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市场调查报告书
商品编码
1284279
到 2028 年的基因组编辑市场预测——按产品/服务、技术、应用、最终用户和地区进行的全球分析Genome Editing Market Forecasts to 2028 - Global Analysis By Product & Service, By Technology, By Application, By End User and By Geography |
根据 Stratistics MRC 的数据,2022 年全球基因组编辑市场规模将达到 61 亿美元,预计到 2028 年将达到 185 亿美元,预测期内復合年增长率为 20.2%。生长。
基因编辑是使用仪器和过程,通过对基因的 DNA 序列进行高度特异性的改变,从而显着改变生物体的遗传蓝图。 与将遗传物质随机加入宿主基因组的基因工程不同,基因编辑旨在修改特定的目标区域。
根据国家转化科学促进中心 2022 年 6 月的更新,美国国立卫生研究院 (NIH) 的体细胞基因组编辑 (SCGE) 计划向美国和加拿大研究人员授予了 24 项额外资助。
最近的发展大大提高了基因组编辑能力,可以修改各种细胞类型和模型物种中的独特基因序列。 特别是在肿瘤学测试中,基因组编辑有可能显着改变诊断工具。 基因组工程已被各国政府和大学等主要研究机构所采用。 然而,基因编辑技术的快速发展正在使研究机构向临床和诊断机构发生重大转变。
基因组仪器价格昂贵,由于其最先进的功能和特性,平均价值在 1000 万美元到 2000 万美元之间。 由于製药公司和实验室需要大量的系统,购买多台基因组仪器的资本投资是巨大的。 中小型药企和实验室大量投资基因组仪器是不切实际的。
随着个性化医疗领域的发展,基因组编辑市场参与者应该看到机遇。 在个性化医疗的帮助下,从业者可以确定患者的确切需求,并据此开出药物和治疗方案。 由于个性化医疗具有节省成本、提高患者依从性、及早发现疾病和改善治疗的潜力,因此在全球范围内的使用正在增长。
CRISPR-Cas9 的脱靶结果备受关注。 因为 Cas9 会产生双链断裂,脱靶核酸□活性会修饰这些基因并导致肿瘤发生。 CRISPR-Cas9 可以容忍靶标中的一到三个错配,并可能导致脱靶核酸□活性。 主要关注的是高频率的脱靶活动 (50%),这是指在预期的目标站点之外进行的修改。 例如,CRISPR 可以激活致癌基因或靶向抑癌基因。 由于这种不良影响,许多组织临床研究的公司都遇到了问题。 临床试验已被取消,监管机构呼吁进行更多研究以提高这种方法的安全性。
COVID-19 正在对基因组编辑市场产生积极影响。 COVID-19 流行病正在增加全球医疗保健系统的压力。 由于 COVID-19 大流行,大型製药和生物技术公司正在增加对疫苗研发和基因组编辑市场参与者的投资。 由于对疫苗接种和潜在抗病毒药物的需求不断增长,基因组编辑和工程技术处于科学研究的前沿。 此外,不仅对基因组编辑市场,而且对其他医疗保健服务也产生了一定的影响。 发现 COVID-19 后,许多研究人员开始研究这种独特的病毒及其产生的疾病。
由于政府在免疫、医疗技术、药物和小工具开发方面的资金增加和努力,成簇常规间隔子短炼长重复序列 (CRISPR) 片段预计在此期间将适度增长。 2021 年 1 月发表在《新英格兰医学杂誌》上的一项题为“针对镰状细胞病和地中海贫血的 CRISPR-Cas9 基因编辑”的研究发现了两例遗传病:TDT(地中海贫血)患者和 SCD(CRISPR-Cas9-基于基因编辑的技术正在镰状细胞病患者中进行测试。 在给予 CTX001 后的第二年,两名患者的胎儿血红蛋白水平早期、显着和长期增加,胰液□99%。 因此,由于 CRISPR 技术在治疗镰状细胞病和 β-地中海贫血等疾病中的应用,预计在预测期内需求将增长。
随着干细胞研究越来越多地使用细胞系工程,细胞系编辑领域预计将实现长期盈利增长。 细胞系工程广泛用于诱导多能干细胞 (iPSC),这些干细胞通过快速改进帮助改变细胞的遗传物质。 此外,锌指核酸□ (ZFN)、CRISPR/Cas 和 TALEN 等先进的基因编辑方法使细胞编辑变得经济实惠且可行。
由于生物技术和製药行业的强劲发展趋势,北美在全球基因组编辑市场占据主导地位。 在预测期内,基因组编辑技术的进步、产品批准的增加以及研发程序的扩大等因素预计将推动市场的扩张。 然而,2021 年 3 月,美国食品和药物管理局宣布,来自加州大学 (UC)、旧金山分校、加州大学伯克利分校和加州大学洛杉矶分校的研究人员将使用患者的造血干细胞来测试针对镰状细胞病患者的基因校正疗法细胞疾病。我们同意共同启动一项早期、首次人体临床试验。
由于基因疗法的进步、转基因作物消费量的增加以及获得研究资金的便利,为基因编辑提供工具和服务,北美将在预测期内保持最高的复合年增长率。我们相信它将继续成为对我们的业务做出重大贡献。 美国也在北美市场占据主导地位,这主要是由于公共和私人对基因组研究的资助不断增加。 此外,北美基因组编辑市场受到美国和加拿大罕见疾病流行率上升的推动。 根据美国国立卫生研究院 (NIH) 的数据,超过 7,000 种罕见病影响着 25 至 3000 万美国人。 根据这一统计数据,十分之一的美国人患有罕见病。 因此,这些国家采用新的 DNA 编辑方法是由于对提供有效药物的需求日益增长。
2022 年 5 月,英国议会出台了允许推出基因编辑产品的立法。 遗传技术(精准育种)法案旨在使企业、农民和消费者受益。 该法案目前正处于众议院的报告阶段。
2022 年 2 月,Integrated DNA Technologies 宣布推出 Alt-R HDR Donor Blocks,这是一种提高同源定向修復 (HDR) 率的改进解决方案。 Alt-R HDR Donor Blocks 是 IDT 完整的 Alt-R CRISPR 基因组编辑解决方案组合的最新成员。
2022 年 2 月,Intellia Therapeutics, Inc. 和 Regeneron Pharmaceuticals, Inc. 宣布了 NTLA-2001(针对转甲状腺素蛋白 (Attr) 淀粉样变性的研究性 Crispr 疗法)的第一项正在进行的研究,这是领先的体内基因组编辑候选药物。提供了分阶段临床试验的中期数据。
2022 年 1 月,CRISPR Therapeutics AG 宣布与 Capsida Biotherapeutics Inc. 建立战略合作伙伴关係,以利用 CRISPR/Cas9 技术开髮用于治疗各种疾病的新型基因疗法。Did。 根据协议,CRISPR Therapeutics 将提供基因组编辑专业知识,Capsida 将提供腺相关病毒(AAV)递送技术。
According to Stratistics MRC, the Global Genome Editing Market is accounted for $6.1 billion in 2022 and is expected to reach $18.5 billion by 2028 growing at a CAGR of 20.2% during the forecast period. Gene editing is the use of instruments and processes that significantly change the genetic blueprints of a living thing by making extremely particular alterations to the DNA sequence of a gene. Gene editing strives to modify particular target regions, as opposed to genetic engineering, which randomly combines genetic material into a host genome.
According to the National Center for Advancing Translational Sciences updates form June 2022, the Somatic Cell Genome Editing (SCGE) Program at the National Institutes of Health (NIH) has awarded 24 more grants to researchers across the United States and Canada.
Recent developments have substantially improved genome editing capabilities, enabling the alteration of unique gene sequences in a variety of cell types and model species. In particular, for oncology tests, genome engineering has developed into a potentially game-changing diagnostic tool. Genome engineering was previously used by major research institutions, including those affiliated with the government and universities. This significant movement away from academics and into clinical and diagnostic facilities is primarily driven by the rapid advancement of gene editing technology.
Because genomic instruments have cutting-edge features and functions, they are more expensive, with costs averaging between USD 10 and USD 20 million. As many of these systems are needed by pharmaceutical businesses and research labs, their capital expenditure to acquire several genomic equipment is very significant. It is not practical for small and medium-sized pharmaceutical corporations and research labs to invest substantially in numerous genomics devices.
Players in the genome editing market should have opportunities as the field of customized medicine grows. With the aid of personalized medicine, practitioners may identify a patient's precise needs and then prescribe medications and treatments in response. Due to its potential for cost reductions, better patient compliance, early disease identification, and therapy improvement, the use of customized medicine is expanding globally.
CRISPR-Cas9's off-target consequences are a significant concern. Any off-target nuclease activity may modify these genes and result in oncogenesis since Cas9 generates double-stranded breaks. One to three mismatches in the target can be tolerated by CRISPR-Cas9, which can result in off-target nuclease activity. A significant concern is the high frequency of off-target activity (50%), which refers to alterations at locations other than the planned on-target site. For instance, CRISPR can activate the cancer-causing gene or target the tumor suppressor gene. Due to this undesirable effect, numerous companies that are organizing clinical studies have experienced problems. Clinical trials have been revoked, and regulatory authorities demand more studies to improve the safety of this procedure.
COVID-19 has a favorable effect on the market for genome editing. The COVID-19 epidemic has increased the strain on healthcare systems around the world. Major pharmaceutical and biotechnology companies have increased their investments in vaccine R&D and market players for genome editing as a result of the COVID-19 pandemic. Due to the rising demand for vaccinations and potential antiviral medications, genome editing and engineering technologies are at the forefront of scientific research. Additionally, there has been a moderate impact on the market for genome editing as well as other healthcare services. Many researchers switched their attention to the investigation of this unique virus and the illness it produces after COVID-19 was originally identified.
Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) segment is expected to have moderate growth over the projected period because of increased government financing and initiatives to develop vaccinations, medical technology, pharmaceuticals, and gadgets. In two cases of inherited diseases-one in a patient with TDT (thalassemia) and the other in a patient with SCD (sickle cell disease)-CRISPR-Cas9-based gene editing is being tested, according to a study titled "CRISPR-Cas9 Gene Editing for Sickle Cell Disease and -Thalassemia," published in the New England Journal of Medicine in January 2021. Both patients witnessed early, significant, and long-lasting increases in fetal hemoglobin levels with more than 99% pancellularity throughout the course of the following year after receiving CTX001. Therefore, it is anticipated that over the forecast period, demand for CRISPR technology will increase due to its use in treating diseases including sickle cell disease and beta-thalassemia.
Due to the expanding use of cell line engineering in stem cell-based research, it is predicted that the cell line editing segment will have profitable growth over an extended period. Cell line engineering is widely used for induced pluripotent stem cells (iPSCs), which help to change the genetic material of the cells as a result of rapid improvements. Additionally, advanced gene editing methods, including zinc finger nucleases (ZFNs), CRISPR/Cas, and TALENs, have made cell editing affordable and feasible.
Due to the biotechnology and pharmaceutical industries' strong development trends, North America has acquired a monopoly on the global market for genome editing. During the anticipated period, it is predicted that factors including technological advancements in genome editing, rising product approvals, and expanding R&D procedures would accelerate market expansion. However, the United States Food and Drug Administration provided consent to researchers at the University of California (UC), San Francisco, UC Berkeley, and UC Los Angeles in March 2021 to jointly begin an early-phase, first-in-human clinical trial of a gene correction therapy in sickle cell disease patients using the patient's blood-forming stem cells.
Due to the advancement of gene therapy, growing consumption of genetically modified crops, and easy access to research funding, North America hold the highest CAGR over the forecasted period and will continue to make the largest contribution to businesses offering tools and services for gene editing. Additionally, the U.S. controls the majority of the market in North America, mostly as a result of increased public and private financing for genomics research. Furthermore, the market for genome editing in North America is being driven by the rising prevalence of rare illnesses in the United States and Canada. More than 7,000 rare diseases affect between 25 and 30 million Americans, according to the National Institutes of Health (NIH). According to this statistic, one in ten Americans has a rare disorder. As a result, the adoption of novel DNA editing methods in these nations is driven by the growing need to provide effective medications.
Some of the key players in Genome Editing market include Agilent Technologies Inc., AstraZeneca, Beam Therapeutics, Bluebird Bio, Caribou Biosciences, Inc, Cellectis S.A., Cibus, Recombinetics, Inc., CRISPR Therapeutics AG, Editas Medicine Inc., Egenesis Inc., GenScript Biotech Corporation, GenScript USA Inc., Horizon Discovery Group plc, Integrated DNA Technologies Inc., Intellia Therapeutics, Inc., Lonza Group Ltd, Merck KGaA, New England Biolabs Inc., Origene Technologies Inc., Precision BioSciences Inc., Sangamo Therapeutics Inc., Takara Bio Inc., Tecan Life Sciences , Thermo Fisher Scientific Inc. and Transposagen Biopharmaceuticals Inc.
In May 2022, the English parliament introduced a Bill that would enable the release of genetically edited products. The Genetic Technology (Precision Breeding) Bill aims to benefit companies, farmers, and consumers. The bill is currently under the report stage in the House of Commons.
In February 2022, Integrated DNA Technologies unveiled Alt-R HDR Donor Blocks, an improved solution for increasing homology-directed repair (HDR) rates. Alt-R HDR Donor Blocks are the latest addition to IDT's complete portfolio of Alt-R CRISPR genome editing solutions.
In February 2022, Intellia Therapeutics, Inc. and Regeneron Pharmaceuticals, Inc. announced the positive interim data from an ongoing Phase I clinical study of their lead in vivo genome editing candidate, NTLA-2001 (Investigational Crispr Therapy For Transthyretin (Attr) Amyloidosis).
In January 2022, CRISPR Therapeutics AG announced a strategic partnership with Capsida Biotherapeutics Inc. to develop new gene therapies using the CRISPR/Cas9 technology for the treatment of various diseases. Under the agreement, CRISPR Therapeutics will provide its genome editing expertise, while Capsida will contribute its adeno-associated virus (AAV) delivery technology.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.