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Viral Vector Manufacturing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

Viral Vector Manufacturing Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021 - 2026)

  • April 2021
  • 148 pages
  • ID: 6062845
  • Format: PDF
  • Mordor Intelligence LLP

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The Viral Vector Manufacturing Market was estimated to be USD 601.36 million in 2020 and is poised to grow at a CAGR of 27.36% by 2026 to reach USD 2,579.85 million.

The COVID-19 pandemic has underlined the importance of vaccine development for the global population. According to the World Health Organisation (WHO), around 151 vaccine candidates have been subjected to preclinical studies and 42 vaccines have reached clinical trials. The importance of viral vector manufacturing is highlighted by the fact that there are at least two adenovirus-based vaccine candidates that are currently in phase III development while another one has been approved in Russia.

Due to the relative ease of manufacturing viral vector vaccines, effective packaging cell line systems have been developed for many viral vector systems such as Ad (adenoviruses), AAV (Adeno-associated viruses), flaviviruses, and lentiviruses. This has also facilitated the rapid and efficient large-scale production of vaccine candidates that are eligible for clinical applications against COVID-19. In July 2020, an article was published in the ‘Nature’ journal where the chimpanzee Ad vector ChAdOx1 nCoV-19 was engineered to express the SARS-CoV-2 S protein. When this protein was subjected to immunization of mice and rhesus macaques, it induced strong humoral and cellular immune responses and prevented COVID-19 pneumonia in macaques. More such research involving viral vectors is expected to continue at least for the next one or two years. This is expected to boost market growth.

The factors that are driving market growth include the rising prevalence of genetic disorders, cancer, and infectious diseases, the increasing number of clinical studies using viral vectors, and the availability of funding for gene therapy development, and potential applications in novel drug delivery approaches.

There is also an increase in several genetic disorders and infectious diseases. For instance, according to the UNAIDS Statistics, in 2019, 38.0 million people worldwide were living with HIV and 1.7 million people became newly infected with HIV. According to the same source, 26 million people were accessing antiretroviral therapy at the end of June 2020. In addition, recombinant viral vectors are highly efficient carriers of sequences encoding virus-disabling sequences. Appropriate viral vectors usually need to be selected and adapted for application for the treatment of specific viral infections. Moreover, retroviral gene therapy is a promising alternative treatment for HIV/AIDS. Foamy virus (FV) vectors are derived from non-pathogenic viruses, and they have been used to deliver HIV-inhibiting transgenes to human HSCs. There have been significant public and private sector initiatives for the development of viral vector vaccines. In fact, many companies are investing in capacity expansion for manufacturing activities. For example, in November 2020, the contract manufacturer Vibalogics announced plans to invest USD 150 million to build a 110,000 square-foot facility near Boston in the United States. The facility will be used to produce clinical and commercial-stage oncolytic viruses and viral vectors. Developments such as these are expected to boost the market growth.

Government initiatives are also driving the market’s growth. These include efforts through direct funding which is increasing awareness while the regulatory environment is getting streamlined via changes, such as fast track approval processes.

Hence, the market for viral vector manufacturing is expected to grow in the future.

Key Market Trends
The Cancer Sub-segment is Expected to Grow Faster in the Disease Segemnt

The upsurge in the global incidence of cancer and modern healthcare facilities are acting as major drivers for the growth of the market studied. According to GLOBOCAN 2020, globally, there were 1,92,92,789 new cancer cases in 2020, and it is projected to increase to 2,88,87,940 cases by 2040. Currently, there are numerous Phase I, Phase II, Phase III, and Phase IV clinical trials related to viral vectors for the treatment of various types of cancers such as brain, skin, liver, colon, breast, and kidney, among others. These trials are being conducted in various academic centers and biotechnology companies. For instance, according to the National Clinical Trial (NCT) Registry, globally, as of 29th March 2021, there are more than 90 ongoing interventional clinical trials related to gene therapy across different phases of development for cancer.

In the field of oncology, viral vector-based gene therapy has demonstrated steady progress. A variety of viral vectors have been engineered for both therapeutic and preventive applications, in cancers. The upsurge in the global incidence of cancer and modern healthcare facilities are acting as major drivers for the growth of the market studied. Many gene therapy strategies have been developed to treat a wide range of cancers, including suicide gene therapy, oncolytic virotherapy, anti-angiogenesis, and therapeutic gene vaccines. All these therapies are viral vector-dependent. Thus, with the increase in the global incidence of cancer, the market is expected to see positive development.

The market players are adopting various market strategies in developing novel products. For instance, in April 2020, VBL Therapeutics announced that it was awarded a non-dilutive grant of up to ILS 3.175 million (approximately USD 0.9 million) by the Israel Innovation Authority to support the continued development of VBL’s lead product candidate, VB-111, a first-in-class targeted anti-cancer gene-therapy agent. VB-111 is currently being evaluated in Phase 3 potential registration study (OVAL) for the treatment of platinum-resistant ovarian cancer. In June 2019, researchers at the São Paulo State Cancer Institute (ICESP) in Brazil used a genetically manipulated virus to destroy tumor cells upon injection into mice with prostate cancer. Such developments and increasing research programs on cancer gene therapy are promoting the demand for manufacturing viral vectors.

A critical factor in viral vector-based cancer therapy has been the application of engineered and naturally occurring oncolytic viral vectors. These vectors are programmed to specifically replicate inside the cancer cells and induce toxic effects, which ultimately results in apoptosis. The attractive features of viral vectors relate to their capability to provide high levels of transgene expression, in a broad range of host cells.

The high demand for effective therapeutics for the management of cancers, the presence of fast track approval process, and the prospects of novel drugs to turn into blockbuster products are primary reasons responsible for the significant R&D investments in the field of viral vector-based cancer therapeutics, which, in turn, is driving the market’s growth.

North America Dominates the Market and is Expected to Follow the Same Trend in the Future As Well

North America currently dominates the market for viral vector manufacturing and is expected to continue its stronghold for a few more years. In the United States, regulatory encouragement and patient advocacy have pushed rare disease clinical research to the center stage. The significant incentives on offer through the Orphan Drugs Act (United States) have encouraged pharmaceutical and biotechnology companies to consider the development of rare disease medicines as a potentially-profitable venture.

Many companies have been expanding their facilities and investing a significant amount of capital in the region. For example, in April 2020, Merck KgaA and its subsidiary MilliporeSigma announced plans to spend USD 110 million to open a second viral vector facility at its Carlsbad, California facility. The projected expansion was expected to double the company’s gene therapy manufacturing capacity. In September 2019, NGen, a Canada-based non-profit that matches manufacturers with new technologies announced that it will provide USD 1.48 million to iVexSol Canada for developing an advanced manufacturing process for lentiviral vectors. Educational and academic institutes have also been at the forefront of R&D investment. In November 2019, Harvard University announced that it was collaborating with contract development and manufacturing organizations (CDMOs) to develop a USD 50 million cell and viral vector manufacturing facility. Such initiatives are expected to boost the market growth.

The United States holds the largest market share in the North American region owing to various factors like the high adoption rate of new therapies and the high incidence rate of cancer. The increasing prevalence of genetic and other chronic disorders, an aging population, growing demand for targeted and personalized medicine, and favorable government initiatives are the factors responsible for future market growth in the United States

Competitive Landscape
The viral vector manufacturing market is moderately competitive and has several key players, such as Merck KgaA, Fujifilm Diosynth Biotechnologies, Thermofisher Scientific, Cognate Bioservices and FinVector. Owing to the growing demand for novel therapeutics to deal with life-threatening diseases, such as cancer, various smaller companies are also entering the market and holding a significant market share.

Several players, including pharmaceutical companies, research institutes, contract manufacturing organizations, and non-profit organizations, are playing a critical role in the development and production of these vectors. For instance, in January 2021, the company Thermo Fisher Scientific acquired Viral Vector’s manufacturing business of HenogenS.A., Novasep’s in Belgium for approximately EUR 725 million

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