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市场调查报告书
商品编码
1423588
到 2030 年肿瘤伴同性诊断市场预测:按产品、技术、适应症、最终用户和地区进行的全球分析Oncology Companion Diagnostic Market Forecasts to 2030 - Global Analysis By Product (Instrument, Consumables and Software), Technology, Indication, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球肿瘤伴同性诊断市场规模将达到 35 亿美元,预计到 2030 年将达到 94 亿美元,预测期内复合年增长率为 14.9%。
肿瘤学中的伴同性诊断是指专门设计用于帮助癌症患者选择最合适的治疗方法或治疗策略的诊断方法和测试。透过识别患者肿瘤中的特定生物标记、基因突变和分子特征,这些测试可以帮助医疗专业人员为个别患者量身定制治疗计划。这些诊断发现了预测患者对特定治疗的潜在反应的生物标记。
根据美国癌症协会2022年1月预测,到年终,美国将总合新增190万癌症病例。此外,患有慢性病的人是美国最常使用伴同性诊断的人,推动了市场的成长。
越来越重视标靶治疗和免疫治疗
标靶治疗和免疫疗法通常需要特定的生物标记或基因指纹来进行最佳患者选择。伴同性诊断对于识别这些预测生物标记至关重要,以便根据患者的分子特征选择最佳治疗药物。伴同性诊断有助于将有效的标靶治疗和免疫疗法更快推向市场。经过验证的诊断的可用性可透过增加监管机构和医疗保健专业人员对其功效的信心来支持这些治疗方法的商业性成功。
开发成本高且报销有限
由于伴同性诊断的开发成本较高,诊断公司可能会选择不进行研发。这可能导致缺乏创造力并延迟新的和增强的癌症诊断的发展。由于成本问题,医疗保健系统或付款人可能不愿意为伴同性诊断提供资金,这可能会延迟测试的采用。因此,临床采用可能会被推迟,进一步阻碍市场成长。
能够缩短临床试验时间
有效伴同性更有可能对特定药物产生反应的患者群体的伴随诊断可以简化临床试验。将具有特定生物标记或基因谱的患者纳入其中有助于更快地在临床试验中证明疗效,从而有可能缩短开发新药的时间。补充诊断使临床试验能够更准确地识别和参与最有可能从正在研究的治疗中受益的人。因此,密集的患者招募可以减少完成实验所需的时间和资源,进一步加快受试者招募速度,并为预测期内的市场成长创造广泛的机会。
监管挑战和严格的核准流程
由于严格的监管标准,伴同性诊断通常需要更长的开发时间和更高的开发成本。获得监管部门的批准需要进行广泛的临床前和临床验证研究,从而导致更长的开发时间和更高的成本。不同肿瘤类型或病患小组之间生物标记表达的差异可能会对验证和解释过程提出挑战,这可能导致缺乏监管核准。
COVID-19 的影响
医疗保健和其他医疗机构已重新分配人员和设备,以适应 COVID-19 患者的增加。非紧急患者和相关诊断测试的积压是由于肿瘤学优先事项的转变,过去将重点放在紧急或严重的癌症病例。随着卫生保健系统适应流行病的障碍,癌症的筛检、诊断和治疗逐渐得到改善。继续努力解决延期病例和诊断测试的积压问题,有助于肿瘤伴同性诊断市场的復苏。
次世代定序仪(NGS)领域预计在预测期内规模最大
由于次世代定序对患者肿瘤 DNA、RNA 和其他遗传资料的全面探索,下一代次世代定序(NGS) 领域预计将出现良好的成长。与传统的单基因测试相比,它透过同时识别与癌症相关的多个基因突变、改变和生物标记来提供更完整的情况。在选择合格的患者进行评估新标靶治疗和免疫疗法的临床试验时,基于次世代定序仪的伴同性诊断至关重要且受市场驱动。
预计白血病领域在预测期内的复合年增长率最高。
由于白血病是一种影响骨髓和血液的恶性,因此预计白血病领域在预测期内将出现最高的复合年增长率。白血病是肿瘤伴同性诊断市场的主要部分之一,因为它是一种影响骨髓和血液的恶性。在寻找合格的患者进行测试新型免疫疗法、标靶治疗或白血病联合治疗的临床试验时,伴同性发挥重要作用。伴同性诊断支持创新治疗方法和治疗方法的创建和评估。
预计北美在预测期内将占据最大的市场占有率。这是因为来自美国癌症研究所 (NCI) 等组织的资金加速了精准治疗的市场开拓,并对当地市场产生了积极影响。 NCI 的小型企业技术转移 (STTR) 和小型企业创新研究 (SBIR) 计划致力于增强和创建用于癌症诊断、预防和治疗的尖端工具和解决方案。此外,在加拿大举行的许多会议旨在提高人们对伴随诊断发展和趋势的认识,进一步支持了这种扩张。
由于各种恶性的盛行率不断增加以及对准确和客製化诊断设备的需求不断增长,预计亚太地区在预测期内将呈现最高的复合年增长率。使用伴同性诊断识别生物标记有助于为特定患者量身定制治疗计划。患者和医疗保健提供者对伴同性诊断和个人化治疗的好处的了解不断增加,导致其采用率不断提高。此外,亚太国家不断上涨的医疗成本也促进了先进诊断技术的取得。
According to Stratistics MRC, the Global Oncology Companion Diagnostic Market is accounted for $3.5 billion in 2023 and is expected to reach $9.4 billion by 2030 growing at a CAGR of 14.9% during the forecast period. Companion diagnostics in oncology refers to diagnostic methods or tests that are intended specially to help cancer patients choose the best therapy or course of treatment. By identifying certain biomarkers, genetic mutations, or molecular features in a patient's tumour, these tests assist medical professionals in customizing treatment plans for individual patients. These diagnostics find biomarkers that predict a patient's potential response to a certain treatment.
According to the American Cancer Society, in January 2022, a total of 1.9 million new cancer cases from cancer are expected to occur in the United States by the end of 2022. Moreover, people with chronic conditions are the most frequent users of companion diagnostics in the United States; they drive the market's growth.
Growing emphasis on targeted therapies and immunotherapies
For the best patient selection, targeted treatments and immunotherapies frequently need for certain biomarkers or genetic fingerprints. In order to match patients with the most appropriate medicines based on their molecular profile, companion diagnostics are essential in the identification of these predictive biomarkers. Complementary diagnostics help effective targeted treatments and immunotherapies reach the market more quickly. The availability of validated diagnostics helps these therapies succeed commercially by boosting the trust of regulators and healthcare professionals in their effectiveness.
High development costs and limited reimbursement
Diagnostic firms may choose not to engage in research and development due to the high development costs involved with companion diagnostics. This can result in a lack of creativity and slow development of fresh, enhanced oncology diagnostic tests. Healthcare systems or payers may be reluctant to fund companion diagnostics owing to cost concerns, which might result in a delayed uptake of the tests. Their incorporation into clinical practice may be delayed as a result and further hamper the growth of the market.
Its ability to reduce clinical trial timelines
Clinical trials can be streamlined by oncology companion diagnostics that effectively identify patient populations likely to react to a certain drug. Trials can prove efficacy faster by including patients with certain biomarkers or genetic profiles, which might shorten the time it takes to create new drugs. Complementary diagnostics enable clinical trials to more accurately identify and enlist people who will most likely benefit from the investigated treatment. Thus, the time and resources required to complete the experiment are decreased as a result of the focused patient recruiting, which speeds up enrolment further creating wide range of opportunities for the growth of the market during the forecast period.
Regulatory challenges and stringent approval processes
Complying with strict regulatory criteria frequently results in longer development times and higher development costs for companion diagnostics. The necessity of conducting extensive preclinical and clinical validation studies in order to obtain regulatory clearance results in longer development times and higher costs. The presence of variability in biomarker expression among distinct tumour types or patient groups might provide challenges to the validation and interpretation process, which may result in regulatory approvals being denied.
Covid-19 Impact
Hospitals and other healthcare institutions reallocated personnel and equipment in order to handle the increase in COVID-19 patients. A backlog of non-urgent patients and accompanying diagnostic tests resulted from priorities shifting in oncology departments, which were centered on urgent or critical cancer cases. Cancer screenings, diagnoses, and treatments have gradually improved as healthcare systems have adjusted to the obstacles presented by the epidemic. Ongoing initiatives to clear the backlog of postponed cases and diagnostic testing have contributed to the market recovery for cancer companion diagnostics.
The next-generation sequencing (NGS) segment is expected to be the largest during the forecast period
The next-generation sequencing (NGS) segment is estimated to have a lucrative growth, because of comprehensive study of a patient's tumor DNA, RNA, and other genetic data which is made possible by next-generation sequencing. Comparing it to conventional single-gene testing, it allows for the simultaneous identification of several genetic mutations, changes, and biomarkers linked to cancer, yielding a more complete picture. When it comes to selecting patients who are qualified for clinical trials evaluating new targeted treatments or immunotherapies, next-generation sequencing -based companion diagnostics are essential thus propelling the market.
The leukemia segment is expected to have the highest CAGR during the forecast period
The leukemia segment is anticipated to witness the highest CAGR growth during the forecast period, as leukemia is a malignancy that affects the bone marrow and blood. It is one of the major segments of the oncology companion diagnostic market. As soon as it comes to finding qualified individuals for clinical trials testing novel immunotherapies, targeted therapies, or combination treatments for leukemia, companion diagnostics play a crucial role. They aid in the creation and assessment of innovative therapies and therapeutic approaches.
North America is projected to hold the largest market share during the forecast period owing funding from organizations like the National Cancer Institute (NCI) would hasten the development of precision therapies and have a favorable impact on the regional market. The NCI's Small Business Technology Transfer (STTR) and Small Business Innovation Research (SBIR) programs work to enhance and create cutting-edge tools and solutions for cancer diagnosis, prevention, and treatment. Furthermore, a number of conferences held in Canada to raise awareness of the developments and trends in CDx serve as an additional boost to this expansion.
Asia-Pacific is projected to have the highest CAGR over the forecast period, owing to growing incidence of different malignancies has increased need for accurate and customized diagnostic instruments. The identification of biomarkers using companion diagnostics facilitates the customization of treatment plans for specific patients. Adoption has expanded as a result of patients' and healthcare professionals' growing understanding of the advantages of companion diagnostics and tailored treatment. Furthermore, access to sophisticated diagnostic technologies has been made easier by the growing cost of healthcare in a number of Asia Pacific nations.
Key players in the market
Some of the key players profiled in the Oncology Companion Diagnostic Market include Roche Ltd., F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific, Inc., Illumina, Inc., Agilent Technologies, Inc., Abbott, Invivoscribe, Inc., bioMerieux SA, Myriad Genetics, Inc., ARUP Laboratories, QIAGEN N.V., Agendia N.V, Biogenex Laboratories, Inc., GE Healthcare, Life Technologies Corporation, Ventana Medical Systems, Inc., Labcorp Drug Development, Leica Biosystems, MolecularMD Corporation and Dako, Inc.
In December 2023, Roche enters into a definitive merger agreement to acquire Carmot Therapeutics, including three clinical stage assets with best-in-class potential in obesity and diabetes.
In November 2023, Roche launches automated serology hepatitis E virus tests, including a test to detect acute HEV infections, recommended in the new WHO 2023 Essential Diagnostics List. The tests complete Roche's panel used for the differential diagnosis of acute viral hepatitis caused by the hepatitis A, B, C and E viruses.
In November 2023, Thermo Fisher Scientific & Flagship Pioneering Expand Ongoing Strategic Partnership to Jointly Create New Platform Companies with First-in-Class Enabling Technologies for Life Sciences.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.