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市场调查报告书
商品编码
1351045
2030 年伴随诊断市场预测:按产品、适应症、技术、最终用户和地区进行的全球分析Companion Diagnostics Market Forecasts to 2030 - Global Analysis By Product, Indication, Technology, End User and By Geography |
根据 Stratistics MRC 的数据,2023 年全球伴随诊断市场规模为 72.4 亿美元,预计到 2030 年将达到 188.1 亿美元,预测期内年复合成长率为 14.6%。
伴随诊断是用于确保可比较生物製剂或药物的使用安全有效的测试。这些检查通常用于诊断癌症、神经系统疾病、心血管疾病和感染疾病。此测试根据检测到的生物标记推荐适当的药物。根据特定患者的反应,这些测试提供量身定制的治疗。在决定是否使用标靶治疗药物时,伴随诊断测试(CDX)至关重要。
根据肺癌研究基金会2022年报告,预计2022年美国将有236,740人被诊断出患有肺癌,增加了对肺癌伴随诊断的需求。
随着基因定序和基因组学的进步,人们普遍认为不同的个体可能会对不同的药物产生反应。透过更了解一个人的遗传特征和生物标记物,我们可以改进技术,在正确的时间、以正确的剂量向正确的人给药正确的药物。为了将治疗给药放在正确的候选人身上,製药和生物製药公司继续努力在药物开发的早期阶段采用患者选择性诊断框架。这有助于市场的进一步扩大。
儘管人们越来越认识到伴随诊断的效用,但尚未建立伴随诊断支付的标准。付款方式依具体情况决定。住院治疗和门诊治疗的医疗费用是不同的。诊断主要由诊断相关团体负责住院治疗系统。门诊护理费用是根据可报销服务的详细清单支付的。结果,缺乏补偿和严格的监管限制了市场的扩张。
胰臟癌、女性乳癌和大肠直肠癌新发病例的增加,以及骨髓瘤、子宫癌和肾癌的停滞,是由于肥胖、糖尿病和缺乏运动的患病上升。事实证明,伴随诊断不仅在临床个别患者的治疗中,而且在新药开发过程中都是至关重要的工具。从伴随诊断中获得的资讯对于安全有效地使用标靶药物至关重要。这项诊断有几个雄心勃勃的目标。由于有效的诊断、监测、筛检和预后预测,市场正在扩大。
儘管免疫疗法是一种非常有前景的癌症治疗方法,但其高昂的成本限制了一般患者的使用。如果您的医师确定合併用药有益,治疗时间可能会从 5 个月延长到 3 年以上。在这种情况下,治疗时间越长,费用就越高。每种 CAR T 细胞疗法都是针对每位患者量身定制的,并且需要大量的研究资源。因此,仅每位患者的药品费用就上升至约 6 万美元。癌症免疫疗法可能比化疗和放射线治疗等其他治疗方法昂贵得多。因此,免疫肿瘤治疗的高成本预计将限制其扩张。
COVID-19 的早期检测在市场上至关重要,因为它可能会导致适当的治疗。使用鼻咽拭子或其他上呼吸道检体(包括咽喉拭子)进行聚合酶连锁反应 (PCR) 检测,是诊断 COVID-19 时使用最广泛、最可靠的方法。自此,基于聚合酶链反应(PCR)的诊断方法成为治疗该疾病的重要领域。市场成长的推动因素包括针对各种疾病的新生物标誌物的开发、标靶治疗的研发不断增加、新兴市场意识的提高对个人化医疗的需求增加以及未满足的医疗需求不断增加,这是要素。
随着全球范围内肺癌患病率的增加,患病领域预计将出现良好的增长。在决定是否使用标靶治疗药物治疗肺癌时,伴随诊断测试(CDX)被认为是必不可少的。在初始治疗中接受伴随测试的肺癌患者比未接受筛检的患者有更高的存活率。非小细胞肺癌(NSCLC)患病的不断上升以及针对该疾病的肿瘤学伴随诊断的加速发展预计将推动该领域在全球范围内的增长。
聚合酶链反应(PCR)领域预计在预测期内年复合成长率最快。高灵敏度 PCR 方法可以快速扩增 DNA 的特定部分。 PCR 使用基于大小和电荷的视觉方法,可以透过产生数十亿个特定 DNA 片段或基因的拷贝来检测和鉴定基因序列。这是一项快速诊断测试,可在 4 至 8 小时内完成。由于更快的结果、有效的适当治疗和抗菌药物抗药性测试,这一类别正在不断增长。
预计北美在预测期内将占据最大的市场份额。美国已成为该地区的主要贡献者。美国开始在该地区发挥重要作用。在美国,伴随诊断最常见的使用者是慢性病患者。随着该地区使用伴随诊断试剂盒的研究活动的增加,以及为了解人类基因组而创建的基因资料库的医疗机构数量也在增加,该市场正在扩大。
由于对个人化医疗的偏好以及公司之间合作的增加,预计欧洲在预测期内将呈现最高的年复合成长率。德国和法国在该地区的市场份额最高。该地区不断发展的医疗旅游业,以及越来越多的老年人口(更容易患癌症和神经系统疾病)正在进一步推动市场需求。
According to Stratistics MRC, the Global Companion Diagnostics Market is accounted for $7.24 billion in 2023 and is expected to reach $18.81 billion by 2030 growing at a CAGR of 14.6% during the forecast period. A companion diagnostic is a test used to ensure the usage of a comparable biological product or medication is both safe and effective. These tests are typically used to diagnose cancer, neurological, cardiovascular and infectious diseases. In this, an appropriate medicine is recommended based on the detected biomarker. Based on a particular patient's reaction, these tests offer tailored treatment. When deciding whether to use targeted therapeutics, companion diagnostic exams (CDXs) are crucial.
According to Lung Cancer Research Foundation report 2022, an estimated 236,740 people were diagnosed with lung cancer in 2022 in the United States, leading to more demand for lung cancer companion diagnostics.
Since genetic sequencing and genomics have advanced, it is generally accepted that various individuals might respond to medications differently. The technique of giving "the right drug, at the right time, at the right dose, for the right person" can be advanced by having a better understanding of a person's genetic traits or biomarkers. In order to give focused therapeutics to the appropriate candidate, pharmaceutical and biopharmaceutical firms are continually working to adopt patient-selection diagnostic frameworks in the early phases of drug development. This helps the market's expansion to grow further.
Despite growing acceptability, there are no established criteria for determining how much should be paid for a companion diagnostic test. Payment is determined on a case-by-case basis. For inpatient and outpatient care, reimbursement is different. Diagnostics are primarily covered for the inpatient care system by diagnosis-related groups. The payment is made in accordance with the detailed list of services that can be reimbursed for outpatient care. Therefore, the absence of compensation and onerous rules restrain market expansion.
The increased trends in new instances of pancreatic, female breast, and colorectal cancer as well as the stagnation of myeloma, uterine, and kidney cancer are attributed to the rising prevalence of obesity, diabetes, and physical inactivity. Companion diagnostics have proven to be a crucial tool for the treatment of individual patients in the clinic as well as for the process of developing new drugs. Information from companion diagnostics is crucial for the safe and efficient use of targeted medicines. This diagnosis has several ambitious objectives. The market is growing because of its effective diagnosis, monitoring, screening, and prognosis.
The high expense of immunotherapy has restricted general patient access even though it has showed tremendous promise in the treatment of cancer. The length of the course of therapy might be increased from five months to over three years if doctors decide that it is beneficial to combine medicines. In this instance, the cost increases as the duration increases. Each CAR T-cell therapy is customized for the patient, requiring significant lab resources. As a result, the price per patient for the medicine alone rises to around USD 60,000. Cancer immune therapies can be far more expensive than other treatment choices like chemotherapy or radiation therapy. Consequently, it is anticipated that the high cost of immune-oncology treatments would restrain their expansion.
Early detection of COVID-19 became crucial in the market since it may aid in people with the condition receiving the right care. The polymerase chain reaction (PCR) test employing nasopharyngeal swabs or other upper respiratory tract specimens, including throat swabs, was the most widely used and trustworthy method for the diagnosis of COVID-19. Polymerase chain reaction (PCR)-based diagnostics, then, became a key area of focus for treating the illness. The development of new biomarkers for various diseases, an increase in research and development of targeted therapies, an increase in demand for customized medicine with increased recognition in developing markets, and a higher number of unmet medical needs are all contributing factors fuelled the market growth.
The cancer segment is estimated to have a lucrative growth, due to the growing prevalence of lung cancer all around the world. When deciding whether to use targeted medicines to treat lung cancer, companion diagnostic tests (CDXs) are regarded as indispensable. Lung cancer patients who obtained companion diagnostics as part of their initial treatment had higher survival rates than patients who did not get screened. The increasing prevalence of non-small cell lung cancer (NSCLC), together with the acceleration of the development of oncology companion diagnostic tests for the condition, are expected to propel the segment's growth on a global scale.
The polymerase chain reaction (PCR) segment is anticipated to witness the fastest CAGR growth during the forecast period. The highly sensitive PCR method enables quick DNA amplification of a particular section. Using visual methods based on size and charge, PCR may detect and identify gene sequences by producing billions of copies of a certain DNA fragment or gene. It is a rapid diagnostic exam that takes 4 to 8 hours to complete. The category is growing as a consequence of its speedier results, efficient appropriate therapy, and anti-microbial resistance testing.
North America is projected to hold the largest market share during the forecast period. United States is emerging as a major contributor in the region. The United States has begun to play a significant role in this region. The most common users of companion diagnostics in the US are those with chronic diseases. The market is expanding as a result of rising research activities employing companion diagnostic kits in this region as well as the rising number of healthcare organizations working on genomic databases created to comprehend the human genome.
Europe is projected to have the highest CAGR over the forecast period, owing to the growing preference for personalized medicine and increasing collaboration among companies. The region's highest market share is held by Germany and France. The market demand is being further fuelled by the region's growing medical tourism industry as well as the region's expanding senior population who are more susceptible to cancer and neurological illnesses.
Some of the key players profiled in the Companion Diagnostics Market include: Abbott, Agendia N.V, Agilent Technologies, ARUP Laboratories, Inc., Biogenex Laboratories, Inc., Dako, Inc., Roche Molecular Systems, Inc., Foundation Medicine, Inc., GE Healthcare, Genomic Health, Illumina, Inc., Genetron Holdings Limited, Labcorp Drug Development, Leica Biosystems, Life Technologies Corporation, MolecularMD Corporation, Myriad Genetic Laboratories, Inc., Ventana Medical Systems, Inc., Exact Sciences Corporation and Qiagen.
In January 2023, Thermo Fisher Scientific partners with Astrazeneca to develop solid tissue and blood-based companion diagnostic test for tagrisso. The collaboration will leverage the Oncomine Dx Express Test* on the Genexus Dx System*, a fully-integrated next-generation sequencing (NGS) platform featuring an automated specimen-to-report workflow that economically delivers results in as little as 24 hours to bring test results to clinicians and patients faster.
In February 2022, Genetron Holdings Limited, a leading precision oncology platform company in China specializing in molecular profiling tests, early cancer screening products, and companion diagnostics development, entered a collaboration agreement with HUTCHMED (China) Limited to develop a companion diagnostic (CDx).
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.