Outsourcing Peptide Synthesis: Preferred Choice of Drug Developers

The peptide therapeutics market has undergone substantial evolution since the inception of insulin. It is worth mentioning that over the span of years, the pharmaceutical companies have shifted their focus from conventional interventions towards more advanced pharmacological strategies, such as peptide therapeutics. Presently, over 80 peptide-based drugs are available in the market for myriad of disorders and diseases. The growing popularity of peptide-based drugs can be attributed to its high specificity, minimal drug-drug interactions, affinity, proven pharmacological value and favorable safety profiles. Given the numerous advantages provided by such drugs, the demand for peptide-based therapeutics is witnessing a significant upswing. However, there are several challenges and complexities that impact both product yield and purity associated with the peptide synthesis and purification of complex long-chain macromolecules.
Owing to the challenges involved in the synthesis process and demands of modern drug development, majority of drug developers in this domain prefer to outsource their development and manufacturing operations to peptide therapeutics contract API manufacturers as a strategic solution to streamline their research and peptide synthesis efforts.

I, recently, worked on a market research report, title Peptide Synthesis Market, Till 2035. During research, I could identify over 75 peptide synthesis companies that offer peptide synthesis services. This article root about highlighting the overall need for outsourcing in this domain of peptide synthesis and potential of outsourcing peptide synthesis.

General Overview of Peptides

Peptides act as essential structural components in cells and tissues as they are pivotal biological molecules. They also play important roles in antibiotics, toxins, hormones, and enzymes. It is worth noting that they occur naturally within organisms and can also be artificially synthesized in laboratories. When introduced into the body, lab-synthesized peptides become active. These versatile molecules serve various diverse roles, functioning as neurotransmitters, growth factors, ion channel ligands, hormones, anti-infectives, and more. Further, many pharmaceutical products utilize different peptides, capitalizing on their potential for anti-inflammatory, fat-burning, and muscle-building benefits. It is worth mentioning that synthetic therapeutic peptide APIs find significant applications in medicine, biochemistry, immunology, and molecular biology. Peptides, vital in diverse research applications, are offered in different purity levels, modifications, and formats to cater to specific experimental needs. Moreover, these short chains of amino acids, distinct from proteins in their shorter length, serve as essential building blocks for various scientific investigations. Peptide active pharmaceutical ingredients exhibit remarkable selectivity, characterized by high specificity, affinity, minimal drug-drug interactions, and diverse biological and chemical activities. It is worth highlighting that their efficacy at lower doses contributes to reduced toxicity levels. Additionally, peptides may offer enhanced absorption compared to proteins, swiftly entering the bloodstream by easily permeating the skin and intestines.

Peptide Synthesis Methods: Which are various chemical techniques?

Peptides are produced through various methods; however, most reliable and popular methods of peptide synthesis is chemical synthesis which includes solid phase, liquid phase, and a hybrid approach, each presenting distinct advantages and disadvantages.

Solid Phase Synthesis: Commonly, a solid phase method is practiced for peptides exceeding 25 amino acids, especially when commercial quantities within the 1-10 kg range is being produced. Solid phase peptide synthesis can increase costs for larger quantities. Despite being an expensive synthesis method, solid phase synthesis demonstrate a notable advantage in shorter cycle times compared to liquid phase synthesis. Additionally, in case of peptides beyond 15 amino acids this peptide synthesis method is less labor-intensive than the other methods.

Liquid Phase Synthesis: Liquid phase synthesis method proves to be an optimal choice for peptides with fewer than 15 amino acids, especially when commercial needs extend from 10+ kilograms to tons. This synthesis method is a traditional technique that offers cost-effectiveness and scalability for producing substantial quantities of high-quality peptides. It is worth mentioning that despite the dominance of solid-phase synthesis, the conventional liquid-phase peptide synthesis still holds value, particularly for large-scale production.

Hybrid Phase Synthesis: The hybrid approach combines solid phase and liquid phase techniques. It is a preferred techniques for creating a 40-amino acid peptide. In this peptide synthesis method small segments are produced on resins using solid phase methods, and these segments are then condensed in a solution to form the entire peptide sequence. Currently, the hybrid peptide synthesis strategy is typically preferred for peptides exceeding 25 amino acids, especially when commercial demands span from 10 to 200 kilograms.

Chemical  Synthesis Methods

Peptide Synthesis Industry and Need for Outsourcing

Owing to the various benefits of peptide-based drugs, the demand for peptide therapeutics is increasing rapidly. It is noteworthy that peptide is a complex class of drugs that possess many manufacturing challenges, including complex process and big-budget development and manufacturing. Furthermore, developing peptide active pharmaceutical ingredients in-house demands expertise and substantial capital investments for facility design, construction, and maintenance. As a result, many small drug developers and occasionally larger pharmaceutical companies prefer to outsource manufacturing to contract service providers. The growing demand for firms offering manufacturing and sometimes development services has led to the emergence of numerous contract manufacturing organizations. Further, these contract manufacturing organizations often specialize in niche and emerging areas, leveraging their expertise and infrastructure to meet client requirements efficiently, minimize errors, and reduce the risk of failure. Given the increasing trend of outsourcing API manufacture, selecting the right contract manufacturing organization becomes critically important for companies.

The peptide therapeutics contact API manufacturing market has experienced substantial growth in outsourcing due to the increasing demand for peptide-based therapeutics. It is worth mentioning that there are numerous pharmaceutical contract manufacturing organizations that specialize in custom peptide production, custom peptides development, GMP contract peptide manufacturing and synthetic peptide API manufacturing. Companies are increasingly relying on contract manufacturing organizations to expedite their workflow, driven by factors like optimized manufacturing services, cost savings, focused expertise, and other compelling reasons. This shift towards outsourcing is a notable trend in response to the evolving landscape of peptide therapeutics.

Majority of the service providers offer analytical / process development services

The trend of peptide therapeutic developers outsourcing various aspects of their operations has led many contract manufacturing organizations to become comprehensive service providers, addressing the varied needs of these developers. With continuous advancements in production technologies, purification techniques, a dynamic pipeline, and increasing demand for peptide-based drug candidates, it is expected that developer companies will persist in relying on contract manufacturing service providers. This reliance is likely to contribute to steady growth of peptide synthesis market in the upcoming decade. It is worth highlighting that analytical / process development services for peptide API synthesis emerged as the most popular service provided by peptide synthesis service providers. Further, we could identify a number of service providers that claimed to operate as a one-stop-shop, offering all the aforementioned peptide synthesis services; some of the prominent examples of companies offering analytical / process development services that were established post-2015 include (in alphabetical order) EUROAPI, KriSan Biotech, NSJ Prayog Life Sciences and PeptiStar.

Peptide Synthesis Market Process Development

For detailed insights about this domain, check out our report on Peptide Synthesis Market, Till 2035.

Author’s Bio

Mahek Saini is a business research analyst and competitive intelligence professional. She is highly skilled at generating useful insights from unstructured / structured datasets. As an experienced analyst at Roots Analysis, Mahek has assisted several clients across multiple industry verticals within the healthcare domain. These verticals include, medical devices / technologies, digital healthcare services and various drugs / disease indications.

Mahek holds a M. Tech degree in Biotechnology from Lovely Professional University. In addition to working on market research and pharmaceutical business analysis, she has hands-on laboratory experience in production and quality assurances department of an esteemed manufacturing firm, Wave beverages, Amritsar. To date, she has contributed to over five full length market research projects.

Email: mahek.saini@rootsanalysis.org

LinkedIn: https://www.linkedin.com/in/mahek-saini/