Global GMP Plasmid DNA Manufacturing Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

Global GMP Plasmid DNA Manufacturing Market Research Report 2023-Competitive Analysis, Status and Outlook by Type, Downstream Industry, and Geography, Forecast to 2029

A circular double-stranded DNA present in the cytoplasm of a bacteria that replicate independently from the bacterial chromosome is called a plasmid DNA. The unique property of self-replication makes it unique and available to use in different molecular genetic research such as gene therapy, gene transfer and recombinant DNA technology. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP Plasmid DNA Manufacturing meets the GMP standard.

Market Overview:

The latest research study on the global GMP Plasmid DNA Manufacturing market finds that the global GMP Plasmid DNA Manufacturing market reached a value of USD 740.12 million in 2022. It’s expected that the market will achieve USD 1458.52 million by 2028, exhibiting a CAGR of 11.97% during the forecast period.

Pharmaceutical companies cooperate with contract plasmid manufacturers to speed up the production of nucleic acid-based biopharmaceuticals-including Covid-19 vaccine and gene therapy-based drugs. Plasmids are essential for nucleic acid-based vaccines and gene therapy. Efficient plasmid production is an important factor for large-scale production of several Covid-19 vaccines.

Kaneka Eurogentec S.A., an affiliate of Kaneka Corporation, signed an agreement with INOVIO Pharmaceuticals Inc. to manufacture COVID-19 DNA vaccine candidate, INO-4800.

Cobra Biologics (Cobra), part of the Cognate BioServices family, an international CDMO manufacturer of biological materials and pharmaceuticals, and Scancell Holdings plc (Scancell), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announced that they have entered into a collaboration for Cobra to manufacture Scancell COVID-19 vaccine. The epidemic has promoted the development of GMP Plasmid DNA Manufacturing industry.

Rapid growth of the biopharmaceutical industry

In the past two years, the number of research new drugs has increased greatly, and many drugs have been authorized for commercial sale. Due to this growth, contract manufacturers providing GMP-grade plasmids are trying to keep up with the increasing demand. The recent epidemic situation has aggravated this problem, because many candidate vaccines are being developed, including DNA-based vaccines and mRNA-based vaccines, in which plasmid DNA is needed as the starting material of mRNA transcription in vitro. The continuous growth of downstream demand will promote the development of GMP Plasmid DNA Manufacturing industry.

The manufacturing process of GMP Plasmid DNA Manufacturing is complicated

High-quality plasmid DNA is a key component in cell and gene therapy manufacturing, so it is in great demand. This leads to the need to optimize manufacturing to meet the volume and quality requirements in the manufacture of therapeutic drugs. Because of the large size, shear sensitivity, high viscosity of plasmid DNA (pDNA) and the similarity between pDNA and impurities in the manufacturing process, its manufacturing faces many challenges.

Region Overview:

In 2021, the share of the GMP Plasmid DNA Manufacturing market in North America stood at 45.6%.

Company Overview

Aldevron is one of the major players operating in the GMP Plasmid DNA Manufacturing market, holding a share of 34.65% in 2021.

Aldevron

Aldevron has grown into a world-class service organization specializing in nucleic acid and protein production, antibody development, and custom services with operations in the United States and Europe.

Kaneka Eurogentec S.A.

Eurogentec, part of Kaneka Corporation, is an international biotechnology supplier, based in Belgium, who specializes in genomics and proteomics. The company is fully ISO 9001, ISO 13485 certified, cGMP accredited by the Belgian Ministry of Health and approved by the US FDA for the commercial manufacturing of a biologic for the US market.

Segmentation Overview:

As for product types, the Clinical Therapeutics segment held the largest market share in 2021.

Pre-Clinical Therapeutics

Pre-clinical is the stage that begins before clinical practice, during which important feasibility, repeated testing and drug safety data are usually collected in experiments.

Clinical Therapeutics

Clinical refers to direct contact with patients and actual observation of patients.

Marketed Therapeutics

Marketed means product to market stage.

Application Overview:

The market's largest segment by application is the segment Gene Therapy, with a market share of 36.02% in 2021.

Gene Therapy

Gene Therapy focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material.

DNA Vaccines

DNA vaccine is a type of vaccine that transfects a specific antigen-coding DNA sequence into the cells of an organism as a mechanism to induce an immune response.

Immunotherapy

Immunotherapy is the treatment of disease by activating or suppressing the immune system.

Key Companies in the global GMP Plasmid DNA Manufacturing market covered in Chapter 3:

Creative Biolabs
Aldevron
Biovian
Catalent Biologics
BioXcellence
Kaneka Eurogentec S.A.
VectorBuilder
PlasmidFactory
Waisman Biomanufacturing
VGXI, Inc
GenScript ProBio
WuXi Advanced Therapies
Thermo Fisher Scientific
LakePharma
Esco Aster
Charles River
Nature Technology Corporation

In Chapter 4 and Chapter 14.2, on the basis of types, the GMP Plasmid DNA Manufacturing market from 2018 to 2029 is primarily split into:

Pre-Clinical Therapeutics
Clinical Therapeutics
Marketed Therapeutics

In Chapter 5 and Chapter 14.3, on the basis of Downstream Industry, the GMP Plasmid DNA Manufacturing market from 2018 to 2029 covers:

Gene Therapy
DNA Vaccines
Immunotherapy
Others

Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2018-2029) of the following regions are covered in Chapter 8 to Chapter 14:

North America (United States, Canada)
Europe (Germany, UK, France, Italy, Spain, Russia, Netherlands, Turkey, Switzerland, Sweden)
Asia Pacific (China, Japan, South Korea, Australia, India, Indonesia, Philippines, Malaysia)
Latin America (Brazil, Mexico, Argentina)
Middle East & Africa (Saudi Arabia, UAE, Egypt, South Africa)