Roots Analysis

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
   • Scope of the Report
   • Research Methodology
   • Chapter Outlines
2. EXECUTIVE SUMMARY
3. INTRODUCTION
   • Context and Background
   • Overview of Oligonucleotide-based Products
   • Types of Oligonucleotides
     • Antisense Oligonucleotides
     • Aptamers
     • miRNA
     • shRNA
     • siRNA
     • Other Oligonucleotides
   • Custom Synthesis of Oligonucleotides
     • Process Development and Characterization
     • Analytical Method Development
     • Method Validation and Testing
     • Quality Control and Quality Assurance
     • Challenges Associated with Custom Synthesis of Oligonucleotides
   • Chemical Modification of Oligonucleotides
     • Backbone Modification
     • Sugar Ring Modification
   • Purification of Oligonucleotides
     • Desalting
     • Cartridge Purification
     • Polyacrylamide Gel Electrophoresis (PAGE)
     • High Performance Liquid Chromatography (HPLC)
   • Outsourcing Oligonucleotide Manufacturing
     • Need for Outsourcing
     • Commonly Outsourced Operations
     • Advantages of Outsourcing Manufacturing Operations
     • Guidelines for Selecting a Service Provider
   • Growth Drivers and Roadblocks to Oligonucleotide Manufacturing
   • Recent Developments and Upcoming Trends
4. MARKET LANDSCAPE: OLIGONUCLEOTIDE MANUFACTURERES (RESEARCH AND DIAGNOSTIC APPLICATIONS)
   • Chapter Overview
   • Oligonucleotide Manufacturers Focused on Research and Diagnostic Applications: Overall Market Landscape
     • Analysis by Year of Establishment
     • Analysis by Company Size
     • Analysis by Scale of Operation
     • Analysis by Geographical Location
     • Analysis by Location of Manufacturing Facilities
     • Analysis by Regulatory Accreditations / Certifications
     • Analysis by Type of Oligonucleotide Manufactured
     • Analysis by Type of Offering
     • Analysis by Type of Manufacturing Service(s) Offered
     • Analysis by Type of Modification(s) Offered
     • Analysis by Type of Purification Method(s) Used
     • Analysis by Compliance to cGMP Standards

1. MARKET LANDSCAPE: OLIGONUCLEOTIDE MANUFACTURERES (THERAPEUTIC APPLICATIONS)
   • Chapter Overview
   • Oligonucleotide Manufacturers Focused on Therapeutic Applications: Overall Market Landscape
     • Analysis by Year of Establishment
     • Analysis by Company Size
     • Analysis by Scale of Operation
     • Analysis by Geographical Location
     • Analysis by Location of Manufacturing Facilities
     • Analysis by Regulatory Accreditations / Certifications
     • Analysis by Type of Oligonucleotide Manufactured
     • Analysis by Type of Offering
     • Analysis by Type of Manufacturing Service(s) Offered
     • Analysis by Type of Modification(s) Offered
     • Analysis by Type of Purification Method(s) Used
     • Analysis by Compliance to cGMP Standards

1. COMPANY COMPETITIVENESS ANALYSIS: OLIGONUCLEOTIDE MANUFACTURES (RESEARCH AND DIAGNOSTIC APPLICATIONS)
   • Chapter Overview
   • Key Assumptions and Methodology
   • Company Competitiveness Analysis: Oligonucleotide Manufacturers Focused on Research and Diagnostic Applications
     • Oligonucleotide Manufacturers in North America
     • Oligonucleotide Manufacturers in Europe
     • Oligonucleotide Manufacturers in Asia-Pacific

1. COMPANY COMPETITIVENESS ANALYSIS: OLIGONUCLEOTIDE MANUFACTURERS (THERAPEUTIC APPLICATIONS)
   • Chapter Overview
   • Key Assumptions and Methodology
   • Company Competitiveness Analysis: Oligonucleotide Manufacturers Focused on Therapeutic Applications
     • Oligonucleotide Manufacturers in North America
     • Oligonucleotide Manufacturers in Europe
     • Oligonucleotide Manufacturers in Asia-Pacific

1. COMPANY PROFILES: OLIGONUCLEOTIDE MANUFACTURERS (RESEARCH AND DIAGNOSTIC APPLICATIONS)
   • Chapter Overview
   • Ajinomoto Bio-Pharma Services
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Integrated DNA Technologies
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Kaneka Eurogentec
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • LGC Biosearch Technologies
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Microsynth
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Sigma Aldrich
     • Company Overview
     • Financial Information
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Thermo Fisher Scientific
     • Company Overview
     • Financial Information
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook

1. COMPANY PROFILES: OLIGONUCLEOTIDE MANUFACTURERS (THERAPEUTIC APPLICATIONS)
   • Chapter Overview
   • Agilent Technologies
     • Company Overview
     • Financial Information
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • BioSpring
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • CordenPharma
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • Nitto Denko Avecia
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • TriLink Biotechnologies
     • Company Overview
     • Service Portfolio
     • Manufacturing Facilities and Capabilities
     • Recent Developments and Future Outlook
   • PARTNERSHIPS AND COLLABORATIONS
     • Chapter Overview
     • Partnership Models
     • Oligonucleotide Manufacturers: Recent Partnerships and Collaborations
       • Analysis by Year of Partnership
       • Analysis by Type of Partnership
       • Analysis by Type of Partner
       • Most Active Players: Analysis by Number of Partnerships
       • Geographical Analysis
         • Most Active Players: Geographical Distribution by Number of Partnerships
         • Intercontinental and Intracontinental Agreements
       • RECENT EXPANSIONS
         • Chapter Overview
         • Oligonucleotide Manufacturers: Recent Expansions
           • Analysis by Year of Expansion
           • Analysis by Type of Expansion
           • Analysis by Application
           • Analysis by Location of Facility
           • Analysis by Expanded Facility Area
           • 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              

• CLINICAL TRIAL ANALYSIS
  • Chapter Overview
  • Scope and Methodology
  • Clinical Trial Analysis: Oligonucleotide-based Drug Products
    • Analysis by Trial Registration Year
    • Analysis by Phase of Development
    • Analysis by Type of Oligonucleotide
    • Analysis by Type of Oligonucleotide and Phase of Development
    • Analysis by Trial Recruitment Status
    • Analysis by Trial Focus Area
    • Analysis by Target Therapeutic Area
    • Geographical Analysis by Number of Clinical Trials
    • Geographical Analysis by Enrolled Patient Population
    • Analysis by Type of Sponsor / Collaborator
    • Most Active Players: Analysis by Number of Registered Trials
  • CAPACITY ANALYSIS
    • Chapter Overview
    • Key Assumptions and Methodology
    • Oligonucleotide Manufacturers: Global, Annual Capacity
      • Analysis by Size of Manufacturer
      • Analysis by Scale of Operation
      • Analysis by Location of Manufacturing Facility
    • DEMAND ANALYSIS
      • Chapter Overview
      • Key Assumptions and Methodology
      • Global Demand for Oligonucleotide Manufacturing
        • Global Commercial Demand for Oligonucleotide Manufacturing
          • Analysis by Type of Oligonucleotide
          • Analysis by Target Therapeutic Area
          • Analysis by Geography
        • Global Clinical Demand for Oligonucleotide Manufacturing
          • Analysis by Type of Oligonucleotide
          • Analysis by Phase of Development
          • Analysis by Target Therapeutic Area
          • Analysis by Geography
        • Demand and Supply Analysis
          • Demand and Supply Analysis (Scenario 1)
          • Demand and Supply Analysis (Scenario 2)
          • Demand and Supply Analysis (Scenario 3)

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Gaurav Chaudhary

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Gaurav.Chaudhary@rootsanalysis.com