GMP Plasmid DNA Manufacturing Market Current Scenario with Forecast to 2031

GMP Plasmid DNA Manufacturing Market worth $908.50 Million by 2024- 2030 Exclusive Report by InsightAce Analytic

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 2030"

According to company's newest research, the Global GMP Plasmid DNA Manufacturing Market is worth US$ 359.75 Mn in 2021 and is predicted to reach US$ 908.50 Mn in 2030, with a promising CAGR of 11.19% between 2022 and 2030.
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 increasingly important in clinical research applications like genetic vaccination and gene therapy. Direct gene transfer into humans requires a suitable manufacturing procedure (GMP) - quality plasmid DNA. Particularly in genetic engineering, plasmids are valuable molecular biology and genetics tools. They are necessary to produce recombinant proteins, gene therapy analysis, and gene cloning.

The synthesis of plasmid DNA ranges from a few micrograms to kilograms. Various forms of plasmid DNA are produced, but GMP grade is more adaptable and has a broader range of uses. Plasmid GMP-quality DNAs are frequently utilized in pre-clinical research, such as toxicological and biodistribution analyses. Direct gene transfer into patients requires this particular strain of plasmid DNA. Because plasmids can transfer large amounts of DNA without causing inflammation or cancer, they are preferable to recombinant viruses in producing vaccines and gene treatments.

Therefore, it is anticipated that these variables will probably promote market expansion. The market expansion also helped raise awareness of gene and cell therapies. The primary contributing elements include the proliferation of cell and gene therapy products used globally to treat various diseases and the availability of licenced gene therapy products. Moreover, the COVID-19 pandemic sparked some research toward developing vaccinations against infection. The leading market players are driving the expansion of the industry as a whole through their strategic alliances and acquisitions.

Charles River purchased Cognate BioServices in March 2021 to advance its gene therapy initiative. Furthermore, new businesses are beginning to use state-of-the-art technology to fulfil the increasing demand and strengthen their positions in the worldwide market. However, the expense of gene therapies and the possibility of insertional mutagenesis will probably restrict the growth of the global market for manufacturing GMP plasmid DNA.

North America held the highest share of the market in 2021, dominating it. The demand for efficient illness treatment treatments is rising, and many businesses and institutes involved in advanced therapy research and development support regional expansion. Renowned North American companies are addressing the market with state-of-the-art technologies to meet growing demand and increase their market share internationally.

The Asia-Pacific region is expected to have the most significant market share throughout the projection period. The rise in growth is ascribed to more spending in the healthcare industry and higher investment by multinational corporations to encourage the manufacturing 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, 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

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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