DKK1

CAMBRIDGE, Mass., March 18, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the fourth quarter and year ended December 31, 2023. Leap Highlights: Presented new clinical data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with standard of care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer, at the 2024 ASCO Gastrointestinal Cancers Symposium Completed enrollment in the randomized controlled Part C of the Phase 2 DisTinGuish study evaluating DKN-01 in combination with tislelizumab and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer "As we reflect on the fourth quarter and the achievements of the past year, we are proud of the strides we've made in advancing DKN-01 and integrating our pipeline of earlier stage biomarker-targeted antibody therapies. The data from Part A of the DeFianCe study, demonstrating a 30% overall response rate and a 93% disease control rate in second-line colorectal cancer patients, showcases a strong foundation as we move into the randomized controlled Part B of the study," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Additionally, the completion of enrollment in Part C of the DisTinGuish study in first-line gastroesophageal junction and gastric cancer patients positions us to deliver the first randomized controlled data for DKN-01 starting in the middle of the year. As we look ahead to a data rich 2024, we remain focused on our mission to deliver new personalized medicines to patients fighting against cancer." DKN-01 Development Update Presented initial clinical data from Part A of the DeFianCe Study of DKN-01 plus bevacizumab and chemotherapy in colorectal cancer (CRC) patients. The Company presented initial data from Part A of the DeFianCe study (NCT05480306), a Phase 2 study evaluating DKN-01 in combination with standard of care (SOC) bevacizumab and chemotherapy in second-line (2L) patients with advanced microsatellite stable (MSS) CRC patients at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium, held in San Francisco on January 18-20, 2024 and during the Company's conference call on January 23, 2024. Key Findings: As of the December 6, 2023 data cutoff, across all patients enrolled (n=33): Overall response rate (ORR) among response-evaluable patients (n=27) was 30% and disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD) Median progression-free survival (PFS) was 6.3 months 9 patients remained on therapy and were beyond 8.5 months Enhanced activity in patients with left-sided tumors (n=25), a group that has more frequent activation of the Wnt pathway modulated by DKK1 33% ORR and 100% DCR in response-evaluable population (7 PRs, 14 SDs) Preliminary median PFS of 8.6 months (9 patients continuing therapy within subgroup) Compelling ORR, DCR and PFS in patients with rectal/rectosigmoid carcinomas (n=15), a population with increasing incidence among young people and shown to have the highest DKK1 levels: 46% ORR and 100% DCR in response-evaluable population (6 PRs, 7 SDs) Preliminary median PFS of 9.4 months (6 patients continuing therapy within subgroup) Higher baseline plasma DKK1 levels correlated with improved responses DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01 related events being low grade (Grade 1/2) The Company expects the 130 patient randomized controlled Part B to complete enrollment in mid-2024. As of March 15, 2024, 80 patients have enrolled in Part B. Announced completion of enrollment in the randomized controlled Part C of the DisTinGuish study evaluating DKN-01 in combination with tislelizumab, BeiGene's anti-PD-1 antibody, and chemotherapy in patients with advanced gastroesophageal junction and gastric cancer. Part C of the DisTinGuish study (NCT0436380) is a Phase 2, randomized, open-label, multicenter study of DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal adenocarcinoma. Part C enrolled 170 first-line, HER2-negative patients randomized 1:1 to evaluate DKN-01 in combination with tislelizumab and SOC chemotherapy, compared to tislelizumab and SOC chemotherapy alone. The primary objective is progression-free survival (PFS) in DKK1-high and in all patients. Secondary objectives of Part C include overall survival and objective response rate as measured by RECIST v1.1 in DKK1-high and in all patients. The Company expects to report initial data from Part C of the DisTinGuish study in mid-2024. Selected Year-End and Fourth Quarter 2023 Financial Results Net Loss was $81.4 million for the year ended December 31, 2023, compared to $54.6 million for the year ended December 31, 2022. The increase was due to in-process research and development acquired in the Flame merger which was expensed during the year ended December 31, 2023, costs incurred in connection with our research and development programs, and from general and administrative costs associated with our operations. Research and development expenses were $73.2 million for the full year 2023, compared to $45.0 million for the same period in 2022. Research and development expenses were $11.7 million for the fourth quarter ended 2023, compared to $11.0 million for the same period in 2022. The increases for the full year 2023 were primarily due to in-process research and development acquired in the Flame merger, an increase in clinical trial costs, and an increase in payroll and other related expenses due to an increase in headcount of research and development full-time employees. General and administrative expenses were $13.8 million for the full year 2023, compared to $11.8 million for the same period in 2022. General and administrative expenses were $3.1 million for the fourth quarter ended 2023, compared to $2.9 million for the same period in 2022. The increases for the full year 2023 were primarily due to costs associated with our business development activities and an increase in payroll and other related expenses due to an increase in headcount of general and administrative full-time employees. Cash and cash equivalents totaled $70.6 million at December 31, 2023. Research and development incentive receivables totaled $0.8 million at December 31, 2023. About Leap Therapeutics Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patients with esophagogastric, gynecologic, and colorectal cancers. FL-301, is a humanized monoclonal antibody targeting Claudin18.2, being developed in patients with gastric and pancreatic cancer. Leap also has preclinical antibody programs targeting Claudin18.2/CD137 and GDF15. For more information about Leap Therapeutics, visit or view our public filings with the SEC that are available via EDGAR at or via . FORWARD-LOOKING STATEMENTS This press release contains forward-looking statements within the meaning of the federal securities laws. Such statements are based upon current plans, estimates and expectations of the management of Leap that are subject to various risks and uncertainties that could cause actual results to differ materially from such statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Words such as "anticipate," "expect," "project," "intend," "believe," "may," "will," "should," "plan," "could," "continue," "target," "contemplate," "estimate," "forecast," "guidance," "predict," "possible," "potential," "pursue," "likely," and words and terms of similar substance used in connection with any discussion of future plans, actions or events identify forward-looking statements. All statements, other than historical facts, including statements regarding the potential safety, efficacy, and regulatory and clinical progress of Leap's product candidates; the anticipated timing for completion of clinical trials and release of clinical trial data and the expectations surrounding the outcomes thereof; Leap's future clinical or preclinical product development plans for any of Leap's product candidates; Leap's estimations of projected cash runway; and any assumptions underlying any of the foregoing, are forward-looking statements. Important factors that could cause actual results to differ materially from Leap's plans, estimates or expectations could include, but are not limited to: (i) Leap's ability to successfully execute its clinical trials and the timing of enrollment in and cost of such clinical trials; (ii) the results of Leap's clinical trials and pre-clinical studies; (iii) Leap's ability to successfully enter into new strategic partnerships for DKN-01 or any of its other programs and to maintain its ongoing collaborations with BeiGene, NovaRock and Adimab; (iv) whether any Leap clinical trials and products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; (v) exposure to inflation, currency rate and interest rate fluctuations, as well as fluctuations in the market price of Leap's traded securities; and (vi) that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by global conflict, or supply chain related issues. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or Implied) are made about the accuracy of any such forward-looking statements. Leap may not actually achieve the forecasts disclosed in such forward-looking statements, and you should not place undue reliance on such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption "Risk Factors" in Leap's most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither Leap, nor any of its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Leap's views as of any date subsequent to the date hereof. CONTACT: Douglas E. Onsi President & Chief Executive Officer Leap Therapeutics, Inc. 617-714-0360 [email protected] Matthew DeYoung Investor Relations Argot Partners 212-600-1902 [email protected] SOURCE Leap Therapeutics, Inc.

▎药明康德内容团队编辑2024年2月，非同生物宣布其研发的新型5T4 x 4-1BB双特异性抗体FTL008.16获得美国FDA批准临床试验，拟开发用于治疗恶性实体肿瘤。2024年1月，爱科瑞思宣布其研发的靶向5T4的抗体偶联药物（ADC）ADC2154获得中国NMPA批准临床试验，拟开发用于治疗晚期实体瘤。在2023年，英百瑞生物也曾宣布其开发的靶向5T4的CAR-NK细胞疗法已获中国NMPA批准临床，拟开发用于实体肿瘤患者的治疗。那么，5T4是什么？从双特异性抗体、ADC到细胞疗法，5T4因何具有这么广的开发潜力？除了上述药物，当前还有哪些靶向5T4的创新疗法已进入到临床试验阶段？它们又有望惠及哪些肿瘤患者？本文将结合公开资料带大家来了解下。图片来源：123RF——✦5T4：肿瘤免疫治疗新星✦——5T4又称滋养层糖蛋白（Trophoblast glycoprotein, TPBG）、Wnt激活抑制因子 1（WAIF1），是由TPBG基因编码的脊椎动物特异性单次跨膜蛋白。5T4蛋白首次在人胎盘组织中发现[1]，是N端高度糖基化的跨膜蛋白。人类5T4全长蛋白的分子量约为72kDa，蛋白序列保守，由420个氨基酸组成。该蛋白在胞外结构域中包含一个细胞外区、一个跨膜区（356-376aa）和一个胞内区（如下图所示）[2,3]，其中胞内区含有PDZ结合基序（Ser-Asp-Val），该结合基序可以与位于细胞附近囊泡相关的细胞质蛋白膜TIP-2/GIPC互相作用，从而可参与细胞迁移和黏附信号转导过程的调控[4]。▲5T4结构（截图来源：Front Mol Neurosci [5]）研究发现，5T4广泛表达于胚胎发育期的各种滋养层细胞，其在成人正常组织中表达受限，只在几种上皮细胞中表达，但却在很多癌症细胞中有表达，包括子宫癌、结肠癌、胃癌、卵巢癌、口腔癌、前列腺癌、肺癌或肾癌等。这一特点使其成为了一种有吸引力的肿瘤免疫治疗新靶点。对于5T4影响肿瘤的作用机制，目前尚不十分清晰。但有相关研究发现，5T4具有阻断经典Wnt/β-catenin通路和非经典Wnt信号通路的双重作用：一方面，5T4会与Wnt共受体LRP6结合并抑制其与Wnt受体的内吞，从而阻断Wnt/β-catenin经典信号通路，继而抑制细胞黏附和细胞骨架的形成，促进肿瘤迁移和扩散；另一方面，5T4还可通过活化DKK1来激活非经典Wnt通路，促进细胞迁移和浸润[6]。此外，还有研究认为，5T4也可能是通过影响上皮间质转化（EMT）和CXCR4/CXCL12相关通路来影响肿瘤细胞的发生、发展、转移等。基于5T4肿瘤表达的选择性模式、与肿瘤起始表型的相关性以及其在癌症扩散中的作用，研究人员认为可以针对该靶点开发不同的免疫疗法[7]，包括疫苗、抗体偶联药物、细胞疗法等等，为患者带来潜在的治疗新选择。——✦多款5T4靶向疗法已迈入临床阶段✦——公开资料显示，目前全球尚无靶向5T4的药物获批上市，但已有很多5T4靶向疗法进入到临床试验阶段。这些在研药物包括双特异性抗体、ADC、细胞疗法、融合蛋白等多种药物类型，针对的适应症均为肿瘤。下面我们将介绍部分已进入临床阶段的在研产品，仅供读者参阅。Aptevo、Alligator：ALG.APV-527作用机制：5T4 x 4-1BB双抗Aptevo Therapeutics和Alligator Biosciences共同开发的ALG.APV-527是一款同时靶向5T4和共刺激受体4-1BB（CD137）的双特异性抗体。在第35届肿瘤免疫治疗学会年会（SITC 2020）上，Aptevo曾展示了ALG.APV-527的研究结果。数据显示，ALG.APV-527具有选择性刺激和增强肿瘤中T细胞反应的潜力，而不会刺激身体其他部位的免疫系统，并在体内动物模型中有效抑制了肿瘤。目前，该候选药正在开展针对实体瘤的1/2期临床研究。非同生物：FTL008.16作用机制：5T4 x 4-1BB双抗FTL008.16是非同生物研发的一款新型5T4 x 4-1BB双特异性抗体，拟开发用于治疗恶性实体肿瘤。该产品可通过5T4抗体引导药物分子聚集于表达5T4抗原的肿瘤部位，由共刺激分子4-1BB抗体诱导肿瘤特异性的免疫细胞激活，产生肿瘤杀伤作用，同时将作用限制在肿瘤部位以降低系统毒性。2024年2月，FTL008.16获美国FDA批准临床试验。NeoTX公司：NAP作用机制：靶向5T4的融合蛋白NeoTX Therapeutics开发的NAP（Naptumomab Estafenatox，ABR-217620）是一款靶向5T4的融合蛋白，该药已完成两项分别针对晚期肾细胞癌患者、晚期或转移性NSCLC受试者的2期临床试验。此外，NAP还正在开展多项1期临床试验，分别为：与阿斯利康（AstraZeneca）PD-L1抑制剂durvalumab联合治疗晚期或转移性实体瘤患者的1期临床；以及联合默沙东（MSD）PD-1抑制剂pembrolizumab治疗尿路上皮癌患者的1期临床。爱科瑞思：ADC2154作用机制：靶向5T4的ADCADC2154是爱科瑞思研发的一款靶向5T4的抗体偶联药物（ADC）。ADC2154结构采用全新结构的拓扑异构酶抑制剂为载荷和全新释放机制的连接子，具有循环系统稳定、靶向肿瘤组织和胞内释放的特点。2024年1月，该药已获中国NMPA批准临床，拟开发用于晚期实体瘤，包括但不限于食管癌、结直肠癌、非小细胞肺癌、前列腺癌、卵巢癌、宫颈癌、胰腺癌、肾癌、乳腺癌。Asana公司、Mersana公司：ASN004作用机制：靶向5T4的ADCASN004是Asana Biosciences与Mersana Therapeutics合作开发的一款靶向5T4的ADC，拟用于治疗实体瘤。根据Asana公司官网资料，ASN004结合了一种新型单链scFv-Fc抗体，该抗体与经过临床验证的auristatin F-羟丙基酰胺细胞毒性药物相连。在临床前癌症模型中，ASN004单次给药实现了完全和持久的肿瘤消退。目前该药正处于1期临床试验阶段。Byondis：SYD-1875作用机制：靶向5T4的ADCSYD-1875是Byondis公司开发的一款靶向5T4的ADC。临床前研究显示，在5T4低、中、高表达的多种肿瘤细胞系和人源性组织异种移植（PDX）模型中，SYD-1875不仅能够实现靶向杀伤，也能够诱导旁观者效应介导的抗肿瘤活性。食蟹猴GLP毒性研究显示，该候选药具有可接受的毒性和PK特征，游离毒素水平极低。目前该药已完成了一项1期临床试验。英百瑞：IBR854作用机制：靶向5T4的CAR-raNK细胞产品IBR854是英百瑞生物研发的一款针对实体肿瘤的非基因修饰的CAR-raNK细胞疗法。其核心构造是将靶向5T4的特异性抗体通过连接子与同种异体的NK细胞进行共价偶联，能够与表达5T4靶抗原的肿瘤细胞特异性结合，从而达到靶向识别和杀伤肿瘤细胞的目的。目前，IBR854正在中国开展一项1期临床试验，该研究旨在评价IBR854细胞注射液在不可切除的局部晚期或转移性实体肿瘤患者中的安全性、耐受性及初步疗效。Barinthus公司：VTP-800、VTP850作用机制：靶向5T4的免疫药物Barinthus Biotherapeutics公司开发了两款靶向5T4的免疫治疗候选药物VTP-800和VTP850，拟用于治疗前列腺癌。其中，VTP-800是Barinthus公司开发的一款靶向5T4的第一代免疫候选药物，其与PD-1抑制剂纳武利尤单抗的组合疗法已在针对前列腺癌的1期临床中取得积极效果。VTP-850是Barinthus公司基于VTP-800的1/2a期积极临床试验数据开发的一款下一代免疫候选药物，它可靶向多个与前列腺癌相关的抗原，包括5T4、PSA、PAP、STEAP等。根据Barinthus公司官网信息，该公司预计将于2025年获得VTP-850治疗前列腺癌的1/2期临床数据。当然，除了肿瘤，研究显示靶向5T4还有治疗更多疾病的可能。近年来，该靶点还被发现是帕金森病相关的新潜在基因、是先兆子痫预测和治疗的潜在遗传生物标志物、并在嗅觉和视觉系统的感觉处理中起着关键作用等[8-10]。期待5T4靶向疗法领域能够取得更多的突破，早日造福广大病患！参考资料：（可上下滑动查看） [1] Hole N, Stern PL. (1988) A 72 kD trophoblast glycoprotein defined by a monoclonal antibody. Br J Cancer. https://pubmed.ncbi.nlm.nih.gov/3355761/[2] Myers KA, Rahi-Saund V, Davison MD, et al. (1994) Isolation of a cDNA encoding 5T4 oncofetal trophoblast glycoprotein. An antigen associated with metastasis contains leucine-rich repeats. J Biol Chem. https://pubmed.ncbi.nlm.nih.gov/8132670/[3] Zhao Y, Malinauskas T, Harlos K, et al. (2014) Structural insights into the inhibition of Wnt signaling by cancer antigen 5T4/Wnt-activated inhibitory factor 1. Structure. https://pubmed.ncbi.nlm.nih.gov/24582434/[4] Awan A, Lucic MR, Shaw DM, et al. (2002) 5T4 interacts with TIP-2/GIPC, a PDZ protein, with implications for metastasis. Biochem Biophys Res Commun. https://pubmed.ncbi.nlm.nih.gov/11798178/[5] Tsuboi A. (2020) LRR-Containing Oncofetal Trophoblast Glycoprotein 5T4 Shapes Neural Circuits in Olfactory and Visual Systems. Front Mol Neurosci. https://pubmed.ncbi.nlm.nih.gov/33192298/[6] Kagermeier-Schenk B, Wehner D, Ozhan-Kizil G,  et al. (2011) Waif1/5T4 inhibits Wnt/β-catenin signaling and activates noncanonical Wnt pathways by modifying LRP6 subcellular localization. Dev Cell.  https://pubmed.ncbi.nlm.nih.gov/22100263/[7] Stern PL, Harrop R. (2017) 5T4 oncofoetal antigen: an attractive target for immune intervention in cancer. Cancer Immunol Immunother. https://pubmed.ncbi.nlm.nih.gov/27757559/[8] Wang Y, Li B, Zhao Y. (2022) Inflammation in Preeclampsia: Genetic Biomarkers, Mechanisms, and Therapeutic Strategies. Front Immunol. https://pubmed.ncbi.nlm.nih.gov/35880174/[9] Park S, Yoo JE, Yeon GB, et al. (2021) Trophoblast glycoprotein is a new candidate gene for Parkinson's disease. NPJ Parkinsons Dis. https://pubmed.ncbi.nlm.nih.gov/34876581/[10] Tsuboi A. (2020) LRR-Containing Oncofetal Trophoblast Glycoprotein 5T4 Shapes Neural Circuits in Olfactory and Visual Systems. Front Mol Neurosci. https://pubmed.ncbi.nlm.nih.gov/33192298/[11]各公司官网本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

DUBLIN, March 1, 2024 /PRNewswire/ -- The "In Vitro Diagnostic (IVD) Reagents Market by Type (Antibodies, Proteins, Oligonucleotides, Nucleic Acid Probes) Technology (Immunoassay, Biochemistry, Molecular Diagnostic, Microbiology, Hematology) Use (Clinical, RUO) End User - Global Forecast to 2030" report has been added to ResearchAndMarkets.com's offering. The global in-vitro diagnostics reagents market is projected to reach $75.67 billion by 2030, at a CAGR of 5.4% from 2023 to 2030. The growth of this market is driven by the increasing prevalence of infectious diseases, increasing funding for research activities, the rising adoption of advanced diagnostic technologies, the growth in proteomics and genomics research studies, and the growing number of clinical laboratories offering advanced diagnostic testing menus. Additionally, emerging economies and the growing demand for protein therapeutics and personalized medicines are expected to offer significant market growth opportunities. However, the stringent regulations for antigen-specific reagents restrain the growth of this market. Additionally, the high costs of reagents and the unfavorable reimbursement scenario pose a significant challenge to the market's growth. Based on type, the IVD reagents market is segmented into antibodies, purified proteins and peptides, oligonucleotides, nucleic acid probes, and other reagents. In 2023, the antibodies segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the increasing R&D funding. For instance, According to Research America, investments in medical and health R&D by the U.S. has increased by 7.0% between 2019 and 2020. In 2020, the total medical and health R&D expenditure was USD 245.1 billion. Furthermore, the huge demand for antibodies in various biomedical & basic research are the factors contributing to the largest share of this segment. Based on technology, the IVD reagents market is segmented into immunoassay/immunochemistry, biochemistry/clinical chemistry, molecular diagnostics, microbiology, hematology, coagulation/hemostasis, urinalysis, and other IVD technologies. In 2023, the immunoassay/immunochemistry segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the increasing use of immunoassays in infectious disease testing, the development of novel tests, and the rising demand for immunoassay-based tests. Further, the coronavirus (COVID-19) outbreak since December 2019 is expected to accelerate the growth of this segment owing to the national emergency declared and the requirement of various reagents for the kits and assay preparation. Based on the use, the IVD reagents market is segmented into clinical use, research use only (RUO), and analyte-specific reagents (ASR). In 2023, the clinical use segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the growing need for the early detection of various epidemic and pandemic infections, the large volume of test samples diagnosed for clinical purposes, and initiatives undertaken by manufacturers to develop advanced IVD reagents drive the demand for IVD reagents for clinical use. Based on the end user, the IVD reagents market is segmented into IVD manufacturers, reference laboratories, academic institutes and research laboratories, and hospital laboratories. In 2023, the IVD manufacturers segment is expected to account for the largest share of the IVD reagents market. The large share of this segment is mainly attributed to the initiatives undertaken by IVD manufacturers and the increasing demand for pharmaceutical & biopharmaceutical products from emerging countries. In 2023, North America is estimated to account for the largest share of the IVD reagents market, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Furthermore, in 2023, the U.S. is expected to account for the largest share of the IVD reagents market in North America. The market growth in the U.S. is attributed to the increasing prevalence of infectious diseases, growing preference for PoC testing and personalized medicine, and rising funds and investments for research reagents. Market Insights Drivers Increasing Prevalence of Infectious Diseases Increasing Funding for Research Activities Growth in Proteomics and Genomics Research Studies Growing Number of Clinical Laboratories Offering Advanced Diagnostic Testing Menus Restraints Stringent Regulations for Antigen-Specific Reagents Opportunities Growing Demand for Protein Therapeutics and Personalized Medicines Emerging Economies Challenges High Costs of Reagents and the Unfavorable Reimbursement Scenario Factor Analysis Regulatory Analysis U.S. Canada Europe China Japan India Latin America Middle East & Africa Porter's Five Forces Analysis Pricing Analysis Company Profiles (Business Overview, Financial Overview, Product Portfolio, and Strategic Developments) Thermo Fisher Scientific (U.S.) Becton Dickinson and Company (U.S.) Merck KGaA (Germany) Bio-Rad Laboratories Inc. (U.S.) Agilent Technologies Inc. (U.S.) Abcam plc (U.K.) Hologic Inc. (U.S.) InBios International Inc. (U.S.) SDIX LLC (U.S.) BioTechne Corporation (U.S.) Bio-Synthesis Inc. (U.S.) RayBiotech Inc. (U.S.) Sino Biological Inc. (China) Oy Medix Biochemica Ab (Finland) QIAGEN N.V. (Netherlands) Beckman Coulter Inc. (U.S.). Competition Analysis Overview Competitive Benchmarking Competitive Dashboard Industry Leaders Market Differentiators Vanguards Emerging Companies Market Share Analysis (2022) Thermo Fisher Scientific (U.S.) Merck KGaA (Germany) Becton, Dickinson and Company (U.S.) Scope of the Report: IVD Reagents Market Size & Trend Analysis - by Type Antibodies Antibodies Market, By Type Monoclonal Antibodies Polyclonal Antibodies Antibodies Market, By Target Cluster of Differentiation (CD) T-cell Receptor (TCR) Epidermal Growth Factor Receptor (EGFR) Other Targets Purified Proteins and Peptides Oligonucleotides Nucleic Acid Probes Other Reagents Notes: 1. Other targets include Nucleic BCMA, DLL/Notch, EpCAM, HER2, PDGFR?, Claudin 18.2, SLAMF7, and DKK1. B-cell maturation antigen (BCMA). 2. Other reagents include blocking agents, detergents, surfactants, wetting agents, buffers, stabilizers, purified water, dyes, standards and controls, enzymes, cell culture reagents, and anti-coagulants. IVD Reagents Market Size & Trend Analysis - by Technology Immunoassay/Immunochemistry Enzyme-linked Immunosorbent Assays (ELISA) and Enzyme-linked Immunospot Assays (ELISpot) Lateral Flow Assays (LFA)/Rapid Tests Western Blotting (WB) Immunofluorescence (IF) Functional Assays Immunoprecipitation (IP) Other Immunoassay Technologies Biochemistry/Clinical Chemistry Molecular Diagnostics Polymerase Chain Reaction (PCR) Hybridization Isothermal Nucleic Acid Amplification Technology DNA Sequencing & Next-generation Sequencing Microarray Other Molecular Diagnostic Technologies Microbiology Hematology Coagulation/Hemostasis Urinalysis Other IVD Technologies Note: 1. Other technologies include virus neutralization tests, agar gel immunodiffusion, and radioimmunoassay. 2. Other molecular diagnostic technologies include electrophoresis, ligase chain reaction (LCR), northern blot, and southern blot. 3. Other IVD technologies include anatomical pathology, histochemistry, and whole blood glucose monitoring. IVD Reagents Market Size & Trend Analysis - by Use Clinical Use Research Use Only (RUO) Analyte-specific Reagents (ASR) IVD Reagents Market Size & Trend Analysis - by End User Reference Laboratories IVD Manufacturers Academic Institutes and Research Laboratories Hospital Laboratories IVD Reagents Market Size & Trend Analysis - by Geography North America U.S. Canada Europe Germany France Italy U.K. Spain Switzerland Netherlands Rest of Europe Asia-Pacific China Japan India South Korea Australia Singapore Rest of Asia-Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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