市場調查報告書
商品編碼
1455093
全球生物製品安全測試市場規模、佔有率、成長分析(依測試、依應用、依最終用途)- 2024-2031 年產業預測Global Biologics Safety Testing Market Size, Share, Growth Analysis, By Test, By Application, By End-use - Industry Forecast 2024-2031 |
2022年,全球生物製品安全測試市場規模為47.0億美元,預計將從2023年的52.5億美元成長到2031年的127.2億美元,在預測期內(2024-2031年)複合年成長率為11.70% 。
生物安全測試涵蓋一系列細緻的程序,對於確保生物來源產品的安全至關重要,特別是生物製藥和醫療器材。其主要目標是透過仔細檢查污染和不良生物效應等因素來評估和減輕與這些產品相關的潛在風險。遵守嚴格的監管標準對於確保生物材料的純度、效力和整體安全性至關重要。無菌檢測、內毒素評估和細胞檢測等技術在徹底評估這些產品、確認其符合嚴格的安全標準並確保其適合臨床應用和公共衛生保護方面發揮著至關重要的作用。
Global Biologics Safety Testing Market size was valued at USD 4.70 billion in 2022 and is poised to grow from USD 5.25 billion in 2023 to USD 12.72 billion by 2031, growing at a CAGR of 11.70% during the forecast period (2024-2031).
Biological safety testing encompasses a wide range of meticulous procedures vital for guaranteeing the safety of products sourced from biological origins, particularly biopharmaceuticals and medical devices. Its primary objective is to evaluate and mitigate potential risks associated with these products by carefully examining factors such as contamination and adverse biological effects. Adherence to strict regulatory standards is essential to ensure the purity, potency, and overall safety of biological materials. Techniques like sterility testing, endotoxin assessment, and cell-based assays play crucial roles in thoroughly assessing these products, confirming their compliance with stringent safety criteria and ensuring their suitability for clinical application and public health protection.
Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biologics Safety Testing Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.
Global Biologics Safety Testing Market Segmental Analysis
The global Biologics Safety Testing market is segmented on the basis of test, application, end-use, and region. Based on Test, it is divided into Endotoxin Test, Bioburden Tests, Sterility Test, Adventitious Agent Detection Test, Others. Based on Application, it is divided into Blood & Blood-based Products, Gene Therapy, Vaccines & Therapeutics, Stem Cells, Others. Based on End-use, it is divided into Pharmaceutical and Biotechnology Companies, Contract Development and Manufacturing Companies, Research and Academia, Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Drivers of the Global Biologics Safety Testing Market
The significant growth observed in the pharmaceutical and biotechnology fields, driven by substantial investments in research and development, marks a crucial era in healthcare advancement. These sectors are leading the way in developing pharmaceuticals, biologics, and vaccines to tackle a wide range of healthcare challenges, particularly in combating complex diseases. This surge in innovation underscores the heightened need for rigorous safety assessments, with biological safety testing playing a pivotal role in ensuring patient safety.
Restraints in the Global Biologics Safety Testing Market
Biologics and biosimilars constitute an innovative class of drugs sourced from living organisms, providing effective therapies for a wide range of conditions such as cancer, diabetes, rheumatoid arthritis, and diverse inflammatory disorders.
Market Trends of the Global Biologics Safety Testing Market
Global regulatory authorities have intensified their oversight of biopharmaceuticals, placing significant importance on patient safety and product quality. These rigorous regulations require comprehensive safety assessments, making biological safety testing a fundamental aspect of the drug approval process. Pharmaceutical and biotech companies must rigorously comply with these evolving standards to ensure product approval and market access. The growing focus on compliance drives a surge in demand for testing services, solidifying the crucial role of biological safety testing in this regulatory landscape.