{"id":11813,"date":"2021-02-26T13:03:19","date_gmt":"2021-02-26T07:33:19","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=11813"},"modified":"2025-02-12T17:36:31","modified_gmt":"2025-02-12T12:06:31","slug":"gene-and-cell-therapies-in-cns-disorders","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders","title":{"rendered":"Gene and Cell Therapies in CNS Disorders: Miracle Cure? Opportunities Galore!"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a068af207dfa\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a068af207dfa\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders\/#Positioning_of_Gene_and_Cell_Therapies_in_Neurosciences\" >Positioning of Gene and Cell Therapies in Neurosciences<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders\/#Gene_Cell_Therapies_and_Key_Indications\" >Gene &amp; Cell Therapies and Key Indications<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders\/#Competition_in_the_Market\" >Competition in the Market<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders\/#Expected_Roadblocks\" >Expected Roadblocks<\/a><\/li><\/ul><\/nav><\/div>\n\n<p>CNS disorders are a wide-ranging set of disorders in which the brain loses its normal functioning, limiting everyday ability to function. These may arise from various reasons-some are inherited, some result from damage, and some from infections. It contributes to the highest <strong>disability-adjusted life years<\/strong>. The current treatment options are minimal. Most of the disorders have no curative treatment available. For most CNS disorders, the development of effective drug candidates is challenging as clinical trials are often long-lasting and with considerable expense. The last few decades have been marked by increased research and development in neuroscience.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-positioning-of-gene-and-cell-therapies-in-neurosciences\"><span class=\"ez-toc-section\" id=\"Positioning_of_Gene_and_Cell_Therapies_in_Neurosciences\"><\/span><strong>Positioning of Gene and Cell Therapies in Neurosciences<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Decades of technological progress and careful research, <em>Gene and cell therapy <\/em>(GCT), which were previously viewed as the \u2018future\u2019 of medicine, are now all set to become a reality. Improving upon the currently available options. Gene and cell therapies hold the potential to provide a one-off cure. The major drivers that have enabled this vision are the advent of safe and effective vectors, newer gene-editing tools, and huge unmet needs for the treatment of devastating CNS disorders.<\/p>\n\n\n\n<p><strong>Race to be the first mover<\/strong><\/p>\n\n\n\n<p>The possibility of high end-rewards in form of high premium pricing and an untapped patient pool has ensured a busy pipeline activity in this space in hopes of a sharp increase in revenues. Currently, pharmaceutical companies such as <strong>Novartis, Hope Biosciences, Roche, Brainstorm Cell Therapeutics, Helixmith, Libella Gene Therapeutics,<\/strong> etc. are the key players that are expanding their pipelines to incorporate GCT to treat a range of CNS disorders. Besides, some pharmaceutical companies are also trying to be a part of this innovation by actively entering into collaborations with other players.<\/p>\n\n\n\n<p><strong>Early Victories<\/strong><\/p>\n\n\n\n<p>Zolgensma by Novartis became the first gene therapy to be approved by the FDA&nbsp; for the treatment of <strong>spinal muscular atrophy<\/strong>. Its high price of <strong>USD 2.125 million per patient<\/strong>, adds it to the list of most expensive treatments. In the US, <a href=\"https:\/\/www.delveinsight.com\/blog\/meet-the-worlds-most-expensive-drug-zolgensma\/\" target=\"_blank\" rel=\"noreferrer noopener\">Zolgensma<\/a> generated around <strong>USD 360.7 million <\/strong>in the first year of launch.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-gene-amp-cell-therapies-and-key-indications\"><span class=\"ez-toc-section\" id=\"Gene_Cell_Therapies_and_Key_Indications\"><\/span>Gene &amp; Cell Therapies and <strong>Key Indications <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The key therapies currently in the development phase for different CNS indications are <a href=\"https:\/\/www.delveinsight.com\/report-store\/amyotrophic-lateral-sclerosis-als-market?utm_source=cision&amp;utm_medium=pr&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Amyotrophic lateral sclerosis<\/a>: <strong>NurOwn (BrainStorm Cell Therapeutics), Engensis (Helixmith), Q cells (Q therapeutics), VM202 (Helixmith<\/strong>); <a href=\"https:\/\/www.delveinsight.com\/report-store\/spinal-cord-injury-market?utm_source=cision&amp;utm_medium=pr&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Spinal cord injury<\/a>: <strong>Neuro-Cells (Neuroplast)<\/strong>, <strong>Umbilical Cord Blood Mononuclear Cell (StemCyte);<\/strong> <a href=\"https:\/\/www.delveinsight.com\/report-store\/parkinsons-disease-market-size-analysis-treatment\" target=\"_blank\" aria-label=\" (opens in a new tab)\" rel=\"noreferrer noopener\" class=\"ek-link\">Parkinson\u2019s disease<\/a>: <strong>Axo Lenti PD (Axovant)<\/strong>; <a href=\"https:\/\/www.delveinsight.com\/report-store\/alzheimers-disease-ad-market?utm_source=cision&amp;utm_medium=pr&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Alzheimer Disease<\/a>: <strong>AAV-hTERT (Libella Gene Therapeutics), VY-AADC (Voyager Therapeutics).<\/strong> Analysts at <strong>DelveInsight estimate<\/strong> a combined market of<strong> USD 3,753.6 million in the United States<\/strong> by end of 2026, with a CAGR of <strong>39.74% <\/strong>from 2018\u20132026.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-competition-in-the-market\"><span class=\"ez-toc-section\" id=\"Competition_in_the_Market\"><\/span><strong>Competition in the Market <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The biggest competition for GCT is the development of antisense therapies. The classic example is <a href=\"https:\/\/www.delveinsight.com\/report-store\/spinraza-nusinersen-drug-insight-market-forecast?utm_source=cision&amp;utm_medium=pr&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Spinraza<\/a> (Biogen), an antisense oligonucleotide that is the key contender to <a href=\"https:\/\/www.delveinsight.com\/report-store\/zolgensma-onasemnogene-abeparvovec-xioi-drug-insight-market-forecast?utm_source=cision&amp;utm_medium=pr&amp;utm_campaign=v\" target=\"_blank\" rel=\"noreferrer noopener\">Zolgensma<\/a> (Novartis) for the treatment of SMA. Both Spinraza and Zolgensma are expensive therapies However, Spinraza is more established being the first to enter the market in 2017. Zolgensma\u2019s approval is in patients aged less than two, Biogen is also competing for those young patients. Nurture study results demonstrated that patients treated with Spinraza before symptoms matched development milestones typical for healthy babies.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-expected-roadblocks\"><span class=\"ez-toc-section\" id=\"Expected_Roadblocks\"><\/span><strong>Expected Roadblocks<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>GCT is usually priced at more than 30 times the median household income<\/strong> of an individual. One-time high payment may discourage payers who prefer significantly lower-cost treatment for a longer duration. Most gene therapies have been only developed recently and<strong> lack long-term efficacy data<\/strong>, making the long-term cost-effectiveness argument even more challenging. Besides, the therapy area also suffers from <strong>regulatory challenges<\/strong>. as the regulatory bodies currently <strong>lack historical process data<\/strong>; hence, making it hard for regulatory bodies to leverage regulatory experience. Also, the lack of guidelines around plasmid quality, animal-free material complicates the regulatory process. Lastly, there are no standardized guidelines that increase the risk of failure of novel gene therapies. Nonetheless, the promising benefits of GCT, have the potential to sideline current roadblocks and emerge as a breakthrough treatment for CNS disorders.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>CNS disorders are a wide-ranging set of disorders in which the brain loses its normal functioning, limiting everyday ability to function. These may arise from various reasons-some are inherited, some result from damage, and some from infections. It contributes to the highest disability-adjusted life years. The current treatment options are minimal. Most of the disorders [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":11816,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17],"tags":[72,74,141,16899,258,423,1826,16900,4221],"industry":[17225],"therapeutic_areas":[17229],"class_list":["post-11813","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","tag-alzheimers-disease","tag-amyotrophic-lateral-sclerosis","tag-car-t-therapy-landscape","tag-central-nervous-system-disorders","tag-gene-therapy","tag-novartis","tag-parkinsons-disease","tag-spinal-cord-injury","tag-zolgensma","industry-pharmaceutical","therapeutic_areas-central-nervous-system"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Gene and Cell Therapies in CNS Disorder | Gene Therapy | DelveInsight<\/title>\n<meta name=\"description\" content=\"Novartis, Hope Biosciences, Roche, Brainstorm Cell Therapeutics, Helixmith, Libella Gene Therapeutics are exploring Gene cell therapies to...\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/gene-and-cell-therapies-in-cns-disorders\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gene and Cell Therapies in CNS Disorder | Gene Therapy | DelveInsight\" \/>\n<meta property=\"og:description\" content=\"Novartis, Hope Biosciences, Roche, Brainstorm Cell Therapeutics, Helixmith, Libella Gene 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