Peptide Therapeutics: Contract API Manufacturing Market by Scale of Operation, Type of Synthesis Method Used, Company Size, and Key Geographical Regions: Industry Trends and Global Forecasts, 2022-2035

Over the years, the popularity of biologics has led to an evident shift in the focus of pharmaceutical companies, from traditional interventions towards more complex and advanced pharmacological interventions, such as peptide therapeutics. Since the discovery of insulin, the peptide therapeutics market has evolved significantly. Presently, over 80 peptide-based drugs are available in the market for the treatment of an array of diseases, including cancer, chronic pain, diabetes, HIV infection, multiple sclerosis and osteoporosis. Further, since 2017, more than 10 peptide-based drugs have been approved by the USFDA. Of these, LupkynisTM and Zegalogue® were recently approved in 2021, while ImcivreeTM, Victoza®, LUPRON DEPOT®, Zoladex®, Sandostatin® and Somatuline® received approval in 2020. In this context, 1,000+ clinical trials have been / are being conducted to evaluate the therapeutic viability and future potential of novel peptides across various phases of development. The increasing popularity of this class of drugs can be attributed to their high specificity, affinity, less drug-drug interactions, diverse biological and chemical activity (enabling the enhancement of their half-lives), proven pharmacological value and favorable safety profiles. Considering the various advantages offered by such drugs, the demand for peptide-based therapeutics is increasing at a considerable pace. 

It is worth highlighting that the peptide synthesis and purification domain is fraught with several challenges, including complexities associated with synthesis of complex, long chain macromolecules, which is known to affect the product yield and purity. In order to mitigate the aforementioned challenges, several players engaged in this domain prefer to outsource their operations to peptide contract manufacturers. Currently, more than 60 contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) claim to offer services for the development, design, manufacturing and purification of peptides. Owing to the fact that a large number of peptide therapeutic developers are outsourcing various aspects of their business processes, several CMOs / CDMOs have become one-stop-shops to cater to the diverse needs of peptide therapeutics developers. Considering the ongoing innovation in production technologies, purification techniques, evolving pipeline and increasing demand for peptide-based drug candidates, we believe that developer companies are likely to continue relying on contract manufacturing service providers and the market is inclined to witness a steady growth in the coming decade. 

As pharma companies resume full-scale operation after the COVID-19 outbreak, the demand for large-scale peptide therapeutics contract API manufacturing is expected to increase significantly. It is worth highlighting that a number of peptide-based COVID-19 vaccines are being developed by pharmaceutical companies which further accelerate the high demand for peptide manufacturing service providers in order to scale-up production of these novel therapeutics post their approval, in order to meet the global demand.

Scope of the Report

The “Peptide Therapeutics: Contract API Manufacturing Market by Scale of Operation (Preclinical / Clinical and Commercial), Type of Synthesis Method Used (Chemical Synthesis Method and Non-Chemical Synthesis Method), Company Size (Small, Mid-sized and Large), and Key Geographical Regions (North America, Europe, Asia Pacific and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of therapeutic peptides, over the next decade. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. 

Amongst other elements, the report includes:

• A detailed overview of the current market landscape of companies offering peptide contract manufacturing services, along with information on several relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), geographical location of CMO, number and location of their respective facilities, type of peptide synthesis method used (chemical and non-chemical), types of peptide modification services offered, type of peptide purification technology used (HPLC / UPLC, Ion-Exchange Chromatography and Size-Exchange Chromatography) and regulatory accreditations / certifications received. 
  
• An insightful company competitiveness analysis of prominent peptide contract manufacturers, based on several relevant parameters, such as service strength (in terms of experience of the service provider), and capabilities related to contract manufacturing of peptides (such as type of product, type of service(s) offered, number of manufacturing facilities, scale of operation, type of synthesis method used, type of purification technique used, and type of peptide modification).
  
• Elaborate profiles of key players (shortlisted on the basis of the company competitiveness analysis) engaged in this domain. Each profile features a brief overview of the company, along with information on year of establishment, number of employees, location of headquarters, key executives, details related to peptide contract manufacturing services offered, recent developments, and an informed future outlook.
  
• An analysis on the recent developments within the peptide contract manufacturing industry, highlighting information on several partnerships and collaborations and facility expansions that have taken place in this domain, during the period 2016-2021. 
  
• An in-depth analysis of completed, ongoing, and planned clinical studies focused on peptide therapeutics, based on several relevant parameters, such as trial registration year, phase of development, current trial status, enrolled patient population, study design, leading industry players (in terms of number of trials conducted), study focus and key geographical regions.
  
• A detailed analysis of peptide contract manufacturing service providers’ capabilities in different regions, based on several relevant parameters, such as number of CMOs, number of clinical sites, number of clinical trials, number of patients enrolled, number of peptide manufacturing facilities, type of product, number of clinical / commercial manufacturing CMOs, demand for peptide therapeutics and installed capacity.
  
• Informed estimates of the annual commercial and clinical demand for peptide therapeutics, based on several relevant parameters, such as target patient population, dosing frequency and dose strength.
  
• An estimate of the overall, installed capacity for manufacturing peptides, based on data reported by industry stakeholders in the public domain; the analysis takes into consideration the distribution of available peptide production capacity across companies of different sizes (small, mid-sized, large and very large firms), scale of operation (clinical and commercial), and key geographical regions (North America, Europe, Asia Pacific). 
  
• An analysis highlighting potential strategic partners segregated based on the likelihood of entering into collaboration with peptide therapeutics developers. These players have been shortlisted based on several relevant parameters, such as pipeline strength, pipeline maturity, year of establishment and company size.
  
• A qualitative analysis highlighting the various factors that need to be taken into consideration by peptide drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
  
• A region-wise, detailed analysis of the total cost of ownership for a peptide contract manufacturing service provider. It features an informed estimate of direct and indirect expenses taking into consideration 11 relevant parameters, over a span of 10 years.
  
• A discussion on regulatory guidelines related to peptide manufacturing, highlighting the key differences across various geographies, including the US, Europe, Australia, China, India, Japan and South Korea. It also includes details related to the various challenges, related to regulatory scrutiny, faced by peptide manufacturers.
  
• An insightful discussion on how the recent COVID-19 pandemic is likely to impact the peptide contract manufacturing market, along with information on the key initiatives undertaken by service providers to overcome the challenges faced due to the pandemic.
  
• A discussion on industry affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the evolution of this field; it includes a Harvey ball analysis, highlighting the relative impact of each SWOT parameter on industry dynamics. 
  

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the peptide contract manufacturing market, based on several relevant parameters, such as projected growth of overall peptide-based products market, cost of goods sold and direct manufacturing costs. We have developed an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, over the period 2022-2035. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] scale of operation (preclinical / clinical and commercial) [B] type of synthesis method used [C] company size (small, mid-sized and large), and [D] key geographical regions (North America, Europe, Asia Pacific and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s evolution. 

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Who are the key players engaged in offering contract manufacturing services for peptide therapeutics?
  
• What are the different partnerships and expansion initiatives undertaken by peptide therapeutics contract manufacturers in the recent past?
  
• Which regions represent the current key contract manufacturing hubs for peptide therapeutics?
  
• What is the current, installed capacity for contract manufacturing of peptides therapeutics?
  
• What is the current, global demand for peptide therapeutics? How is the demand for such candidates likely to evolve in the foreseen future? 
  
• What percentage of the peptide therapeutics manufacturing operations are presently outsourced?
  
• What factors should be taken into consideration while deciding whether the manufacturing operations for peptide therapeutics should be kept in-house or outsourced?
  
• How is the current and future opportunity likely to be distributed across key market segments?
  

Please note: This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.