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Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030

Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030

  • March 2020
  • 318 pages
  • ID: 5893050
  • Format: PDF
  • Roots Analysis Private Ltd.

Summary

Table of Contents

INTRODUCTION
Oligonucleotides have a wide range of applications in medical science. In basic research and diagnostics, these are indispensable to contemporary molecular testing and analytical protocols (such as the polymerase chain reaction (PCR), and DNA sequencing), genomic library construction and artificial gene synthesis. , As therapeutic agents, oligonucleotides are known to be associated with certain unique features, such as high selectivity and potency (similar to biologics), and differentiated pharmacology, which further augment their drug-like properties. Moreover, there are established rational approaches that can be leveraged to design oligonucleotide leads, and the overall cost of such drug development initiatives, compared to conventional small molecule drugs and biologics, is reportedly lower. Vitravene® was the first antisense oligonucleotide-based product in 1998. At present, eight oligonucleotide-based drugs are available in the market, namely (in reverse chronological order of year of approval) GIVLAARI™ (2019), ONPATTRO® (2018), TEGSEDI™ (2018), SPINRAZA® (2016), EXONDYS 51® (2016), DEFITELIO® (2016), KYNAMRO™ (2013), and MACUGEN® (2004). Further, more than 200 unique oligonucleotide-based product candidates are currently being evaluated in various preclinical / clinical phases of development.

According to experts, the use of oligonucleotides as a treatment option is limited due to complexities associated with the synthesis of such compounds. Similar to small molecule drugs, oligonucleotides can be manufactured via chemical synthesis methods, solid phase synthesis being one of the most popular approaches used. However, there are certain technical requirements (chemical modification-related expertise) and complex analytical expertise required for development, synthesis and purification of this class of molecules. As a result, oligonucleotide manufacturing has emerged as a much sought-after capability within the modern biopharmaceutical industry. Presently, a significant proportion of the existing expertise and manufacturing capacity for oligonucleotides belong to contract service providers. In fact, most researchers and many therapy / diagnostic developers have demonstrated preference to outsource oligonucleotide manufacturing operations, instead of building in-house capabilities for the same. Several big pharma companies, despite having proprietary manufacturing capabilities, are known to outsource more than half of their clinical stage oligonucleotide manufacturing operations. In the foreseen future, we anticipate the demand and opportunities for contract manufacturing organizations (CMO) in this domain to rise. Consequently, CMOs need to continue to upgrade their capabilities and infrastructure to keep pace with the evolving product development landscape.

SCOPE OF THE REPORT
The “Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030” report features a detailed study of the current scenario and future potential of the custom synthesis, modification and purification services market for oligonucleotides, which are intended for research, diagnostic, and therapeutic applications. The study includes in-depth analyses, highlighting the capabilities of service providers engaged in this domain. In addition to other elements, it includes:
• A detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on research and diagnostic, and therapeutic applications. It features information on the year of establishment, company size, scale of operation (preclinical, clinical, and commercial), location of headquarters, number of manufacturing facilities, along with their locations (country-wise), and regulatory accreditations and certifications received by them, type of oligonucleotide manufactured (antisense oligonucleotides, aptamers, decoys, miRNA, shRNA, siRNA, specialty amidites, and others), type of offering (custom synthesis, modification and purification), type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, sequencing capabilities, stability studies, quality assurance and control, scale-up, fill/finish, downstream processing, regulatory support, data analytics and reporting, and others), type of modification(s) offered (amino modifiers, backbone modifications, fluorescent probes, dyes and quenchers, modified bases, phosphorylation, thiol modifications, and others), type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others), and compliance to cGMP standards.
• A company competitiveness analysis, highlighting prominent oligonucleotide manufacturers for research and diagnostic, and therapeutic applications, based on supplier strength (which was calculated by considering the size of employee base of a company and its experience in this field) and service strength (quantified based on scale of operation, expertise in manufacturing different types of oligonucleotides, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, compliance to cGMP standards, as well as number and location of manufacturing facilities).
• Elaborate profiles of key players that offer a diverse range of capabilities for custom synthesis, modification and purification of oligonucleotides for use in research and diagnostic, and therapeutic applications. Each profile includes an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, details on partnerships, recent developments (expansions), and awards received by the firm, as well as an informed future outlook.
• An analysis of the various partnerships pertaining to oligonucleotide manufacturing, which have been established since 2014, based on several parameters, such as the year of partnership, type of partnership, type of partner, most active players (in terms of number of partnerships signed), and a geographical analysis.
• An analysis of the various expansion initiatives undertaken by service providers engaged in this domain, in order to augment their respective oligonucleotide manufacturing capabilities, over the period 2014-2019, taking into consideration several relevant parameters, such as year of expansion, type of expansion (capability expansion, capacity expansion, facility expansion and new facility), scale of operation (preclinical, clinical and commercial), application (research and manufacturing operations), and location of manufacturing facility.
• A detailed analysis of completed, ongoing and planned clinical research studies of various oligonucleotide-based drug products, highlighting prevalent trends across several relevant parameters, such as trial registration year, phase of development, type of oligonucleotide, current trial recruitment status, study focus area, key therapeutic areas (in terms of number of trials undertaken / conducted), enrolled patient population and trial location, and leading industry and non-industry players (in terms of number of trials undertaken / conducted).
• An estimate of the overall, installed capacity for manufacturing oligonucleotides based on data reported by industry stakeholders in the public domain; it highlights the distribution of available oligonucleotide synthesis capacity on the basis of company size (small, mid-sized, and large firms), scale of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia-Pacific and rest of the world).
• An informed estimate of the annual commercial demand for oligonucleotide-based drug products (in grams), taking into account the marketed oligonucleotide products; the analysis takes into consideration the target patient population, dosing frequency and dose strength, of the aforementioned products. The annual clinical demand for oligonucleotide-based drug products was also estimated, taking into account ongoing and planned clinical trials.
• A discussion on affiliated trends, key drivers and challenges, under an elaborate 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 industry.
• A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing custom synthesis, modification and purification services for oligonucleotides.

One of the key objectives of this report was to evaluate the current opportunity and the future potential within the oligonucleotide synthesis, modification and purification services market, over the coming decade. Based on various parameters, such as anticipated growth in number of oligonucleotide-focused projects, 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 long term, for the period 2020-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] application (research and diagnostic, and therapeutic applications), [B] type of oligonucleotide manufactured (antisense oligonucleotides, siRNA, miRNA, and others), [C] scale of operation (preclinical / clinical, and commercial), [D] company size (small, mid-sized, and large companies), [E] key therapeutic areas (oncological disorders, eye disorders, metabolic disorders, autoimmune disorders, and other therapeutic areas), and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world). To account for the uncertainties associated with the growth of the oligonucleotide synthesis, modification and purification services market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions presented in this study were influenced by inputs (through an industry-wide survey) of several key players in this domain. In addition, the report features detailed transcripts of interviews held with the following individuals:
• Tobias Pohlmann (Founder and Managing Director, BianoScience)
• Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Life Sciences)

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 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 till 2030, the report also provides our independent view on various non-commercial trends emerging 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 likely evolution of the oligonucleotide synthesis, modification and purification services market in the mid to long term.

Chapter 3 presents a general introduction to oligonucleotides, featuring information on the oligonucleotide-based products available in the market. Further, it features a detailed discussion on different steps involved in the custom synthesis, chemical modification and purification of oligonucleotides, along with information on the key challenges that are currently associated with this market. In addition, the chapter includes a brief discussion on the need for outsourcing within the oligonucleotides market. Further, it includes a list of commonly outsourced oligonucleotide synthesis, modification and purification operations, and highlights the key factors that need to be considered while selecting a service provider. The chapter concludes with a discussion on the key growth drivers and roadblocks related to oligonucleotide manufacturing, as well as upcoming trends in this field.

Chapter 4 provides a detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on research and diagnostic applications. The chapter features information on the year of establishment, company size, scale of operation (small, medium, and large), location of headquarters, number of manufacturing facilities, along with their locations (country-wise), and regulatory accreditations and certifications received by them, type of oligonucleotide manufactured (antisense oligonucleotides, aptamers, decoys, miRNA, shRNA, siRNA, specialty amidites, and others), type of offering (custom synthesis, modification and purification), type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, sequencing capabilities, stability studies, quality assurance and control, scale-up, fill/finish, downstream processing, regulatory support, data analytics and reporting, and others), type of modification(s) offered (amino modifiers, backbone modifications, fluorescent probes, dyes and quenchers, modified bases, phosphorylation, thiol modifications, and others), type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others), and compliance to cGMP standards.

Chapter 5 provides a detailed review of the current status of the market with respect to oligonucleotide manufacturers focused on therapeutic applications. The chapter features information on the year of establishment, company size, scale of operation (preclinical, clinical, and commercial), location of headquarters, number of manufacturing facilities, along with their locations (country-wise), and regulatory accreditations and certifications received by them, type of oligonucleotide manufactured (antisense oligonucleotides, aptamers, decoys, miRNA, shRNA, siRNA, specialty amidites, and others), type of offering (custom synthesis, modification and purification), type of manufacturing service(s) offered (process development and characterization, method validation and testing, analytical development, sequencing capabilities, stability studies, quality assurance and control, scale-up, fill/finish, downstream processing, regulatory support, data analytics and reporting, and others), type of modification(s) offered (amino modifiers, backbone modifications, fluorescent probes, dyes and quenchers, modified bases, phosphorylation, thiol modifications, and others), type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others), and compliance to cGMP standards.

Chapter 6 features an insightful company competitiveness analysis of oligonucleotide manufacturers for research and diagnostic applications, based in North America, Europe and Asia-Pacific, that we came across during our research. The analysis compares companies within each geography on the basis of supplier strength (which was calculated by considering the size of employee base of a company and its experience in this field) and service strength (quantified based on scale of operation, expertise in manufacturing different types of oligonucleotides, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, compliance to cGMP standards, as well as number and location of manufacturing facilities).

Chapter 7 features an insightful company competitiveness analysis of oligonucleotide manufacturers for therapeutic applications, based in North America, Europe and Asia-Pacific, that we came across during our research. The analysis compares companies within each geography on the basis of supplier strength (which was calculated by considering the size of employee base of a company and its experience in this field) and service strength (quantified based on scale of operation, expertise in manufacturing different types of oligonucleotides, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, compliance to cGMP standards, as well as number and location of manufacturing facilities).

Chapter 8 includes elaborate profiles of key industry players (shortlisted on the basis of company competitiveness analysis scores) that offer a diverse range of capabilities for the custom synthesis, modification and purification of oligonucleotides for use in research and diagnostic applications. Each profile includes an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, details on partnerships, recent developments (expansions), and awards received by the firm, as well as an informed future outlook.

Chapter 9 includes elaborate profiles of key industry players (shortlisted on the basis of company competitiveness analysis scores) that offer a diverse range of capabilities for the custom synthesis, modification and purification of oligonucleotides for use in therapeutic applications. Each profile includes an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, details on partnerships, recent developments (expansions), and awards received by the firm, as well as an informed future outlook.

Chapter 10 features an elaborate analysis of the various partnerships and collaborations that have been inked amongst players in this domain, in the time period 2014-2019. It provides a brief description on the various types of partnership models (which include asset purchase agreements, distribution agreements, manufacturing agreements, mergers / acquisitions, product development agreements, R&D agreements, service alliances, and others) that have been adopted by stakeholders in this domain. Further, it includes analyses based on the year of agreement, type of partner, and most active players. 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 11 presents detailed analysis on the various expansion initiatives undertaken by service providers engaged in this domain, in order to augment their respective oligonucleotide manufacturing capabilities, over the period 2014-2019. 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 (capability expansion, capacity expansion, facility expansion, and new facility), scale of operation (preclinical, clinical and commercial), application (research and manufacturing operations), and location of manufacturing facility.

Chapter 12 provides a detailed analysis of completed, ongoing and planned clinical research studies of various oligonucleotide-based drug products, highlighting prevalent trends across several relevant parameters, such as trial registration year, phase of development, type of oligonucleotide, current trial recruitment status, study focus area, key therapeutic areas (in terms of number of trials undertaken / conducted), enrolled patient population and trial location, and leading industry and non-industry players (in terms of number of trials undertaken / conducted).

Chapter 13 features a detailed analysis of the global / regional capacity of manufacturers that are engaged in the synthesis of oligonucleotides. The analysis takes into consideration the individual manufacturing capacities of various stakeholders (small, mid-sized, and large manufacturers) in the market, using data from both secondary and primary research. It also examines the likely distribution of the global oligonucleotide manufacturing capacity available across different types of companies (small, mid-sized, and large manufacturers), scales of operation (preclinical, clinical and commercial), and key geographical regions (North America, Europe, Asia-Pacific, and rest of the world).

Chapter 14 features a detailed estimate of the annual demand for oligonucleotide-based drug products (in grams), offering an informed opinion on the required scale of supply (in terms of oligonucleotide synthesis services). In order to estimate the annual commercial demand, we considered the marketed oligonucleotide products; the analysis takes into consideration the target patient population, dosing frequency and dose strength of the aforementioned products. The annual clinical demand for oligonucleotide-based drug products was also estimated, taking into account the ongoing and planned clinical trials.

Chapter 15 presents an insightful market forecast analysis, highlighting the likely growth of the oligonucleotide synthesis, modification and purification services market, till 2030. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] application (research and diagnostic, and therapeutic applications), [B] type of oligonucleotide manufactured (antisense oligonucleotides, siRNA, miRNA, and others), [C] scale of operation (preclinical / clinical, and commercial), [D] company size (small, mid-sized, and large companies), [E] key therapeutic areas (oncological disorders, eye disorders, metabolic disorders, autoimmune disorders, and other therapeutic areas), and [F] key geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 16 provides a detailed analysis capturing the key parameters and trends that are likely to influence the future of oligonucleotide synthesis, modification and purification services market, under a detailed SWOT framework.

Chapter 17 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the oligonucleotide synthesis, modification and purification services market.

Chapter 18 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with Tobias Pohlmann (Founder and Managing Director, BianoScience) and Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Life Sciences).

Chapter 19 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of this 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 oligonucleotide synthesis, modification and purification service providers.

Chapter 20 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 21 is an appendix, which provides the list of companies and organizations mentioned in the report.

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