Plasmid DNA Manufacturing Market Size, Share & Trends Analysis Report By Disease (Cancer, Infectious Diseases), By Grade (R&D, GMP), By Application, By Development Phase, And Segment Forecasts, 2022 - 2030

Report Overview

The global plasmid DNA manufacturing market size was valued at USD 478.95 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 13.71% from 2022 to 2030. Plasmid DNA plays an important role in the healthcare industry. Today, it is crucial for the development of vaccines and next-generation cell and gene therapies. New plasmid DNA vaccines are now being developed, leading to more efficient and clean manufacturing processes. In the production of vaccines and gene therapies, plasmids are more attractive than recombinant viruses as they can deliver significant amounts of DNA with a low risk of oncogenesis or immunogenicity. Such factors are expected to propel industry growth.

Increasing awareness about cell and gene therapy boosts industry growth. This is mainly due to a rise in cell and gene therapy products accepted to treat various diseases globally and the availability of approved gene therapy products. Plasmid DNA is the base for gene therapies and DNA vaccines for several infectious, genetic, and acquired diseases, enteric pathogens, and influenza. With the rising demand for robust disease treatment therapies, various companies and research organizations are accelerating R&D efforts for advanced therapies that target the cause of disease at a genomic level, resulting in increased demand for plasmid DNA.

For instance, in October 2021, the National Institutes of Health, the FDA, five nonprofit organizations, and ten pharmaceutical companies entered into a partnership to ramp up the development of gene therapies for 30 million individuals in the U.S. who suffer from rare disorders. The outbreak of the COVID-19 pandemic led to an increase in the use of plasmid DNA. The COVID-19 pandemic resulted in extensive research efforts for the development of vaccines against the infection. For instance, in November 2021, Enzychem entered into Manufacturing License and Technology Transfer Agreement with Zydus Cadila to develop a COVID-19 plasmid DNA vaccine in South Korea.

Under this initiative, Zydus provided its technical assistance and manufacturing technology to Enzychem. Increased prevalence of cancer is anticipated to boost the production of plasmid DNA. Plasmid DNA is used in gene therapy to identify and treat illnesses in patients. According to the WHO, cancer is one of the leading causes of death globally and is reported for around 10 million deaths in 2020. The most common cancers are lung, breast, prostate, colon, and rectum cancers. In 2020, around 2.26 million cases of breast cancer were reported.

In addition, emerging companies are entering the industry with advanced technologies to meet the increasing demand and strengthen their position in the global market. For instance, in June 2021, Biotage launched a new automated solution for plasmid DNA purification, Biotage PhyPrep. A new automated solution for plasmid DNA purification saves lab technicians’ time by eliminating the need to perform repetitive, manual work. It also fully utilizes the dual flow chromatography technology of the PhyTip columns to produce supercoiled, endotoxin-free, transfection-grade pDNA.

Development Phase Insights

On the basis of development phases, the global industry has been further divided into pre-clinical therapeutics, clinical therapeutics, and marketed therapeutics. The pre-clinical therapeutics development phase segment is estimated to register the fastest growth rate of more than 14.00% during the forecast period. The clinical therapeutics segment dominated the global industry in 2021 and accounted for the maximum share of the overall revenue. The segment will expand further at a significant growth rate during the forecast period. Many plasmid DNA-based therapies are advancing rapidly through the clinical development stage and will soon be commercialized.

In current clinical trials based on plasmid DNA, the immunization against or the treatment of various diseases, especially Cardiovascular Diseases (CVDs) and cancer, is investigated, including pancreatic carcinoma, malignant melanoma, critical limb ischemia, and renal cell carcinoma, and coronary heart disease. Furthermore, plasmid DNA is currently increasing in importance for clinical research applications in genetic vaccination and gene therapy. Particularly, plasmid DNA gene therapy is utilized for cardiovascular disorders due to plasmid DNA transfer is possible for skeletal or cardiac muscle. Patients with peripheral artery disease have undergone clinical angiogenic gene therapy employing plasmid DNA gene transfer.

Application Insights

On the basis of applications, the global industry has been further categorized into DNA vaccines, cell & gene therapy, immunotherapy, and others. The cell & gene therapy application segment dominated the global industry market in 2021 and accounted for the maximum share of more than 58.00% of the overall revenue. This high share can be attributed to the fact that gene therapy is broadly applied in the treatment of several inherited and genetic diseases. Moreover, continuous technological improvements in developing a safe and reliable treatment for various disorders are propelling the segment growth.

Furthermore, the growing need for large quantities of plasmid DNA for gene therapy development has led to the introduction of more scalable and cost-effective manufacturing processes. The ongoing research to explore the potential of plasmid DNA in therapy development is driving the segment growth. On the other hand, approval of gene-based therapy products in the U.S. has fueled the necessity for completely scalable and clinical-grade GMP solutions to develop gene therapies for large patient groups. These patients generally suffer from cardiovascular disease, cancers, and rheumatoid arthritis.

Disease Insights

On the basis of diseases, the global industry has been further categorized into cancer, genetic disorders, and infectious diseases. The cancer disease segment dominated the global industry in 2021 and accounted for the maximum share of more than 37.25% of the overall revenue. The segment is expected to register the fastest growth rate and remain dominant throughout the forecast period. The rising use of DNA plasmids for the development of cancer treatment therapies is propelling the growth of this segment. Over 60% of all ongoing clinical gene therapy trials globally focus on cancer right now.

Various gene therapy strategies have been used for cancer, such as genetic manipulation of apoptotic, gene therapy-based immune modulation, and oncolytic virotherapy. The infectious disease segment is estimated to have significant growth in the future. Gene therapies for HIV, HPV, influenza virus, and hepatitis B are under trial. Around 5–7% of gene therapy clinical trials are intended for the treatment of infectious diseases. Furthermore, the segment share is expected to grow over the forecast period due to the high prevalence of HIV & HPV infections and the presence of government-aided programs to prevent HPV infections.

Grade Insights

On the basis of grades, the global industry has been further categorized into GMP grade and R&D grade. The GMP grade segment dominated the global industry in 2021 and accounted for the maximum share of more than 88.25% of the overall revenue. The high share of this segment can be attributed to its wide applications in preclinical studies, such as animal testing for drug safety and metabolism. Moreover, it can be utilized for direct injection as vaccines, or ex-vivo applications, such as cell and gene therapy. Plasmid DNA that meets GMP standards is required for direct gene transfer into humans.

It is made in a way that adopts important GMP requirements, such as a comparable production method and comparable quality standards. Furthermore, several manufacturers of therapeutics opt for GMP-grade plasmid DNA to meet the demand for volume as well as the quality required for use in therapeutics. Plasmids are a crucial component of material since they can impact the quality and safety of the final product. Therefore, it is strongly advised to start utilizing GMP-compliant plasmids when developing clinical batches (starting from phase 1).

Regional Insights

North America dominated the global industry in 2021 and accounted for the largest share of more than 48.95% of the overall revenue. Some of the major factors that have contributed to the large share of this region are the presence of a substantial number of centers and institutes that are engaged in the R&D of advanced therapies. Moreover, the establishment of the Recombinant DNA Advisory Committee by NIH to monitor scientific, ethical, and legal issues pertaining to the use of rDNA techniques is playing a significant role in driving the adoption of these techniques. The major role of the body is to review human gene transfer research.

Asia Pacific is estimated to be the fastest-growing regional segment from 2022 to 2030 on account of its untapped potential and large population pool in the region. Moreover, this region offers relatively inexpensive operating and manufacturing units for conducting research. Japan is leading the Asian market as it is considered a hub for regenerative medicine research. Moreover, according to the Japanese prime minister, regenerative medicine and cell therapy is key to the economic growth of the country. The country is geared to establish a global leader in the development and marketing of stem cells.

Key Companies & Market Share Insights

This industry is highly competitive with the presence of a few established players, mid-tier companies, and startups. These companies are adopting various growth strategies to gain a competitive edge. Strategic alliances, collaborations, and agreements with various companies and research institutes are considered key strategies employed by companies in this industry. For instance, in July 2021, Thermo Fisher established a current Good Manufacturing Practice (cGMP) facility in Carlsbad, California, to increase its clinical and business capabilities for the synthesis of pDNA for cells and gene-based therapies. Some of the key players in the global plasmid DNA manufacturing market include:

• Charles River Laboratories

• VGXI, Inc.

• Aldevron

• Kaneka Corp.

• Nature Technology

• Cell and Gene Therapy Catapult

• Eurofins Genomics

• Lonza

• Luminous BioSciences, LLC

• Akron Biotech

Plasmid DNA Manufacturing Market Report Scope

Global Plasmid DNA Manufacturing Market Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global plasmid DNA manufacturing market report on the basis of grade, development phase, application, disease, and region:

• Grade Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • R&D Grade

  • GMP Grade

• Development Phase Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • Pre-clinical Therapeutics

  • Clinical Therapeutics

  • Marketed Therapeutics

• Application Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • DNA Vaccines

  • Cell & Gene Therapy

  • Immunotherapy

  • Others

• Disease Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Disease

  • Cancer

  • Genetic Disorder

• Regional Scope Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE