Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead

By Sharvari Rale, Fairfield Market Research

The quest for the most effective disease treatments has become more urgent than ever. The global chronic disease burden is swelling at alarming rates, pointing to growing severity of the situation for the global healthcare system, economy, and public health. Prevalence of chronic conditions such as cancers, heart diseases, diabetes, chronic lung disease, and chronic kidney disease continues to reach new heights. Cancers, diabetes, and heart diseases remain the major disease categories, and the leading causes of mortalities worldwide, whereas rare disease is another sizably large category that has an equal significance.

Some Facts and Figures:

• Six out of 10 adults in the U.S. alone suffer from a chronic ailment.¹
• Four out of 10 adults in the U.S. tend to have more than one chronic condition.¹
• Rare diseases affect approximately 350 million individuals worldwide.²
• Over 500 types of rare cancers exist.²
• A rare disease patient occupies one out of three beds at a pediatric hospital.³
• Just 10% of the entire rare diseases category has an FDA-approved therapy for treatment.²
• Around 80% rare diseases have been identified to have a genetic or genomic origin.³
• The accurate diagnosis of a rare disease typically takes longer than other diseases, at between six and eight years. There is a greater need to reduce the timespan and achieve early diagnosis of such diseases. Plasmid DNA therapies play a crucial role in hastening the diagnosis.
• Collated data by central cancer registries, and the National Center for Health Statistics estimates nearly 1,958,310 new cases of cancers, and around 609,820 cancer mortalities in 2023 in the U.S.⁴

All in all, these factors indicate a highly favorable breeding ground for the market.

Plasmid DNA Manufacturing Market May See Over 20% Growth By 2030

The surging significance of plasmid DNA as the next generation of DNA vaccines and gene medicines has facilitated its entry in the clinical trials space. As plasmid DNA makes inroads into the world of biopharmaceuticals, the need to manufacture it will spiral. As it gains ground as an ideal starting material for gene therapy, as well as for vaccine production, plasmid DNA certainly represents an important piece of the solution to our huge contemporary healthcare conundrum. The growth of plasmid DNA vaccines is taking over that of vaccines produced using recombinant viruses, as the former delivers relatively large amounts of DNA at a minimal oncogenesis risk. This creates a strong foundation for the massive application potential of plasmid DNA.

The manufacturing of plasmid DNA has an impressive outlook in the years to come. A recent study on the global plasmid DNA manufacturing market reveals it exceeded $445 million in 2022. The study conducted a close examination of the plasmid DNA space and foresees more than 20% growth in market valuation between 2023 and 2030. Let’s look at the growth of the gene therapy industry, the indication showing the most promise, the vital roadblocks, regional analysis, and the leading players in the space.

Gene Therapy Makes Headway

The US market had 13 approved cell and gene therapies as of the end of 2022, and 12 new are awaiting approvals around the end of 2023. The 2,000+ active clinical trials of new gene therapies that are currently underway will further add value to the entire scenario.⁵

With skyrocketing prospects for gene therapy, DNA vaccines, and immunotherapy, the demand for plasmid DNA manufacturing has also been experiencing a high tide. Vaccine development, especially, created strong tailwinds during the recent pandemic crisis. Plasmid DNA manufacturing offers advantages in the form of stable gene expression, efficient gene delivery, and improved transfection. Given the proven safety and efficacy of plasmid DNA, a growing number of collaborations is likely to be seen in this industry. The various contract manufacturing organizations have also been showing interest, which further paves the way for plasmid DNA in the future.

The Bespoke Gene Therapy Consortium (BGTC), which is an alliance of five NGOs, 10 pharma players, the National Institutes of Health, and the U.S. FDA is targeting faster gene therapy discovery for 30 million Americans who are living with uncommon health conditions. The level of acceptance of cell and gene therapy as a reliable means of treatment for various ailments has been increasing. Understanding of these potentially mainstream therapies is also rising visibly. In addition, the availability of licensed cell and gene therapy products is broadening. With the healthcare industry eyeing delivery of an improved patient outcome via a targeted medicine approach, plasmid DNA will experience greater demand as it renders the ability to explore the genomic origin of diseases.

Cancer Gene Therapy: A Window Of Opportunity

Several techniques of gene therapy have been developed to target specific cancer types. These techniques include gene therapy-based immune modulation, anti-angiogenic gene therapy, genetic manipulation of apoptotic and tumor invasion pathways, gene deficiency manipulation, antisense, RNAi tactics, and genetic manipulation of tumor invasion and apoptotic pathways.

Cancer remains the largest category generating demand for plasmid DNA and given the pace of advancement in oncology, this dominance will continue in the long run. DNA plasmids have seen increasing demand for use in cancer treatment medicines as the disease stands at the heart of over 60% of all the active clinical gene therapy trials underway worldwide. While DNA-based vaccines have already displayed an exceptional ability to trigger the immune system to combat cancer cells, the use of DNA plasmids in cancer gene therapy can immediately direct protein expressions to kill those cancer cells. These proteins are meant for different functions, including toxins, enzymes, and proapoptotic (or cytotoxic) proteins. Several clinical trials have delivered promising outcomes so far and several are currently in the pipeline, involving both animal and human models. An approved DNA plasmid-based gene therapy for cancer treatment may be a reality soon. In addition, treatments for major infectious diseases like flu, hepatitis B, AIDS, and HPV are also being targeted in gene therapy clinical trials.

The cost looks prohibitive now but over a period of the next few decades, gene therapy may stand tall as a preferred, one-time cancer treatment. Revolutionary cancer gene therapies are likely to avert a lifetime of illness for cancer patients, breathing life into the world of oncology.

The Biggest Roadblocks

While rapid progression of the plasmid DNA manufacturing market is challenged by certain longstanding factors, including the exorbitant costs involved in gene therapy, challenges in the form of insertional mutation or insertional mutagenesis (popularly, gene or DNA insertion) pose a major threat to the market. There are multiple risks that accompany the process of gene insertion into the tumor suppressor gene, as the inactivation of any tumor suppressor gene by mutation leads to altered functioning of the associated protein. And this, in fact, may be conducive to cancer development.

A similar set of concerns arises when it comes to activation of an oncogene with the vector(s). Commercialization thus seems far-fetched as the costs of scaling up the manufacturing are prohibitive. A lot of research is in process around this, contributing heavily to the overall progress of this space in the long term.

North America: The First Mover But Not The Fastest Growing Market

North America, especially the U.S., has the first mover’s advantage. The presence of pioneering organizations and research institutes continues to uphold the region’s primacy in the global plasmid DNA manufacturing industry. Certain bodies (e.g., NIH’s Recombinant DNA Advisory Committee) that are genuinely involved in the evaluation of research around cell, gene, and DNA also play a crucial part here.

The fastest growth of the market is, however, expected in the Asian subcontinent. The study clearly indicates a promising window of opportunity in Asia Pacific as the region has been witnessing consistent growth in expenditures on plasmid DNA research and development projects. Both governments and private sector entities have been participating in this as part of overall oncology and gene therapy research initiatives. A noticeable rise in adoption of good manufacturing practices is more likely to complement the performance of the plasmid DNA manufacturing market across Asia Pacific.

Leading Players In Plasmid DNA Manufacturing

Several large companies are actively investing funds and effort in exploring the application potential of plasmid DNA. Several biopharma players have also been stepping into the game given the prospective profitability of plasmids DNAs in cancer gene therapeutics. Thermo Fisher Scientific, Inc., Merck KgaA, Lonza, OriGene Technologies, Inc., FUJIFILM Diosynth Biotechnologies U.S.A. Inc., Cobra Biologics Ltd., Integrated DNA Technologies, Inc., GenScript, Waisman Biomanufacturing, Laboratories Inc. (A.B.L. Inc.), Genezen, Eurofins Scientific, Codex DNA, Advanced BioScience, YPOSKESI, Novasep Holding S.A.S, Brammer Bio, and ProteoGenix are some of the prominent names in this space. The prominent pipeline companies involved in gene therapy development include Pfizer Inc., Novartis AG, UniQure, Biogen, Intellia Therapeutics, Sangamo Biosciences, Spark Therapeutics, Orchard Therapeutics, Bluebird Bio, and Editas Medicine.

Takeaways

• Viral vectors lead the plasmid DNA space and contribute the lion’s share to overall market revenue. Extensive consumption of viral vectors in cell-based gene therapy will continue to keep this market segment afloat in the future.
• The application of plasmid DNA is the highest in gene therapy.
• Despite infectious diseases’ dominance in generating demand for plasmid DNA, cancer is rapidly emerging as the most lucrative segment of the market.
• The North American biopharmaceutical industry has jumped on the bandwagon with hefty investments in R&D around gene therapy.
• Asia Pacific promises ample opportunity on the back of rapid sophistication of healthcare infrastructure and pacing R&D activity.

References

1.  https://www.cdc.gov/chronicdisease/index.htm
2. https://rarediseases.org/understanding-rare-disease/rare-disease-facts-and-statistics/
3. https://www.weforum.org/reports/global-access-for-solving-rare-disease-a-health-economics-value-framework/
4. https://pubmed.ncbi.nlm.nih.gov/36633525/
5. https://www.criver.com/eureka/age-cell-and-gene-therapy-here

About The Author:

Sharvari Rale is a senior content strategist and works closely with the life science and healthcare research teams at Fairfield Market Research. With more than seven years of experience in writing market research, she is also a bioscience graduate.