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市場調査レポート
商品コード
1479062
体外毒性試験の世界市場の評価、製品・サービス別、毒性エンドポイント・試験別、手法別、技術別、エンドユーザー別、地域別、機会、予測(2017年~2031年)In-vitro Toxicology Testing Market Assessment, By Product and Services, By Toxicity Endpoint & Test, By Method, By Technology, By End-user, By Region, Opportunities and Forecast, 2017-2031F |
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カスタマイズ可能
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体外毒性試験の世界市場の評価、製品・サービス別、毒性エンドポイント・試験別、手法別、技術別、エンドユーザー別、地域別、機会、予測(2017年~2031年) |
出版日: 2024年05月14日
発行: Market Xcel - Markets and Data
ページ情報: 英文 245 Pages
納期: 3~5営業日
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世界の体外毒性試験の市場規模は、2023年の142億2,000万米ドルから2031年に307億3,000万米ドルに達すると予測され、予測期間の2024年~2031年にCAGRで10.11%の成長が見込まれます。市場は近年著しい成長を示しており、今後も堅調な拡大ペースを維持すると予測されます。体外毒性試験は、実験室のような管理された環境で、さまざまな化学品、医薬品、化粧品などの多くの製品の試験を可能にします。開発の初期段階におけるこのステップは、化学的に作られた物質が消費者にとって有害でないように、その毒性を知るために必須です。この試験により、動物や人間に投与することなく、化学品、医薬品、化粧品の安全性が評価されます。
市場は、製薬、化学、化粧品産業に直接の影響を与える多くの要因によって成長を示しています。規制分析の増加と、世界中の政府機関が課す厳格な安全性評価が、この巨大な市場の主な成長促進要因です。これらの方策により、市場の産業や企業は厳しい規制を遵守し、製品の安全性を確保する手順を踏むことができます。さらに、ハイスループットや3Dモデル、臓器オンチップモデルなどの技術の進歩により、より信頼性が高く正確な結果が短時間で得られることが証明されています。これは市場に機能への信頼を与え、その成長を支えています。さまざまな技術や医薬品を開発するための業界大手の戦略的パートナーシップが、市場成長を後押ししています。
例えば、2023年6月、製薬、バイオテクノロジー、栄養補助食品市場の世界的製造パートナーであるLonzaは、抗体薬物複合体の開発に向けた臨床段階技術プラットフォームの商業化に注力するSynaffixの買収決定を発表しました。
新薬や化学品の評価への需要の高まり
市場の成長は、新薬や化学品の安全性の評価に対する需要の高まりによって後押しされています。これらの評価は、包括的な毒性の評価を義務付ける厳しい規制要件によって推進されています。体外試験はコスト効率が高く効率的であり、動物実験などの旧来の方法から解放され、製品について迅速でより正確な知見を得ることができます。ハイスループットスクリーニングや臓器オンチップモデルのような技術の進歩は、動物実験のような非倫理的な方法に頼らない自由をもたらしました。これらの新しいモデルは、アッセイの予測精度と妥当性を高めることが証明されています。
さらに、注目を集めた医薬品の開発中止による安全性への懸念の高まりを受けて、医薬品開発プロセス全体を通じて厳格な安全性の評価がますます重要になってきています。体外試験はコストと時間の効率化を実現し、慢性疾患の流行と高齢化の進行に対応するための、より安全で効果的な治療法の開発を促進することで、製薬およびバイオテクノロジー産業の力強い成長を支えています。
2022年10月、Thermo Fisher Scientific Inc.は、ケンタッキー州での事業を拡大し、患者の人生を変える医薬品を提供することで顧客を支援すると発表しました。現在の施設には中央研究所とバイオマーカーサービスがあり、バイオ医薬品の消費者に、医薬品開発を後押しする高品質な実験室業務を提供しています。これにより、同社は世界のさまざまな地域で診断事業を拡大しており、世界的なプレゼンスを高めることに寄与しています。
技術の進歩
アッセイの予測精度と関連性を高めるために、多くの新開発技術がこの市場に導入されています。ハイスループットスクリーニング、3D細胞培養、臓器オンチップなどのモデルは、信頼性の高い毒性評価を可能にし、動物実験モデルのような従来のモデルに依存しないプラットフォームを提供しています。これらの先進のモデルは、複雑な生理学的プロセスや臓器間相互作用を刺激することを可能にし、同時に薬物毒性のよりヒトに関連した理解を提供します。さらに、これらのモデルにAIを統合することで、データの解釈と分析が向上し、潜在的な毒性学的リスクの特定に役立ちます。自動化とロボティクスは、多数の化合物を同時にハイスループットスクリーニングできるようにすることで、体外毒性試験の手順に革命をもたらしました。
当レポートでは、世界の体外毒性試験市場について調査分析し、市場規模と予測、市場力学、主要企業の情勢と見通しなどを提供しています。
Global in-vitro toxicology testing market is projected to witness a CAGR of 10.11% during the forecast period 2024-2031, growing from USD 14.22 billion in 2023 to USD 30.73 billion in 2031. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years. In-vitro toxicology testing enables testing of various chemicals, drugs, cosmetics and many other products in a controlled environment such as a laboratory. This step in the earlier stages of development is mandatory to know the toxicity of any chemically made substance so that it is not harmful for the consumers. This test evaluates the safety of any chemicals, drugs, or cosmetics without subjecting them to any animals or humans.
The in-vitro toxicology testing market is witnessing growth driven by many factors directly affecting the pharmaceutical, chemical and cosmetics industries. Increasing regulatory analysis and stringent safety evaluations imposed by governmental bodies worldwide are the main factors fueling the growth of this huge market. These measures make industries and players in its market comply with strict regulations and enable them to follow a procedure that ensures the safety of the product. Additionally, advancements in technology such as high-throughput and 3D models, organ-on-a-chip models, have proven to offer much more reliable and accurate results in less times. It has given the market confidence to function, hence supporting its growth. Strategic partnerships between industry giants to develop different technologies and drugs is driving the market growth.
For instance, in June 2023, a global manufacturing partner of pharmaceutical, biotech, and nutraceutical markets, Lonza announced its decision to acquire Synaffix which focuses on commercializing its clinical-stage technology platform for developing antibody-drug conjugates.
Rising Demand for Assessment of New Drugs and Chemicals
The growth of in-vitro toxicology testing market is fueled by increasing demand for safety assessments of new drug and chemicals. These assessments are driven by stringent regulatory requirements mandating comprehensive toxicity evaluations. In-vitro testing is cost-effective and efficient and saves us from the old methods such as animal testing and provides us with quick and more accurate insights for our product. Technological advancements like that of high-throughput screening and organ-on-a-chip models have given us the freedom to not rely on unethical methods such as that of animal-testing. These new models have been proven to enhance the predictive accuracy and relevance of assays.
Moreover, rigorous safety assessments have become increasingly important throughout the drug development process following the increased safety concerns for high-profile drug withdrawals. In-vitro testing offers cost and time efficiencies and supports the pharmaceutical and biotechnology industries' robust growth by facilitating the development of safer and more effective therapeutic agents to address the increasing prevalence of chronic diseases and aging populations.
In October 2022, Thermo Fisher Scientific Inc. announced that they will expand operations in Kentucky to help customers by delivering life-changing medicines to patients. The current facility includes central lab and biomarker services, providing biopharma consumers with high-quality lab work to boost drug development. It has helped the company expand its diagnostics business across various regions in the world and helped increase its global presence.
Technological Advancements
Many newly developed technologies have been introduced to this market to enhance the predictive accuracy and relevance of assays. Models such as high-throughput screening, 3D cell culture, and organ-on-a-chip have enabled reliable toxicity assessments giving us the platform to be able to not rely on traditional models like that of animal testing models. These advanced models allow stimulation of complex physiological processes and organ interactions, while providing a more human-relevant understanding of drug toxicity. Additionally, integration of AI with these models improves the data interpretation and analysis which is helpful in identifying any potential toxicological risks. Automation and robotics have revolutionized the procedure of in-vitro toxicology testing by enabling high-throughput screening of a large number of compounds simultaneously.
The adoption of stringent guidelines, standardized protocols, and regulations ensure consistency and reproducibility across assays, strengthening their acceptance by regulatory agencies and pharmaceuticals. It underscores the importance of in-vitro testing in the early stages of drug development and ensures the market of in-vitro toxicology testing is driven by expansion of its applications during pre-clinical trials and drug screening. Thermo Fisher Scientific launched the first of 37 CE-IVD- marked real-time PCR assay kits in April 2023 for infectious diseases. These assays were available in countries recognizing CE marking for use with the CE-IVD marked QS5 Dx, a diagnostic testing platform compliant with the EU's new in-vitro medical devices regulation framework.
Dominance of Cell Culture Technology
In-vitro toxicology testing market is experiencing robust growth due to advancing cell culture technology. The advancements in cell culture technology are driving the in-vitro toxicology testing market with its ability to provide predictive, demonstrative, and reliable results while toxicity screening of a wide range of chemicals, including nanomaterials and airborne materials. The advancements have enabled the expansion of the toxicology testing market as it involves using cells and tissues grown and maintained in controlled environments inside laboratories. Toxic properties of any drug or chemical can be examined easily.
For instance, Xenobiotics can be examined at the basic level of cell without involving the interplay of complex physiological systemic effects. Cellular assays can be easily integrated with technology such as high throughput formats or 3D formats enabling faster screening of large numbers of compounds for potential toxicity. The level of efficiency and accuracy is important on a large scale for pharmaceutical industries, biotechnology companies, or any company developing chemically related substances.
On November 17, 2023, the University of Texas MD Anderson Cancer Centre and Toppan Holdings signed a research collaboration agreement to assess Toppan Holdings' cell culture technology to advance personalized medicine and drug screening initiatives. During the three-year partnership, patient-derived tumor tissue will be used to produce in vitro "cancer patient avatars" utilizing Toppan Holdings' exclusive 3D cell culture technology, Invivoid. The avatars will be given anticancer medications, and the therapeutic usefulness of this technique for determining medication efficacy will be evaluated.
North America Will Dominate In-vitro Toxicology Testing Market Share
North America is anticipated to dominate the global market share over the forecast period in the in-vitro toxicology testing market. Due to the rising burden of chronic diseases and population in North America, healthcare-related engagement is increasing, which encourages more R&D of drugs and vaccines. North America is experiencing a significant increase in different diseases that can be treated or managed with drugs.
For instance, about 2.4 million Canadians have a heart disease according to a report by Canadian Institute for Health Information updated in June 2022. According to a report by Spotlight on Heart failure published in 2022, more than 100,000 Canadians are likely to be diagnosed with heart failure each year. North America, being a hub of healthcare and pharmaceutical companies expedites innovation and product launches which enables growth in research and development activities. Evotec announced in February 2023 about the relocation of its subsidiary, Cyprotex US, LLC, from Watertown to Framingham, U.S. It was done to expand the new facility to enable faster turnaround times.
Future Market Scenario (2024 - 2031F)
Increasing prevalence of various chronic diseases is the biggest reason behind the growth of in-vitro toxicology testing market. For management and treatment of diseases a lot of R&D is required to develop a drug with high clinical efficacy. Rapidly developing healthcare and biotechnological forums present an evergreen opportunity for the global in-vitro toxicology testing market value to grow and multiply manifolds. The scope of the market extends beyond pharmaceutical industry. Scientists, biotechnologists, healthcare professionals, and other healthcare professionals in the industry are dedicated towards introducing advanced technologies and modern diagnostic techniques which will contribute towards market growth.
For instance, Eurofins Scientific in January 2023, expanded its presence in India with the establishment of a new, fully equipped, state-of-the-art laboratory campus in Hyderabad. The lab is aimed at supporting pharma and biotechnology companies in the domain of synthetic organic chemistry, analytical R&D, bioanalytical services, in vivo pharmacology safety toxicology, and formulation R&D.
Key Players Landscape and Outlook
Several companies are expanding their business by planning and adopting new strategies. Companies are forming strategic partnerships to increase their presence in different geographies. Product launches, distribution agreements, mergers and acquisitions, and investments, and partnerships are some of the strategies being followed by leading pharmaceutical and biotechnology companies.
Agilent Technologies (US) acquired e-MSion (US) in March 2023. Through this acquisition, they plan to integrate the e-MSion's ExD cell into portfolio of advanced workflows, instruments, and analytical solutions for biotherapeutic characterization and development.
In August 2023, Evotec announced its partnership with STORM, the world's leading small RNA molecule modifying enzyme drug discovery company. They aimed to present the discovery of STORM's leading clinical candidate, STC-15. STC-15 is a highly selective, orally bioavailable, and RME inhibitor for METTL3, which was developed by both STORM and Evotec.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.