Nucleic Acid Therapeutics Market to Reach USD 44.5 Bn by 2035, Expanding at a CAGR of 14.7% | TMR

Rising prevalence of genetic disorders, supportive regulatory frameworks, and advancements in gene and RNA-based therapies are fueling market expansion.

WILMINGTON, DE, UNITED STATES, September 5, 2025 /EINPresswire.com/ -- The global nucleic acid therapeutics market is entering a phase of accelerated growth, driven by strong innovation pipelines and favorable policy support. Valued at US$ 8.8 Bn in 2024, the market is projected to grow at a robust CAGR of 14.7% between 2025 and 2035, reaching US$ 44.5 Bn by 2035. Growing awareness of genetic diseases, widespread clinical trials, and rapid progress in RNA-based platforms are reshaping the future of precision medicine.

Market Introduction

Nucleic acid therapeutics represent one of the most transformative innovations in modern biotechnology. These therapies leverage engineered DNA and RNA molecules to correct or silence defective genes, introduce beneficial genetic material, or modulate protein expression. Core modalities include gene therapies, antisense oligonucleotides (ASOs), RNA interference (RNAi), aptamers, and messenger RNA (mRNA)-based therapeutics.

Their therapeutic applications extend across neuromuscular disorders, oncology, viral infections, ophthalmological diseases, metabolic syndromes, and autoimmune conditions, providing high specificity, targeted action, and the potential for one-time curative treatments. Unlike traditional pharmaceuticals, nucleic acid therapeutics address the root cause of diseases at the genetic level, minimizing systemic toxicity and enabling personalized medicine.

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Analyst Viewpoint
Analysts at Transparency Market Research note that the nucleic acid therapeutics market is on the cusp of becoming a mainstream segment in the biopharmaceutical industry.

Key growth catalysts include:

Rising prevalence of rare and inherited disorders such as Duchenne muscular dystrophy, cystic fibrosis, and sickle cell anemia, which remain underserved by conventional treatments.

Regulatory acceleration through FDA Fast Track, Breakthrough Therapy, and EMA Priority Medicines (PRIME) designations, which shorten development timelines for critical therapies.

Challenges remain in terms of manufacturing scalability, delivery mechanisms, and cost-effectiveness, particularly for therapies requiring complex viral or lipid nanoparticle vectors. However, the success of mRNA vaccines during the COVID-19 pandemic has proven the scalability and adaptability of RNA-based platforms, catalyzing confidence among investors and policymakers. The increasing number of clinical trials, coupled with strategic collaborations, points to a market that is set to transform global healthcare by 2035.

Key Market Drivers

1. Rising Prevalence of Genetic Disorders

Genetic diseases affect millions worldwide, with a growing number being diagnosed through advancements in genomic sequencing and prenatal screening. This improved detection rate is expanding the eligible patient pool for nucleic acid therapeutics. As these therapies directly correct or silence defective genes, their adoption is expected to increase significantly in the coming years.

2. Regulatory Approvals and Expedited Pathways

Regulatory agencies such as the U.S. FDA and the European Medicines Agency (EMA) are creating streamlined approval frameworks for nucleic acid therapeutics, particularly in the area of rare and orphan diseases. Expedited review processes reduce time-to-market, encouraging pharmaceutical and biotech companies to increase investment in clinical development.

3. Advancements in RNA-based and Gene Therapies

Breakthroughs in antisense oligonucleotides, siRNA, and mRNA platforms are enabling therapies that target diseases previously considered untreatable. The integration of artificial intelligence, nanotechnology-driven delivery systems, and improved chemical modifications has enhanced drug stability, precision targeting, and reduced off-target effects, making RNA-based treatments commercially viable.

Segment Analysis

By Therapy Type

Antisense Oligonucleotides (ASOs): Largest segment due to their efficacy in modulating gene expression; widely used in neuromuscular and rare genetic disorders.

Small Interfering RNA (siRNA): Emerging as a strong segment with applications in oncology and metabolic diseases.

Gene Therapies: High growth potential owing to curative benefits in monogenic disorders.

Aptamers: Gaining momentum in targeted oncology treatments.

Others (including mRNA therapies): Strong future growth expected, particularly post-COVID-19 success.

By Delivery Method

Viral Vector-based Systems: Widely used but face challenges in immunogenicity and manufacturing scalability.

Non-viral Delivery Systems: Lipid nanoparticles and polymer-based carriers showing promising safety and efficiency.

By Route of Administration

Intravenous: Dominant due to systemic distribution.

Subcutaneous: Preferred for ease of administration and chronic therapies.

Others (Intrathecal, etc.): Specialized routes for targeted disease conditions.

By Therapeutic Area

Neuromuscular Disorders (DMD, SMA)

Metabolic Disorders

Cardiovascular Disorders

Ophthalmological Disorders

Oncological Disorders

Others (Infectious, Autoimmune, etc.)

By End-user

Hospitals (largest share due to advanced care infrastructure)

Academic and Research Institutes (driving clinical trials and innovation)

Specialty Centers (focusing on genetic and rare disorders)

Regional Insights

North America: Leads the global market due to strong biotech infrastructure, presence of leading companies, and early adoption of innovative therapies. Favorable reimbursement policies and active regulatory support enhance growth prospects.

Europe: Rapid adoption supported by EMA’s proactive stance on genetic therapies. Strong research ecosystems in Germany, the UK, and France are advancing innovation.

Asia Pacific: Poised for fastest growth with rising healthcare investments, supportive government initiatives, and a growing patient pool in China, India, and Japan.

Latin America & Middle East & Africa: Emerging regions where adoption is gradually increasing, though affordability and access remain challenges. Partnerships with global biotech firms are expected to enhance growth.

Key Players

Novartis AG

Pfizer, Inc.

Sanofi

Novo Nordisk A/S

AstraZeneca plc

Alnylam Pharmaceuticals, Inc.

Amgen Inc.

Sarepta Therapeutics, Inc.

Bluebird Bio, Inc.

CSL Behring LLC

Ferring Pharmaceuticals Inc.

Krystal Biotech, Inc.

PTC Therapeutics, Inc.

Jazz Pharmaceuticals plc

Astellas Pharma Inc.

Recent Developments

Novartis (Nov 2024): Acquired Kate Therapeutics, expanding its AAV-based gene therapy pipeline for neuromuscular diseases in a deal valued up to US$ 1.1 Bn.

Sarepta Therapeutics (Nov 2024): Entered into a licensing agreement with Arrowhead Pharmaceuticals for siRNA programs in muscle and rare pulmonary disorders, valued at US$ 825 Mn.

Market Trends

Accelerating investments in RNA-based and gene-editing platforms.

Rising demand for personalized and precision medicine approaches.

Continuous technological innovations in viral and non-viral delivery platforms.

Increasing collaborations between pharma companies, biotech firms, and academic institutions to fast-track clinical pipelines.

Future Outlook

The nucleic acid therapeutics market is expected to remain one of the fastest-growing sectors within biotechnology and pharmaceuticals through 2035.
Factors such as increasing prevalence of genetic disorders, regulatory acceleration, advancements in RNA and gene therapy platforms, and strong demand for personalized medicine will drive market expansion. With a projected CAGR of 14.7%, the sector is set to deliver groundbreaking treatments that could redefine modern healthcare.

Why Buy This Report?

Reliable market size forecasts and CAGR projections through 2035

In-depth assessment of market drivers, restraints, and opportunities

Comprehensive segmentation by therapy type, delivery method, therapeutic area, and region

Competitive landscape with profiles of leading companies and recent strategic developments

Analysis of emerging technologies and trends shaping future growth

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