The global plasmid DNA manufacturing market size is expected to hit around USD 1.71 billion by 2030 and growing at a CAGR of 15.43% from 2022 to 2030.
The global plasmid DNA manufacturing market size is expected to hit around USD 1.71 billion by 2030 and growing at a CAGR of 15.43% from 2022 to 2030.
Report Highlights
- The pre-clinical therapeutics development phase segment is estimated to register the fastest growth rate of more than 14.03% during the forecast period.
- The cell & gene therapy application segment dominated the global industry market in 2021 and accounted for the maximum share of more than 58.12% of the overall revenue.
- 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 GMP grade segment dominated the global industry in 2021 and accounted for the maximum share of more than 88.42% of the overall revenue.
- North America dominated the global industry in 2021 and accounted for the largest share of more than 49.03% of the overall revenue.
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The rising prevalence of chronic diseases, combined with the wide application scope of plasmid DNA in the healthcare industry is expected to drive the industry growth. Plasmid DNA can be used directly for therapeutic applications, such as the production of vaccine antigens or gene therapy. Moreover, it can be utilized for various research purposes, such as gene cloning, gene mapping, etc. The rising number of patients choosing gene therapy is expected to drive industry growth in the coming years.
According to clinicaltrials.gov, the number of cell & gene therapies across global pipeline programs (Phase I to Phase III trials) increased from 289 in 2018 to 327 in 2022. Furthermore, the U.S. FDA provides constant support for innovations in the advanced therapy arena via several policies concerning product manufacturing. With increased cell and gene therapy products, the industry will see an increased need for manufacturing plasmid DNA on a larger scale. The COVID-19 pandemic is anticipated to positively impact industry growth. For instance, in September 2021, India approved the first COVID-19 DNA vaccine. It is the world’s first COVID-19 DNA vaccine manufactured in partnership with DBT-BIRAC as part of Mission COVID Suraksha.
Circular DNA is used in India’s ZyCoV-D vaccination to protect against COVID-19 infection. Furthermore, key entities in the global industry are undertaking various strategic initiatives to strengthen their market presence, which is also expected to propel growth. For instance, in June 2022, BioCina announced the expansion of the production of plasmid DNA in a new dedicated GMP suite to its offering of CDMO services. The suite has a single-use fermentation capacity of up to 300 L and appropriately scaled downstream processing machinery.
Scope of The Report
| Report Coverage | Details |
| Market Size in 2021 | USD 470.02 million |
| Revenue Forecast by 2030 | USD 1.71 billion |
| Growth rate from 2022 to 2030 | CAGR of 15.43% |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segmentation | Grade, development phase, application, disease, region |
| Companies Covered | Charles River Laboratories; VGXI, Inc.; Aldevron; Kaneka Corp.; Nature Technology; Cell and Gene Therapy Catapult; Eurofins Genomics; Lonza; Luminous BioSciences, LLC; Akron Biotech. |
Covid-19 Impact :
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization has declared it as a public health emergency. According to the World Health Organization’s report, the manifestation of coronavirus disease (COVID-19) has resulted in more than 166 million infected individuals worldwide as of May 24, 2021.
COVID-19 has affected the world economy in three main ways; by directly affecting production and demand of plasmid DNA manufacturing, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to the lockdown, several countries such as China, India, Saudi Arabia, UAE, Egypt, and others are facing problems with regards to the transportation of drugs and devices from one place to another.
Furthermore, players operating in the global plasmid dna manufacturing market are facing major challenges on various fronts due to the COVID-19 pandemic. The major challenges include supply of raw materials for manufacturing drug formulations due to irregularities in transportation facility. Moreover, distributors are experiencing irregular demand for products from the retailers due to increasing patient population suffering from COVID-19 and other life-threatening disorders.
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 14.03% 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.
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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 58.12% 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 88.42% 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 49.03% 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 Players
- Charles River Laboratories
- VGXI, Inc.
- Aldevron
- Kaneka Corp.
- Nature Technology
- Cell and Gene Therapy Catapult
- Eurofins Genomics
- Lonza
- Luminous BioSciences, LLC
- Akron Biotech
Market Segmentation
- By Grade Scope Outlook
- R&D Grade
- GMP Grade
- By Development Phase Scope Outlook
- Pre-clinical Therapeutics
- Clinical Therapeutics
- Marketed Therapeutics
- By Application Scope Outlook
- DNA Vaccines
- Cell & Gene Therapy
- Immunotherapy
- Others
- By Disease Scope Outlook
- Infectious Disease
- Cancer
- Genetic Disorder
- By Regional Scope Outlook
- North America
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- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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