세계의 생물학적 안전성 시험 시장 규모는 2024년에 49억 5,000만 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 132억 9,000만 달러에 달하고, 2025-2033년에 걸쳐 10.38%의 연평균 복합 성장률(CAGR)을 나타낼 것으로 예측했습니다. 현재 북미가 시장을 독점하고 있으며 2024년에는 38.8% 이상의 큰 시장 점유율을 차지했습니다. 제약 및 바이오테크놀러지 분야의 확대, COVID-19 팬데믹의 영향, 규제 준수와 안전 기준의 중시의 고조 등이 생물학적 안전성 시험 시장 점유율을 높이는 주요 요인이 되고 있습니다.
바이오 의약품, 백신 및 바이오시밀러에 대한 수요 증가는 건강 관리 요구 증가와 만성 질환의 만연으로 생물학적 안전성 시험 시장을 견인하고 있습니다. 제품의 안전성과 효능에 대한 엄격한 규제 지침, 생명 공학 연구 개발에 대한 투자 증가가 시장 성장을 더욱 강화하고 있습니다. 또한 세포치료와 유전자치료의 진보와 CRO(의약품개발업무수탁기관)의 확대도 신뢰성 높은 안전성시험 수요를 끌어올리고 있습니다. 감염증 증가와 유행에 대비하는 것은 백신 제조를 가속화하고 엄격한 안전성 시험이 필요합니다. 자동화 시스템과 높은 처리량 스크리닝과 같은 테스트 기술의 혁신은 테스트 효율성을 높이고 시장 확대에 기여합니다. 제품의 품질에 대한 의식이 높아짐에 따라 세계의 생물학적 안전성 테스트 시장 성장이 더욱 강화되고 있습니다.
미국의 생물학적 안전성 시험 시장은 만성 질환과 감염의 유행이 증가함에 따라 바이오 의약품, 백신 및 첨단 치료에 대한 수요가 증가하고 있습니다. FDA와 같은 엄격한 규제 기준으로 제품의 품질과 규정 준수를 보장하기 위한 종합적인 안전 테스트가 필요합니다. 미국은 또한 자동화 및 고처리량 시스템과 같은 혁신적인 검사 기술을 채택하여 업계를 선도하고 있으며 검사의 정확성과 효율성을 높이고 있습니다. 게다가 정평이 있는 제약기업의 존재, 유행대책에 대한 강한 관심, CRO(의약품개발업무수탁기관)의 성장은 주요 시장 동향의 일례입니다. 예를 들어, 2024년 10월, 미국 메릴랜드 주 록빌에서 Merck KGaA(독일, 다름슈타트)의 생명과학 부문인 MilliporeSigma가 2억 9,000만 유로 상당의 새로운 바이오 세이프티 시험 시설을 발표했습니다. 기존의 방법에서도 혁신적인 방법에서도, 바이오 세이프티 시험과 분석 개발은 의약품 개발과 상품화에 필수적인 요소입니다. 이러한 서비스에 대한 수요는 전 세계적으로 2자리의 속도로 증가하고 있습니다. 이 회사는 이번 확장으로 자동화와 기술 개발을 단일 통합 허브로 추진할 수 있게 되어, 위탁 시험에 대한 투자로서는 과거 최대가 됩니다.
확대하는 의약품 및 바이오테크놀러지 분야
연구개발에 대한 투자 확대로 의약품 및 바이오테크놀러지 산업이 확대되고 있습니다. 한 산업 보고서에 따르면 2023년 제약 부문의 세계 R&D 비용은 약 3,000억 달러를 초과했습니다. 복잡한 질병을 포함한 다양한 의학적 상태에 대한 의약품, 생물학적 제제 및 백신의 개발은 이러한 부서가 중심으로 하고 있습니다. 그 결과, 철저한 안전성 평가의 필요성이 증가하고 있으며, 생물학적 안전성 시험은 환자의 안전을 보장하기 위해 필수적입니다. 박테리아, 바이러스, 내독소를 포함한 오염물질을 종합적으로 평가하여 안전성과 법적 요건을 준수해야 합니다. 동시에, 질병의 진화와 제품의 지속적인 혁신은 유전자 치료 및 세포 치료를 포함한 새로운 치료법에 대한 전문적인 평가를 포함한 안전성 시험에 대한 높은 수요를 유지하며 생물학적 안전성 시험 시장 수요에 크게 기여하고 있습니다.
COVID-19 팬데믹의 영향
COVID-19 팬데믹은 백신과 치료법의 개발과 개발을 가속화함으로써 업계에 큰 영향을 미쳤습니다. 예를 들어, 세계보건기구(WHO)에 따르면 2021년까지 세계에서 130억 회 이상의 COVID-19 백신이 투여되었습니다. 이것은 엄격한 안전성 시험의 중요한 역할을 강조합니다. 이 외에도 각국 정부와 규제 당국은 이러한 제품에 대한 모니터링을 강화하고 있으며, 백신 안전성 평가, 바이러스 검출 분석 : COVID-19 진단 및 치료제의 품질 관리 대책 등 다양한 검사 서비스에 대한 수요가 급증하고 있습니다. 게다가 유행은 와야 할 건강 긴급 상황에 대비할 필요성을 강조함으로써 업계의 중점을 변화시키고 시장 확대를 유지하고 있습니다.
규제 준수의 중요성 증가
세계의 규제기관은 바이오의약품에 대한 감시를 강화하고 환자의 안전성과 제품의 품질을 중시하고 있습니다. 이러한 규제는 종합적인 안전성 평가를 의무화하고 있으며 생물학적 안전성 시험은 의약품 승인에 필수적입니다. 유전자치료나 세포치료 등의 선진치료제는 최근 수년간 승인이 진행되고 있습니다. 예를 들어, 유럽의약청의 선진치료위원회는 2024년 5월 본회의에서 중증 및 중등증 혈우병 B의 치료제로서 Durveqtix(fidanacogene elaparvovec)의 긍정적 의견안을 채택했습니다. 검사 서비스에 대한 요구가 커지고 있으며, 제약 및 생명 공학 기업이 제품 승인 및 시장 진입을 얻기 위해 따라야하는 변화하는 기준을 엄격하게 준수함으로써 규정 준수에서 생물학적 안전성 시험의 중요성이 강조되고 있습니다. 게다가, 전문가에 의한 시험의 필요성은 특히 유전자 치료 및 세포 치료와 같은 고급 치료제에 대한 규제의 복잡화에 의해 강조됩니다. 전문가의 평가가 이러한 치료의 특징에 적응하고 변화하는 규제 요건을 충족시키면서 그 효과와 안전성을 보장함으로써 시장 성장이 유지됩니다.
The global biological safety testing market size was valued at USD 4.95 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 13.29 Billion by 2033, exhibiting a CAGR of 10.38% during 2025-2033. North America currently dominates the market, holding a significant market share of over 38.8% in 2024. The expansion of the pharmaceutical and biotechnology sectors, the impact of the COVID-19 pandemic, and the rising emphasis on regulatory compliance and safety standards are some of the major factors increasing the biological safety testing market share.
The increasing demand for biopharmaceuticals, vaccines, and biosimilars drives the biological safety testing market due to rising healthcare needs and chronic disease prevalence. Stringent regulatory guidelines for product safety and efficacy, and the growing investment in biotechnology research and development, further fuel market growth. Advancements in cell and gene therapies and the expansion of contract research organizations (CROs) have also boosted the demand for reliable safety testing. The rise in infectious diseases and pandemic preparedness has accelerated vaccine production, necessitating rigorous safety testing. Innovations in testing technologies, such as automated systems and high-throughput screening, enhance testing efficiency, contributing to the market's expansion. The increasing awareness about product quality further drives the biological safety testing market growth across the globe.
The biological safety testing market in the United States is driven by the growing demand for biopharmaceuticals, vaccines, and advanced therapies due to the rising prevalence of chronic and infectious diseases. Stringent regulatory standards from the FDA and other authorities necessitate comprehensive safety testing to ensure product quality and compliance. The U.S. is also a leader in adopting innovative testing technologies, including automation and high-throughput systems, enhancing testing accuracy and efficiency. Additionally, the presence of well-established pharmaceutical companies, a strong focus on pandemic preparedness, and the growth of contract research organizations (CROs) represent some of the key biological safety testing market trends. For instance, in October 2024, in Rockville, Maryland, USA, MilliporeSigma, the Life Science division of Merck KGaA, Darmstadt, Germany, unveiled a new biosafety testing facility worth €290 million. For conventional and innovative modalities, biosafety testing and analytical development are essential elements of medication development and commercialization. The demand for these services is increasing at a double-digit rate on a global scale. The company will be able to drive automation and technological development in a single integrated hub due to this expansion, which represents the largest investment in contract testing in its history.
Expanding Pharmaceutical and Biotechnology Sectors
The pharmaceutical and biotechnology industries are expanding due to increased investments in research and development. According to an industrial report, in 2023, global R&D spending in the pharmaceutical sector exceeded approximately USD 300 billion. The development of medications, biologics, and vaccines for a range of medical conditions, including complicated illnesses, is dominated by these sectors. As a result, there is a greater need for thorough safety evaluations, and biological safety testing is essential to guaranteeing patient safety. It entails comprehensive assessments for pollutants including bacteria, viruses, and endotoxins, ensuring adherence to safety and legal requirements. Concurrently, the evolving nature of diseases and the continuous innovation in products maintain a high demand for safety testing, including specialized assessments for emerging therapies including gene and cell therapies, contributing significantly to the biological safety testing market demand.
Impact of the COVID-19 Pandemic
The COVID-19 pandemic has significantly impacted the industry by accelerating the development and deployment of vaccines and treatments. For instance, according to the World Health Organization (WHO), more than 13 billion COVID-19 vaccine doses were administered globally by 2021. This has emphasized the crucial role of rigorous safety testing. In addition to this, governments and regulatory authorities globally have intensified their scrutiny of these products, leading to a surge in demand for various testing services, including vaccine safety assessments, virus detection assays, and quality control measures for COVID-19 diagnostics and treatments. In addition, the pandemic has changed the industry's emphasis by emphasizing the necessity of readiness for upcoming health emergencies, which has maintained market expansion.
Rising Emphasis on Regulatory Compliance
Global regulatory bodies are tightening oversight of biopharmaceutical products, emphasizing patient safety and product quality. These regulations mandate comprehensive safety evaluations, making biological safety testing integral to drug approvals. Advanced therapy medicinal products, such as gene and cell therapies, have been receiving more approvals over the past few years. For example, the Committee for Advanced Therapies of the European Medicines Agency adopted a positive draft opinion for Durveqtix (fidanacogene elaparvovec) during its plenary meeting in May 2024 for the treatment of severe and moderately severe haemophilia B. This is part of a general trend where the number of approved ATMPs is constantly on the rise. The need for testing services is increased and the significance of biological safety testing in compliance is emphasized by the strict adherence to changing standards that pharmaceutical and biotech businesses must follow to obtain product approval and market access. Additionally, the necessity for specialist testing is highlighted by the growing complexity of regulatory regulations, particularly for sophisticated therapeutics like gene and cell therapies. As specialist evaluations adjust to the distinct features of these treatments, guaranteeing their efficacy and safety while satisfying changing regulatory requirements, this maintains market growth.
Kits and reagents leads the market with around 41.3% of market share in 2024. The increasing trend towards decentralized testing and point-of-care (POC) diagnostics driving the need for user-friendly and portable testing kits represents one of the prime factors fueling the demand for biological safety testing. These kits enable healthcare professionals to perform safety assessments quickly and efficiently, especially in resource-limited settings. In confluence with this, the expansion of research and development activities in the life sciences, including genomics, proteomics, and cell culture, necessitates a continuous supply of high-quality testing reagents and kits for various applications, spurring market growth. Furthermore, the growing focus on ensuring product quality and safety in the food and beverage (F&B) industry, where biological contaminants can pose significant risks, is boosting demand for testing kits and reagents for microbiological analysis, aiding market expansion.
Endotoxin tests leads the market with around 24.9% of market share in 2024. The rising demand for endotoxin tests primarily propelled by the critical need to ensure the safety and efficacy of medical devices and pharmaceutical products is strengthening the global biological safety testing market. Endotoxins, toxic substances present in the cell walls of Gram-negative bacteria, can lead to severe health complications when introduced into the human body. The increasing complexity and diversity of medical devices, including implants and drug delivery systems, necessitate stringent testing for endotoxins to mitigate potential patient risk. Furthermore, the rising focus on personalized medicine and biopharmaceuticals, such as gene therapies and monoclonal antibodies, requires meticulous endotoxin testing to guarantee the purity and safety of these advanced therapies, strengthening the market. Besides this, regulatory agencies worldwide mandate compliance with strict endotoxin limits, reinforcing the demand for accurate and reliable endotoxin tests in pharmaceutical manufacturing and healthcare settings, thereby bolstering the market growth.
Vaccine development leads the market with around 28.7% of market share in 2024. The demand for biological safety testing in vaccine development is primarily propelled by the urgent global need for safe and effective vaccines. As the world faces various infectious diseases and viral outbreaks, including the COVID-19 pandemic, there is an unprecedented focus on vaccine development. Regulatory authorities require comprehensive safety assessments to ensure that vaccines are not only effective but also free from harmful contaminants. Biological safety testing plays a critical role in this process, involving the evaluation of vaccine candidates for potential viral and microbial contaminants, ensuring the absence of endotoxins, and assessing their overall safety for human use. Moreover, the emergence of novel vaccine technologies, such as mRNA-based vaccines, necessitates specialized safety evaluations, contributing to the growing demand for biological safety testing services. This heightened emphasis on vaccine safety underscores the crucial role played by such testing in safeguarding public health on a global scale.
Regional Analysis
In 2024, North America accounted for the largest market share of over 38.8%. North America boasts a robust pharmaceutical and biotechnology industry, with a strong emphasis on research and development. The constant innovation and introduction of new drugs, biologics, and medical devices necessitate rigorous safety evaluations, driving the demand for biological safety testing services. In addition to this, the region's proactive regulatory environment, governed by stringent standards set by the FDA and other regulatory bodies, mandates comprehensive safety assessments, further propelling market growth. Moreover, the ongoing efforts to combat public health threats, such as the COVID-19 pandemic, have heightened the demand for vaccine development and testing, particularly in North America, where numerous pharmaceutical companies and research institutions are actively involved in vaccine research and production. These factors, combined with the region's advanced healthcare infrastructure and the increasing awareness of product quality and safety, continue to fuel the expansion of the North America biological safety testing market.
United States Biological Safety Testing Market Analysis
In 2024, the United States accounted for the largest market share of over 88.60% in North America. There are increased growth aspects related to U.S. biological safety testing with an increase in the development of pharmaceuticals, the rise of treatments based on biologics. In 2023 alone, the FDA approved 25 biologics under 55 newly approved drugs; 12 monoclonal antibodies (mAbs) and 5 of those were either an enzyme or protein. According to an industrial report, as of January 2024, there were 20,465 clinical trials accepting patients in the United States that clinically signified the growing need for biologics safety testing. There are major vendors of companies such as Charles River Laboratories and WuXi AppTec, which are interested in bringing testing technologies forward. The high urge for advanced safety testing of gene therapies and vaccines further amplified the market growth. The increasing focus on in-vitro testing and automation is also augmenting enhanced market efficiency. Improvements in technology are enhancing testing accuracy and reducing the turnaround time, while higher standards of safety regulatory requirements continue to drive innovation that positions the United States as the key player globally in the field of biological safety testing.
Europe Biological Safety Testing Market Analysis
The biological safety testing market is also growing in Europe due to strong regulatory framework and increased demands for safe pharmaceutical and biologic products. A recent industrial report suggests that revenue in the European pharmaceutical industry already surpassed EUR 300 billion (USD 309 billion) in 2022, which creates high demand for solutions in terms of safety testing. Germany and Switzerland happen to be strong market contributors while the pharmaceutical leaders Roche and Bayer are always concerned about their biologic safety. In more detail, especially, regulatory institutions such as EMA have upgraded testing standards due to which more quality biologic testing services flourished. Growth in the demand for clinical research, gene therapy, and also the increasing significance of biosimilars fuels the market demand. Additionally, the emerging concept of personalized medicine, coupled with precision testing, is further changing the playing field for regional safety testing service providers. Efficiency in testing has been improved with the increasing utilization of automation and AI technology.
Asia Pacific Biological Safety Testing Market Analysis
Asia Pacific's market for biological safety testing is fast growing due to increased investments in biotechnology as well as increasing pharmaceutical manufacturing. According to industrial reports, China's pharmaceutical market reached a value of USD 160 billion in 2023, which also led to greater demand for biologics. Rising population with above the age bracket population makes investment by the nation, in region attractive to multinationals for example Labcorp and Bio-merieux extending the presence based on rising spending in R and D. Advanced technologies like high-throughput testing and next-generation sequencing have been adopted by the biotech sector in the region, leading to a more sophisticated safety testing environment. In addition, strong manufacturing capabilities in the region along with cost-effective testing solutions have made it an important player in the global biological safety testing arena.
Latin America Biological Safety Testing Market Analysis
The biological safety testing market in Latin America is also on the rise, that is driven by growing pharmaceutical production and a deepening focus on compliance with international standards for safety. Brazil leads this boom, and the growing demand for biologic safety testing services can be tracked in response to the country's further increasing biologics production capability. Argentina and Mexico are also contributing to the growth through investments in upgrading their pharmaceutical manufacturing capabilities. According to an industry report, as of April 2024, Brazil boasts the highest number of clinical trials in the region with approximately 10,000 studies. Mexico ranks next with about 5,000 studies. Thus, this signifies a heavy reliance on clinical research and biologic safety. Testing requirements have become even more rigorous on the part of Brazil's regulatory body, ANVISA. This is leading to increased demands for high-tech safety testing to meet the new international standards set. Moreover, the investment by local manufacturers in testing services and infrastructure enhancement to meet the increasing demands is directly contributing to the expanding market and makes the region increasingly significant in the global biological safety testing market.
Middle East and Africa Biological Safety Testing Market Analysis
In the Middle East and Africa, the biological safety testing market is burgeoning, driven by increased healthcare investment and pharmaceutical production in many countries. Saudi Arabia's defense spending, which includes allocations for medical and pharmaceutical safety, fuels the growth of the market. The pharmaceutical market in the UAE remains in growth mode, and biological safety testing is fast becoming a key area of focus. South Africa is emerging as one of the key biomanufacturing hubs. There is a huge growth in domestic biologic production. There are 4,593 clinical trials in the Middle East and 861 in Africa as of 2022 according to the WHO International Clinical Trial Registry Platform, where there is increased demand for clinical research and biologic safety. Demand for biological safety testing services will be raised due to increases in healthcare facilities and clinical trials in the region. Testing service will grow annually at 10% over the next five years. This trend is further supported by the efforts of local governments to improve healthcare standards and infrastructure.
The fierce competition among major companies in the global biological safety testing market is a result of the sector's vital role in guaranteeing the quality and safety of pharmaceuticals, biologics, and medical devices. Prominent companies in this landscape engage in various strategies to maintain their market positions, such as mergers, acquisitions, and collaborations to expand their service portfolios and geographic reach. Furthermore, companies can also remain ahead of industry trends by investing in research and development to adopt cutting-edge testing technologies and procedures. The increasing focus on personalized medicine and advanced therapies, such as gene and cell therapies, presents growth opportunities for firms specializing in specialized safety testing services. Overall, the competitive landscape of the global biological safety testing market is marked by a dynamic interplay of established players.
The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include: