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市場調查報告書
商品編碼
1284279
到 2028 年的基因組編輯市場預測——按產品/服務、技術、應用、最終用戶和地區進行的全球分析Genome Editing Market Forecasts to 2028 - Global Analysis By Product & Service, By Technology, By Application, By End User and By Geography |
根據 Stratistics MRC 的數據,2022 年全球基因組編輯市場規模將達到 61 億美元,預計到 2028 年將達到 185 億美元,預測期內復合年增長率為 20.2%。生長。
基因編輯是使用儀器和過程,通過對基因的 DNA 序列進行高度特異性的改變,從而顯著改變生物體的遺傳藍圖。 與將遺傳物質隨機加入宿主基因組的基因工程不同,基因編輯旨在修改特定的目標區域。
根據國家轉化科學促進中心 2022 年 6 月的更新,美國國立衛生研究院 (NIH) 的體細胞基因組編輯 (SCGE) 計劃向美國和加拿大研究人員授予了 24 項額外資助。
最近的發展大大提高了基因組編輯能力,可以修改各種細胞類型和模型物種中的獨特基因序列。 特別是在腫瘤學測試中,基因組編輯有可能顯著改變診斷工具。 基因組工程已被各國政府和大學等主要研究機構所採用。 然而,基因編輯技術的快速發展正在使研究機構向臨床和診斷機構發生重大轉變。
基因組儀器價格昂貴,由於其最先進的功能和特性,平均價值在 1000 萬美元到 2000 萬美元之間。 由於製藥公司和實驗室需要大量的系統,購買多台基因組儀器的資本投資是巨大的。 中小型藥企和實驗室大量投資基因組儀器是不切實際的。
隨著個性化醫療領域的發展,基因組編輯市場參與者應該看到機遇。 在個性化醫療的幫助下,從業者可以確定患者的確切需求,並據此開出藥物和治療方案。 由於個性化醫療具有節省成本、提高患者依從性、及早發現疾病和改善治療的潛力,因此在全球範圍內的使用正在增長。
CRISPR-Cas9 的脫靶結果備受關注。 因為 Cas9 會產生雙鏈斷裂,脫靶核酸□活性會修飾這些基因並導致腫瘤發生。 CRISPR-Cas9 可以容忍靶標中的一到三個錯配,並可能導致脫靶核酸□活性。 主要關注的是高頻率的脫靶活動 (50%),這是指在預期的目標站點之外進行的修改。 例如,CRISPR 可以激活致癌基因或靶向抑癌基因。 由於這種不良影響,許多組織臨床研究的公司都遇到了問題。 臨床試驗已被取消,監管機構呼籲進行更多研究以提高這種方法的安全性。
COVID-19 正在對基因組編輯市場產生積極影響。 COVID-19 流行病正在增加全球醫療保健系統的壓力。 由於 COVID-19 大流行,大型製藥和生物技術公司正在增加對疫苗研發和基因組編輯市場參與者的投資。 由於對疫苗接種和潛在抗病毒藥物的需求不斷增長,基因組編輯和工程技術處於科學研究的前沿。 此外,不僅對基因組編輯市場,而且對其他醫療保健服務也產生了一定的影響。 發現 COVID-19 後,許多研究人員開始研究這種獨特的病毒及其產生的疾病。
由於政府在免疫、醫療技術、藥物和小工具開發方面的資金增加和努力,成簇常規間隔子短鍊長重複序列 (CRISPR) 片段預計在此期間將適度增長。 2021 年 1 月發表在《新英格蘭醫學雜誌》上的一項題為“針對鐮狀細胞病和地中海貧血的 CRISPR-Cas9 基因編輯”的研究發現了兩例遺傳病:TDT(地中海貧血)患者和 SCD(CRISPR-Cas9-基於基因編輯的技術正在鐮狀細胞病患者中進行測試。 在給予 CTX001 後的第二年,兩名患者的胎兒血紅蛋白水平早期、顯著和長期增加,胰液□99%。 因此,由於 CRISPR 技術在治療鐮狀細胞病和 β-地中海貧血等疾病中的應用,預計在預測期內需求將增長。
隨著幹細胞研究越來越多地使用細胞系工程,細胞系編輯領域預計將實現長期盈利增長。 細胞系工程廣泛用於誘導多能幹細胞 (iPSC),這些幹細胞通過快速改進幫助改變細胞的遺傳物質。 此外,鋅指核酸□ (ZFN)、CRISPR/Cas 和 TALEN 等先進的基因編輯方法使細胞編輯變得經濟實惠且可行。
由於生物技術和製藥行業的強勁發展趨勢,北美在全球基因組編輯市場佔據主導地位。 在預測期內,基因組編輯技術的進步、產品批准的增加以及研發程序的擴大等因素預計將推動市場的擴張。 然而,2021 年 3 月,美國食品和藥物管理局宣布,來自加州大學 (UC)、舊金山分校、加州大學伯克利分校和加州大學洛杉磯分校的研究人員將使用患者的造血幹細胞來測試針對鐮狀細胞病患者的基因校正療法細胞疾病。我們同意共同啟動一項早期、首次人體臨床試驗。
由於基因療法的進步、轉基因作物消費量的增加以及獲得研究資金的便利,為基因編輯提供工具和服務,北美將在預測期內保持最高的複合年增長率。我們相信它將繼續成為對我們的業務做出重大貢獻。 美國也在北美市場佔據主導地位,這主要是由於公共和私人對基因組研究的資助不斷增加。 此外,北美基因組編輯市場受到美國和加拿大罕見疾病流行率上升的推動。 根據美國國立衛生研究院 (NIH) 的數據,超過 7,000 種罕見病影響著 25 至 3000 萬美國人。 根據這一統計數據,十分之一的美國人患有罕見病。 因此,這些國家採用新的 DNA 編輯方法是由於對提供有效藥物的需求日益增長。
2022 年 5 月,英國議會出台了允許推出基因編輯產品的立法。 遺傳技術(精準育種)法案旨在使企業、農民和消費者受益。 該法案目前正處於眾議院的報告階段。
2022 年 2 月,Integrated DNA Technologies 宣布推出 Alt-R HDR Donor Blocks,這是一種提高同源定向修復 (HDR) 率的改進解決方案。 Alt-R HDR Donor Blocks 是 IDT 完整的 Alt-R CRISPR 基因組編輯解決方案組合的最新成員。
2022 年 2 月,Intellia Therapeutics, Inc. 和 Regeneron Pharmaceuticals, Inc. 宣布了 NTLA-2001(針對轉甲狀腺素蛋白 (Attr) 澱粉樣變性的研究性 Crispr 療法)的第一項正在進行的研究,這是領先的體內基因組編輯候選藥物。提供了分階段臨床試驗的中期數據。
2022 年 1 月,CRISPR Therapeutics AG 宣布與 Capsida Biotherapeutics Inc. 建立戰略合作夥伴關係,以利用 CRISPR/Cas9 技術開髮用於治療各種疾病的新型基因療法。Did。 根據協議,CRISPR Therapeutics 將提供基因組編輯專業知識,Capsida 將提供腺相關病毒(AAV)遞送技術。
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.