Viral Vector Manufacturing Market

Market Overview

The global viral vector manufacturing market size was valued at USD 355 million in 2022. It is projected to reach USD 1790 million by 2031, growing at a CAGR of 19.7% during the forecast period (2023–2031).

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 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.

Viral vectors are being investigated as potential technologies for vaccines and regenerative medicine, and their value is based on the viruses' ability to infect cells. Generally speaking, viral vectors have the following benefits, improved cellular immunity, particular targeted therapy for cancer treatment, and high-efficiency gene transmission. Since recombinant viral vectors enable intracellular antigen interpretation and incite a vigorous cytotoxic T lymphocyte (CTL) response that results in the elimination of virus-infected molecules that are fueling market expansion, they have the potential to be therapeutic agents. Other advantages of viral vectors, such as improved safety and effectiveness, decreased administration dosing frequency, large-scale industrial production, and potential targets ranging from cancer to a wide range of infectious diseases, are also boosting the market's growth over the course of the forecast period.

Market Dynamics

What are the driving factors for Viral Vector Manufacturing?

Growth In the Genetic Disorder

People with ancestry from a specific region are more likely to develop certain genetic disorders. Genes passed down from shared ancestors are frequently shared by members of an ethnic group. Growing evidence supports the effectiveness of genetic therapies delivered via viral vectors in treating childhood monogenic diseases. It is crucial to create a product that enables efficient transduction of target cells for gene therapy to succeed. This is done by efficiently transferring genetic sequences using cloned recombinant viruses. Additionally, it is crucial to guarantee proper transgene expression in cells where it is physiologically required. Increasingly, more recent vectors combine endogenous cis-regulatory elements with chimeric promoters of mammalian genes.

Why is Viral Vector Manufacturing limiting the market?

Gene Therapy Has Expensive Costs

The high cost of gene therapies limits the market expansion for the production of viral vectors. Gene therapies aim to cure by correcting the underlying genetic abnormalities that cause the disease, rather than just being another new class of specialty drugs to treat symptoms of a specific disease. What was once a futuristic idea is now a reality as some of the country's top pharmaceutical and biotech companies ramp up product development and commercialization.

What are the future opportunities for Viral Vector Manufacturing?

Viral Vectors are Highly Effective

The use of viral vectors in vaccines and gene therapy is promising. Without an adjuvant, viral vector-based vaccines can boost immunogenicity and stimulate a potent cytotoxic T lymphocyte (CTL) response to destroy virus-infected cells. Over the past few decades, many different virus types have been used as vaccine vectors. Each has distinctive qualities and potential risks from parental viruses. Additionally, genetically modified vectors have been created to increase efficacy and safety, lower the dosage required for administration, and enable mass production. Successful and unsuccessful outcomes from clinical trials have both been documented thus far. These studies offer crucial details on toxicity, tolerable administration doses, and the most effective vaccination strategy. The main viral vectors that are the best candidates for clinical use are highlighted in this review. A high level of biological safety is necessary for viral vectors to be developed. Viruses with low or no pathogenicity are frequently chosen. Viruses are frequently genetically altered to lessen or remove pathogenicity. Furthermore, the majority of viral vectors have replication flaws.

Regional Analysis

The global viral vector manufacturing market is bifurcated into four regions: North America, Europe, Asia-Pacific, and LAMEA.

North America Dominates the Global Market.

North America is the most significant shareholder in the global viral vector manufacturing market and is expected to grow at a CAGR of 17.9% during the forecast period. The U.S. and Canada are included in the analysis of the viral vector manufacturing market in North America. The expanding use of gene therapy to treat a variety of illnesses. Future market expansion in the US will be fueled by factors such as the rising prevalence of genetic and other chronic illnesses, the rapidly aging population, the rising demand for targeted and customized medications, and supportive governmental initiatives. Due to several major companies in this region using different business expansion strategies, the market for manufacturing viral vectors in North America is highly competitive. The two main factors anticipated to boost the viral vector manufacturing market in the region over the forecast period are the availability of gene therapy products approved by the U.S. FDA (Food and Drug Administration) and a strong product pipeline. Clinical research on rare diseases has taken center stage in the United States thanks to regulatory support and patient advocacy.

Asia Pacific is expected to grow at a CAGR of 23.4% during the forecast period. China, India, Japan, Australia, and the rest of Asia-Pacific are all included in the analysis of the Asia-Pacific viral vector manufacturing market. Chemical drug entities and entities that deliver genes are also included in drug development. Over 2 million people have cancer, and more than 1.1 million new cases are registered yearly, claims the Indian Council of Medical Research. An aging population would drive the market, an increase in chronic disease incidence, an increase in healthcare costs, and rising consumer purchasing power. The market is expanding in this region due to rising R&D costs incurred by industry players and rising government funding for vaccine development. According to the International Quarterly Journal of Research in Ayurveda, genetic disorders account for 20 to 30 percent of infant deaths and approximately 11.1% of pediatric hospital admissions for inherited disorders.

Segmental Analysis

The market is segmented by type, disease, and application.

The global viral vector manufacturing market is bifurcated based on type into adenovirus vectors, adeno-associated viral vectors, and others.

The adeno-associated viral vectors segment is the highest contributor to the market and is expected to grow at a CAGR of 20% during the forecast period. The most widely used vectors are the vaccine and adenovirus because they can effectively trigger an immune response against expressed foreign substances, specifically involving CTL. The most effective method for delivering genes to treat various human diseases is through adeno-associated virus (AAV) vectors. The field of gene therapy has expanded significantly due to recent improvements in the creation of clinically desirable AAV capsids, genome design optimization, and the utilization of cutting-edge biotechnologies. Two AAV-based therapeutics have received regulatory approval in Europe or the US, demonstrating AAV’s preclinical and clinical success as the ideal therapeutic vector for gene replacement, gene silencing, and gene editing.

Based on disease, the global market is bifurcated into cancer, genetic disorders, and infectious diseases.

The cancer segment is the highest contributor to the market and is expected to grow at a CAGR of 18.9% during the forecast period. Because they are highly effective at delivering genes, viruses are a desirable vehicle for cancer gene therapy. Numerous viruses can influence long-term gene expression; some can infect dividing and non-dividing cells. Given the vastly different capacities of different viral vectors, the virus’ functionality must comply with the demands of the particular treatment. Various viral vectors have been used in immunogen therapy strategies, and studies on patients and animal models have shown the therapeutic potential of viral vectors to deliver genes to cancer cells and trigger anti-tumor immune responses.

Based on 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 20.3% during the forecast period. The use of viral viruses as a vector in gene therapy experiments has several benefits, including integration into the host chromosome, lack of viral genetics, the ability to engineer cells that are not actively proliferating genetically, a wide variety of host cells, and non-inflammatory and non-pathogenic nature. Viral-vector gene therapies deliver specific DNA sequences—encoding genes, regulatory, or other therapeutic substrates—to cells using modified viruses that act as drug-delivery vehicles. The technology has attracted interest for a long time because of its potential advantages over conventional modalities. Once a target has been identified, various therapeutic agents can be encoded in quickly designed and synthesized DNA sequences.

Recent Developments

• October 2022, To support the creation of potentially game-changing cell and gene therapies, Charles River Laboratories International, Inc. has formally opened the doors of its Alderley Park facility in Cheshire, United Kingdom.

• October 2022, Yposkesi Inc. Utilizing "HEK+" cells that lack the SV40 large T antigen encoding sequences, the production of adeno-associated viral vectors is improved.