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Drug Delivery Technologies Provide Growth Opportunities for Biopharmaceuticals
While clearly the active pharmaceutical ingredient is the primary component of any formulated drug, the mechanism of drug delivery plays a critical role in determining the safety and efficacy of therapeutics. Access to novel drug delivery mechanisms and devices can have a significant impact for drug manufacturers. In fact, drug delivery technologies can help drug manufacturers in differentiating new therapeutics from existing products, provide a means for extending patent protection, and enable novel treatments. While the majority of drug delivery devices are related to oral delivery, however, it is not surprising given the growth of the biopharmaceutical market that the fastest growing segments of the drug delivery market address the delivery of biologic drugs. Different models for development, including outsourcing, partnering, collaboration, and licensing have resulted.
The novel peptides, protein, nucleic acid, growth factor, cytokine, interferon, and antibody-based drugs available today provide new mechanisms for treating diseases, but also pose challenges with respect to successful drug delivery. "The large size of most biopharmaceuticals, combined with their other molecular properties, lead to poor physical and chemical stability within the body and limited membrane permeability, and severe toxicity when applied systematically. Therefore researchers are developing a range of new delivery technologies and materials to enable these new drugs to be delivered intact to their target sites," says Rajveer Singh Rathor, a senior research analyst for healthcare with MarketsandMarkets.
At the same time, both analysts point to recent drug failures and recalls, stringent regulatory processes, various technical barriers, and the difficulty in striking the right partnership deals to the development of drug delivery platforms as negative factors affecting the growth of the drug delivery market.
North America, which has a well-established healthcare infrastructure and a large number of leading pharmaceutical and biopharmaceutical companies (around 80% of the world’s research and development in biopharmaceutical is conducted by US-based firms), is the largest market for drug delivery, accounting for 45-50% followed by Europe with 25-30%, according to MarketsandMarkets. North America and Europe are expected to grow at a slower pace (8-9%/year) than emerging markets, primarily due to a certain amount of saturation in the market, but also due to increasing competition from drug delivery firms in emerging countries and unstable and uneven reimbursement policies for innovative drug delivery devices. The Asian region however, and particularly India and China, is expected to grow at a double-digit CAGR from 2012 to 2017 due to the expansion of the Asian economy, an increase in disposable income, the development of healthcare infrastructures, increasing penetration of health insurance, and the rising prevalence of chronic diseases, according to Rathor.
Advantages of advanced delivery
Technologies of note
For biopharmaceuticals, pegylation is currently the leading drug delivery technology and is used with products such as interferon. Pen injectors, which are used for insulin delivery in the treatment of diabetes mellitus, are the leading device for biopharmaceuticals. The rising incidence of diabetes will continue to drive the growth of this drug delivery technology, according to Rathor. He also notes that pen injectors offer the simplest and safest way of delivering biopharmaceuticals such as peptides, hormones, and monoclonal antibodies that cannot be taken orally. Liposomal delivery is another very popular method for the delivery of biologic drugs.
The more scientists learn about the molecular causes for disease, the better targeted and effective nanotechnology-enabled drug delivery therapies will become,” Dewan says. Finally, she notes that increasing interest in prodrugs is due to their ability to overcome formulation, delivery, and toxicity barriers for better drug utilization.
The importance of partnering
Nectar Therapeutics has also worked with many biopharmaceutical companies, such as Roche, Astrazeneca, Amgen, Baxter, Novartis, and Pfizer, to develop biological products (i.e., Pegasys, Neulasta, Omontys, Cimzia, Mircera, PEG-Interon) based on Nectar’s patente PEGylation technology. These products have been developed by their respective companies using PEGylation technology of Nector Therapeutics, according to Rathor.
In a third representative collaboration, Radius Health and 3M Drug Delivery Systems formed a exclusive partnership for the development and commercialization of BA058-transdermal in December 2012. BA058 is a novel, synthetic proprietary peptide analog of human parathyroid hormone related protein which is used to treat patients with osteoporosis that are at high risk of fracture. This agreement updates the general development agreement announced in May 2011 by the two companies for BA058-TD.