Peptide drugs, such as insulin, have been on the market for decades. Only recently, however, as firms have beefed up their synthetic and biological peptide libraries, has the pharmaceutical industry taken a more serious look at peptide-based therapeutics. According to a new report just published by Frost & Sullivan (London), the global therapeutic peptide market is primed to take off. The market, which was valued around $1 billion in 2003, should see double-digit growth through 2010, the report says. While just over 40 peptide drugs Oxytocin, Cyclosporin and Zoladex are a few are on the market today, around 270 are in clinical trials, and some 400 are in advanced preclinical trials.Approximately 65 percent of that market is in the U.S., says analyst Himanshu Parmar, author of the report, which focuses primarily on the European market. (You may access the executive summary a 22-page PDF document by clicking the "Download Now" button at the bottom of the page.)We talked with Parmar to get more of his thoughts on peptides:PM: Your report cautions that manufacturers will need to scale-up their production processes to meet demand. What are the greatest challenges in scaling up for peptides, and how are some manufacturers overcoming these challenges?HP: The challenges are the R&D cost, scaling up cost, low stability, and technical problems in handling the peptides. The extensive R&D is going on worldwide for cost-effective peptide manufacturing and companies are trying various methods to optimize the scalability of peptides to enable a commercially viable peptide-based drug manufacturing at large scale.PM: Can you share more about the technological challenges in peptide delivery?HP: Technological challenges involve instability and short half-lives, which means the peptides get degraded in vivo before reaching the intended site. Major R&D work is going on and scientists have successfully developed some peptides with modifications to improve half-lives or they have come up with various drug delivery systems which enable increased stability of the peptides once delivered.The report mentions some major peptide drugs, and there are many others coming to market, thus promising a bright future of peptide-based drugs These drugs have low toxicity and high potency and are more viable options than antibodies, as in the case of cancer with more tumor penetration ability. However, the cost challenges remain.PM: Which delivery forms will dominate?The oral delivery form is often a preferred route for drug delivery because of ease of administration, patient compliance and cost. However, the peptide instability in vivo presents challenges. In order to deliver peptides orally, key barriers must be overcome: degradation resulting from gastric and intestinal enzymes and the limited permeability to large molecules.PM: You mention one-stop-shop and niche manufacturers in the report. Which strategy is taking root faster?HP: All the major manufacturing companies are continuously working towards improving their product and technology portfolio. The customer is the key.Mostly pharmaceutical companies are outsourcing the peptide manufacturing.Emphasis on maintaining a strong relation with customer and gaining competitive advantage with differentiable product and technology portfolio will determine the strategies for a company.