Article -> Article Details
| Title | Oligonucleotide CDMO Market’s CAGR of 8.9%: Key Players |
|---|---|
| Category | Business --> Biotechnology |
| Meta Keywords | Oligonucleotide CDMO Market |
| Owner | shivani |
| Description | |
| According to a newly published
market research report by 24LifeSciences, global oligonucleotide process development and manufacturing
market was valued at USD 1.14 billion in 2024 and is
projected to reach USD 2.04 billion by 2031, growing at a compound
annual growth rate (CAGR) of 8.9% during the forecast period 2025-2031. Oligonucleotides, which are short,
single-stranded DNA or RNA molecules typically consisting of 20 to 30
nucleotides, play crucial roles in antisense therapy, gene silencing, and as
primers or probes in molecular biology. The manufacturing process involves
sophisticated techniques including solid-phase synthesis using phosphoramidite
chemistry, followed by deprotection, cleavage, purification (typically using
reverse-phase HPLC), and rigorous quality control analysis to ensure high
purity and correct sequence integrity. These precision molecules continue to
underpin the advancement of nucleic acid therapeutics and personalized medicine
approaches. Download a Free Sample Report
(PDF): https://www.24lifesciences.com/download-sample/5182/oligonucleotide-process-development-and-manufacturing-market Expansion
of RNA Therapeutics and Personalized Medicine Fuels Market Growth The remarkable growth of mRNA
vaccines and RNA-based therapeutics following the COVID-19 pandemic has created
unprecedented demand for high-quality oligonucleotide manufacturing at
commercial scale. Pharmaceutical companies are increasingly investing in
advanced manufacturing capabilities to support the robust pipeline of over 500
oligonucleotide drugs currently in clinical development. The success of mRNA
vaccine technology has demonstrated the tremendous potential of nucleic acid
therapeutics, leading to increased R&D investment across this sector. Additionally, the rising adoption of
personalized medicine approaches, particularly in oncology and rare genetic
disorders, is driving demand for custom oligonucleotide therapies that require
sophisticated manufacturing processes. The U.S. FDA's approval of several
oligonucleotide drugs has created clearer regulatory pathways and increased
confidence in these advanced therapies among healthcare providers and patients. Technological
Advancements Enhance Manufacturing Efficiency and Scalability Significant advancements in
solid-phase synthesis and purification technologies have transformed the market
by enabling more efficient production of complex oligonucleotides. Modern
automated synthesis platforms now achieve 98.5% coupling efficiency,
representing a substantial improvement over traditional methods. These
innovations have reduced production costs while accelerating development
timelines, making oligonucleotide therapies more accessible. Continuous manufacturing approaches
are revolutionizing production by reducing processing times from weeks to days
while simultaneously improving batch consistency. These advancements are
particularly crucial for antisense oligonucleotides and siRNA therapeutics that
require complex modifications and high purity standards. The evolution of
chromatography and purification technologies has been equally impressive, with
new systems achieving 99.8% purity rates for therapeutic-grade
oligonucleotides. Market
Challenges: Cost Pressures and Regulatory Complexity Despite the positive growth
trajectory, the market faces several notable challenges that require careful
navigation:
The high cost of oligonucleotide
therapeutics, with some treatments costing approximately $450,000 annually,
creates significant pricing pressure that manufacturers must address through
continuous process optimization and cost reduction strategies. Get the Complete Report & Table
of Contents: https://www.24lifesciences.com/oligonucleotide-process-development-and-manufacturing-market-5182 North
America Leads the Global Oligonucleotide Manufacturing Market The North American region
dominates the global oligonucleotide process development and manufacturing
market, accounting for approximately 42% of total market share. This
leadership position is driven by several key factors:
Europe maintains a strong secondary
position with 31% market share, characterized by advanced regulatory frameworks
and quality standards, while the Asia-Pacific region shows the fastest growth
rate due to increasing outsourcing to CMOs and government initiatives
supporting biotechnology development. Pharmaceutical
Companies Dominate Market by End User By end user, pharmaceutical and
biotechnology companies represent the largest and most critical segment due
to their significant investments in oligonucleotide therapeutics and the need
for robust manufacturing processes to support clinical trials and
commercialization. The complex nature of oligonucleotide drugs requires specialized
expertise and infrastructure, making this segment particularly important for
market growth. Competitive
Landscape: Innovation-Driven with Strategic Partnerships Global oligonucleotide process
development and manufacturing market features a competitive landscape where
innovation and technological capability determine market position. The
environment is shaped by factors including product quality, regulatory compliance,
manufacturing scale, and research collaboration networks. Key companies profiled in the report
include:
Get the Complete Report & Table
of Contents: Market
Opportunities: Emerging Applications and Geographic Expansion Significant growth opportunities
exist in emerging markets across Asia-Pacific and Latin America,
supported by improving healthcare access and rising awareness of advanced
therapies. Countries like China and India are developing sophisticated
manufacturing capabilities, reducing dependence on imports and creating new
hubs for oligonucleotide production. Furthermore, the development of novel
oligonucleotide applications in areas such as CRISPR gene editing,
personalized cancer vaccines, and targeted drug delivery systems is expected to
generate new intellectual property and expand clinical adoption. The
convergence of oligonucleotide technology with other advanced therapeutic
modalities presents additional avenues for market expansion and innovation. Access
the Full Report Download a Free Sample Report (PDF): Get the Complete Report & Table
of Contents: About
24LifeSciences 24LifeSciences is a leading provider
of market intelligence and strategic research reports across pharmaceuticals,
biotechnology, medical devices, and healthcare technologies. Our reports
are designed to support data-driven decision-making for manufacturers,
healthcare providers, investors, consultants, and policy makers worldwide. Follow
us on LinkedIn: | |
