Viral Vector Manufacturing Market is expected to grow at a CAGR of 20.3 % during the forecasting period 2021-2028.

The global viral vector manufacturing market size was worth USD 589.9 million in 2020 and is estimated to reach USD XX million by 2028, at a CAGR of 20.3% during the forecast period (2021-2028).

Viral vector is referred to as the tool for delivering the genetic material into cells. The modified viral vector is used as the viral vectors in gene therapy. Plasmid DNA is a bacterial smaller, circular and extrachromosomal DNA used in the different molecular genetic research such as gene therapy, gene transfer and recombinant DNA technology due to its self-replication property. A gene of interest is transferred into the target cell for studying the function or expression of a gene. 

The market is driven by the increasing demand for the viral vectors and plasmid DNA manufacturing for developing the DNA vaccines, gene therapy, immunotherapy, and others. There is growing usage of the viral vectors & plasmid DNA due to their advantages such as high transfection efficiency, effective gene delivery, and stable gene expression. There is an increase in the number of clinical studies for examining the efficacy and safety of the viral vectors.

Geographically, the global viral vector manufacturing market is divided into North America, Europe, South America, Asia-Pacific, and the Middle East and Africa.

Presence of several biopharmaceutical manufacturers in the U.S., coupled with advanced funding and public awareness are going to increase the market in North America. The Alliance for Regenerative Medicine (ARM), a U.S.-based non-profit organization in the field of gene therapy, reported a 164% increase in funding for gene and gene-modified cell therapy in 2017 over 2016 and a global investment of USD 4.5 billion in 2017. In November 2018, the National Institutes of Health (NIH) launched a new initiative to accelerate the adoption of gene therapy to cure around 20 million patients diagnosed with sickle cell disease.

Market Dynamics

Drivers

• Recombinant adeno-associated viral vectors as therapeutic agents to treat neurological disorders
• Increase in preference of viral vectors in various treatments
• Rising number of gene therapy patients is expected to drive the market growth
• Increasing collaboration among companies and organizations for development of viral vectors
• Increasing approvals for novel gene therapies

Restraints

• Limitation of gene therapy will hamper the market
• Risk associated with Viral vector
• Complex and expensive manufacturing processes
• Regulatory challenges will hamper the market growth 

Increasing Approvals For Novel Gene Therapies Will Drive The Market

The increasing number of approvals for novel gene therapies by regulatory authorities is also a major factor contributing to the market's growth.

 For instance, in May 2019, AveXis Inc. received the U.S. Food and Drug Administration approval for its Zolgensma (onasemnogene abeparvovec-xioi), an adeno-associated virus vector-based gene therapy for the treatment of spinal muscular atrophy (SMA) in children less than two years old.

In September 2017, GeneOne Life Science, Inc., received approval from the South Korean Ministry of Food and Drug Safety (KMFDS) for an Investigational New Drug Application for a Phase I/IIa study of its investigational vaccine, GLS-5300, against the Middle East Respiratory Syndrome coronavirus (MERS-CoV). 

There is an increase in the contract manufacturing business launch for viral vectors and plasmid DNA manufacturing. For instance, in December 2019, Helixmith Co., Ltd. and Genopis had launched the contract manufacturing business for plasmid DNA production. The company would establish additional smaller-scale reactors (60-300 L, 6-30 L) with feasibility runs and start a small-volume production service. Genopis is equipped with the right technologies and quality systems.

Geographical Analysis

 The  Middle East & Africa viral vector manufacturing market was valued USD XXmillion in 2020 and is estimated to reach USD XX million by 2028, at a CAGR of  17.4% during the forecast period (2021-2028). 

The Middle East & Africa segment is estimated to account for a share of approximately 14.8% of the  viral vector manufacturing market by 2020 and is anticipated to grow to 20.4% by 2028.

Middle East & Africa  is considered as the moderate fastest growing region in the market due to the rising prevalence of the infectious disease. HIV/AIDS continues to devastate the Africa Region, which has 11% of the world's population but 60% of the people with HIV/AIDS. 

Although HIV/AIDS remains the leading cause of death for adults, more and more people are receiving life-saving treatment. The number of HIV-positive people on antiretroviral medicines increased eight-fold, from 100 000 in December 2003 to 810 000 in December 2005.

Scientists have worked on adenoviral vector vaccines against a range of viruses, including Zika, RSV, HIV, influenza, tuberculosis, dengue, and MERS. During the Ebola outbreaks in West Africa and the Democratic Republic of the Congo, two adenoviral vector vaccines were quickly developed and deployed.

Because these types of vaccines had been in development for so long, all scientists had to do was adapt them to COVID-19. For instance, the platform used in the AstraZeneca/Oxford vaccine had been in clinical trials in humans for over 10 years for various other diseases. Going forward, that adaptability may also prove useful when updating vaccines to protect against new variants of COVID-19.

Scientists have worked on adenoviral vector vaccines against a range of viruses, including Zika, RSV, HIV, influenza, tuberculosis, dengue, and MERS. During the Ebola outbreaks in West Africa and the Democratic Republic of the Congo, two adenoviral vector vaccines were quickly developed and deployed.

The paucity of information, lack of knowledge, limited resources, and climate change, coupled with cultural traditions make the African continent a hotspot for vector-borne and zoonotic viral diseases, which may spread globally.

In Saudi Arabia, according to WHO, the 50–59 age group continues to be at most  risk of acquiring MERS infection of primary (or original) cases. The 30–39 age group is most at risk for secondary cases (human-to-human transmission). The number of deaths is higher in the age group 50–59 years for primary cases and 70–79 years for secondary cases. Thus the growing cases of MERS in middle east region is driving the Middle East & Africa viral vector manufacturing market. 

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