Oligonucleotide Synthesis Market: Industry Trends and Global Forecasts, Till 2035 - Application Area, Type of Product Synthesized, Type of Oligonucleotide Synthesized, Scale of Operation, Therapeutic Area, End-Users, Company Size and Key Geographical Regions

Current Demand Driven by Antisense Oligonucleotides, a Trend Set to Continue in the Foreseeable Future

The global oligonucleotide synthesis market is estimated to be worth $ 4.8 billion in 2024 and is expected to grow at compounded annual growth rate (CAGR) of 9.9% during the forecast period 2024-2035.

The new research study consists of industry trends, detailed oligonucleotide synthesis market analysis, key market insights, market impact analysis, and oligonucleotide synthesis market forecast and opportunity analysis. The growth in the opportunity for contract manufacturers over the next decade is likely to be the result of the anticipated rise in the demand for oligonucleotide therapeutics.

Oligonucleotides or oligos are short single stranded fragments of DNA or RNA molecules. These typically consist of 10-50 nucleotide chains with each chain made up of phosphate group, a sugar molecule (deoxyribose in DNA and ribose in RNA), and a nitrogenous base. The nitrogenous base can be adenine (A), cytosine (C), guanidine (G) and thymine (T) in DNA, or adenine (A), cytosine (C), guanidine (G) and uracil (U) in RNA. These molecules play a crucial role in genetic testing, molecular testing and various other analytical testing procedures, such as artificial gene synthesis and polymerase chain reactions.

With the approval of the first antisense oligonucleotide drug, Vitravene, the applications of oligonucleotides in research and diagnostics, in addition to therapeutics, have significantly increased. Several preclinical and clinical studies have demonstrated the potential of oligonucleotides as a safe and effective treatment modality; these molecules possess unique characteristics, such as high target specificity and superior pharmacokinetic profile.

Presently, over 15 oligonucleotide-based therapies have been approved globally. Notable examples of recently approved products include (in reverse chronological order of year of approval) Amvuttra (2022), AMONDYS 45 (2021), Leqvio (2021) and Oxlumo (2020). Additionally, close to 300 clinical studies are currently evaluating around 80 oligonucleotides for over 102 different indications across 14 therapeutic areas, targeting 66 different genes.

Oligonucleotides are usually manufactured using chemical synthesis approaches, such as phosphoramidite synthesis and solid-phase synthesis (used for manufacturing small molecules). However, these approaches for production of synthetic oligonucleotides are fraught with various challenges, such as long development timelines, lack of purification techniques for oligonucleotides synthesized, regulatory and compliance-related issues, and lack of expertise among the developers. Therefore, several researchers and therapy / diagnostic developers in the oligonucleotide synthesis market prefer to outsource their oligonucleotide manufacturing operations to contract service providers, which possess the required manufacturing capabilities and expertise in the oligonucleotide synthesis market.

Further, it is worth noting that, with the rise in global disease burden, specifically, post 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 the growing oligonucleotide-based drugs pipeline, encouraging clinical trial results and extensive research activity in the domain, is likely to present lucrative market growth opportunities for custom / contract service providers, during the forecast period.

Oligonucleotide Synthesis Market Share Insights

The oligonucleotide synthesis market research report presents an in-depth analysis of the various firms / organizations in the oligonucleotide synthesis industry, across different segments, as defined below:

• Historical Trend: 2018-2022
• Base Year: 2023
• Forecast Period: 2024-2035
• Market Size in 2024: $4.8 Billion
• CAGR: 9.9%
• Application Area
• Research and Diagnostics
• Therapeutics
• Type of Product Synthesized
  • Active Pharmaceutical Ingredients
  • Finished Dosage Forms
• Type of Oligonucletide Synthesized
  • Antisense
  • DNA
  • siRNA
  • Other Oligonucleotides
• Scale of Operation
  • Clinical
  • Commercial
• Therapeutic Area
  • Cardiovascular Disorders
  • Genetic Disorders
  • Liver Disorders
  • Rare Diseases
  • Other Disorders
• End-users
  • Pharmaceutical/Biopharmaceutical Companies
  • Academic And Research Institutes
  • Hospitals
• Company Size
  • Small
  • Mid-sized
  • Large and Very Large
• Key Geographical Regions
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World
• Key Companies Profiled
  • Agilent Technologies
  • Ajinomoto Bio-Pharma Services
  • CordenPharma
  • Creative Biolabs
  • Ella Biotech
  • Eurofins Genomics
  • Future synthesis
  • Integrated DNA Technologies
  • Kaneka Eurogentec
  • LGC Biosearch Technologies
  • Merck
  • Microsynth
  • Nitto Avecia
  • Ribo Biotechnology
  • STA Pharmaceutical / Wuxi STA
  • Sumitomo Chemical
  • Thermo Fisher Scientific
  • TriLink Biotechnologies
  • (Full list of more than 100 companies captured is available in the report)
• PowerPoint Presentation (Complimentary)
• Customization Scope: 15% Free Customization
• Excel Data Packs (Complimentary)
  • Market Landscape
  • Company Competitiveness Analysis
  • Clinical Trial Analysis
  • Big Pharma Initiatives
  • Partnerships and Collaborations
  • Recent Expansions
  • Capacity Analysis
  • Demand Analysis
  • Market Forecast and Opportunity Analysis

Oligonucleotide Synthesis Market Segmentation Overview

Market Share by Type of Product Synthesized

The global oligonucleotide synthesis market is segmented into active pharmaceutical ingredients and finished dosage forms, based on the type of product synthesized. The oligonucleotide finished dosage occupies the highest share in 2024 and is expected to remain dominant during the forecast period. This can be attributed to the rising approval of oligonucleotide therapies in the coming years and higher profit margins for finished dosage forms.

Market Share by Type of Oligonucleotide Synthesized

Based on the type of oligonucleotide synthesized, the global oligonucleotide synthesis market is segmented into antisense, DNA, siRNA and other oligonucleotides. The antisense oligonucleotide segment occupies the highest share in 2024 and is expected to be dominant during the forecast period. With the rising number of approved siRNA and antisense oligonucleotides-based therapies for various rare diseases, genetic disorders and other disorders, these segments are likely to grow at a higher CAGR as compared to other types of oligonucleotides in the coming years.

Market Share by Scale of Operation

This section segments the global oligonucleotide synthesis market across different scales of operation, such as clinical and commercial scale. Presently, the market is dominated by revenues generated from commercial scale synthesis of oligonucleotides and this trend (in terms of market share) is likely to remain same during the forecast period.

Market Share by Therapeutic Area

The global oligonucleotide synthesis market is segmented into cardiovascular disorders, genetic disorders, liver disorders, rare diseases and other disorders. The rare diseases segment occupies the highest share in 2024. However, cardiovascular disorders market segment is expected to witness substantial market growth in the coming years.

Market Share by Company Size

This section segments the global oligonucleotide synthesis market based on the company size into small, mid-sized, and large and very large companies. Presently, the market is dominated by large and very large players. This can be attributed to the fact that large and very large players have well-established facilities and capabilities to improve operational efficiencies and reduce the manufacturing cost of novel therapeutics. It is worth highlighting that mid-sized companies are likely to grow at a relatively higher pace in the coming years, as compared to small, and large and very large companies in the oligonucleotide synthesis market.

Market Share by Key Geographical Regions

This segment highlights the distribution of oligonucleotide synthesis market across various geographies, such as North America, Europe, Asia-Pacific and rest of the world. According to the projections, the market in North America is likely to capture majority (45%) of the share, and this trend is unlikely to change in the future. It is worth highlighting that the market in Asia-Pacific is likely to grow at a relatively higher CAGR (10.7%), during the period 2024-2035.

Oligonucleotide Synthesis Market Key Insights

The market report features an extensive study of the current market landscape, market size and future opportunities within the domain of oligonucleotide synthesis, during the given forecast period. Further, the oligonucleotide synthesis market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the oligonucleotide synthesis market research report are briefly discussed below.

Pipeline Analysis: Competitive Landscape of Oligonucleotide Synthesis Providers

The oligonucleotide synthesis market landscape features 110+ very large, large, mid-sized and small oligonucleotide synthesis providers offering custom oligonucleotide synthesis, oligonucleotide modification and oligonucleotide purification services, which are intended for research, diagnostic and therapeutic applications. Further, the most commonly adopted modification techniques for oligonucleotides include labeling modifications, backbone modifications and modified bases.

It is worth highlighting that modified bases are locked nucleic acids that can be incorporated into DNA or RNA at multiple sites during synthesis in order to enhance the therapeutic effect of the product. Examples of companies offering modified bases include (arranged in alphabetical order) Eurofins Genomics, Integrated DNA Technologies, LGC Biosearch Technologies and ThermoFisher Scientific. Furthermore, HPLC is the most commonly used technique for oligonucleotides purification, followed by polyacrylamide gel electrophoresis. This can be attributed to the fact that these techniques help to obtain highly pure and premium quality oligonucleotides. In addition, various high throughput RNA/DNA synthesizers are being launched with advanced purification technology to improve yield.

siRNA and Antisense Oligonucleotides are Most Widely Adopted for Gene Therapies

siRNA (short double-stranded RNA molecules) and antisense oligonucleotides (short single-stranded DNA or RNA molecules) are designed to bind complementary RNA and guide the RNA-induced silencing complex to block protein synthesis (translation). Both the molecules offer targeted approach to modulate gene expression via several therapies, available commercially. In June 2022, the US Food and Drug Administration (US FDA) approved the siRNA oligonucleotide-based medicine, Amvuttra (developed by Alnylam Pharmaceuticals) for the treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis in adult patients. Further, according to the clinical data available on clinicaltrials.gov.in, currently oligo therapies, specifically antisense oligonucleotide-based therapies are gaining significant recognition for their use in treatment of duchenne muscular dystrophy, alzheimer’s disease, asthma, lung cancer and huntington’s disease.

Market Trend Analysis: Partnerships and Collaborations have Fueled the Oligonucleotide Synthesis Market Growth

In recent years, several partnerships have been established by industry stakeholders, in order to consolidate their presence in this field, and enhance their capabilities and product portfolio to meet the growing demand for oligonucleotide-based therapeutics. It is worth highlighting that over 30% of these partnerships have been inked in the past two years. Interestingly, most of the agreements signed between the stakeholders were acquisition and manufacturing agreements. For instance, in August 2023, EUROAPI acquired BianoGMP to strengthen its CDMO expertise in the domain.

Clinical Trial Analysis: Close to 300 Trials are Evaluating Oligonucleotides to Treat Myriad of Disease Indications

Close to 300 clinical trials have been registered across different geographical regions to evaluate various oligonucleotides. Majority (>50%) of these trials were registered in North America. Further, the maximum number of patients (19,590) have been enrolled in clinical trials conducted in Europe, which account for 26% of the overall enrollment. It is worth mentioning that Ionis Pharmaceuticals is conducting the maximum number of trials in this industry for various target indications, including atherosclerosis, Crohn’s disease, elevated triglycerides, familial chylomicronemia syndrome, hATTR amyloidosis rheumatoid arthritis, transthyretin-mediated amyloid cardiomyopathy and type 2 diabetes mellitus.

More than 70% of the Global Oligonucleotide Synthesis Capacity is Installed in Facilities owned by Large and Very Large Companies

Maximum (49%) capacity for oligonucleotide manufacturing is installed in facilities located in North America; of which, more than 95% of the capacity is installed in facilities owned by players based in the US. It is worth mentioning that, over the past few years, the oligonucleotide synthesis capacity installed in Asia-Pacific and rest of the world has also increased at a substantial pace. This is primarily driven by the technical advances, low labor costs and socio-economic reforms favoring the growth of specialty industries, such as the oligonucleotide industry.

Estimates of the Annual Demand for Oligonucleotide-based Drugs

The demand for oligonucleotides is projected to reach over 2,200 kgs in 2035, growing at a CAGR of 17%. In addition, the commercial and clinical demand for oligonucleotides is projected to reach 2,044 kgs and 152 kgs in 2035, respectively. Further, in terms of types of oligonucleotides, the current demand is driven by antisense oligonucleotides, and this trend is unlikely to change in the foreseen future.

Market Analysis: Global Oligonucleotide Synthesis Market Size

The global oligonucleotide synthesis market is estimated to be worth $ 4.8 billion in 2024. Driven by the increasing potential of synthetic oligonucleotides as therapeutic agents and increase in the demand of oligo-based products, the oligonucleotide synthesis market is anticipated to grow at a CAGR of 9.9% during the forecast period.

Further, by 2035, in terms of type of oligonucleotide synthesized, majority of the market share is anticipated to be captured by antisense oligonucleotides. However, some interesting developments are taking place in the DNA synthesis market segment, specifically the advent of enzymatic DNA synthesis. This technological development can provide a breakthrough for the manufacturing of long DNA fragments, driving the market growth in this market segment. DNA synthesis is finding its application in development of cell and gene therapies as well in the niche area of DNA data storage.

Regional Analysis: North America Emerges as the Hub of Oligonucleotide Synthesis Market; Asia-Pacific to be the Fastest Growing Market

Majority of the oligonucleotide synthesis providers are headquartered in North America, followed by companies based in Europe. Currently, North America and Europe capture around 75% of the market share of the global oligonucleotide synthesis market. In recent years, demand for oligonucleotide-based products in the North America region has witnessed a significant increase owing to increasing R&D investments and number of clinical studies pertaining to the development of oligonucleotides / oligonucleotide-based products. It is worth highlighting that, in the coming years, the market in Asia-Pacific is likely to grow at a higher owing to the lower manufacturing costs, cheap and skilled labor and supportive regulatory landscapes in this region.

Leading Oligonucleotide Manufacturing Companies

Examples of key oligo synthesis companies (which have also been profiled in this market report; the complete list of companies is available in the full report) include Agilent Technologies, Ajinomoto Bio-Pharma Services, CordenPharma, Creative Biolabs, Ella Biotech, Eurofins Genomics, Future synthesis, Integrated DNA Technologies, Kaneka Eurogentec, LGC Biosearch Technologies, Microsynth, Nitto Avecia, Merck, Ribo Biotechnology, STA Pharmaceutical, Sumitomo Chemical, Thermo Fisher Scientific, TriLink Biotechnologies. This market report includes an easily searchable excel database of all the companies offering oligonucleotide synthesis services for research or therapeutic applications.

Recent Developments in the Oligonucleotide Synthesis Market

Several recent developments have taken place in the field of oligonucleotide synthesis to advance targeted therapeutics, some of which have been outlined below. These developments, even if they took place post the release of the market report, substantiate the overall oligonucleotide synthesis market trends that the analyst has outlined in the analysis.

• In October 2023, Integrated DNA Technologies opened a new therapeutic oligonucleotide manufacturing facility in Iowa, US. The new 41,000 sq ft facility will support customers with new research and manufacturing capabilities and expertise.
• In May 2023, Aptamer Sciences entered into a partnership with Hycelltech to develop an aptamer drug conjugate (ApDC) anticancer drug by combining former company’s SELEX and antibody-drug conjugate (ADC) technology and latter company’s core technologies.
• In March 2023, Ansa Biotechnologies synthesized a 1005 bases long oligonucleotide using de novo synthesis.
• In January 2023, Twist Bioscience began the shipment of twist oligo pools from its newly expanded facility in Oregon, US.

Oligonucleotide Synthesis Market Report Coverage

The market report presents an in-depth analysis, highlighting the capabilities of various oligonucleotide synthesis companies, across different geographies. Amongst other elements, the market report includes:

• A preface providing an introduction to the full report, Oligonucleotide Synthesis Market (3rd Edition), till 2035.
• An outline of the systematic research methodology adopted to conduct the study on oligonucleotide synthesis market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
• An overview of economic factors that impact the overall oligonucleotide synthesis industry, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the insights captured during the research. It offers a high-level view on the current state of oligonucleotide synthesis market and its likely evolution in the mid-long term.
• A general overview of oligonucleotides and its different types. The chapter also features a detailed discussion on different steps involved in custom oligonucleotide synthesis, chemical modification and purification of oligonucleotides. Further, it highlights the various challenges associated with oligonucleotide manufacturing, as well as the growing need for outsourcing the manufacturing operations of such products. 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.
• A detailed assessment of the oligonucleotide synthesis providers, based on several relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters, location of oligonucleotide synthesis facilities, scale of operation (preclinical, clinical and commercial), type of oligonucleotide synthesized (antisense oligonucleotides, aptamers, DNA oligonucleotides, oligonucleotide probes, primers, RNA oligonucleotides and others), type of product synthesized (oligonucleotide API and finished dosage form / drug product), application area (research, diagnostic and therapeutic) and type of additional services offered (process development / method validation, analytical testing, custom synthesis, sequencing, modification, purification, fill-finish, quality assurance and control, and regulatory support).
• A detailed competitiveness analysis of oligonucleotide synthesis providers based on supplier strength (in terms of years of experience), service strength (in terms of scale of operation, type of oligonucleotide synthesized, application area, type of product synthesized, and type of additional services offered) and number of oligonucleotide synthesis facilities.
• Elaborate profiles of prominent players (shortlisted based on the proprietary criteria) engaged in offering oligonucleotide synthesis services. Each profile features a brief overview of the company (including information on year of establishment, location of headquarters, number of employees and leadership team), financial information (if available), service portfolio, recent developments and an informed future outlook.
• An insightful make versus buy framework, highlighting the key indicators / factors that influence the decision-making of sponsors / developers, whether to outsource the oligonucleotide manufacturing operations or develop the means to carry it in-house.
• An in-depth analysis of completed, ongoing, and planned clinical studies evaluating various oligonucleotide therapeutics, based on several relevant parameters, such as trial registration year, trial status, trial phase, enrolled patient population, type of sponsor, most active industry players (in terms of number of trials conducted), study design, therapeutic area and key geographical regions.
• A detailed analysis of the partnerships inked between stakeholders in this industry, since 2014, based on several parameters, such as year of partnership, type of partnership, type of oligonucleotide, therapeutic area, application area and the most active players (in terms of the number of partnerships signed). It also provides the regional distribution of the companies involved in these agreements.
• A detailed review of expansion initiatives undertaken by oligonucleotide synthesis providers, during the period, since 2015, along with information on several relevant parameters, such as year of expansion, type of expansion, scale of operation, application area, amount invested, area of facility and location of expanded facility.
• A review of the various oligonucleotide-focused manufacturing initiatives undertaken by top 13 big pharma players (shortlisted on the basis of 2022 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, type of initiative, type of initiative, scale of operation, type of oligonucleotide manufactured, and amount invested.
• An estimate of the overall installed capacity for manufacturing of oligonucleotides, based on information reported by various industry stakeholders in the public domain. The analysis highlights the distribution of the available capacity based on the company size (small, mid-sized, and large and very large firms) and key geographical regions (North America, Europe and, Asia-Pacific and Rest of the World).
• An informed estimate of the annual clinical demand for oligonucleotide therapeutics, taking into account the target patient population in ongoing and planned clinical trials of oligonucleotide therapeutics, sponsored by both industry and non-industry players. Further, we estimated the commercial demand for oligonucleotides, taking into account the top 12 oligonucleotide-based therapies and phase III drugs, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
• An in-depth analysis of the factors that can impact the growth of oligonucleotide synthesis services market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
• A detailed oligonucleotide synthesis market forecast in order to estimate the current market size and future opportunity over the next 11 years. Based on multiple parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market size during the forecast period 2024-2035.
• Detailed projections of the current and future opportunity within the oligo synthesis market across different application area, such as research and diagnostics, and therapeutics.
• Detailed projections of the current and future opportunity within the oligo synthesis market across different type of product synthesized, such as active pharmaceutical ingredients and finished dosage forms.
• Detailed projections of the current and future oligo synthesis market across different type of oligonucleotide synthesized, such as antisense, DNA, siRNA and other oligonucleotides.
• Detailed projections of the current and future opportunity within the oligonucleotide synthesis market across different scales of operation, such as clinical and commercial.
• Detailed projections of the current and future opportunity within the oligonucleotide synthesis industry across different therapeutic area, such as cardiovascular disorders, genetic disorders, liver disorders, rare diseases, and other disorders.
• Detailed projections of the current and future opportunity within the field of oligonucleotide synthesis across different end-users, such as pharmaceutical / biopharmaceutical companies, academic and research institutes, and hospitals.
• Detailed projections of the current and future opportunity within the field of oligonucleotide synthesis across different company size, such as small, mid-sized, and large and very large.
• Detailed projections of the current and future opportunity within the oligonucleotide synthesis market across key geographical regions, such as North America, Europe, Asia-Pacific and Rest of the World.

One of the key objectives of oligonucleotide synthesis market report was to estimate the current market size, opportunity and the future growth potential of the oligonucleotide synthesis market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035. The market report also features the likely distribution of the current and forecasted opportunity within the oligonucleotide synthesis market across various segments, such as application area (research and diagnostics, and therapeutics), type of product synthesized (active pharmaceutical ingredients and finished dosage forms), type of oligonucleotide synthesized (antisense, DNA, siRNA and other oligonucleotides), scale of operation (clinical and commercial), therapeutic area (cardiovascular disorders, genetic disorders, liver disorders, rare diseases, and other disorders), end-users (pharmaceutical / biopharmaceutical companies, academic and research institutes, and hospitals), company size (small, mid-sized, and large and very large) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to the model, the analyst has provided three market 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 the oligonucleotide synthesis market. In addition, the research report features detailed transcripts of interviews held with the following industry stakeholders (arranged on the basis of designation):

• Founder and Managing Director, Small Company, Germany
• Co-Founder and Managing Director, Small Company, India
• Chief Scientific Officer and Managing Director, Small Company, Germany
• Managing Director, Mid-sized Company, Germany
• Business Officer, Mid-sized Company, China
• Chem Lab Manager, Small Company, US
• Global Corporate Sales and Business Development, Small Company, Germany

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

Key Benefits of Buying this Report

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on the Oligonucleotide Synthesis Market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.