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Plasmid DNA Manufacturing Market Is Estimated To Witness High Growth Owing To Increasing Drug Approvals For Gene Therapies

Plasmid DNA Manufacturing Market Is Estimated To Witness High Growth Owing To Increasing Drug Approvals For Gene Therapies

The plasmid DNA manufacturing market is estimated to be valued at US$ 901.2 Bn in 2023 and is expected to exhibit a CAGR of 22.% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.

Market Overview:

Plasmid DNA is circular DNA molecules that can replicate independently of the chromosomal DNA. They are used in gene therapy as they act as vectors to deliver therapeutic genes into targeted cells of the human body. Plasmid DNA has applications in developing therapies for various indication areas including cancer, infectious diseases, cardiovascular diseases, central nervous system disorders etc. The demand for plasmid DNA is increasing as more number of gene therapy clinical trials and approvals are taking place.

Market Dynamics:

The growth of the plasmid DNA manufacturing market is majorly driven by the increasing drug approvals for gene therapies. For instance, according to the American Society of Gene and Cell Therapy (ASGCT), in 2021, there were 5 new gene therapy approvals by the FDA, taking the total number of approved gene therapies in the US to 26. Moreover, there has been a significant rise in clinical trials for various indications using plasmid DNA. As of June 2022, there were over 230 clinical trials using plasmid DNA vectors. Another major driver is the strong pipeline of gene therapies in clinical development. Large number of companies are engaged in research and development of plasmid DNA based therapies for a wide range of diseases. However, high cost associated with plasmid DNA production acts as a major challenge for market growth. Production of plasmid DNA involves complex multi-step process and requires extensive purification procedures to eliminate contaminants like endotoxins and host cell DNA which increases the production cost.

SWOT Analysis

Strength: Plasmid DNA manufacturing is gaining momentum due to the growing cell and gene therapy market. The technology allows for cost-effective production at scale. Leading players have established validated protocols and production pipelines.

Weakness: Regulatory compliance and quality standards are complex requiring specialized expertise and infrastructure. Raw material shortage and competing technology advancements could impact growth.

Opportunity: Increasing R&D in DNA vaccines and genetic medicine offer new application areas. Emerging markets in Asia Pacific provide an untapped customer base.

Threats: Stringent regulatory environment can delay product approvals. Intellectual property issues around novel gene sequences pose risks.

Key Takeaways

The global Plasmid DNA Manufacturing market is expected to witness high growth, exhibiting a CAGR of 22.% over the forecast period, due to increasing demand for cell and gene therapies. Gene therapies require high-quality plasmids produced at scale in a regulated environment.

Regional analysis

North America dominated the market in 2023, accounting for over 45% share, due to presence of key players and favorable regulations. Asia Pacific is expected to grow at the fastest pace, exhibiting a CAGR of around 25%, owing to rising biopharma industry and investments in new facilities by global vendors aiming to tap the regional potential. Countries like China, India, and South Korea are emerging hubs.

Key players analysis

Key players operating in the Plasmid DNA Manufacturing market are Cobra Biologics and Pharmaceutical Services (Charles River Laboratories), VGXI, Inc., Aldevron (Danaher), Kaneka Corporation, Nature Technology, PlasmidFactory GmbH & Co. KG, Cell and Gene Therapy Catapult, LakePharma, Inc., MeiraGTx Limited, Eurofins Genomics, Vigene Biosciences, Luminous BioSciences (LBS), LLC, GenScript, GENEWIZ, Creative Biogene, Akron Biotech, Biomay, JAFRAL Ltd., WuXi Biologics, GeneImmune Biotechnology Corp., Lonza, Greenpak Biotech Ltd., Luina Bio (AcuraBio), Ajinomoto Bio-Pharma, Synbio Technologies, Genopis Inc., Altogen Biosystems, Puresyn, Inc., Cepham Life Sciences, Catalent, Inc., Biomiga, Waisman Biomanufacturing.

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