Roots Analysis has done a detailed study on Oligonucleotide Synthesis Market : Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030.”” covering key aspects of the industry’s evolution and identifying potential future growth opportunities.

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Key Market Insights

• More than 80 companies currently claim to offer manufacturing related services, at different scales of operations, for a variety of oligonucleotide-based products
• A wide range of services related to the synthesis, modification and purification of oligonucleotides, are currently offered within a fragmented service provider landscape that is mostly concentrated in the developed geographies
• In order to cater to the growing needs of clients / sponsors, companies have established presence across different regions; the US and some European nations have emerged as current hubs for oligonucleotide production
• Players involved in this domain are steadily expanding their capabilities in order to enhance their respective service portfolios and thereby, achieve an edge over competing firms
• Service providers are actively investing in expansion projects to upgrade existing capabilities and capacity; several partnerships, mostly focused on offering manufacturing and supply services, have been forged
• Over the past few years, more than 270 trials of oligonucleotide-based interventions, across various phases of development and to treat a diverse range of diseases, have been registered across different centers worldwide
• Most of the global, annual oligonucleotide manufacturing capacity belongs to established service providers, accounting for over 80% of available capacity across various geographies
• The demand for manufacturing of oligonucleotide-based products is expected to increase in the coming years; we believe that the stakeholders may have to expand their respective capacities to ensure consistent supply
• We expect oligonucleotide-based drug developers to continue to outsource their manufacturing operations in the short to mid-term; service-based revenues are estimated to grow at an annualized rate of more than 10%
• In the long-term, the projected opportunity is anticipated to be well distributed across various therapeutic areas, scales of operation and across companies of different sizes
• In order to account for the uncertainties associated with the Oligonucleotide Synthesis Market Growth 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.

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Table of Contents

1. PREFACE

1.1.      Scope of the Report

1.2.      Research Methodology

1.3.      Chapter Outlines

2. 
   EXECUTIVE SUMMARY

3. INTRODUCTION

3.1.      Context and Background

3.2.      Overview of Oligonucleotide-based Products

3.3.      Types of Oligonucleotides

3.3.1.   Antisense Oligonucleotides

3.3.2.   Aptamers

3.3.3.   miRNA

3.3.4.   shRNA

3.3.5.   siRNA

3.3.6.   Other Oligonucleotides

3.4.      Custom Synthesis of Oligonucleotides         

3.4.1.   Process Development and Characterization

3.4.2.   Analytical Method Development

3.4.3.   Method Validation and Testing

3.4.4.   Quality Control and Quality Assurance

3.4.5.   Challenges Associated with Custom Synthesis of Oligonucleotides

3.5.      Chemical Modification of Oligonucleotides

3.5.1.   Backbone Modification

3.5.2.   Sugar Ring Modification

3.6.      Purification of Oligonucleotides

3.6.1.   Desalting

3.6.2.   Cartridge Purification

3.6.3.   Polyacrylamide Gel Electrophoresis (PAGE)

3.6.4.   High Performance Liquid Chromatography (HPLC)

3.7.      Outsourcing Oligonucleotide Manufacturing

3.7.1.   Need for Outsourcing

3.7.2.   Commonly Outsourced Operations

3.7.3.   Advantages of Outsourcing Manufacturing Operations

3.7.4.   Guidelines for Selecting a Service Provider

3.8.      Growth Drivers and Roadblocks to Oligonucleotide Manufacturing

3.9.      Recent Developments and Upcoming Trends

4. MARKET LANDSCAPE: OLIGONUCLEOTIDE MANUFACTURERES (RESEARCH AND DIAGNOSTIC APPLICATIONS)

4.1.      Chapter Overview

4.2.      Oligonucleotide Manufacturers Focused on Research and Diagnostic Applications: Overall Market Landscape

4.2.1.   Analysis by Year of Establishment

4.2.2.   Analysis by Company Size

4.2.3.   Analysis by Scale of Operation

4.2.4.   Analysis by Geographical Location

4.2.5.   Analysis by Location of Manufacturing Facilities

4.2.6.   Analysis by Regulatory Accreditations / Certifications

4.2.7.   Analysis by Type of Oligonucleotide Manufactured

4.2.8.   Analysis by Type of Offering

4.2.9.   Analysis by Type of Manufacturing Service(s) Offered

4.2.10. Analysis by Type of Modification(s) Offered

4.2.11. Analysis by Type of Purification Method(s) Used

4.2.12. Analysis by Compliance to cGMP Standards

5. MARKET LANDSCAPE: OLIGONUCLEOTIDE MANUFACTURERES (THERAPEUTIC APPLICATIONS)

5.1.      Chapter Overview

5.2.      Oligonucleotide Manufacturers Focused on Therapeutic Applications: Overall Market Landscape

5.2.1.   Analysis by Year of Establishment

5.2.2.   Analysis by Company Size

5.2.3.   Analysis by Scale of Operation

5.2.4.   Analysis by Geographical Location

5.2.5.   Analysis by Location of Manufacturing Facilities

5.2.6.   Analysis by Regulatory Accreditations / Certifications

5.2.7.   Analysis by Type of Oligonucleotide Manufactured

5.2.8.   Analysis by Type of Offering

5.2.9.   Analysis by Type of Manufacturing Service(s) Offered

5.2.10. Analysis by Type of Modification(s) Offered

5.2.11. Analysis by Type of Purification Method(s) Used

5.2.12. Analysis by Compliance to cGMP Standards

6. COMPANY COMPETITIVENESS ANALYSIS: OLIGONUCLEOTIDE MANUFACTURES (RESEARCH AND DIAGNOSTIC APPLICATIONS)

6.1.      Chapter Overview

6.2.      Key Assumptions and Methodology

6.3.      Company Competitiveness Analysis: Oligonucleotide Manufacturers Focused on Research and Diagnostic Applications

6.3.1.   Oligonucleotide Manufacturers in North America

6.3.2.   Oligonucleotide Manufacturers in Europe

6.3.3.   Oligonucleotide Manufacturers in Asia-Pacific

7. COMPANY COMPETITIVENESS ANALYSIS: OLIGONUCLEOTIDE MANUFACTURERS (THERAPEUTIC APPLICATIONS)

7.1.      Chapter Overview

7.2.      Key Assumptions and Methodology

7.3.      Company Competitiveness Analysis: Oligonucleotide Manufacturers Focused on Therapeutic Applications

7.3.1.   Oligonucleotide Manufacturers in North America

7.3.2.   Oligonucleotide Manufacturers in Europe

7.3.3.   Oligonucleotide Manufacturers in Asia-Pacific

8. COMPANY PROFILES: OLIGONUCLEOTIDE MANUFACTURERS (RESEARCH AND DIAGNOSTIC APPLICATIONS)

8.1.      Chapter Overview

8.2.      Ajinomoto Bio-Pharma Services

8.2.1.   Company Overview

8.2.2.   Service Portfolio

8.2.3.   Manufacturing Facilities and Capabilities

8.2.4.   Recent Developments and Future Outlook

8.3.      Integrated DNA Technologies

8.3.1.   Company Overview

8.3.2.   Service Portfolio

8.3.3.   Manufacturing Facilities and Capabilities

8.3.4.   Recent Developments and Future Outlook

8.4.      Kaneka Eurogentec

8.4.1.   Company Overview

8.4.2.   Service Portfolio

8.4.3.   Manufacturing Facilities and Capabilities

8.4.4.   Recent Developments and Future Outlook

8.5.      LGC Biosearch Technologies

8.5.1.   Company Overview

8.5.2.   Service Portfolio

8.5.3.   Manufacturing Facilities and Capabilities

8.5.4.   Recent Developments and Future Outlook

8.6.      Microsynth

8.6.1.   Company Overview

8.6.2.   Service Portfolio

8.6.3.   Manufacturing Facilities and Capabilities

8.6.4.   Recent Developments and Future Outlook

8.7.      Sigma Aldrich

8.7.1.   Company Overview

8.7.2.   Financial Information

8.7.3.   Service Portfolio

8.7.4.   Manufacturing Facilities and Capabilities

8.7.5.   Recent Developments and Future Outlook

8.8.      Thermo Fisher Scientific

8.8.1.   Company Overview

8.8.2.   Financial Information

8.8.3.   Service Portfolio

8.8.4.   Manufacturing Facilities and Capabilities

8.8.5.   Recent Developments and Future Outlook

9. COMPANY PROFILES: OLIGONUCLEOTIDE MANUFACTURERS (THERAPEUTIC APPLICATIONS)

9.1.      Chapter Overview

9.2.      Agilent Technologies

9.2.1.   Company Overview

9.2.2.   Financial Information

9.2.3.   Service Portfolio

9.2.4.   Manufacturing Facilities and Capabilities

9.2.5.   Recent Developments and Future Outlook

9.3.      BioSpring

9.3.1.   Company Overview

9.3.2.   Service Portfolio

9.3.3.   Manufacturing Facilities and Capabilities

9.3.4.   Recent Developments and Future Outlook

9.4.      CordenPharma

9.4.1.   Company Overview

9.4.2.   Service Portfolio

9.4.3.   Manufacturing Facilities and Capabilities

9.4.4.   Recent Developments and Future Outlook

9.5.      Nitto Denko Avecia

9.5.1.   Company Overview

9.5.2.   Service Portfolio

9.5.3.   Manufacturing Facilities and Capabilities

9.5.4.   Recent Developments and Future Outlook

9.6.      TriLink Biotechnologies

9.6.1.   Company Overview

9.6.2.   Service Portfolio

9.6.3.   Manufacturing Facilities and Capabilities

9.6.4.   Recent Developments and Future Outlook

10. PARTNERSHIPS AND COLLABORATIONS

10.1.    Chapter Overview

10.2.    Partnership Models

10.3.    Oligonucleotide Manufacturers: Recent Partnerships and Collaborations

10.3.1. Analysis by Year of Partnership

10.3.2. Analysis by Type of Partnership

10.3.3. Analysis by Type of Partner

10.3.4. Most Active Players: Analysis by Number of Partnerships

10.3.5. Geographical Analysis

10.3.5.1. Most Active Players: Geographical Distribution by Number of Partnerships

10.3.5.2. Intercontinental and Intracontinental Agreements             

11. RECENT EXPANSIONS

11.1.    Chapter Overview

11.2.    Oligonucleotide Manufacturers: Recent Expansions

11.2.1. Analysis by Year of Expansion

11.2.2. Analysis by Type of Expansion

11.2.3. Analysis by Application

11.2.4. Analysis by Location of Facility

11.2.5. Analysis by Expanded Facility Area

11.2.6. Analysis by Expanded Scale of Operation

11.3.7. Most Active Players: Analysis by Number of Expansions

11.3.8. Geographical Analysis

11.3.8.1. Continent-wise Distribution

11.3.8.2. Country-wise Distribution              

12. CLINICAL TRIAL ANALYSIS

12.1.    Chapter Overview

12.2.    Scope and Methodology

12.3.    Clinical Trial Analysis: Oligonucleotide-based Drug Products

12.3.1. Analysis by Trial Registration Year

12.3.2. Analysis by Phase of Development

12.3.3. Analysis by Type of Oligonucleotide

12.3.4. Analysis by Type of Oligonucleotide and Phase of Development

12.3.5. Analysis by Trial Recruitment Status

12.3.6. Analysis by Trial Focus Area

12.3.7. Analysis by Target Therapeutic Area            

12.3.8. Geographical Analysis by Number of Clinical Trials

12.3.9. Geographical Analysis by Enrolled Patient Population

12.3.10. Analysis by Type of Sponsor / Collaborator

12.3.11. Most Active Players: Analysis by Number of Registered Trials

13. CAPACITY ANALYSIS

13.1.    Chapter Overview

13.2.    Key Assumptions and Methodology

13.3.    Oligonucleotide Manufacturers: Global, Annual Capacity

13.3.1. Analysis by Size of Manufacturer

13.3.2. Analysis by Scale of Operation

13.3.3. Analysis by Location of Manufacturing Facility

14. DEMAND ANALYSIS

14.1.    Chapter Overview

14.2.    Key Assumptions and Methodology

14.3.    Global Demand for Oligonucleotide Manufacturing

14.3.1. Global Commercial Demand for Oligonucleotide Manufacturing

14.3.1.1. Analysis by Type of Oligonucleotide

14.3.1.2. Analysis by Target Therapeutic Area

14.3.1.3. Analysis by Geography

14.3.2. Global Clinical Demand for Oligonucleotide Manufacturing

14.3.2.1. Analysis by Type of Oligonucleotide

14.3.2.2. Analysis by Phase of Development

14.3.2.3. Analysis by Target Therapeutic Area

14.3.2.4. Analysis by Geography

14.4.    Demand and Supply Analysis

14.4.1. Demand and Supply Analysis (Scenario 1)

14.4.2. Demand and Supply Analysis (Scenario 2)

14.4.3. Demand and Supply Analysis (Scenario 3)

15. MARKET SIZING AND OPPORTUNITY ANALYSIS

15.1.    Chapter Overview

15.2.    Key Assumptions and Forecast Methodology

15.3.    Overall Oligonucleotide Manufacturing Market, 2020-2030

15.4.    Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Type of Manufacturing

15.4.1. Custom Oligonucleotide Manufacturing Market, 2020-2030

15.4.2. Large-scale Oligonucleotide Manufacturing Market, 2020-2030

15.4.2.1 Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Type of Oligonucleotide Manufactured

15.4.2.1.1. Oligonucleotide Manufacturing Market for Antisense Oligonucleotides, 2020-2030

15.4.2.1.2. Oligonucleotide Manufacturing Market for miRNA, 2020-2030

15.4.2.1.3. Oligonucleotide Manufacturing Market for shRNA, 2020-2030

15.4.2.1.4. Oligonucleotide Manufacturing Market for siRNA, 2020-2030

15.4.2.1.5. Oligonucleotide Manufacturing Market for Other Oligonucleotides, 2020-2030

15.4.2.2. Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Scale of Operation

15.4.2.2.1. Oligonucleotide Manufacturing Market for Clinical Scale Operations, 2020-2030

15.4.2.2.2. Oligonucleotide Manufacturing Market for Commercial Scale Operations, 2020-2030

15.4.2.3. Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Purpose of Production

15.4.2.3.1. Oligonucleotide Manufacturing Market for In-House Operations, 2020-2030

15.4.2.3.2. Oligonucleotide Manufacturing Market for Outsourced Operations, 2020-2030

15.4.2.4. Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Target Therapeutic Area

15.4.2.4.1. Oligonucleotide Manufacturing Market for Autoimmune Disorders, 2020-2030

15.4.2.4.2. Oligonucleotide Manufacturing Market for Cardiovascular Disorders, 2020-2030

15.4.2.4.3. Oligonucleotide Manufacturing Market for Genetic Disorders, 2020-2030

15.4.2.4.4. Oligonucleotide Manufacturing Market for Infectious Diseases, 2020-2030

15.4.2.4.5. Oligonucleotide Manufacturing Market for Metabolic Disorders, 2020-2030

15.4.2.4.6. Oligonucleotide Manufacturing Market for Neuromuscular Disorders, 2020-2030

15.4.2.4.7. Oligonucleotide Manufacturing Market for Oncological Disorders, 2020-2030

15.4.2.4.8. Oligonucleotide Manufacturing Market for Ophthalmic Disorders, 2020-2030

15.4.2.4.9. Oligonucleotide Manufacturing Market for Other Therapeutic Areas, 2020-2030

15.4.2.5. Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Size of Manufacturer

15.4.2.5.1. Oligonucleotide Manufacturing Market for Small Companies, 2020-2030

15.4.2.5.2. Oligonucleotide Manufacturing Market for Mid-sized Companies, 2020-2030

15.4.2.5.3. Oligonucleotide Manufacturing Market for Large Companies, 2020-2030

15.4.2.6. Oligonucleotide Manufacturing Market, 2020-2030: Analysis by Geography

15.4.2.6.1. Oligonucleotide Manufacturing Market in North America, 2020-2030

15.4.2.6.2. Oligonucleotide Manufacturing Market in Europe, 2020-2030

15.4.2.6.3. Oligonucleotide Manufacturing Market in Asia-Pacific and Rest of the World, 2020-2030

16. SWOT ANALYSIS

16.1.    Chapter Overview

16.2.    Comparison of SWOT Factors

17. SURVEY ANALYSIS

17.1.    Chapter Overview

17.2.    Overview of Respondents

17.2.1. Seniority Level of Respondents

17.3.    Survey Insights          

17.3.1. Type of Offering

17.3.2. Application

17.3.3. Manufacturing Capacity        

17.3.4. Location of Manufacturing Facilities

17.3.5. Extent of Outsourcing

17.3.6. Current Market Opportunity              

18. EXECUTIVE INSIGHTS            

18.1.    Chapter Overview

18.2.    BianoScience

18.2.1. Company Snapshot

18.2.2. Interview Transcript: Tobias Pohlmann, Founder and Managing Director

18.3.    IBA Life Sciences

18.3.1. Company Snapshot

18.3.2. Interview Transcript: Joachim Bertram, Chief Scientific Officer and Managing Director          

19. CONCLUDING REMARKS

19.1.    Chapter Overview

19.2.    Key Takeaways

20. APPENDIX 1: TABULATED DATA

21. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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