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Oligonucleotide Therapeutics Market, Analysis and Forecast: 2025-2035

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    Report

  • March 2025
  • Region: Global
  • BIS Research
  • ID: 6054261
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Technological advancements play a pivotal role in market expansion. Innovations in drug synthesis and delivery mechanisms have led to improved production efficiency, higher purity, and greater stability of oligonucleotide drugs. Enhanced delivery systems ensure that these therapies reach their intended targets more effectively, thereby increasing their clinical success. In a way, these technological improvements mirror the evolution of digital content strategies where refined processes lead to more efficient production and better audience engagement, ultimately driving overall growth.

A surge in product launches and regulatory approvals is creating momentum that is expected to drive significant growth in the oligonucleotide drug market. For instance, in February 2021, the USFDA approved the Amondys 45 (casimersen) injection as a treatment for Duchenne muscular dystrophy (DMD) in patients with a confirmed DMD gene mutation demonstrating the potential of these innovative therapies.

Additionally, the rising incidence of genetic disorders, such as cystic fibrosis, Huntington’s disease, and muscular dystrophy, is a significant driver for the oligonucleotide therapeutics market. According to the data published by Genetics in Medicine approximately 3.5% to 5.9% of individuals worldwide are affected by one of approximately 7,000 rare or genetic conditions. As genetic diseases become more prevalent, the demand for targeted therapies grows. Advances in genomics and personalized medicine allow for the development of treatments that specifically target genetic anomalies, leading to better patient outcomes. Consequently, pharmaceutical companies are investing heavily in research and development to create oligonucleotide-based therapies, spurred by the need to address unmet medical needs, ultimately propelling market growth.

In addition, to ongoing clinical advancements, rising R&D investments, and increasing acceptance of oligonucleotide-based therapies, the market is expected to witness strong growth in the coming years. The potential for personalized medicine, targeted gene therapies, and improved drug delivery technologies will continue to shape the future of the oligonucleotide therapeutics market, offering new treatment options for patients with previously untreatable genetic and chronic diseases.

However, a major challenge in the oligonucleotide therapeutics market is the efficient delivery of these drugs to target cells. Oligonucleotides like antisense oligonucleotides (ASOs) and siRNAs are unstable in the bloodstream and prone to degradation. Developing effective delivery systems, such as lipid nanoparticles (LNPs) or viral vectors, remains difficult and costly, limiting the widespread use of oligonucleotide therapies.

Key players in the oligonucleotide therapeutics market are actively advancing the field through various initiatives and collaborations. In November 2024, Arrowhead Pharmaceuticals and Sarepta Therapeutics entered into an $11.38 billion licensing deal over five years. This agreement includes an upfront payment and equity investment, with additional performance-related payments, to advance gene-silencing products, potentially incorporating oligonucleotide therapeutics. Adding to this, in December 2024, Ionis Pharmaceuticals secured FDA approval for Tryngolza (olezarsen), a treatment for familial chylomicronemia syndrome (FCS). This approval marks a significant milestone for Ionis as it prepares for its first independent drug launch, emphasizing the growing acceptance of oligonucleotide therapies in clinical practice.

Key players in the market are Sarepta Therapeutics., Alnylam Pharmaceuticals, Inc., Novartis, Nippon Shinyaku Co., Ltd., Ionis Pharmaceuticals., Biogen, Jazz Pharmaceuticals, Akcea Therapeutics, miRaX Therapeutics, Resalis Therapeutics, Stoke Therapeutics, Dyne Therapeutics, and ProQR Therapeutics, etc.

Market Segmentation:

Segmentation 1: by Therapy Type

  • Antisense Oligonucleotides (ASOs)
  • RNA Interference (RNAi) Therapeutics
  • Aptamers
  • CpG Oligonucleotides
  • Guide RNA (gRNA)
  • Others

Segmentation 2: by Application Type

  • Oncology
  • Infectious Diseases
  • Cardiovascular Diseases
  • Neurological Disorders
  • Genetic Disorders
  • Others

Segmentation 3: by Route of Administration

  • Subcutaneous
  • Intravenous
  • Intramuscular
  • Others

Segmentation 4: by Clinical Phase

  • Clinical Phase
  • Approved Therapies

Segmentation 5: by Delivery Method

  • In Vivo Delivery
  • Ex Vivo Delivery

Segmentation 6: by Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East and Africa

North America to Lead the Global Oligonucleotide Therapeutics Market (by Region)

North America is poised to lead the global oligonucleotide therapeutics market, driven by a confluence of advanced research infrastructure, substantial R&D investments, and a robust regulatory environment. The region benefits from a dense network of biotechnology firms, academic research institutions, and clinical trial centers, which together foster rapid innovation and swift translation from laboratory discoveries to market-ready therapies. With the U.S. playing a pivotal role, supported by agencies such as the FDA that streamline approval processes for novel therapeutics, North America has consistently demonstrated its ability to accelerate clinical development and commercial success.

This product will be updated with the latest data at the time of order. Consequently, dispatch time for this product will be 7-10 business days.

Table of Contents

1. Market
1.1 Market Outlook
1.1.1 Definitions
1.1.2 Inclusion and Exclusion Criteria
1.1.3 Key Findings
1.1.4 Market Growth Scenario
1.1.4.1 Realistic Scenario
1.1.4.2 Optimistic Scenario
1.1.4.3 Pessimistic Scenario
1.2 Industry Outlook
1.2.1 Market Overview and Ecosystem
1.2.2 Key Trends
1.2.3 Opportunity Assessment
1.2.4 Product Benchmarking
1.2.5 Regulatory Landscape / Compliances
1.3 Business Dynamics
1.3.1 Business Drivers
1.3.1.1 Impact Analysis
1.3.2 Business Restraints
1.3.2.1 Impact Analysis
1.3.3 Business Opportunities
2. Global Oligonucleotide Therapeutics Market by Therapy Type
2.1 Overview
2.2 Growth Share Matrix
2.2.1 Antisense Oligonucleotides (ASOs)
2.2.2 RNA Interference (RNAi) Therapeutics
2.2.3 Aptamers
2.2.4 CpG Oligonucleotides
2.2.5 Guide RNA (gRNA)
2.2.6 Others
3. Global Oligonucleotide Therapeutics Market by Application Type
3.1 Overview
3.2 Growth Share Matrix
3.2.1 Oncology
3.2.2 Infectious Diseases
3.2.3 Cardiovascular Diseases
3.2.4 Neurological Disorders
3.2.5 Genetic Disorders
3.2.6 Others
4. Global Oligonucleotide Therapeutics Market by Route of Administration
4.1 Overview
4.2 Growth Share Matrix
4.2.1 Subcutaneous
4.2.2 Intravenous
4.2.3 Intramuscular
4.2.4 Others
5. Global Oligonucleotide Therapeutics Market by Clinical Phase
5.1 Overview
5.2 Growth Share Matrix
5.2.1 Clinical Phase
5.2.1.1 Preclinical
5.2.1.2 Phase 1
5.2.1.3 Phase 2
5.2.1.4 Phase 3
5.2.2 Approved Therapie
6. Global Oligonucleotide Therapeutics Market by Delivery Method
6.1 Overview
6.2 Growth Share Matrix
6.2.1 In Vivo Delivery
6.2.2 Ex Vivo Delivery
7. Global Oligonucleotide Therapeutics Market by Geography
7.1 Overview
7.2 Growth Share Matrix
7.2.1 North America
7.2.2 Europe
7.2.3 Asia Pacific
7.2.4 Latin America
7.2.5 Middle East and Africa (MEA)
7.3 North America Oligonucleotide Therapeutics Market
7.3.1 U.S.
7.3.1.1 U.S. Market by Therapy Type
7.3.1.1.1 Antisense Oligonucleotides (ASOs)
7.3.1.1.2 RNA Interference (RNAi) Therapeutics
7.3.1.1.3 Aptamers
7.3.1.1.4 CpG Oligonucleotides
7.3.1.1.5 Others
7.3.1.2 U.S. Market by Application
7.3.1.2.1 Oncology
7.3.1.2.2 Infectious Diseases
7.3.1.2.3 Cardiovascular Diseases
7.3.1.2.4 Neurological Disorders
7.3.1.2.5 Genetic Disorders
7.3.1.2.6 Others
7.3.2 Canada
7.3.2.1 Canada Market by Therapy Type
7.3.2.1.1 Antisense Oligonucleotides (ASOs)
7.3.2.1.2 RNA Interference (RNAi) Therapeutics
7.3.2.1.3 Aptamers
7.3.2.1.4 CpG Oligonucleotides
7.3.2.1.5 Others
7.3.2.2 Canada Market by Application
7.3.2.2.1 Oncology
7.3.2.2.2 Infectious Diseases
7.3.2.2.3 Cardiovascular Diseases
7.3.2.2.4 Neurological Disorders
7.3.2.2.5 Genetic Disorders
7.3.2.2.6 Others
7.4 Europe Oligonucleotide Therapeutics Market
7.4.1 U.K.
7.4.1.1 U.K. Market by Therapy Type
7.4.1.1.1 Antisense Oligonucleotides (ASOs)
7.4.1.1.2 RNA Interference (RNAi) Therapeutics
7.4.1.1.3 Aptamers
7.4.1.1.4 CpG Oligonucleotides
7.4.1.1.5 Others
7.4.1.2 U.K. Market by Application
7.4.1.2.1 Oncology
7.4.1.2.2 Infectious Diseases
7.4.1.2.3 Cardiovascular Diseases
7.4.1.2.4 Neurological Disorders
7.4.1.2.5 Genetic Disorders
7.4.1.2.6 Others
7.4.2 Germany
7.4.2.1 Germany Market by Therapy Type
7.4.2.1.1 Antisense Oligonucleotides (ASOs)
7.4.2.1.2 RNA Interference (RNAi) Therapeutics
7.4.2.1.3 Aptamers
7.4.2.1.4 CpG Oligonucleotides
7.4.2.1.5 Others
7.4.2.2 Germany Market by Application
7.4.2.2.1 Oncology
7.4.2.2.2 Infectious Diseases
7.4.2.2.3 Cardiovascular Diseases
7.4.2.2.4 Neurological Disorders
7.4.2.2.5 Genetic Disorders
7.4.2.2.6 Others
7.4.3 France
7.4.3.1 France Market by Therapy Type
7.4.3.1.1 Antisense Oligonucleotides (ASOs)
7.4.3.1.2 RNA Interference (RNAi) Therapeutics
7.4.3.1.3 Aptamers
7.4.3.1.4 CpG Oligonucleotides
7.4.3.1.5 Others
7.4.3.2 France Market by Application
7.4.3.2.1 Oncology
7.4.3.2.2 Infectious Diseases
7.4.3.2.3 Cardiovascular Diseases
7.4.3.2.4 Neurological Disorders
7.4.3.2.5 Genetic Disorders
7.4.3.2.6 Others
7.4.4 Italy
7.4.4.1 Italy Market by Therapy Type
7.4.4.1.1 Antisense Oligonucleotides (ASOs)
7.4.4.1.2 RNA Interference (RNAi) Therapeutics
7.4.4.1.3 Aptamers
7.4.4.1.4 CpG Oligonucleotides
7.4.4.1.5 Others
7.4.4.2 Italy Market by Application
7.4.4.2.1 Oncology
7.4.4.2.2 Infectious Diseases
7.4.4.2.3 Cardiovascular Diseases
7.4.4.2.4 Neurological Disorders
7.4.4.2.5 Genetic Disorders
7.4.4.2.6 Others
7.4.5 Spain
7.4.5.1 Spain Market by Therapy Type
7.4.5.1.1 Antisense Oligonucleotides (ASOs)
7.4.5.1.2 RNA Interference (RNAi) Therapeutics
7.4.5.1.3 Aptamers
7.4.5.1.4 CpG Oligonucleotides
7.4.5.1.5 Others
7.4.5.2 Spain Market by Application
7.4.5.2.1 Oncology
7.4.5.2.2 Infectious Diseases
7.4.5.2.3 Cardiovascular Diseases
7.4.5.2.4 Neurological Disorders
7.4.5.2.5 Genetic Disorders
7.4.5.2.6 Others
7.4.6 Rest of Europe
7.4.6.1 Rest of Europe Market by Therapy Type
7.4.6.1.1 Antisense Oligonucleotides (ASOs)
7.4.6.1.2 RNA Interference (RNAi) Therapeutics
7.4.6.1.3 Aptamers
7.4.6.1.4 CpG Oligonucleotides
7.4.6.1.5 Others
7.4.6.2 Rest of Europe Market by Application
7.4.6.2.1 Oncology
7.4.6.2.2 Infectious Diseases
7.4.6.2.3 Cardiovascular Diseases
7.4.6.2.4 Neurological Disorders
7.4.6.2.5 Genetic Disorders
7.4.6.2.6 Others
7.5 Asia Pacific Oligonucleotide Therapeutics Market
7.5.1 Japan
7.5.1.1 Japan Market by Therapy Type
7.5.1.1.1 Antisense Oligonucleotides (ASOs)
7.5.1.1.2 RNA Interference (RNAi) Therapeutics
7.5.1.1.3 Aptamers
7.5.1.1.4 CpG Oligonucleotides
7.5.1.1.5 Others
7.5.1.2 Japan Market by Application
7.5.1.2.1 Oncology
7.5.1.2.2 Infectious Diseases
7.5.1.2.3 Cardiovascular Diseases
7.5.1.2.4 Neurological Disorders
7.5.1.2.5 Genetic Disorders
7.5.1.2.6 Others
7.5.2 China
7.5.2.1 China Market by Therapy Type
7.5.2.1.1 Antisense Oligonucleotides (ASOs)
7.5.2.1.2 RNA Interference (RNAi) Therapeutics
7.5.2.1.3 Aptamers
7.5.2.1.4 CpG Oligonucleotides
7.5.2.1.5 Others
7.5.2.2 China Market by Application
7.5.2.2.1 Oncology
7.5.2.2.2 Infectious Diseases
7.5.2.2.3 Cardiovascular Diseases
7.5.2.2.4 Neurological Disorders
7.5.2.2.5 Genetic Disorders
7.5.2.2.6 Others
7.5.3 India
7.5.3.1 India Market by Therapy Type
7.5.3.1.1 Antisense Oligonucleotides (ASOs)
7.5.3.1.2 RNA Interference (RNAi) Therapeutics
7.5.3.1.3 Aptamers
7.5.3.1.4 CpG Oligonucleotides
7.5.3.1.5 Others
7.5.3.2 India Market by Application
7.5.3.2.1 Oncology
7.5.3.2.2 Infectious Diseases
7.5.3.2.3 Cardiovascular Diseases
7.5.3.2.4 Neurological Disorders
7.5.3.2.5 Genetic Disorders
7.5.3.2.6 Others
7.5.4 Rest of Asia Pacific
7.5.4.1 Rest of Asia Pacific Market by Therapy Type
7.5.4.1.1 Antisense Oligonucleotides (ASOs)
7.5.4.1.2 RNA Interference (RNAi) Therapeutics
7.5.4.1.3 Aptamers
7.5.4.1.4 CpG Oligonucleotides
7.5.4.1.5 Others
7.5.4.2 Rest of Asia Pacific Market by Application
7.5.4.2.1 Oncology
7.5.4.2.2 Infectious Diseases
7.5.4.2.3 Cardiovascular Diseases
7.5.4.2.4 Neurological Disorders
7.5.4.2.5 Genetic Disorders
7.5.4.2.6 Others
7.6 Latin America Oligonucleotide Therapeutics Market
7.6.1 Brazil
7.6.1.1 Brazil Market by Therapy Type
7.6.1.1.1 Antisense Oligonucleotides (ASOs)
7.6.1.1.2 RNA Interference (RNAi) Therapeutics
7.6.1.1.3 Aptamers
7.6.1.1.4 CpG Oligonucleotides
7.6.1.1.5 Others
7.6.1.2 Brazil Market by Application
7.6.1.2.1 Oncology
7.6.1.2.2 Infectious Diseases
7.6.1.2.3 Cardiovascular Diseases
7.6.1.2.4 Neurological Disorders
7.6.1.2.5 Genetic Disorders
7.6.1.2.6 Others
7.6.2 Mexico
7.6.2.1 Mexico Market by Therapy Type
7.6.2.1.1 Antisense Oligonucleotides (ASOs)
7.6.2.1.2 RNA Interference (RNAi) Therapeutics
7.6.2.1.3 Aptamers
7.6.2.1.4 CpG Oligonucleotides
7.6.2.1.5 Others
7.6.2.2 Mexico Market by Application
7.6.2.2.1 Oncology
7.6.2.2.2 Infectious Diseases
7.6.2.2.3 Cardiovascular Diseases
7.6.2.2.4 Neurological Disorders
7.6.2.2.5 Genetic Disorders
7.6.2.2.6 Others
7.6.3 Rest of Latin America
7.6.3.1 Rest of Latin America Market by Therapy Type
7.6.3.1.1 Antisense Oligonucleotides (ASOs)
7.6.3.1.2 RNA Interference (RNAi) Therapeutics
7.6.3.1.3 Aptamers
7.6.3.1.4 CpG Oligonucleotides
7.6.3.1.5 Others
7.6.3.2 Rest of Latin America Market by Application
7.6.3.2.1 Oncology
7.6.3.2.2 Infectious Diseases
7.6.3.2.3 Cardiovascular Diseases
7.6.3.2.4 Neurological Disorders
7.6.3.2.5 Genetic Disorders
7.6.3.2.6 Others
7.7 MEA Oligonucleotide Therapeutics Market
7.7.1 GCC Countries
7.7.1.1 GCC Countries Market by Therapy Type
7.7.1.1.1 Antisense Oligonucleotides (ASOs)
7.7.1.1.2 RNA Interference (RNAi) Therapeutics
7.7.1.1.3 Aptamers
7.7.1.1.4 CpG Oligonucleotides
7.7.1.1.5 Others
7.7.1.2 GCC Countries Market by Application
7.7.1.2.1 Oncology
7.7.1.2.2 Infectious Diseases
7.7.1.2.3 Cardiovascular Diseases
7.7.1.2.4 Neurological Disorders
7.7.1.2.5 Genetic Disorders
7.7.1.2.6 Others
7.7.2 South Africa
7.7.2.1 South Africa Market by Therapy Type
7.7.2.1.1 Antisense Oligonucleotides (ASOs)
7.7.2.1.2 RNA Interference (RNAi) Therapeutics
7.7.2.1.3 Aptamers
7.7.2.1.4 CpG Oligonucleotides
7.7.2.1.5 Others
7.7.2.2 South Africa Market by Application
7.7.2.2.1 Oncology
7.7.2.2.2 Infectious Diseases
7.7.2.2.3 Cardiovascular Diseases
7.7.2.2.4 Neurological Disorders
7.7.2.2.5 Genetic Disorders
7.7.2.2.6 Others
7.7.3 Rest of MEA
7.7.3.1 Rest of MEA Market by Therapy Type
7.7.3.1.1 Antisense Oligonucleotides (ASOs)
7.7.3.1.2 RNA Interference (RNAi) Therapeutics
7.7.3.1.3 Aptamers
7.7.3.1.4 CpG Oligonucleotides
7.7.3.1.5 Others
7.7.3.2 Rest of MEA Market by Application
7.7.3.2.1 Oncology
7.7.3.2.2 Infectious Diseases
7.7.3.2.3 Cardiovascular Diseases
7.7.3.2.4 Neurological Disorders
7.7.3.2.5 Genetic Disorders
7.7.3.2.6 Others
8. Global Oligonucleotide Therapeutics Market - Competitive Benchmarking and Company Profiles
8.1 Competitive Benchmarking
8.2 Competitive Landscape
8.2.1 Key Strategies and Developments
8.2.1.1 Funding Activities
8.2.1.2 Mergers and Acquisitions
8.2.1.3 Regulatory Approvals
8.2.1.4 Partnerships, Collaborations, and Business Expansions
8.2.2 Key Developments Analysis
8.2.3 Company Competition Matrix
8.2.3.1 Sample Preparation
8.2.3.2 Reagents & Kits
8.2.3.3 Consumables
8.2.3.4 Instruments & Software
8.2.4 Company Share Analysis, 2022/2023
8.3 Company Profiles
8.3.1 Sarepta Therapeutics
8.3.1.1 Overview
8.3.1.2 Top Products/Product Portfolio
8.3.1.3 Top Competitors
8.3.1.4 Target Customers
8.3.1.5 Analyst View
8.3.2 Alnylam Pharmaceuticals, Inc.
8.3.2.1 Overview
8.3.2.2 Top Products/Product Portfolio
8.3.2.3 Top Competitors
8.3.2.4 Target Customers
8.3.2.5 Analyst View
8.3.3 Novartis
8.3.3.1 Overview
8.3.3.2 Top Products/Product Portfolio
8.3.3.3 Top Competitors
8.3.3.4 Target Customers
8.3.3.5 Analyst View
8.3.4 Nippon Shinyaku Co., Ltd.
8.3.4.1 Overview
8.3.4.2 Top Products/Product Portfolio
8.3.4.3 Top Competitors
8.3.4.4 Target Customers
8.3.4.5 Analyst View
8.3.5 Ionis Pharmaceuticals
8.3.5.1 Overview
8.3.5.2 Top Products/Product Portfolio
8.3.5.3 Top Competitors
8.3.5.4 Target Customers
8.3.5.5 Analyst View
8.3.6 Biogen
8.3.6.1 Overview
8.3.6.2 Top Products/Product Portfolio
8.3.6.3 Top Competitors
8.3.6.4 Target Customers
8.3.6.5 Analyst View
8.3.7 Jazz Pharmaceuticals
8.3.7.1 Overview
8.3.7.2 Top Products/Product Portfolio
8.3.7.3 Top Competitors
8.3.7.4 Target Customers
8.3.7.5 Analyst View
8.3.8 Akcea Therapeutics
8.3.8.1 Overview
8.3.8.2 Top Products/Product Portfolio
8.3.8.3 Top Competitors
8.3.8.4 Target Customers
8.3.8.5 Analyst View
8.3.9 miRaX Therapeutics
8.3.9.1 Overview
8.3.9.2 Top Products/Product Portfolio
8.3.9.3 Top Competitors
8.3.9.4 Target Customers
8.3.9.5 Analyst View
8.3.10 Resalis Therapeutics
8.3.10.1 Overview
8.3.10.2 Top Products/Product Portfolio
8.3.10.3 Top Competitors
8.3.10.4 Target Customers
8.3.10.5 Analyst View
8.3.11 Stoke Therapeutics
8.3.11.1 Overview
8.3.11.2 Top Products/Product Portfolio
8.3.11.3 Top Competitors
8.3.11.4 Target Customers
8.3.11.5 Analyst View
8.3.12 Dyne Therapeutics
8.3.12.1 Overview
8.3.12.2 Top Products/Product Portfolio
8.3.12.3 Top Competitors
8.3.12.4 Target Customers
8.3.12.5 Analyst View
8.3.13 ProQR Therapeutics
8.3.13.1 Overview
8.3.13.2 Top Products/Product Portfolio
8.3.13.3 Top Competitors
8.3.13.4 Target Customers
8.3.13.5 Analyst View
8.4 Emerging Companies

Companies Mentioned

  • Sarepta Therapeutics
  • Alnylam Pharmaceuticals, Inc.
  • Novartis
  • Nippon Shinyaku Co., Ltd.
  • Ionis Pharmaceuticals
  • Biogen
  • Jazz Pharmaceuticals
  • Akcea Therapeutics
  • miRaX Therapeutics
  • Resalis Therapeutics
  • Stoke Therapeutics
  • Dyne Therapeutics
  • ProQR Therapeutics