Plasmid DNA Manufacturing Market Size to Increase USD 12.36 billion by 2033

According to Vision Research Reports, the global plasmid DNA manufacturing market size was estimated at USD 1.83 billion in 2023 and it is increasing around USD 12.36 billion by 2033, growing at a CAGR of 21.05% from 2024 to 2033. The plasmid DNA manufacturing market driven by advancements in biotechnology and an increasing demand for plasmid DNA across various applications.

Understanding Plasmid DNA Manufacturing

Plasmid DNA manufacturing refers to the process of producing large quantities of plasmid DNA molecules for various purposes, including research, diagnostics, and therapeutic applications. Plasmids are small, circular DNA molecules that are commonly found in bacteria and are widely used in molecular biology for tasks such as cloning genes, expressing proteins, and studying gene function.

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Key Pointers

• In 2023, North America emerged as the dominant force in the market, capturing the largest share at 43%.
• Asia Pacific is poised to exhibit the swiftest compound annual growth rate (CAGR) of 22.56% from 2024 to 2033.
• Within the Development Phase, the clinical therapeutics segment took the lead in revenue, commanding a share of 55% in 2023.
• In terms of Application, the cell & gene therapy sector secured the highest market share, accounting for 55% in 2023.
• The cancer domain emerged as the frontrunner in Disease segments, claiming the largest market share of 43% in 2023.
• Among Grades, the GMP grade segment stood out with a commanding market share of 87% in 2023.

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Here’s a general overview of the steps involved in plasmid DNA manufacturing:

• Plasmid Design: The first step is to design the plasmid DNA sequence according to the desired application. This may involve selecting appropriate promoters, enhancers, and other regulatory elements, as well as incorporating specific genes or genetic elements.

• Plasmid Construction: Once the plasmid design is finalized, it is constructed using molecular biology techniques such as PCR (Polymerase Chain Reaction), restriction enzyme digestion, and ligation. This involves inserting the desired DNA sequences into a plasmid vector, typically derived from naturally occurring plasmids.
• Plasmid Amplification: After construction, the plasmid is introduced into a host organism, often Escherichia coli (E. coli), which serves as a factory for producing copies of the plasmid through bacterial replication machinery. The bacteria are grown in large fermenters under controlled conditions to maximize plasmid yield.
• Plasmid Purification: Once the bacteria have produced a sufficient amount of plasmid DNA, they are harvested, and the plasmid DNA is isolated and purified from other cellular components. This typically involves cell lysis, followed by various purification steps such as centrifugation, filtration, and chromatography.
• Quality Control: Throughout the manufacturing process, quality control measures are implemented to ensure the purity, integrity, and stability of the plasmid DNA. This includes analytical techniques such as agarose gel electrophoresis, spectrophotometry, and sequencing to confirm the identity and sequence of the plasmid.
• Formulation and Storage: Once purified, the plasmid DNA may be formulated into a suitable solution or lyophilized (freeze-dried) for long-term storage. Proper storage conditions, such as temperature and humidity, are crucial to maintaining the stability of the plasmid DNA.
• Packaging and Distribution: Finally, the purified plasmid DNA is packaged and labeled according to regulatory requirements and distributed to end-users, which may include academic researchers, biotechnology companies, or clinical laboratories.

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Development Phase Insights

In 2023, the clinical therapeutics sector led the market, holding the majority share at 55%. Plasmid DNA’s importance is growing, especially in clinical research for genetic vaccination and gene therapy. Notably, plasmid DNA gene therapy is being utilized for cardiovascular conditions, enabling the transfer of plasmid DNA to skeletal or cardiac muscle. Clinical angiogenic gene therapy using plasmid DNA transfer has been administered to patients with peripheral artery disease, contributing to growth in this area.

Expected to see the fastest compound annual growth rate (CAGR) from 2024 to 2033 is the pre-clinical therapeutics segment, forecasted at 23.62%. This growth is driven by factors like increased clinical trials showing promising outcomes, a rise in chronic diseases, and heightened efforts in gene therapy advancement. The advancement of gene therapy’s clinical application and industrialization is particularly notable in Asian countries. For instance, in June 2021, Aldevron and Aruvant Sciences announced their collaboration, with Aldevron aiding in the development of ARU-1801—an investigational gene therapy for sickle cell disease (SCD), alongside ARU-2801, a gene therapy for hypophosphatasia (HPP). Additionally, to support Aruvant’s planned pivotal study for ARU-1801, Aldevron will supply a plasmid adhering to good manufacturing practice (GMP) standards.

Application Insights

In 2023, the cell & gene therapy sector took the lead in the market, commanding a substantial share of 55%. This dominance stems from the widespread use of gene therapy in treating various inherited and genetic disorders. The ongoing technological advancements aimed at creating safe and effective treatments for a range of conditions further bolster the growth of this sector.

Expected to demonstrate the highest compound annual growth rate (CAGR) from 2024 to 2033 is the DNA vaccines segment, forecasted at 23.68%. The rise in chronic illnesses and the global repercussions of the COVID-19 pandemic have spurred intensified research and development efforts for new therapies and vaccines. This increased demand drives the necessity for plasmid DNA manufacturing solutions for research purposes. For instance, in May 2020, Takara Bio partnered with AGC Biologics to produce an intermediate COVID-19 DNA vaccine—a circular DNA (plasmid DNA) containing the target pathogen’s protein. Developed through collaboration between Osaka University and AnGes Inc., this vaccine is expected to boost the revenue share of DNA vaccines in the plasmid DNA manufacturing sector.

Disease Insights

In 2023, the cancer segment held the largest market share at 43%, and it is expected to demonstrate the fastest compound annual growth rate (CAGR) of 22.77% from 2024 to 2033. The predominant use of DNA plasmids in the development of cancer treatment therapies is a significant driver propelling the expansion of this segment. The increasing adoption of various gene therapy strategies for cancer, such as genetic manipulation of apoptotic pathways, immune modulation through gene therapy, and oncolytic virotherapy, is driving up the demand for plasmid DNA and fostering substantial growth in this sector.

The rising incidence of cancer is expected to positively influence regional market dynamics throughout the forecast period. Furthermore, with the expansion of vaccine production and technological advancements, there is an anticipated increase in the demand for plasmid DNA manufacturing. According to estimates from the American Cancer Society, the projected number of new cancer cases in 2023 is approximately 1,958,310, with 609,820 expected cancer-related deaths in the U.S. This data further supports market growth, underscoring the vital role of plasmid DNA in addressing the challenges posed by cancer.

Grade Insights

In 2023, the GMP grade segment dominated the market with a substantial share of 87%. This segment’s prominence can be attributed to its extensive applications in preclinical studies, particularly in animal testing for drug safety and metabolism. Additionally, GMP-grade plasmid DNA finds utility in various applications, including direct injection as vaccines and ex-vivo applications like cell and gene therapy. Notably, plasmid DNA meeting Good Manufacturing Practice (GMP) standards is imperative for safe and effective gene transfer into humans.

This process aligns with crucial GMP requirements, ensuring a consistent production method and maintaining comparable quality standards. Moreover, many therapeutic manufacturers prefer GMP-grade plasmid DNA to meet both the volume and quality demands necessary for therapeutic applications. Recognizing the pivotal role of plasmids in influencing the quality and safety of the final product, the adoption of GMP-compliant plasmids is strongly recommended, particularly during the development of clinical batches, starting from phase 1.

Regional Insights

In 2023, North America held the largest market share globally at 43%. This significant share can be attributed to the presence of numerous research and development centers dedicated to advanced therapies. Additionally, the establishment of the Recombinant DNA Advisory Committee by the National Institutes of Health (NIH), tasked with overseeing scientific, ethical, and legal aspects related to the use of recombinant DNA techniques, has significantly influenced the adoption of these technologies. Notably, the committee plays a crucial role in evaluating research involving human gene transfer.

Expected to demonstrate the fastest compound annual growth rate (CAGR) from 2024 to 2033 is the Asia Pacific region, forecasted at 22.58%. This rapid growth is driven by factors such as untapped opportunities, economic development, improving healthcare infrastructure, and supportive government initiatives alongside efforts by biotechnology manufacturers. Furthermore, the region offers cost-effective operating and manufacturing units for research purposes. Japan leads the Asian market, serving as a prominent hub for regenerative medicine research. The Japanese government recognizes regenerative medicine and cell therapy as vital contributors to the country’s economic growth, aiming to establish global leadership in stem cell development and marketing, thereby fueling market growth in the Asia Pacific region.

Plasmid DNA Manufacturing Market Key Companies

• Charles River Laboratories
• VGXI, Inc.
• Danaher (Aldevron)
• Kaneka Corp.
• Nature Technology
• Cell and Gene Therapy Catapult
• Eurofins Genomics
• Lonza
• Luminous BioSciences, LLC
• Akron Biotech

Plasmid DNA Manufacturing Market Segmentations:

By Grade

• R&D Grade
• GMP Grade

By Development Phase

• Pre-Clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

By Application

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

By Disease

• Infectious Disease
• Cancer
• Genetic Disorder
• Others

By Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

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