Plasmid DNA Manufacturing Market By Product (Viral Vectors and Non-viral Vectors), By Grade (R&D Grade, GMP Grade, and Clinical Grade), By Application (DNA Vaccines, Cell & Gene Therapy, Immunotherapy, and Others), By Development Phase (Pre-clinical Therapeutics, Clinical Therapeutics, and Marketed Therapeutics), By Disease (Infectious Disease, Cancer, Genetic Disorder, and Others), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Plasmid DNA Manufacturing Market Size is expected to be worth around USD 8544.5 million by 2033 from USD 1185.7 million in 2023, growing at a CAGR of 21.8% during the forecast period from 2024 to 2033.

Plasmid DNA plays a vital role in healthcare, particularly in the development of vaccines and advanced cell and gene therapies. These plasmids offer advantages over recombinant viruses, as they can efficiently deliver DNA with minimal risk of oncogenicity or immunogenicity. The industry is expected to grow due to increased awareness of cell and gene therapies globally.

Plasmid DNA serves as the foundation for gene therapies and vaccines targeting infectious, genetic, and acquired diseases. As demand for robust disease treatments grows, research organizations and companies are intensifying efforts to develop advanced therapies at the genomic level. For example, in October 2021, five nonprofit organizations, the FDA, the National Institutes of Health, and around ten pharmaceutical companies collaborated to speed up the development of gene therapies for over 30 million patients in the US who have rare disorders.

Key Takeaways

• In 2023, the market for plasmid DNA manufacturing generated a revenue of USD 7 million, with a CAGR of 21.8%, and is expected to reach USD 8544.5 million by the year 2033.
• The product segment is divided into viral vectors and non-viral vectors, with viral vectors taking the lead in 2023 with a market share of 79.2%.
• Considering grade, the market is divided into R&D grade, GMP grade, and clinical grade. Among these, GMP grade held a significant share.
• Furthermore, concerning the application segment, the market is segregated into DNA vaccines, cell & gene therapy, immunotherapy, and others. The cell & gene therapy sector stands out as the dominant player, holding the largest revenue share of 51.7% in the plasmid DNA manufacturing market.
• The development phase segment is segregated into pre-clinical therapeutics, clinical therapeutics, and marketed therapeutics, with the clinical therapeutics segment leading the market.
• Considering disease, the market is divided into infectious disease, cancer, genetic disorder, and others. Among these, cancer held a significant share of 42.2%.
• North America led the market by securing a market share of 42.1% in 2023.

Product Analysis

The viral vectors segment led in 2023, claiming a market share of 79.2%, and is anticipated to maintain its dominance throughout the forecast period. Viral vectors, such as adenovirus and lentivirus, are used to deliver genetic materials into cells, enabling precise gene editing and expression. The rise of gene editing technologies such as CRISPR is further boosting the demand for viral vectors.

The adeno-associated viral vector plays a significant role due to its widespread use in cell-based gene therapies. Its ability to integrate large transgenes and facilitate higher production contributes to its substantial share in the overall market.

Grade Analysis

The GMP grade held a significant share due to its widespread use in preclinical studies (such as animal testing for drug safety and metabolism) and applications like direct injection vaccines and ex-vivo cell and gene therapy contribute to its prominence. GMP-grade plasmid DNA is essential for safe gene transfer into humans, meeting stringent quality standards.

Moreover, numerous manufacturers of therapeutics favor GMP-grade plasmid DNA for meeting the demand for quality and volume required for therapeutic usage. These factors are projected to fuel the market during the forecast period.

Development Phase Analysis

The clinical therapeutics segment had a tremendous growth rate, with a revenue share of 54.2% as plasmid DNA’s importance is rising for clinical research, especially in genetic vaccination and gene therapy.

Notably, plasmid DNA gene therapy is employed for cardiovascular disorders, allowing transfer to skeletal or cardiac muscle. Patients with peripheral artery disease have undergone clinical angiogenic gene therapy using plasmid DNA transfer, driving segment growth.

Application Analysis

The cell & gene therapy segment grew at a substantial rate, generating a revenue portion of 51.7% due to the fact that gene therapy is broadly applied in the treatment of several inherited and genetic diseases. It is extensively used in the development of personalized medicines.

Plasmid DNA is used as a crucial raw material in cell & gene therapies. The use of CAR-T cell therapies and gene editing technologies such as CRISPR is driving the demand for high-quality plasmid DNA. Moreover, continuous technological improvements in developing a safe and reliable treatment for various disorders are propelling the segment’s growth.

Disease Analysis

The cancer segment had a tremendous growth rate, with a revenue share of 42.2%. The increasing use of DNA plasmids in developing cancer treatment therapies is driving this segment’s growth. Various gene therapy approaches, including genetic manipulation of apoptosis, immune modulation-based gene therapy, and oncolytic virotherapy, contribute to the rising demand for plasmid DNA.

As cancer prevalence continues to grow, the regional market is expected to benefit throughout the forecast period. Additionally, with expanding vaccine production and technological advancements, the need for plasmid DNA manufacturing will also increase. As per the estimate of the American Cancer Society, the total number of new cases of cancer in 2023 was around 1,958,310, with deaths caused by cancer reaching 609,820 in the US. With the rise in the number of cancer cases, the need for Plasmid DNA Manufacturing is set to increase.

Key Market Segments

By Product

• Viral Vectors
• Non- Viral Vectors

By Grade

• R&D Grade
• GMP Grade
• Clinical Grade

By Application

• DNA Vaccines
• Cell & Gene Therapy
• Immunotherapy
• Others

By Development Phase

• Pre-clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

By Disease

• Infectious Disease
• Cancer
• Genetic Disorder
• Others

Drivers

Growing Demand for Gene Therapy

The growing demand for gene therapy has spurred investments in plasmid DNA manufacturing technologies and facilities due to the growing requirement to produce gene therapies that employ the use of plasmids as vectors for delivering therapeutic genes into cells. Plasmids, which can be customized to carry specific genes and regulatory elements, allow precise control over gene expression.

In January 2023, Charles River Laboratories International introduced the eXpDNA platform, leveraging their biological testing expertise. This platform supports cell and gene therapies as well as vaccine development by ensuring consistent production quality. Consequently, the rise in gene therapy production is anticipated to fuel the market during the forecast period.

Restraints

Production Issues with Large-scale Production

Large-scale plasmid DNA manufacturing faces challenges related to maintaining purity, scalability, consistency, and quality. As production scales up, maintaining healthy cell cultures becomes more complex.

Factors like oxygen distribution, shear stress, and waste accumulation impact cell growth and plasmid yield. Scaling up processes can lead to reduced yields and lower efficiency due to factors such as increased reactor volumes and changes in mixing dynamics. These scalability issues pose a restraint for the market.

Opportunities

Increase in Academic Research Activities

Academic researchers continually explore new applications for plasmid DNA, such as gene editing, synthetic biology, and personalized medicine. These discoveries drive the development of novel manufacturing processes and products. Collaborations between academic institutions and biotech/pharmaceutical companies lead to joint projects that require significant amounts of plasmid DNA. As these partnerships grow, so does the demand for plasmid DNA manufacturing. Additionally, increased academic research highlights regulatory and quality standards in plasmid DNA production.

Thus, the rise in academic research activities is projected to create lucrative opportunities for the market in the coming years. In February 2022, GenScript ProBio, one of the prominent market players, and the National Cancer Center, Japan, began a research collaboration for the development of a lentiviral & plasmid vector for CMC. This partnership is expected to boost the research and development of Plasmid DNA and novel viral vectors.

Impact of Macroeconomic / Geopolitical Factors

Macroeconomic and geopolitical factors exert a significant influence on the plasmid DNA manufacturing market, shaping its growth trajectory and dynamics. The plasmid DNA manufacturing market is influenced by Macroeconomic factors such as increased healthcare spending and government funding, which drive growth by supporting research and development. However, geopolitical tensions, trade restrictions, and export controls can create obstacles and slow market expansion. On the other hand, international collaborations and strategic partnerships can foster innovation and accelerate market growth.

Latest Trends

Expanding Gene Therapy Applications

The growing use of gene therapy presents a significant opportunity for the plasmid DNA (pDNA) manufacturing market. Gene therapy’s ability to address various genetic disorders and chronic illnesses drives demand for high-quality pDNA, crucial for delivering therapeutic genetic material into cells. As research identifies new targets and treatments, pDNA manufacturers are ready to meet increased production requirements.

Advances in bioprocessing technologies and regulatory frameworks further facilitate this expansion, allowing companies to innovate and scale production effectively to address diverse medical needs. pDNA plays a pivotal role in shaping the future of genetic medicine.

Regional Analysis

North America is leading the Plasmid DNA Manufacturing Market

North America dominated the market with the highest revenue share of 42.1% owing to the presence of numerous biopharmaceutical industry players. The region benefits from high disposable income, increased awareness of gene therapies, improved healthcare infrastructure, and growing adoption of gene therapy for various diseases.

In March 2024, Novel Bio, based in Portland, US, announced a product development and scale-up agreement with Culture Biosciences. The collaboration aims to accelerate the development of scalable fermentation processes for Culture Biosciences’ proprietary NBx Platform, used in plasmid DNA production.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

The Asia Pacific region is poised to be the most promising market during the forecast period. Factors driving this growth include increased government investments in healthcare, private sector funding for research and development in plasmid DNA, and adoption of advanced technologies such as cell culture systems and GMP practices. With key players expanding production capabilities, substantial market growth is expected.

In January 2022, Samsung Biologics, a CDMO, announced plans to construct a new facility (Plant 5) in Songdo, South Korea. This facility will enable multi-modal product manufacturing, including cell and gene therapies, viral products, and next-generation vaccines based on mRNA and plasmids.

Key Regions and Countries

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Russia
  • Netherland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • South Korea
  • India
  • Australia
  • New Zealand
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
  • Middle East & Africa
• South Africa
  • Saudi Arabia
  • UAE
  • Rest of MEA

Key Players Analysis

The major players in the plasmid DNA manufacturing market are actively engaged in the development and introduction of innovative products, as well as implementing strategic initiatives aimed at enhancing their competitive positioning. These key players are investing in new facilities, equipment, and technologies to increase production capacity and meet growing demand.

They implement advanced technologies and process improvements to enhance efficiency, yield, and quality. These companies also collaborate with biotech, pharma, and research institutions to secure long-term contracts and access new markets.

Top Key Players in the Plasmid DNA Manufacturing Market

• VGXI, Inc.
• Akron Biotech
• Cobra Biologics & Pharmaceutical Services
• Aldevron
• Plasmidfactory GmbH
• Vigene Biosciences
• Luminous Biosciences
• Nature Technology Corporation
• Delphi Genetics
• BioNTech SE
• KromaTiD
• GenScript ProBio
• JAFRAL Ltd.
• Other Key Players

Recent Developments

• In February 2023, BioNTech SE, one of the prominent market players, unveiled a new unit for plasmid DNA manufacturing in Marburg, Germany. The company expects to form an independent facility for producing plasmid DNA for clinical product candidates as well as commercial products with the inauguration of the new manufacturing unit.
• In January 2023, KromaTiD, a supplier of unique molecular tools & services, declared the extension of its services for plasmid DNA. The company has grown its portfolio with the opening of its plasmid production facilities. The company intends to aid the commercialization of regenerative medicine through these services.

Report Scope