市场调查报告书
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到 2030 年免疫肿瘤检测市场预测:按产品、适应症、技术、应用和地区进行的全球分析Immuno Oncology Assay Market Forecasts to 2030 - Global Analysis By Product, Indication, Technology, Application and By Geography |
根据 Stratistics MRC 的数据,2023 年全球免疫肿瘤检测市场规模为 50.4 亿美元,预计在预测期内复合年增长率为 12.8%,到 2030 年将达到 117.1 亿美元。
免疫肿瘤学检测市场是指医疗保健行业内的一个部门,专注于利用人体免疫系统支持癌症研究和治疗的检测方法的开发和商业化。这些检测方法在药物开发中发挥重要作用,能够评估新型免疫肿瘤治疗方法,帮助研究人员识别有前景的候选药物并评估其疗效和安全性。
根据 ECIS 的数据,2040 年欧洲癌症患者人数预计将达到 336 万人,而 2025 年将达到 294 万人。
人们对免疫疗法的兴趣日益浓厚
免疫疗法已成为一种有前途的癌症治疗方法,它利用人体的免疫系统有效对抗肿瘤。传统的癌症治疗经常遇到抗药性,并可能产生严重的副作用,因此免疫疗法很有吸引力,因为它的副作用较少,并且有望产生有针对性的持久反应。免疫肿瘤学检测对于免疫疗法药物的开发和评估至关重要,使研究人员和临床医生能够评估其疗效、安全性和作用机制。
开发成本高
免疫肿瘤学检测法的研发过程包括广泛的验证研究、检测法通讯协定优化和临床验证研究,以确保准确性、重现性和法律规章。此类活动需要大量的财务投资,包括设备、试剂、人员和监管备案。对于资源有限的小型企业来说,高昂的初始成本和漫长的开发时间可能会阻碍它们进入市场并与较大的现有企业进行有效竞争。
技术进步
多重检测、次世代定序(NGS) 和高通量筛检等技术创新使研究人员能够以更高的效率和精度同时分析多个参数,从而彻底改变了免疫肿瘤学领域。多重检测可测量单一样本中的多种分析物,从而全面了解免疫系统与癌细胞之间复杂的相互作用。 NGS 技术为基因组和转录组分析提供了前所未有的机会,有助于识别新型生物标记和治疗标靶。
来自替代技术的竞争
液态切片和诊断成像方法等替代技术具有非侵入性、即时监测和全面分子分析等独特优势。这些替代技术有可能为癌症进展、治疗效果和患者结果提供有价值的见解,并且在许多情况下补充甚至超越免疫肿瘤学测试的能力。因此,研究人员和临床医生可能会选择这些替代方法,特别是在免疫肿瘤学检测受到样本可用性、检测复杂性或成本限制的情况下。
最初,疫情爆发扰乱了供应链、实验室业务和临床试验,导致检测开发、验证和商业化延迟。对非必要医疗程序和实验室活动的限制也阻碍了免疫肿瘤学研究的实施以及检测技术在临床实践中的采用。此外,医疗保健资源和资金被用于对抗 COVID-19,从而转移了对免疫肿瘤学研究和开发的注意力和投资。然而,随着大流行的进展,免疫学和感染疾病研究的重要性被认识,可能引发对免疫肿瘤学检测的兴趣和投资。
预计消耗品领域在预测期内将是最大的
在预测期内,消耗品领域占据了市场的最大份额,因为它在支持免疫肿瘤检测的操作和扩充性发挥着至关重要的作用。在癌症发生率上升和免疫疗法普及的推动下,对免疫肿瘤检测的需求持续增长,对耗材的需求也相应增长。此外,检测开发的创新通常依赖于旨在提高检测灵敏度、特异性和通量的专用耗材。这创造了免疫肿瘤检测市场对耗材的持续需求。
流式细胞技术领域预计在预测期内复合年增长率最高
由于流式细胞技术仪在分析免疫细胞群及其在肿瘤微环境中的相互作用方面的多功能性和精确性,预计在预测期内将出现最高的复合年增长率。在单细胞层面同时测量多个参数的能力为了解免疫细胞表型、活化状态和功能反应提供了宝贵的见解。此外,流式细胞技术可以评估免疫查核点表达和细胞激素的产生,有助于评估免疫治疗效果和患者分层。
在估计期间,亚太地区占据最大份额。随着人口快速增长、人口老化和生活方式的改变,亚太国家的癌症发病率和死亡率正在迅速上升。都市化、烟草消费、污染和饮食习惯等因素导致该地区癌症发生率增加。因此,医疗基础设施的改善、诊断服务的获取以及对癌症筛检计划的认识的提高正在导致癌症患者的早期发现和诊断。
预计欧洲地区在预测期内将实现盈利成长。欧洲药品管理局 (EMA) 和欧盟委员会等欧洲监管机构建立的严格法规结构确保了临床研究和患者治疗中使用的免疫肿瘤检测的安全性、有效性和品质。欧洲法规环境强调透明度、基于证据的决策和道德考虑,这有助于在相关人员之间建立对免疫肿瘤学检测的信任和信心。因此,监管合规性将透过促进及时进入市场、促进创新以及加速在整个欧洲采用精准医学和个人化癌症治疗的免疫肿瘤学测试来推动市场成长。
According to Stratistics MRC, the Global Immuno Oncology Assay Market is accounted for $5.04 billion in 2023 and is expected to reach $11.71 billion by 2030 growing at a CAGR of 12.8% during the forecast period. The Immuno Oncology Assay Market refers to the sector within the healthcare industry focused on developing and commercializing assays that aid in the study and treatment of cancer by harnessing the body's immune system. These assays play a pivotal role in drug development by enabling the evaluation of novel immuno-oncology therapies, helping researchers identify promising candidates and assess their efficacy and safety profiles.
According to the ECIS, the European cancer burden is expected to reach 3.36 million new cases by 2040, compared to 2.94 million patients in 2025.
Growing interest in immunotherapy
Immunotherapy has emerged as a promising approach for cancer treatment, leveraging the body's immune system to combat tumors effectively. As traditional cancer treatments often encounter resistance and can have severe side effects, the appeal of immunotherapy lies in its potential for targeted and durable responses with fewer adverse effects. Immuno-oncology assays are integral to the development and evaluation of immunotherapeutic agents, allowing researchers and clinicians to assess their efficacy, safety, and mechanism of action.
High development costs
The research and development (R&D) process for immuno-oncology assays involves extensive validation studies, optimization of assay protocols, and clinical validation trials to ensure accuracy, reproducibility, and regulatory compliance. These activities require substantial financial investment, including expenditures on equipment, reagents, personnel, and regulatory submissions. For smaller companies with limited resources, the high upfront costs and long development timelines can be prohibitive, preventing them from entering the market or competing effectively with larger established players.
Technological advancements
Innovations such as multiplex assays, next-generation sequencing (NGS), and high-throughput screening are revolutionizing the field of immuno-oncology by enabling researchers to analyze multiple parameters simultaneously with greater efficiency and precision. Multiplex assays allow the measurement of multiple analytes in a single sample, providing comprehensive insights into the complex interactions between the immune system and cancer cells. NGS technologies offer unprecedented opportunities for genomic and transcriptomic profiling, facilitating the identification of novel biomarkers and therapeutic targets.
Competition from alternative technologies
Alternative technologies such as liquid biopsy assays or imaging modalities offer distinct advantages, such as non-invasiveness, real-time monitoring, and comprehensive molecular profiling. These alternatives may provide valuable insights into cancer progression, treatment response, and patient outcomes, often in ways that complement or surpass the capabilities of immuno-oncology assays. As a result, researchers and clinicians may opt for these alternative approaches, particularly in settings where immuno-oncology assays may be limited by sample availability, assay complexity, or cost.
Initially, the outbreak led to disruptions in supply chains, laboratory operations, and clinical trials, causing delays in assay development, validation, and commercialization. Restrictions on non-essential medical procedures and laboratory activities also hindered the conduct of immuno-oncology research and the adoption of assay technologies in clinical settings. Furthermore, the redirection of healthcare resources and funding towards COVID-19 response efforts diverted attention and investment away from immuno-oncology research and development. However, as the pandemic progressed, there emerged a heightened recognition of the importance of immunology and infectious disease research, potentially stimulating interest and investment in immuno-oncology assays.
The consumables segment is expected to be the largest during the forecast period
Consumables segment dominated the largest share of the market during the forecast period due to its indispensable role in supporting the operation and scalability of immuno-oncology assays. As the demand for immuno-oncology assays continues to rise, fueled by increasing cancer prevalence and the growing adoption of immunotherapy, the need for consumables also escalates proportionally. Moreover, innovations in assay development often rely on specialized consumables designed to improve assay sensitivity, specificity, and throughput. This creates a continuous demand for consumables within the immuno-oncology assay market.
The flow cytometry segment is expected to have the highest CAGR during the forecast period
Flow Cytometry segment is expected to have the highest CAGR during the projection period due to its versatility and precision in analyzing immune cell populations and their interactions within the tumor microenvironment. This segment allows for the simultaneous measurement of multiple parameters at the single-cell level, providing valuable insights into immune cell phenotypes, activation states, and functional responses. Additionally, flow cytometry enables the assessment of immune checkpoint expression and cytokine production, facilitating the evaluation of immunotherapy efficacy and patient stratification.
Asia Pacific region commanded the largest share over the extrapolated period. With a rapidly expanding population, aging demographics, and changing lifestyles, countries across Asia Pacific are experiencing a surge in cancer incidence and mortality rates. Factors such as urbanization, tobacco consumption, pollution, and dietary habits contribute to the rising burden of cancer in the region. As a result, improvements in healthcare infrastructure, access to diagnostic services, and awareness of cancer screening programs are leading to earlier detection and diagnosis of cancer cases in the region thereby enhancing the market growth.
Europe region is poised to witness profitable growth throughout the estimation period. The stringent regulatory framework established by European regulatory bodies, such as the European Medicines Agency (EMA) and the European Commission, ensures the safety, efficacy, and quality of immuno-oncology assays used in clinical research and patient care. The European regulatory environment emphasizes transparency, evidence-based decision-making, and ethical considerations, which contribute to building trust and confidence in immuno-oncology assays among stakeholders. As a result, regulatory compliance serves as a catalyst for market growth by facilitating timely market entry, encouraging innovation, and promoting the adoption of immuno-oncology assays for precision medicine and personalized cancer care throughout the European region.
Key players in the market
Some of the key players in Immuno Oncology Assay market include Agilent Technologies, Inc, Bio-Rad Laboratories, Inc, Charles River Laboratories, Inc, F. Hoffmann-La Roche Ltd, Guardant Health, Inc, HTG Molecular Diagnostics, Inc, llumina, Inc, NanoString Technologies, Inc, Novartis International AG, Perkinelmer, Inc, Qiagen Nv, Sartorius AG, Sysmex Corporation and Thermo Fisher Scientific, Inc.
In January 2024, Thermo Fisher Scientific introduced Gibco(TM) Cell Therapy Systems (CTS(TM)) Cellmation(TM) Software, a new automation solution. It integrates workflows across Thermo Fisher Scientific cell therapy instruments and ensures cGMP compliance for innovators in breakthrough cell therapies.
In March 2023, Mimetas, a company that models human diseases, formed a strategic alliance with Astellas Pharma Inc., a multinational pharmaceutical corporation. The partnership entails using MIMETAS' exhaustive tumor models to assist the next generation of immuno-oncological therapies.
In February 2023, Agilent Technologies, Inc. revealed that their xCELLigence RTCA HT (real-time cell analysis high-throughput) platform is compatible with the BioTek BioSpa 8 Automated Incubator. This combination, developed in response to market demands, enables a higher level of workflow automation and provides novel functionality for developing label-free high-throughput potency assays for the immuno-oncology market and high-throughput viral cytopathic effects (CPE) assays for the vaccine market.