市场调查报告书
商品编码
1155433
全球基因毒性检测市场规模、份额和行业趋势分析报告:按产品、类型、应用(製药/生物技术、食品行业、化妆品行业)、区域展望和预测2022-2028Global Genetic Toxicology Testing Market Size, Share & Industry Trends Analysis Report By Product, By Type, By Application (Pharmaceutical & Biotechnology, Food Industry, Cosmetics Industry), By Regional Outlook and Forecast, 2022 - 2028 |
到 2028 年,全球基因毒性检测市场规模预计将达到 24 亿美元,预测期内復合年增长率为 13.2%。
此外,这些研究侧重于体外药物发现和定製药物。除了这些用途之外,对人源化动物模型日益增长的需求将为遗传毒性测试市场的主要竞争者提供许多机会。遗传毒性测试用于化妆品、食品、製药和生物技术行业的各种应用。
由于药物研究和发现的增加以及药物基因组学应用的扩大,预计对遗传毒性信息的需求会增加。这是因为可以评估可能导致染色体损伤和基因改变的物质。遗传毒性测试领域的一个重要增长因素是全球设施和资金的可用性。
COVID-19 影响分析
製造业停工和因封锁而实施的旅行限制影响了货运,而 COVID-19 的迅速传播导致医疗设备和用品短缺。 COVID-19 并未对基因毒理学中使用的原材料的可用性产生严重影响,但由于旅行限制和劳动力短缺导致的与运输相关的延误除外。进行了毒性研究以了解病毒突变。此外,许多研究人员正在使用基因毒性来观察药物是否对 COVID-19 病毒有效。因此,大流行对遗传毒性测试市场产生了积极影响。
市场增长因素
企业加大医药研发投入
研发活动的主要目的是通过增加临床前阶段物质的吸收来提高 I 期候选治疗药物的接受率。在药物开发的早期阶段,为此积极开展研发活动。因此,越来越需要进行遗传毒性研究。在药物进入昂贵的临床阶段之前,早期药物不断上升的研发成本预计也将推动体内毒理学技术的使用。
在涉及动物的体内研究中对人性化方法的需求不断增加
越来越多的生物医学研究应用正在使用人源化小鼠作为受试者。 2017 年,耶鲁大学和杰克逊研究所(美国)的教授获得了一项为期三年的资助,用于对人源化 MISTRG 模型进行高级研究,以了解人类黑色素瘤的生物学特性,并确定治疗靶点。该项目获得了金奖。康涅狄格生物科学创新基金 (CBIF) 于 2018 年 11 月向杰克逊实验室和耶鲁大学(美国)提供了 700,000 美元的赠款。该奖项支持科学合作,以创建准确反映人类对疾病和癌症治疗反应的人性化小鼠模型。
市场约束
复杂终点研究缺乏经过验证的体外模型
鑑于人类蛋白质和抗体占所有新药的一半以上,自身免疫性疾病和免疫激活是药物开发的关键终点。这些药物仍然只能在动物模型中进行测试。体外遗传毒性试验技术不能用于评估继发感染后在体内引起的反应。也不可能评估身体对短期和长期免疫抑制的恢復能力。
产品展望
基因毒性检测市场按产品细分为试剂和耗材、化验和服务。服务部门在 2021 年获得了基因毒性测试市场最大的收入份额。该领域的扩张是由合同研究组织 (CRO) 通过对该领域的投资不断增强的战略雄心推动的。表皮和遗传毒性检测服务范围的扩大也是服务业加速发展的因素之一。例如,Gentronix 宣布将扩大其在皮肤毒性领域的服务范围,以满足不断增长的全球需求。
按类型划分的前景
遗传毒性测试市场按类型分为体外和体内。 2021年,基因毒性检测市场将由体内部分主导。一般来说,医学研究的一个重要组成部分是体内测试,尤其是在临床试验中。体内进行的研究提供了有关物质影响和疾病进展的有用知识。临床试验和动物研究是体内研究的两大类。
应用展望
基因毒性测试市场按应用细分为製药/生物技术、食品工业、化妆品工业等。 2021 年,製药和生物技术行业将在基因毒性检测市场中占据最大的收入份额。预计增长的驱动因素之一是在药物开发和研究中广泛使用遗传毒性测试。遗传毒性研究在临床前阶段进行。生物技术和製药行业预计也将快速增长。鑑于需要测试任何数量的药物或物质。
区域展望
按地区划分,对北美、欧洲、亚太地区和 LAMEA 的遗传毒性测试市场进行了分析。 2021 年,北美地区在基因毒性检测市场的收入份额最高。该地区的主导地位可归因于不断增长的药物开发和大量的管道支出。此外,该地区主要参与者的存在使得当地製药和生物技术公司更容易进行基因毒性测试。该行业的很大一部分归因于基于结构的药物设计的增长、生命科学研究资金的增加、生物製药行业的高研发支出以及北美对尖端技术的快速采用。
The Global Genetic Toxicology Testing Market size is expected to reach $2.4 billion by 2028, rising at a market growth of 13.2% CAGR during the forecast period.
The genetic toxicology testing research and observes the consequences of numerous physical, biological, and chemical substances on the heredity of live creatures. Genetic toxicology is the study of the harmful outcomes of DNA damage. These examinations are carried out either to detect chromosomal damage or gene mutation.
Agrochemicals, pharmaceutical impurities, chemicals utilized in the cosmetics industry, pharmaceutical medications, and industrial chemicals are all subjected to toxicological studies. Genetic toxicology is a crucial component of research and development (R&D), where novel medications are developed and designed through a variety of studies. These tests aid in the development of novel medications and vaccinations.
These studies also concentrate on in vitro drug discovery and tailored pharmaceuticals. In addition to these applications, there is a growing need for humanized animal models, which will present a plethora of chances for the major competitors in the genetic toxicology testing market. Testing for genetic toxicity has a variety of uses in the cosmetics, food, pharmaceutical, and biotech industries.
The requirement for genetic toxicology information is predicted to increase due to the increased medication research and discovery as well as the expanding usage of pharmacogenomics. This is because it can evaluate the substances that can cause chromosomal damage or genetic alterations. A significant growth factor in the genetic toxicity testing field is also the development of facilities and the availability of funding globally.
COVID - 19 Impact Analysis
Due to lockdowns that have halted manufacturing operations and enforced travel restrictions, affecting the transit of shipments, the rapid expansion of COVID-19 has resulted in a lack of medical equipment and supplies. COVID-19 has not severely affected the availability of raw materials used in genetic toxicology, with the exception of transportation-related delays brought on by travel restrictions and labor scarcity difficulties. Toxicology research was being conducted to comprehend the virus mutation. Similar to this, many researchers used genotoxic to evaluate how well medications worked on the COVID-19 virus. Therefore, it can be said that the pandemic had a positive impact on the genetic toxicology testing market.
Market Growth Factors
Rising investments in pharmaceutical R&D by companies
By raising the adoption of substances in the preclinical phases, R&D operations primarily aim to raise the overall likelihood of acceptance of Phase I therapeutic candidates. In the initial stages of medication development, intense R&D activities are carried out to accomplish this. The necessity for genetic toxicology research is consequently increased. Before a medicine enters the pricey clinical stages, higher R&D expenditures in the early phases of drug products are also anticipated to enhance the usage of in vivo toxicity techniques.
Increasing demand for humanized methods of in vivo testing including animals
More and more biomedical research applications use humanized mice as test subjects. Professors at Yale University and the Jackson Laboratory (US) were awarded a three-year grant in 2017 to perform advanced research on humanized MISTRG models for understanding the biology of human melanoma along with identifying therapeutic targets. The Connecticut Bioscience Innovation Fund (CBIF) awarded the Jackson Laboratory and Yale University (US) a grant in the amount of USD 700,000 in November 2018. This award supported scientific collaboration to create humanized mouse models that correctly reflect how people react to disease and cancer treatments.
Market Restraining Factors
Insufficient verified in vitro models for complex endpoint research
Given that human proteins and antibodies make over half of the novel medications created, autoimmune disease and immunological activation are crucial endpoints for drug development. These medicinal compounds can only yet be tested in animal models. The use of in vitro genetic toxicology testing techniques does not permit the assessment of the response induced within a body following secondary infection. These techniques can't assess how well a body recovers in response to short-term versus long-term immunosuppression.
Product Outlook
Based on product, the genetic toxicology testing market is classified into reagents & consumables, assays, and services. The service segment procured the largest revenue share in the genetic toxicology testing market in 2021. The segment expansion is being fuelled by Contract Research Organizations' (CROs') growing strategic ambitions through investment in this sector. The rising scope of services in the epidermis and genetic toxicological testing is another factor fuelling the service sector. For instance, in order to meet the growing demand around the world, Gentronix announced that the scope of its services in the field of cutaneous toxicity will be expanding.
Type Outlook
On the basis of type, the genetic toxicology testing market is bifurcated into In Vitro and In Vivo. The in vivo segment procured a significant revenue share in the genetic toxicology testing market in 2021. An essential component of medical research generally is in vivo testing, particularly in clinical trials. Studies conducted in living organisms (in vivo) offer useful knowledge about a substance's effects or the progression of a disease. Clinical trials and animal studies are the two main categories of in vivo testing.
Application Outlook
By application, the genetic toxicology testing market is segmented into pharmaceutical & biotechnology, food industry, cosmetics industry, and other. The pharmaceutical and biotechnology segment witnessed the maximum revenue share in the genetic toxicology testing market in 2021. It is projected that one of the driving forces behind the rise will be the extensive utilization of genotoxicity testing in medicine development and research. Testing for genetic toxicity is done at the preclinical stage. Additionally, it is predicted that the biotechnology and pharmaceutical sector will increase at a fast pace as well. Given that testing is necessary for all quantities of medications and substances.
Regional Outlook
Region-wise, the genetic toxicology testing market is analysed across North America, Europe, Asia Pacific and LAMEA. The North American region witnessed the highest revenue share in the genetic toxicology testing market in 2021. The dominance in the region can be due to rising medication development and significant pipeline spending. Additionally, the presence of important actors in the region makes genotoxicology testing more accessible for local pharmaceutical and biotech firms. The significant share of this industry is due to the growth of structure-based medication designs, rising financing for life sciences research, high R&D costs in the biopharmaceutical industry, and the burgeoning uptake of cutting-edge techniques in North America.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Charles River Laboratories International, Inc., Laboratory Corporation of America Holdings, Eurofins Scientific Group, Jubilant Pharmova Limited., Syngene International Limited, Gentronix Ltd., Inotiv Inc., Creative Bioarray and MB Research Laboratories.
Strategies deployed in Genetic Toxicology Testing Market
Feb-2022: Eurofins Clinical Testing Lux Sarl, a subsidiary of Eurofins Scientific acquired Genetic Testing Service, (Gentis), the market leader in specialized genetic analysis in Vietnam. With the acquisition, Eurofins focused on expanding its reach in Asia and complemented its worldwide network of clinical diagnostics laboratories working on technical and advanced genetic testing.
Jan-2022: Inotiv acquired Integrated Laboratory Systems, a portfolio company of Sier Capital Partners. Through the acquisition, Inotiv aimed to diversify the company's in vivo and in vitro toxicology services, comprising of prominent pathology and toxicology expertise. The acquisition increased the company's services into genomics, bioinformatics, and computational toxicology which further extended its market reach and created effective new cross-selling possibilities.
Sep-2021: Labcorp took over operating assets and intellectual property (IP) of the autoimmune business unit of Myriad Genetics, together with Vectra rheumatoid arthritis (RA) assay. The inclusion of Vectra testing abilities to Labcorp products' range presented the tremendous potential for the company to develop the test's availability and make Labcorp a single-source diagnostics solution for RA providers.
Aug-2021: Inotiv announced the acquisition of Gateway Pharmacology Laboratories, a preclinical contract research organization specializing in cardiovascular pharmacology studies. Following this acquisition, Inotiv augmented its array of in vivo abilities and integrated laboratory support assistance to include cardiovascular and renal pharmacology.
Jul-2021: Gentronix took over Big Blue transgenic mutation assay models by Bioreliance, the largest provider of outsourcing services focused on the rapidly growing biologics sector of the pharmaceutical industry. Through this acquisition, Gentronix aimed to double its revenues and augment its genetic toxicology capabilities in vitro skin and in vitro ocular toxicity testing.
Jun-2021: Charles River Laboratories acquired Vigene Biosciences, a premier, a gene therapy contract development and manufacturing organization. Through the acquisition, Charles River focused on augmenting its extensive cell and gene therapy range by utilizing the gene therapy expertise of Vigene Biosciences. The increased portfolio span incorporated each of the major CDMO platforms - cell therapy, viral vector, and plasmid DNA production.
Jan-2021: Charles River Laboratories partnered with Cypre, a biotechnology company that utilizes 3D hydrogel technology to advance the knowledge of the tumor microenvironment and predict therapeutic usefulness. This partnership helped the former company's clients with access to Falcon-X, Cypre's proprietary 3D tumor model platform. Moreover, the partnership broadened Charles River's 3D in vitro testing services to further optimize immuno-oncological methods for its clients.
Jan-2019: Charles River Laboratories formed an agreement with Toxys, a company that provides innovative in vitro toxicity screening solutions. Under the agreement, CRL focused on providing ToxTracker, a range of assays that enable rapid carcinogenicity toxicity hazard identification in novel and existing drugs, chemicals, and other substances in North America. The agreement equipped CRL's client base with the utilization of the ToxTracker assay that can assist in mitigating the risk of regulatory rejection by illustrating the exact mechanism of genotoxicity.
Market Segments covered in the Report:
By Product
By Type
By Application
By Geography
Companies Profiled
Unique Offerings from KBV Research
List of Figures