|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The viral vector manufacturing market was valued at USD 769.75 million in 2021 and is expected to register a CAGR of 27.36% over the forecast period.
The COVID-19 pandemic has underlined the importance of vaccine development for the global population, and it has had a positive impact on the growth of the viral vector manufacturing market. According to the World Health Organization (WHO) Global COVID-19 Vaccination - Strategic Vision for 2022, there are at least 17 vaccines in use. As of September 6, 2021, 5.4 billion doses were administered, and another 300 and more vaccine candidates were in clinical and preclinical development. Two viral vector vaccines have been authorized for emergency use in many countries for the COVID-19 vaccine as of January 7, 2022, according to the Viral Vector Vaccines segment published by the Infectious Diseases Society of America. For instance, in April 2020, AstraZeneca and Oxford University announced their partnership to develop a viral vectored vaccine utilizing a modified replication-deficient chimp adenovirus vector, ChAdOx1. Also, Janssen Biotech (Johnson & Johnson) has developed a viral vectored vaccine utilizing a replication-incompetent human adenovirus vector and received approval from Food and Drug Administration (FDA) in February 2021. The importance of viral vector manufacturing is increasing owing to the increasing research and developments occurring in current times.
Due to the relative ease of manufacturing viral vector vaccines, effective packaging cell line systems have been developed for many viral vector systems such as Ad (adenoviruses), AAV (Adeno-associated viruses), flaviviruses, and lentiviruses. This has also facilitated the rapid and efficient large-scale production of vaccine candidates that are eligible for clinical applications against COVID-19.
The increase in several genetic disorders and infectious diseases is also affecting the growth of viral vector production. For instance, according to the Joint United Nations Programme on HIV/AIDS (UNAIDS) Statistics, in 2021, 27.5 million [26.5 million - 27.7 million] people were living with human immunodeficiency virus (HIV) globally at the end of 2020, and 1.5 million (1.0 million – 2.0 million) people became newly infected with HIV. Among the total HIV infected, 87% of people living with HIV knew that their HIV status was accessing antiretroviral therapy, and 90% of people on treatment were virally suppressed. This prevalence of numerous infectious and viral diseases is motivating the major companies to focus on viral vector product development and manufacturing.
Additionally, as the recombinant viral vectors are highly effective carriers of sequences encoding virus-disabling sequences, the appropriate and exact viral vectors usually need to be selected and adapted for application in the treatment of specific viral infections. Currently, there have been significant public and private sector initiatives are being taken for the development of viral vector vaccines, leading the key players to invest in capacity expansion for manufacturing activities. For example, in November 2020, a global contract development and manufacturing organization, Vibalogics announced its plans to invest USD 150 million to build a 110,000 square-foot facility near Boston in the United States. The facility will be used to produce clinical and commercial-stage oncolytic viruses and viral vectors. These related development activities by major players are also expected to boost the market’s growth.
Government initiatives such as direct funding towards viral vector manufacture, which is increasing awareness, while the regulatory environment is getting streamlined via changes, such as prompt approval processes, are driving the studied market’s growth. These aforementioned factors can propel the market for viral vector manufacturing and are expected to grow in the future. However, the high cost of gene therapies and challenges in viral vector manufacturing capacity can impact market growth negatively.
Scope of the Report
As per the scope of this report, viral vectors represent one of the primary tools that can be used to deliver genetic material into cells. The viral vector manufacturing market is segmented by Type (Adenoviral Vectors, Adeno-associated Viral Vectors, Lentiviral Vectors, Retroviral Vectors, and Other Types), Disease (Cancer, Genetic Disorders, Infectious Diseases, and Other Diseases), Application (Gene Therapy and Vaccinology), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
|Adeno-associated Viral Vectors|
Key Market Trends
Cancer Sub-segment is Expected to Grow Faster in the Disease Segment
The upsurge in the global incidence of cancer and modern healthcare facilities are acting as major drivers for the growth of the market studied. According to GLOBOCAN 2020, globally, there were 1,92,92,789 new cancer cases in 2020, and it is projected to increase to 2,88,87,940 cases by 2040. Currently, there are numerous Phase I, Phase II, Phase III, and Phase IV clinical trials related to viral vectors for the treatment of various types of cancers such as brain, skin, liver, colon, breast, and kidney. These trials are being conducted in various academic centers and biotechnology companies. For instance, as of March 29, 2021, more than 90 ongoing interventional clinical trials related to gene therapy across different phases of development for cancer were there globally, as mentioned in the National Clinical Trial (NCT) Registry.
In the field of oncology, viral vector-based gene therapy has demonstrated steady progress. A variety of viral vectors have been engineered for both therapeutic and preventive applications in cancers. The upsurge in the global incidence of cancer and modern healthcare facilities is acting as a major driver for the growth of the market studied. Many gene therapy strategies have been developed to treat a wide range of cancers, including suicide gene therapy, oncolytic virotherapy, anti-angiogenesis, and therapeutic gene vaccines. All these therapies are viral vector dependent. Thus, owing to the increase in global cancer incidence, the market is expected to see growth.
The increasing research and development activities for the development of viral vector vaccines or therapies are increasing the opportunity for novel products developments. For instance, in June 2019, researchers at the Sao Paulo State Cancer Institute (ICESP) in Brazil used a genetically manipulated virus to destroy tumor cells upon injection into mice with prostate cancer. The increasing research and development programs on cancer gene therapy generate demand for manufacturing viral vectors.
The surge in demand for the development of effective therapeutics for cancer management, the presence of a prompt approval process, and the prospects of novel drugs for significant product developments are the primary reasons responsible for significant research and development investments in the field of cancer therapeutics that are based on viral vectors. This, in turn, affects the growth of the cancer segment positively, and the cancer segment is hence expected to boost the market’s growth.
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North America Dominates the Market, and the Region is Expected to Follow the Same Trend in the Future
North America currently dominates the market for viral vector manufacturing and is expected to continue its stronghold for a few more years. In the United States, regulatory encouragement and patient advocacy have pushed rare disease clinical research to the center stage. The significant incentives on offer through the Orphan Drugs Act (the United States) have encouraged pharmaceutical and biotechnology companies to consider the development of rare disease medicines as a potentially profitable venture.
Many companies have been expanding their facilities and investing a significant amount of capital in the region. For example, in April 2020, Merck KgaA and its subsidiary MilliporeSigma announced plans to spend USD 110 million to open a second viral vector facility at its Carlsbad, California facility. The projected expansion was expected to double the company’s gene therapy manufacturing capacity. In September 2019, NGen, a Canada-based non-profit that matches manufacturers with new technologies, announced that it would provide USD 1.48 million to iVexSol Canada for developing an advanced manufacturing process for lentiviral vectors. Educational and academic institutes have also been at the forefront of R&D investment. In November 2019, Harvard University announced that it was collaborating with contract development and manufacturing organizations (CDMOs) to develop a USD 50 million cell and viral vector manufacturing facility. Such initiatives are expected to boost the market’s growth.
The United States holds the largest market share in the North American region owing to various factors like the high adoption rate of new therapies and the high incidence rate of cancer. The increasing prevalence of genetic and other chronic disorders, an aging population, growing demand for targeted and personalized medicine, and favorable government initiatives are the factors responsible for future market growth in the United States.
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The viral vector manufacturing market is moderately competitive and has several key players. Owing to the growing demand for novel therapeutics to deal with life-threatening diseases, such as cancer, various smaller companies are also entering the market and holding a significant market share. Some of the key market players are Cognate BioServices Inc. (Cobra Biologics), Finvector, Fujifilm Holdings, Corporation (Fujifilm Diosynth Biotechnologies), Kaneka Corporation (Eurogentec), Merck KGaA, Uniqure NV, Oxford BioMedica PLC, Johnson & Johnson (Janssen Global Services LLC), AstraZeneca, Vibalogics, Danaher (Cytiva), Sanofi SA, F. Hoffmann-La Roche Ltd (Spark Therapeutics), Lonza, and Thermo Fisher Scientific Inc.
- In October 2021, Merck opened a new viral vector contract development manufacturing facility for gene therapy in Carlsbad, California, to expand its global contract development and manufacturing organization (CDMO) footprint.
- In October 2021, LEXEO Therapeutics and FUJIFILM Diosynth Biotechnologies announced a strategic collaboration to support the development and manufacturing of LEXEO’s adeno-associated virus (AAV)-mediated gene therapies.
- In January 2021, Fujifilm Corporation announced plans to invest USD 40 million, which will be used to establish a new processing facility for viral vector manufacturing and associated research.
Table of Contents
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Prevalence of Genetic Disorders, Cancer, and Infectious Diseases
4.2.2 Increasing Number of Clinical Studies and Availability of Funding for Gene Therapy Development
4.2.3 Potential Applications in Novel Drug Delivery Approaches
4.3 Market Restraints
4.3.1 High Cost of Gene Therapies
4.3.2 Challenges in Viral Vector Manufacturing Capacity
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Type
5.1.1 Adenoviral Vectors
5.1.2 Adeno-associated Viral Vectors
5.1.3 Lentiviral Vectors
5.1.4 Retroviral Vectors
5.1.5 Other Types
5.2 By Disease
5.2.2 Genetic Disorders
5.2.3 Infectious Diseases
5.2.4 Other Diseases
5.3 By Application
5.3.1 Gene Therapy
5.4.1 North America
22.214.171.124 United States
126.96.36.199 United Kingdom
188.8.131.52 Rest of Europe
184.108.40.206 South Korea
220.127.116.11 Rest of Asia-Pacific
5.4.4 Middle East & Africa
18.104.22.168 South Africa
22.214.171.124 Rest of Middle East & Africa
5.4.5 South America
126.96.36.199 Rest of South America
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 Charles River Laboratories (Cobra Biologics)
6.1.3 Fujifilm Holdings Corporation (Fujifilm Diosynth Biotechnologies)
6.1.4 Kaneka Eurogentec SA
6.1.5 Merck KGaA
6.1.6 uniQure NV
6.1.7 Oxford Biomedica PLC
6.1.8 Johnson & Johnson (Janssen Global Services LLC)
6.1.11 Danaher (Cytiva)
6.1.13 F. Hoffmann-La Roche Ltd (Spark Therapeutics)
6.1.15 Thermo Fisher Scientific Inc.
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Viral Vector Manufacturing Market market is studied from 2019 - 2027.
What is the growth rate of Global Viral Vector Manufacturing Market?
The Global Viral Vector Manufacturing Market is growing at a CAGR of 27.36% over the next 5 years.
What is Global Viral Vector Manufacturing Market size in 2019?
The Global Viral Vector Manufacturing Market is valued at 769 Million USD in 2019.
Which region has highest growth rate in Global Viral Vector Manufacturing Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Viral Vector Manufacturing Market?
North America holds highest share in 2021.
Who are the key players in Global Viral Vector Manufacturing Market?
FUJIFILM Diosynth Biotechnologies U.S.A. Inc., Thermo Fisher Scientific, Cognate Bioservices, Merck KgaA, FinVector are the major companies operating in Global Viral Vector Manufacturing Market.