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Antibody Contract Manufacturing Market, 2020 - 2030

Antibody Contract Manufacturing Market, 2020 - 2030

  • January 2020
  • 305 pages
  • ID: 5877766
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Since the approval of Orthoclone OKT3® in 1986, monoclonal antibodies have become an important part of modern healthcare practices. In fact, several experts consider monoclonal antibodies to be the backbone of the biopharmaceutical industry. It is worth noting that, till date, more than 100 therapeutic monoclonal antibodies have been approved across different geographies; recent approvals include (in reverse chronological order) Adakveo® (November 2019), Beovu® (October 2019), SKYRIZI™ (April 2019) and EVENITY™ (April 2019). Owing to their high specificity and the favorable safety profile associated with the therapeutic use of such molecules, antibody based interventions presently constitute the largest class of biologics in the industry. This trend is unlikely to change in the near future as advanced variants, such as bispecific antibodies and antibody fragments-based products, are steadily gaining traction. Further, owing to legacy challenges associated with the development and production of biologics, such as advanced supply chain requirements, outsourcing antibody production operations is a popular trend.

The antibody contract manufacturing market is highly competitive, featuring companies of all sizes, some of which claim to offer end-to-end solutions, ranging from antibody development to commercial production. Historical and prevalent trends suggest that sponsor companies are likely to continue relying on contract service providers for various aspects of antibody-based product development and manufacturing. This dependence on outsourcing can be attributed to the high cost and time investment required to establish the necessary infrastructure and expertise in biologics. The competition among contract manufacturing organizations (CMOs) engaged in this domain is high, with the availability of cutting-edge tools and technologies being one of the key differentiating factors that grant a competitive advantage over other players. Therefore, in order to establish a strong foothold in the market and also meet the growing demand for antibody therapeutics / reagents, CMOs are actively expanding their capacities and capabilities.

SCOPE OF THE REPORT
The “Antibody Contract Manufacturing Market, 2020 – 2030” report features an extensive study of the current market landscape and future opportunities associated with the contract manufacturing of antibodies. 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 the manufacturing of antibodies, along with information on year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, number of manufacturing facilities and location of these facilities, type of antibody manufactured (monoclonal antibodies, bispecific antibodies and polyclonal antibodies), type of expression systems used (mammalian, microbial and others), fill / finish operations and affiliations to regulatory agencies.
• A competitiveness analysis of key players engaged in this domain, featuring an assessment based on their supplier strength (related to the experience of a contract manufacturer), and service strength (which takes into account the size of service portfolio and scale of operation).
• A benchmark analysis, highlighting the key focus areas of small, mid-sized and large companies, comparing their existing capabilities within and beyond their respective (geography-based) peer groups.
• An analysis of the various partnerships pertaining to contract manufacturing of antibodies, which have been established since 2013, based on several parameters, such as the year of agreement, type of partnership, project scale and focus therapeutic area.
• An analysis of the various expansion initiatives undertaken by service providers, in order to augment their respective antibody manufacturing capabilities, over the period 2017-2019 (till October), taking into consideration parameters, such as year of expansion, type of expansion (capacity expansion, facility expansion and new facility), type of antibodies manufactured and location of manufacturing facility.
• An estimate of the overall, installed capacity for manufacturing antibodies based on data reported by industry stakeholders in the public domain; it highlights the distribution of available antibody 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).
• Informed estimates of the annual commercial and clinical demand for antibodies, based on various relevant parameters, such as target patient population, dosing frequency and dose strength.
• Elaborate profiles of the key industry players that offer contract manufacturing services at all scales of operation and have more than two manufacturing facilities. 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 case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps and challenges involved in their respective manufacturing processes.
• A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.

One of the key objectives of the report was to estimate the existing market size and the future growth potential within the antibody contract manufacturing market. Based on multiple parameters, such as projected growth of overall antibody-based products market, cost of goods sold and direct manufacturing costs, we have developed informed estimates on the financial evolution of the market over the period 2020-2030. The report also provides details on the likely distribution of the current and forecasted opportunity across [A] type of antibodies (monoclonal antibodies, bispecific antibodies and others), [B] company size (small, mid-sized and large / very large), [C] scale of operation (preclinical / clinical and commercial), [E] expression systems (mammalian, microbial and others), and [F] key geographical regions (North America, Europe, Asia). 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.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:
• Dietmar Katinger, Chief Executive Officer, Polymun Scientific
• David C Cunningham, Director Corporate Development, Goodwin Biotechnology
• Claire Otjes, Assistant Marketing Manager, Batavia Biosciences

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 antibody contract manufacturing market and its likely evolution in the short-mid term and long term.

Chapter 3 provides a general introduction to antibodies, including a brief discussion on the historical evolution of this class of medical products. It highlights the different categories of antibodies, namely monoclonal antibodies, bispecific antibodies and polyclonal antibodies, their potential applications, and mechanisms of action (as therapeutic interventions). In addition, it includes information on the structure of an antibody and its isotypes. Further, the chapter features a brief overview of contract manufacturing and includes a detailed discussion on the need for outsourcing within the biopharmaceutical industry and its advantages.

Chapter 4 provides an overview of the antibody contract manufacturing landscape. It includes information on over 115 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 of manufacturing facilities, as well as location of these facilities, type of antibody manufactured, types of expression systems being used, fill / finish operations and affiliations to regulatory agencies.

Chapter 5 features a company competitiveness analysis of key players engaged in this domain. The analysis compares companies on the basis of their supplier strength (related to the experience of a contract manufacturer), and service strength (which takes into account the size of service portfolio and scale of operation).

Chapter 6 features detailed profiles of industry players that offer contract manufacturing services at preclinical, clinical and commercial scale and have more than two manufacturing facilities. Each profile provides a brief overview of the company, its contract service offerings, manufacturing capabilities and facilities and an informed future outlook.

Chapter 7 is a case study comparing the key characteristics of large and small molecule drugs, along with information on the steps and challenges involved in their respective manufacturing processes.

Chapter 8 presents a benchmark analysis, highlighting the capabilities of small, mid-sized and large companies in terms of their service portfolio. Further, the analysis allows companies to compare their existing capabilities within and beyond their respective (geography-based) peer groups, providing a means for stakeholders to identify ways to gain a competitive edge in the industry.

Chapter 9 features an analysis of the various collaborations and partnerships that have been inked amongst players in the time period 2013-2019 (till October). It provides a brief description on the various types of partnership models (which include manufacturing agreements, process development and manufacturing agreements, licensing agreements, acquisitions, joint ventures, service alliances and others) that have been adopted by stakeholders in this domain. Further, it includes analyses based on year of agreement, type of partnership, project scale and focus therapeutic area. Furthermore, we have provided a world map representation of all the deals inked in this field, highlighting those that have been established within and across different continents.

Chapter 10 presents detailed analysis on the recent expansions that have taken place in the antibody contract manufacturing industry, since 2017. It includes information on expansions carried out for increasing existing capabilities, as well as those intended for setting-up of new facilities by manufacturers engaged in this domain. The expansion instances that we came across were analyzed based on various parameters, including year of expansion, type of expansion (capacity expansion, facility expansion, new facility), type of antibodies (monoclonal antibodies, bispecific antibodies and polyclonal antibodies) and geographical location of the facility.

Chapter 11 features an analysis of the overall, installed capacity for manufacturing antibodies based on data reported by industry stakeholders in the public domain; it highlights the distribution of available antibody 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 features a detailed analysis of the annual commercial and clinical demand for antibodies, based on various relevant parameters, such as target patient population, dosing frequency and dose strength.

Chapter 13 presents a detailed market forecast analysis, highlighting the likely growth of the antibody 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] type of antibodies (monoclonal antibodies, bispecific antibodies and others), [B] company size (small, mid-sized and large / very large), [C] scale of operation (preclinical / clinical and commercial), [E] expression systems (mammalian, microbial and others), and [F] key geographical regions (North America, Europe, Asia).

Chapter 14 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of antibody 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 antibody 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 antibody CMOs.

Chapter 16 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details of interviews held with Dietmar Katinger (Chief Executive Officer, Polymun Scientific), David C Cunningham (Director Corporate Development, Goodwin Biotechnology) and Claire Otjes (Assistant Marketing Manager, Batavia Biosciences).

Chapter 17 is an appendix that contains the list of companies that offer custom manufacturing services for different type of antibodies.

Chapter 18 is an appendix that contains tabulated data and numbers for all the figures provided in the report.

Chapter 19 is an appendix that provides the list of companies and organizations mentioned in the report.

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