Peptide Therapeutics: Contract API Manufacturing-Current Market Landscape
by Crescendo Global Crescendo Global Leadership hiringOver the years, the peptide therapeutics
domain has evolved significantly. In fact, till date, more than 60 peptide
therapeutics have been approved across different parts of the globe.
However, the upsurge in demand for such treatment modalities has compelled
developers to outsource some key operations, specifically the complex
manufacturing process, to contract service providers, which enable reduction in
cost as well as overall time to market. During our research, we identified over
50 CMOs that are actively involved in the production of therapeutic peptides. It
was further observed that more than 85% CMOs engaged in this domain claim to
offer services for peptide APIs, while 46% players have the required
capabilities for the manufacturing of both peptide APIs and finished dosage
formulation (FDF). Further, companies offering only peptide FDF manufacturing
services are (in alphabetical order) Ajinomoto
Bio-Pharma, Baccinex, ChemPartner and UPM Pharmaceuticals. Further, the peptide
contract manufacturing market is presently dominated by the presence of
mid-sized companies (between 51 to 500 employees) and small companies (less
than 51 employees), which collectively capture more than 70% of the
dataset. In addition, the domain features the presence of some large / very
large CMOs. Examples of companies that have more than 1,000 employees include (in alphabetical order) Asymchem, CordenPharma,
Neuland and STA Pharmaceutical.
Peptide contract manufacturers across the
globe differ in their working capacities and can supply products at different
scales. Here, the CMOs have been categorized based on their ability to offer
services at the preclinical, clinical and / or commercial scales. It is worth
highlighting that more than 65% players engaged in this domain claim to have
the required capabilities to manufacture peptide APIs at all scales of
operation. This indicates that stakeholders are actively striving to adopt the
one stop shop model and provide end to end services to customers worldwide. Examples
of companies that offer services for clinical and commercial scale
manufacturing include (in alphabetical
order) Anaspec, BCN Peptides, Chemi Peptide and CPC Scientific.
Manufacturing processes for peptides require
the use of different synthesis methods, such as chemical (liquid phase
synthesis, solid phase synthesis and hybrid phase synthesis) and non-chemical
synthesis. Majority (80%) of the CMOs engaged in this domain manufacture
peptides using the chemical synthesis methods; of these, solid phase synthesis
(41%) emerged as the most preferred method for peptide manufacturing, followed
by solution phase (39%) and hybrid phase synthesis techniques (15%). This was
followed by players that use the non-chemical synthesis methods, including the
recombinant approach. It is important to highlight that three companies claim
to have the required capabilities to manufacture peptides using both chemical
and non-chemical approaches; these are (in
alphabetical order) Bachem, Bio-Synthesis and CBL.
A range of peptide
purification techniques / methods are used in order to produce high quality
peptide drug products and substances. Majority (51%) of the CMOs engaged in
this domain use high-performance liquid chromatography (HPLC) for the
purification of the manufactured peptides. This is followed by players using
ion-exchange and size-exclusion chromatography for purifying their therapeutics
products. It is important to highlight that five companies claim to have the
required capabilities to purify manufactured peptides using all types of
purification technologies; examples include (in alphabetical order) Almac,
Chinese Peptide and Novetide.
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Created on Aug 13th 2020 00:31. Viewed 316 times.