Viral Vectors And Plasmid DNA Manufacturing Market Size, Share & Trends Report

Viral Vectors And Plasmid DNA Manufacturing Market Size, Share & Trends Analysis Report By Vector Type (AAV, Lentivirus), By Workflow, By Application, By End Use, By Disease, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: May, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-2-68038-695-0
  • Format: Electronic (PDF)
  • Historical Data: 2017 - 2019
  • Number of Pages: 300

Report Overview

The global viral vectors and plasmid DNA manufacturing market size was valued at USD 2.2 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 18.8% from 2021 to 2028. Along with the ongoing shift in the treatment paradigm of several life-threatening diseases through advanced therapies, there is rising demand for viral vector-based vaccines for infectious diseases. This has resulted in increasing employment of viral vectors and plasmid DNA for the R&D of advanced therapies, thereby driving the market for viral vectors and plasmid DNA manufacturing.

China viral vectors & plasmid DNA manufacturing market size, by workflow, 2017 - 2028 (USD Million) 

Furthermore, the COVID-19 pandemic has created lucrative opportunities for the operating players in the market. For instance, global pharmaceutical companies such as AstraZeneca, and Janssen Pharmaceuticals has developed COVID-19 viral vector-based vaccine in December 2020 and February 2021, respectively. Apart from these companies, several viral vector-based vaccines are currently in the development phase. This has accelerated the demand for viral vectors, thereby increasing revenue for viral vector manufacturers.

With the approvals of Tecartus, Zolgensma, and Kymriah, several biopharmaceutical developers have shifted their focus on this new treatment area, in turn, increasing investment flow in this market. In March 2021, the U.S. FDA approved ABECMA (idecabtagene vicleucel), a lentivirus-based gene therapy to treat R/R multiple myeloma. With the increasing gene therapy approvals and consequent increase in manufacturing capabilities, the competition in this arena is anticipated to intensify in the near future.

Moreover, market players are engaged in leveraging external capital to advance their business operations and further boost their revenue growth. Recently in April 2021, Albumedix extended research collaboration with Cobra Biologics for the upstream and downstream processing of AAV and lentiviral vector. Collaboration is intended for stability enhancement and process optimization.

Tedious and highly regulated processes for vector production and inadequate capacity for vector production are some of the key challenges in the market for viral vectors and plasmid DNA manufacturing. To overcome these challenges, more focused attempts are required. These challenges create opportunities for emerging CDMOs to capitalize on the avenues and gain considerable market share. Moreover, companies are collaborating with key operating stakeholders; including regulatory bodies, industry, and non-industry players, and others; to effectively address the challenges in viral vector production.

Vector Type Insights

The Adeno Associated Virus (AAV) segment dominated the market for viral vectors and plasmid DNA manufacturing and accounted for the largest revenue share of 19.0% in 2020. The growing demand and their usage in clinical trials owing to the highest accuracy in delivering the gene to the region of interest has impacted the revenue generation in this segment. The usage of AAV is rising considerably, consequently witnessing a significant boost in the adoption rate. Proven records of non-pathogenicity have boosted their adoption.

Furthermore, Adenoviral vectors are considered safe, thus are increasingly being employed across various research settings. ADV vectors are extensively being used as vaccines as they are capable of inducing strong humoral and T cell responses. Studies based on adenovirus vector as a delivery tool for CRISPR/Cas9 have resulted in effective gene disruption in the host genome of various human cells.

On the other hand, Oxford Biomedica Plc has an exclusive lentivector platform, safe and advanced gene delivery system capable of carrying payloads of up to 9kb. Such advanced products would supplement the segment revenue growth. The success of lentiviral-based gene therapy products has augmented the adoption of these vectors across several end-users.

Workflow Insights

The downstream processing segment dominated the market for viral vectors and plasmid DNA manufacturing and accounted for the largest revenue share of 53.0% in 2020. To fulfill the requirement of a polished and purified clinical-grade final product, several highly complex procedures are deployed. The introduction of technologically advanced chromatography products and the development of novel technologies to serve fill-finish processing for vector manufacturing has propelled revenue generation.

Implementation of Single-use Technology (SUT) in viral vector manufacturing workflow has also resulted in cost and time-saving procedures. For instance, scalable SUT such as membrane-based ion-exchange chromatography, direct-flow filtration (depth and sterile), and Tangential-flow Filtration (TFF) can be employed for the purification of viral vectors.

Furthermore, several companies have shifted their focus on offering a broad range of advanced products and services for upstream processing, in turn accelerating the segment growth. For instance, Boehringer Ingelheim offers a high titer plasmid DNA fermentation process that enables the production of high yield plasmid DNA in E. coli biomass. Moreover, Companies like GE Healthcare are involved in the development of upstream cell culture processes using modern tools and technologies.

Application Insights

In 2020, the vaccinology segment dominated the market for viral vectors and plasmid DNA manufacturing and accounted for the largest revenue share of 24.9% in 2020. This can be attributed to the high employment of viral vectors in vaccine development owing to their efficiency-related advantages. Some advantages are the potential to elicit a wide immune response, safety profiles, and easy manufacturing.

The recent outbreak of the COVID-19 virus has driven the use of viral vectors in vaccine development. Although viral vectors were widely used for vaccine development before the emergence of COVID-19, the urgency to develop a vaccine against this virus has led the scientific community to repurpose the existing approaches. Non-replicating viral vectors are being used in the COVID-19 viral vector vaccines.

Companies such as ViroCell Biologics are launching platforms for the clinical trial base manufacturing for addressing the bottlenecks associated with the viral vector supply chain amidst the covid situation. Such initiatives are attributive to drive manufacturing and research practices in viral vector academic organizations and CROs.

End-use Insights

The research institutes segment dominated the market for viral vectors and plasmid DNA manufacturing and accounted for the largest revenue share of 57.0% in 2020. The increasing involvement of the research community in gene and cell therapy research activities is expected to increase the demand for viral vectors in the global market. Maine Medical Center Research Institute, National Institute for Physiological Sciences, and the Viral Vector Core (VVC) are some research institutes that are engaged in the production of vectors.

An increase in the introduction of advanced therapies along with the rising number of gene therapy-based R&D programs by companies, pharmaceutical, and biopharmaceutical companies are emerging as the significant end-users of the market for viral vectors and plasmid DNA manufacturing. For instance, Abeona Therapeutics is one of such companies that is actively evaluating AAV9-based gene therapies for CLN1 and CLN3 diseases.

Disease Insights

In 2020, the cancer segment dominated the market for viral vectors and plasmid DNA manufacturing and accounted for the largest revenue share of 37.0%. Viruses have proven their efficiency as an ideal vector for gene therapy production against various cancer types. Also, the success of viral vector-based CAR-T cell therapies for hematologic malignancies such as mantle cell lymphoma and B-cell lymphoma has gained the attention of end-users.

Gene therapy also focuses on the treatment of rare genetic disorders like hemophilia, Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID), and Lipoprotein Lipase Deficiency (LPLD. There are many private and public companies in the U.S. that are focusing on these disease categories, thus, positively impacting the segment growth.

Global viral vectors & plasmid DNA manufacturing market share, by disease, 2020 (%)

Currently, genetic disorders are one of the most focused application areas for gene therapy research programs. This makes gene therapy for genetic disorders one of the most crucial markets in the forecast years. Besides, the rising burden of genetic diseases has majorly driven investments in this segment.

Regional Insights

North America dominated the viral vectors and plasmid DNA manufacturing market and accounted for the largest revenue share of 49.0% in 2020. The presence of a substantial number of centers and institutes that are engaged in the R&D of advanced therapies is one of the key contributing factors for the dominance of the region. With the increasing regulatory approvals for advanced therapies, the U.S. significantly contributed to the regional revenue generation.

In addition, U.S.-based companies are investing a significant amount to expand their manufacturing capabilities. For instance, in January 2021, Thermo Fisher Scientific acquired the viral vector manufacturing business of Groupe Novasep SAS (Novasep). This acquisition aimed at the expansion of the company’s CDMO service offerings. On the other hand, Asia Pacific is projected to witness the fastest growth rate throughout the forecast period.

Over the past several years, the Asian cell and gene therapy market has gained momentum in terms of product approvals and pipeline programs. This can be attributed to the establishment of accelerated approval pathways, growing private and government investments, and increasing healthcare needs. Besides, the unmet needs in the personalized medicine arena are driving the research for regenerative medicine, leading to increasing demand for viral vector supply.

Key Companies & Market Share Insights

The market for viral vectors and plasmid DNA manufacturing is highly competitive with the presence of well-established as well as mid and small-sized emerging players. The increasing number of entities in the advanced therapy arena is anticipated to increase the demand for viral vectors, thereby intensify the market competition. Companies are undertaking various strategic initiatives to strengthen their market position.

Facility expansion is one of the initiatives undertaken to maintain a market presence. For instance, in February 2021, Vibalogics, a Germany-based CDMO initiated the building of new virotherapy manufacturing plant in Massachusetts. The company aimed to expand its manufacturing capabilities with the investment of USD 150 million. The plant is expected to be operational in the second half of 2021. Some of the prominent players in the viral vectors and plasmid DNA manufacturing market include:

  • Merck KGaA

  • Lonza

  • FUJIFILM Diosynth Biotechnologies

  • Thermo Fisher Scientific

  • Cobra Biologics

  • Catalent Inc.

  • Wuxi Biologics

  • Takara Bio Inc.

  • Waisman Biomanufacturing

  • Genezen laboratories

  • Batavia Biosciences

  • Miltenyi Biotec GmbH

  • SIRION Biotech GmbH

  • Virovek Incorporation

  • BioNTech IMFS GmbH

  • Audentes Therapeutics

  • BioMarin Pharmaceutical

  • RegenxBio, Inc.

Viral Vectors And Plasmid DNA Manufacturing Market Report Scope

Report Attribute

Details

Market size value in 2021

USD 2.9 billion

Revenue forecast in 2028

USD 8.6 billion

Growth Rate

CAGR of 18.8% from 2021 to 2028

Base year for estimation

2020

Historical data

2017 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD Million and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company share, competitive landscape, growth factors, and trends

Segment coverage

Vector type, workflow, application, end use, disease, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

U.S.; Canada; Germany; France; Italy; Spain; U.K.; China; Japan; India; South Korea; Brazil; Mexico; South Africa; Saudi Arabia

Companies profiled

Merck KGaA; Lonza; FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; Cobra Biologics Ltd.; Thermo Fisher Scientific, Inc.; Waisman Biomanufacturing; Genezen; YPOSKESI; Advanced BioScience Laboratories, Inc. (ABL, Inc.); Novasep Holding S.A.S; Orgenesis Biotech Israel Ltd (formerly ATVIO Biotech ltd.); Vigene Biosciences, Inc.; General Electric Company (GE Healthcare); CEVEC Pharmaceuticals GmbH; Batavia Biosciences B.V.; Biovion Oy; Wuxi AppTec Co., Ltd.; VGXI, Inc.; Catalent Inc.; Miltenyi Biotec GmbH; SIRION Biotech GmbH; Virovek Incorporation; BioNTech IMFS GmbH; VIVEbiotech S.L.; Creative Biogene; Vibalogics GmbH; Takara Bio.; Cell and Gene Therapy Catapult; BlueBird Bio; Addgene, Inc.; Aldevron, L.L.C.; Audentes Therapeutics; BioMarin Pharmaceutical; RegenxBio, Inc.

Customization scope

If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of the customization

Pricing and purchase options

Avail customized purchase options to meet your exact research needs. Explore purchase options


Segments Covered in the Report

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 2017 to 2028. For the purpose of this study, Grand View Research has segmented the global viral vectors and plasmid DNA manufacturing market report on the basis of vector type, workflow, application, end use, disease, and region:

  • Vector Type Outlook (Revenue, USD Million, 2017 - 2028)

    • Adeno associated virus (AAV)

    • Lentivirus

    • Adenovirus

    • Retrovirus

    • Plasmid DNA

    • Others

  • Workflow Outlook (Revenue, USD Million, 2017 - 2028)

    • Upstream Processing

      • Vector Amplification & Expansion

      • Vector Recovery/Harvesting

    • Downstream Processing

      • Purification

      • Fill Finish

  • Application Outlook (Revenue, USD Million, 2017 - 2028)

    • Antisense & RNAi

    • Gene Therapy

    • Cell Therapy

    • Vaccinology

    • Research Applications

  • End-Use Outlook (Revenue, USD Million, 2017 - 2028)

    • Pharmaceutical and Biopharmaceutical Companies

    • Research Institutes

  • Disease Outlook (Revenue, USD Million, 2017 - 2028)

    • Cancer

    • Genetic Disorders

    • Infectious Diseases

    • Others

  • Regional Outlook (Revenue, USD Million, 2017 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • France

      • Italy

      • Spain

      • U.K.

    • Asia Pacific

      • China

      • India

      • Japan

      • South Korea

    • Latin America

      • Brazil

      • Mexico

    • Middle East & Africa

      • South Africa

      • Saudi Arabia

Frequently Asked Questions About This Report

gvr icn

GET A FREE SAMPLE

gvr icn

This FREE sample includes market data points, ranging from trend analyses to market estimates & forecasts. See for yourself...

gvr icn

NEED A CUSTOM REPORT?

We can customize every report - free of charge - including purchasing stand-alone sections or country-level reports, as well as offer affordable discounts for start-ups & universities.

Contact us now to get our best pricing.

BBB icon D&B icon

We are GDPR and CCPA compliant! Your transaction & personal information is safe and secure.