§ A detailed review of the overall market landscape of gene therapies and gene editing therapies, including information on phase of development (marketed, clinical, preclinical and discovery) of pipeline candidates, key therapeutic areas (autoimmune disorders, cardiovascular diseases, dermatological disorders, genetic disorders, hematological disorders, immunological disorders, infectious diseases, inflammatory disorders, liver diseases, metabolic disorders, muscle-related diseases, nervous system disorders, oncological disorders, ophthalmic diseases and others), target disease indication(s), type of vector used, type of gene, therapeutic approach (gene augmentation, oncolytic viral therapy and others), type of gene therapy (ex vivo and in vivo), route of administration and special drug designation(s) awarded (if any).
§ A detailed review of the players engaged in the development of gene therapies, along with information on their year of establishment, company size, location of headquarters, regional landscape and key players engaged in this domain.
§ An elaborate discussion on the various types of viral and non-viral vectors, along with information on design, manufacturing requirements, advantages and limitations of currently available gene delivery vectors.
§ A discussion on the regulatory landscape related to gene therapies across various geographies, namely North America (the US and Canada), Europe and Asia-Pacific (Australia, China, Hong Kong, Japan and South Korea), providing details related to the various challenges associated with obtaining reimbursements for gene therapies.
§ Detailed profiles of marketed and late stage (phase II/III and above) gene therapies, including development timeline of the therapy, information on the current development status, mechanism of action, affiliated technology, strength of patent portfolio, dosage and manufacturing details, as well as details related to the developer company.
§ An elaborate discussion on the various commercialization strategies that can be adopted by drug developers across different stages of therapy development, including prior to drug launch, at / during drug launch and post-marketing.
§ A review of the various emerging technologies and therapy development platforms that are being used to design and manufacture gene therapies, featuring detailed profiles of technologies that were / are being used for the development of four or more products / product candidates.
§ An in-depth analysis of various patents that have been filed / granted related to gene therapies and gene editing therapies, since 2016. The analysis assesses several relevant parameters associated with the patents, including type of patent (granted patents, patent applications and others), publication year, regional applicability, CPC symbols, emerging focus areas, leading industry players (in terms of the number of patents filed / granted), and patent valuation.
§ A detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2020, based on several relevant parameters, such as year of agreement, type of deal, geographical location of the companies involved, key value drivers, highest phase of development of the acquired company' product and target therapeutic area.
§ An analysis of the investments made at various stages of development in companies that are focused in this area, between 2015-2020, including seed financing, venture capital financing, IPOs, secondary offerings, debt financing, grants and other equity offerings.
§ A detailed geographical clinical trial analysis of completed, ongoing and planned studies of numerous gene therapies, based on various relevant parameters, such as trial registration year, trial status, trial phase, target therapeutic area, geography, type of sponsor, prominent treatment sites and enrolled patient population.
§ An analysis of the various factors that are likely to influence the pricing of gene therapies, featuring different models / approaches that may be adopted by manufacturers to decide the prices of these therapies.
§ An analysis of the big biopharma players engaged in this domain, featuring a heat map based on parameters, such as number of gene therapies under development, funding information, partnership activity and strength of patent portfolio.
§ An informed estimate of the annual demand for gene therapies, taking into account the marketed gene-based therapies and clinical studies evaluating gene therapies; the analysis also takes into consideration various relevant parameters, such as target patient population, dosing frequency and dose strength.
§ A case study on the prevalent and emerging trends related to vector manufacturing, along with information on companies offering contract services for manufacturing vectors. The study also includes a detailed discussion on the manufacturing processes associated with various types of vectors.
§ A discussion on the various operating models adopted by gene therapy developers for supply chain management, highlighting the stakeholders involved, factors affecting the supply of therapeutic products and challenges encountered by developers across the different stages of the gene therapy supply chain.
The report also features the likely distribution of the current and forecasted opportunity across important market segments, mentioned below:
§ Therapeutic approach
§ Gene augmentation
§ Oncolytic therapy
§ Type of gene therapy
§ Ex vivo
§ In vivo
§ Type of vector used
§ Adeno associated virus
§ Herpes simplex virus
§ Plasmid DNA
§ Key therapeutic areas
§ Autoimmune disorders
§ Cardiovascular diseases
§ Dermatological disorders
§ Genetic disorders
§ Hematological disorders
§ Metabolic disorders
§ Muscle-related diseases
§ Oncological disorders
§ Ophthalmic diseases
§ Route of administration
§ Key geographical regions
§ North America
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Key Questions Answered
§ Who are the leading players engaged in the development of gene therapies?
§ How many gene therapies are presently being evaluated across different stages of development?
§ What are various diseases targeted by gene therapies?
§ What are the key technology platforms that are either available, or being developed for gene therapy discovery and production?
§ What kind of vectors are commonly used for the delivery of gene therapies?
§ What are the key regulatory guidelines governing the approval of gene therapies, across various geographies?
§ What kind of pricing models and reimbursement strategies are currently used by gene therapy developers?
§ What kind of contract services are offered related to gene therapies? Who are the key players in this market?
§ What are the drivers of the M&A activity in this market?
§ What kind of investors have stake in the gene therapy market?
§ What kind of commercialization strategies are used by gene therapy developers?
§ How is the current and future market opportunity likely to be distributed across key market segments?
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