Oligonucleotide Synthesis, Modification and Purification Services Market (2nd Edition): Focus on Research, Diagnostic and Therapeutic Applications, 2021-2031

Oligonucleotide Synthesis, Modification and Purification Services Market (2nd Edition): Focus on Research, Diagnostic and Therapeutic Applications, 2021-2031

INTRODUCTION

Post the marketing of Vitravene®, the first antisense oligonucleotide-based therapy to receive approval (in 1998), various stakeholders have undertaken multiple research initiatives to verify the potential of oligonucleotides as therapeutic agents. The known applications of oligonucleotides in research and diagnostics, in addition to their therapeutic use, have significantly increased. It is worth mentioning that these molecules play a crucial role in genetic testing, molecular testing protocols and various analytical testing procedures, such as artificial gene synthesis and polymerase chain reaction. In fact, several preclinical and clinical studies have demonstrated the potential of oligonucleotides as a safe and effective treatment modality, owing to their unique characteristics, such as high target specificity and superior pharmacokinetic profile. , As a result, over 14 oligonucleotide-based therapies have been approved till date. Notable examples of recently approved products include (in reverse chronological order of year of approval) AMONDYS 45 (2021), Oxlumo™ (2020) and Viltepso™ (2020). Further, over 350 oligonucleotide-based therapies are currently being evaluated across different development stages.

Oligonucleotides are usually manufactured using chemical synthesis approaches, such as phosphoramidite synthesis and solid-phase synthesis (used for manufacturing small molecules). Given to the intricacy of the aforementioned synthesis procedures, production of oligonucleotides is often associated with several challenges, such as lack of purification and analytical expertise among the stakeholders. Presently, a significant portion of the existing manufacturing capabilities and expertise in this domain belong to contract service providers. Therefore, several researchers and therapy / diagnostic developers engaged in this domain prefer to outsource their oligonucleotide manufacturing operations. Moreover, with the rise in global disease burden, there has been an increase in the demand for effective targeted therapies. Specifically, post the onset of the COVID-19 pandemic, there has been a significant rise in the demand for oligonucleotides, given their use in COVID-19 testing kits. Consequently, contract service providers are expanding their existing capacities and capabilities in order to cater to the growing demand. In addition, we believe that encouraging clinical trial results and extensive research activity related to oligonucleotides, coupled to their growing demand, is likely to result in lucrative opportunities for custom / contract service providers, in the foreseen future.

SCOPE OF THE REPORT

The “Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications (2nd Edition), Distribution by Type of Manufacturing (Custom Manufacturing and Contract Manufacturing), Type of Oligonucleotide Manufactured (Antisense, siRNA, shRNA, miRNA and Others), Scale of Operation (Clinical and Commercial), Purpose of Production (In-house Operations and Outsourced Operations), Type of Operation (API and FDF), Size of Manufacturer (Small, Mid-sized and Large), Key Therapeutic Areas (Autoimmune Disorders, Cardiovascular Disorders, Genetic Disorders, Infectious Diseases, Metabolic Disorders, Neuromuscular Disorders, Oncological Disorders, Ophthalmic Disorders, And Other Therapeutic Areas) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts, 2021-2031” 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. Further, the study underlines an in-depth analysis, highlighting the capabilities of service providers engaged in this domain. In addition to other elements, the study covers:

A detailed overview of the current market landscape of oligonucleotide manufacturers focused on research and diagnostic and therapeutic applications, based on several relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical, and commercial), location of headquarters, number of manufacturing facilities, along with information on the location of facility (country-wise), regulatory accreditations and certifications received, 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, fill / finish, 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) and type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE and others).

An insightful company competitiveness analysis, highlighting the key oligonucleotide manufacturers focused on research and diagnostic, and therapeutic applications, based on supplier strength (on the basis of size of employee base and its experience) and service strength (on the basis of scale of operation, type of oligonucleotide manufactured, type of offering, type of manufacturing service(s) offered, type of modification(s) offered, type of purification method(s) used, and number and location of manufacturing facilities).

Elaborate profiles of key players engaged in offering custom synthesis, modification and purification of oligonucleotides for 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 inked, recent developments and an informed future outlook.

A qualitative analysis highlighting the various factors that need to be considered by players engaged in this domain, while deciding whether to manufacture their respective products in-house or engage the services of a service provider.

A detailed review of the various oligonucleotide-based manufacturing initiatives undertaken by big pharma players (on the basis of revenues generated by top 5 pharmaceutical companies in 2020), highlighting trends across parameters, such as year of initiative, type of initiative and type of oligonucleotide.

An analysis of recent partnerships inked between players engaged in oligonucleotide manufacturing, during the period 2014-2021, based on several parameters, such as year of partnership, type of partnership, type of partner, most active players (in terms of number of partnerships signed), and region.

An analysis of the various expansion initiatives undertaken by service providers engaged in this domain, during the period 2016-2021, along with information on 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), type of application (research and manufacturing operations), and location of manufacturing facility.

An in-depth analysis of over 90 oligonucleotide-based therapy developers that are likely to partner with contract service providers engaged in this domain, based on several relevant parameters, such as developer strength (on the basis of company size and its experience), pipeline strength and maturity (on the basis of number of drugs in pipeline and their stage of development) and other manufacturing capabilities.

A detailed analysis of completed and ongoing clinical research studies of various oligonucleotide-based drugs, based on 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 global, installed capacity for the manufacturing of oligonucleotides, based on information provided by various industry stakeholders in the public domain. It also features 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 drugs (in kilograms), based on several relevant parameters, such as target patient population, dosing frequency and dose strength. The annual clinical demand for oligonucleotide-based drug products was also estimated, taking into account ongoing clinical trials.

An elaborate discussion on how the recent COVID-19 pandemic is likely to impact the oligonucleotide synthesis market, along with information on the key initiatives undertaken by players engaged in this domain to overcome the challenges faced due to the pandemic.

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 next decade. Based on multiple parameters, such as anticipated growth in number of oligonucleotide-focused projects, cost of goods sold, and direct manufacturing costs, we have developed informed estimates of the likely evolution of the market over the coming decade. Additionally, the report features the likely distribution of the current and forecasted opportunity across [A] type of manufacturing (custom manufacturing, and contract manufacturing), [B] type of oligonucleotide manufactured (antisense oligonucleotides, miRNA, shRNA, siRNA, and others), [C] scale of operation (clinical and commercial), [D] purpose of production (in-house operations and outsourced operations), [E] type of operation (active pharmaceutical ingredient (API) and finished dosage form (FDF)) [F] size of manufacturer (small, mid-sized, and large companies), [G] key therapeutic areas (autoimmune disorders, cardiovascular disorders, genetic disorders, infectious diseases, metabolic disorders, neuromuscular disorders, oncological disorders, ophthalmic disorders, and other therapeutic areas), and [H] key geographical regions (North America, Europe, and Asia-Pacific and rest of the world). In order 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:

Arun Shastry (Co-Founder and Managing Director, Hanugen Therapeutics)

Hans-Peter Vornlocher (Managing Director, Axolabs)

Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Life Sciences)

Tobias Pohlmann (Founder and Managing Director, BianoScience)

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 have conducted interviews with various experts in this domain (academia, industry and other associations) in order 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 2031, 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.

KEY QUESTIONS ANSWERED

Who are the leading players offering oligonucleotide synthesis, modification and purification services for research, diagnostic and therapeutic applications?

What are the preferred modification and purification methods used for oligonucleotides?

What are the key challenges faced by stakeholders engaged in this domain?

What kind of partnership models are commonly adopted by industry stakeholders?

What are the recent expansion initiatives undertaken by service providers within this domain?

Which therapy developers are likely to partner with oligonucleotide manufacturing service providers?

What is the annual, clinical and commercial demand for oligonucleotides?

What is the current, installed manufacturing capacity for oligonucleotides?

What percentage of oligonucleotide manufacturing operations are outsourced to service providers?

What factors should be taken into consideration while deciding whether the manufacturing operations for oligonucleotides should be kept in-house or outsourced?

What are the different initiatives undertaken by big pharma players engaged in this domain, in the recent past?

What are the opportunities in emerging markets for oligonucleotide manufacturing?

How is the current and future market opportunity likely to be distributed across key market segments?

What are the anticipated future trends related to oligonucleotide manufacturing?

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-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 custom synthesis, chemical modification and purification of oligonucleotides, along with information on the key challenges associated. In addition, the chapter includes a brief discussion on the need for outsourcing within the oligonucleotides market. Furthermore, it lists the commonly outsourced oligonucleotide synthesis, modification and purification operations, along with information on 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 associated with 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) and type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others).

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, fill/finish, 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) and type of purification method(s) used (desalting, cartridge purification, HPLC, ion exchange purification, PAGE, and others).

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, 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, 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 presents a qualitative analysis highlighting the various factors that need to be taken into consideration by oligonucleotide-based therapy developers, while deciding whether to manufacture their respective products in-house or engage the services of a service provider.

Chapter 11 provides a detailed analysis of oligonucleotide-based manufacturing related initiatives of the big pharma players (shortlisted on the basis of the revenues generated by the top 5 pharmaceutical companies in 2020), featuring trends across various parameters, such as year of initiative, type of initiative and type of oligonucleotide.

Chapter 12 features an elaborate analysis of the various partnerships and collaborations that have been inked amongst players in this domain, in the time period 2014-2021. 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 13 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 2016-2021. 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 14 features an in-depth analysis of more than 96 oligonucleotide-based therapy developers that are anticipated to partner with contract service providers and have been shortlisted on the basis of several relevant parameters, such as developer strength (which takes into account a company’s size and its experience in this field), pipeline strength and maturity (based on the number of pipeline drugs and affiliated stage of development) and availability of other oligonucleotide-based therapy capabilities.

Chapter 15 provides a detailed analysis of completed and ongoing 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 16 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, and Asia-Pacific and rest of the world).

Chapter 17 features a detailed estimate of the annual demand for oligonucleotide-based drug products (in kilograms), 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 clinical trials.

Chapter 18 presents an insightful market forecast analysis, highlighting the likely growth of the oligonucleotide synthesis, modification and purification services market, till 2031. In order to provide details on the future opportunity, our projections have been segmented on the basis of [A] type of manufacturing (custom manufacturing, and contract manufacturing), [B] type of oligonucleotide manufactured (antisense oligonucleotides, miRNA, shRNA, siRNA, and others), [C] scale of operation (clinical and commercial), [D] purpose of production (in-house operations and outsourced operations), [E] type of operation (API and FDF) [F] size of manufacturer (small, mid-sized, and large companies), [G] key therapeutic areas (autoimmune disorders, cardiovascular disorders, genetic disorders, infectious diseases, metabolic disorders, neuromuscular disorders, oncological disorders, ophthalmic disorders, and other therapeutic areas), and [H] key geographical regions (North America, Europe, and Asia-Pacific and rest of the world)

Chapter 19 features an insightful discussion on how the recent COVID-19 pandemic is likely to impact the oligonucleotide synthesis market, along with information on the key initiatives undertaken by the developers engaged in this domain to overcome the challenges faced due to the pandemic.

Chapter 20 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 21 presents the insights generated from a detailed survey, wherein we invited multiple stakeholders involved in the oligonucleotide synthesis, modification and purification services market.

Chapter 22 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 Hans-Peter Vornlocher (Managing Director, Axolabs), Tobias Pohlmann (Founder and Managing Director, BianoScience), Arun Shastry (Co-Founder and Managing Director, Hanugen Therapeutics) and Joachim Bertram (Chief Scientific Officer and Managing Director, IBA Life Sciences).

Chapter 23 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 24 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 25 is an appendix, which provides the list of companies and organizations mentioned in the report.