NEW YORK, Nov. 3, 2016 /PRNewswire/ --
Gene therapy has emerged as a promising treatment option for various diseases (primarily the ones that currently have no cure) including cancers, inherited disorders and some viral infections. Gene therapies and genetically modified therapies involve the introduction of therapeutic DNA (gene of interest) into the patient's body. There have been a number of successful trials in several systems showing the efficient transfer and expression of a variety of human genes into target cells.
This process of gene delivery into cells is accomplished by the use of vectors. Over the last few decades, various viral and non-viral vectors have been optimized and standardized for this purpose. Currently, the most popular viral vectors used for gene therapies are those based on adenovirus, retrovirus, AAV and lentivirus vectors (these respectively form 20%, 16%, 8% and 8% of the active gene therapy clinical trials). Similarly, among non-viral gene delivery tools, plasmid DNA has emerged as the most commonly used vector. It is also used in the development and production of viral vectors and DNA vaccines.
Eight gene therapies have been approved so far; these are (in the order of their approval) Gendicine®, Oncorine®, Rexin-G®, Glybera®, Neovasculagen®, Imlygic®, Strimvelis™ and Zalmoxis®. Strimvelis™, one of the most recently approved gene therapy, received a market authorization from the European Commission in May 2016. In addition, over 500 gene therapy candidates are in different stages of clinical development; for these, approximately 1,700 clinical studies are currently being conducted in various regions across the globe.
The growing number of gene therapy candidates coupled with their rapid progression through the various phases of clinical development continues to create an increasing demand for vectors. The market already has a wide array of well-established players, mid-sized companies and start-ups. Several industrial players as well as academic institutes are significantly contributing to the production of GMP and non-GMP grade vectors. In the recent past, these players have signed multiple partnerships / collaborations with an aim to optimize and scale-up the production processes and expand their capabilities of vector production.
Looking at the evolutionary trends, we believe that the market will continue to be steadily driven in the mid to long term by expansions of existing and establishment of new dedicated manufacturing facilities. Technological advancements to mitigate challenges posed by conventional methods of vector production will act as a key enabler to this growth.
SCOPE OF THE REPORT
The "Viral Vectors and Plasmid DNA Manufacturing Market, 2016-2026" report provides an extensive study of the rapidly growing market of gene therapy vectors, with a special focus on lentivirus, AAV, adenovirus, retrovirus and plasmid DNA. Gene therapies require a viral or non-viral vector to efficiently transfer the therapeutic gene into targets cells. It is well known that the gene therapy market is characterized by a robust pipeline of drugs targeting several therapeutic indications.
The pipeline is witnessing continuous progression that has further led to an upward surge in demand for gene delivery tools, including both viral and non-viral vectors. Several players, including pharmaceutical companies, research institutes, contract manufacturing organizations and non-profit organizations, are playing a critical role in the development and production of these vectors. Led by technological advancements, these organizations have developed and introduced proprietary platforms to overcome the challenges posed by conventional production technologies and have also made heavy investments in the expansion of their existing capabilities for vector production.
During the course of our study, we identified over 140 organizations that are actively involved in the production of viral vectors and plasmid DNA. In addition to other elements, the study provides information on:
- The current status of the market with respect to key players along with information on the location of their manufacturing facilities, scale of production, type of vectors manufactured, purpose of production (fulfilling in-house requirement / as a contract service provider) and the type of organization (industry / academia).
- Most active regions in terms of vector manufacturing; the report contains schematic representations of world maps that clearly indicate the locations of global vector manufacturing hubs.
- Elaborate profiles of key players that have commercial scale production capabilities for viral vector / plasmid DNA; each profile covers an overview of the company, its financial performance, information on its manufacturing facilities, vector manufacturing technology, recent investments, expansions and collaborations.
- A discussion on the key enablers of the market and challenges associated with the vector production process.
- Potential future growth of the vector manufacturing market segmented by the type of vector and phase of development. For the purposes of our analysis, we took into consideration several parameters that are likely to impact the growth of this market over the next decade; these include the likely increase in the number of clinical studies, increase in the patient population, existing price variations among different vector types, estimated dosage frequency and the anticipated success of commercial gene therapy products.
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. Actual figures have been sourced and analyzed from publicly available data. For the purpose of the study, we invited over 100 stakeholders to participate in a survey to solicit their opinions on upcoming opportunities and challenges that must be considered for a more inclusive growth. Our opinions and insights presented in this study were influenced by discussions conducted with several key players in this domain. The report features detailed transcripts of interviews held with Alain Lamproye (President of Biopharma Business Unit, Novasep), Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital), Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing), Joost van den Berg (Director, Amsterdam BioTherapeutics Unit), Nicole Faust (Chief Scientific Officer, Cevec) and Semyon Rubinchik (Scientific Director, ACGT).
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 may evolve across different regions and technology segments. Wherever 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 over the coming ten years, the report also provides our independent view on various technological and 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 2 is an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of the viral vectors and plasmid DNA manufacturing market over the coming decade.
Chapter 3 provides a general introduction to the various types of viral and non-viral vectors. It includes a detailed discussion on the design, manufacturing requirements, advantages, limitations and applications of currently available gene delivery vectors. The chapter also provides a brief description of the clinical and approved pipeline of gene therapies.
Chapter 4 identifies the contract service providers / in-house manufacturers that are actively involved in the production of viral vectors and plasmid DNA. The chapter provides details on the vector production capabilities of these organizations, specifically focusing on the type of organization, geographic location of their facilities, scale of operation and the purpose of vector production (in-house requirement / third party manufacturing). It contains schematic representations of world maps highlighting the geographical locations of vector manufacturing facilities. Further, it discusses the development trends within the overall vector manufacturing landscape.
Chapter 5 contains detailed profiles of viral vector manufacturers having commercial scale production capacities. Each profile provides a brief overview of the company, its financial performance, details on vector manufacturing facilities, vector manufacturing technology, manufacturing experience, recent investments / expansions and the relevant collaborations and partnerships that have been inked over the last few years. In addition, the chapter summarizes the key drivers and challenges associated with the production of these vectors.
Chapter 6 contains detailed profiles of plasmid DNA manufacturers having commercial scale production capacities. Each profile provides a brief overview of the company, its financial performance, details on plasmid manufacturing facilities, manufacturing experience, recent investments / expansions and the relevant collaborations and partnerships that have been inked over the last few years. In addition, the chapter summarizes the key drivers and challenges associated with the production of these vectors.
Chapter 7 presents a ten year sales forecast to highlight the likely growth of the market of gene therapy vectors. We have segregated the financial opportunity by type of vectors (lentivirus, adenovirus, AAV, retrovirus and plasmid DNA) and the phase of development. All our predictions related to this market's future are backed by robust analysis of data procured from both secondary and primary sources. Due to the uncertain nature of the market, we have presented three different growth tracks outlined as the conservative, base and optimistic scenarios.
Chapter 8 presents insights from the survey conducted for this study. We invited over 100 stakeholders involved in the development of different types of gene therapy vectors. The participants, who were primarily Director / CXO level representatives of their respective companies, helped us develop a deeper understanding on the nature of their services and the associated commercial potential.
Chapter 9 summarizes the entire report. The chapter presents a list of key takeaways and offers our independent opinion on the current market scenario and evolutionary trends that are likely to determine the future of this segment of the industry.
Chapter 10 is a collection of interview transcripts of the discussions held with key stakeholders in the industry. We have presented details on our discussions with Alain LAMPROYE (President of Biopharma Business Unit, Novasep), Bakhos A Tannous (Director, MGH Viral Vector Development Facility, Massachusetts General Hospital), Brain M Dattilo (Business Development Manager, Waisman Biomanufacturing), Joost van den Berg (Director, Amsterdam BioTherapeutics Unit (AmBTU), Nicole Faust (Chief Scientific Officer, Cevec), Semyon Rubinchik, (Scientific Director, ACGT).
Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures in the report.
Chapter 12 is an appendix, which contains the list of companies and organizations that have been mentioned in the report.
1. Overall, we came across over 90 manufacturers producing viral vectors and over 30 manufacturers producing plasmid DNA. In addition, we observed that there are 14 manufacturers that have the capabilities to produce both viral vectors and plasmid DNA.
2. Several established organizations have been involved in the production of vectors since the inception of this domain. However, the growing demand for these programs have spurred the establishment of many start-ups as well. Examples include (indicative list, in alphabetical order) Batavia Biosciences, Brammer Bio, GenIBET Biopharmaceuticals, Immune Technology, Lentigen Technology, Luminous Biosciences, Oxford Genetics, SignaGen Laboratories, Vectalys and Virovek. It is also worth highlighting that over 50 academic institutes / non-profit organizations are currently involved in the production of vectors for use in gene therapies.
3. As most of the gene therapy candidates are in development stage, the demand for research and clinical grade vectors is more as compared to the demand for commercial grade vectors. However, some players (as per our research, 24) have developed / are developing commercial scale capacity for vector production. Examples include (in alphabetical order) Aldevron, BioReliance / SAFC, Cobra Biologics, Eurogentec, FUJIFILM Diosynth Biotechnologies, Lonza, MassBiologics and WuXi AppTec.
4. Although the current market landscape is dominated by contract manufacturers, some drug developers have established in-house capabilities to produce vectors for internal programs. Example include (in alphabetical order) Amsterdam BioTherapeutics Unit (AmBTU), bluebird bio, BioVex (Amgen subsidiary), Epeius Biotechnologies, GeneCure Biotechnologies, MolMed and uniQure. Some of these are well established players and have approved gene therapies in their pipeline whereas some are being supported by large pharmaceutical companies, venture capital firms or non-profit organizations.
5. Despite the fact that the first three gene therapy candidates (Gendicine®, Oncorine® and Rexin-G®) were approved in Asian countries, the US and Europe have emerged as vector manufacturing hubs over the last few years. This is a result of the high volume of ongoing clinical studies in these developed regions. Approximately 68% of the total worldwide active clinical studies for gene therapies are underway in North America. The second major market is Europe where around 21% of the trials are ongoing.
6. The heightened competition has resulted in the emergence of innovative technologies that mitigate the challenges of safety, stability, purification and scale up posed by conventional methods of vector production. There is a growing focus on the cultivation of suspension cell cultures in serum free media using large scale bioreactors, adoption of more efficient downstream processes based on chromatographic techniques and use of baculovirus based cultures systems. Some organizations have also developed proprietary platform processes to optimize and scale-up the vector production process. Examples include Herpes-Assisted Vector Expansion (AGTC), LentiVector® platform (Oxford BioMedica), CAP®-GT (Cevec) and NAV® technology (REGENXBIO). In addition, Aldevron and Plasmid Factory have introduced a new technology based on minicircle DNA that has so far demonstrated superior results as compared to the conventional plasmid production process.
7. The growing interest in vector manufacturing domain is further highlighted by the increasing number of collaborations / partnerships among the organizations involved in this field. The motives behind the partnerships vary; collaborations have been signed for purposes such as out / in licensing of vector manufacturing technology, production of vector promoters and acquisition / development of manufacturing facilities.
8. The short-term demand for viral and non-viral vectors will primarily be driven by clinical candidates. In the longer term, the currently approved therapies and late-stage molecules (that are likely to get commercialized in future) will act as key drivers of the market. Our outlook is highly promising; we expect the market for viral vectors and plasmid DNA manufacturing to grow at an annualized growth rate of ~17% and be worth over USD 1 billion over the course of next ten years.
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