The global viral vector manufacturing market size was valued at USD 537 million in 2021. It is expected to reach USD 2628.68 million by 2030, growing at a CAGR of 19.30% during the forecast period (2022–2030). Molecular biologists use viral vectors to introduce genetic material into cells. It is used to express and present pathogenic antigens to trigger an immune response by simulating a natural infection and replacing defective genes to treat genetic disorders. Oncolytic therapies frequently use it to target and eradicate tumor cells. It also has numerous uses in life science research, gene therapy, and vaccination because it helps treat various diseases, including heart defects, metabolic diseases, and neurodegenerative disorders. Due to the increasing prevalence of genetic disorders brought on by a combination of chromosome damage and gene mutations in the body, there is a rise in the production of viral vectors.
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Increasing Prevalence of Cancers, Infectious Diseases, and Genetic Disorders
Virus-based gene therapy has shown promising results for several diseases. Cancer, genetic conditions, and infectious diseases are treated by fixing defective genes or helping the body fight diseases. Chronic diseases are a growing economic burden. NIH in 2020 predicted 1,806,590 new cancer cases and 606,520 cancer-related deaths. In gene therapy clinical trials, cancer is most common. Cancer gene therapy destroys cancerous cells, prevents tumor vascularization, and boosts the immune response to tumor antigens. Due to promising therapeutic results and rising competition among top biopharmaceutical companies to get gene therapy products approved and sold for unmet medical needs, viral vector manufacturing is expected to grow during the forecast period.
Possible Applications in Emerging Drug Delivery Systems
Viral vector-based therapy is at the forefront of contemporary medicine due to advancements in vector engineering, delivery, and safety. Many metabolic, cardiovascular, muscular, hematologic, cancerous, ophthalmologic, and infectious diseases are treated with viral vectors. The viral vectors hold enormous promise for improved targeting, decreased toxicity, and controlled release, all of which can help reduce concerns about toxicity in the gene delivery system. Retrovirus, adenovirus, adeno-associated viruses, and herpes simplex viruses are a few other viruses utilized in gene delivery systems. The targeted treatment of unhealthy tissue remained a priority despite recent improvements in drug delivery.
Vectors for diseases like cancer are created to take advantage of unhealthy tissues' biological and physical characteristics. A very effective way to transfer genetic material to cells and tissues is through viral vectors. Due to their long-term expression, stability, and integrity, some viral vectors, including lytic and non-lytic vectors used for drug delivery, are highly preferred by researchers. The factors above make it clear that viral vectors have enormous potential in novel drug delivery systems, which is anticipated to accelerate the overall growth of market research.
Production Limitations of Viral Vectors
The viral vector production capacity difficulties impede the expansion of the global viral vector manufacturing market. The production of advanced therapies medicinal products (ATMPs) involves labor and resource-intensive process for viral vector products. Additionally, capacity expansion is hampered by technical difficulties and a talent gap. Further, the regulatory challenges linked to the same also impede the expansion of the market. Gene therapies are examined by regulatory organizations for their potential impact on public health, despite their high level of effectiveness.
Furthermore, the legal standards for determining the security and effectiveness of such novel techniques are still not clearly defined in developing nations like Mexico. This deters pharmaceutical and research firms from making investments in nations like Mexico. Gene therapies are gaining popularity as hopeful first-line successes in clinical studies. Still, strict regulations and limited manufacturing capacity for viral vectors can present a challenge that may be challenging to solve.
Favorable Government Initiatives
Significant government initiatives are in place to advance precision and personalized medicine, enhancing the R&D efforts of academia and business. Government initiatives are fueling market expansion through direct funding, raising public awareness, and streamlining the regulatory landscape through adjustments like expedited approval procedures. In addition, several businesses combine, buy, and release products related to viral vectors. For instance, Merck announced opening a second Carlsbad in the United States in April 2020 to support its Bio Reliance viral and gene therapy service. Additionally, in October 2020, the business FUJIFILM Corporation announced the expansion of its GMP manufacturing and viral vector process development services in the UK. These advancements have made viral vector manufacturing capacity problems less of a burden, potentially opening several opportunities over the forecast period.
The global viral vector manufacturing market is segmented by type, disease, and application.
Based on type, the global market is bifurcated into adenoviral vectors, adeno-associated viral vectors, lentiviral vectors, and retroviral vectors.
The adeno-associated viral vectors segment is the highest contributor to the market and is expected to grow at a CAGR of 28% during the forecast period. Adeno-associated viral (AAV) vectors are single-stranded DNA parvoviruses with replication defects that need a helper Ad to replicate. Long-term transgene expression is produced by site-specific or random AAV vector integration into the host cell genome without a helper virus. Additionally, various target cells, quiescent and dividing, exhibit high transduction efficiency when using AAV vectors.
Many of the benefits of Adv vectors are also present in Adeno-associated virus (AAV) vectors, including a broad host-cell range and a relatively high transduction efficiency. These elements are responsible for a sizable portion of these vectors. AAV is currently being used in numerous trials to treat diseases of the muscles and eyes, two tissues that appear to be particularly beneficial. However, clinical trials utilizing AAV vectors to deliver genes to the brain have also been started. This is possible because AAV viruses can infect quiescent (non-dividing) cells like neurons, whose genomes are persistently expressed.
Adenoviral vectors are used to deliver genes and are nonenveloped, double-stranded DNA viral vectors with a 35 kb capacity. Over fifty different adenoviral serotypes have been identified in six different species. Adenovirus-based vectors have a broad tissue tropism, a well-characterized genome, ease of genetic manipulation, acceptance of large transgene DNA insertions, inherent adjuvant properties, the ability to incite robust T cell and antibody responses specific to the transgene, non-replicative host nature, and ease of large-scale production. Since their initial use in gene therapy, adenoviral vectors have advanced and are being tested in gene therapy, vaccine vector, and anticancer studies.
Based on disease, the global market is bifurcated into cancer, genetic disorders, and infectious diseases.
The cancer segment owns the highest market share and is expected to grow at a CAGR of 27.54% during the forecast period. Modern healthcare facilities and rising cancer rates are driving market growth. By 2040, GLOBOCAN 2020 estimates that 2,88,87,940 people will be diagnosed with cancer. Anti-angiogenesis, therapeutic gene vaccines, oncolytic virotherapy, and suicide gene therapy have been developed to treat cancer. In addition, according to a 2019 research article titled "Chemovirotherapeutic Treatment Using Camptothecin Enhances Oncolytic Measles Virus-Mediated Killing of Breast Cancer Cells," oncolytic virotherapy is an emerging anticancer therapy.
Oncolytic viral vector monotherapy has limited efficacy against breast cancer and other cancers. Oncolytic virotherapy eliminates cancerous tissues while sparing healthy cells. Many Phases I, II, III, and IV clinical trials test the use of viral vectors to treat brain, skin, liver, colon, breast, and kidney cancers. Several academic institutions and biotech companies are conducting these studies. The National Clinical Trials (NCT) Registry listed more than 90 active gene therapy clinical trials for cancer as of March 29, 2021. Cancer gene therapy using viral vectors has made recent progress. Therapeutic and preventative viral vectors have been developed.
Gene therapy treats bacterial and viral infections like the flu, HIV, and hepatitis. Some of these infections have entered clinical trials or will soon. Recombinant viral vectors deliver virus-disabling sequences effectively. Most viral infections require selecting and modifying viral vectors. Human hematopoietic stem cells have also been transduced with HIV-inhibiting transgenes using FV vectors.
Based on the application, the global market is bifurcated into gene therapy and vaccinology.
The gene therapy segment is the highest contributor to the market and is expected to grow at a CAGR of 26.16% during the forecast period. Cells undergo gene therapy to correct defective genes or produce a helpful protein. Gene therapy may replace a defective or missing necessary protein with a healthy copy of the gene to restore the protein's functionality if the gene is mutated. The development of gene therapy, which makes use of various viral vectors, has made it possible to treat several inherited and acquired diseases that were previously untreatable. Drug developers are now considering using viral vectors in these novel therapeutic areas as a viable business strategy.
A biological preparation known as a vaccine offers active acquired immunity to a specific infectious disease. The use of viral vectors in vaccines is promising. The development of efficient and secure vaccines for many chronic diseases is made possible by viral vectors. Compared to conventional vaccines, viral vector-based vaccines enhance a wide range of immunogenicity without using an adjuvant and inducing a potent cytotoxic T lymphocyte (CTL) response to destroy virus-infected cells. Innovators in the biopharmaceutical industry are leading the way in how people reacted to the coronavirus pandemic. Several major biotech companies competed in studying the Sars-Cov-2 genome and developed a workable vaccine. This increased the demand for viral vectors employed in vaccine production.
By region, the global viral vector manufacturing market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.
Europe Dominates the Global Market
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Europe is the most significant shareholder in the global viral vector manufacturing market and is expected to grow at a CAGR of 28.37% during the forecast period. Due to increased R&D efforts and favorable pharmaceutical regulations, the German viral vector manufacturing market is expanding. A high incidence of cancer cases and many healthcare-related businesses are also present in the nation. The market growth has been fueled by new developments made by the nation's major market players and advancements in the technology used to produce viral vectors. Additionally, businesses are eager to increase their market share in producing viral vectors through alliances, mergers, and acquisitions. Therefore, due to the developments above, the viral vector manufacturing market is anticipated to grow over the forecast period.
North America is expected to grow at a CAGR of 26.84% during the forecast period. The United States is anticipated to hold a dominant position in the global viral vector manufacturing market over the forecast period as a result of the rising number of clinical studies, the funding for viral vector development, the presence of key market players, and the rising incidence of genetic disorders, cancer, and infectious diseases. In a report from the Organization for Economic Co-operation and Development (OECD) from 2020, it is stated that US biotechnology companies devote 15% of their total budgets to R&D. To improve their market positions, domestic companies are implementing strategies like R&D, mergers, and acquisitions, and product launches.
Asia-Pacific is anticipated to grow significantly over the forecast period. Growing cancer, infectious disease, and genetic disease cases, rising demand for gene therapy, and increasing demand to produce viral vectors drive China's market expansion. According to Globocan 2020 data, 4.57 million cancer cases were reported in 2020, and 5.81 million patients are anticipated in China by 2030. From process development to clinical GMP production, Porton Biologics' Platform for CDMO services, which integrates plasmid, viral vector, and cell therapy, was launched in November 2020. Therefore, it is anticipated that these factors will spur demand for China's production of viral vectors.
The Gulf Cooperation Council (GCC) region comprises Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, and Oman. The demand for the same in the GCC region is expected to increase due to the need for viral vector engineering and personalized medicine. The rising prevalence of diseases like cancer and infectious diseases, as well as government and local market player initiatives to promote the use of and advance viral vector manifesting, are also anticipated to fuel market growth. Additionally, major corporations with a strong presence in the area, like Thermo Fisher Scientific, are contributing to expanding the studied market in the GCC.
Brazil had 592,212 cases of cancer overall, and there were 300,114 cancer-related deaths reported there, according to Globocan 2020 data. Rising R&D expenses and the prevalence of chronic diseases like cancer and other infectious diseases are driving market expansion. The two main elements attributed to Brazil's rapid growth in the healthcare sector are the government's role in enhancing the country's healthcare infrastructure and expanding the middle class. The country's pharmaceutical and healthcare markets are anticipated to grow even more thanks to legislative changes that permit excellent foreign investment by increasing the number of industry-academia research partnerships.
The global viral vector manufacturing market’s major key players are Cognate BioServices Inc. (Cobra Biologics), Finvector, Fujifilm Holdings Corporation (Fujifilm Diosynth Biotechnologies), Kaneka Corporation (Eurogentec), Merck KGaA, Uniqure NV, Oxford BioMedica PLC, Sanofi SA, F Hoffmann-La Roche Ltd (Spark Therapeutics), and Thermo Fisher Scientific Inc.
|Market Size||USD in Billion By 2030|
|Forecast Units||Value (USD Million)|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
|Segments Covered||by Type (Retrovirus Vectors, Adenovirus Vectors), Disease(Infectious Disease), Application (Gene Therapy)|
|Geographies Covered||North America, Europe, Asia-Pacific, LAME and Rest of the World|
|Key Companies Profiled/Vendors||Merck kGA (Germany), Lonza (Switzerland), BD (U.S.), Fujifilm Diosynth biotechnologies USA Inc (U.S.), Brammer Bio (U.S.), Cell Therapy Catapult Limited (U.K.), Waisman Biomanufacturing (U.S.), GENEZEN LABORATORIES (U.S.), Yposkesi, Inc. (France), and REGENXBIO Inc (U.S)|
|Key Market Opportunities||Growing Prevalence Of Healthcare It Industry Helps To Grow Viral Vector Manufacturing Market Share|