市場調查報告書
商品編碼
1155433
全球基因毒性檢測市場規模、份額和行業趨勢分析報告:按產品、類型、應用(製藥/生物技術、食品行業、化妝品行業)、區域展望和預測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,全球基因毒性檢測市場規模預計將達到 24 億美元,預測期內復合年增長率為 13.2%。
此外,這些研究側重於體外藥物發現和定製藥物。除了這些用途之外,對人源化動物模型日益增長的需求將為遺傳毒性測試市場的主要競爭者提供許多機會。遺傳毒性測試用於化妝品、食品、製藥和生物技術行業的各種應用。
由於藥物研究和發現的增加以及藥物基因組學應用的擴大,預計對遺傳毒性信息的需求會增加。這是因為可以評估可能導致染色體損傷和基因改變的物質。遺傳毒性測試領域的一個重要增長因素是全球設施和資金的可用性。
COVID-19 影響分析
製造業停工和因封鎖而實施的旅行限制影響了貨運,而 COVID-19 的迅速傳播導致醫療設備和用品短缺。 COVID-19 並未對基因毒理學中使用的原材料的可用性產生嚴重影響,但由於旅行限制和勞動力短缺導致的與運輸相關的延誤除外。進行了毒性研究以了解病毒突變。此外,許多研究人員正在使用基因毒性來觀察藥物是否對 COVID-19 病毒有效。因此,大流行對遺傳毒性測試市場產生了積極影響。
市場增長因素
企業加大醫藥研發投入
研發活動的主要目的是通過增加臨床前階段物質的吸收來提高 I 期候選治療藥物的接受率。在藥物開發的早期階段,為此積極開展研發活動。因此,越來越需要進行遺傳毒性研究。在藥物進入昂貴的臨床階段之前,早期藥物不斷上升的研發成本預計也將推動體內毒理學技術的使用。
在涉及動物的體內研究中對人性化方法的需求不斷增加
越來越多的生物醫學研究應用正在使用人源化小鼠作為受試者。 2017 年,耶魯大學和傑克遜研究所(美國)的教授獲得了一項為期三年的資助,用於對人源化 MISTRG 模型進行高級研究,以了解人類黑色素瘤的生物學特性,並確定治療靶點。該項目獲得了金獎。康涅狄格生物科學創新基金 (CBIF) 於 2018 年 11 月向傑克遜實驗室和耶魯大學(美國)提供了 700,000 美元的贈款。該獎項支持科學合作,以創建準確反映人類對疾病和癌症治療反應的人性化小鼠模型。
市場約束
複雜終點研究缺乏經過驗證的體外模型
鑑於人類蛋白質和抗體佔所有新藥的一半以上,自身免疫性疾病和免疫激活是藥物開發的關鍵終點。這些藥物仍然只能在動物模型中進行測試。體外遺傳毒性試驗技術不能用於評估繼發感染後在體內引起的反應。也不可能評估身體對短期和長期免疫抑制的恢復能力。
產品展望
基因毒性檢測市場按產品細分為試劑和耗材、化驗和服務。服務部門在 2021 年獲得了基因毒性測試市場最大的收入份額。該領域的擴張是由合同研究組織 (CRO) 通過對該領域的投資不斷增強的戰略雄心推動的。表皮和遺傳毒性檢測服務範圍的擴大也是服務業加速發展的因素之一。例如,Gentronix 宣布將擴大其在皮膚毒性領域的服務範圍,以滿足不斷增長的全球需求。
按類型劃分的前景
遺傳毒性測試市場按類型分為體外和體內。 2021年,基因毒性檢測市場將由體內部分主導。一般來說,醫學研究的一個重要組成部分是體內測試,尤其是在臨床試驗中。體內進行的研究提供了有關物質影響和疾病進展的有用知識。臨床試驗和動物研究是體內研究的兩大類。
應用展望
基因毒性測試市場按應用細分為製藥/生物技術、食品工業、化妝品工業等。 2021 年,製藥和生物技術行業將在基因毒性檢測市場中佔據最大的收入份額。預計增長的驅動因素之一是在藥物開發和研究中廣泛使用遺傳毒性測試。遺傳毒性研究在臨床前階段進行。生物技術和製藥行業預計也將快速增長。鑑於需要測試任何數量的藥物或物質。
區域展望
按地區劃分,對北美、歐洲、亞太地區和 LAMEA 的遺傳毒性測試市場進行了分析。 2021 年,北美地區在基因毒性檢測市場的收入份額最高。該地區的主導地位可歸因於不斷增長的藥物開發和大量的管道支出。此外,該地區主要參與者的存在使得當地製藥和生物技術公司更容易進行基因毒性測試。該行業的很大一部分歸因於基於結構的藥物設計的增長、生命科學研究資金的增加、生物製藥行業的高研發支出以及北美對尖端技術的快速採用。
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