The biotech industry is growing faster than expected fulfilling its consumers, investors and workers’ great expectations. However, the pandemic of Covid-19 is partly related as it has motivated the acceleration in investments in the sector that is characterized by its long-term results.
There has been an extraordinary impact on science, healthcare, law and the business of biotechnology for over more than three decades. More than 260 novel biotech products for over 230 indications were approved during this time. Including more than 4,600 biotech companies globally, global sales of these products exceeded $175 billion in 2013 and thus have helped in the sustaining of a vibrant life sciences sector.
However, it has been assumed that the future impact of biotechnology is expected to be promising as long as both the public and private sectors continue to foster policies and provide funds that lead to breakthroughs.
We all have noticed that for more than thirty years, the biotech industry has made a tremendous and extraordinary advance in both business and therapeutics. Twenty innovative technologies have made the invention of new products, the approval of more than 260 novel human therapeutics which cover over 230 indications and the creation of more than four thousand six hundred biotech companies globally including global sales of more than $175billion in 2013, all these things are included in the development.
The need for extensive funding along with the high-risk business model which combined highly innovative and novel science with long R&D cycles made the business environment of biotechnology characterized by variation in operations and culture from the pharmaceutical industry. Biotech business culture tended to be wider, science-focused and challenging as compared to huge pharmaceutical companies at the time. A more action-oriented and entrepreneurial environment was fostered by team-oriented decision-making and communications.
Making a very important discovery, biotechnology company formation in the 1980s often emerged as a result of a university scientist’s making such as identifying important disease photosynthesis’s involved molecular target or pathway or via new technologies for disease treatment discovering a new novel molecule.
During the early 1980s, products were developed for patient care by focusing primarily on endocrine and blood disorders. Addressed twelve clinical indications, and five companies developed sixteen products. Insulin was the first biotechnology product in 1982 which used recombinant human protein to receive FDA approval.
The regulatory environment focused on boosting drug reviews and their approvals during the 1990s. The germane laws and regulations were enacted in the 1990s. Accordance to ‘The Prescription Drug User Fee Act (PDUFA) of 1992’ there is a requirement for companies to pay user fees for the FDA to review new drug applications and biologics license applications. The agencies are expected to complete these reviews within a certain period of time in exchange, the time mentioned is six months for priority drugs (those treating a serious condition and providing significant improvement in safety or effectiveness) and twelve months for standard drugs. The time required for FDA approval has been substantially reduced by the PDUFA, and according to both the regulated industry and FDA, it has been considered a success.
The future of biotechnology
The genetics of the individual patient will indicate the likely response of the disease to the biological treatment and therefore it is a key initiative that will be continued in the development of personalized medicine or pharmacogenomics in the future. Avoiding those treatments that might result in serious adverse events, will allow prescribers to tailor individual treatment regimens to include medicine that has a high likelihood of offering a positive therapeutic outcome.
During the past thirty years, biotechnology has had an extraordinary and more and more impact on healthcare. Thus, it is also expected to continue into the foreseeable future, the growth of understanding of the pathophysiology of many newly erupted untreatable diseases which are growing faster, governments worldwide throughout the globe continue to advance initiatives that behold and support biotech innovations, and business practices evolve to manage the costly, a little time consuming and risky process of product development of the biotechnology industry. Leading to breakthroughs in patient care, the result will be a continuing stream of novel medicines.