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市場調査レポート
商品コード
1155433
遺伝子毒性試験の世界市場規模、シェア、産業動向分析レポート:製品別、タイプ別、用途別(医薬品・バイオテクノロジー、食品産業、化粧品産業)、地域別展望と予測、2022年~2028年Global 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 |
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遺伝子毒性試験の世界市場規模、シェア、産業動向分析レポート:製品別、タイプ別、用途別(医薬品・バイオテクノロジー、食品産業、化粧品産業)、地域別展望と予測、2022年~2028年 |
出版日: 2022年10月31日
発行: KBV Research
ページ情報: 英文 199 Pages
納期: 即納可能
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遺伝子毒性試験の世界市場規模は、2028年までに24億米ドルに達し、予測期間中に13.2%のCAGRの市場成長率で上昇すると予測されています。
また、これらの研究は、試験管内創薬やテーラーメイド医薬品に集中しています。これらの用途に加えて、ヒト化動物モデルのニーズが高まっており、遺伝子毒性試験市場の主要な競合他社に多くのチャンスを与えることになるでしょう。遺伝子毒性試験は、化粧品、食品、医薬品、バイオテクノロジー産業でさまざまな用途に利用されています。
遺伝毒性情報の要件は、薬物研究・発見の増加やファーマコゲノミクスの利用拡大により増加することが予測されます。これは、染色体損傷や遺伝子変化を引き起こす可能性のある物質を評価することができるからです。また、遺伝子毒性試験分野の重要な成長要因は、世界の施設の整備と資金の確保です。
COVID-19影響度分析
ロックダウンによる製造業の操業停止や渡航制限の実施により、貨物の輸送に影響が出ており、COVID-19の急速な拡大により、医療機器や物資の不足が発生しています。COVID-19は、渡航制限と労働力不足による輸送関連の遅延を除いて、遺伝子毒性学に使用される原材料の入手に深刻な影響を及ぼしていないです。毒性研究は、ウイルスの変異を理解するために行われていました。また、COVID-19のウイルスに薬が効くかどうかを調べるために、遺伝毒性を利用する研究者も少なくなかっています。したがって、このパンデミックは、遺伝子毒性試験市場にプラスの影響を与えたといえます。
市場の成長要因
企業による医薬品研究開発への投資の増加
研究開発事業は、前臨床段階での物質の採用率を高めることで、フェーズIの治療薬候補が受け入れられる可能性を高めることを主目的としています。医薬品開発の初期段階においては、そのための研究開発活動が活発に行われています。そのため、遺伝毒性研究の必要性が高まっています。医薬品が高価な臨床段階に入る前に、医薬品の初期段階における研究開発費の増加は、in vivo毒性技術の利用を促進するとも予想されています。
動物を含むin vivo試験におけるヒト化手法の需要の増加
ヒト化したマウスを被験者として使用する生物医学研究用途がますます増えています。エール大学とジャクソン研究所(米国)の教授は、治療標的の特定とともに、ヒト黒色腫の生物学を理解するためのヒト化MISTRGモデルに関する高度な研究を行うために、2017年に3年間の助成金を授与されました。コネティカット・バイオサイエンス・イノベーションファンド(CBIF)は、2018年11月にジャクソン研究所とイェール大学(米国)に対して、70万米ドルの助成金を授与しました。この賞は、病気やがん治療に対する人の反応を正しく反映するヒト化マウスモデルを作成するための科学的共同研究を支援するものです。
市場の抑制要因
複雑なエンドポイント研究のための検証済みin vitroモデルの不足
ヒトのタンパク質や抗体が作られる新規医薬品の半分以上を占めることを考えると、自己免疫疾患や免疫活性化は医薬品開発にとって極めて重要なエンドポイントです。これらの医薬品は、まだ動物モデルでしか試験することができません。試験管内の遺伝子毒性試験技術を使用しても、二次感染後に体内で引き起こされる反応を評価することはできないです。また、短期的な免疫抑制と長期的な免疫抑制に対する身体の回復を評価することもできないです。
製品の展望
遺伝子毒性試験市場は、製品によって試薬・消耗品、アッセイ、サービスに分類されます。サービスセグメントは、2021年の遺伝子毒性試験市場で最大の収益シェアを調達しました。このセグメントの拡大は、この分野への投資を通じた契約研究機関(CRO)の戦略的野心の高まりによって促進されています。表皮・遺伝子毒性試験におけるサービス範囲の拡大も、サービス部門を加速させる要因の一つです。例えば、Gentronix社は、世界の需要増に対応するため、皮膚毒性分野のサービス範囲を拡大することを発表しています。
タイプ別展望
遺伝子毒性試験市場は、タイプ別にIn VitroとIn Vivoに二分されます。2021年の遺伝子毒性試験市場では、インビボ部門が大きな収益シェアを獲得しました。一般的に医学研究の不可欠な要素は、特に臨床試験におけるin vivo試験です。生体内(in vivo)で行われる研究は、物質の効果や病気の進行について有用な知識を提供します。臨床試験と動物実験がin vivo試験の2つの主要なカテゴリーです。
アプリケーションの展望
遺伝子毒性試験市場は、用途別に製薬・バイオテクノロジー、食品産業、化粧品産業、その他に区分されます。2021年の遺伝子毒性試験市場では、製薬・バイオテクノロジー分野が最大の収益シェアを示しています。上昇の原動力の1つは、医薬品の開発や研究における遺伝子毒性試験の広範な活用であると予測されます。遺伝子毒性試験は前臨床段階で行われます。また、バイオテクノロジーや製薬分野も速いペースで増加すると予測されています。あらゆる量の薬や物質に対して試験が必要であることを考えると。
地域別の展望
地域別では、遺伝子毒性試験市場は、北米、欧州、アジア太平洋およびLAMEAで分析されます。北米地域は、2021年に遺伝子毒性試験市場で最も高い収益シェアを示しました。同地域の優位性は、薬物開発の上昇と重要なパイプラインの支出に起因する可能性があります。さらに、この地域の重要なアクターの存在は、地元の製薬会社やバイオテクノロジー企業にとって、遺伝子毒性試験をより身近なものにしています。この業界の大きなシェアは、構造ベースの投薬設計の成長、生命科学研究への融資の増加、生物医薬品業界における高い研究開発費、北米における最先端技術の急速な取り込みに起因しています。
List of Figures
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
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