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市場調査レポート
商品コード
1540986
ADME毒性試験市場レポート:技術、製品タイプ、手法、用途、地域別、2024年~2032年ADME Toxicology Testing Market Report by Technology, Product Type, Method, Application, and Region 2024-2032 |
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ADME毒性試験市場レポート:技術、製品タイプ、手法、用途、地域別、2024年~2032年 |
出版日: 2024年08月10日
発行: IMARC
ページ情報: 英文 145 Pages
納期: 2~3営業日
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世界のADME毒性試験市場規模は2023年に92億米ドルに達しました。今後、IMARC Groupは、市場は2032年までに261億米ドルに達し、2024年から2032年の間に11.9%の成長率(CAGR)を示すと予測しています。同市場は、より安全で効果的な医薬品に対する需要の増加、医薬品開発に対する規制要件の厳格化、個別化医療の需要、試験管内検査法の進歩などにより、緩やかな成長を遂げています。
市場の成長と規模世界のADME毒性試験市場は緩やかな成長を遂げています。医薬品の研究開発および医薬品の安全性評価に対する需要の増加が市場を牽引しています。
技術の進歩:技術の進歩により、より高度で正確なADME毒性試験法が開発されています。自動化、ハイスループットスクリーニング、インシリコモデリングの統合により、試験の効率と精度が向上しています。臓器オンチップや3D細胞培養システムのような新たな技術は、将来ADME検査に革命をもたらす態勢を整えています。
産業への応用:ADME毒物学試験は、医薬品開発や安全性評価のために製薬会社やバイオテクノロジー企業で広く応用されています。また、化学物質が生態系に与える影響を評価するための環境毒性試験にも利用されています。開発業務受託機関(CRO)は、さまざまな業界にADME試験サービスを提供する上で極めて重要な役割を果たしています。
地理的動向:北米は、製薬会社や研究機関の存在感が強く、ADME毒性試験において重要な位置を占めています。アジア太平洋は、インドや中国のような国々への医薬品開発プロセスのアウトソーシングに牽引され、急成長を遂げています。
競合情勢:市場の競争は激化しており、主要企業は技術革新、M&A(合併・買収)、世界展開に注力しています。これらの戦略は、製品ポートフォリオを強化し、業界の特定のニーズを満たし、進化する市場の課題に対処することを目的としています。
課題と機会:課題には、高度なADME試験技術の高コストとデータ解釈の複雑さが含まれます。機会としては、食品や化粧品業界など医薬品以外の分野への応用拡大や、専門的なADMEサービスの提供が挙げられます。
将来の展望テクノロジーの進歩、個別化医療に対する需要の高まり、様々な産業における応用の拡大により、ADME毒性試験市場は継続的な成長を遂げるものと思われます。業界と規制機関の連携が今後の情勢を形成し、医薬品や化学物質の安全性と有効性が確保されます。
慢性疾患の蔓延
ADME毒性試験市場を推進する主な要因のひとつは、世界の慢性疾患の有病率の上昇です。がん、糖尿病、心血管疾患などの慢性疾患は、新薬の広範な研究開発を必要とします。ADME毒性試験は、こうした医薬品の安全性と有効性を確保することで、このプロセスにおいて重要な役割を果たしています。これらの疾患が世界的に重大な健康課題をもたらし続けているため、潜在的な副作用を軽減し、患者の安全性を確保するための広範な医薬品試験の必要性が高まっています。ADME毒性試験は、薬物が体内でどのように吸収、分布、代謝、排泄されるかについての貴重な知見を提供し、慢性疾患に対する有効かつ安全な医薬品の開発に不可欠です。したがって、慢性疾患と闘うための新たな医薬品ソリューションに対するこの継続的な需要は、市場成長の重要な促進要因となっています。
技術の進歩
ADME毒性試験市場は、技術の急速な進歩からも恩恵を受けています。in vitroやin silicoモデルのような最新の試験法は、従来のin vivo法よりもますます採用されるようになっており、より正確で効率的、かつ費用対効果の高い試験オプションを提供しています。こうした革新的なアプローチは、動物実験への依存を減らし、倫理基準に合致し、より迅速な結果をもたらします。また、技術の進歩により、複数の化合物を同時に試験できるハイスループット・スクリーニング法の開発が可能になり、医薬品開発プロセスが大幅に加速されています。さらに、計算生物学とバイオインフォマティクスの進歩により、ADME毒性試験の予測精度が向上し、信頼性と効率が高まっています。
規制遵守の高まり
医薬品承認のためにFDAやEMAなどの当局が設定する厳格な規制基準も、ADME毒性試験市場の重要な促進要因です。これらの規制機関は、新薬の臨床使用が承認される前に、新薬の徹底的な安全性評価を義務付けています。ADME毒性試験は、人体に対する薬剤の潜在的な毒性学的影響に関する重要なデータを提供するため、これらの評価には不可欠です。新しい医薬品化合物の複雑さが増し、薬剤誘発毒性に対する意識が高まるにつれて、規制要件はより厳格になっています。このため、製薬企業やバイオテクノロジー企業は、これらの規制への準拠を確実にするため、ADME毒性学的試験にさらなる投資を余儀なくされています。
製薬産業の拡大
ADMEを推進する主な要因の一つは、製薬セクターにおける研究開発費の大幅な増加です。企業が新薬開発に多くの投資を行うにつれて、医薬品の安全性と有効性を確保するための包括的なADME毒性試験の必要性が高まっています。この試験は、潜在的な毒性作用や代謝経路を医薬品開発プロセスの早い段階で特定し、後期段階での失敗のリスクを低減する上で極めて重要です。さらに、新規化合物の複雑化に伴い、これらの化合物の体内での挙動を理解するための高度なADME毒性学試験への依存度が高まっています。この動向は、医薬品が承認される前に徹底的な毒性試験を義務付けている厳格な規制要件によってさらに強化され、この市場セグメントの需要を促進しています。
The global ADME toxicology testing market size reached US$ 9.2 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 26.1 Billion by 2032, exhibiting a growth rate (CAGR) of 11.9% during 2024-2032. The market is experiencing moderate growth driven by the increasing demand for safer and more effective pharmaceuticals, stringent regulatory requirements for drug development, demand for personalized medicine, and advancements in in vitro testing methods.
Market Growth and Size: The global ADME toxicology testing market is experiencing moderate growth. It is driven by increasing pharmaceutical R&D and drug safety assessment demands.
Technological Advancements: Technological advancements have led to the development of more sophisticated and accurate ADME toxicology testing methods. The integration of automation, high-throughput screening, and in-silico modeling is enhancing testing efficiency and accuracy. Emerging technologies like organ-on-a-chip and 3D cell culture systems are poised to revolutionize ADME testing in the future.
Industry Applications: ADME toxicology testing is extensively applied in pharmaceutical and biotechnology companies for drug development and safety evaluation. It is also used in environmental toxicology studies to assess the impact of chemicals on ecosystems. Contract research organizations (CROs) play a pivotal role in providing ADME testing services to various industries.
Geographical Trends: North America holds a significant position in the ADME toxicology testing market, with a robust presence of pharmaceutical companies and research institutions. Asia-Pacific is witnessing rapid growth, driven by the outsourcing of drug development processes to countries like India and China.
Competitive Landscape: The market is characterized by intense competition with key players focusing on innovation, mergers and acquisitions (M&A), and expanding their global footprint. These strategies aim to enhance product portfolios, meet specific industry needs, and address the challenges of an evolving market.
Challenges and Opportunities: Challenges include the high cost of advanced ADME testing technologies and the complexity of interpreting data. Opportunities lie in expanding applications beyond pharmaceuticals, such as in the food and cosmetics industries, and in offering specialized ADME services.
Future Outlook: The ADME toxicology testing market is poised for continued growth, driven by advancements in technology, increasing demand for personalized medicine, and expanding applications in various industries. Collaboration between industry and regulatory bodies will shape the future landscape, ensuring the safety and efficacy of drugs and chemicals.
Increasing prevalence of chronic diseases
One of the major factors propelling the ADME toxicology testing market is the rising prevalence of chronic diseases worldwide. Chronic illnesses like cancer, diabetes, and cardiovascular diseases necessitate extensive research and development of new drugs. ADME toxicology testing plays a crucial role in this process by ensuring the safety and effectiveness of these pharmaceuticals. As these diseases continue to pose significant health challenges globally, there is a growing need for extensive drug testing to mitigate potential side effects and ensure patient safety. The ADME toxicology tests provide valuable insights into how drugs are absorbed, distributed, metabolized, and excreted by the body, which is vital in the development of effective and safe medications for chronic diseases. This ongoing demand for new pharmaceutical solutions to combat chronic conditions is, therefore, a significant driver for the growth of the market.
Technological advancements
The ADME toxicology testing market is also benefiting from rapid advancements in technology. Modern testing methods, such as in vitro and in silico models, are increasingly being adopted over traditional in vivo methods, offering more accurate, efficient, and cost-effective testing options. These innovative approaches reduce the reliance on animal testing, align with ethical standards, and provide faster results. Technological advancements have also enabled the development of high-throughput screening methods, which allow for the simultaneous testing of multiple drug compounds, significantly accelerating the drug development process. Furthermore, advancements in computational biology and bioinformatics are enhancing the predictive accuracy of ADME toxicology tests, thereby increasing their reliability and efficiency.
Increasing regulatory compliance
The stringent regulatory standards set by authorities like the FDA and EMA for drug approval are another significant driver for the ADME Toxicology Testing market. These regulatory bodies mandate thorough safety assessments of new drug entities before they can be approved for clinical use. ADME toxicology testing is integral to these assessments, as it provides crucial data on a drug's potential toxicological effects on the human body. The increasing complexity of new pharmaceutical compounds and the heightened awareness of drug-induced toxicities have led to more rigorous regulatory requirements. This has compelled pharmaceutical and biotechnology companies to invest more in ADME toxicology testing to ensure compliance with these regulations.
Expanding pharmaceutical industry
One of the primary factors driving the ADME is the significant increase in research and development expenditure in the pharmaceutical sector. As companies invest more in developing new drugs, there is a heightened need for comprehensive ADME toxicology testing to ensure drug safety and efficacy. This testing is critical in identifying potential toxic effects and metabolic pathways early in the drug development process, thereby reducing the risk of late-stage failures. Moreover, with the growing complexity of new pharmaceutical compounds, there is an increased reliance on sophisticated ADME toxicology studies to understand the behavior of these compounds within the body. This trend is further bolstered by stringent regulatory requirements that mandate thorough toxicology testing before a drug can be approved, thereby driving demand in this market segment.
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on technology, product type, method, and application.
Cell Culture
High Throughput Screening
Molecular Imaging
OMICS Technology
Others
Cell culture accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the market based on the technology. This includes cell culture, high throughput screening, molecular imaging, omics technology, and others. According to the report, cell culture represented the largest segment.
The cell culture segment accounts for the largest share in the ADME Toxicology Testing market. This segment involves the cultivation of cells in controlled laboratory conditions to study their behavior in response to various drugs and chemicals. Cell culture-based ADME testing provides valuable insights into drug absorption, metabolism, and toxicity within living cells, making it an essential component of preclinical drug development. It allows researchers to evaluate drug candidates in a biological context, providing data on cell viability, drug interactions, and potential adverse effects, ultimately aiding in the selection of safe and efficacious drug candidates.
High throughput screening (HTS) is a crucial segment in the ADME Toxicology Testing market, characterized by the automated and rapid screening of a large number of compounds to identify potential drug candidates. HTS allows for the efficient evaluation of drug metabolism, toxicity, and efficacy by assessing the interactions between compounds and cellular targets on a high-throughput scale. This segment plays a vital role in streamlining drug discovery processes, reducing costs, and expediting the identification of promising drug candidates.
Molecular imaging is another significant segment within the ADME Toxicology Testing market. It involves the use of advanced imaging technologies, such as positron emission tomography (PET) and magnetic resonance imaging (MRI), to visualize and track molecular processes within living organisms. Molecular imaging allows researchers to gain real-time insights into drug distribution, tissue uptake, and metabolic changes, facilitating the assessment of drug behavior at the molecular level. This segment is particularly valuable in drug development and personalized medicine, where precise molecular information is essential for decision-making.
The OMICS technology segment encompasses a range of advanced analytical techniques, including genomics, proteomics, metabolomics, and transcriptomics. These technologies allow for comprehensive profiling of biological molecules and pathways affected by drugs and chemicals. OMICS-based ADME testing provides a holistic understanding of how compounds interact with biological systems, enabling researchers to identify biomarkers, assess drug responses, and predict potential toxicities. This segment is at the forefront of personalized medicine, where individual patient profiles are used to tailor drug therapies.
Instruments
Software Solutions
Assay Systems
Reagents
Others
Software solutions dominate the market
A detailed breakup and analysis of the market based on the product type have also been provided in the report. This includes instruments, software solutions, assay systems, reagents, and others. According to the report, software solutions accounted for the largest market share.
The market segmentation based on instruments includes a wide array of laboratory equipment and tools essential for ADME toxicology testing. This segment encompasses high-throughput screening (HTS) systems, liquid chromatography-mass spectrometry (LC-MS) instruments, and various analytical instruments used for studying drug metabolism and pharmacokinetics. These instruments enable researchers to conduct precise and efficient testing, making them indispensable in the ADME testing process.
Software solutions represent the largest segment within the ADME toxicology testing market. These software platforms play a pivotal role in data analysis, modeling, and prediction. They facilitate the interpretation of complex test results, provide insights into drug interactions, and aid in predicting toxicity levels. Advanced software solutions incorporate artificial intelligence (AI) and machine learning algorithms, enhancing their capabilities for predictive toxicology and personalized medicine. The growing emphasis on data-driven decision-making and the need for efficient data management have propelled the dominance of software solutions in the market.
Assay systems are an integral part of ADME toxicology testing, encompassing a wide range of assays used to evaluate drug metabolism, drug-drug interactions, and toxicity. These systems include in vitro and in vivo assays, cell-based assays, and enzyme-linked immunosorbent assays (ELISA). Assay systems are essential for determining the pharmacokinetics and pharmacodynamics of drugs, making them crucial components of ADME testing.
The reagents segment includes a variety of chemicals and compounds used in ADME toxicology testing. These reagents are vital for preparing samples, conducting assays, and assessing toxicity. They encompass substances such as cell culture media, buffers, substrates, and markers. Reagents play a critical role in ensuring the accuracy and reliability of test results, making them indispensable components of the ADME testing process.
In-Vivo
In-Vitro
In-Silica
Others
In-vivo exhibits a clear dominance in market
A detailed breakup and analysis of the market based on the method have also been provided in the report. This includes in-vivo, in-vitro, in-silica, and others. According to the report, in-vivo accounted for the largest market share.
In-vivo ADME toxicology testing involves studying the effects of drugs or chemicals within a living organism, typically animals. This segment comprises experiments conducted in animals like rodents or non-human primates to assess various pharmacokinetic and toxicological parameters. In-Vivo testing is considered the gold standard for evaluating drug safety and efficacy, especially in the early stages of drug development. It provides crucial insights into how a substance behaves within a complex biological system. The In-Vivo segment remains the largest due to regulatory requirements that often mandate animal testing before human trials, making it a fundamental component of pharmaceutical research and development.
In-vitro ADME toxicology testing involves conducting experiments in controlled laboratory environments using isolated cells, tissues, or biological molecules. This segment includes a wide range of assays and methodologies that allow researchers to assess drug metabolism, toxicity, and interactions without the need for live animals. In-Vitro testing offers several advantages, such as reduced ethical concerns, cost-effectiveness, and the ability to perform high-throughput screening. It is increasingly gaining importance as an alternative to animal testing and is widely utilized in the pharmaceutical industry for early-stage drug screening and toxicity profiling.
In-silica ADME toxicology testing, also known as computational or in-silico modeling, relies on computer simulations and mathematical models to predict the pharmacokinetic and toxicological properties of drugs or chemicals. This segment involves leveraging advanced algorithms and data-driven approaches to analyze molecular structures, predict metabolic pathways, and assess toxicity risks. In-Silica testing is a rapidly evolving field driven by technological advancements and the need to reduce the time and cost associated with traditional testing methods. It is particularly valuable for virtual screening of potential drug candidates, facilitating the identification of lead compounds and optimizing their properties. While currently a smaller segment, In-Silica testing is poised for significant growth as computational techniques become increasingly sophisticated and integrated into drug development pipelines.
Systemic Toxicity
Renal Toxicity
Hepatotoxicity
Neurotoxicity
Others
Systemic toxicity represents the leading market segment
The report has provided a detailed breakup and analysis of the market based on the application. This includes systemic toxicity, renal toxicity, hepatotoxicity, neurotoxicity, and others. According to the report, systemic toxicity represented the largest segment.
The systemic toxicity segment holds the largest share in the ADME toxicology testing market. This segment encompasses assessments of the potential toxicity of substances that affect the entire organism or system, reflecting their ability to cause harm or adverse effects throughout the body. Systemic toxicity testing is vital in pharmaceutical and chemical industries to evaluate the overall safety of drugs and compounds before they are introduced into clinical trials or marketed to the public. Comprehensive testing in this segment involves a range of in vitro and in vivo assays to assess the impact of substances on vital organs, immune responses, and overall physiological functions, ensuring that potentially harmful compounds are identified and their risks mitigated before reaching consumers.
Renal toxicity, focusing on the evaluation of substances' adverse effects on the kidneys, is a crucial segment in ADME toxicology testing. The kidneys play a pivotal role in filtering waste products from the blood, and any damage to renal function can have severe health implications. Testing for renal toxicity involves a battery of assays to assess markers of kidney function, including glomerular filtration rate (GFR), tubular function, and markers of kidney injury. Identifying compounds with potential renal toxicity is essential in drug development, as it helps prevent nephrotoxicity-related adverse events in clinical trials and post-market surveillance.
Hepatotoxicity, referring to the potential harm caused to the liver by substances, is another critical segment in ADME toxicology testing. The liver is a central organ in drug metabolism and detoxification. Assessing hepatotoxicity involves a range of in vitro and in vivo tests to evaluate the impact of compounds on liver function, including hepatocyte integrity, enzyme levels, and liver histopathology. Early detection of hepatotoxicity is crucial in pharmaceutical research, as liver damage can lead to severe drug-induced liver injury and withdrawal of potentially harmful drugs from the market.
Neurotoxicity testing focuses on assessing the adverse effects of substances on the nervous system, including the brain and peripheral nerves. This segment plays a vital role in drug development, as neurotoxicity can lead to serious central nervous system-related side effects. Tests for neurotoxicity encompass a wide range of in vitro and in vivo models, evaluating parameters such as neuronal function, neurotransmitter release, and neurobehavioral changes. Identifying compounds with neurotoxic potential helps in optimizing drug safety profiles and avoiding neurological adverse events during clinical trials and patient use.
North America
United States
Canada
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Asia Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
North America leads the market, accounting for the largest ADME toxicology testing market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
In North America, the ADME toxicology testing market is the largest, driven primarily by the extensive pharmaceutical and biotechnology industry in the United States and Canada. The region's robust research and development activities, stringent regulatory requirements, and the presence of major pharmaceutical companies contribute significantly to market growth. Moreover, the increasing demand for personalized medicine and precision drug development is propelling the adoption of ADME toxicology testing in this region. Technological advancements and collaborations between industry and academic institutions further enhance the market's expansion.
Europe is a significant market for ADME toxicology testing, driven by the pharmaceutical and biotechnology sectors in countries like the United Kingdom, Germany, France, and Switzerland. Stringent regulatory frameworks in the European Union necessitate rigorous drug safety assessments, fueling the demand for ADME testing services. Additionally, the growing focus on environmental toxicology and chemical safety evaluation contributes to the market's growth. Technological advancements in the region, along with increasing research initiatives, continue to shape the European ADME testing market.
The Asia Pacific region is experiencing rapid growth in the ADME toxicology testing market, primarily due to the outsourcing of drug development processes to countries like India and China. The presence of a skilled workforce, lower operational costs, and a burgeoning pharmaceutical and biotechnology industry are driving factors. Additionally, the region's increasing research and development investments, along with growing awareness of precision medicine, are fueling market expansion. Collaborations between global pharmaceutical giants and local research organizations further contribute to the growth of the Asia Pacific ADME testing market.
Latin America represents a growing market for ADME toxicology testing, driven by the expansion of pharmaceutical and biotechnology activities in countries like Brazil and Mexico. The region's evolving regulatory landscape and increased emphasis on drug safety are fostering the adoption of ADME testing services. Additionally, the rising demand for personalized medicine and a greater focus on clinical research contribute to market growth. Partnerships and collaborations between local CROs and international pharmaceutical companies are expected to drive further expansion in Latin America.
The Middle East and Africa region are emerging markets for ADME toxicology testing, characterized by increasing pharmaceutical investments and research activities. Countries like the United Arab Emirates and South Africa are at the forefront of market growth, driven by a growing pharmaceutical industry and a focus on healthcare infrastructure development. While the market in this region is smaller compared to others, it is anticipated to witness steady growth as pharmaceutical research and development efforts expand and regulatory requirements become more stringent. The adoption of advanced ADME testing technologies is expected to gain traction in the Middle East and Africa, supporting market development.
Key players in the market are actively engaged in strategic initiatives to maintain their competitive edge. These initiatives include mergers and acquisitions to expand service portfolios, collaborations with pharmaceutical companies for early-stage toxicity assessment, and the development of cutting-edge technologies for ADME testing. Additionally, market leaders are focusing on geographic expansion, especially in high-growth regions like Asia-Pacific and Latin America, to tap into emerging markets. Furthermore, investments in research and development are aimed at enhancing the accuracy and efficiency of ADME testing methodologies, catering to the evolving needs of the pharmaceutical, biotechnology, and environmental sectors.
Agilent Technologies Inc.
Beckman Coulter Inc. (Danaher Corporation)
Bioivt LLC
Bio-Rad Laboratories Inc.
Charles River Laboratories International Inc.
Cyprotex Plc (Evotec AG)
Molecular Discovery Ltd.
Perkinelmer Inc.
Promega Corporation
Thermo Fisher Scientific, Inc.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
March 2023: Agilent Technologies' acquisition of e-MSion, the developer of ExD cell technology, represents a strategic move by Agilent to strengthen its position in the field of mass spectrometry and analytical chemistry. ExD cell technology is known for its capabilities in high-resolution mass spectrometry and ion mobility, making it a valuable addition to Agilent's portfolio. This acquisition aligns with Agilent's commitment to delivering innovative solutions to its customers in the life sciences and chemical analysis sectors.
January 2020: Thermo Fisher Scientific's introduction of a next-generation, compressor-free plate sealer in the biotechnology and pharmaceutical sectors signifies a significant advancement in laboratory automation. This innovation streamlines plate sealing processes and also minimizes the need for operator maintenance, enhancing overall operational efficiency. The plate sealer's customization features cater to the diverse requirements of research laboratories, offering flexibility and adaptability for a range of applications. Its integration capabilities with robotic systems further boost productivity, making it a valuable tool for high-throughput environments. Thermo Fisher Scientific's commitment to providing cutting-edge solutions aligns with the industry's demand for improved reliability, precision, and user-friendly operation in laboratory automation, ultimately benefiting research, drug discovery, and academic projects.