GMP Plasmid DNA Manufacturing Market: A Catalyst for Innovation in Cancer Treatments, Rare Disease Therapies, and Gene Editing Technologies pen_spark

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"

According to company's newest research, the Global GMP Plasmid DNA Manufacturing Market is worth US$ 389.00 Mn in 2022 and is predicted to reach US$ 1047.14 Mn in 2031, with a promising CAGR of 12.1% between 2023 and 2031.

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.

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Plasmid DNA is becoming more and more essential in clinical research applications, including genetic vaccination and gene therapy. Direct gene transfer into humans necessitates plasmid DNA that is of good manufacturing procedure (GMP) quality. Plasmids are significant instruments in the fields of molecular biology and genetics, particularly in the field of genetic engineering. They are indispensable for the purposes of gene therapy analysis, recombinant protein production, and gene cloning. The magnitude of these plasmid DNA productions ranges from a few milligrams to kilograms. Plasmid DNA is produced in a variety of forms, with the GMP grade being the most versatile and having a wider range of applications. GMP-grade plasmid DNAs are frequently employed in preclinical studies, such as toxicology and biodistribution tests. For the direct transfer of genes into patients, this particular type of plasmid DNA is required.

Plasmids are more effective than recombinant viruses in the production of gene therapies and vaccinations because they can transport substantial quantities of DNA without causing inflammation or malignancy. Consequently, it is anticipated that these factors will serve as a catalyst for market expansion. The increasing awareness of cell and gene therapy was also influenced by the market growth. The availability of licensed gene therapy products and the proliferation of cell and gene therapy products that are employed to treat a variety of diseases on a global scale are the primary factors.

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Additionally, the COVID-19 pandemic stimulated a significant amount of research into the development of vaccines to prevent infection. The overall market growth is the result of the strategic acquisitions and partnerships that the main market players are executing. Charles River acquired Cognate BioServices in March 2021 for the gene therapy program. Additionally, in order to satisfy the expanding market and enhance their market positions, numerous organizations are establishing themselves with state-of-the-art technologies. Nevertheless, the global GMP plasmid DNA manufacturing market is expected to experience a setback due to the high cost of gene treatments and the risk of insertional mutagenesis.

The market was primarily dominated by North America in 2021, with the largest share. The regional growth is influenced by a significant number of organizations and institutions that are involved in the research and development of advanced therapies, as well as the growing demand for effective disease treatment treatments. Prominent companies in North America are employing state-of-the-art technology to meet the increasing demand and enhance their market share on a global scale.

It is anticipated that the Asia-Pacific region will maintain the highest market share during the forecast period. The growth is ascribed to the healthcare sector's increased expenditure, and international companies are increasing their spending to facilitate the production of GMP plasmid DNA.

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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, 2023-2031 (Value US$ Mn)
• Viral Vectors
o Retroviral
o Adenoviral
o Lentiviral
o Adeno-Associated
o Others
• Plasmid DNA
• Electroporation
• Nanoparticles
• Non-viral
• Lipid/polymer
• Others

Global GMP Plasmid DNA Manufacturing Market, by Types, 2023-2031 (Value US$ Mn)
• Pre-Clinical Therapeutics
• Clinical Therapeutics
• Marketed Therapeutics

Global GMP Plasmid DNA Manufacturing Market, by Application, 2023-2031 (Value US$ Mn)
• Gene Therapy
• DNA Vaccines
• Immunotherapy

Global GMP Plasmid DNA Manufacturing Market, by Region, 2023-2031 (Value US$ Mn)
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

North America GMP Plasmid DNA Manufacturing Market, by Country, 2023-2031 (Value US$ Mn)
• U.S.
• Canada

Europe GMP Plasmid DNA Manufacturing Market, by Country, 2023-2031 (Value US$ Mn)
• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe

Asia Pacific GMP Plasmid DNA Manufacturing Market, by Country, 2023-2031 (Value US$ Mn)
• India
• China
• Japan
• South Korea
• Australia & New Zealand

Latin America GMP Plasmid DNA Manufacturing Market, by Country, 2023-2031 (Value US$ Mn)
• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa GMP Plasmid DNA Manufacturing Market, by Country, 2023-2031 (Value US$ Mn)
• GCC Countries
• South Africa
• Rest of Middle East & Africa

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