Oligonucleotide Synthesis Market (3rd Edition): Industry Trends and Global Forecasts, Till 2035 - Application Area

Oligonucleotide Synthesis Market (3rd Edition): Industry Trends and Global Forecasts, Till 2035 - Application Area

The Oligonucleotide Synthesis Market is valued at USD 4.8 billion in 2024 growing at a CAGR of 9.9% during the forecast period 2024-2035.

Oligonucleotides, commonly referred to as oligos, are short single-stranded segments of DNA or RNA molecules. Typically composed of 10-50 nucleotides, each oligonucleotide chain consists of a phosphate group, a sugar molecule (deoxyribose in DNA and ribose in RNA), and a nitrogenous base. The nitrogenous base can vary, with DNA containing adenine (A), cytosine (C), guanine (G), and thymine (T), while RNA includes adenine (A), cytosine (C), guanine (G), and uracil (U). These molecules play pivotal roles in genetic testing, molecular analysis, and various analytical procedures such as artificial gene synthesis and polymerase chain reactions (PCR). The approval of the first antisense oligonucleotide drug, Vitravene, has significantly expanded the applications of oligonucleotides beyond therapeutics, into research and diagnostics. Numerous preclinical and clinical studies have highlighted the potential of oligonucleotides as safe and effective treatment modalities, thanks to their unique characteristics like high target specificity and superior pharmacokinetic profiles.

Currently, more than 15 oligonucleotide-based therapies have received global approval. Recent examples include Amvuttra (2022), AMONDYS 45 (2021), Leqvio (2021), and Oxlumo (2020). Additionally, there are nearly 300 clinical studies investigating approximately 80 oligonucleotides for over 102 different indications across 14 therapeutic areas, targeting 66 different genes. Oligonucleotides are primarily manufactured using chemical synthesis methods like phosphoramidite synthesis and solid-phase synthesis, although these approaches pose challenges such as extended development timelines, purification issues, and regulatory compliance concerns. Consequently, many researchers and developers in the oligonucleotide synthesis market opt to outsource manufacturing to contract service providers with the requisite expertise and capabilities. Moreover, the global demand for oligonucleotides has surged, particularly post the COVID-19 pandemic, due to their widespread use in COVID-19 testing kits. Consequently, contract service providers are expanding their capacities and capabilities to meet this rising demand. Additionally, the growing pipeline of oligonucleotide-based drugs, promising clinical trial outcomes, and extensive research activities in the field are expected to create lucrative growth opportunities for custom/contract service providers in the foreseeable future.

Key Market Segments

Application Area

Research and Diagnostics

Therapeutics

Type of Product Synthesized

Active Pharmaceutical Ingredients

Finished Dosage Forms

Type of Oligonucleotide 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

Research Coverage:

This chapter provides a comprehensive overview of oligonucleotides and their various types. It delves into the different steps involved in custom oligonucleotide synthesis, as well as the processes of chemical modification and purification of oligonucleotides. Additionally, the chapter discusses the challenges associated with oligonucleotide manufacturing, including regulatory hurdles and technical complexities, leading to the growing trend of outsourcing manufacturing operations. Furthermore, it examines the key growth drivers and barriers in oligonucleotide manufacturing, along with upcoming trends in the field. Through this discussion, readers gain a thorough understanding of the oligonucleotide manufacturing landscape and its evolving dynamics.

This chapter conducts a comprehensive evaluation of oligonucleotide synthesis providers, considering various crucial parameters, such as the year of establishment, company size, location of headquarters, location of oligonucleotide synthesis facilities, and scale of operation. Additionally, the assessment covers the types of oligonucleotides synthesized, such as antisense oligonucleotides, aptamers, DNA oligonucleotides, oligonucleotide probes, primers, RNA oligonucleotides, and others. It also examines the type of products synthesized, including oligonucleotide APIs and finished dosage forms/drug products, as well as the application areas such as research, diagnostics, and therapeutics. Furthermore, the evaluation considers the additional services offered by these providers, encompassing process development/method validation, analytical testing, custom synthesis, sequencing, modification, purification, fill-finish, quality assurance and control, and regulatory support. Through this thorough assessment, readers gain insights into the capabilities and offerings of various oligonucleotide synthesis providers, aiding informed decision-making in selecting suitable partners or suppliers within the industry.

This chapter undertakes an extensive competitiveness analysis of oligonucleotide synthesis providers, focusing on several key parameters, such as supplier strength, which is evaluated based on years of experience in the industry. Additionally, service strength is assessed, considering factors such as the scale of operation, types of oligonucleotides synthesized, application areas served, types of products synthesized, and the range of additional services offered. Moreover, the number of oligonucleotide synthesis facilities operated by each provider is considered a crucial factor in evaluating their competitiveness. Through this detailed analysis, readers gain insights into the competitive positioning of oligonucleotide synthesis providers, aiding informed decision-making in selecting suitable partners or suppliers within the industry.

Detailed company profiles of prominent players (shortlisted based on our 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.

This section presents an insightful make-versus-buy framework, examining the key indicators and factors affecting the developers' decision-making whether to outsource oligonucleotide manufacturing operations or set-up in-house capabilities. Through this framework, various critical factors such as cost analysis, technological expertise, regulatory compliance, scalability, timelines, and strategic alignment are examined in detail. By considering these factors, sponsors and developers can make informed decisions that align with their organizational goals, resources, and long-term strategies.

Comprehensive 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.

Elaborate assessment 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 for the regional distribution of the companies involved in these agreements.

Comprehensive assessment 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.

Comprehensive 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.

Elaborate insight on 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).

This chapter provides an informed estimate of the annual clinical demand for oligonucleotide therapeutics, considering the target patient population in ongoing and planned clinical trials sponsored by both industry and non-industry players. Additionally, we estimate the commercial demand for oligonucleotides by analyzing the top 12 oligonucleotide-based therapies and phase III drugs. This estimation takes into account various relevant parameters such as the target patient population, dosing frequency, and dose strength of the aforementioned products. Through this analysis, readers gain insights into the expected clinical and commercial demand for oligonucleotide therapeutics, aiding in strategic planning and decision-making within the industry.

Comprehensive assessment 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.

This section presents a detailed forecast of the oligonucleotide synthesis market to estimate both the current market size and future opportunities over the next 11 years. Leveraging multiple parameters and anticipated adoption trends, we have provided an informed estimate of the market size during the forecast period from 2024 to 2035. These estimations are further validated through primary research and analysis to ensure accuracy and reliability. Through this forecast, readers gain insights into the expected growth trajectory and potential opportunities within the oligonucleotide synthesis market, aiding in strategic planning and decision-making for stakeholders in the industry.

Comprehensive projections of the current and future opportunity within the oligo synthesis market across different application area, such as research and diagnostics, and therapeutics.

Elaborate 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.

Comprehensive 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.

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.

Leading Market Companies

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