Viral Vector Purification / Virus Purification Products Market (kit, prepacked column, resin, cassette, filter plate, capsule, reagent, and others), 2020-2030
NEW YORK, Aug. 12, 2020 /PRNewswire/ --
INTRODUCTION
Since the approval and launch of cell and gene therapy products, such as Zolgensma® (2019), ZYNTEGLO™ (2019), Luxturna® (2017), KYMRIAH® (2017) and YESCARTA® (2017), there has been a significant increase in demand for viral vectors. Experts believe that the number of such therapies is likely to double over the next couple of years. It is also worth mentioning that this particular field of medical research received close to USD 10 billion in funding in 2019. Currently, over 1,000 cell and gene therapy-related clinical trials are being conducted, worldwide. Genetic manipulation is a basic requirement of cell and gene therapy development, and, as a result, gene delivery vectors are considered to be of utmost importance in this domain. So far, viral vectors (such as those based on adeno-associated viruses (AAV), adenoviruses, lentivirus, retroviruses and other viruses) have been shown to be the most versatile gene delivery tools available, having demonstrated high transfection efficiencies in both preclinical and clinical settings. Further, taking into account the therapeutic efficacy and low side effects profiles of cell and gene therapies, the demand for such interventions is anticipated to grow at a rapid pace, resulting in a proportional increase in need for appropriate vector systems, as well. However, viral vector development and manufacturing is a complex and cost intensive process. One of the primary concerns associated with viral vector production is related to yield; in fact, a singular batch run is estimated to incur losses of up to 70% during the purification step alone.
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A number of techniques are presently used for viral vector purification. Over the years, size-based viral purification strategies, such as density-gradient ultracentrifugation, ultrafiltration, precipitation and size-exclusion chromatography (SEC), have become part of the accepted industry standard. However, recently, stakeholders have begun relying more on affinity chromatography-based purification regimens, given its robustness and high selectivity. Presently, several companies claim to offer a diverse range of virus purification solutions, including, filter plates, prepacked chromatography columns and resins, and consolidated kits, for viral vector (virus) purification. As indicated earlier, downstream processing of viral vector products is challenging. Existing separation and purification techniques are not efficient when it comes to purifying viral vectors at large scales. Moreover, these techniques are often unable to separate complete viruses from empty capsids, thereby, compromising product recovery. Therefore, it has become essential for stakeholders to develop innovative ways to optimize the purification process, in order to further improve virus recovery and facilitate effective removal of contaminants / impurities. Currently, the viral vector purification products market is driven by abovementioned surge in demand for viral vectors. In this context, it is worth mentioning that there are several virus based vaccines under development against the novel SARS-CoV-2 coronavirus strain. In fact, according to the WHO, there are over 20 viral vaccines currently being investigated against the novel coronavirus. Developing the means to better purify viruses is, therefore, likely to significantly impact viable vaccine yield. The current crisis is definitely going to have a strong impact on the virus purification products market.
SCOPE OF THE REPORT
The 'Viral Vector Purification / Virus Purification Products Market (kit, prepacked column, resin, cassette, filter plate, capsule, reagent and others), 2020-2030' report features an extensive study of various products available for viral vector purification, in addition to the current market landscape and future potential of product developers.
Amongst other elements, the report features:
- An overview of the current market landscape of companies providing products for purification of viruses / viral vectors, using different techniques, such as chromatography, centrifugation and filtration. It features information on the type of product (kit, prepacked column, resin, cassette, filter plate, capsule and reagent), type of purification technique (chromatography, centrifugation and filtration), scale of operation (lab-scale, clinical and commercial), type of viral vector (AAV, adenovirus, lentivirus, retrovirus and others) and details on other physical and operational parameters of the product (such as matrix, pore size, volume of bed, flow rate, operating pressure, working temperature, pH, filtration area and process time). In addition, the chapter includes information on the purification product developers, including details on the year of establishment, company size and location of headquarters.
- Elaborate profiles of key players, including an overview of the company, product portfolio (viral vector purification products), recent developments and an informed future outlook.
- An analysis evaluating the potential strategic partners (comprising of viral vector-based therapy developers and viral vector manufacturers) for viral vector purification product developers, based on several parameters, such as type of viral vector, developer strength, operational strength, therapeutic area, strength of clinical pipeline and strength of preclinical pipeline.
- A clinical trial analysis of completed, ongoing and planned studies of various viral vector-based cell therapies, gene therapies and vaccines (approved / under development). It features detailed analyses of clinical studies of different viral-vector based therapies on the basis of their registration year, phase of development, trial status, type of therapy, therapeutic area, type of sponsor / collaborator, geographical location, number of patients enrolled and key players.
- An informed estimate of the annual clinical and commercial demand (in terms of number of patients) for 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. Further, the demand has been segregated on the basis of type of viral vector, type of therapy, therapeutic are and geographical location.
- A case study on tangential flow filtration (TFF), highlighting the role, advantages and disadvantages of the technique for purification of viral vectors; the chapter features details of products used for TFF, including product type, scale of operation, membrane material, flow rate and filtration area.
- A case study featuring the viral vector manufacturers providing commercial scale production, highlighting details on their year of establishment, company size, type of viral vector (AAV, adenovirus, lentivirus, retrovirus and others), purpose of production (in-house and contract-basis), and location of headquarters and manufacturing facilities.
One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for viral vector purification product developers, over the coming decade. Based on various parameters, such as the likely increase in number of clinical studies related to viral vector-based therapies, anticipated growth in target patient population, existing price variations across different purification techniques, and the success of cell and 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 2020-2030. In order to provide a detailed future outlook, our projections have been segmented on the basis of [A] type of viral vector (AAV, adenovirus, lentivirus, retrovirus and others), [B] type of purification technique (chromatography, centrifugation and filtration), [C] type of therapy (gene therapy, cell therapy and viral vaccines) [D] therapeutic area (oncological disorders, cardiovascular disorders, ophthalmic disorders, metabolic disorders, inflammation & immunological diseases and others), [E] scale of operation (preclinical / clinical and commercial) and [F] key geographical regions (North America, Europe, Asia Pacific and rest of the world).
The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The opinions and insights presented in the report were influenced by discussions held with several players in this industry. The study includes detailed transcripts of discussions held with the following individuals:
- Haifeng Chen (Chief Executive Officer, Virovek)
- Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences)
- Kai Lipinski (Chief Scientific Officer, Vibalogics)
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.
RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Industry analysts' views
While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the viral vector purification product in the short to mid-term, and long term.
Chapter 3 provides a general overview of various types of viral and non-viral vectors. It includes a detailed discussion on the methods of gene transfer, type of viral vectors and applications of viral vectors in various advanced therapies. It provides information on the different stages of the viral vector purification process, type of purification techniques used and the key challenges associated with the purification of viral vectors. Further, it includes a review of the latest trends and innovations in the vector purification market.
Chapter 4 is an overview of the various types of products used for purification techniques based on principles of chromatography, centrifugation and filtration. It highlights product specific information, such as type of product (kit, prepacked column, resin, cassette, filter plate, capsule and reagent), type of purification technique (chromatography, centrifugation and filtration), scale of operation (lab-scale, clinical and commercial), type of viral vector (adenovirus, AAV, lentivirus, retrovirus and others), type of chromatographic technique (affinity chromatography, ion-exchange chromatography, size-exclusion chromatography and hydrophilic interaction chromatography), pack size (wherever specified) and price (wherever specified). In addition, the chapter provides details on certain additional parameters (based on the purification technique, wherever applicable), such as type of matrix, binding capacity, particle size, volume of bed, flow rate, operating pressure, working temperature, process time and pH. The chapter also provides information on the purification product developers, including year of establishment, company size and location of headquarters.
Chapter 5 includes detailed profiles of players offering products for viral vector purification. Each profile features an overview of the company, , information on its product portfolio, recent developments and an informed future outlook.
Chapter 6 highlights potential strategic partners (comprising of viral vector-based therapy developers and viral vector manufacturers) for viral vector purification product developers, based on multiple parameters, such as type of viral vector, developer strength, operational strength, therapeutic areas, strength of clinical pipeline and strength of preclinical pipeline. The analysis aims to provide the necessary inputs to the product developers, enabling them to make the right decisions to collaborate with industry stakeholders with relatively more initiatives in the domain.
Chapter 7 features a geographical clinical trial analysis of completed, ongoing and planned studies of viral vector-based cell therapies, gene therapies and vaccines (approved / under development). The analysis provides details related to the different types of viral vectors investigated / being investigated across various geographies, based on the number of clinical trials, registration year, phase of development, trial status, type of therapy, therapeutic area, type of sponsor / collaborator, number of patients enrolled, key players and type of viral vector.
Chapter 8 features an informed estimate of the annual demand for viral vectors, taking into account the viral vector based marketed therapies and clinical studies. For the purpose of estimating the current clinical demand, we considered the active clinical studies of different types of vector-based therapies that have been registered till date. The data was analyzed on the basis of various parameters, such as number of annual clinical doses, trial location, and the enrolled patient population across different geographies. Further, in order to estimate the commercial demand, we considered the marketed vector-based therapies, based on various parameters, such as target patient population, dosing frequency and dose strength. The chapter features analyses demand on the basis of type of viral vector, type of therapy, therapeutic are and geographical location.
Chapter 9 is a detailed case study which provides an overview of the tangential flow filtration, highlighting its role, advantages and disadvantages. It features key details of the products used for tangential flow filtration, such as type of product, scale of operation, membrane material, flow rate and filtration area.
Chapter 10 is a detailed case study which provides an overview of the viral vector manufacturers. It features an in-depth analysis of the commercial scale viral vector manufacturers, highlighting details on their year of establishment, company size, types of vectors (AAV, adenovirus, lentivirus, retrovirus and others), purpose of production (in-house and contract-basis), headquarters and manufacturing facilities.
Chapter 11 presents an insightful market forecast analysis, highlighting the future potential of the virus purification products market till the year 2030. We have segregated the opportunity of the market on the basis of [A] type of viral vector (AAV, adenovirus, lentivirus, retrovirus and others), [B] type of purification technique (chromatography, centrifugation and filtration), [C] type of therapy (gene therapy, cell therapy and viral vaccines) [D] therapeutic area (oncological disorders, cardiovascular disorders, ophthalmic disorders, metabolic disorders, inflammation & immunological diseases and others), [E] scale of operation (preclinical / clinical and commercial) and [F] geographical location (North America, Europe, Asia Pacific and rest of the world).
Chapter 12 summarizes the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.
Chapter 13 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with (in alphabetical order) Haifeng Chen (Chief Executive Officer, Virovek), Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences) and Kai Lipinski (Chief Scientific Officer, Vibalogics).
Chapter 14 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 15 is an appendix, which provides a list of companies and organizations mentioned in this report.
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