The global Viral Vector Manufacturing Market was worth $YY million in 2019 and is forecasted to reach $YY million by 2026, at a CAGR of YY% during the forecast period.
Gene therapy is used as a treatment option for most of the chronic diseases like cancers, genetic disorders, cardiovascular diseases, and infectious pathogen neurological disorders. It involves the insertion of a functional copy of a gene into a defective cell. Viral vectors are tools used by molecular biologists in the efficient transfer of therapeutic gene into the target cells. Viral Vector manufacturing can be performed inside a living organism (in vivo) or in cell culture (in vitro). Viral vectors used in gene therapy are adenovirus, lentivirus, retrovirus, and adeno-associated viral (AAV).
Vector manufacturing with good formulation, physical size, cost, and delivery function is a complex and resource-intensive process. Manufacturers use different processes such as the development of cell line culture, cell culture system, and expression systems for the development of vectors. There is a surge in demand for vectors, due to usage expansion of clinical therapeutics. Vector purification is considered the most complicated process and accounts for the majority of the overall manufacturing cost. With an increase in the demand for clinical-grade vectors, manufacturers are engaged in the development of economic downstream processes to develop conventional lab-scale manufacturing process.
The major factors driving the market are an increase in funding, pipeline researches in various phases of clinical progression, the ability of vectors to express therapeutic genes efficiently, and nonpathogenic nature of vectors.
According to the Journal of Gene Medicine, about 2,825 clinical trials have been completed or are currently in progress, most of which are likely to be completed by 2020. Thus highly efficient and cost-effective procedures are expected to emerge, which would increase the adoption of gene therapy. Higher adoption of gene therapy would result in the increased consumption of viral vectors due to its use as carriers in gene therapy. The Alliance for Cancer Gene Therapy (ACGT) is a public charity foundation in the U.S. which funds for advancement in cancer gene therapies from the laboratory to clinical trials.
The high price of gene therapies, short shelf-life of viral vectors, and possible risk of mutagenesis are going to restrain the market over the period of forecast.
Market Segmentation
The global viral vector market is segmented by type as retroviral vectors, adenoviral vectors, adeno-associated viral vectors, and other viral vectors, by disease like into cancer, genetic disorders, infectious diseases and other diseases, by application as gene therapy and vaccinology and by the end user as pharmaceutical and biopharmaceutical companies and research institutes.
Adeno-associated viral vector are small viruses with a genome of single-stranded DNA. These viruses can insert genetic material at a specific site on chromosome 19 with near 100% certainty, hence helpful in their ease of application in major target diseases such as cancer, and genetic disorders. The adeno-associated viral vector is most commonly used and has been a part of maximum clinical trials conducted worldwide over the past years.
According to the World Health Organisation, in 2018, around 20 million people were suffering from cancer. The number of new cases of cancer is expected to rise by around 70% by the end of 2026. Hence a large number of resources are estimated to be used in growing research on viral vector gene therapies for cancer.
Geographical Analysis:
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.
Maine Medical Center Research Institute, Viral Vector Core, Penn Vector Core, and American Society of Gene & Cell Therapy are some of the research institutes working in this segment.
Asia Pacific region, including India, Japan, and Australia, are going to develop at highest CAGR over the period of forecast due to the rise in population and high infant mortality rate. According to the International Quarterly Journal of Research in Ayurveda, in 2017 around 20 30% of all infant deaths were due to genetic disorders, and around 11.1% of pediatric hospital admissions are for children with inherited disorders.
Competitive Analysis
Companies involved in the development of vector agent-based products often seek support from contract service providers for the launch of clinical grade product. This is primarily because of the complexity and limited availability of technologies and platforms used for vector designing, production, packaging, and release testing. Lonza, Merck, Oxford BioMedica, CGT Catapult, Cobra Biologics, UniQure, Sanofi, FUJIFILM Diosynth Biotechnologies, Cobra Biologics, Thermo Fisher Scientific, Inc. and Spark Therapeutics are some of the major key players in the global market. Few of the key strategies adopted by key companies include
In September 2018, Brammer Bio invested around USD 50 million for its production capabilities expansion in Florida and Boston.
In August 2018, Boehringer Ingelheim collaborated with Oxford Biomedica for development of lentiviral-based therapy for cystic fibrosis.
In May 2018, Kymriah (tisagenlecleucel) for B-cell precursor Acute Lymphoblastic Leukemia gained approval for treatment of relapsed or refractory large B-cell lymphoma.
In April 2018, GE Healthcare launched ready-to-run factory-in-a-box for rapid production of virus-based therapeutics.
In March 2018, CEVEC introduced novel helper-virus-free stable production system for scalable manufacturing of Adeno-associated viral vector.
March 2018 Sanofi acquired Bioverativ Inc. for USD 11.6 billion.
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