Global Market Outlook on Peptide APIs

The advances in chemical synthesis and peptide formulation boost the advent of new peptide APIs in the market.

  • The global annual demand of peptide API was ~1,600 kg 2016 and is growing at a CAGR of 10%
  • Increasing demand of peptide-based drugs and the patent expiration of blockbuster drugs are to boost peptide API market
  • Due to the complex and capital-intensive manufacturing, pharmaceutical companies seek CMOs as a best option for peptide API production to cut internal cost
  • Peptide API CMOs are concentrated in Europe and the US, followed by China and India

Supply–Demand – Peptide API 

CMOs are able to meet an increasing demand of innovator pharmaceutical companies, and they are increasing their capacity with a focus on producing API in the cost-efficient manner

Supply

  • Currently, CMOs are able to meet the demand of pharmaceutical companies
  • However, the number of approved peptides would increase. It is important for CMO to be flexible enough to increase manufacturing capacity
  • The current focus of suppliers is to synthesize peptide API in low cost
  • Now, large peptides can be manufactured at both small and large-scale in cost-effective manner. Example: Trimeris and Roche were able to successfully commercialize enfuvirtide

Demand

  • Most of the pharmaceutical companies buying peptides are located in the US, Europe, and Japan
  • Currently, demand in the emerging markets is less, as the generic products are still under review, and there is not much growth in the NCE segment
  • In the US, innovative US biotech companies are driving peptide API demand
  • Constant stream of NCEs in peptide gives potential opportunities to CMOs for expanding capacity

End-Use Analysis – Peptide Drugs

As the capability of CMOs enhance and more dosage forms available in the market, more suppliers would add peptide products

  • Oncology, diabetes, and obesity are the three prominent therapeutic areas, where peptide APIs are used
  • In addition, peptides are in high demand for treating cardiovascular, renal failure, etc., as antibiotics and vaccines
  • Currently, >80% of approved peptide drugs are administered by injection. The trend is moving toward oral and other delivery ways
  • About 9% of the peptide can now be taken orally and suppliers are collaborating with pharma majors to increase this share
  • Nasal is another way of delivering peptide drugs. Other ways, such as sublingual and transdermal dosage forms, are still under R&D

Market Trends – Peptide API

Acquisition of Medium/Small CMOs by Large CMOs and Capacity Expansion

  • Consolidation is expected to occur in peptide API market to support the growing industry demand and increasing number of clinical peptides in the pipeline
  • Bachem, Corden, and Polypeptide are the key players, who have done major investments. Large CMO players are upgrading their capabilities by investment in equipment, R&D, strategically positioning their facility (nearby raw material supply market) and innovative manufacturing methods

Demand for Conjugated Peptides

  • Demand for conjugated peptides (lipidations, PEG-ylations, glycosylation) is on the rise, increasing the bioavailability of drugs. Hence, pharmaceutical companies are looking for CMOs, who have the capability to handle this
  • Trend as targeted synthesis of specifically glycosylated proteins and peptides demand CMO who can handle it. Bachem developed an industrial-scale process for Interferon beta-1a with Japanese partner GlyTech Inc.

Emerging New Suppliers

  • Though the current market is oligopolistic in nature, however, new suppliers are emerging in Asia, such as Aurobindo Pharma (2012), etc.
  • The US, Europe, and Japan are the major regions, which drive peptide API. In another five years, Asia will be the growing market in peptide API space

Innovative Technology for Peptide API Manufacturing

  • Peptide CMOs have been developing new technologies to increase yield, reduce manufacturing cost, and to enhance drug delivery
  • Current CMOs are mostly using SPSS, LPSS, and mixed phase synthesis to manufacture peptides. These chemical synthesis is now competing with recombinant DNA technology
  • New technology, namely Molecular Hiving developed by Sosei, which reduces the API manufacturing costs to one-tenth of the cost of existing methods (SPSS and LPSS). Other recent methods include fermentation and recombinant methods, but have few limitations.