Future Developments In Biopharmaceuticals Promise Cost-Effective And Innovative Therapies
作者: 整理时间:2005-10-27
10/26/2005
Palo Alto, CA -- 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 behavior 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 program.
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Once biopharmaceutical developers thresh out a solution for meeting 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 are likely to continue to emerge, a variety of supportive production technologies enables a growing pipeline of novel therapeutics," says Frost & Sullivan Research Analyst A. N. Aditya. "Developments in bioprocess technology have resulted in high outputs, thereby minimizing 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 replace any type of tissue and the faster healing repair process has gained 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.
"Emerging stem cell research has led to development of novel biodrugs," notes Aditya. "Application 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."
Some 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.
SOURCE: Frost & Sullivan
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