A basis for agricultural independence at home has been established by the development of water conservation and purification technology. Moreover, advancements in genomic technologies such as Next-generation sequencing (NGS), RNA-Seq, Oligonucleotide-directed mutagenesis (ODM), Transcription activator-like effector nucleases (TALENS), Clustered Regularly Interspaced Short Palindromic Repeat-Cas9, and molecular markers and mapping populations, in conjunction with doubled haploids, hold great potential to enhance crop productivity. These developments have the potential to transform plant breeding methods, which, when combined with the exponential rise in genome sequence data availability, presents a strong opportunity for the agricultural biotechnology business to expand.
Market Overview Market for adeno-associated virus (AAV) vector manufacturing is expanding quickly due to the use of these vectors in gene therapy and their capacity to transport up to 5 kb of foreign DNA. AAV vectors can integrate viral genomes into host chromosomes, albeit erratically in current iterations due to transgenes that need their own promoters. Because of their straightforward genetic structure, AAV vector systems require parts that provide assistance viruses, transgene-containing vectors, and capsid proteins. These vectors' wide host range, tissue tropism, and nonpathogenic nature make them ideal for gene transfer and therapy in clinical settings. Their capacity to infect non-dividing cells and their capability for targeted integration are two important advantages that make them very appealing for cutting-edge therapeutic applications.
Key Insights
• North America generated largest market share and is anticipated to sustain its dominance during the estimated period. • Asia-Pacific is considered the fastest-growing region in the forecast period. • By Scale of Operations, the commercial segment had the largest share in the forecast period. • By Method, the in vivo segment is predicted to record maximum growth throughout the estimated period. • By Application, the vaccine segment contributed largest market share and is dominating with the highest CAGR during the projected period. • By Therapeutic Area, the neurological disorder segment anticipated in dominating the adeno associated virus vector manufacturing market worldwide.
Regional Stance Because of significant expenditures and a strong infrastructure, North America was able to obtain the biggest market share during the forecast period. In order to improve national pandemic response capabilities and promote life science innovation, the Canadian government has allocated over $2.2 billion to 38 initiatives in the biomanufacturing, vaccine, and pharmaceuticals ecosystem. Canada is a leading biosciences, pharmaceutical, and medical technology hub in the world, drawing top academic institutions, powerful R&D environments, highly qualified personnel, vast research networks, and cooperative opportunities for research and skill development. Canada has a responsive and effective regulatory environment that is favourable to pharmaceutical operations and is home to the best pharmaceutical businesses in the world. At the same time, the US government is increasing access to biotechnology and biomanufacturing training and education, which strengthens the region's position as a leader in the field.
Adeno-associated virus (AAV) vector production is expected to develop at the quickest rate in the Asia-Pacific region due to rising biotech investments spurred by increasing financing, advances in precision medicine, and technical breakthroughs. The region's ongoing innovation and growth portend exciting new breakthroughs in the biotech sector. The creation of more focused medications that improve patient outcomes is made possible by advances in genomics, proteomics, and related sciences, which is a major growth driver for precision medicine. Leading companies in this field include South Korea's Celltrion and Japan's Astellas, demonstrating the region's growing interest and leadership in precision medicine.
Report Highlights By scale of Operations During the forecast period, the global market for the manufacturing of Adeno-associated virus (AAV) vectors is expected to be dominated by the commercial segment. AAV vectors have shown great promise in the field of gene therapy, offering the possibility to treat a vast range of hereditary illnesses. Large-scale commercial operations focused on creating cutting-edge therapeutic solutions find this adaptable viral vector technology appealing since it can be tailored for extremely specialised functioning in gene therapy applications. AAV vectors are being more widely used in commercial gene therapy, which highlights their expanding significance in the biotechnology and pharmaceutical sectors. In the global market for the manufacture of Adeno-associated virus (AAV) vectors, the clinical segment is expanding at the quickest rate. AAV's low pathogenicity and capacity to create stable gene expression in a variety of organs have made it an essential delivery mechanism in therapeutic gene therapy. Due of its wide tissue tropism, good safety profile, and flexible manufacturing techniques, AAV vectors are the recommended option for FDA-approved applications and clinical studies. AAV maintains transgenic expression over an extended period of time, seldom integrates into the host genome, and is not harmful. Based on certain AAV serotypes, vectors possess inherent efficiency in cellular entrance and transgene expression, hence augmenting transduction efficacy and reinforcing their significance in sophisticated clinical gene therapy uses.
By Method Market for Adeno-associated virus (AAV) vector manufacturing is dominated by the in vivo sector, which is anticipated to continue growing during the forecast period. The most popular method of delivering gene therapy in vivo is by AAV vectors, which have shown substantial therapeutic advantages for individuals suffering from monogenetic illnesses. These vectors, which are perfect for both in vitro and in vivo applications, exhibit high transduction efficiency, safety, and extended stable gene expression thanks to their utilisation of natural AAV isolates. Recent clinical trials have confirmed AAVs' significance in the market by highlighting their full potential in human gene therapy.
By Application Market for the production of Adeno-associated virus (AAV) vectors is dominated by the vaccines segment. Herpes virus (HSV) and adenovirus (AdV) are the two typical helper viruses required for AAV propagation in tissue culture. The lateral ITR, the only cis-acting element necessary for AAV DNA replication and encapsidation, is retained in the AAV vector, a recombinant variation of the wild-type AAV virus, which substitutes its native coding and non-coding areas with the desired gene. Due to these changes, recombinant adeno-associated viruses (rAAV) are no longer replication-defective, which allows them to effectively infect cells and transfer DNA to the nucleus. This use in the creation of vaccines highlights the critical role that AAV vectors play in developing novel and potent vaccination strategies. During the anticipated time, the Adeno-associated virus (AAV) vector manufacturing market would see the fastest-growing segment: gene therapy. AAV has proven to be safe and tolerable in almost all clinical settings, making it the vector of choice for most gene therapy applications. The field is starting to investigate localised AAV administration for gene therapy, taking use of the virus's versatility and wide tropism for different types of cells and tissues. Almost all tissue types have an AAV variation available, and new AAV discoveries and continuous engineering efforts should enable the on-demand creation of specialised variants. These developments will surely lead to novel treatment approaches for a variety of conditions, enhancing AAV's standing in the field of gene therapy.
By Therapeutic Area Throughout the anticipated period, the neurological diseases segment had the biggest revenue share in the Adeno-associated virus (AAV) vector manufacturing market. New developments in AAV technology have made a major difference in the way recognised therapeutic targets for neurological disorders are treated. The blood-brain barrier (BBB) may be crossed by AAVs, and they are distinguished by their low immunogenicity, persistent transgenic expression, pleiotropic effects, and selective neuronal tropism. Due of these characteristics, AAVs are very useful for creating treatments for neurological illnesses, which has led to a significant increase in the market for this therapeutic segment.
Thanks to advances in genetic understanding and potential treatments, the genetic disorders segment is expected to increase significantly over the projected period. The possibility for treatments that target mutated or damaged genes has increased significantly since it was discovered that DNA forms the basis of both genetic inheritance and disease. Nucleic acid sequence data are abundant thanks to recent developments in human genetics, such as the quick and inexpensive sequencing of entire genomes. This has made it easier to identify the genes that cause particular diseases. Adeno-associated virus (AAV), which was first discovered as a contamination in adenovirus preparations, has become a prominent gene therapy vehicle. Because of its structure, which consists of a tiny, single-stranded DNA genome enclosed in a protein shell, AAV holds great promise for the development of therapeutics for genetic illnesses. These elements highlight the growing importance of AAV-based treatments in treating genetic illnesses, which is propelling the market's growth in this therapeutic sector.
Market Dynamics Driver Advancements in AAV Vector Production The capacity of adeno-associated virus (AAV) to effectively transfer DNA to target cells has attracted a lot of interest in clinical-stage experimental therapeutics. One of the safest gene therapy approaches is the use of engineered recombinant AAV particles, which are free of viral genes and carry therapeutic DNA sequences. Transfecting HEK293 cells with plasmids expressing the target gene, AAV rep/cap genes, and helper genes from adenovirus or herpes viruses is the main technique for creating recombinant AAV (rAAV). After been optimised in adherent cells with roller bottles or cell stacks, production rates of roughly 10^5 genome copies (GC)/cell, or 10^14 GC/L, are now attainable in HEK293 cells that have been modified for suspension. The market for the manufacturing of Adeno-associated viral vectors is developing significantly because to these innovations, which are also improving production efficiency and opening up new therapeutic application opportunities.
Restraints Challenges in AAV Vector Manufacturing AAV viral vector production involves intricate issues that call for creative solutions to satisfy strict safety and efficacy standards, clinical needs, and budgetary constraints. It is crucial but difficult to maintain viral vector stability during production, handling, and storage while preserving long-term efficacy. Using both established techniques and cutting-edge technology, manufacturing procedures for gene therapy products must be stable and scalable. These difficulties impede the market for the production of Adeno-associated viral vectors, highlighting the continuous need for improvements in manufacturing techniques and technology.
Enhanced Therapeutic Potential Decades of significant technological progress have made it possible to treat and manage life-threatening diseases more effectively. Because of its remarkable safety profile and effective transduction across a variety of tissues, adeno-associated virus (AAV) has become a prominent gene delivery technology. Opportunities for innovation exist in the Adeno-associated virus vector manufacturing industry due to challenges with large-scale production and long-term storage of viral vectors, which lead to lower yields, moderate purity, and shorter shelf-life compared to recombinant protein treatments. Improving production and storage techniques to overcome these obstacles may be able to increase therapeutic potential and market opportunities for AAV-based gene treatments.
Recent Developments
• In August 2022, Merck became one of the pioneering Contract Development and Manufacturing Organizations (CDMOs) to introduce a comprehensive viral vector offering with the launch of its VirusExpress 293 Adeno-Associated Virus Production Platform. • In January 2024, Charles River Laboratories launched Rep/Cap plasmids to streamline the manufacturing of Adeno-Associated Viral Vectors. • In October 2023, NIIMBL initiated a Viral Vector Program aimed at enhancing patient access to AAV gene therapy. • In May 2023, Forge initiated a gene therapy production partnership with Life Biosciences.
Key Players in the Adeno Associated Virus Vector Manufacturing Market Roche Audentes Therapeutics WuXi AppTec BioMarin Pharmaceutical Oxford BioMedica YPOSKESI Sarepta Therapeutics GenScript Pfizer Audentes Therapeutics LifeSpan BioSciences, Inc.
Market Segmentation By Scale of Operations Clinical Preclinical Commercial By Method In Vivo In Vitro By Application Vaccine Cell Therapy Gene Therapy By Therapeutic Area Genetic Disorders Infectious Diseases Neurological Disorders Hematological Diseases Ophthalmic Disorders
By Geography North America U.S. Canada Europe Germany France United Kingdom Rest of Europe Asia Pacific China Japan India Southeast Asia Rest of Asia Pacific Latin America Brazil Rest of Latin America Middle East & Africa (MEA) GCC North Africa South Africa Rest of Middle East & Africa
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Research Methodology
The process of market research at Ultra Market Research is an iterative in application and usually follows following path. Information from secondary used to build data models, then results from data models are validated from primary participants. Then cycle repeats where, according to inputs from primary participants, additional secondary research is done and new Information is again incorporated into data model. The process continues till desired level of Information is not generated
To calculate the market size, the report considers the revenue generated from the sales of Ultra Market Research providers. The revenue generated from the sales of Ultra Market Research has been calculated through primary and secondary research. The report also presents the key players operating in the Ultra Market Research market across the globe identified through secondary research and a corresponding detailed analysis of the top vendors in the market. The market size calculation also includes distribution channel segmentation determined using secondary sources and verified through primary sources.
Secondary Research
The secondary research source that are typically referred to include, but are not limited to:
Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings
Internal and external proprietary databases, relevant patent and regulatory databases
National government documents, statistical databases and market reports
News articles, press releases and web-casts specific to the companies operating in the market
The source for secondary research includes but is not limited to: Factiva, Hoovers and Statista
Inner Circle Represents – Stage of Research Process
Middle Circle Represents – Source of Information
Outer Circle Represents – Information Derived from that source
Primary Research We conduct primary interviews on an ongoing basis with industry participants and commentators in order to validate data and analysis. A typical research interview fulfills the following functions:
It provides first-hand Information on the market size, market trends, growth trends, competitive landscape, future outlook etc.
Helps in validating and strengthening the secondary research findings
Further develops the analysis team’s expertise and market understanding
Primary research involves E-mail interactions, telephonic interviews as well as face-to-face interviews for each market, category, segment and sub-segment across geographies
The participants who typically take part in such a process include, but are not limited to:
Industry participants: CEOs, VPs, marketing/ distribution channel managers, market intelligence managers and national sales managers
Purchasing managers, technical personnel, distributors and resellers
Outside experts: Investment bankers, valuation experts, research analysts specializing in specific markets
Key opinion leaders specializing in different areas corresponding to different industry distribution channels
Models Where no hard data is available, we use modeling and estimates in order to produce comprehensive data sets. A rigorous methodology is adopted in which the available hard data is cross referenced with the following data distribution channels to produce estimates:
Demographic data: Population split by segment
Macro-economic indicators: GDP, etc.
Industry indicators: Expenditure, distribution channel stage & infrastructure, sector growth and facilities.
Data is then cross checked by the expert panel.
2..1 Company Share Analysis Model
Company share analysis is used to derive the size of Global market. As well as study of revenues of companies for last three to five years also provide the base for forecasting the market size and its growth rate. This model is built in following steps: 2..2 Revenue Based Modeling
Revenue based models can be built in two ways – Top-Down or Bottom-Up irrespective of industry. Market size estimated from company share analysis acts as a validation point for bottom-up approach where as it acts as starting point for top-down approach.
2.1 Research Limitations Inflation is not a part of pricing in this report. Prices of Biologics Market and its derivatives vary in each region and hence similar revenue ratio does not follow for each individual region. The same price for each distribution channel has been taken into account while estimating and forecasting market revenue Globally. Regional average price has been considered while breaking down this market by application in each region. This report provides market size of Global Biologics Market for the past year and forecasts for the next six years. Global Biologics Market. Market size is given in terms of revenue. Market revenue is defined in USD Million. Market numbers are given on the basis of different Biologics Market categories. Market size and forecasts for each major application is provided in the context of Global market. The numbers provided in this report are derived on the basis of demand for Biologics Market from different application industries in different regions.
Market Segmentation By Scale of Operations Clinical Preclinical Commercial By Method In Vivo In Vitro By Application Vaccine Cell Therapy Gene Therapy By Therapeutic Area Genetic Disorders Infectious Diseases Neurological Disorders Hematological Diseases Ophthalmic Disorders
By Geography North America U.S. Canada Europe Germany France United Kingdom Rest of Europe Asia Pacific China Japan India Southeast Asia Rest of Asia Pacific Latin America Brazil Rest of Latin America Middle East & Africa (MEA) GCC North Africa South Africa Rest of Middle East & Africa
