Bharat Book Bureau Provides the Trending Market Research Report on “ Global Gene Therapy Market Analysis & Forecast to 2022 “ under Healthcare category. The report provides information on industry overview, market size, latest developments, industry trends, key players, global presence, and their future prospects.
Growing at a CAGR of over x% the global gene therapy marketis forecast to hit $ 363 million by 2022 from $ x million in 2017. Strengthened by recent approvals of Kymriah, Yescarta and Luxturna in the US, and a committed European, Japanese and Chinese environment, gene therapy is set to become a significant player in the bio-pharmaceutical industry. The space covers many therapeutic areas specifically, oncology, rare diseases, Parkinson’s, HIV, severe combined immunodeficiencies (SCID) and hemophilia. Gene therapy is driven by 2,200 clinical trials globally, with over 55% of those occurring in the US, followed by Europe, Canada and China. Recently, in November 2017, the FDA indicated that it wants to qualify for a fast approval process, which will bring more therapies to market faster. However, the space has significant challenges, such as manufacturing logistics, reimbursement and its high cost. This section of the paper discusses the growing and challenging industry, and highlights its strengths, weaknesses and opportunities and provides a comprehensive account of major companies, clinical trials and technological advancement.
Since the FDA approved Kymriah (tisagenlecleucel), Yescarta (Axicabtagene ciloleucel) and Luxturna (neutrophysic neparvovec-rzyl) in 2017, the US gene therapy space has expanded significantly, underlined 55% of completed and ongoing trials are located in this geographic. Growth in the gene therapy industry has resulted in new commercial initiatives and the emergence of new startups and spin-off biotechs. Furthermore, gene therapy has raised well over $ 600 million of venture capital in the last five years. Early stage companies have raised seed, Series A and Series B investment steadily since the market took off, including Spark Therapeutics, Avalanche Biotech, UniQure, Voyager Therapeutics, Editas Medicine and GenSight.
In 2017, the gene therapy market for technologies, services and products is estimated to be $ x million, with a potential to reach $ 363 million by 2022. The main market space is cancer which currently holds x% market share. This indication is $ x million in 2017 and will generate $ x million in 2022. This is followed by rare diseases, cardiovascular, neurological and ocular indications. Looking at the marketplace by technology, at present, gene product will generate revenue in excess of $ x million in 2017, growing to $ x million by 2022. Viral vectors are set to generate $ x million in 2017, and will rise to $ x million in 2022, and by then gene therapy services search as vector development and transfection will hit $ x million. At present, the Americas have penetrated the market significantly with 65% geographic share,
Gene therapy products approved between 2003 and 2017 include Gendicine, Oncorine, Rexin-G, Neovasculgen, Glybera, Imlygic, Strimvelis, Zalmoxis, Kymriah, Yescarta and Luxturna. Gendicine was approved in the Chinese market since 2003. Rexin-G was approved in the Philippines back in 2007 for the treatment of primary and metastatic cancer. Oncorine was approved in China in 2005 for nasopharyngeal carcinoma. The Russian market has Neovasculgen from 2011 for the treatment of peripheral arterial disease (PAD) and critical limb ischemia. The first gene therapy approved in EU was Glybera in 2012 for the treatment of familial lipoprotein lipase deficiency (LPL), however in October 2017 it pulled off the market due to lack of patient demand. In 2015, Imlygic was approved in EU and thus in the US to treat melanoma, and Phase II results released in 2017 indicated its efficacy in combination with the checkpoint inhibitor, Yervoy. In the EU, Strimvelis was approved in 2016 for the treatment of adenosine deaminase severe combined immunodeficiency (ADA-SCID). In 2016, Zalmoxis was approved in EU for the treatment of leukemia. 2017 what a bumper year for gene therapy with Kymriah, Yescarta and Luxturna all gaining FDA approval.
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Renewed interest has encouraged start-up companies to become acquainted with academic centers for tech know-how. As clinical trials advance toward licensure, more meticulous product characterization using improved analytical methods and progressively higher regulatory compliance. Some of the ongoing clinical trials are due to the deficiency of factor IX using a recombinant adeno-associated virus (AAV) as a vector. The product candidate if succeeds wants to be cheaper alternative to the expensive and lifelong factor replacement therapy.
AAV expressing retinal pigment epithelial RPE65 for liver Congenital amaurosis type 2. A third example of the clinical trial involving nine children with X- autologous bone marrow CD34 + cells transduced with a self-inactivating (SIN) γ-retroviral vector expressing the IL-2 receptor γ-chain. Many unique teams using CAR-T-cell technology.
As long as they are short term treatments, they are customized to individual patients. Therefore, manufacturing firms are expected to seek care for these therapies. Because of this, these therapies will have to face valuation and reimbursement challenges. Stakeholders want to make a reservation about the price tag. With the removal of Gylbera from the EU market in 2017, due to the fact that only one patient is treated with the drug, all eyes are focused on the number of patients being treated, and their ability to pay. To that end, launching of new drugs may have to be delayed in order to collect more data for payers. Further More,
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