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Roots Analysis has done a detailed study on “Oligonucleotide Synthesis, Modification and Purification Services Market: Focus on Research, Diagnostic and Therapeutic Applications, 2020-2030” covering key aspects of the industry’s evolution and identifying potential future growth opportunities.
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
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)
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Gaurav.Chaudhary@rootsanalysis.com