This market research study includes detailed analyses of monoclonal antibodies, hormones and enzymes, cytokines and peptide therapeutics, vaccines and antigens and tissue engineering
Biopharmaceutical products are considerably more expensive than traditional ones, largely due to the high-cost technology required for production.
Apart from the various investments in the development and registration of new drugs, meeting regulatory specifications can take eight to twelve years and the entire product launch can cost between $200 million and $500 million.
To successfully introduce drugs, product developers need to be familiar with the intricacies of biologic behaviour and should be able to define a regulatory path by working with regulatory agencies.
Regulations for fine-chemical/small molecule drugs have clearly delineated guidelines and precedents that can be relied upon to advance a development programme.
Once biopharmaceutical developers find a way to meet stringent regulatory requirements by hiring expert personnel and installing sophisticated facilities, the biological manufacturing processes - especially for monoclonal antibodies - are expected to become a lot simpler.
This will encourage the development of several new biopharmaceuticals.
"While new technologies for identification of novel biopharmaceuticals will continue to emerge, a variety of supportive production technologies enable a growing pipeline of novel therapeutics," says Frost and Sullivan research analyst AN Aditya.
"Developments in bioprocess technology have resulted in high outputs, thereby minimising cost and time".
These advances in biopharmaceuticals have coincided with a drop in the number of innovations in the area of traditional small molecules.
While the number of approvals for new small molecules is waning, there has been a marked increase in the approvals for biopharmaceuticals.
Although small molecule therapies' inherent simplicity of operation has given them an edge over newer ones such as stem cell therapies, the latter's ability to eliminate concerns over viral or prion contamination during organ replacement has gained a lot of popularity.
Stem cell therapy is also a cheaper and faster route to repairing damaged or diseased tissues.
It involves the use of some of the patients' own cells to grow replacement parts on biodegradable scaffolds.
Researchers at Geron have collaborated with scientists from Edinburgh, UK, to culture human embryonic stem cells (hESCs) in an in vitro system that requires only human cells without either direct or indirect exposure to mouse cells.
This greatly reduces the risk of contamination from potential mouse pathogens in stem cells that might be administered to humans.
"The research also makes it possible to produce immortalised cells derived from stem cells for research, biologics production and therapeutic applications," observes Aditya.
"Differentiated cells derived from stem cells have enormous potential for replacing dead or damaged cells in patients to treat a long list of disorders for which effective therapies currently do not exist".
Meanwhile, scientists from Newcastle University, UK, claimed to have produced an early stage embryo cloned from a human cell through nuclear transfer.
The UK was the first country to licence cloning for creating stem cells and is likely to become a leading stem cell research hub.
"Emerging stem cell research has led to development of novel biodrugs," notes Aditya.
"Applications include gene therapy, tissue engineering, neurological therapies, bone and cartilage repair, cancer, cardiovascular disease, diabetes and other autoimmune disorders, wound healing, and cell replacement for failing organs".
Other distinct advantages of biopharmaceuticals include fewer side effects and more potent effect on target cells.
Pharmaceutical biotechnology is being further developed to fight cancer, viral infections, diabetes and hepatitis as well as for developing safer and more effective antibiotics, insulins, interferons, estrogens and human growth hormone.
Biopharmaceutical Developments - an emerging technology analysis is part of the Technical Insights Healthcare vertical subscription service.
The study includes detailed analyses of monoclonal antibodies, hormones and enzymes, cytokines and peptide therapeutics, vaccines and antigens and tissue engineering.
It also provides technology challenges, market drivers and restraints as well as assesses innovations and opportunities.
This research service enables companies to align their positioning strategies to benefit from these technologies.
