Viral Vectors & Plasmid DNA Manufacturing Market– Statistics And Analysis

Posted by Mrudula Anil Karmarkar on April 28th, 2021

The global viral vectors & plasmid DNA manufacturing market size is expected to reach USD 1.1 billion by 2027, exhibiting a 14.52% CAGR, during the forecast period, according to a new report by Grand View Research, Inc. Currently, more than 700 cell and gene therapies are in clinical trials and vectors are used in nearly 70% of these therapies. As a result, demand for vectors has exceeded the supply rate. Thus, an increase in the number of advanced therapy-based discovery programs initiated by biotechnology and pharmaceutical companies is expected to drive investments in the market.

Biopharmaceutical innovators are at the forefront of the human response to the coronavirus pandemic. A significant number of major biotech firms are in the midst of a race to investigate the Sars-Cov-2 genome and prepare a viable vaccine for the same. As compared to the speed of response to SARS/MERs etc, the biotech entities are investigating SARs-Cov-2 at an unprecedented rate and a considerable amount of funds are being put into the R&D. With multiple candidates in trial, the public and private sectors are anticipated to work in unison for the foreseeable period, until a vaccine is developed for Covid-19. The report will account for Covid19 as a key market contributor.

Current production methods for viral vectors are considered tedious, as they are only applicable for scale-out but not for scale-up. Development of a proprietary CAP-GT technology-based cell suspension system by CEVEC Pharmaceuticals GmbH has effectively addressed the challenge of scaling-up by allowing easy handling and improved efficiency of cells.

Considering growing opportunities in vector production, the Original Equipment Manufacturers (OEMs) are making focused efforts to gain a competitive advantage in the market. For example, the introduction of ready-to-run factory-in-a-box to accelerate the production of virus-based therapeutics by GE healthcare, as a solution to simplify and advance the manufacturing process.

High transfection efficiency, effective gene delivery, and stable gene expression have made viral vectors a preferred choice for gene transfer. The rising preference for viral vectors in gene transfer is evident by the increase in registration of clinical trials on viral vector-mediated gene therapy. In the first quarter of 2020, around 372 clinical trials were registered that involved vector-mediated gene therapy production.

Viral Vectors & Plasmid DNA Manufacturing Market Report Highlights

• With high usage, attributed to its ability of high titer production and capability to induce strong humoral and T cell responses in various research applications, adenovirus held the leading viral vectors and plasmid DNA manufacturing market share in terms of revenue, in 2020
• Lentivirus vector is anticipated to register the fastest CAGR over the forecast period. This can be attributed to constant growth in the lentivirus-based gene therapy pipeline program
• Downstream processing held the dominant revenue share in 2020, owing to the fact that this process involves purification steps that account for the majority of the overall manufacturing cost. Employment of expensive equipment and requirement of trained personnel for product recovery has further driven revenue in the segment
• Antisense and RNAi therapy production is estimated as the key application of vector manufacturing, resulting in the dominance of this segment over other applications
• The high adoption rate of viruses for aptamers and oligonucleotide development in comparison to other applications has driven revenue in antisense and RNAi therapy segment
• High usage of vectors for therapeutic production have contributed to the large revenue share of pharmaceutical and biopharmaceutical companies. The number of biotech companies employing vector for therapies production is anticipated to multiply over the forecast period
• Presence of a substantial number of advanced therapy products in the pipeline targeting various cancer forms has accelerated revenue share of the cancer segment over the years
• Given the high number of biotech entities in parts of U.S., such as in California and Massachusetts, North America has maintained its dominance in terms of revenue. In addition, the active participation of regulatory bodies in improving the regulatory scenario for the market launch of advanced therapies has facilitated the high usage of vectors in U.S.
• Merck, Cobra Biologics, Novasep, and uniQure N.V., are some key participants that are geared towards capitalizing the untapped opportunities in the market

Considering the efficiency and clinical benefits of Advanced Therapies Medicinal Products (ATMPs), various market stakeholders are constantly designing strategies to overcome the existing challenges and spur ATMPs usage. Moreover, the recent announcement by the Food and Drug Administration (FDA) commissioner about improving regulatory support for the cell and gene therapy sector to keep up the pace with the clinical progress has substantiated the anticipated success of ATMPs.

Vector manufacturing is one of the most complex and resource-intensive processes in ATMPs manufacturing. In October 2020, GE Healthcare Life Sciences launched FlexFactory single-use biomanufacturing platform-based KUBio box as a fully-integrated and flexible biomanufacturing environment to affectively address the aforementioned challenge and speed-up the development of viral vector-based gene therapies.

However, expensive and highly regulated processes for vector production in large quantities required for large-scale clinical trials are the key challenges cited by industry experts. Moreover, the shortfall of expertise in terms of scale, complexities, and quality assurance for vector production has hampered in-house manufacturing to a certain extent. The proliferation of contract manufacturers has effectively addressed the above-articulated manufacturing challenges by offering a wide array of services for vector manufacturing, thus driving the market growth.

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The market is witnessing high competition with the presence of few established players and a growing number of mid-tier companies and startups. The companies are adopting various business strategies, such as strategic alliances with biopharmaceutical companies and research institutes, to gain a competitive edge.

In addition, expansion of production sites and operational capacity in markets such as the U.S. and U.K. to cater to the growing demand for viral vectors is anticipated to accelerate the revenue share of the companies. Furthermore, high-tier companies are marking the entry in this space through acquisitions of emerging players. For example, in May 2020, Thermo Fisher acquired Brammer Bio and in August 2020, FUJIFILM acquired Biogen (Denmark) Manufacturing ApS.

Novasep, Merck, Cobra Biologics, uniQure N.V., Waisman Biomanufacturing, Creative Biogene, The Cell and Gene Therapy Catapult, Aldevron, and Addgene are some key companies operating in this market. They offer services for manufacturing of DNA plasmids and virus for pre-clinical research, human clinical trials, and toxicology studies.

Grand View Research has segmented the global viral vectors and plasmid DNA manufacturing market on the basis of vector type, workflow:

Viral Vector and Plasmid DNA Manufacturing Vector Type Outlook (Revenue, USD Million, 2016 - 2027)

• Adenovirus
• Retrovirus
• Plasmid DNA
• AAV
• Lentivirus
• Others

Viral Vector and Plasmid DNA Manufacturing Workflow Outlook (Revenue, USD Million, 2016 - 2027)

• Upstream Processing
• Vector Amplification & Expansion
• Vector Recovery/Harvesting
• Downstream Processing
• Purification
• Fill-finish

About Grand View Research

Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.

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