Viral Vector Manufacturing Market

Viral Vector Manufacturing Market

The viral vector manufacturing, non-viral vector manufacturing and gene therapy manufacturing market is estimated to be worth $651 million in 2022 and is expected to grow at compounded annual growth rate (CAGR) of 14.0% during the forecast period. With the increasing number of cell and gene therapies being developed and launched for a wide range of therapeutic areas, these modalities are on their way to become one of the highest valued markets in the biopharmaceutical domain. In fact, in 2021, cell and gene therapy developers raised capital worth more than USD 20 billion, registering an increase of 19% from the amount raised in 2020 (~USD 17 billion). It is worth highlighting that, in February 2022, the USFDA approved second CAR-T therapy, CARVYKTI™, developed by Johnson and Johnson, which can be used for the treatment of relapsed or refractory multiple myeloma. Additionally, close to 1,500 clinical trials are being conducted, globally, for the evaluation of cell and gene therapies. Over time, it has been observed that the clinical success of these therapies relies on the design and type of gene delivery vector used (in therapy development and / or administration). At present, several innovator companies are actively engaged in the development / production of viral vectors and / or non-viral vectors for cell and gene therapies. In this context, it is worth mentioning that, over the past few years, multiple viral vector and non-viral vector based vaccine candidates have been developed against COVID-19 (caused by novel coronavirus, SARS-CoV-2) and oncological disorders; this is indicative of lucrative opportunities for companies that have the required capabilities for viral vector manufacturing and gene therapy manufacturing.

The viral vector manufacturing and non-viral vector manufacturing landscape features a mix of industry players (well-established companies, mid-sized firms and start-ups / small companies), as well as several academic institutes. Figure below provides a sample insight into the level of information covered in the report.

It is worth highlighting that several companies that have the required capabilities and facilities to manufacture vectors for both in-house requirements and offer contract services (primarily to ensure the optimum use of their resources and open up additional revenue generation opportunities) have emerged in this domain. Further, in order to produce more effective and affordable vectors, several stakeholders are integrating various novel technologies; these technologies are likely to improve the scalability and quality of the resultant therapy. In addition, this industry has also witnessed a significant increase in the partnership and expansion activities over the past few years, with several companies having been acquired by the larger firms. Given the growing demand for interventions that require genetic modification, the vector and gene therapy manufacturing market is poised to witness substantial growth in the foreseen future.

Recent Developments in Viral Vector Manufacturing Market

Several recent developments have taken place in the field of viral vector manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In July 2023, Biovian invested EUR 50 million to expand its manufacturing facility in Turku, Finland. Additionally, the new facility has an area of 6,400 sq m and will be used for manufacturing adenoviral and adeno-associated viral therapies. 
• In June 2023, Albumedix entered into a collaboration agreement with Cell and Gene Therapy Catapult (CGT Catapult) to investigate the use of Albumedix´ proprietary albumin-based solutions for advanced therapy applications, including viral vectors manufacturing. 
• In June 2023, Charles River Laboratories in collaboration with INADcure Foundation formed an alliance for plasmid DNA manufacturing. The alliance aims to leverage Charles River’s expertise in High Quality (HQ) plasmid DNA production, to manufacture its lead candidate for Phase I/II clinical trials. 

Scope of the Report

The “Viral Vector Manufacturing, Non-Viral Vector Manufacturing and Gene Therapy Manufacturing Market (5th Edition) by Scale of Operation (Preclinical, Clinical and Commercial), Type of Vector (AAV Vector, Adenoviral Vector, Lentiviral Vector, Retroviral Vector, Plasmid DNA and Others), Application Area (Gene Therapy, Cell Therapy and Vaccine), Therapeutic Area (Oncological Disorders, Rare Disorders, Neurological Disorders, Sensory Disorders, Metabolic Disorders, Musco-skeletal Disorders, Blood Disorders, Immunological Diseases, and Others), and Geographical Regions (North America, Europe, Asia Pacific, MENA, Latin America and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the rapidly growing market of vector and gene therapy manufacturing, focusing on contract manufacturers, as well as companies having in-house manufacturing facilities.

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments as defined in the below table:

Segmentation

Amongst other elements, the report includes:

• An overview of the current status of the market with respect to the players engaged (both industry and non-industry) in the manufacturing of viral, non-viral and other novel types of vectors and gene therapies. It features information on the year of establishment, company size, location of headquarters, type of product manufactured (vector and gene therapy / cell therapy / vaccine), location of manufacturing facilities, type of manufacturers (in-house and contract services), scale of operation (preclinical, clinical and commercial), type of vector manufactured (AAV, adenoviral, lentiviral, retroviral, plasmid DNA and others) and application area (gene therapy, cell therapy, vaccine and others).
• An analysis of the technologies offered / developed by the companies enagaged in this domain, based on the type of technology (viral vector manufacturing related platform, non-viral vector manufacturing related platform and others), type of manufacturer (vector manufacturing, gene delivery, product manufacturing, transduction / transfection, vector packaging and other), scale of operation (preclinical, clinical and commercial), type of vector involved (AAV, adenoviral, lentiviral, retroviral, non-viral and other viral vectors), application area (gene therapy, cell therapy, vaccine and others). It also highlights the most prominent players within this domain, in terms of number of technologies. Figure below provides an example insight
• A region-wise, company competitiveness analysis, highlighting key players engaged in the manufacturing of vectors and gene therapies, across key geographical areas, featuring a four-dimensional bubble representation, taking into consideration supplier strength (based on experience in this field), manufacturing strength (type of product manufactured, number of manufacturing facilites and number of application areas), service strength (scale of operation, number of vectors manufactured and geographical reach) and company size (small, mid-sized and large). 
• Elaborate profiles of key players based in North America, Europe and Asia-Pacific (shortlisted based on proprietary criterion). Each profile features an overview of the company / organization, its financial performance (if available), information related to its manufacturing facilities, vector manufacturing technology and an informed future outlook.
• Tabulated profiles of the other key players headquartered in different regions across the globe (shortlisted based on proprietary criterion). Each profile features an overview of the company, its financial performance (if available), information related to its manufacturing capabilities, and an informed future outlook.
• An analysis of partnerships and collaborations established in this domain since 2015; it includes details of deals that were / are focused on the manufacturing of vectors, which were analyzed on the basis of year of partnership, type of partnership (manufacturing agreement, product / technology licensing, product development, merger / acqusition, research and development agreement, process development  / optimization, service alliance, production asset / facility acquisition, supply agreement and others), scale of operation (preclinical, clinical and commercial), type of vector involved (AAV, adenoviral, lentiviral, retroviral, plasmid and others), region and most active players (in terms of number of partnerships). 
• An analysis of the expansions related to viral vector manufacturing and non-viral vector manufacturing, which have been undertaken since 2015, based on several parameters, such as year of expansion, type of expansion (new facility / plant establishment, facility expansion, technology installation / expansion, capacity expansion, service expansion and others), type of vector (AAV, adenoviral, lentiviral, retroviral, plasmid and others), application area (gene therapy, cell therapy, vaccine and others) and geographical location of the expansion.
• An analysis evaluating the potential strategic partners (comparing vector based therapy developers and vector purification product developers) for vector and gene therapy product manufacturers, based on several parameters, such as developer strength, product strength, type of vector, therapeutic area, pipeline strength (preclinical and clinical). Figure below provides an example insight
• An overview of other viral / non-viral gene delivery approaches that are currently being researched for the development of therapies involving genetic modification.
• An in-depth analysis of viral vector manufacturers and plasmid DNA manufacturers, featuring three schematic representations, a three dimensional grid analysis, representing the distribution of vector manufacturers (on the basis of type of vector) across various scales of operation and type of manufacturer (in-house operations and contract manufacturing services), a heat map of viral vector manufacturers and plasmid DNA manufacturers based on the type of vector (AAV, adenoviral vector, lentiviral vector, retroviral vector and plasmid DNA) and type of organization (industry (small, mid-sized and large) and non-industry), and a schematic world map representation, highlighting the headquarters and geographical location of key vector manufacturing hubs.
• An analysis of the various factors that are likely to influence the pricing of vectors, featuring different models / approaches that may be adopted by product developers / manufacturers in order to decide the prices of proprietary vectors.
• An estimate of the overall, installed vector manufacturing capacity of industry players based on the information available in the public domain, and insights generated via both secondary and primary research. The analysis also highlights the distribution of the global capacity by company size (small, mid-sized and large), scale of operation (clinical and commercial), type of vector (viral vector and plasmid DNA) and region (North America, Europe, Asia Pacific and the rest of the world).
• An informed estimate of the annual demand for viral and non-viral vectors, taking into account the marketed gene-based therapies and clinical studies evaluating vector-based therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength.
• A discussion on the factors driving the market and various challenges associated with the vector production process.
• A qualitative analysis, highlighting the five competitive forces prevalent in this domain, including threats for new entrants, bargaining power of drug developers, bargaining power of vector and gene therapy manufacturers, threats of substitute technologies and rivalry among existing competitors.

One of the key objectives of this report was to evaluate the current market size and the future opportunity associated with the vector and gene therapy manufacturing market, over the coming decade. Based on various parameters, such as the likely increase in number of clinical studies, anticipated growth in target patient population, existing price variations across different types of vectors, and the anticipated success of gene therapy products (considering both approved and late-stage clinical candidates), we have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2022-2035. In order to provide a detailed future outlook, our projections have been segmented on the basis of scale of operation (preclinical, clinical and commercial), type of vector (AAV vector, adenoviral vector, lentiviral vector, retroviral vector, plasmid DNA and others), application area (gene therapy, cell therapy and vaccine), therapeutic area (oncological disorders, rare disorders, neurological disorders, sensory disorders, metabolic disorders, musco-skeletal disorders, blood disorders, immunological diseases, and others) and geographical region (North America, Europe, Asia Pacific, MENA, Latin America and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth. Figure below provides an example insight

The research, analysis and insights presented in this report are backed by a deep understanding of key insights generated from both secondary and primary research. For the purpose of the study, we invited over 300 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. The opinions and insights presented in this study were also influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry and non-industry players:

• Menzo Havenga (Chief Executive Officer and President, Batavia Biosciences)
• Nicole Faust (Chief Executive Officer & Chief Scientific Officer, CEVEC Pharmaceuticals)
• Cedric Szpirer (Former Executive & Scientific Director, Delphi Genetics)
• Olivier Boisteau, (Co-Founder / President, Clean Cells), Laurent Ciavatti (Former Business Development Manager, Clean Cells) and Xavier Leclerc (Head of Gene Therapy, Clean Cells)
• Alain Lamproye (Former President of Biopharma Business Unit, Novasep)
• Joost van den Berg (Former Director, Amsterdam BioTherapeutics Unit)
• Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital)
• Eduard Ayuso, DVM, PhD (Scientific Director, Translational Vector Core, University of Nantes)
• Colin Lee Novick (Managing Director, CJ Partners)
• Semyon Rubinchik (Scientific Director, ACGT)
• Astrid Brammer (Senior Manager Business Development, Richter-Helm)
• Marco Schmeer (Project Manager, Plasmid Factory) and Tatjana Buchholz (Former Marketing Manager, Plasmid Factory)
• Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing)
• Beatrice Araud (ATMP Key Account Manager, EFS-West Biotherapy)
• Nicolas Grandchamp (R&D Leader, GEG Tech)
• Géraldine Guérin-Peyrou (Director of Marketing and Technical Support, Polypus Transfection)
• Naiara Tejados, Head of Marketing and Technology Development, VIVEBiotech)
• Jeffery Hung (Independent Consultant) 

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Who are the leading players (contract service providers and in-house manufacturers) engaged in the development of vectors and gene therapies?
• Which regions are the current manufacturing hubs for vectors and gene therapies?
• Which type of vector related technologies are presently offered / being developed by the stakeholders engaged in this domain?
• Which companies are likely to partner with viral vector manufacturing and non-viral vector manufacturing service providers?
• Which partnership models are commonly adopted by stakeholders engaged in this industry?
• What type of expansion initiatives are being undertaken by players in this domain?
• What are the various emerging viral and non-viral vectors used by players for the manufacturing of genetically modified therapies?
• What are the strengths and threats for the stakeholders engaged in this industry?
• What is the current, global demand for viral and non-viral vector, and gene therapies?
• How is the current and future market opportunity likely to be distributed across key market segments?