Viral Vector Manufacturing Market Analysis

Global Viral Vector Manufacturing Market Overview

Viral Vector Manufacturing Market Size valued at USD 0.24 Billion in 2023. 

The Viral Vector Manufacturing industry is projected to rise from USD 0.29 Billion in 2024 to USD 1.04 Billion by 2032, exhibiting a compound yearly growth rate (CAGR) of 17.39% during the forecast period (2024 - 2032).

Increased demand for gene therapy, and rising prevalence of the chronic diseases, and advancements in technology are the key market drivers enh the growth of market.

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review 

The market is fueled by the rising incidence of genetic abnormalities, cancer, and infectious diseases, the expansion of clinical trials and financing for the development of gene therapy, and the potential for novel drug delivery methods. Several nations' governments are investing considerably in gene therapy research and development. The efficiency of creating high-quality vectors used for various applications, such as vaccinations or cell-based treatments, has been significantly improved, while production costs have been reduced thanks to technical innovation. One of the major technological breakthroughs that has completely transformed the market is CRISPR-Cas9. It allows scientists to edit DNA sequences more precisely by removing specific sections of genomes without affecting nearby tissue, making creating personalized viruses targeted at specific individuals easier.

The right and precise viral vectors typically need to be selected and modified to treat certain viral illnesses because recombinant viral vectors are particularly successful carriers of sequences encoding virus-disabling sequences. The research and production of viral vector vaccines is the focus of large private and public endeavors, prompting major companies to invest in manufacturing activity capacity growth. The market for producing viral vectors and plasmid DNA is expanding due to the rising incidence of target illness and disease and the efficiency of viral vectors in delivering gene therapy. Viral vector-based gene therapy has made consistent advancements in the field of oncology. Numerous viral vectors have been developed for therapeutic and preventive cancer applications.

Numerous gene therapy approaches, such as anti-angiogenesis, oncolytic virotherapy, suicide gene therapy, and therapeutic gene vaccines, have been created to treat a variety of malignancies. Viral vectors have several potential applications in cancer therapy. This increase is made possible by funding for the development of gene therapy and ongoing research into cell and gene therapies based on viral vectors. The requirement for scalable production of gene therapy vectors is also anticipated to rise due to an upsurge in the variety of gene therapy-based discovery initiatives launched by biotechnology and pharmaceutical businesses.

Kite Pharma, a division of Gilead Sciences, previously revealed plans to construct a new viral vector manufacturing plant. The US Food and Drug Administration (FDA) gave the new plant the go-ahead for commercial production last year. It is employed in producing viral vectors for cell therapy and Yescarta®, the company's first commercially available CAR T (chimeric antigen receptor T) cell treatment. The new facility enhances Kite Pharma's CAR T-cell treatment development capacity, manufacture, supply, and future pipeline items.

In June 2023, INADcure Foundation announced that they are in a manufacturing partnership with Charles River Laboratories, where Charles River will be the one to produce high-quality plasmid DNA for phase I/II clinical trials of gene therapy for MND.

In April 2023, Bristol Myers Squibb declared that they have added an in-house viral vector production facility to satisfy their cell therapy needs.

In February 2023, BioNTech reported that it had finished building its own Marburg-based clinical and commercial scale plasmid DNA manufacturing facility.

In June 2022 saw Avid Bioservices, Inc. unveil the analytical and process development (AD/PD) suites as part of its new world-class viral vector development and Current Good Manufacturing Plant (CGMP) manufacturing facility. The build-out of the viral vector facility's CGMP manufacturing suites is ongoing, with capabilities expected to come online mid-calendar 2023.

October 2022 To support potentially game-changing cell and gene therapies, Charles River Laboratories International, Inc. officially opened the doors of its Alderley Park facility in Cheshire, United Kingdom.

October 2022 Yposkesi increased production efficiency by using “HEK+” cells lacking SV40 large T antigen encoding sequences for adeno-associated viral vectors.

Takara Bio Inc. launched a new CDMO service utilizing the brain-tropic AAV (adeno-associated virus) vector, “CereAAV,” in July this year to cater to clients in the gene and cell therapy industry.

Charles River Labs International Incorporated introduced the nAAVigation Vector Platform (nAAVigation) as a new offering in October this year. Based on extensive experience in Adeno-Associated Virus (AAV) vector contract development and manufacturing (CDMO) coupled with biologics testing, Charles River has created a platform to simplify the production of GMP-grade AAV vectors.

Viral Vector Manufacturing Market Trends

• Growing demand for gene therapy is driving the market growth

Market CAGR for viral vector manufacturing is being driven by the surging demand for gene therapy. Gene therapy is a favorable treatment alternative for several genetic disorders, inclusive of inherited diseases, cancer and viral infection. The utilization of viral vectors in gene therapy has attained significant attention owing to their capability to deliver therapeutic genes in the target cells efficiently. Additionally, technological advancements have played an important role in boosting innovation in the market of viral vector production globally.

The viral vector production market is anticipated to experience vigorous growth in recent years. The growth in the prevalence of genetic disorders and chronic ailments like cancer has led to a rise in the demand for gene therapies throughout the globe. The continuous advancements in biotechnology have helped researchers in developing new gene therapies which can treat previously untreatable conditions. The government of different countries is hugely investing significantly in research & development activities related to gene therapy. The technological advancement has made significant improvements to improve efficiency while minimizing costs related to producing high-quality vectors utilized for several applications like vaccines or cell-based therapeutics. CRISPR-Cas9 technology is one of the key technological advancements which has revolutionized the market globally, allowing scientists greater precision while editing DNA sequences by cutting out specific sections from genomes without damaging surrounding areas, making it simpler to generate custom-made viruses tailored toward individual requirements.

Automation technologies have been created which can streamline the whole process from start to finish. The growing requirement for effective treatments against viral infections is the factor boosting the growth of the market. Gene therapy utilizing viral vectors has reflected promising results in preclinical studies for treating viral infections like HIV/AIDS and hepatitis C. The vaccines based on viral vectors have been successful in offering protection against different viruses like Ebola and influenza; these vaccines function by delivering a piece of viral DNA cells that triggers an immune response against that specific virus. Thus, driving the Viral Vector Manufacturing market revenue.

However, the high operational prices related to cell and gene therapy manufacturing than conventional biologics is the restraining reason for the growth of the market. Further, the risk of immune responses or adverse reactions in the patients taking viral-vector-based therapies and also the production of viral vectors can be expensive and complex, and needing specialized equipment facilities are the factor restraining the market growth.

Viral Vector Manufacturing Market Segment Insights

Viral Vector Manufacturing Workflow Insights

The Viral Vector Manufacturing market segmentation, based on workflow, includes Upstream Manufacturing and Downstream Manufacturing. The downstream manufacturing segment dominated the market, accounting for the biggest market revenue due to the highly complex process carried out for polishing and purification of clinical-grade final products. The rising demand for viral vectors owing to their raised adoption as therapeutics has caused an increase in the demand for optimizing downstream manufacturing. The small-scale virus preparation methods continuously include procedures that are difficult to scale up and considered complex. Development of advanced products like the amber 15 microbioreactor systems for high-throughput upstream process development is anticipated to fuel the segment.

Figure 1: Viral Vector Manufacturing Market, by Workflow, 2023 & 2032 (USD Billion) 

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Viral Vector Manufacturing End User Insights

The Viral Vector Manufacturing market segmentation, based on end users, includes Pharmaceutical and Biopharmaceutical Companies and Research Institutes. The research institutes segment dominated the market due to the growing demand for vectors in order to conduct research, and the rising involvement of scientific communities in cell and gene therapy research is anticipated to raise the demand for viral vectors. Additionally, pharmaceutical, research organizations, and biopharmaceutical companies are the major end-users in the viral vectors and plasmid DNA manufacturing market. The pharmaceutical and biotechnological companies are leading in regard to the utilization of vectors.

Viral Vector Manufacturing Regional Insights

By region, the study gives market insights into the North America, Europe, Asia-Pacific and the Rest of the World. The North American Viral Vector Manufacturing market area dominates the market because to the availability of a substantial number of institutes and centers that are involved in the R&D of advanced therapies. The investments made by the federal bodies for the expansion of the cell therapy research base in the North American region.

Further, the prime countries studied in the market report are The US, Canada, the UK, German, France, Italy, Spain, Japan, India, China, Australia, South Korea, and Brazil.

Figure 2: VIRAL VECTOR MANUFACTURING MARKET SHARE BY REGION 2023 (USD Billion) 

Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe's Viral Vector Manufacturing market accounts for the second-largest market share due to the creation of accelerated approval processes, rising pool of patient population, and surging healthcare requirements. Further, the German Viral Vector Manufacturing market held the largest market share, and the UK Viral Vector Manufacturing market was the fastest-growing market in the European region.

The Asia-Pacific Viral Vector Manufacturing Market is expected to grow at the rapid CAGR from 2024 to 2032. This is due to the adoption of advanced technology and the increasing requirement for advanced healthcare technology. Moreover, China’s Viral Vector Manufacturing market held the largest market share, and the Indian Viral Vector Manufacturing market was the fastest-growing market in the Asia-Pacific region.

Viral Vector Manufacturing Key Market Players & Competitive Insights

Leading market players are investing hugely in research and development in order to expand their product lines, which will help the Viral Vector Manufacturing market grow even more. Market players are also undertaking a variety of strategic activities to spread their footprint, with important market developments inclusive of new product launches, mergers and acquisitions, higher investments, contractual agreements, and collaboration with other organizations. To spread and survive in a more competitive and the rising market climate, the Viral Vector Manufacturing industry must offer cost-effective items.

Manufacturing locally to reduce the operational costs is one of the key business tactics used by the manufacturers in the Viral Vector Manufacturing industry to benefit the clients and increase the market sector. In recent years, the Viral Vector Manufacturing industry has provided with some of the most significant advantages to medicine. Major players in the Viral Vector Manufacturing Market, including Catalent Inc., Avid Bioservices Inc., AGC Biologics, Thermofisher Scientific Inc., Cognate Bioservices, FinVector, Merck KgaA, Waisman Biomanufacturing, GenScript Biotech Corporation, FUJIFILM Diosynth Biotechnologies, LONZA and others, are trying to increase market demand by investing in the research and development operations.

Avid Bioservices Inc., is a dedicated contract developer and manufacturing organization aiming for the development and CGNP manufacturing of biopharmaceutical products gained from mammalian cell culture. The company offers a comprehensive range of process development, better quality CGMP commercial and clinical manufacturing services for the biopharmaceutical and biotechnology industries. The service of the company includes CGMP clinical and commercial product manufacturing, release and stability testing, purification, regulatory strategy and support. The company also offers several process development activities, product characterization and analytical methods of development. In June 2022, the company opened the analytical and process development suits within the new, world-class viral vector development and Current Good Manufacturing Plant manufacturing facility of the company. Built-out of the viral vector CGMP manufacturing suites of the facility is ongoing, with those abilities anticipated to come in mid-calendar 2023.

Catalent Inc., formed in 2007, and headquartered in New Jersey, is a multinational corporation. The company is a provider of delivery, drug manufacturing, developments, biologics, consumer health products, and gene therapy. The company also offers comprehensive development, pre-formulation, and both commercial and clinical scale for most traditional and modern oral solid dose formats and also injectable manufacturing solutions inclusive of biologics into pre-filled syringes and glass-free vials. In May 2022, the company launched its new UpTempo Virtuos platform for manufacturing CGMP and adeno-associated viral vectors. This platform can standardize and streamline various time taking steps in AAV manufacturing to minimize the timeline from gene to clinic and allow fast first-in-human clinical evaluation. To manufacture viral gene therapies, oncolytic viruses, and viral vaccines for clinical trials, Diosynth Biotechnologies, a contract development, and production organization partner, recently finished a new facility in Darlington, UK. This facility is now cGMP operational. The company's dedication to producing early-stage clinical trials (first-in-human) experimental viral vector medicines and investment in the new facility are highlighted. Cell culture capacity up to 200 L, segregated viral and non-viral suites, and state-of-the-art high isolation clean rooms are all available at the cGMP site in Darlington.

Key Companies in the Viral Vector Manufacturing market include 

• Catalent Inc.


• Avid Bioservices Inc.


• AGC Biologics


• Thermofisher Scientific Inc.


• Cognate Bioservices


• FinVector


• Merck KgaA


• Waisman Biomanufacturing


• GenScript Biotech Corporation


• FUJIFILM Diosynth Biotechnologies


• LONZA

Viral Vector Manufacturing Industry Developments

May 2022:AGC Biologics announced the addition of viral vector suspension technology and capacity for the development and production of gene therapies at its commercial-grade campus in Longmont, Colo.

November 2022:VidPrevtyn Beta as a booster to prevention of Covid-19 in the adults 18 years of age and older was approved by the European Commission after the Committee for Medical Products for Human Use of European Medicines Agency issued a positive opinion.

August 2022:Themofisher Scientific Inc. constructed a cutting-edge, brand-new manufacturing facility for viral vectors in Plainville, Massachusetts. The ability of the company to offer cell and gene therapy would benefit from this.

Viral Vector Manufacturing Market Segmentation

Viral Vector Manufacturing Workflow Outlook

• Upstream Manufacturing


• Downstream Manufacturing

Viral Vector Manufacturing End User Outlook

• Pharmaceutical and Biopharmaceutical Companies


• Research Institutes

Viral Vector Manufacturing Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America