Plasmid DNA Manufacturing Market Size Expected to Reach USD 10.22 Bn by 2033

The global plasmid DNA manufacturing market size is expected to reach around USD 10.22 billion by 2033 from USD 1.8 billion in 2023, expanding at a healthy CAGR of 18.73% from 2024 to 2033.

Ottawa, May 01, 2024 (GLOBE NEWSWIRE) — The global plasmid DNA manufacturing market size is calculated at USD 2.18 billion in 2024, According to Precedence Research. Rising research on gene therapies and genetic vaccination plasmid DNA are applied that contribute to the market’s growth.

The plasmid DNA manufacturing market growing due to the increasing demand for gene therapies. The plasmid DNA manufacturing process involves the selection and isolation of plasmid for design, growth of the cell and DNA replication, harvesting, purification, quality control, and the plasmids grown in controlled conditions by using E. coli as host cell culture. Plasmid DNA manufacturing increases due to its importance in clinical research used in genetic vaccination and DNA/RNA-based therapies. Plasmid DNA is the most important for genetic engineering including manufacturing of advanced biotherapeutics, recombinant proteins, and viral vectors.

Purified plasmid DNA may be used as a raw material in processes like the production of lentiviral and adeno-associated vectors (AAV), in vitro transcription (IVT) reactions during mRNA production, and direct gene transfer which contribute to the growth of the plasmid DNA manufacturing market.

Key Insights

  • North America dominated the plasmid DNA manufacturing market in 2023 and is estimated to be the fastest-growing during the forecast period of 2024-2033.
  • Asia-Pacific is estimated to be the most opportunistic market during the forecast period of 2024-2033.
  • By product, the viral vector segment dominated the market in 2023 and also the segment is the fastest-growing during the forecast period.
  • By application, the gene therapy segment dominated the market in 2023.
  • By disease, the infectious disease segment dominated the market in 2023.
  • By disease, the cancer segment is the most opportunistic segment during the forecast period.

U.S. Plasmid DNA Manufacturing Market Size 2024 to 2033

The U.S. plasmid DNA manufacturing market size surpassed USD 550 million in 2023 and is anticipated to hit around USD 3,270 million by 2033, growing at a notable CAGR of 19.26% from 2024 to 2033.

North America dominated the plasmid DNA manufacturing market in 2023 and is estimated to be the fastest growing during the forecast period of 2024-2033.

Thermo Fisher Scientific, Inc., Voyager Therapeutics, UniQure and MassBiologics, and Renova Therapeutics are the key players in the market in North America. Many clinical and preclinical trials have been done and going on for the production of high-quality plasmid DNA in the North American region. Most of the mRNA vaccine production is contributed by biopharma companies based in North America. A major bottleneck is the supply of raw materials and other critical ingredients, including plasmid DNA templates, deoxynucleotide triphosphates, and in-vitro-transcription, capping, and DNA digestion enzymes from the North American region.

  • In a significant move reported in October 2023, Akron Biotechnology, a biotechnology company headquartered in the United States, inaugurated a manufacturing facility in Sarasota, Florida. This facility commenced operations in April 2022 with a primary focus on producing plasmid DNA. The aim behind this strategic initiative is to meet the escalating demands within the swiftly expanding vaccine and gene therapy sectors.

Asia-Pacific is estimated to be the most opportunistic marketplace during the forecast period of 2024-2033. For the treatment of intra-abdominal infections and treatment of chronic hepatitis-B, cancer diseases in the Asia-Pacific region, the use of gene therapies contributes to the growth of the market. The government and private sectors of the Asia-Pacific region are investing in healthcare and the field of plasmid DNA which contributes to the growth of the market.

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Scope of Plasmid DNA Manufacturing Market

Report Coverage         Details
CAGR 18.73 % from 2024 to 2033
Market Size in 2023 USD 1.8 Billion
Market Size in 2024 USD 2.18 Billion
Market Size by 2033 USD 10.22 Billion
Largest Market North America
Base Year 2023
Forecast Year         2024 to 2033
Historical Year         2021-2022
Segments Covered Product Type, Application Type, Disease Type, and Regions
Regions Covered         North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Report Highlights

By Product Type

The viral vector segment dominated the market in 2023 and is also the fastest-growing during the forecast period. The manufacturing of investigational new drugs (IND), like viral vectors used in gene therapy, needs to obey the CGMP. The utilization of viruses to convert genes of importance into mammalian cells has been very revolutionary, both in terms of laboratory research and clinical purposes. This advance has allowed over-expression and expression of proteins of interest and the understanding of both eukaryotic cell and virus life cycle mechanisms.

Viral vectors have been modified step by step to increase their transduction effectiveness and to reduce their inflammatory, toxicity, and immunogenicity potential. Viral vectors are normally safer than replicating vectors. Viral vectors are used in clinical as well as pre-clinical trials as vaccines against many infectious diseases, such as Ebola, HIV, Malaria, and recently, SARS-CoV-2. Each has risks and benefits regarding efficacy, immunogenicity, and safety.

By Application Type

The gene therapy segment dominated the market in 2023 and is also the fastest-growing during the forecast period. The application of gene therapy is introducing genetic material into the cells to recompense for the unusual genes, and to make favorable and advantageous protein. Gene therapy may be capable of introducing a common copy of the gene for protein function restoration if an essential protein is caused by a mutated gene missing. There is an advantage of gene therapy for viral vectors to achieve more effective transfer of the genes in vivo. Gene expression therapy studies in human and mammalian cells are important for proceeding with our knowledge in generating disease gene models in animals and for developing human gene therapy studies.

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By Disease Type

The infectious disease segment dominated the market in 2023 and is also the fastest-growing during the forecast period. The manufacturing capability of DNA vaccines may be important for infectious diseases including the novel H1N1 Influenza A, where pre-existing immunity is restricted. Plasmid DNA vaccines may be an option to effectively combat emerging infectious diseases.

The cancer segment is the most opportunistic segment during the forecast period. Cancer is the main cause of death worldwide according to the World Health Organization (WHO). Various treatments and methods are used for cancer. Among the other treatments and methods for cancer treatment, the most optimistic results are from the DNA plasmid molecules.

Market Dynamics

Driver

Rising demand for plasmid DNA:

For therapeutic applications, the demand for plasmid DNA is high. Plasmid DNA stands for favorable gene therapies and DNA vaccines against many genetic, infectious, and acquired diseases, including Malaria, HIV-AIDS, Ebola, and enteric pathogens, influenza, and types of cancer. As compared to other conventional vaccines DNA vaccines have more advantages like not being infectious, high stability, long-term persistence vaccine protection, and focusing the immune response to only those antigens desired for immunization. Especially in developing regions, where effective vaccines are frequently unavailable or too costly, there is a necessity for both improved and new vaccines.

Restraint

Expandability issues in high-scale plasmid DNA:

To get better high-scale plasmid DNA may be difficult due to their similarity in some contaminants, size, and shear sensitivity. High-scale cell cultures may be difficult to harvest, maintain, and monitor. Shear forces may harm plasmid DNA and reduce or degrade precipitated genomic DNA, contaminating the plasmid extract. Large plasmid DNAs are challenging to purify by using normal methods like resins they may not smoothly diffuse through the pores. Separation of plasmid DNA from contaminants like unwanted isoforms of the plasmid to obtain a homogeneous product may be difficult and require multiple chromatographic steps.

Browse More Insights:

  • Viral Vectors & Plasmid DNA Manufacturing Market: The global viral vectors & plasmid DNA manufacturing market size was estimated at USD 5.4 billion in 2023 and it is expected to hit around USD 23.7 billion by 2033 and expanding growth at a noteworthy CAGR of 15.94% from 2024 to 2033.
  • DNA Sequencing Market: The global DNA sequencing market size is expected to be worth around USD 37.99 billion by 2032 from USD 11.06 bn in 2023, with a compound annual growth rate (CAGR) of 14.7% from 2023 to 2032.
  • Recombinant DNA Technology Market: The global recombinant DNA technology market size was accounted for USD 754 billion in 2022 and is expected to surpass around USD 1395.50 billion by 2032, poised to grow at a CAGR of 6.40% from 2023 to 2032.
  • DNA Synthesis Market: The global DNA synthesis market size was reached at USD 3.50 billion in 2022 and is expected to hit around USD 20.87 billion by 2032, poised to grow at a CAGR of 19.6% from 2023 to 2032.
  • DNA Polymerase Market: The global DNA polymerase market size was estimated at USD 329.1 million in 2022 and is expected to hit around USD 582.6 million by 2032, registering a CAGR of 5.87% from 2023 to 2032.
  • DNA Synthesizer Market: The global DNA synthesizer market size accounted for USD 274.11 million in 2022 and it is expected to hit around USD 1,070.02 million by 2032, poised to grow at a CAGR of 14.59% from 2023 to 2032.
  • DNA Diagnostics Market: The global DNA diagnostics market size was reached at USD 12.46 billion in 2022 and it is projected to hit around USD 20.1 billion by 2032, registering a CAGR of 4.9% during the forecast period 2023 to 2032.
  • DNA Microarray Market: The global DNA microarray market size reached USD 2.28 billion in 2023 and is projected to be worth around USD 5.04 billion by 2032, growing at a CAGR of 9.20% from 2023 to 2032.
  • DNA Forensics Market: The global DNA forensics market size was valued at USD 2.79 billion in 2023 and is anticipated to reach around USD 5.52 billion by 2033, growing at a CAGR of 7.05% from 2024 to 2033. 
  • Gene Synthesis Market: The global gene synthesis market size was exhibited at USD 2.10 billion in 2022 and is expected to surpass around USD 17.99 billion by 2032 with an enhanced CAGR of 23.97% during the forecast period 2023 to 2032.

Opportunity

Technological advancements:

Technological advancement in medicinal products is necessary with the opportunity to treat patients at the genetic level, the pharmaceutical industry expanded the pattern of the treatment to potentially curative and innovative approaches. Technological advancements in gene therapy provide an opportunity not only for addressing an unmet medical need but also to truly target the cause of disease at the genetic level. This is different from the traditional treatment-based medicine approach, which the classified as advanced therapy medicinal products (ATMPs). Plasmid generation normally requires a standalone process of manufacturing based on microbial expression technology.

Not only for the quality of the plasmid used in the manufacturing process but also the AAV production processes require starting material, either plasmid or HSV or baculoviral starting viruses. For fast isolation of high-purity plasmid DNA is suitable for all of the conventional molecular biology procedures like, PCR, fast digestion, in vitro transcription, transformation, etc.

Recent Developments

  • In September 2022, Forge Biologics launched plasmid DNA manufacturing services at its Columbus, Ohio, location.
  • In January 2023, Catalent launched the new US FDA and EMA-approved pDNA manufacturing facility in Belgium.
  • In January 2023, a supplier of unique next-level molecular tools and services, KromaTiD, announced that it has expanded its offerings to include plasmid DNA manufacturing.
  • In January 2023, Charles River Laboratories International, Inc., launched its eXpDNA™ plasmid platform, established from the Company’s contract development and manufacturing (CDMO) and biologics testing experience. This platform remarkably reduces plasmid production and development timelines when streamlining the producing journey for cell and gene therapy and vaccine manufacturers with a focus on product consistency and quality.

Market Key Players

  • Akron Biotech
  • Aldevron
  • Cobra Biologics & Pharmaceutical Services
  • Delphi Genetics
  • JAFRAL Ltd.
  • Luminous Biosciences
  • Nature Technology Corporation
  • Plasmidfactory GmbH
  • Vigene Biosciences
  • VGXI, Inc.

Market Segmentation

By Product

  • Viral Vectors
  • Plasmid DNA
  • Non-Viral
  • Electroporation
  • Lipid/Polymer
  • Nanoparticles
  • Others

By Application

  • Gene Therapy
  • DNA Vaccines
  • Immunotherapy
  • Others

By Disease

  • Infectious Disease
  • Genetic Disorder
  • Cancer

By Regions

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

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