Oligonucleotide Synthesis Market by 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 Ot

Oligonucleotide Synthesis Market by 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): Industry Trends and Global Forecasts, Till 2035

OLIGONUCLEOTIDE SYNTHESIS MARKET: OVERVIEW

As per Roots Analysis, the global oligonucleotide synthesis market is estimated to grow from USD 4.8 billion in the current year to USD 13.5 billion by 2035, at a CAGR of 9.9% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

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

OLIGONUCLEOTIDE SYNTHESIS MARKET: GROWTH AND TRENDS

Oligonucleotides are one of the fastest growing segments in the pharmaceutical industry. These molecules are extensively utilized in biopharmaceutical and biotechnology fields for various applications, including research, genetic testing, forensic analysis, and other analytical methods. Currently, researchers are investigating the potential of oligonucleotides as a pharmacological approach for the treatment of a myriad of disease indications. In addition, it is worth noting that close to 300 clinical trials have been registered across different geographical regions to evaluate various oligonucleotides for therapeutic purposes. As the oligonucleotide manufacturing industry advances, numerous automatic oligo synthesizers are being incorporated into large scale production for developing and producing oligonucleotide therapeutics. These synthesizers can execute steps, such as molecule synthesis, removal of protecting groups, purification, desalting and lyophilization, with increased efficiency. However, the challenges associated with oligonucleotide production, including extended timelines, lack of purification techniques, lack of expertise, and regulatory and compliance-related issues among the developers, have driven drug developers to outsource key operations. At present, over 110 oligonucleotide synthesis providers offer custom oligonucleotide synthesis, oligonucleotide modification and oligonucleotide purification services, which are intended for research, diagnostic and therapeutic applications. 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: KEY INSIGHTS

The report delves into the current state of the oligonucleotide synthesis market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, over 110 synthesis providers claim to have the necessary capabilities to offer oligonucleotide synthesis services; the majority of these firms are based in North America.

2. Stakeholders in this domain synthesize various types of oligonucleotides, across different scales of operations; close to 90% of the players offer purification services.

3. In pursuit of building a competitive edge in this field, stakeholders are actively upgrading their existing capabilities and adding new competencies in order to enhance their respective portfolios.

4. Close to 300 clinical trials (with over 75,000 enrolled patients) have been registered to investigate oligonucleotide based-therapeutic products, across different geographies.

5. Since 2017, several deals have been inked between various stakeholders engaged in this domain; acquisitions emerged as the most common type of partnership model.

6. To keep pace with the growing demand for oligonucleotides, companies have made elaborate investments to expand their existing capacities and capabilities; this trend is most pronounced in the US and China.

7. Several big pharma players have undertaken various initiatives, including partnerships, expansions and funding initiatives; 48% of such initiatives were focused on the development and manufacturing of RNAi oligonucleotides.

8. The global, installed oligonucleotide synthesis capacity is spread across various geographies; interestingly, more than 75% of the total capacity is installed at the facilities owned by large and very large players.

9. Given the growing complexity of APIs, the demand for oligonucleotides has upsurged; by 2035, it is anticipated to reach around 2,200 kilograms, across clinical and commercial scales.

10. Considering the wide array of applications of oligonucleotides and the continuous research efforts of stakeholders in this domain, the adoption of these modalities is poised to witness steady growth in the foreseeable future.

11. Driven by the increasing number of chronic indications (requiring novel personalized therapies) and ongoing research on oligonucleotide-based therapeutics, this market is anticipated to grow at a CAGR of 9.9%, till 2035.

12. Over 40% of the market is expected to be captured by revenues generated from manufacturing drugs for rare diseases; further, oligonucleotide synthesis market in China is likely to grow at a faster pace.

OLIGONUCLEOTIDE SYNTHESIS MARKET: KEY SEGMENTS

Currently, the Oligonucleotide Finished Dosage Form holds the Largest Share of the Oligonucleotide Synthesis Market

Based on the type of product synthesized, the market is segmented into active pharmaceutical ingredients and finished dosage forms. It is worth highlighting that the majority of the current oligonucleotide synthesis market is captured by oligonucleotide finished dosage form and this trend is likely to remain same in the coming decade.

Antisense Oligonucleotide is Likely to Dominate the Oligonucleotide Synthesis Market During the Forecast Period

Based on the type of oligonucleotide synthesized, the market is segmented into antisense, DNA, siRNA and other oligonucleotides. It is worth highlighting that siRNA and antisense oligonucleotides-based therapies are likely to grow at a relatively higher CAGR, during the forecast period. This can be attributed to the rising number of approved siRNA and antisense oligonucleotides-based therapies for various rare diseases, genetic disorders and other disorders.

By Scale of Operation, Commercial Scale is Likely to Capture the Larger Share of the Oligonucleotide Synthesis Market During the Forecast Period

Based on scales of operation, the market is segmented into clinical and commercial scale. It is worth highlighting that the commercial scale manufacturing will be the primary driver of the overall market in the coming decade.

Currently, Pharmaceutical and Biopharmaceutical Companies hold the Largest Share within the Oligonucleotide Synthesis Market

Based on end user, the market is segmented into pharmaceutical and biopharmaceutical companies, academic and research institutes, and hospitals. It is worth highlighting that the revenues generated from manufacturing of oligonucleotides by pharmaceutical and biopharmaceutical companies is expected to grow substantially in the coming decade as compared to other end-users.

By Company Size, Mid-Sized Companies are Likely to Grow at a Relatively Higher Pace During the Forecast Period

Based on company size, the market is segmented into small, mid-sized, and large and very large companies. It is worth highlighting that the majority of the current oligonucleotide synthesis market is captured by large and very large players.

Rare Diseases Segment Accounts for the Largest Share for the Oligonucleotide Synthesis Market

Based on therapeutic areas, the market is segmented into cardiovascular disorders, genetic disorders, liver disorders, rare diseases and other disorders. While rare diseases account for a relatively higher market share, it is worth highlighting that cardiovascular disorders segment is expected to witness substantial market growth in the coming years.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. It is worth highlighting that over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Oligonucleotide Synthesis Market

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

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

Founder and Managing Director, BianoGMP

Co-Founder and Managing Director, Hanugen Therapeutics

Chief Scientific Officer and Managing Director, IBA Life Sciences

Chief Scientific Officer, Axolabs

Business Officer, SBS Genetech

Chem Lab Manager, Aptagen

Global Corporate Sales and Business Development, Invitek Diagnostics

OLIGONUCLEOTIDE SYNTHESIS MARKET: RESEARCH COVERAGE

The report features an in-depth analysis of the oligonucleotide synthesis market, focusing on key market segments, including application area, type of product synthesized, type of oligonucleotide synthesized, scale of operation, therapeutic area, end-users, company size and key geographical regions.

The report analyzes various factors such as drivers, restraints, opportunities, and challenges affecting the market growth.

A comprehensive evaluation of companies involved in oligonucleotide synthesis, considering various 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 comprehensive competitive analysis of oligonucleotide synthesis providers, examining factors such as supplier strength (in terms of years of experience), service strength and number of oligonucleotide synthesis facilities.

In-depth profiles of key industry players engaged in oligonucleotide synthesis services, focusing on company overviews, financial information (if available), service portfolio, recent developments and an informed future outlook.

An insightful framework for the make-or-buy decision, emphasizing the key indicators and factors that affect sponsors and developers in determining whether to outsource oligonucleotide manufacturing or develop the means to carry it in-house.

Examination of completed, ongoing, and planned clinical studies based on parameters like 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.

An analysis of partnerships established in this sector, 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.

An examination of the different expansion efforts made by oligonucleotide synthesis providers in this field to enhance their manufacturing capabilities, since 2015. This analysis considers various factors, including the year of expansion, type of expansion, scale of operation, application area, amount invested, area of facility and location of expanded facility.

Assessment of the various oligonucleotide-focused manufacturing initiatives undertaken by big pharma players, based on several relevant 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.

Estimation of global oligonucleotides manufacturing capacity, derived from data provided by various industry stakeholders in the public domain. This analysis emphasizes the distribution of the available capacity on the basis of 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).

Informed estimates of the annual clinical demand for oligonucleotide therapeutics (in terms of target patient population in ongoing and planned clinical trials of oligonucleotide therapeutics). It also includes 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.

KEY QUESTIONS ANSWERED IN THIS REPORT

How many companies are currently engaged in this market?

Which are the leading companies in this market?

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

What kinds of expansion initiatives have been undertaken by industry stakeholders?

What is the current annual demand for oligonucleotides?

What are the factors that are likely to influence the evolution of this market?

What is current and future market size?

What is the CAGR of this market?

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

REASONS TO BUY THIS REPORT

The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.

Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.

The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

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