Global Nucleic Acid Therapeutics CDMO Market

MARKET SCOPE:

The global Nucleic Acid Therapeutics CDMO market is projected to grow significantly, registering a CAGR of 12.6% during the forecast period (2024 – 2032).

A contract development and manufacturing organization (CDMO) is an entity that provides a range of services, including the development of medications, manufacturing, and pharmaceutical packaging with serialization and aggregation capabilities. These organizations offer supportive services to various businesses based on their own designs, formulas, specifications, or those of their clients. As defined by the National Centre for Biotechnology Information (NCBI), therapeutic nucleic acids (TNAs) constitute a specific category of nucleic acids closely associated with compounds used for the treatment of diseases through sequence-specific recognition of endogenous nucleic acids. The therapeutic application of nucleic acids can be broadly categorized into two groups: DNA therapies (encompassing gene therapy, DNA aptamers, and antisense oligonucleotides) and RNA therapeutics (including micro RNAs, short interfering RNAs, ribozymes, RNA decoys, and circular RNAs). The nucleic acid therapeutics CDMO market pertains to the products and services offered by CDMO companies for the manufacturing of nucleic acid therapeutics. These therapeutics can be manufactured by either CDMO companies or pharmaceutical firms.

MARKET OVERVIEW:

Driver: Increasing demand for nucleic acid therapeutics applications to treat chronic and genetic diseases is driving the market growth.

Surging Demand for Applications of Nucleic Acid Therapeutics in Addressing Chronic and Genetic Diseases: The increasing demand for nucleic acid therapeutics is driven by their potential to effectively treat chronic and genetic diseases. Nucleic acids, such as DNA and RNA, play crucial roles in regulating gene expression and protein synthesis within cells. Recent advancements in research have led to significant progress in developing novel techniques for delivering nucleic acids to specific cells and tissues in the body, paving the way for the creation of targeted therapeutic solutions.

Rising Approvals from Regulatory Authorities like FDA or European Medicines Agency (EMA) for Nucleic Acid Therapeutics: The approval and development of nucleic acid therapeutics, encompassing RNA and DNA-based treatments, have witnessed a substantial increase in recent years. This surge can be attributed to technological advancements and a deeper understanding of the genetic mechanisms underlying various diseases. Notably, treatments based on nucleic acid, such as Onpattro (patisiran), a small interfering RNA (siRNA) therapy for hereditary transthyretin-mediated amyloidosis (hATTR), have gained approval. In 2018, Onpattro became the first RNA interference (RNAi) therapy to receive approval from the U.S. FDA, marking a significant milestone in the field of nucleic acid therapeutics.

Opportunities: Continued research and development activities for manufacturing innovative nucleic acid therapeutics are expected to pave the way for market growth in the upcoming years.

Ongoing Research and Development Initiatives Drive Pharmaceutical Companies to Expand Operations in the Manufacturing of Innovative Nucleic Acid Therapeutics: The pharmaceutical landscape is witnessing a surge in research and development activities focused on nucleic acid therapeutics, encompassing RNA-based treatments like messenger RNA (mRNA) vaccines and small interfering RNA (siRNA) drugs. This rapidly evolving sector holds promising potential for addressing a diverse array of conditions, including genetic disorders, infectious diseases, and cancer, through the precise targeting of specific genes and proteins.

Increasing Outsourcing Orientation among Pharmaceutical Firms: A notable trend within the pharmaceutical industry is the growing inclination of companies towards outsourcing, presenting a significant opportunity for contract development and manufacturing organizations (CDMOs). Pharmaceutical entities are progressively opting to delegate various facets of their operations to external partners, spanning drug development, manufacturing processes, and clinical trials. This shift is propelled by factors such as the imperative for cost reduction, the escalating complexity of drug development, and the demand for specialized expertise.

COVID IMPACT:

The surge of the COVID-19 pandemic significantly contributed to the expansion of the market for contract development and manufacturing organizations (CDMOs) specializing in nucleic acid therapeutics. The pandemic played a pivotal role in expediting research and development activities related to nucleic acid therapeutics. Various governments and private entities augmented their financial support for research associated with COVID-19, directly fueling the growth of CDMOs operating in this domain. Additionally, the remarkable success of COVID-19 vaccines, particularly those based on mRNA technology like Pfizer-BioNTech and Moderna, garnered substantial attention towards mRNA advancements. This heightened awareness and confidence in nucleic acid treatments have led to an increased demand for CDMO services within this industry. The forthcoming influence of COVID-19 on the global market for contract development and manufacturing organizations (CDMOs) specializing in nucleic acid therapeutics hinges on the resilience of stakeholders in facing unforeseen circumstances. The extent of the future impact of COVID-19 will be determined by the ongoing initiatives of companies to fortify their supply chains with essential components and processes, ensuring adaptability and responsiveness.

SEGMENTATION ANALYSIS:

The Genetic disorders is anticipated to grow significantly during the forecast period.

The dominant share of the Genetic Disease segment in the nucleic acid therapeutics CDMO market is primarily attributed to the substantial number of FDA approvals granted for nucleic acid drugs specifically tailored to address genetic diseases. This segment plays a pivotal role in the market landscape owing to significant advancements in therapeutic approaches that focus on addressing the root causes of genetic abnormalities. Within the Genetic Disease segment, nucleic acid therapeutics encompass a diverse array of sequence-programmable medications. These therapeutic solutions provide an effective and clinically pragmatic avenue to modulate gene expression or rectify genetic abnormalities that serve as the underlying factors for various diseases. The distinctive strength of nucleic acid therapies lies in their capacity to intuitively interact with genome sequences, facilitating precise and targeted interventions at the genetic level. The Genetic Disease segment's prominence is underscored by its transformative impact on therapeutic strategies, enabling a more direct and personalized approach to addressing genetic abnormalities. This stands in contrast to conventional treatments that often manage symptoms without directly targeting the fundamental genetic triggers. The unique ability of nucleic acid therapies to engage with genome sequences positions them as a powerful tool in the pursuit of precision medicine.

REGIONAL ANALYSIS:

The North American region is set to witness significant growth during the forecast period.

In 2022, North America emerged as the dominant force in the nucleic acid therapeutics CDMO market, holding a highest share. This dominance can be attributed to several key factors, including a robust biotech industry, an advanced healthcare ecosystem, substantial investment and funding support, a well-established clinical trial infrastructure, and the presence of strong academic and research institutions in the region. Furthermore, North America's leadership in the nucleic acid therapeutics CDMO market is bolstered by global expansion efforts by CDMOs, the active involvement of key industry players, a regulatory environment that encourages proactive measures, and the growing approvals for nucleic acid therapeutics. An illustrative example of this is the FDA's approval in June 2023 for the first gene therapy designed to treat specific patients with Duchenne Muscular Dystrophy, further contributing to the region's overall growth.

COMPETITIVE ANALYSIS

The global Nucleic Acid Therapeutics CDMO market is reasonably competitive with mergers, acquisitions, and product launches. See some of the major key players in the market.

Agilent Technologies, Inc.

• In January 2022, Agilent Technologies, Inc. had invested $725 million to increase its manufacturing capacity for therapeutic nucleic acids.

Danaher Corporation

• In June 2021, Danaher Corporation had acquired Aldeveron. This acquisition had done for $9.6 billion. Through this acquisition, the company had expanded its manufacturing capacity in plasmid DNA and mRNA.

Catalent

Thermo Fisher Scientific

Lonza

FUJIFILM Diosynth Biotechnologies

Cognate BioServices

Eurofins Genomics

Sirion Biotech

Oxford Biomedica

Scope of the Report

By Type

• Gene Therapy
• RNA-based Therapies

By Service

• Process Development and Optimization
• Manufacturing Services
• Analytical and Quality Control Services
• Others

By Application

• Oncology
• Genetic Disorders
• Infectious Diseases
• Others

By End Users

• Pharmaceutical Companies
• Government & Academic Research Institutes
• Biotech Companies

By Region

North America (the United States & Canada)

Europe (Germany, UK, France, Spain, Italy, and the Rest of Europe)

Asia Pacific (China, Japan, India, and Rest of Asia Pacific)

Rest of the World (the Middle East & Africa, and Latin America)

Keys reasons to purchasing this report

It provides a technological development map over time to understand the industry’s growth rate and indicates how the Nucleic Acid Therapeutics CDMO market is evolving.

The report offers a dynamic method to various factors that drive or restrain the growth of the market and specifies which Nucleic Acid Therapeutics CDMO submarket will be the main driver of the overall market from 2024 to 2032.

It renders a definite analysis of changing competitive dynamics and stipulates the leading players and what are their prospects over the forecast period.

It builds a nine-year estimate based on how the market is predicted to grow and shows what will market shares of the global region change by 2032 and which country will lead the market in 2032.