From 2024 to 2031, the worldwide oligonucleotide therapy market is expected to develop at a CAGR of 3.4%. USD 8.2 billion is the market size in 2022; by 2031 it is predicted to have risen to USD 21.4 billion. Thanks to its sophisticated healthcare system and large R&D spending in oligonucleotide based treatments, North America now rules the industry.
Rising prevalence of genetic diseases, cancer, and neurological diseases is driving notable expansion in the oligonucleotide therapy market. Oligonucleotide-based medicines are appealing for treating once undruggable targets since they have extremely selective gene targeting powers. Market expansion is being driven by the increasing pipeline of oligonucleotide therapies and widening uses across several disease domains. Furthermore enhancing the efficiency and commercial feasibility of these treatments are developments in manufacturing techniques and oligonucleotide delivery systems.
Market Trend: growing acceptance of individualized medicine
The market for oligonucleotide therapy is being greatly expanded by the growing trend toward personalized medicine. More customized and effective treatments are made possible by oligonucleotide based medications, which can be made to target particular genetic mutations or disease causing genes. In oncology, where knowledge of tumor genetic profile helps to create focused treatments, this method is especially helpful. Customized oligonucleotide sequences for individual patients or particular disease subtypes allow one to match the ideas of precision medicine rather perfectly. Demand for oligonucleotide treatments is likely to grow as healthcare systems adopt customized treatment approaches more and more. Driven by this trend are investments in companion diagnostics to find patients most likely to benefit from oligonucleotide-based medicines, biomarker development, and genomic research. Advances in genomes, bioinformatics, and oligonucleotide technology taken together provide fresh chances for tailored treatments in several disease domains.
Market Driver: Increasing frequency of uncommon and genetic disorders
A major factor driving the expansion of the oligonucleotide therapy market is the increasing frequency of uncommon diseases and genetic disorders. Many genetic disorders arise from particular DNA or RNA defects that oligonucleotide based treatments could be able to fix. These treatments provide special means to control gene expression, fix splicing errors, or stop the synthesis of proteins causing diseases. More targets for oligonucleotide treatments are becoming known as our knowledge of the genetic cause of diseases advances. For uncommon diseases—many of which have few or no therapy choices—this is especially crucial. For some with once untreatable diseases, oligonucleotide treatments give hope. Government programs encouraging orphan drug creation and rare disease research have also helped to drive more funding in this area. The success of licensed oligonucleotide medications for diseases including spinal muscular atrophy and Duchenne muscular dystrophy has shown the promise of this treatment method, therefore motivating more research for other genetic disorders.
Market Restraint: Expensive manufacturing and development costs
Market development is seriously hampered by the high expenses connected with oligonucleotide treatment development and manufacture. Oligonucleotide synthesis is a difficult and costly process needing specific tools and strict quality control procedures. Further driving production costs are the necessity of chemical changes to increase stability and cellular absorption. Furthermore, time-consuming and costly is the creation of oligonucleotide treatments, which usually entails thorough preclinical and clinical research to prove safety and efficacy. Furthermore driving research and development costs are the need for new delivery technologies to improve tissue targeting and cellular penetration. These elements lead to expensive oligonucleotide medicine pricing, hence maybe restricting patient availability and reimbursement. The intricate intellectual property terrain around oligonucleotide technology might cause legal issues or licensing fees, therefore affecting general expenses. Improving the cost-effectiveness of oligonucleotide treatments will depend critically on ongoing technological developments in synthesis and delivery techniques as well as economies of scale in manufacturing to overcome this constraint.
Dominant in the market are antisense oligonucleotides
Currently ruling the oligonucleotide therapy business, antisense oligonucleotides (ASOs) hold the biggest market share among all oligonucleotide forms. Designed to connect to complementary mRNA sequences, ASOs—single strand DNA or RNA molecules—modulate gene expression. Highly specific targeting of disease related genes made possible by this approach makes ASOs flexible instruments for treating different disorders. Approved ASO medicines for neuromuscular diseases, including nusinersen for spinal muscular atrophy, have validated this strategy and driven more research since they show efficacy. Among numerous benefits ASOs provide include rather simple design and synthesis, the possibility to target previously "undruggable" genes, and possible usage in a variety of therapeutic domains. Treating some malignancies, neurological illnesses, and hereditary disorders, they have shown especially promise. The efficacy and safety profiles of these treatments have been raised by increasing knowledge of ASO pharmacology and chemical changes to boost stability and cellular absorption. Furthermore, ASOs' proven regulatory route helps to perhaps simplify the approval process for novel medications in this class. The predominance of ASOs in the oligonucleotide therapy market is projected to remain as research reveals fresh targets and improves delivery systems, therefore fostering innovation and increasing treatment options for patients.
Market for oligonucleotide therapy is led by North America.
Currently holding the biggest share in the worldwide oligonucleotide treatment market, North America is likely to keep its leading position all through the forecast period. The advanced healthcare system of the area, great research and development capacity, and favorable legislative climate help to explain this leadership. Particularly the United States is leading in oligonucleotide therapy development; many biotech firms and university institutions are involved in research and clinical studies. Key players in the market and their strong product lines greatly help to drive regional market development. Higher healthcare costs and more acceptance of creative ideas by North America also help the country compared to others. Further driving market growth are the established reimbursement systems and government policies encouraging rare disease research and precision medicine. Furthermore, the great frequency of genetic diseases, malignancies, and neurological illnesses in the area generates a significant patient pool for oligonucleotide treatments. Several FDA approved oligonucleotide medicines' success has opened the path for more funding and development activity in this area. North America is expected to remain a major center of innovation in oligonucleotide based therapeutics as the market develops, therefore promoting worldwide market expansion.
Extreme competition and fast innovation define the oligonucleotide treatment market. Important players in the industry are well-known pharmaceutical companies, specialized biotech companies, and startup companies emphasizing new oligonucleotide technology. Seeking to increase their product lines and get regulatory clearances, these companies are involved in significant research and development initiatives. Common in the sector, strategic alliances and partnerships let businesses mix knowledge in oligonucleotide design, delivery methods, and particular disease areas. Larger pharmaceutical companies and venture capital firms seeing the promise of oligonucleotide based treatments have driven notable investment in the field recently. The competitive scene depends much on intellectual property protection; businesses aim to get patents for their own drugs and technologies. Competition is probably going to get more fierce as the area develops, which will inspire more creativity in oligonucleotide design, manufacturing techniques, and delivery systems to raise efficiency and lower costs.
Ionis Pharmaceuticals gained FDA clearance for WAINUA (eplontersen), an antisense oligonucleotide therapeutic for the treatment of polyneuropathy of hereditary transthyretin mediated amyloidosis in adults, in 2023.
Alnylam Pharmaceuticals revealed in 2022 favorable Phase 3 data for its novel RNAi therapy patisiran in the treatment of transthyretin mediated (ATTR) amyloidosis with cardiomyopathy.
1. INTRODUCTION
1.1. Market Definition
1.2. Study Scope
1.3. Currency Conversion
1.4. Study Period (2022 2031)
1.5. Regional Coverage
2. RESEARCH METHODOLOGY
2.1. Primary Research
2.2. Secondary Research
2.3. Company Share Analysis
2.4. Data Triangulation
3. EXECUTIVE SUMMARY
3.1. Global Oligonucleotide Therapy Market (2018 – 2022)
3.2. Global Oligonucleotide Therapy Market (2023 – 2031)
3.2.1. Market Segment By Type (2023 – 2031)
3.2.2. Market Segment By Application (2023 – 2031)
3.2.3. Market Segment By Route of Administration (2023 – 2031)
3.2.4. Market Segment By End User (2023 – 2031)
4. MARKET DYNAMICS
4.1. Market Trends
4.1.1. Rising adoption of personalized medicine
4.1.2. Increasing focus on rare disease treatments
4.1.3. Advancements in oligonucleotide delivery technologies
4.2. Market Drivers
4.2.1. Increasing prevalence of genetic and rare diseases
4.2.2. Growing pipeline of oligonucleotidebased therapies
4.2.3. Expanding applications in oncology and infectious diseases
4.3. Market Restraints
4.3.1. High cost of development and manufacturing
4.3.2. Challenges in cellular uptake and tissue targeting
4.4. Porter's Five Forces Analysis
4.4.1. Threat of New Entrants
4.4.2. Bargaining Power of Buyers/Consumers
4.4.3. Bargaining Power of Suppliers
4.4.4. Threat of Substitute Products
4.4.5. Intensity of Competitive Rivalry
4.5. Supply Chain Analysis
4.6. Pricing Analysis
4.7. Regulatory Analysis
4.8. Pipeline Analysis
5. BY TYPE (MARKET VALUE (US$ MILLION) – 2022-2031*)
5.1. Antisense Oligonucleotide
5.2. siRNA
5.3. miRNA
5.4. Others
6. BY APPLICATION
6.1. Oncology
6.2. Genetic Disorders
6.3. Neurological Disorders
6.4. Infectious Diseases
6.5. Others
7. BY ROUTE OF ADMINISTRATION
7.1. Subcutaneous
7.2. Intravenous
7.3. Intravitreal
7.4. Others
8. BY END USER
8.1. Hospitals
8.2. Specialty Clinics
8.3. Research Institutes
8.4. Others
9. GEOGRAPHY
9.1. North America
9.1.1. United States
9.1.2. Canada
9.1.3. Mexico
9.2. South America
9.2.1. Brazil
9.2.2. Argentina
9.2.3. Rest of South America
9.3. Europe
9.3.1. Germany
9.3.2. United Kingdom
9.3.3. France
9.3.4. Italy
9.3.5. Spain
9.3.6. Russia
9.3.7. Rest of Europe
9.4. AsiaPacific
9.4.1. China
9.4.2. Japan
9.4.3. India
9.4.4. Australia
9.4.5. South Korea
9.4.6. Rest of AsiaPacific
9.5. MiddleEast
9.5.1. UAE
9.5.2. Saudi Arabia
9.5.3. Turkey
9.5.4. Rest of Middle East
9.6. Africa
9.6.1. South Africa
9.6.2. Egypt
9.6.3. Rest of Africa
10. COMPETITIVE LANDSCAPE
10.1. Key Developments
10.2. Company Market Share Analysis
10.3. Product Benchmarking
11. SWOT ANALYSIS
12. COMPANY PROFILES
12.1. Ionis Pharmaceuticals, Inc.
12.2. Sarepta Therapeutics, Inc.
12.3. Alnylam Pharmaceuticals, Inc.
12.4. Biogen Inc.
12.5. Moderna, Inc.
12.6. Arrowhead Pharmaceuticals, Inc.
12.7. Wave Life Sciences Ltd.
12.8. Silence Therapeutics plc
12.9. Antisense Therapeutics Limited
12.10. ProQR Therapeutics N.V.
12.11. Stoke Therapeutics, Inc.
12.12. Dicerna Pharmaceuticals, Inc. (*LIST NOT EXHAUSTIVE)
13. MARKET OPPORTUNITIES
Antisense Oligonucleotide
siRNA
miRNA
Others
By Application:
Oncology
Genetic Disorders
Neurological Disorders
Infectious Diseases
Others
By Route of Administration:
Subcutaneous
Intravenous
Intravitreal
Others
By End User:
Hospitals
Specialty Clinics
Research Institutes
Others
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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