市场调查报告书
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1372028
到 2030 年的生物分析测试服务市场预测:按类型、分子、工作流程、治疗、最终用户和地区进行的全球分析Bioanalytical Testing Services Market Forecasts to 2030 - Global Analysis By Type, Molecule, Workflow, Therapeutic, End User and By Geography |
根据 Stratistics MRC 的数据,全球生物分析测试服务市场预计在预测期内将以 12.2% 的年复合成长率成长。
生物分析测试是用来测试生物和生物技术产品的分析过程的术语。分析程序在生物技术和药品生产中至关重要。药物研发、开发和商业化都涉及生物分析评估的使用。生物分析测试服务部门是更大的生命科学和医疗保健部门的一个子集,该部门使用组织、血液、尿液和其他体液来收集法规遵循、临床诊断和研究的关键资料。生物样本,例如。它对许多行业至关重要,包括生物技术、製药、环境监测、食品安全和临床研究。
印度製药协会(IPA)的报告显示,印度製药业正以7-8%的成长率成长,预计2030年年度将达到80-900亿美元。
製药公司越来越多地利用品质源于设计 (QbD) 的概念,该概念已被 EMA 和美国FDA 等法规机构广泛接受,以提高产品品质、製造流程的稳健性和工厂生产力。看起来像这样。随着ICH Q8(R2)(药物开发)、ICH Q9(品质风险管理)和ICH Q10(药品品质系统)的发布,製药业的QbD方法与时俱进。未来年度,全球製药和生物製药企业越来越多地接受和使用 QbD 方法,预计将为全球市场的扩张做出重大贡献。
生物分析测试服务市场受到高营运成本的严重限制。这些成本是僱用高技能员工、维护最先进的分析设备和实施严格的品管程序所必需的。生物分析所需的昂贵设备的购买和维护成本通常很高。此外,由于需要化学、生物学和资料处理等领域的专业人员,导致人事费用高。较小的公司尤其发现很难透过提供生物分析测试服务来扩张和获利,并且需要持续投资以保持竞争力并遵守行业标准和立法。这可能会成为。
改进创新方法的先进、灵活平台的出现正在影响生物分析测试服务的成长。生物分析领域最近取得了进步,因为该领域的新方法可以解决所有可能的问题。这些因素预计将推动生物分析测试服务产业的整体成长。重要市场引进了干血斑法等尖端最尖端科技来检测药物动力学。干血斑法具有许多重要的优点,包括需要少量的处理样本、易于样本储存、减少生物危害问题以及无需采集后处理。因此,先进技术的出现预计将简化定量过程,从而增加预测期内生物分析测试服务的市场成长。
生物分析测试服务市场面临客户依赖的严峻挑战。如果服务公司过度依赖某些关键客户群,它们可能会在财务上变得脆弱。然而,随着主要客户迁移到其他提供者或降低其测试要求,可能会出现严重的收益短缺。为了降低这些风险,至关重要的是使您的客户群多样化并透过卓越的客户服务和附加价值服务来维持牢固的客户关係。透过客户群多元化,公司可以减少单一客户的潜在损失,并确保在竞争激烈的生物分析测试市场中实现更稳定和永续的成长。
COVID-19 的传播减少了工业部门的产出,并对多家全球企业产生了重大影响,导致对有效疫苗、治疗方法和其他医疗服务的需求增加。因此,疫情期间生物分析检测服务市场呈现需求成长。医疗保健提供者依靠即时护理服务和筛检技术来进行早期病毒诊断。此外,操作员还引入了减少处理时间的尖端方法和技术。基本技术包括自动化样品製备、高效液相层析和质谱。机器人和条码系统等先进技术在疫情期间已被证明是有效的。
样品製备部分估计占最大份额。分析过程中一个重要的步骤是样品製备,这是生物分析测试服务市场的一个新兴领域。在测试或分析之前,必须仔细、有条理地製备生物样品。此外,样品製备技术包括样品萃取、精製、浓缩,有时还包括变性。该元素对于提高分析技术的灵敏度、特异性和精确度以及实现少量目标化合物的检测和定量至关重要。
预计病毒检测产业在预测期内将出现良好成长。生物样本中病毒的分析和检测是该市场病毒学检测的主要焦点。对于临床研究、药物开发和公共卫生至关重要。由于新的病毒性疾病和流行病带来的持续危险,对病毒检测服务的需求正在增加。本部分对于感染疾病控制和预防至关重要,因为使用多种技术来诊断和测试病毒感染,包括 PCR、血清学和次世代定序。
由于该地区可用的设施以及美国大型大型製药企业对研发的投资不断增加,北美在预测期内获得了最大的市场占有率。此外,製药公司正在努力开发新药,目前有超过 1,100 种癌症治疗药物处于不同的临床开发阶段。由于辉瑞等主要市场参与者的存在,生物分析测试服务业务正在北美范围内扩展。
预计亚太地区在预测期内将实现获利成长。在亚太地区提供生物分析测试服务的组织投资不断增加、采用这些服务的公司数量不断增加、企业和法规改革是推动亚太市场的其他因素。专注于建造生技药品管道的中国和印度小公司以及提供生物分析测试服务的公司越来越多地采用最尖端科技,例如一次性技术,正在推动市场发展。
According to Stratistics MRC, the Global Bioanalytical Testing Services Market is accounted for $5207.3 million in 2023 and is expected to reach $116.38 million by 2030 growing at a CAGR of 12.2% during the forecast period. Bioanalytical testing is the term for the analytical process used to examine biological and biotechnological products. In the production of biotechnology and pharmaceuticals, analytical procedures are essential. Drug discovery, development, and commercialization all involve the use of bio analytical evaluation. The bio analytical testing services sector is a subset of the larger life sciences and healthcare sectors that focuses on the examination and testing of biological samples, such as tissues, blood, urine, and other bodily fluids, in order to gather important data for regulatory compliance, clinical diagnosis, and research. It is crucial to many industries, including biotechnology, medicines, environmental monitoring, food safety, and clinical research.
According to a report from the Indian Pharmaceutical Alliance (IPA), the Indian pharmaceutical industry was growing at a rate of 7-8% and is estimated to register USD 80-90 billion in annual revenue by 2030.
Pharmaceutical companies are increasingly using the Quality-by-Design (QbD) concept, which has been widely embraced by regulatory bodies like the EMA and US FDA, to improve the quality of their products, the robustness of their manufacturing processes, and the productivity of their factories. With the release of ICH Q8 (R2) (pharmaceutical development), ICH Q9 (quality risk management), and ICH Q10 (pharmaceutical quality system), the QbD method in the pharmaceutical business has evolved throughout time. In the upcoming years, it is anticipated that the growing acceptance and use of the QbD approach among pharmaceutical and biopharmaceutical operations around the world will significantly contribute to the expansion of the global market.
The market for bio analytical testing services is significantly constrained by high operational costs. These costs are required in order to hire highly skilled employees, maintain cutting-edge analytical equipment, and implement strict quality control procedures. The pricey equipment needed for bio analysis is frequently expensive to buy and keep up. Furthermore, high labour expenses are a result of the demand for specialised talent in sectors like chemistry, biology, and data processing. Smaller companies in particular may find it challenging to scale their businesses and make a profit from offering bio analytical testing services, and they may need to make continual investments to stay competitive and comply with industry standards and laws.
The emergence of sophisticated and flexible platforms that improve innovative methods has had an impact on the growth of bio analytical testing services. The discipline of bio analysis has advanced recently since new approaches in the sector are capable of handling any issues that can arise. These elements are anticipated to boost the industry's overall growth for bio analytical testing services. Prominent markets are implementing cutting-edge technologies, like dry blood spot technology, to measure pharmacokinetics because it has more benefits than other traditional methods. The dry blood spot method has a number of important advantages, including the need for a small processing sample, easy sample storage, reduced biohazard concerns, the lack of post-collection processing, and many more. Therefore, the presence of advanced technologies is simplifying the quantification process and thereby expected to increase the bio analytical testing services market growth during the forecast period.
The market for bio analytical testing services faces a serious challenge from client dependence. Services companies may be financially vulnerable if they rely excessively on a select group of important customers. However, a significant revenue shortfall could come from a key client shifting to another provider or reducing their testing requirements. It is crucial to reducing this danger to diversify the client base and retain solid client relationships through outstanding customer service and value-added services. By diversifying their clientele, businesses can reduce their exposure to the potential loss of a single customer and assure steadier, sustainable growth in the competitive bio analytical testing market.
The spread of COVID-19 has reduced the output of the industrial sectors, and as a result of its significant impact on several worldwide operations, there has been a rise in demand for effective vaccines, treatments, and other medical services. As a result, the market for bio analytical testing services saw an increase in demand during the epidemic. Healthcare providers relied on point of care services and screening techniques for early viral diagnosis in people. Additionally, the businesses have introduced cutting-edge methodologies and technology that have reduced processing time. The essential techniques include automated sample preparation, ultra-performance liquid chromatography, mass spectrometry, and others. Such advanced technologies as robotics and barcode systems have proved efficient during the pandemic.
The sample preparation segment is estimated to hold the largest share. An essential step in the analysis process is sample preparation, which is an emerging area in the bio analytical testing services market. Before being tested or analysed, biological samples must be carefully and methodically prepared. Moreover, techniques for sample preparation include sample extraction, purification, concentration, and occasionally alteration. This component is essential for improving the sensitivity, specificity, and accuracy of analytical techniques and allowing the detection and quantification of small amounts of target compounds.
The virology testing segment is anticipated to have lucrative growth during the forecast period. The analysis and detection of viruses in biological samples is the primary focus of the virology testing component of the market. It is essential to clinical research, pharmaceutical development, and public health. The need for virology testing services has grown due to the persistent hazards posed by new viral illnesses and pandemics. This section is crucial for the management and prevention of infectious diseases because it uses a variety of techniques to diagnose and examine viral infections, including PCR, serology, and next-generation sequencing.
North America commanded the largest market share during the extrapolated period due to the facilities available across the region and increasing investment for the R&D from US pharmaceutical titans. Additionally, pharmaceuticals are working very hard to create new medicines and they have developed over 1100 oncology treatments that are in various phases of clinical development. The business for bio analytical testing services is expanding across North America because of the presence of major market players like Pfizer.
Asia Pacific is expected to witness profitable growth over the projection period. A rise in investments made by organisations offering bio analytical testing services in the region, an increase in the number of companies adopting these services, and corporate and regulatory reforms are other factors driving the market in Asia Pacific. Small enterprises in China and India that are focused on building biologics pipelines, as well as an increase in the pace of adoption of cutting-edge technologies, like single-use technologies, by businesses that provide bio analytical testing services, have boosted the market.
Some of the key players in the Bioanalytical Testing Services Market include: Syneos Health, Intertek Group, Med pace, PPD, Inc., Euro fins Scientific, Laboratory Corporation of America, Pace Analytical Services, ICON plc, PRA Health Sciences , Charles River Laboratories International, Inc., WuXi App Tec, SGS SA Toxikon, Inc., IQVIA, Pharmaceutical Product Development, Frontage Labs, Covance Inc., Alta sciences, BioAgilytix Labs, Vipragen Biosciences and Bio needs India Private Limited.
In June 2023, ICON plc, one of the world leaders in CRO and healthcare intelligence, announced the release of its new ICON Digital Platform. The platform facilitates seamless integration of ICON site, patient, site, and sponsor services along with harmonized and customizable data delivery.
In June 2023, Syneos Health, one of the leading companies in biopharmaceutical solutions, announced a patient-centric partnership with uMotif, a clinical trial solutions organization. The collaboration is aimed at aiding the acceleration of clinical trials and introducing new therapies to patients via an end-to-end and more effective digital platform. This platform comprises robust Electronic Patient-reported Outcomes (ePRO) and Electronic Clinical Outcome Assessment (eCOA) capabilities
In May 2023, IQVIA a significant provider of advanced analytics, clinical research services, and technology solutions in the world, announced a strategic partnership RED, to battle against AIDS and the injustices that permit pandemics to thrive. This partnership supports laboratory system strengthening.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.