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市场调查报告书
商品编码
1423609
到 2030 年生殖毒理学测试市场预测:按产品、方法、技术、最终用户和地区分類的全球分析Reproductive Toxicity Testing Market Forecasts to 2030 - Global Analysis By Product (Consumables, Assays and Equipment), Method (Cellular Assays, In-Silico Models, Biochemical Assays and Ex-Vivo Models), Technology, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球生殖毒性检测市场规模为 118 亿美元,预计在预测期内复合年增长率为 11.4%,到 2030 年将达到 251.4 亿美元。
生殖毒性测试涉及评估各种物质对人类和动物生殖器官的潜在不利影响。采用多种调查方法来评估生殖毒性,包括体内(动物研究)、体外测定、计算模型和高通量筛检。评估包括评估生育力、胚胎发育、致畸性、致突变性和荷尔蒙失调等终点,提供关键资料来指南风险评估和监管决策。
根据 ClinicalTrials.gov 统计,截至 2020 年 8 月,资料库中总合281,305 项试验註册。
检验技术的进步
持续不断的技术创新,例如高通量筛检、先进的体外测定和预测计算模型正在彻底改变毒性测试领域。这些进步使得测试更加准确、高效且具有成本效益,可以对生殖毒性进行全面评估,同时减少对动物研究的依赖。此外,开发更灵敏和特异性的测试方法将更能预测人类对物质的反应,加速药物开发和产品安全评估的决策。因此,它们越来越多地被化学、製药和消费品行业采用,推动了市场扩张。
成本和时间问题
全面的生殖毒性测试需要大量的成本和较长的研究週期,特别是对于长期评估和法规遵循。资源和时间的投资可能令人望而却步,特别是对于小型公司和研究机构来说,影响了他们进行大规模试验的能力。财务负担和漫长的时间表可能会阻碍这些测试的广泛普及,限制获得全面的生殖毒性评估,并影响产品开发和监管核准流程的步伐。
扩大医药化工产业
製药和化学产业的持续成长导致新药、化学品和消费品的开发增加。需要进行全面的生殖毒性测试,以确保这些产品在进入市场之前的安全性和法规合规性。对彻底安全评估的需求不断增长,为测试服务提供者提供可靠、高效的测试服务提供了机会。此外,满足不断扩大的行业需求正在推动生殖毒性测试市场的成长,并满足药品和化学品安全评估的需求,确保为消费者提供更安全的产品。
监管障碍
多样化且严格的区域监管标准给实验室和服务供应商带来了挑战。不同的合规性要求使统一测试通讯协定的建立变得复杂,并可能延迟产品核准和市场进入。谈判这些不同的法律规范会带来复杂性,并影响生殖毒性测试服务的效率和可及性。
COVID-19 的影响
由于供应链中断、实验室关闭和研究重点的变化,COVID-19 爆发对生殖毒性测试市场产生了负面影响。这些因素使得生殖毒性测试变得更加困难和耗时。这种最初的影响反映了生物技术和製药业在疫情期间遇到的更大困难。然而,随着时间的推移和世界适应大流行的挑战,市场表现出稳健性并持续扩张。
细胞培养技术领域预计将成为预测期内最大的市场
预计细胞培养技术领域将占据最大份额。细胞培养技术可以透过观察细胞对化合物和药物的反应来评估毒性、遗传毒性和其他生殖终点。基于细胞培养的检测提供了生殖毒性的宝贵见解,并有助于药物开发、安全评估和法规遵循。此外,细胞培养技术的进步提高了准确性、效率和预测能力,塑造了生殖毒性测试方法的格局,并为该细分市场的成长做出了重大贡献。
製药和生物技术公司领域预计在预测期内复合年增长率最高
预计製药和生物技术公司部门在预测期内将出现良好成长。製药和生物技术公司广泛利用生殖毒性测试来评估对生殖健康的潜在不利影响。此类测试可确保符合监管标准,增强药物的安全性,并支持药物开发阶段的明智决策。此外,这些公司在推动对全面和专业的生殖毒性测试服务的需求和塑造市场方面发挥着重要作用,同时优先考虑其产品对全球消费者的安全性和有效性。
由于严格的法律规范、不断提高的生殖健康意识以及检测方法的技术进步,亚太地区在预测期内占据了最大的市场占有率。此外,合作研究的增加和对药物安全评估的日益关注也进一步刺激了市场需求。亚太地区製药业的发展和政府的支持措施使该地区成为生殖毒性检测服务的中心,竞争的加剧和技术创新塑造了行业形势。
由于严格的法律规范和对药品安全的日益关注,预计北美在预测期内将实现盈利增长。该地区(尤其是美国和加拿大)强劲的製药和生物技术产业正在推动对生殖毒性测试服务的需求。此外,研究机构和产业参与者之间的合作研究进一步促进了测试方法的进步,使北美成为生殖毒性测试服务和製药业创新的关键中心。
According to Stratistics MRC, the Global Reproductive Toxicity Testing Market is accounted for $11.80 billion in 2023 and is expected to reach $25.14 billion by 2030 growing at a CAGR of 11.4% during the forecast period. Reproductive toxicity testing involves assessing the potential adverse effects of various substances on the reproductive systems of humans or animals. Various testing methodologies, including in vivo (animal testing), in vitro assays, computational models, and high-throughput screening, are employed to assess reproductive toxicity. The assessments encompass evaluating endpoints such as fertility, embryonic development, teratogenicity, mutagenicity, and hormonal disruptions, providing essential data to guide risk assessment and regulatory decisions.
According to the ClinicalTrials.gov, a total of 281,305 studies are registered on their database as of August 2020.
Advancements in testing technologies
Ongoing innovations, such as high-throughput screening, sophisticated in vitro assays, and predictive computational models, revolutionise the field of toxicity testing. These advancements enhance testing accuracy, efficiency, and cost-effectiveness, allowing for comprehensive evaluation of reproductive toxicity with reduced reliance on animal testing. Furthermore, the development of more sensitive and specific testing methods enables better prediction of human responses to substances, expediting decision-making in drug development and product safety assessments. Consequently, the chemical, pharmaceutical, and consumer goods industries will employ it more frequently, driving market expansion.
Cost and time intensiveness
Conducting comprehensive reproductive toxicity studies involves substantial expenses and lengthy testing periods, especially for long-term assessments and regulatory compliance. The investment of resources and time can be prohibitive, particularly for smaller companies or research institutions, impacting their ability to conduct extensive testing. The financial burden and extended timelines hinder widespread adoption of these tests, potentially limiting access to comprehensive reproductive toxicity evaluations and affecting the pace of product development and regulatory approval processes.
Expanding Pharmaceutical and Chemical Industries
With continuous growth in the pharmaceutical and chemical sectors, there's been an increased development of new drugs, chemicals, and consumer products. Ensuring the safety and regulatory compliance of these products before market entry necessitates comprehensive reproductive toxicity testing. This rising demand for thorough safety assessments presents an opportunity for testing service providers to offer reliable and efficient testing services. Moreover, addressing the needs of expanding industries fuels the growth of the reproductive toxicity testing market, catering to the demand for safety evaluations in pharmaceuticals and chemicals, thus ensuring safer products for consumers.
Regulatory hurdles
Diverse and stringent regulatory standards across regions pose challenges for testing laboratories and service providers. Varying compliance demands complicate the establishment of uniform testing protocols, potentially delaying product approvals and market entry. Negotiating these diverse regulatory frameworks creates complexity, impacting the efficiency and accessibility of reproductive toxicity testing services.
Covid-19 Impact
The COVID-19 pandemic had a detrimental impact on the market for reproductive toxicity testing due to supply chain disruptions, laboratory closures, and a change in research priorities. These factors made reproductive toxicity testing more difficult and time-consuming to perform. This initial effect was a reflection of the larger difficulties that the biotechnology and pharmaceutical sectors experienced during the epidemic. However, the market demonstrated robustness and sustained expansion as time passed and the world adjusted to the pandemic's challenges.
The cell culture technology segment is expected to be the largest during the forecast period
The cell culture technology segment is estimated to hold the largest share. Cell culture technology allows for the evaluation of toxicity, genotoxicity, and other reproductive endpoints by observing cellular responses to chemical compounds or pharmaceuticals. Cell culture-based assays provide valuable insights into reproductive toxicity, aiding in drug development, safety assessment, and regulatory compliance. Moreover, advancements in cell culture techniques enhance accuracy, efficiency, and predictive capabilities, shaping the landscape of reproductive toxicity testing methodologies and contributing significantly to this market segment's growth.
The pharmaceutical and biotechnology companies segment is expected to have the highest CAGR during the forecast period
The pharmaceutical and biotechnology companies segment is anticipated to have lucrative growth during the forecast period. Pharmaceutical and biotechnology companies extensively utilise reproductive toxicity testing to assess potential adverse effects on reproductive health. Such testing ensures compliance with regulatory standards, enhances drug safety profiles, and aids in making informed decisions during drug development stages. Moreover, these companies drive the demand for comprehensive and specialised reproductive toxicity testing services, playing a critical role in shaping the market while prioritising the safety and efficacy of their products for global consumers.
Asia Pacific commanded the largest market share during the extrapolated period owing to its stringent regulatory frameworks, rising awareness of reproductive health, and technological advancements in testing methodologies. Furthermore, growing research collaborations and a burgeoning focus on drug safety assessment further propel market demand. The region's evolving pharmaceutical industry, coupled with supportive government initiatives, positions the Asia-Pacific as a hub for reproductive toxicity testing services, with heightened competition and innovation shaping its landscape.
North America is expected to witness profitable growth over the projection period, due to stringent regulatory frameworks and a heightened focus on pharmaceutical safety. The region's robust pharmaceutical and biotechnology industries, particularly in the United States and Canada, drive the demand for reproductive toxicity testing services. Furthermore, collaborations between research institutions and industry players further contribute to advancements in testing methodologies, positioning North America as a pivotal hub for reproductive toxicity testing services and innovations in the pharmaceutical sector.
Key players in the market
Some of the key players in the Reproductive Toxicity Testing Market include Thermo Fisher Scientific, Laboratory Corporation of America Holdings, Charles River Laboratories International, Eurofins Scientific, Syngene International Limited, Jubilant Life Sciences Limited, Gentronix Ltd, Creative Bioarray, Inotiv Inc, MB Research Laboratories, Catalent, Inc., Bio-Rad Laboratories, Evotec, QIAGEN and Promega Corporation.
In May 2023, Wheeler Bio, a CDMO, collaborated with Charles River Labs to utilize RightSource, a flexible biologic testing lab, at its Oklahoma City facility. This partnership aimed to enhance Wheeler Bio's quality control without the need to establish its own lab, ultimately benefiting its biologic products and potential clients.
In October 2022, Thermo Fisher Scientific Inc. declared that it had expanded its laboratory operations in Highland Heights, Kentucky, to assist customers in delivering personalized medications to patients. The existing facility, which included central laboratory and biomarker operations, provided biopharma customers with high-quality laboratory services to accelerate drug development. This move increased the company's clinical diagnostics business worldwide and enhanced its global presence across the business space.