E. RODNEY LAX
Business Development Consultant,
PolyPeptide Laboratories Inc., 365 Maple Avenue, Torrance, CA 90503, USA

Abstract

The market for peptide therapeutic drug products has grown at an approximately linear rate of 7.6% per year to reach close to US$19 Bn in 2015. Most of the growth is fueled by increasing sales of individual products, not by introduction of newly approved peptide therapeutics, which currently average about 2.5 per year. There are over 70 approved peptide therapeutics world-wide and a healthy pipeline of clinical candidates in Phase III trials.  Of the latter, close to 30% are peptide vaccines. About 40% of the corresponding drug substances are outsourced to contract manufacturing organizations (CMOs) that specialize in the production of peptide-based pharmaceutical ingredients. 

This paper discusses the criteria that are used to define “peptide therapeutics”, in particular how market research organizations, regulatory authorities and the CMOs differentiate between peptides and proteins. Current and future manufacturing technologies are discussed and some pointers are provided as to how these might be used to develop future classes of biologics.

INTRODUCTION

This paper is the first of two addressing the status of the peptide therapeutic manufacturing industry in the 21^st century. This first paper looks at the current status of the industry and at how manufacturing technologies might adapt to enable the production of chemically synthesized and semi-synthetic proteins. The second paper will address some of the challenges the industry faces.

PEPTIDE THERAPEUTICS

Why peptide therapeutics?

The advantages and disadvantages of using peptide-based molecules (including biologics) as therapeutics are well-known. The upsides include their exceptional specificity, high potency, low toxicity, good tolerance, low incidence of side-effects and suitability for engineering analogs and mimetics. The downsides are seemingly many. Some are associated with their lack of oral availability - susceptibility to gut proteases and poor absorption across mucous membranes, necessitating parenteral injection as the normal mode of administration, which in turn leads to patient inconvenience and disco ...