Viral Vector Manufacturing Market

Global Viral Vector Manufacturing Market Size (2023 to 2028)

The global viral vector manufacturing market is forecasted to be worth USD 1594.11 million by 2028 from USD 608.13 million in 2023, growing at a CAGR of 21.24% from 2023 to 2028.

MARKET DRIVERS:

The growing prevalence of genetic diseases, cancer and infectious diseases primarily drives the growth of the viral vector manufacturing market. Viral vectors have become a promising tool in gene therapy, immunotherapy, and vaccine development and these are being used to deliver genetic material into target cells. The growing understanding of genetic disorders and advancements in gene therapy research contributes to the growing demand for viral vector manufacturing. The growing patient population suffering from cancer and the continuous pursuit of more effective treatment strategies fuels the demand for viral vector manufacturing in this field. The ongoing efforts to combat infectious diseases and the need for effective preventive measures also boost the demand for viral vector manufacturing and drive market growth.

The growing number of clinical trials of viral vectors and the availability of financing for gene therapy development is primarily driving the expansion of the global viral vector manufacturing market. Due to an increase in the number of gene therapy-based products, the global viral vector manufacturing market is rapidly expanding. In addition, the rise of molecular biology hastened genomic sequencing, which is projected to strengthen precision medicine even further. The advancements in molecular biology and medical research bring gene therapy closer to a progressive threshold, allowing viral vector manufacturing to expand and revolutionize patient care. The high demand for effective cancer therapeutics, a fast-track approval process, and the potential for novel drugs to become blockbuster products further drive notable R&D investments in viral vector-based cancer therapeutics and support market growth.

The competition in this field is expected to heat up in the near future due to a rise in gene therapy approvals and, as a result, an increase in manufacturing capabilities. As a result, the companies collaborate for advanced gene therapy as an effective strategy to establish worldwide leadership. While some viral vector manufacturing market players engage in partnership programs, others expand their current viral vector manufacturing capabilities, boosting their position as viral vector manufacturing market drivers.

MARKET RESTRAINTS:

Virus vectors have the limitation of having a short lifespan. Furthermore, the expensive cost of gene-based medical interventions may restrict viral vector demand. Some other vital restraints to the market for viral vectors and plasmid DNA manufacture are time-consuming and highly regulated vector production methods and insufficient capacity for vector production. Stringent regulations and complex approval processes associated with viral vector manufacturing is one of the major factors hampering the market growth. Safety issues related to viral vectors, such as immune response, toxicity, and potential adverse effects and the complex manufacturing processes involved in viral vector production, including scalability, purification, and quality control hinder the market growth. The cost-intensive nature of viral vector manufacturing, limited vector efficiency in delivering genetic material to target cells and immunogenicity issues further impede the market growth.

Impact of COVID-19 on the global viral vector manufacturing market:

The COVID-19 pandemic has opened significant opportunities for market participants. For example, in December 2020 and February 2021, multinational pharmaceutical companies such as AstraZeneca and Janssen Pharmaceuticals developed COVID-19 viral vector-based vaccines, respectively. Aside from these firms, several viral vector-based vaccines are now in development. As a result, demand for viral vectors has increased, resulting in increased revenue for viral vector manufacturers. Thus, the global importance of vaccine development has been highlighted by the COVID-19 pandemic. According to the World Health Organization (WHO), preclinical investigations have been conducted on 151 vaccine candidates, with 42 vaccines advancing to clinical trials. The fact that at least two adenovirus-based vaccine candidates are now in phase III development, and another has been approved in Russia highlights the relevance of viral vector manufacture. In addition, the recent COVID-19 virus outbreak has prompted the use of viral vectors in vaccine research. Although viral vectors were widely employed for vaccine production before the introduction of COVID-19, the scientific community has had to repurpose existing approaches due to the necessity of developing a vaccine against this virus. In the COVID-19 viral vector vaccines, non-replicating viral vectors are used.

REPORT COVERAGE:

This research report on the global viral vector manufacturing market has been segmented and sub-segmented based on type, disease application, end-user, and region.

Viral Vector Manufacturing Market – By Type:

• Adeno-Associated Viral Vectors
• Retroviral Vectors
• Adenoviral Vectors

Based on type, the adeno-associated viral (AAV) vectors segment held the major share of the global market in 2022 and is anticipated to hold a promising occupancy in the worldwide market during the forecast period. The growing adoption of the AAV vectors segment in gene therapy applications due to their favorable safety profile is one of the major factors propelling the segmental growth. Low immunogenicity and a wide range of applications in treating genetic diseases, such as hemophilia, muscular dystrophy, and inherited retinal disorders further boost the growth rate of the segment. Ongoing advancements in AAV vector engineering, such as capsid modifications and tissue-specific targeting and positive results from clinical trials using AAV vectors further propel the growth of the AAV segment.

The adenoviral vectors segment is anticipated to account for a considerable share of the global market during the forecast period. The broad cell infectivity and immune response induction, ease of manufacturing and scalability of adenoviral vectors primarily propel the segmental growth. Versatile gene delivery capacity and success in vaccine development, including COVID-19 vaccines further boost the growth rate of the adenoviral vectors segment in the global market.

Viral Vector Manufacturing Market – By Application:

• Gene Therapy
• Vaccinology Development

Based on application, the gene therapy segment is anticipated to account for a promising share of the global market during the forecast period. The growing prevalence of genetic disorders such as inherited genetic diseases, increasing number of advancements in viral vector technology, particularly the development of safer and more efficient vectors and rising investments in research and development, along with regulatory approvals for gene therapy products drive the growth of the gene therapy segment in the global viral vector manufacturing market.

On the other hand, the vaccinology segment is predicted to witness a healthy CAGR during the forecast period owing to the widespread use of viral vectors in vaccine development because of their efficiency-related benefits. The global focus on vaccine development, increasing number of vaccination campaigns and rising investments in viral vector manufacturing for vaccinology development majorly drive the growth of the vaccinology development segment in the worldwide market. The growing need for novel vaccines, advancements in viral vector design and manufacturing processes, and global efforts to combat infectious diseases further fuel the growth rate of the vaccinology development segment.

Viral Vector Manufacturing Market - By Disease:

• Cancers
• Genetic Disorders
• Infectious diseases
• Other Diseases

Based on disease, the cancer segment is expected to grow at the fastest CAGR in the global market during the forecast period due to the growing global cancer prevalence and an increasing number of advanced healthcare facilities. There is now a slew of Phase I, II, III, and IV clinical trials involving viral vectors to treat brain tumors, skin, liver, colon, breast, and kidney, among others. These tests are being carried out at several academic institutions and biotechnology enterprises. Virus vector-based gene therapy has made steady development in the field of oncology. In cancer, various viral vectors have been created for therapeutic and preventative purposes. Suicide gene therapy, oncolytic virotherapy, anti-angiogenesis, and therapeutic gene vaccines are some of the gene therapy treatments developed to treat a variety of tumors and all these treatments are reliant on viral vectors. The rising demand for targeted and personalized cancer therapies, the increasing number of advancements in gene therapy approaches for cancer treatment and the potential of viral vectors in delivering therapeutic genes to cancer cells drive the growth of the cancer segment in the global market.

The genetic disorders segment is estimated to hold a considerable share of the worldwide market during the forecast period owing to the rising prevalence of genetic disorders globally, the growing number of advancements in understanding genetic diseases and their underlying mechanisms and increasing interest in gene therapy as a potential treatment option for genetic disorders. Factors such as the potential of viral vectors in delivering functional genes to correct genetic mutations and the development of gene editing technologies, such as CRISPR-Cas9, complementing viral vector-based approaches further promote segmental growth. The supportive regulatory landscape for gene therapy products targeting genetic disorders, growing investments in genetic research and development, increasing number of collaborations between academic institutions, healthcare providers, and pharmaceutical companies for advancing genetic therapies and growing awareness and acceptance of gene therapy as a viable treatment option for genetic disorders favor the growth rate of the segment.

Viral Vector Manufacturing Market – By Region:

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

Geographically, the North American region held the largest share of the global market in 2022 and is anticipated to continue its domination throughout the forecast period. The presence of well-established healthcare infrastructure, advanced research capabilities, strong presence of pharmaceutical and biotechnology companies driving innovation and a favorable regulatory environment supporting the development and commercialization of viral vector-based therapies. The high prevalence of diseases, such as cancer and genetic disorders, the availability of skilled professionals and expertise in viral vector manufacturing, rising investments in research and development activities and supportive reimbursement policies for viral vector therapies further boost the growth rate of the North American market. The U.S. accounted for the major share of the North American market in 2022, followed by Canada and the same pattern is likely to continue throughout the forecast period. The growth of the U.S. market is majorly driven by the rapid adoption of gene therapies and viral vector-based vaccines in clinical practice, an increasing number of collaborations between academic institutions, research organizations, and industry players, high healthcare expenditure and willingness to adopt advanced therapies.

Europe is a prominent regional market for viral vector manufacturing and is anticipated to account for a substantial share of the worldwide market during the forecast period. The presence of a robust healthcare infrastructure, growing support from the governments of European countries for research and development and the presence of leading pharmaceutical and biotechnology companies in the European region drive the European market growth. Strong regulatory framework ensuring the safety and efficacy of viral vector-based therapies, rising awareness and acceptance of gene therapy and viral vector-based vaccines, growing patient population of diseases such as cancer and genetic disorders and the presence of well-established clinical trial networks and research centers further propel the European market growth. The UK led the market in Europe in 2022 and the lead of the UK market is expected to continue during the forecast period. Favorable reimbursement policies for gene therapies and viral vector-based treatments, technological advancements and expertise in vector design and production and growing investments in healthcare and biotechnology sectors contribute to the growth of the UK market.

APAC is anticipated to witness the fastest CAGR among all the regions in the worldwide market during the forecast period. Factors such as a large patient population, rapidly developing healthcare infrastructure in countries like China and India, growing investments in biotechnology and pharmaceutical sectors and an increasing number of initiatives from the governments of APAC countries to promote research and development in viral vector manufacturing propel the market growth in the Asia-Pacific region.  The growing awareness and acceptance of advanced therapies, including gene therapy and viral vector-based vaccines, the availability of skilled workforce and cost advantages in manufacturing and an increasing number of collaborations between international and domestic players in the APAC region further boost the growth rate of the APAC market. China held the largest share of the APAC market in 2022, followed by India and Japan and the same trend is expected to continue in the coming years. Favorable regulatory reforms supporting the development of viral vector therapies, growing healthcare expenditure, improving access to healthcare services and the potential for market expansion and clinical trials in emerging economies drive the APAC market.

KEY MARKET PLAYERS:

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, and Audentes Therapeutics are some of the major companies in the global viral vector manufacturing market.

RECENT MARKET DEVELOPMENTS:

• Shape Therapeutics introduced a new capsid discovery platform in December 2020, intending to improve the delivery and safety of gene treatments. In addition, the platform might create tissue-specific adeno-associated virus (AAV) vectors.
• The FDA authorized ABECMA, lentivirus-based gene therapy for R/R multiple myeloma, in March 2021.
• Fujifilm Corporation announced intentions to invest USD 40 million in establishing a new processing facility for viral vector manufacture and related research in January 2021.