Viral Vector Purification / Virus Purification Products Market (kit, prepacked column, resin, cassette, filter plate, capsule, reagent and others), 2020-2030

Overview

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.  

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 the 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.