities and are also more costly to run.
Therefore, biological drugs are often included in the expression 'the process is the product', indicating the significance of the manufacturing process to guarantee quality. Another parameter that is pivotal for biologics is immunogenicity, which is the ability of a substance to trigger an immune response. Since these substances are generally macromolecules, they are usually immunogenic and therefore they can provoke an immune response which can lead to serious consequences if not properly controlled, such as an immune tolerance breakdownwhereby the body cannot tolerate its own proteins.
In Brazil, the sixth largest pharma market in the world, retail sales jumped from R$28.7 billion ($8.3...