Plasmid DNA Manufacturing Market by Scale of Operation, Application Area, Therapeutic Area, and Geography: Industry Trends and Global Forecasts, 2023-2035

The global plasmid DNA manufacturing market is expected to grow at compounded annual growth rate (CAGR) of ~15% during the forecast period. The plasmid DNA manufacturing market is a dynamic and rapidly growing sector that plays a pivotal role in biotechnology and genetic research. Plasmid DNA is a circular, double-stranded DNA molecule that replicates independently of chromosomal DNA. With its ability to be genetically engineered, plasmid DNA serves as a crucial component in the development of advanced therapy medicinal products (ATMPs), such as cell and gene therapy, and nucleic acid vaccines. Having said that, it is important to highlight that the current demand for plasmid DNA is experiencing exponential growth due to the expanding landscape of cell and gene therapies. This surge in demand got further amplified in the global COVID-19 pandemic, as plasmid-based delivery became an indispensable approach in the development of RNA/DNA vaccines and therapeutics. During this time, several big pharma players, including Moderna and Pfizer-BioNTech utilized plasmid-based platforms for their mRNA vaccines, which significantly contributed towards increased demand for plasmid DNA.

However, the process of plasmid production is fraught with various challenges, including low yield, plasmid instability, and regulatory concerns, which necessitate specialized facilities and adherence to good manufacturing practices (GMP). As a result, an increasing number of researchers and drug developers are relying on contract service providers with specialized expertise and advanced technologies for their GMP plasmid manufacturing requirements. These service providers offer comprehensive services, including process development and optimization, plasmid construction, plasmid design, and plasmid engineering. In addition, there are specialty service providers that help to streamline the pDNA manufacturing process, optimize resource utilization, and ensure the delivery of high-quality plasmid DNA to fulfill the rigorous requirements of regulatory authorities and research standards. With growing demand for ATMPs and the increasing trend of outsourcing pDNA manufacturing operations, the pDNA manufacturing market is expected to witness substantial growth during the forecast period.

Key Market Insights

This report features an extensive study of the current market landscape, market size and future opportunities within the plasmid DNA manufacturing market during the forecast period. The market report highlights the efforts of various stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the plasmid DNA manufacturing market are briefly discussed below.

Enhanced Reliability on pDNA Manufacturing Service Providers

The development and manufacturing of plasmid DNA requires significant investment in terms of time, expertise, and resources. While a few large pharmaceutical companies have established in-house manufacturing facilities, the need for substantial capital investment and complex infrastructure to produce plasmid DNA has led many other drug developers to outsource pDNA manufacturing operations to specialized service providers. Consequently, there has been an increased emphasis on collaboration, aimed at outsourcing pDNA manufacturing operations to experienced partners. Outsourcing offers a viable solution to overcome challenges associated with plasmid stability, ensuring the integrity and functionality of the desired DNA constructs. Further, there are several challenges in scaling up plasmid DNA production, particularly in process development, maintaining construct consistency, and ensuring reproducibility. These technical and operational obstacles have prompted the pharmaceutical industry to increasingly rely on plasmid manufacturers with the capability to provide contract services related to plasmid manufacturing. Additionally, the COVID-19 pandemic has fueled a surge in outsourcing activities, because of the rising demand for nucleic acid-based COVID-19 vaccines. In response to this urgent global need, numerous vaccine developers have established strategic collaborations with contract service providers to effectively meet the demand.

Plasmid Manufacturer Market Landscape

The current market landscape features the presence of over 70 companies offering a range of plasmid DNA services, including plasmid design, plasmid engineering, plasmid construction, process development and optimization, and plasmid manufacturing. Overall, the market seems to be well-fragmented, featuring the presence of very small, small, mid-sized, large, and very large companies having the required expertise to offer pDNA manufacturing services across different scales of operations, such as preclinical, clinical, and commercial. It is worth mentioning that around 80% of the plasmid manufacturer offer GMP-grade plasmid DNA for commercial-scale applications; notable examples (which have also been captured in this market report) include AGC Biologics, Aldevron, Biomay, Catalent Pharma Solutions, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI.

Technology Trends: Doggybone DNATM is Likely to Revolutionize Gene Therapy

The plasmid DNA industry is on the verge of a groundbreaking revolution, driven by the emergence of Doggybone DNA™ (dbDNA) technology developed by Touchlight. This pioneering linear plasmid technology, produced abiotically through rolling circle amplification, represents a seismic shift in this field. DbDNA™ offers unparalleled advantages, including enhanced stability, simplified purification, and cost-effective scalability, challenging conventional plasmid production methods. With its remarkable versatility in genetic engineering, gene therapy, and mRNA production, dbDNA™ stands as a highly promising solution. It is interesting to note that in February 2023, Touchlight received FDA clearance for the Investigational New Drug (IND) application utilizing doggybone DNA (dbDNA™) as an in vitro transcription template for mRNA production in the manufacturing of a cell therapy product.  Adoption of such novel plasmid DNA technologies will support the efforts of the industry to meet the growing demand for this starting material for cell therapy and mRNA therapy. Novel technologies will propel the plasmid DNA manufacturing market growth during the forecast period.

Leading Companies Engaged in Plasmid DNA Manufacturing Market

Examples of key plasmid manufacturers (which have also been profiled in this report) offering pDNA manufacturing services include (in alphabetical order) AGC Biologics, Aldevron, Biomay, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI. It is interesting to note that in January 2023, Charles River expanded its portfolio by launching the eXpDNA™ plasmid manufacturing platform, in order to offer efficient and accelerated GMP plasmid manufacturing and supply services to ATMP developers. Such portfolio additions are expected to drive plasmid DNA manufacturing market growth during the forecast period.

Expansion of Facilities for Building GMP Plasmid Manufacturing Capabilities

The players in this market are continuously expanding their facilities in order to accommodate the growing demand for plasmid DNA. They are vigorously advancing their capabilities to serve as a fully integrated one-stop-shop by offering a range of plasmid services, including process development and optimization, plasmid design, plasmid engineering and plasmid construct, and GMP plasmid manufacturing. In January 2023, Catalent Pharma Solutions, a US-based CDMO, established a new commercial scale plasmid development and manufacturing facility to expand its end-to-end capabilities for the production of GMP-grade plasmid DNA. An increase in the demand for plasmid DNA to support the production of cell and gene therapies is one of the reasons for the facility/capability expansion by the contract organizations.

Market Trends: Partnership and Collaboration on the Rise for Plasmid DNA Manufacturing

Stakeholders in the plasmid manufacturing industry have forged several partnerships to enhance their service portfolios and augment the reach of their proprietary plasmid DNA technology. It is worth highlighting that over 55% of these partnerships have been inked since 2021. Notably, the majority of such deals are focused on manufacturing and supply of plasmid products, followed by product development and technology utilization agreements. In May 2023, Aldevron signed an agreement with Evanoa Bioscience to improve its fermentation process by using the latter’s novel strains of Escherichia Coli. In another similar deal inked between AcuraBio and Cytiva in February 2023, the former company adopted Cytiva’s single-use bacterial plasmid purification technology to expand its cGMP pDNA manufacturing service.

Plasmid DNA Manufacturing Market Size: Gene Therapy Market Segment to Hold the Largest Market Share

Driven by the increasing adoption of gene therapies and rising demand for nucleic acid vaccines, the plasmid DNA manufacturing market is anticipated to grow at an annualized rate (CAGR) of ~15% during the forecast period 2023-2035. It is worth highlighting that, in terms of application area, gene therapy manufacturing is expected to capture the majority of the market share in the plasmid DNA manufacturing market in 2023.

Recent Developments

Several recent developments have taken place in the field of plasmid manufacturing. Some of these recent initiatives have been mentioned below. These developments, even if they took place post the release of the market report, substantiate the overall market trends that the publisher has outlined in the analyses.

• In June 2023, INADcure Foundation announced a manufacturing alliance with Charles River Laboratories, under which the latter will be responsible for manufacturing high-quality pDNA for phase I/II clinical trials of gene therapy against Infantile Neuroaxonal Dystrophy.
• In February 2023, BioNTech, a leader in mRNA vaccine and therapy developer, announced the completion of its in-house clinical and commercial scale pDNA manufacturing facility at Marburg, Germany.

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined below:

Historical Trend: 2018-2022

Base Year: 2022

Forecast Period: 2023-2035

CAGR: ~15%

Scale of Operation

• Commercial 
• Clinical 
• Preclinical

Application Area

• Cell Therapy Manufacturing
• Gene Therapy Manufacturing
• DNA / RNA Vaccine Development 
• Viral Vector Manufacturing
• Other Application Areas

Therapeutic Area

• Metabolic Disorders 
• Neurological Disorders 
• Oncological Disorders 
• Rare Disorders
• Other Disorders

Geography

• North America
• Europe
• Asia
• Latin America
• Middle East and North Africa
• Rest of the World

Key Companies Profiled

• AGC Biologics 
• Aldevron 
• Biomay
• Catalent Pharma Solutions
• Charles River 
• Cytovance Biologics 
• Forge Biologics 
• GenScript ProBio 
• Thermo Fisher Scientific
• VGXI

(Full list of more than 70 companies captured is available in the report)

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different geographies. Amongst other elements, the market research report features:

• A preface providing an introduction to the full report, Plasmid DNA Manufacturing Market, 2023-2035.
• An outline of the systematic research methodology adopted to conduct the study on the plasmid DNA manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure the accuracy and reliability of the findings.
• An overview of economic factors that impact the overall plasmid DNA manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during the research, offering a high-level view of the current state of the plasmid DNA manufacturing market and its likely evolution in the short to mid and long term.
• A general overview of plasmid DNA, highlighting details on different types of plasmids based on their function. It also features the various applications of plasmid DNA in the pharmaceutical industry. Further, it provides information on the challenges associated with pDNA manufacturing, as well as the growing need for outsourcing the production of such products.
• An overview of the current market landscape of plasmid DNA service providers based on relevant parameters, such as year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe, Asia, and rest of the world), type of company (CDMOs, CMOs, CROs/CMOs, CROs, suppliers and others), type of venture (private companies, acquired by public companies, public companies, acquired by private companies),  type of service(s) offered (plasmid design, and plasmid construction, process development and optimization, and plasmid manufacturing), location of manufacturing facility (North America, Europe, Asia and rest of the world), key offerings (proprietary technology / platforms and plasmid DNA products), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (preclinical, clinical, and commercial) and application area(s) (cell and gene therapy manufacturing, DNA / RNA vaccine development, viral vector manufacturing, and other application areas).
• An insightful analysis, highlighting the contemporary market trends in the plasmid DNA manufacturing market through different representations, based on relevant parameters, such as company size and location of headquarters; company size and type of venture; key offerings and location of headquarters; scale of operation and company size; grade of plasmid DNA and application area(s); scale of operation, application area(s) and location of manufacturing facility.
• A detailed analysis of the partnerships inked between various stakeholders engaged in this market, since 2015, covering manufacturing and supply agreements, product development and manufacturing agreements, technology utilization agreements, service alliances, and product development agreements.
• A detailed analysis of the acquisitions reported in the plasmid manufacturing market, during the period 2015-2023. It is worth mentioning that the data captured during the research was analyzed based on multiple parameters, such as year of acquisition, type of acquisition, geographical location, company size and ownership of the companies involved, key value drivers, and acquisition deal multiples (based on revenues).
• An estimate of the overall installed pDNA manufacturing capacity of industry players based on the information available in the public domain, and insights generated via both secondary and primary research. It also highlights the distribution of global capacity by company size (very small, small, mid-sized, large, and very large), grade of plasmid DNA (research grade plasmid DNA, and GMP grade plasmid DNA), scale of operation (pre-commercial and commercial), and location of manufacturing facility (North America, Europe, Asia and rest of the world).
• Detailed competitiveness analysis of pDNA manufacturing service providers based on supplier power (based on the experience), their respective capabilities (types of services offered, grade of plasmid DNA, scale of operation, application areas, total capacity, number of acquisitions), and partnership activity (in terms of number of partnerships and type of agreement).
• Elaborate profiles of prominent players (shortlisted based on the proprietary company competitiveness) engaged in offering plasmid manufacturing services. Each profile features a brief overview of the company (including information on the year of establishment, number of employees, location of headquarters, and key executives), details related to its financial performance (if available), recent developments, and an informed future outlook.
• An in-depth analysis to estimate the current and future demand for plasmid DNA, based on several relevant parameters, such as scale of operation (commercial, clinical, and preclinical), application area (cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, and viral vector manufacturing), and geography (North America, Europe, Asia, Latin America, Middle East, and North Africa, and Rest of the World) for the period 2023-2035. Kindly note that input parameters considered for this analysis include target patient population, dosing frequency, and dose strength.
• An in-depth analysis of the factors that can impact the growth of the plasmid DNA manufacturing market. It also features the identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

The key objective of this market report is to provide a detailed market forecast analysis to estimate the existing market size and future opportunities for plasmid manufacturers over the next decade. Based on multiple parameters, likely adoption trends, and through primary validations, the publisher has provided an informed estimate of the market evolution during the forecast period 2023-2035. The report also features the likely distribution of the current and forecasted opportunity within the plasmid DNA manufacturing market across various segments, such as scale of operation (commercial, clinical, and preclinical), application area (cell therapy manufacturing, gene therapy manufacturing, DNA / RNA vaccine development, and viral vector manufacturing, and other application areas), therapeutic area (metabolic disorders, neurological disorders, oncological disorders, rare disorders, and other disorders), and geography (North America, Europe, Asia, Latin America, Middle East, and North Africa and rest of the world). In order to account for future uncertainties and to add robustness to the model, the publisher has provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the market report were influenced by discussions held with stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders: 

• Frenk Smrekar (Chief Executive Officer and Co-Founder, JAFRAL Biosolutions) 
• Jeff Briganti (Senior Director of Global Strategic Marketing, Aldevron) 
• Francisco Manuel Reyes Sosa (Business Development Manager, 53Biologics)
• Blaine Rathmann (Client Engagement Manager, Center for Breakthrough Medicines)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are the steps in plasmid DNA manufacturing?
Answer: The steps involved in plasmid DNA manufacturing include plasmid design and plasmid construction, host cell transformation, culture expansion, plasmid isolation and purification, and quality control testing.

Question 2: What is GMP plasmid manufacturing?
Answer: GMP plasmid manufacturing involves compliance with comprehensive quality control and assurance standards, including facility design, equipment qualification, raw material selection, process controls, documentation, quality control testing, and personnel training, in order to ensure the production of high-quality plasmid DNA.

Question 3: Who manufactures plasmid DNA?
Answer: Plasmid DNA is manufactured by various organizations, including biotechnology companies, contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), academic institutions, and research laboratories with the necessary capabilities and expertise in molecular biology and bioprocessing.

Question 4: Who are the key players in the plasmid DNA manufacturing market?
Answer: Examples of key players engaged in the plasmid manufacturing market (which have also been captured in this report) include AGC Biologics, Aldevron, Biomay, Catalent Pharma Solutions, Charles River, Cytovance Biologics, Forge Biologics, GenScript ProBio, Thermo Fisher Scientific, and VGXI.

Question 5: What are the leading market segments in the plasmid DNA manufacturing market?
Answer: Currently, in terms of scale of operation, commercial scale manufacturing of plasmid DNA captures the largest market share. Further, in terms of therapeutic area, metabolic disorders and oncology are expected to capture a prominent share of the current and future market.

Question 6: Which region has the highest market share in plasmid DNA manufacturing market?
Answer: Currently, North America and Europe collectively hold around 70% of the market share. However, in the long run, the pDNA manufacturing market in Asia is expected to grow at a relatively faster pace.

Question 7: What is the plasmid DNA manufacturing market growth?
Answer: The global plasmid manufacturing market revenue is anticipated to grow at a compound annual growth rate (CAGR) of ~15%, during the forecast period, 2023-2035.

Question 8: What are the factors driving the plasmid DNA manufacturing market?
Answer: Advancements in genetic engineering, coupled with the increasing demand for genetically modified therapies and nucleic acid vaccines will lead to a significant growth in the plasmid DNA manufacturing market, over the forecast period.

Question 9: What are the upcoming trends in the plasmid DNA manufacturing market?
Answer: The plasmid DNA manufacturing market is witnessing a shift towards automation, with the implementation of robotic systems and automated technologies across various manufacturing stages. This has led to enhanced efficiency, scalability, and productivity; for instance, the use of robotic systems for high-throughput screening of transformed cells enabled rapid identification and selection of desired plasmid constructs with improved efficiency and accuracy.