Nucleic Acid Therapeutics CDMO

Global Nucleic Acid Therapeutics CDMO Market to Reach US$39.5 Billion by 2030

The global market for Nucleic Acid Therapeutics CDMO estimated at US$16.6 Billion in the year 2024, is expected to reach US$39.5 Billion by 2030, growing at a CAGR of 15.6% over the analysis period 2024-2030. RNA-based Therapies, one of the segments analyzed in the report, is expected to record a 17.3% CAGR and reach US$28.3 Billion by the end of the analysis period. Growth in the Gene Therapies segment is estimated at 11.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$4.4 Billion While China is Forecast to Grow at 14.6% CAGR

The Nucleic Acid Therapeutics CDMO market in the U.S. is estimated at US$4.4 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$6.1 Billion by the year 2030 trailing a CAGR of 14.6% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 14.6% and 13.3% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 11.2% CAGR.

Global Nucleic Acid Therapeutics CDMO Market – Key Trends & Drivers Summarized

Why Are Nucleic Acid Therapeutics Reshaping the Role of CDMOs in the Biopharmaceutical Supply Chain?

Nucleic acid therapeutics—comprising modalities like antisense oligonucleotides (ASOs), small interfering RNA (siRNA), messenger RNA (mRNA), aptamers, and CRISPR-based gene editors—are driving a paradigm shift in the global pharmaceutical landscape. Their growing potential to treat previously intractable diseases, from rare genetic disorders to cancer and infectious diseases, is generating a massive wave of research and commercial interest. In this context, contract development and manufacturing organizations (CDMOs) have emerged as essential partners in the delivery pipeline. Unlike traditional biologics or small molecules, nucleic acid therapeutics require highly specialized capabilities in oligonucleotide synthesis, enzymatic production, lipid nanoparticle formulation, and sterile fill-finish processes. The complexity, customization, and regulatory rigor involved in developing and scaling these therapies have prompted biopharma innovators—especially small and mid-sized biotech firms—to increasingly outsource their manufacturing operations to experienced CDMOs. As clinical pipelines grow and diversify, CDMOs are assuming more strategic roles in process optimization, analytical method development, and cGMP manufacturing, often becoming long-term collaborators from preclinical stages to commercial launch. The success of mRNA-based COVID-19 vaccines has also validated the scalability and commercial viability of nucleic acid platforms, further accelerating demand for CDMOs with robust infrastructure, technical expertise, and regulatory track records in this space.

How Are Technological Capabilities and Infrastructure Investments Driving CDMO Differentiation?

With the nucleic acid therapeutics market maturing, CDMOs are undergoing a significant transformation in their service portfolios and technological capabilities to keep pace with evolving client demands. High-performance oligonucleotide synthesis platforms, automated purification systems, and next-generation analytical tools are now central to a CDMO’s competitive edge. In parallel, the industry is seeing massive investments in dedicated manufacturing suites for RNA and DNA therapeutics, modular cleanroom facilities, and high-throughput fill-finish lines capable of handling complex formulations such as lipid nanoparticle (LNP) encapsulated mRNA. Single-use bioreactor systems, closed processing units, and microfluidic technologies are being adopted to minimize contamination risks and optimize yields. Moreover, digital transformation is becoming a key enabler of efficiency, with CDMOs deploying electronic batch records, real-time monitoring systems, and data-driven process control to enhance quality assurance and reduce time-to-market. A critical area of differentiation lies in the ability to provide integrated end-to-end services—from process development and analytical characterization to scale-up and regulatory documentation. CDMOs that offer early-phase flexibility combined with late-stage scalability are increasingly preferred by biotech clients with accelerated development timelines and complex therapeutic profiles. Strategic acquisitions, partnerships, and geographic expansions are further shaping the competitive landscape, as players race to build specialized infrastructure capable of supporting a global pipeline of nucleic acid therapies.

How Are Regulatory Complexity and Market Dynamics Shaping the CDMO Opportunity Landscape?

As nucleic acid therapeutics transition from experimental platforms to mainstream treatment modalities, the regulatory environment surrounding their development and manufacturing is rapidly evolving. Agencies such as the FDA, EMA, and PMDA are introducing more specific guidelines for oligonucleotide synthesis, mRNA production, and LNP formulation, which places additional compliance burdens on CDMOs. Those capable of navigating this complexity with regulatory foresight and robust quality systems are increasingly favored by biopharma clients aiming to de-risk their development paths. Moreover, the trend toward accelerated approvals, fast-track designations, and orphan drug incentives has created compressed timelines, compelling sponsors to rely more heavily on CDMOs with proven track records in rapid scale-up and tech transfer. Simultaneously, global disparities in cold-chain logistics, GMP standards, and local regulatory expectations are pushing CDMOs to diversify their operations and establish regionally compliant hubs in North America, Europe, and Asia-Pacific. The competitive intensity in the nucleic acid CDMO space is also heightened by the entry of legacy biologics manufacturers and emerging players, leading to a surge in capacity building, talent acquisition, and specialization. Additionally, pricing pressures and cost-sensitive clients in the rare disease and personalized medicine sectors are prompting CDMOs to balance customization with manufacturing efficiency. These market dynamics are not only reshaping CDMO-client relationships but are also fostering the emergence of innovation-focused, quality-driven service models across the nucleic acid therapeutics value chain.

What’s Driving the Growth of the Nucleic Acid Therapeutics CDMO Market?

The growth in the nucleic acid therapeutics CDMO market is driven by several factors spanning technological innovation, evolving biopharma pipelines, changing regulatory landscapes, and increasing outsourcing trends. First, the rapid expansion of mRNA, siRNA, ASO, and gene-editing programs across biotech and pharmaceutical companies is creating sustained demand for specialized development and manufacturing expertise. Second, the technical and logistical complexity of producing nucleic acid-based drugs—especially those requiring lipid nanoparticles, cold-chain handling, and cGMP-grade purity—is pushing sponsors to engage with CDMOs that offer end-to-end capabilities. Third, the success of mRNA vaccines and the broader validation of nucleic acid platforms have attracted significant investment into the sector, enabling both established and emerging CDMOs to expand infrastructure and innovate in process technology. Fourth, the global push toward faster development timelines and regulatory acceleration is driving demand for CDMOs that can navigate complex compliance requirements while ensuring rapid scalability. Fifth, personalized medicine, rare disease treatments, and oncology pipelines increasingly rely on nucleic acid modalities, further boosting the need for flexible, agile manufacturing partners. In addition, rising outsourcing across the biopharma sector—particularly by small and virtual biotech firms with limited in-house capacity—is fueling continuous demand for CDMO collaboration. Together, these factors are shaping a robust, high-growth global market for CDMOs specializing in nucleic acid therapeutics, positioning them as critical enablers of the next wave of biopharmaceutical innovation.

SCOPE OF STUDY:

The report analyzes the Nucleic Acid Therapeutics CDMO market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Type (RNA-based Therapies, Gene Therapies); Service (Manufacturing Services, Process Development & Optimization Services, Analytical & Quality Control Services, Other Services); End-Use (Biotech Companies End-Use, Pharmaceutical Companies End-Use, Government & Academic Research Institutes End-Use); Application (Genetic Disorders, Rare Diseases, Infectious Diseases, Other Applications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 34 Featured) -

• Agilent Technologies, Inc.
• Ajinomoto Co., Inc.
• Bachem Holding AG
• BioCina Pty Ltd.
• BIOSPRING GmbH
• Catalent, Inc.
• Corden Pharma International
• Curia Global, Inc.
• Danaher Corporation (Aldevron)
• Eurogentec
• FUJIFILM Diosynth Biotechnologies
• Integrated DNA Technologies, Inc.
• KNC Laboratories Co., Ltd.
• LGC Limited
• Lonza Group Ltd
• Merck KGaA
• Nitto Denko Avecia Inc.
• Syngene International Limited
• Thermo Fisher Scientific Inc.
• WuXi AppTec

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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