U.S. Plasmid DNA Contract Manufacturing Market (By Application; By End-use; By Therapeutic Area) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. plasmid DNA contract manufacturing market size was estimated at USD 146.03 million in 2023 and it is expected to surpass around USD 849.23 million by 2033, poised to grow at a CAGR of 19.25% from 2024 to 2033. The U.S. plasmid DNA contract manufacturing market is driven by the increasing demand for plasmid DNA in various biotechnological applications.

Key Pointers

• By Application, the cell and gene therapy segment held the largest revenue share of 61% in 2023.
• By Application, the immunotherapy segment is anticipated to experience substantial growth from 2024 to 2033.
• By Therapeutic Area, the cancer segment generated the maximum market share of 40% in 2023.
• By End-use, the pharmaceutical and biotechnology companies contributed the largest market share of 60% in 2023.
• By End-use, the research institutes segment is expected to expand at the highest CAGR from 2024 to 2033.

U.S. Plasmid DNA Contract Manufacturing Market Overview

The U.S. plasmid DNA contract manufacturing market has witnessed significant growth in recent years, driven by the increasing demand for plasmid DNA in various biotechnological applications. This overview delves into the key factors shaping the market landscape, exploring market trends, major players, and future prospects.

U.S. Plasmid DNA Contract Manufacturing Market Growth

The growth of the U.S. plasmid DNA contract manufacturing market can be attributed to several key factors. Firstly, the increasing demand for plasmid DNA in the biopharmaceutical industry for the production of therapeutic proteins and vaccines plays a pivotal role. The expanding applications of gene therapies and personalized medicine further fuel the demand for plasmid DNA manufacturing services. Additionally, advancements in genetic engineering technologies and the rise of innovative therapeutic modalities contribute to market growth. Collaborations between pharmaceutical companies and contract manufacturers also foster the market, allowing for cost-effective and efficient production processes. Furthermore, the growing investment in research and development activities within the biotechnology sector amplifies the need for outsourced plasmid DNA manufacturing services, driving sustained market expansion.

U.S. Plasmid DNA Contract Manufacturing Market Trends:

• Rising Demand for Gene Therapies: The market is witnessing a surge in demand driven by the increasing prominence of gene therapies. Plasmid DNA serves as a crucial component in the development of these innovative therapeutic approaches, propelling the contract manufacturing sector.
• Advancements in Genetic Engineering Technologies: Continuous advancements in genetic engineering technologies contribute to the market's growth. The adoption of cutting-edge techniques enhances the efficiency and scalability of plasmid DNA manufacturing processes, meeting the evolving needs of the biopharmaceutical industry.
• Expanding Applications in Biopharmaceuticals: Plasmid DNA finds extensive applications in the production of therapeutic proteins and vaccines within the biopharmaceutical sector. This diversification of applications increases the market's significance, with contract manufacturing services playing a pivotal role in meeting the industry's production demands.
• Increasing Embrace of Personalized Medicine: The trend towards personalized medicine amplifies the demand for plasmid DNA, as it is integral to the development of tailored therapeutic solutions. Contract manufacturers play a key role in facilitating the production of personalized treatments, contributing to market expansion.
• Growing Research and Development Investments: The biotechnology sector's increasing investment in research and development activities positively influences the U.S. plasmid DNA contract manufacturing market. As companies focus on developing novel therapies, the demand for outsourced manufacturing services continues to grow, fostering market expansion.

Application Insights

In 2023, the cell and gene therapy segment secured the largest market share at 61%, establishing its dominance and poised for continued growth. This trend is primarily fueled by a surge in clinical trials and subsequent drug approvals within the field. The market's expansion is underpinned by the increasing trust, efficiency, and safety of gene treatments, addressing a spectrum of chronic and genetic disorders.

The involvement of Contract Development and Manufacturing Organizations (CDMOs) in the development of new plasmid DNA significantly contributes to market growth. A notable example is the collaboration between Ray Therapeutics and Forge Biologics, a CDMO. Their extended partnership in October 2022 focuses on manufacturing clinical-stage plasmid DNA to support Ray Therapeutics' lead optogenetics gene therapy program.

Looking ahead, the immunotherapy segment is anticipated to experience substantial growth from 2024 to 2033. This growth is propelled by heightened research and development activities in the realm of immunotherapy. Given the high prevalence of cancer, the adoption rates for novel immunotherapies have soared. A JAMA Oncology report from 2023 reveals adoption rates of approximately 11% and 27% in rural and urban clinical practices in the U.S., respectively. This prevalence is expected to drive the growth of the immunotherapy segment in the forecast years.

Therapeutic insights

In 2023, the cancer segment emerged as the dominant force in this market, claiming a substantial 40% share. This growth is primarily fueled by the escalating prevalence of cancer and the intensified focus of key industry players on cancer therapeutics. The increasing adoption of cell and gene therapy for cancer treatment is a key driver propelling the expansion of the U.S. plasmid DNA contract manufacturing market. A noteworthy example is Charles River's collaboration with Rznomics, announced in October 2023, to manufacture viral vectors for gene therapy targeting patients with liver cancer.

Anticipated to exhibit the fastest growth rate from 2024 to 2033, the infectious segment is propelled by the growing commercialization of plasmid DNA therapeutics for treating infectious diseases. For instance, the collaboration between GeneScript ProBio and RVAC in February 2023 aimed to manufacture a COVID-19 Vaccine plasmid DNA. This partnership seeks to accelerate the clinical manufacturing of RVM-V001 and future mRNA-based vaccines addressing infectious diseases such as Clostridioides difficile infection (CDI) and Respiratory Syncytial Virus (RSV).

End-use Insights

In 2023, the pharmaceutical and biotechnology companies held a commanding share of 60%, asserting their dominance in the market. This growth is attributed to the escalating production of plasmid DNA-based therapeutics throughout the U.S. Key market players are actively engaging in strategic initiatives to enhance plasmid DNA production, contributing significantly to the segment's expansion. A notable example is Charles River Laboratories International, Inc., which, in January 2023, announced the launch of the eXpDNA™ plasmid platform. This innovative platform aims to streamline plasmid manufacturing and production timelines, particularly in the context of gene therapy.

The research institutes segment is poised for the fastest growth from 2024 to 2033, fueled by increasing funding for cell and gene therapy-based research. Research institutes play a crucial role in advancing the research and development of cell and gene therapies, responding to the growing demand for plasmid DNA. The combination of augmented funding and the rising demand for plasmid DNA-based therapeutics is set to propel robust growth in this segment within the plasmid DNA contract manufacturing market. As an example, in September 2019, the National Institutes of Health (NIH) disclosed the allocation of 24 grants to researchers across the United States through the Somatic Cell Genome Editing (SCGE) Program. Funded by the NIH Common Fund, this program aims to enhance genome-editing techniques and the manufacturing of genome-editing therapies.

U.S. Plasmid DNA Contract Manufacturing Market Key Companies

• Aldevron
• Charles River Laboratories
• Akron Biotech
• VGXI, Inc.
• Catalent, Inc
• DH Life Sciences, LLC
• Recipharm AB
• TriLink BioTechnologies
• AGC Biologics
• Thermo Fisher Scientific Inc.

Recent Developments

• In February 2023, PackGene Biotech announced the expansion of its services with the addition of a new GMP biomanufacturing and processing facility in Houston, Texas. This consists of gene therapy programs and provides economical, reliable, and scalable AAV products. Through this expansion, the company aims to become a one-stop-shop solution provider for gene therapy developers.
• In January 2023, Catalent announced the new EMA and US FDA-approved pDNA manufacturing facility in Belgium. Through this, Catalent launched a new range of cataloged plasmids to offer support to cell and gene therapy developers

U.S. Plasmid DNA Contract Manufacturing Market Segmentations:

By Application

• Cell & gene therapy
• Immunotherapy
• Other application

By Therapeutic Area

• Cancer
• Infectious Diseases
• Autoimmune Diseases
• Cardiovascular Diseases
• Others

By End-use

• Pharmaceutical and Biotechnology Companies
• Research Institutes