市場調查報告書
商品編碼
1403336
全球毒理學測試市場預測(-2030):按產品、測試類型、方法、技術、最終用戶和地區進行分析Toxicology Testing Market Forecasts to 2030 - Global Analysis By Product, Test Type, Method, Technology, End User and By Geography |
預測期內,全球毒性測試市場規模將以 15.9% 的複合年成長率成長。
毒理學測試涉及評估物質對生物體的影響,以評估對人類健康或環境的潛在危害。確定與化學品、藥品、消費品和環境污染物相關的安全性、毒性和風險。其重要性在於透過識別和減輕風險、支持監管合規性以及指南產品開發來保護公眾健康。
根據 NCBI 的數據,在發現階段合成的每 10,000 種化合物中,只有 250 種達到臨床前階段,並且有一種藥物最終獲得 FDA核准。
增加研發活動
製藥、生物技術和化學製造等行業不斷尋找新的化合物、配方和產品。毒理學測試在這些領域發揮著至關重要的作用,在這些創新技術引入市場之前對其安全性、有效性和潛在風險進行評估。此外,強大的毒性評估可確保符合監管標準,並有助於減少對人類健康和環境的不利影響。隨著消費者需求的變化和技術突破,研發工作不斷增加,徹底的毒性測試的需求也在增加,這對於新藥、化學品和產品的創造和核准至關重要。
資料解釋的複雜性
許多實驗和最尖端科技產生的複雜多樣的資料使得分析具有挑戰性,並且難以轉化為有用的見解。準確評估這種複雜性需要特定的知識、先進的設備和標準化的框架。解釋此類複雜統計資料時的錯誤和不確定性可能會損害風險評估、監管備案和產品開發中的決策,並可能阻礙市場核准和開發。
對替代測試方法的需求不斷成長
試管內測定、類器官、微流體系統和計算模型等先進技術為毒性評估提供了有前途的替代方案,提供更準確、更具成本效益和道德的測試工具。投資研發以檢驗這些替代品並將其商業化的公司將能夠利用這種不斷成長的需求。此外,這些替代品的廣泛採用將簡化測試過程並提供更快的結果,這符合更人性化和可預測的毒性評估的全球趨勢。這樣,就成為了市場拓展的動力。
監管變化
不斷發展和收緊的安全評估法規會影響測試方法、驗證要求和產品核可時間表,需要不斷調整和遵守。監管標準的突然變化或新指南的引入可能會導致不確定性、成本增加和核准過程的延遲。如果無法快速回應新標準,可能會導致違規處罰、競爭力下降和市場准入減少,從而使毒理學測試市場難以保持效率並應對不斷變化的要求,這給企業帶來了挑戰。
由於業務關閉和研究影響,COVID-19 爆發最初導致資源重新轉向與大流行相關的研究。測試和監管流程繼續延遲,導致產品核准延遲。然而,這場危機凸顯並提高了毒性測試在疫苗開發和藥物安全評估中的重要性。業界以遠距工作和虛擬考試作為回應,刺激了創新和數位化。對安全評估意識的提高導致人們重新重視穩健的調查方法,為疫情後的恢復鋪路。
遺傳毒性測試部分預計將在預測期內成為最大的部分
遺傳毒性測試部分估計佔最大佔有率。遺傳毒性測試採用評估物質誘導突變、染色體畸變和 DNA 損傷的能力的分析方法,對於識別潛在的致癌物質和有害化合物至關重要。這些試驗包括Ames試驗、微核試驗、彗星試驗等體外及體內方法,綜合分析遺傳毒性。此外,了解基因毒性有助於確定藥物、化學物質、農藥和消費品的安全性,並為監管評估做出巨大貢獻,以確保人類健康和環境免受有害的基因變化的影響。
體內測試領域預計在預測期內複合年成長率最高。
預計體內測試領域在預測期內將出現良好的成長。體內測試是對整個活體(例如植物或動物)進行的實驗類型。它有助於確定毒性水平、不良反應和潛在的健康危害,為監管和安全評估提供關鍵資料。此外,儘管存在倫理方面的考慮,這些測試對於全面了解物質的生物效應並確保保護人類健康和環境免受潛在有害化合物的侵害至關重要。
由於工業化程度不斷提高、監管指南更加嚴格以及環境安全意識不斷增強,亞太地區在預測期內佔據了最大的市場佔有率。技術進步、製藥和生物技術領域的擴張以及化妝品和食品行業對毒性評估的需求正在推動市場擴張。此外,中國、印度、日本和韓國等國家正在透過擴大經濟和擴大研究舉措做出重要貢獻。推動該市場成長的是對產品安全評估的重視以及對可靠毒性測試方法的需求。
由於嚴格的法律規範、對產品安全的日益關注和技術進步,預計北美在預測期內將實現盈利成長。該地區擁有成熟的製藥和生物技術產業,研發活動不斷增加,因此市場預計將擴大。此外,對化學品暴露的日益關注以及醫療、化妝品和環境監測等各個領域對有效毒性評估的需求正在推動市場成長。美國和加拿大等主要貢獻國家見證了測試方法的不斷進步,推動了創新和市場滲透。
According to Stratistics MRC, the Global Toxicology Testing Market is growing at a CAGR of 15.9% during the forecast period. Toxicology testing involves evaluating the effects of substances on living organisms to assess potential hazards to human health and the environment. It determines the safety, toxicity, and risks associated with chemicals, pharmaceuticals, consumer products, and environmental pollutants. Its importance lies in safeguarding public health by identifying and mitigating risks, aiding regulatory compliance, and guiding product development.
According to NCBI, for every 10,000 compounds synthesized in the discovery phase, only 250 reach the preclinical phase, ultimately resulting in one approved drug by the FDA.
Industries such as pharmaceuticals, biotechnology, and chemical manufacturing are continually exploring novel compounds, formulations, and products. Toxicology testing plays a pivotal role in these sectors by evaluating the safety, efficacy, and potential risks of these innovations before market introduction. Moreover, robust toxicological assessments ensure compliance with regulatory standards and help mitigate adverse effects on human health and the environment. The need for thorough toxicological testing is growing as R&D efforts to address changing consumer demands and technological breakthroughs rise, making it an essential step in the creation and approval of novel medications, chemicals, and products.
The complex and varied data produced by many experiments and cutting-edge technologies presents analytical difficulties that make it difficult to analyze and translate into useful insights. Accurate assessment of this complexity necessitates specific knowledge, advanced instruments, and standardized frameworks. Errors or uncertainty when interpreting these complex statistics can impair decision-making in risk assessments, regulatory filings, and product development, thereby impeding market approvals and developments.
Advanced technologies such as in vitro assays, organoids, microfluidics systems, and computational models offer promising alternatives for toxicology assessments, providing more accurate, cost-effective, and ethical testing avenues. Companies investing in research and development to validate and commercialize these alternative methods stand to capitalize on this growing demand. Moreover, the widespread adoption of these alternatives also streamlines testing processes, fosters quicker results, and aligns with the global trend towards more humane and predictive toxicology evaluations. Thus, there is propelling market expansion.
Evolving and stringent regulations governing safety assessments necessitate continuous adaptation and compliance, impacting testing methodologies, validation requirements, and timelines for product approvals. Sudden shifts in regulatory standards or the introduction of new guidelines may lead to uncertainties, increased costs, and delays in the approval process. Failure to promptly align with new standards could result in non-compliance penalties, reduced competitiveness, and impediments to market access, posing challenges for companies in maintaining efficiency and meeting evolving requirements within the toxicology testing market.
The COVID-19 outbreak initially affected operations and research due to lockdowns and redirected resources towards pandemic-related studies. Delays in trials and regulatory processes ensued, slowing down product approvals. However, the crisis highlighted the criticality of toxicology testing in vaccine development and drug safety assessments, elevating its importance. The industry adapted with remote work and virtual trials, fostering innovation and digitalization. Increased awareness of safety evaluations resulted in a renewed emphasis on robust testing methodologies, paving the way for a resilient recovery post-pandemic.
The genetic toxicology testing segment is estimated to hold the largest share. Genetic toxicology testing employs assays to evaluate a substance's ability to induce mutations, chromosomal aberrations, or DNA damage, which is crucial in identifying potential carcinogens or harmful compounds. These tests encompass in vitro and in vivo methods, such as the Ames test, micronucleus assay, and comet assay, to comprehensively analyze genotoxicity. Moreover, understanding genetic toxicity aids in determining the safety of pharmaceuticals, chemicals, pesticides, and consumer products, contributing significantly to regulatory evaluations, and ensuring the protection of human health and the environment from harmful genetic alterations.
The in-vivo testing segment is anticipated to have lucrative growth during the forecast period. In vivo tests refer to a type of experiment that is carried out within a whole, living organism, such as a plant or animal. It helps to determine toxicity levels, adverse reactions, and potential health hazards, providing crucial data for regulatory assessments and safety evaluations. Moreover, these tests, despite ethical considerations, remain essential for comprehensively understanding the biological effects of substances and ensuring the protection of human health and the environment from potentially harmful compounds.
Asia Pacific commanded the largest market share during the extrapolated period owing to increasing industrialization, stringent regulatory guidelines, and rising awareness regarding environmental safety. Advancements in technology and expanding pharmaceutical and biotechnology sectors, coupled with the demand for toxicological evaluations in the cosmetics and food industries, drive market expansion. Moreover, countries like China, India, Japan, and South Korea are pivotal contributors due to their expanding economies and growing research initiatives. This market's growth is fuelled by the emphasis on product safety assessment and the need for reliable toxicology testing methods.
North America is expected to witness profitable growth over the projection period, due to stringent regulatory frameworks, heightened focus on product safety, and technological advancements. The region's well-established pharmaceutical and biotechnology industries, along with increased R&D activities, propel market expansion. Moreover, rising concerns about chemical exposure, coupled with the need for efficient toxicological evaluations in various sectors, including healthcare, cosmetics, and environmental monitoring, are driving market growth. Key contributors like the United States and Canada witness continual advancements in testing methodologies, fostering innovation and market penetration.
Some of the key players in the Toxicology Testing Market include Abbott Laboratories, Eurofins Scientific, Laboratory Corporation Of America Holdings, Thermo Fisher Scientific, Inc., Danaher Corporation, Agilent Technolgies, Inc., Catalent, Inc., Bio-Rad Laboratories, Inc., Bioivt and Gentronix.
In November 2023, Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences.
In October 2023, Thermo Fisher Scientific, the world leader in serving science, has introduced the Thermo Scientific™ Meridian™ EX System- an electron-beam-based failure analysis solution designed to enable precise fault localization on advanced semiconductor logic technologies.
In September 2023, Thermo Fisher Scientific and National Minority Quality Forum Collaborate to support biopharmaceutical and biotech customers in meeting regulatory expectations to enroll and retain patients in clinical trials who more fully reflect real-world populations experiencing the disease or health condition being studied, including U.S. Food and Drug Administration requirements around diversity action plans.