Biopharmaceutical technology is the process of manufacturing drug product in extracted or synthesized form from a biological source. Pharmaceuticals are produced in synthesized forms whereas biopharmaceuticals include vaccines, blood components, allergenic, gene therapies, recombinant therapeutic protein, somatic cells, and living cells. The drug is obtained from a living source like human, plant, microorganisms, or fungal.
Biopharmaceuticals occupy 20% of the pharma market. It is the fastest growing technology in the pharmaceutical industry. Biopharmaceutical manufacturing has evolved products that have treated the previous untreatable issues. There is a strong demand for these highly innovative drugs. Biopharmaceutical companies have come up with blockbuster drugs (drugs that have more than $1billion sale in a year). One such anti-inflammatory drug Humira, generates sales of more than $10 billion a year.
Challenges and future trends in Biopharmaceutical Technology
Biopharmaceutical companies are moving from the scientific front to the business front as there is the exorbitant demand of biopharmaceuticals. With the blockbuster drugs, the future seems bright and clear. The biopharmaceutical manufacturers are growing at a rate of 8% every year. The drugs are safe, effective, and even treat the untreatable diseases. Thus, they have been strongly demanded despite high costs. The biopharmaceutical companies face a challenge to meet the demand. To meet the demand the focus of biopharmaceuticals is shifted from R&D to large molecule products.
Future trends suggest investment in biotech R&D would yield much better results than the pharma industry. The current pipeline gives a continued healthy growth. Biopharma patents applications incrementing and approximately 1500 biopharmaceutical products are under clinical trials. The new molecules launches are difficult to predict. There are a handful of biopharma products that are waiting for approvals from US Food and Drug Administration.
The scope of biopharmaceutical business is excellent, showing a steep increase as many companies are going to get approval for the biopharma products production and marketing. Biopharmaceutical companies are putting lofty efforts to make the picture more exciting. The exciting innovation of future is immunotherapy, gene cell therapies, 4D bio printing, cellular therapies, and 4D NMR.
This particular technology of pharma industry would surely bring a 360-degree turn. The treatment process would be far effective as the interaction between drug and the genetic map would be understood; low-cost genetic profiling would be possible and accurate clinical outcomes. On the whole, the drug development process would be easy and cost effective in future.
The outburst comes with a lot of challenges for the biopharmaceutical manufacturers. The cost pressure and increased competitiveness are a reason to worry. Biosimilar industries would come up as an inevitable part. With the surge, the patent protection process would be more complex and intrinsic.
Another biggest challenge for the biopharmaceuticals is focussing on the quality functions and regulatory scrutiny. The quality functions are unable to cope up with the demand. Furthermore, it can be said the new drug development process would definitely be a turn over for the health sector. However, it is unsure for how long the benefits would outweigh the risks.