Delray Beach, FL, Feb. 16, 2026 (GLOBE NEWSWIRE) — Strategic investments in ASO and siRNA platforms, coupled with breakthrough delivery technologies, position oligonucleotide therapeutics as cornerstone of next-generation drug development for C-suite leaders navigating biopharma innovation The global oligonucleotide therapeutics market, valued at US$5.92 billion in 2024, stood at US$7.19 billion in 2025 and is projected to advance at a resilient CAGR of 19.7% from 2025 to 2030, culminating in a forecasted valuation of US$17.70 billion by the end of the period. This expansion signals a fundamental shift in pharmaceutical strategy as RNA-targeting therapies gain unprecedented clinical acceptance and commercial traction across key therapeutic areas. Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=41710113 What is driving this rapid market acceleration? Why does this matter now for industry decision-makers? Who is benefiting from this transformation? Strategic Market Drivers: Understanding the Commercial Imperative Request Sample Pages : https://www.marketsandmarkets.com/requestsampleNew.asp?id=41710113 Market Challenges: Navigating Complexity and Regulatory Fragmentation Where do regulatory inconsistencies create market friction? Strategic Opportunities: Emerging Markets and R&D Investment Trends Market Structure and Ecosystem Analysis Segment Leadership and Commercial Performance Disease Type Analysis: Neurological Disorders Lead Market Share Route of Administration: Subcutaneous Delivery Dominates Market Preference Regional Market Dynamics: North America Leads Growth Trajectory Competitive Landscape: Market Consolidation and Strategic Positioning Strategic Company Profiles Alnylam Pharmaceuticals, Inc. drives substantial market demand through its RNAi (siRNA) portfolio, including marketed products AMVUTTRA, GIVLAARI, and OXLUMO. Expanding patient access translates directly into increased manufacturing cycles and clinical-commercial supply requirements. Sarepta Therapeutics, Inc. commands a significant market position through exon-skipping products for Duchenne muscular dystrophy, including approved antisense oligonucleotides EXONDYS 51, VYONDYS 53, and AMONDYS 45. Recent Strategic Developments Shaping Market Dynamics March 2025: Alnylam received extended US FDA approval for AMVUTTRA (vutrisiran) to treat cardiomyopathy associated with wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. This label expansion enables the company to address cardiovascular mortality reduction, hospitalization prevention, and urgent heart failure intervention–significantly broadening commercial opportunity. February 2025: Biogen Inc. and Stoke Therapeutics, Inc. announced a collaboration for development and commercialization of zorevunersen, an investigational antisense oligonucleotide targeting the SCN1A gene for Dravet syndrome treatment, demonstrating continued industry confidence in ASO therapeutic potential. Market Value Drivers and Pricing Dynamics Why are procurement costs increasing? Strategic Implications for C-Suite Decision-Makers Organizations capable of securing high-quality oligonucleotide supply chains, navigating fragmented regulatory environments, and capitalizing on emerging market opportunities will be optimally positioned to capture value in this rapidly expanding sector. For more information, Inquire Now! Discover Connected Healthcare Market Opportunities: Get access to the latest updates on Top Companies in Oligonucleotide Therapeutics and Oligonucleotide Therapeutics Market Size
The surge is primarily fueled by the clinical success of antisense oligonucleotides (ASOs) and small interfering RNA (siRNA) candidates, reinforced by transformative advances in delivery mechanisms including GalNAc conjugates and lipid nanoparticle formulations. These innovations address longstanding challenges in potency, stability, and tissue selectivity–critical factors that pharmaceutical executives must consider when evaluating pipeline investments and strategic partnerships.
Pharmaceutical and biotechnology companies are significantly increasing procurement of high-purity therapeutic oligonucleotides, including custom sequences, chemically modified backbones, and conjugated formats designed to enhance targeting precision and extend dosing intervals. This commercial momentum reflects a broader industry transition toward molecular decision-making frameworks, where RNA-based modalities are becoming central to competitive differentiation and patent strategies.
The demand extends beyond traditional therapeutics into gene editing applications, where guide RNA design and optimization are creating substantial opportunities for specialized oligonucleotide capabilities. As companies advance ASO and siRNA programs through late-stage clinical development, requirements for stringent purity standards, minimal impurity profiles, and comprehensive regulatory compliance are intensifying–driving premium valuations for suppliers who can meet these exacting specifications.
Expanding Therapeutic and Diagnostic Applications Create Dual Revenue Streams
A fundamental growth driver lies in the increasing adoption of synthesized oligonucleotides across both therapeutic and diagnostic sectors. While oligonucleotides form the backbone of ASO and siRNA drug development, they are simultaneously essential for PCR, qPCR, next-generation sequencing (NGS), and molecular diagnostic assays. The rising implementation of precision medicine protocols and liquid biopsy procedures is amplifying volume growth at both development and commercial scales, creating compelling investment opportunities for companies positioned across this value chain.
When do development complexities become strategic risks?
Therapeutic oligonucleotides present inherent challenges that C-suite executives must acknowledge in portfolio planning. These molecules demand precise sequence design, sophisticated chemical modifications, and rigorous purity controls. Manufacturing and analytical testing protocols are considerably more complex than those for traditional small molecules. Additional hurdles–including targeted tissue delivery and endosomal escape mechanisms–increase development timelines, capital requirements, and program risk profiles.
The absence of harmonized global regulations remains the primary strategic challenge. Oligonucleotides occupy an intermediate classification between small molecules and biologics, and regulatory frameworks vary substantially across jurisdictions. Divergent expectations in chemistry, manufacturing, and controls (CMC), impurity profiling, and analytical characterization create complications for companies designing multinational development strategies and scaling commercial manufacturing operations.
How are emerging economies reshaping competitive dynamics?
Escalating R&D investments by major players in Asia and other developing regions present significant growth opportunities. Pharmaceutical and biotechnology firms in these markets are expanding RNA therapeutics pipelines, supported by government grants and dedicated manufacturing infrastructure. This localization of oligonucleotide synthesis capabilities, analytics, and GMP production reduces Western vendor dependency while unlocking new commercial markets–a trend that forward-thinking executives should monitor closely.
The oligonucleotide therapeutics ecosystem encompasses a comprehensive supply chain extending from raw material suppliers to commercial-scale drug production. Upstream participants include providers of synthesis inputs (phosphoramidites, controlled pore glass solid supports, activators, oxidizers, deblocking reagents, and high-purity solvents), as well as synthesizer and automation technology vendors enabling scalable, consistent manufacturing across laboratory, pilot, and GMP environments.
Market Leadership by Molecule: Nusinersen Maintains Commercial Dominance
In 2024, nusinersen (SPINRAZA) commanded the largest market segment within oligonucleotide therapeutics. Approved in 2016 for spinal muscular atrophy (SMA), the drug benefits from established prescriber familiarity and secured reimbursement across major healthcare markets. Despite emerging competitive therapies, demand remains robust–Biogen reported approximately USD 1.5 billion in global SPINRAZA revenue for 2024, underscoring the commercial durability of first-mover advantage in rare disease indications.
Neurological disorders represented the largest therapeutic segment in 2024, reflecting the historical development focus of early oligonucleotide programs. Indications such as SMA and hereditary transthyretin amyloidosis with polyneuropathy demonstrate sustained commercial demand for ASO and siRNA treatments, driven by chronic disease management requirements and specialist-directed care pathways.
Subcutaneous administration captured the largest market share in 2024, driven by practical advantages for repeated dosing and real-world implementation scalability. This delivery method supports patient-centric outpatient treatment protocols, reducing dependency on infusion infrastructure. As GalNAc-conjugated, liver-targeted oligonucleotide therapies gain commercial prominence, subcutaneous dosing preference continues strengthening–a critical consideration for companies designing patient access strategies.
North America represents the fastest-growing regional market, propelled by concentrated RNA drug development activity, robust venture capital and institutional funding, and extensive clinical trial infrastructure. This ecosystem generates sustained demand for GMP-grade ASOs and siRNAs across preclinical, clinical, and commercial supply chains. The region's mature network of contract development and manufacturing organizations (CDMOs), specialized analytical laboratories, and regulatory expertise facilitates efficient program scaling and seamless late-stage supply transitions.
The oligonucleotide therapeutics market exhibits notable consolidation among key industry participants:
Leading Market Players:
Biogen maintains strong market presence through its antisense oligonucleotide foundation, generating recurring manufacturing demand via marketed products SPINRAZA (nusinersen) and QALSODY (tofersen). Repeat dosing requirements and long-term patient management protocols ensure sustained commercial-grade oligonucleotide procurement.
Growth is substantially supported by governmental and institutional funding for genomics initiatives, precision medicine programs, and rare disease infrastructure. This financial commitment enhances genetic testing accessibility, patient identification protocols, and referral pathway efficiency, directly expanding the addressable patient population for approved oligonucleotide therapies.
As programs transition from clinical to commercial phases, pharmaceutical companies are elevating requirements for sequence accuracy, impurity control, and regulatory-grade documentation. Complex synthesis protocols, advanced purification techniques, and comprehensive analytical release testing command premium pricing, with therapeutic-grade supply now representing the largest value segment within the oligonucleotide market.
The oligonucleotide therapeutics market presents compelling opportunities for executives evaluating portfolio expansion, strategic partnerships, or vertical integration strategies. The convergence of clinical validation, delivery technology maturation, and regulatory pathway clarity creates favorable conditions for investment. However, success requires sophisticated understanding of manufacturing complexity, regulatory variability, and competitive positioning.
Gene Therapy Market
Molecular Diagnostics Market
Next Generation Sequencing Market
Genomics Market
Precision Medicine Market
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