GMP Plasmid DNA Manufacturing Market Growth and Restrain Factors Analysis Report

InsightAce Analytic Pvt. Ltd. has announced the publication of a market research report titled "Global GMP Plasmid DNA Manufacturing Market By Product(Viral Vectors(Retroviral, Adenoviral, Lentiviral, Adeno-Associated, Others), Plasmid DNA, Non-viral, Lipid/polymer, Electroporation, Nanoparticles, Others), Types (Pre-Clinical Therapeutics, Clinical Therapeutics, Marketed Therapeutics), Application(Gene Therapy, DNA Vaccines, Immunotherapy)) Market Outlook and Industry Analysis 2031" .

The GMP Plasmid DNA Manufacturing Market Size is valued at 389.00 Million in 2022 and is predicted to reach 1047.14 Million by the year 2031 at a 12.1 % CAGR during the forecast period for 2023-2031.

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The major market players includes BioXcellence, Patheon (Thermo Fisher Scientific), Cobra Bio, GenScript ProBio, WuXi Advanced Therapies, Waisman Biomanufacturing, Aldevron, LakePharma, Kaneka Eurogentec S.A., Catalent Biologics, VectorBuilder, VGXI, Inc, Delphi Genetics (Catalent), Esco Aster, Biovian, Vigene Biosciences(Charles River), Cognate BioServices (Charles River), Creative Biolabs, Forge Biologics, Akron Biotech, PackGene Biotech lnc., ACG Biologics, Ajinomoto Bio-Pharma and other market players.

Plasmid DNA is becoming increasingly crucial in clinical research applications such as gene therapy and genetic vaccination. Good manufacturing procedure (GMP)-grade plasmid DNA is required for direct gene transfer into humans. Plasmids are valuable molecular biology and genetics tools, particularly in genetic engineering. They are essential for cloning genes, making recombinant proteins, and analyzing gene therapy. These plasmid DNA productions scale from a few milligrams to Kilograms. Plasmid DNA is manufactured in different types, in which GMP grade is versatile and has more applications. GMP-grade plasmid DNAs are commonly used for pre-clinical studies, including toxicology and biodistribution studies. This type of plasmid DNA is needed for direct gene transfer into patients.

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Plasmids are superior to recombinant viruses for manufacturing vaccinations and gene therapies since they can transport massive amounts of DNA without triggering inflammation or cancer. Thus, It is expected that these factors are likely to fuel the market growth. The market growth also contributed to growing awareness of cell and gene therapy. The main factors are the availability of licenced gene therapy products and the rise of cell and gene therapy products used to treat different diseases worldwide.
Furthermore, the COVID-19 pandemic led to a share of research into making vaccines to prevent infection. The key market players are performing strategic acquisitions and partnerships, which are responsible for the overall market growth. In March 2021, Charles River acquired the Cognate BioServices for the gene therapy program. Moreover, new companies are starting with cutting-edge technology to meet the growing demand and improve their positions in the global market. However, The progress of the global GMP plasmid DNA manufacturing market is likely to be slowed by the high cost of gene treatments and the risk of insertional mutagenesis.

North America dominated the market in 2021, accounting for the largest share. A large number of organizations and institutes engaged in advanced therapy research and development, along with increased demand for effective disease treatment treatments, contribute to regional growth. To address rising demand and expand their position in the global market, prominent companies in North America are approaching the market with cutting-edge technology.
The Asia-Pacific region is anticipated to hold the largest market share during the forecast period. The growth is attributed to increased spending on the healthcare sector, and international companies are boosting their spending to promote GMP plasmid DNA production.

Key Market Developments
• In Sept 2022, Charles River Laboratories and Cure AP-4 announced a production partnership. Charles River will provide HQ plasmid DNA for Phase I/II gene therapy trials against AP-4 HSP by Cure AP-4.
• In Dec 2021, Aldevron is now launching its pALD-HELP, an off-the-shelf solution that aids in the production of AAV viral vectors under its patented GMP-Source® (GMP-S) quality level. The plasmid is royalty-free for all uses ranging from pre-clinical through clinical research.
• In Jun 2021, Charles River Laboratories finished buying Vigene Biosciences, Inc. for $292.5 million in cash, with the usual adjustments made at closing. In addition to the initial pricing, the deal calls for up to $57.5 million in additional payments, depending on how well the company does in the future. The acquisition allowed clients to do all of their process development, analytical testing and manufacturing for advanced modalities with the same scientific partner. This helped them reach their goal of making their products more efficient and getting them to market faster.
• In Jan 2021, Cobra Biologics, the gene therapy subsidiary of Cognate BioServices, announced a multi-phase expansion of its plasmid DNA services as part of the company's Gene Therapy services expansion project for viral vectors and plasmid DNA. This features a fourfold expansion in HQ (High Quality) DNA manufacturing capacity at its European sites and new clinical and commercial GMP DNA facilities.
• In Dec 2020, Thermo Fisher Scientific announced the development of a new plasmid DNA cGMP production facility in Carlsbad, California. The site extended the company's clinical and commercial capabilities for cGMP plasmid DNA, a crucial raw material used to develop and manufacture cell and gene-based therapeutics, such as lifesaving cancer treatments and mRNA vaccines. In addition, the location will be able to synthesize plasmid DNA as a primary therapeutic ingredient for DNA therapies on a big scale.
• In Dec 2019, AGC Biologics substantially increased its CDMO services with the addition of plasmid DNA (pDNA) capabilities at its Heidelberg, Germany, location. The site has completed a pDNA manufacturing process enhancement project that has enabled the extension of the offer in hosts and plasmids (low and high copy pDNA expression systems) through a broad toolbox in process development with sizes ranging from 1L to 10L for High-Quality pDNA.

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Market Segmentation
Global GMP Plasmid DNA Manufacturing Market, by Products, 2022-2030 (Value US$ Mn)
• Viral Vectors
o Retroviral
o Adenoviral
o Lentiviral
o Adeno-Associated
o Others
• Plasmid DNA
• Non-viral
• Lipid/polymer
• Electroporation
• Nanoparticles
• Others

Global GMP Plasmid DNA Manufacturing Market, by Types, 2022-2030 (Value US$ Mn)
• Pre-Clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

Global GMP Plasmid DNA Manufacturing Market, by Application, 2022-2030 (Value US$ Mn)
• Gene Therapy
• DNA Vaccines
• Immunotherapy

Global GMP Plasmid DNA Manufacturing Market, by Region, 2022-2030 (Value US$ Mn)
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
North America GMP Plasmid DNA Manufacturing Market, by Country, 2022-2030 (Value US$ Mn)
• U.S.
• Canada
Europe GMP Plasmid DNA Manufacturing Market, by Country, 2022-2030 (Value US$ Mn)
• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe
Asia Pacific GMP Plasmid DNA Manufacturing Market, by Country, 2022-2030 (Value US$ Mn)
• India
• China
• Japan
• South Korea
• Australia & New Zealand
Latin America GMP Plasmid DNA Manufacturing Market, by Country, 2022-2030 (Value US$ Mn)
• Brazil
• Mexico
• Rest of Latin America
Middle East & Africa GMP Plasmid DNA Manufacturing Market, by Country, 2022-2030 (Value US$ Mn)
• GCC Countries
• South Africa
• Rest of Middle East & Africa

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Other Related Reports Published by InsightAce Analytic:
Global mRNA Synthesis and Manufacturing Services Market
Global Lipid Nanoparticles (LNPs) CDMO Market
Global DNases, ligases, and RNA Polymerases Market
Global Advanced Therapy Medicinal Products CDMO Market
Global DNA and Gene Cloning Services Market
Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market

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