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市場調查報告書
商品編碼
1804252
in-vitro毒性實驗的全球市場:解決方案·手法·技術·毒性端點&實驗·終端用戶·各地區 - 市場規模·產業動態·機會分析·預測 (2025~2033年)Global In-Vitro Toxicology Testing Market: Solution, Method, Technology, Toxicity End Point & Test, End User, Region-Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2025-2033 |
全球體外毒性測試市場正經歷快速成長,這得益於重大技術進步、人們對動物試驗倫理和科學局限性的認識不斷提高,以及日益嚴格的監管框架。預計到2033年,市場規模將從2024年的約260億美元增加至575.5億美元。 2025年至2033年9.23%的複合年增長率反映了市場對傳統毒性測試方法替代方案的強勁且持續的需求。
隨著市場不斷發展並進入更成熟的階段,利害關係人的注意力正轉向透過普及體外毒性測試技術並擴大標準化程度來維持和加速這一成長動能。推動這項轉變的關鍵因素之一是微流控晶片成本的快速下降,而微流控晶片是進行複雜生物檢測的關鍵工具。這些晶片目前採用注塑成型的環烯烴聚合物製造,零售價不到每單位 12 美元。這比 2021 年玻璃裝置通常的 48 美元售價大幅下降。
按解決方案劃分,檢測佔主導地位,佔超過 42.70% 的市場佔有率。這得益於其獨特的優勢,能夠提供監管信任、運行速度和成本效益的強大組合。對於尋求推進化合物研發管線的申辦者而言,檢測提供了一種可靠且有效率的解決方案,可滿足科學和監管需求。檢測方法的廣泛接受和納入測試方案,表明人們越來越相信,它們能夠提供準確且可重複的毒性數據,而無需擔心動物試驗相關的倫理問題。
依方法分類,細胞檢測佔最大的市場佔有率,約佔44.5%。這是因為它們在生物學相關性和實驗室可擴展性之間實現了理想的平衡。細胞檢測方法能夠深入了解細胞反應和表型,這對於理解毒理學效應至關重要,而這些是更簡單的非細胞生化方法無法獲得的。利用活細胞,研究人員可以以更接近人體生理狀態的方式觀察複雜的生物交互作用和毒性機制,從而提高安全評估的預測準確性。
依技術分類,細胞培養技術發揮核心作用,佔超過47.60%的市場。這是因為它具有獨特的能力,能夠在實驗規模上重現人體生物學過程,而器官切片或動物組織則無法做到這一點。這項技術使研究人員能夠精確模擬人體細胞的行為,為安全性和有效性評估提供重要見解。它還避免了與動物試驗相關的倫理和轉化限制。全球自動化細胞培養生物反應器的累積安裝數量已超過3,400台,證明了該技術的廣泛應用和可擴展性。根據 "2024年細胞培養產業調查" ,賽默飛世爾將在2021年至2023年期間銷售1,260台Nunc高容量生物反應器,佔這一增長的大部分,彰顯其在先進細胞培養設備供應方面的領先地位。
按地區細分
歐洲在市場中佔主導地位,這得益於嚴格的監管框架、大量的研發投入以及成熟的專業實驗室網路。 2023年,市場收入達到約99.191億美元,彰顯了該地區在推廣和應用替代毒性測試方法方面的領導地位。預計到2030年,這一強勁的成長軌跡將成長近一倍,這得益於歐盟化妝品法規和REACH化學品安全框架等監管要求,這兩項法規均要求使用獨立於動物試驗的測試數據。
該地區擁有超過33個專門從事替代毒性測試的科研設施,基礎設施完善。這些中心為申辦者提供經經濟合作暨發展組織 (OECD) 批准的驗證檢測方法和先進的人源細胞模型。該網路能夠進行快速合規的測試,以滿足日益增長的對符合倫理和科學的動物試驗替代方案的需求,從而促進監管審批並加速產品開發流程。
本報告研究了全球體外毒性測試市場,並提供了市場概況、影響市場成長的各種因素分析、市場規模趨勢和預測、細分市場的詳細分析、競爭格局以及主要公司的概況。
The global in-vitro toxicology testing market is experiencing rapid growth, fueled by significant technological advancements, heightened recognition of the ethical and scientific limitations associated with animal testing, and the enforcement of increasingly stringent regulatory frameworks. In 2024, the market was valued at approximately US$ 26.00 billion, and it is projected to expand substantially, reaching an estimated valuation of US$ 57.55 billion by 2033. This growth corresponds to a compound annual growth rate (CAGR) of 9.23% over the forecast period from 2025 to 2033, reflecting strong and sustained demand for alternatives to traditional toxicological testing methods.
As the market evolves and moves into a more mature phase, attention among stakeholders has shifted toward democratizing access to in-vitro toxicology technologies and scaling standards to maintain and accelerate this growth momentum. One key development facilitating this transition is the dramatic reduction in the cost of microfluidic chips, which are critical tools for conducting complex biological assays. These chips, now fabricated using injection-molded cyclic olefin polymers, are available at retail prices below USD 12 per unit-a sharp decrease from the USD 48 price point typical of glass devices in 2021.
Competition in the in-vitro toxicology testing market is increasingly focused on integrated platforms that combine high-content imaging with mass-spectrometric metabolite profiling, reflecting a trend toward more comprehensive and precise toxicological assessments. Thermo Fisher Scientific has established a strong presence with an installed base exceeding 400 CellInsight CX7 LZR systems, while Agilent Technologies supports toxicology laboratories worldwide with 310 Seahorse XF Pro analyzers. These numbers highlight the rapid turnover and widespread adoption of advanced instrumentation designed to deliver detailed cellular and metabolic insights.
For example, Eurofins' Predictiv AI suite processed an astonishing 18 billion cellular images last year, significantly accelerating the decision-making process for cardiotoxicity prediction by reducing the timeline from seventeen days to just nine. This combination of cutting-edge imaging, metabolite analysis, and artificial intelligence-driven data processing is reshaping how toxicology testing is conducted, enabling faster, more accurate, and more actionable results. The market's competitive landscape is further energized by a vibrant investment environment that mirrors both the scientific advances and favorable regulatory momentum propelling the sector forward. In 2023 alone, there were 41 publicly disclosed venture capital deals focused on key areas such as assay development, bioinformatics analytics, and organ-chip hardware.
Core Growth Drivers
Between 2022 and 2024, the introduction of stringent legislative timelines has significantly reshaped the in-vitro toxicology testing market, compelling sponsors to prioritize cell-based safety studies earlier in their development processes rather than relying on traditional animal models. These regulatory changes are designed to accelerate the adoption of alternative testing methods that reduce animal use while maintaining or enhancing the rigor of safety evaluations.
A notable example of this regulatory tightening is the U.S. Environmental Protection Agency's Revised New Approach Methodologies (NAM) Directive, which came into effect in January 2024. This directive explicitly requires that toxicology submissions include at least one validated in vitro assay addressing critical endpoints such as acute toxicity, developmental toxicity, or endocrine disruption. Submissions that fail to meet this criterion are no longer accepted, representing a clear mandate for the inclusion of cell-based testing methods in safety assessments.
Emerging Opportunity Trends
Microphysiological systems (MPS) transitioned from experimental pilot projects to integral components of mainstream workflows in the in-vitro toxicology testing market during 2023 and 2024. This advancement was driven by remarkable performance achievements and significant regulatory endorsements that underscored the technology's growing reliability and acceptance. MPS, which simulate human organ functions using interconnected microfluidic chips, offer more physiologically relevant models compared to traditional in-vitro assays, enabling detailed study of complex biological interactions and drug metabolism.
A pivotal moment for MPS came with the U.S. Food and Drug Administration's (FDA) Innovative Science Group formally accepting liver-kidney dual-chip data as part of two Investigational New Drug (IND) applications. The compounds involved were Bayer's candidate for non-alcoholic steatohepatitis, BAY 123456, and Amgen's oncology drug AMG 957. In both cases, the 28-day exposure studies conducted using MPS demonstrated metabolite profiles that closely matched in vivo biopsy results, with convergence within just 3.8 nanomoles.
Barriers to Optimization
Despite significant advancements in hardware and in vitro modeling technologies, accurately replicating xenobiotic metabolism remains a persistent challenge within the in vitro toxicology testing market, often causing delays in product development timelines. One of the key hurdles is the limited enzymatic diversity present in current models, even among the most sophisticated 3D hepatic spheroids. While these advanced systems have improved the representation of liver function, they still fall short of mimicking the full spectrum of metabolic activity found in adult human liver tissue.
Specifically, the human liver contains 57 active cytochrome P450 isozymes responsible for metabolizing a wide range of xenobiotics, but most commercial testing panels include no more than 14 isoforms. This gap in enzymatic coverage limits the ability of in-vitro models to fully replicate human metabolic processes, leading to incomplete or inaccurate predictions of how compounds are processed in the body.
By Solutions, assays hold a dominant position in the in-vitro toxicology testing market, capturing over 42.70% of the market share due to their unique ability to provide a powerful combination of regulatory confidence, operational speed, and cost-effectiveness. For sponsors looking to advance compounds through the development pipeline, assays offer a reliable and efficient solution that meets both scientific and regulatory demands. Their widespread acceptance and integration into testing protocols reflect a growing trust in their ability to deliver accurate and reproducible toxicity data without the ethical concerns associated with animal testing.
By Method, cellular assays hold the largest share in the in-vitro toxicology testing market, accounting for approximately 44.5% of the total, due to their ability to deliver an ideal balance between biological relevance and laboratory scalability. These assays provide valuable insights into cellular responses and phenotypes that are crucial for understanding toxicological effects in a way that simpler, acellular biochemical methods cannot achieve. By using living cells, researchers can observe complex biological interactions and mechanisms of toxicity that more closely mimic human physiological conditions, thereby improving the predictive accuracy of safety assessments.
By Toxicity Endpoint & Test, skin-related toxicity endpoints dominate the in-vitro toxicology testing market, capturing over 38.3% of the market share due to their critical importance at the crossroads of strict regulatory requirements, heightened consumer awareness, and substantial testing volumes. These endpoints are essential for assessing the safety of substances that come into direct contact with human skin, such as cosmetics, personal care products, and topical pharmaceuticals. The regulatory environment in the European Union (EU) has played a significant role in driving demand in this segment, particularly through the EU Cosmetics Regulation, which has prohibited animal testing for dermal toxicity endpoints since 2013. This ban has created a pressing need for reliable alternative testing methods that can accurately evaluate skin-related toxicity without relying on animal models.
By Technology, cell culture technology holds a central position in the in-vitro toxicology testing market, commanding over 47.60% of the revenue share due to its unique ability to replicate human biological processes at experimental scales that are impossible to achieve with organotypic slices or animal tissues. This technology enables researchers to model human cell behavior precisely, providing critical insights during safety and efficacy assessments without the ethical and translational limitations associated with animal testing. The global installed capacity for automated cell-culture bioreactors has now surpassed 3,400 units, highlighting the widespread adoption and scalability of this technology. According to the 2024 Cell Culture Industry Survey, Thermo Fisher alone accounted for a significant portion of this growth by selling 1,260 Nunc High-Volume bioreactors between 2021 and 2023, underscoring its leadership in supplying advanced cell culture equipment.
By Solutions
By Method
By Technology
By Toxicity Endpoint & Test
By End User
By Region
Geography Breakdown
Europe holds a dominant position in the in-vitro toxicology testing market, driven by a combination of stringent regulatory frameworks, substantial research and development investments, and a well-established network of specialized laboratories. In 2023, market revenues reached approximately 9,919.1 million dollars, reflecting the region's leadership in advancing and applying alternative toxicology methods. This strong growth trajectory is expected to nearly double by 2030, largely propelled by regulatory mandates such as the EU Cosmetics Regulation and the REACH chemical-safety framework, both of which require the use of non-animal testing data.
The region benefits from an extensive infrastructure of more than thirty-three dedicated scientific facilities that focus exclusively on alternative toxicology testing. These centers provide sponsors with immediate access to validated assays recognized by the Organisation for Economic Co-operation and Development (OECD), as well as advanced human-derived cell models. This network enables rapid, compliant testing that meets the rising demand for ethical and scientifically robust alternatives to animal testing, facilitating smoother regulatory approvals and accelerating product development pipelines.