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市場調查報告書
商品編碼
1423609
到 2030 年生殖毒理學測試市場預測:按產品、方法、技術、最終用戶和地區分類的全球分析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 |
根據 Stratistics MRC 的數據,2023 年全球生殖毒性檢測市場規模為 118 億美元,預計在預測期內複合年成長率為 11.4%,到 2030 年將達到 251.4 億美元。
生殖毒性測試涉及評估各種物質對人類和動物生殖器官的潛在不利影響。採用多種調查方法來評估生殖毒性,包括體內(動物研究)、體外測定、計算模型和高通量篩檢。評估包括評估生育力、胚胎發育、致畸性、致突變性和荷爾蒙失調等終點,提供關鍵資料來指南風險評估和監管決策。
根據 ClinicalTrials.gov 統計,截至 2020 年 8 月,資料庫中總合281,305 項試驗註冊。
檢驗技術的進步
持續不斷的技術創新,例如高通量篩檢、先進的體外測定和預測計算模型正在徹底改變毒性測試領域。這些進步使得測試更加準確、高效且具有成本效益,可以對生殖毒性進行全面評估,同時減少對動物研究的依賴。此外,開發更靈敏和特異性的測試方法將更能預測人類對物質的反應,加速藥物開發和產品安全評估的決策。因此,它們擴大被化學、製藥和消費品行業採用,推動了市場擴張。
成本和時間問題
全面的生殖毒性測試需要大量的成本和較長的研究週期,特別是對於長期評估和法規遵循。資源和時間的投資可能令人望而卻步,特別是對於小型公司和研究機構來說,影響了他們進行大規模試驗的能力。財務負擔和漫長的時間表可能會阻礙這些測試的廣泛普及,限制獲得全面的生殖毒性評估,並影響產品開發和監管核准流程的步伐。
擴大醫藥化工產業
製藥和化學產業的持續成長導致新藥、化學品和消費品的開發增加。需要進行全面的生殖毒性測試,以確保這些產品在進入市場之前的安全性和法規合規性。對徹底安全評估的需求不斷成長,為測試服務提供者提供可靠、高效的測試服務提供了機會。此外,滿足不斷擴大的行業需求正在推動生殖毒性測試市場的成長,並滿足藥品和化學品安全評估的需求,確保為消費者提供更安全的產品。
監管障礙
多樣化且嚴格的區域監管標準給實驗室和服務供應商帶來了挑戰。不同的合規性要求使統一測試通訊協定的建立變得複雜,並可能延遲產品核准和市場進入。談判這些不同的法律規範會帶來複雜性,並影響生殖毒性測試服務的效率和可及性。
COVID-19 的影響
由於供應鏈中斷、實驗室關閉和研究重點的變化,COVID-19 爆發對生殖毒性測試市場產生了負面影響。這些因素使得生殖毒性測試變得更加困難和耗時。這種最初的影響反映了生物技術和製藥業在疫情期間遇到的更大困難。然而,隨著時間的推移和世界適應大流行的挑戰,市場表現出穩健性並持續擴張。
細胞培養技術領域預計將成為預測期內最大的市場
預計細胞培養技術領域將佔據最大佔有率。細胞培養技術可以透過觀察細胞對化合物和藥物的反應來評估毒性、遺傳毒性和其他生殖終點。基於細胞培養的檢測提供了生殖毒性的寶貴見解,並有助於藥物開發、安全評估和法規遵循。此外,細胞培養技術的進步提高了準確性、效率和預測能力,塑造了生殖毒性測試方法的格局,並為該細分市場的成長做出了重大貢獻。
製藥和生物技術公司領域預計在預測期內複合年成長率最高
預計製藥和生物技術公司部門在預測期內將出現良好成長。製藥和生物技術公司廣泛利用生殖毒性測試來評估對生殖健康的潛在不利影響。此類測試可確保符合監管標準,增強藥物的安全性,並支持藥物開發階段的明智決策。此外,這些公司在推動對全面和專業的生殖毒性測試服務的需求和塑造市場方面發揮著重要作用,同時優先考慮其產品對全球消費者的安全性和有效性。
由於嚴格的法律規範、不斷提高的生殖健康意識以及檢測方法的技術進步,亞太地區在預測期內佔據了最大的市場佔有率。此外,合作研究的增加和對藥物安全評估的日益關注也進一步刺激了市場需求。亞太地區製藥業的發展和政府的支持措施使該地區成為生殖毒性檢測服務的中心,競爭的加劇和技術創新塑造了行業形勢。
由於嚴格的法律規範和對藥品安全的日益關注,預計北美在預測期內將實現盈利成長。該地區(尤其是美國和加拿大)強勁的製藥和生物技術產業正在推動對生殖毒性測試服務的需求。此外,研究機構和產業參與者之間的合作研究進一步促進了測試方法的進步,使北美成為生殖毒性測試服務和製藥業創新的關鍵中心。
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.