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Peptide Therapeutics: Contract API Manufacturing Market, 2020 - 2030

Peptide Therapeutics: Contract API Manufacturing Market, 2020 - 2030

  • March 2020
  • 285 pages
  • ID: 5893045
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Since the establishment of the therapeutic relevance of insulin in the early 1920s, peptide therapeutics have come a long way. Presently, there are over 60 peptide-based drugs available in the market. Specifically, these products represent one of the earliest classes of biologics and have, so far, demonstrated significant potential in the treatment of a variety of metabolic and oncological disorders. Examples of popular, marketed therapeutic peptides include Victoza®, LUPRON DEPOT®, Zoladex®, Sandostatin® and Somatuline®. Further, according to experts, more than 600 pharmacological leads based on peptides are currently being investigated across various phases of development. Owing to their proven pharmacological value and favorable safety profiles, the demand for peptide drugs is on the rise. As a result, there is increasing interest in manufacturing solutions for large quantities of such molecules, often requiring complex manipulations of long macromolecular structures, chemical modifications and thorough purification, for both clinical and basic research applications.

Although a lot has been achieved in terms of improvements in peptide synthesis and purification methods, there are certain challenges, especially those related to large-scale manufacturing capabilities, which continue to plague drug developers in this domain. Additionally, there are certain technical complications related to the synthesis of complex, long chain macromolecules, which are known to compromise both product yield and purity. In order to optimize production processes and associated expenses, leverage superior expertise and infrastructure, and expedite time to market, many innovator companies have demonstrated the preference to work with specialty service providers. Presently, there are a number of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that offer elaborate portfolios of services focused on peptide design, manufacturing and purification. Given the historical and prevalent trends in demand for peptide synthesis and purification services, several CMOs / CDMOs are actively expanding their capabilities and capacity to ensure consistent supply. We are led to believe that sponsor companies are likely to continue relying on contract manufacturing service providers over the coming decade.

SCOPE OF THE REPORT
The “Peptide Therapeutics: Contract API Manufacturing Market, 2020-2030” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of therapeutic peptides. The study also features a detailed analysis of key drivers and trends related to this evolving domain. Amongst other elements, the report includes:
• A detailed review of the overall landscape of companies offering contract services for manufacturing of peptides, along with information on 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, type of peptide modification services offered, peptide purification technology used, and regulatory accreditations / certifications.
• An analysis on the recent developments in the industry, highlighting collaborations, facility expansions, and upcoming peptide synthesis technologies within this domain.
• Informed estimates of the annual commercial and clinical demand for manufacturing peptides for therapeutic use, based on various relevant parameters, such as target patient population, dosing frequency and dose strength.
• A clinical trial analysis of completed, and active studies related to peptide therapeutics that are have been / being / likely to be conducted across various geographies, based on the trial registration year, trial phase, trial recruitment status, therapeutic areas type of sponsor / collaborator, geography and number of patients enrolled.
• An estimate of the overall, installed capacity for manufacturing peptides, based on data reported by industry stakeholders in the public domain; it highlights 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).
• A discussion on regulatory guidelines related to peptide manufacturing, highlighting 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.
• Elaborate profiles of the key players that offer contract manufacturing services across different geographies, namely North America, Europe and Asia Pacific. Each profile features a brief overview of the company, information on its service portfolio, details related to its manufacturing capabilities and facilities, and an informed future outlook.
• 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 multiple parameters, such as projected growth of overall peptide-based products market, cost of goods sold and direct manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the short to mid-term and mid to long term, for the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] distribution scale of operation (preclinical / clinical and commercial) [B] type of synthesis method used [C] end user (small, mid-sized and large / very large), and [D] key geographical regions (North America, Europe, Asia Pacific). 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 growth.

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.

RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
• Annual reports
• Investor presentations
• SEC filings
• Industry databases
• News releases from company websites
• Government policy documents
• Industry analysts’ views

While the focus has been on forecasting the market over the coming decade, the report also provides our independent view on various emerging trends in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market, gathered from various secondary and primary sources of information.

CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of the peptide contract manufacturing market and its likely evolution in the short-mid-term and long term.

Chapter 3 provides a general introduction to peptides, including a brief overview of different peptide classes, popular methods used for peptide synthesis and modification. It also highlights the different purification strategies that are available in the market. The chapter includes information on the various applications of peptides. In addition, it features a brief overview of contract manufacturing and a detailed discussion on the need for outsourcing peptide manufacturing operations and its advantages.

Chapter 4 features a detailed discussion on the regulatory landscape related to peptide contract manufacturers across various geographies, such as 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.

Chapter 5 provides an overview of the peptide contract manufacturing landscape. It includes information on close to 50 CMOs that are currently active in this domain. In addition, it features an in-depth analysis of the market, based on a number of parameters, such as year of establishment, company size, scale of operation, geographical location of the CMO, number and location of manufacturing facilities, type of peptide synthesis method used, type of peptide modification services offered, peptide purification technology used, and regulatory accreditations / certifications. In addition, the chapter provides details of service providers that offer custom peptide synthesis services.

Chapter 6 features detailed profiles of industry players that offer various contract manufacturing services in different geographies such as, North America, Europe and Asia Pacific, at different scales of operation. Each profile features a brief overview of the company, information on its service portfolio, details related to its manufacturing capabilities and facilities, and an informed future outlook.

Chapter 7 presents an analysis of the recent developments in the peptide contract manufacturing market. It provides an overview of other market trends, such as collaborations and facility expansions. In addition, it features a discussion on the key developments related to manufacturing process, such as use of single-use technologies, continuous manufacturing and introduction of green chemistry for peptide synthesis.

Chapter 8 presents a geographical clinical trial analysis of completed and active related to peptide therapeutics / drugs. For the purpose of this analysis, we considered those clinical studies that have been initiated since 2010 and analyzed them on the basis of various parameters, such as trial registration year, trial phase, trial recruitment status, therapeutic areas, type of sponsors / collaborators and number of patients enrolled across different geographies.

Chapter 9 provides an overview of various recent developments that have been undertaken in different geographies namely, North America, Europe and Asia Pacific. Thus, depicting the emerging strength of the contract peptide manufacturers in different regions.

Chapter 10 features a detailed analysis of the annual commercial and clinical demand for peptide therapeutics / drugs, based on various relevant parameters, such as target patient population, dosing frequency and dose strength.

Chapter 11 features an analysis of the overall, installed capacity for manufacturing peptide therapeutics / drugs based on data reported by industry stakeholders in the public domain; it highlights the distribution of available peptide production capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia).

Chapter 12 presents a qualitative analysis that highlights the various factors that need to be taken into consideration by peptide therapeutics / drug developers while deciding whether to manufacture their respective products in-house or engage the services of CMOs.

Chapter 13 presents a detailed market forecast analysis, highlighting the likely growth of the peptide contract manufacturing market till the year 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] distribution scale of operation (preclinical / clinical and commercial) [B] type of synthesis method used [C] end user (small, mid-sized and large / very large), and [D] key geographical regions (North America, Europe, Asia Pacific).

Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of peptide contract manufacturing market, under a SWOT framework.

Chapter 15 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the peptide CMOs market, based on the research and analysis described in the previous chapters. It also provides a recap of some of the upcoming future trends, which, we believe, are likely to influence the growth of peptide CMOs.

Chapter 16 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the peptide therapeutics contract manufacturing market.

Chapter 17 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix that provides the list of companies and organizations mentioned in the report.

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