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<section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.png" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械第一新媒体</span></p><p><span>分享最专业的医疗器械知识</span></p></section><section><section><section>关注</section></section></section></section><p><br /></p><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section><p><strong>1</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>分子诊断</strong></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section></section></section></section></section><section><section powered-by="gulangu"><section><section><p>分为核酸检测和生物芯片两大类</p></section></section></section></section><section><section powered-by="gulangu"><section><section><br /></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>分子诊断主要是应用分子生物学方法检测生物体内遗传物质的结构或表达水平的变化而做出的诊断技术，可以从基因层次进行检测，因此在检测的灵敏度和准确性上的优势较为明显，能够在感染初期识别病毒或者提早确认基因缺陷，从而提供个性化的医疗诊断服务（如肿瘤缺陷基因检测）。</p><p><br /></p><p>目前，全球主要的分子诊断技术可以分为<strong>核酸检测和生物芯片</strong>两大类。在<span>核酸检测中，有聚合酶链式反应（PCR），荧光原位杂交技术（FISH），基因测序技术</span>；在<span>生物芯片技术中，又分为基因芯片和蛋白芯片技术</span>，其中，和基因相关的检测是分子诊断的最重要组成部分。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 分子诊断行业细分|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/79edeab0a66e4a93cd98b23490b1f44b_2.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：公开资料</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国分子诊断市场份额细分|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/ee958d51f65d72c0a68954a5378f15ba_3.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：中讯咨询，东兴证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 分子诊断市场格局情况|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/f0afbe38348ee57b677f27d022d57598_4.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华创证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>行业集中度高。从全球范围看，<strong>罗氏、诺华、Hologic等几大分子诊断领域巨头垄断该市场，前8大公司市场份额占比达88%，市场集中度非常高。</strong>其中，<strong>罗氏为全球最大的分子诊断公司，市场占比达32%，是全球分子诊断领域的领军企业。</strong>而我国分子诊断相关公司尚处于起步阶段，以分子诊断作为主营业务的公司主要包括<strong>达安基因、迪安诊断、华大基因</strong>等。目前，华大基因领跑整个国内分子诊断行业，从上游仪器制造到下游检测服务，形成全产业链。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span><span></span></section><section><p><strong>全球分子诊断行业现状及趋势</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 全球分子诊断领域巨头市场份额|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/2663728afc60e808fcc9f377bbf1c662_5.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：Roche Diagnostics Insight</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>分子诊断并非会完全替代传统生化、免疫诊断。</strong>从检测疾病的阶段看，三大主流诊断方法各有检测优势，生化检测侧重于已经发生的疾病检测，免疫诊断侧重于已经感染的疾病检测，而分子诊断则对感染初期和有可能发生的基因性疾病具有独特的检测优势，所以三种检测方法有重叠和交叉，也有互补，并非会简单替代。从全球来看，分子诊断作为体外诊断的重要细分行业，是体外诊断中技术要求最高，发展最快的领域，但市场份额相对较小。该领域对通量要求不高，国内PCR均可满足市场需求，应用广泛，未来随着市场需求逐渐增大，基因测序实现降价，势必成为主流趋势。</p><p><br /></p><p><strong>PCR国内市场上游依靠进口，中下游已实现国产应用。</strong>PCR技术应用最广泛，较为成熟，技术经历了三大发展时代，由定性向定量发展，可以通过大量的体外复制将病原信号加以放大，实现准确的诊断检测。上游原材料如聚合酶、引物片段等几乎都需要进口，供应商为赛默飞、伯乐和罗氏等国际PCR巨头，上游原材料对技术要求较高，国内企业基本没有能力进行生产，因此定价权牢牢掌握在外资厂商手中。中游PCR诊断产品已基本国产化，试剂方面，国内企业不断创新，在中高端的荧光PCR领域已实现试剂的国产化，在临床诊断和血筛领域进行广泛应用。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| PCR技术发展路径|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/76cd3966a9fbad49734c8ae969c71229_6.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：生物谷，东兴证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>定性PCR技术，通过凝胶电泳得到定性检测结果，有交叉污染的风险。</p><p><br /></p><p>实时荧光定量PCR是在DNA扩增过程中，采用荧光探针，测定每次聚合酶链式反应（PCR）循环后产物总量的方法，从而实现了定量测定。</p><p><br /></p><p>数字式PCR（DPCR）实现了对核酸分子绝对定量技术，相较于QPCR，数字PCR可让你能够直接读出DNA分子的个数，是PCR检测中最先进的技术。</p><p><br /></p><p><span><strong>高端的数字PCR仪器领域，国内处于起步阶段</strong></span>，CFDA在2017年审批了诺禾致源的数字PCR芯片阅读仪，应用于EGFR的突变检测，伯乐和赛默飞的DPCR目前尚未在国内拿到临床注册证。</p><p><br /></p><p><span><strong>基因芯片—高通量检测，国内处于刚起步阶段</strong></span><strong>。</strong>基因芯片的核心原理是分子杂交，但是具有高通量的特点，可以一次对十几万甚至几包万条DNA分子序列进行检测，远高于杂交技术的检测量，因此芯片在生命科学研究、医学诊断、新药筛选具有巨大而广泛的应用。跨国公司Affymetrix和Illumina在基因芯片领域有沉厚积淀，是国际知名的芯片公司，我国以基因芯片技术为代表的生物芯片技术还相对处于起步阶段，但仍然保持了较快的发展速度，部分芯片和试剂已国产化，但临床检测应用较少。在基因芯片生产制造方面，CFDA批准了达安基因，珠海赛乐奇，亚能生物等厂商的基因芯片仪，而基因芯片试剂生产厂商更多，包括达安基因、珠海赛乐奇、博奥生物、百傲科技等厂商的芯片试剂盒得到CFDA批准。</p><p><br /></p><p><strong>基因测序-拓展产业链、基因信息解读、肿瘤测序成为大趋势。</strong>基因测序优势明显，是未来分子诊断的主流方向。同PCR技术、基因芯片相比的最大区别在于，PCR技术、基因芯片只能检测样本里有无已知的基因信息，而基因测序则可以发现未知的基因信息，从而打开了解码生命的大门。基因测序是精准医疗的重要组成部分，基因异常、基因受损都会引起对应的蛋白质或酶的功能变化，从而引起疾病。所以基因测序一方面能够对人体DNA序列进行分析并解读，了解个体发病的深层机制，制定精准的治疗方案，以此达到疗效更显著，副作用小的目的，较传统治疗有显著优势。另一方面，基因测序可以检测人体基因是否有缺陷，是否携带易感基因，提示高危人群接受健康管理。</p><p><br /></p><p>根据原理的不同，测序技术的发展大致可划分为第一代测序、第二代测序和第三代测序3个历史阶段。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 基因测序技术发展历程|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><strong>向左滑动查看全图<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section></section><section><p><img src="image/20201014/11278affb84d4fb6eb2cb7d4cd12c397_7.png" /></p></section><section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/55781403e1b7bb15f9c837a3eedbf335_8.png" /></p></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><span>基因测序行业的上游为测序仪、测序试剂和耗材的供应，代表公司为Illumina、Roche、Thermo Fisher 等。</span></p><p><br /></p><p><span>中游主要是测序服务以及测序数据的处理和解读，代表公司为Thermo Fisher、华大基因等。</span></p><p><br /></p><p><span>下游为测序服务的终端应用，包括临床检测、生命科学研究等领域，面向对象主要是医院、科研机构、药企等。</span></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 基因测序行业产业链|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/4539e1b4fa3e46e60dd2923020bf257b_9.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>上游Illumina 一家独大。</strong>全球的测序仪市场被Illumina、Life Technologies（2012年被Thermo Fisher 收购）和Roche 三家公司瓜分，长期处二寡头垄断的局面，其中又以Illumina的市场份额最大，从测序仪型号的角度看，Illumina的HiSeq 2000 是目前市场上最主流的测序仪，占据了绝对的优势。短期内Illumina 等公司的行业垄断地位难以被打破，其它公司也难以进入测序仪市场参不竞争。在国内，Illumina 采取与多家公司，如贝瑞和康、安诺优达等合作的策略垄断市场，不让任何一家下游企业壮大，从而掌握绝对的话语权，同时又通过下游企业的代理和市场推广来培养市场。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 2013 年全球新一代测序仪市场格局|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/f487ea17a7e73bc45b2843d698cd4bbd_10.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><strong>| 2016 年全球新一代测序仪市场格局|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/723b21cd8b1990b69c1ac88ad3ceeeaa_11.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：Genomeweb， Next Generation Genomics World Map of High-throughput Sequencers，华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 2016 年全球新一代测序仪市场格局</strong>（按仪器型号分类）<strong>|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/ce8d87206675507a4c168c0cdb6c8762_12.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：Next Generation Genomics World Map of High-throughput Sequencers，华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>第三代测序技术由于其独特的技术优势，是未来的发展方向。</strong>技术成型以后有望撼动目前Illumina 一家独大的市场格局。就第三代测序本身而言，Oxford Nanopore Technologies 的纳米孔测序与Pacific Biosciences 的单分子实时测序相比，纳米孔测序的通量更高、成本更低，机型也更小巧便携，未来取代单分子实时测序的可能性非常大。</p><p><br /></p><p>近年来，我国的测序企业也开始尝试突围测序仪市场，方式有三种：<span>（1）并购国外的测序仪公司，在其核心技术的基础上推出自主品牌的测序仪，以华大基因为代表。（2）利用内生科研能力自主研发，以华因康基因、紫鑫药业等公司为代表。（3）与国外知名测序仪生产企业合作，在其测序仪原型的基础上加以改造，形成具有特殊用途的自主品牌的测序仪，代表公司是贝瑞和康、达安基因和博奥生物等。</span></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 国内企业测序仪开发模式|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/4b42070c2bae1ec60c88d5e047faadde_13.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>中游测序服务竞争激烈，数据分析尚需提高。</strong>测序行业中游的公司可分为提供测序服务和测序数据分析两大类。</p><p><br /></p><p>测序服务行业准入门槛不高，市场竞争激烈，市场高度分散，与测序仪寡头垄断的格局相反，前五大测序服务供应商仅占据了20%左右的市场份额，未来随着测序仪的进一步普及，各科研机构都会逐渐自配测序仪导致测序服务市场加速分散。国内市场测序服务的发展进入白热化阶段，全国提供测序服务的公司超过200家，高度集中于一二线城市。</p><p><br /></p><p>第二代测序技术数据处理和分析的过程与第一代测序仪迥然不同，面临许多难题，如海量的测序数据导致数据输入输出困难，目前国家基因库的原始数据达到1000TB，通过采用云计算的方式来解决等。测序数据处理和分析的技术壁垒较高，是该环节最重要的部分，是掣肘基因测序行业中游发展的关键因素，也是各大测序公司的核心竞争力所在。但是生物信息学分析在整个基因测序产业链中只是较小的环节，直观上现阶段的价值并不是很大，但意义重大。目前国内测序数据分析领域进入的公司相对还不多，以华大基因、荣之联等为代表。</p><p><br /></p><p><strong>下游基因测序应用服务遍地开花。</strong>相对于上游的技术壁垒和中游的竞争激烈，我们更看好下游应用广阔的是市场前景，兼具测序和终端市场的企业将会脱颖而出。</p><p><br /></p><p>根据全球目前的Illumina的预测数据，全球目前的基因检测市场容量为200亿美元。基因测序最主要的下游应用是临床检测和科研服务两方面，其中临床检测项目占据了70%以上的市场，以科研机构、药企、CRO 公司和第三方实验室等一线科研单位为用户群体的科研服务也占据了25%左右的市场。随着技术的发展和临床转化的不断加深，预计未来临床检测的市场比重将会继续增加。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 基因测序的应用领域|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/bb33810e73e3ef43e634889028c57b10_14.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 全球基因检测市场主要应用领域占比|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/50dab801a9ba4c602bdb701a0a6c9c8d_15.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>基因测序领域应用最为广泛的是无创产前（NIPT）项目</strong>，通过第二代测序平台测序，并对测序结果进行生物信息学分析，即可判断胎儿是否患有染色体非整倍体相关的疾病。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 无创产前检测与传统产前检测方法对比|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/6fcc9bba150e6d865bbecb2525e11a0d_16.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>胚胎植入前遗传学检测（PGD/PGS）是继NIPT 之后，下一个热点。</strong>胚胎植入前遗传学检测主要用于检查胚胎的染色体是否存在缺陷，是辅助生殖技术和分子生物学技术飞速发展的结果。在将胚胎植入子宫之前，对其进行遗传学筛查，对胚胎的染色体异常或者遗传性疾病进行诊断，选择无异常的胚胎植入母体，提高“试管婴儿”癿妊娠成功率，提高出生后婴儿的质量。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 胚胎移植筛选流程|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/23e5b10a04d9bfc3e731f5d12c12ce3f_17.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：安诺优达官网，华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>最具应用前景的是肿瘤检测领域。</strong>应用主要包括肿瘤易感基因筛查、肿瘤早期诊断、肿瘤伴随诊断和用药指导、肿瘤愈后监控4个方面。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 肿瘤基因测序的应用领域|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/2380677d898529afcff7e3572e87844b_18.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华金证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span><span></span></section><section><p><strong>国内分子诊断上市公司</strong><strong>标的简介</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span></section><section><p><strong>华大基因</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>华大基因成立于1999年，2017年7月于创业板上市，是全球最大的基因组学研发机构。主营业务为通过基因检测等手段，为医疗机构、科研机构、企事业单位等提供基因组学类的诊断和研究服务。</p><p><br /></p><p>股权结构：公司实际控制人为汪健，通过华大控股及华大三生园间接控制公司32.51%的股份。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 华大基因股权结构|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><strong>向左滑动查看全图<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/3bbf9dbf3a4a45932de499f5a31d3b9d_19.png" /></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/35fde67fc6804d09c4e8dd3851b3cb7d_20.png" /></p></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华创证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 华大基因历次融资情况|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/2477217b1168f10d91194d08d26563b2_21.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：华创证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 华大基因公司主营业务的收入构成|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/cbb8b977fb8b4bedc31f4060ab9d5270_22.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：公司招股说明书</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>在公司的营收中占比最大的是生育健康类，且其占比逐年提升，2016年已经达到54.62%，国内高通量测序试点资质情况如下图，目前国内获得NIPT试点牌照和产品证书公司已有数家，竞争会越来越激烈。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 高通量测序试点资质情况|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/0f559e36155504959742b0637d23d713_23.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：卫计委，华创证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span></section><section><p><strong>达安基因</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>公司依托中山大学雄厚的科研平台, 是以分子诊断技术为主导的，集临床检验试剂和仪器的研发、生产、销售以及全国连锁医学独立实验室临床检验服务为一体的生物医药高科技企业。业务范围涵盖了分子诊断技术、免疫诊断技术、生化诊断技术、医疗器械、检测服务、优生优育、食品安全和产业投资等诸多领域，试剂类产品主要为：荧光定量PCR系列产品、公共卫生系列产品、时间分辨系列产品、酶联免疫系列产品、病理诊断系列产品等；仪器类产品主要为：荧光定量PCR仪、核酸提取仪和全自动核酸分子杂交仪等仪器；检测服务产品主要为：公司医学独立实验室提供医学检验、健康服务，如遗传易感性基因检测、肿瘤标志物检测、宫颈癌筛查、无创基因检测、病原微生物基因检测等健康服务。</p><p><br /></p><p>股权结构：达安基因成立于1988年8月，公司的前身是广东省科四达医学仪器实业公司，2004年8月深交所挂牌上市，控股股东为中山大学，持有公司20%股份。2006年4月中山大学将其持有中山大学达安基因股份有限公司20%的国有法人股份无偿转至其全资子公司广州中大控股有限公司，公司控股股东变更为广州中大控股有限公司。目前实际控制人为中山大学，持有公司股份为16.63%。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 达安基因公司股权结构|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/7f88f2b662e3bac1c67c67cd04a2431f_24.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：公司2016年年报</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 达安基因公司营业收入构成|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/9c3164c68e4694fccb98344036934143_25.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：公司年报</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>公司营业收入中占比较高的是试剂类和服务类营收，两者营收之和超过总营收的80%，第三方临床检测业务增长较快。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section><p><strong>2</strong></p></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>POCT</strong></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section></section></section></section></section><section><section powered-by="gulangu"><section><section><p>IVD的一个新兴细分行业</p></section></section></section></section><section><section powered-by="gulangu"><section><section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>POCT（Point of Care Testing，称为即时诊断或者床边检测）是指在采样现场进行的、利用便携式分析仪器及配套试剂快速得到检测结果的一种检测方式，是体外诊断行业的一个新兴细分行业。其核心要素在于满足临床治疗或家用监护的快速诊断需求，以快速、即时得到可信赖的诊断结果为最终目标，与传统诊断互补。</p><p><br /></p><p>常见的POCT 产品应用于血糖测试、妊娠检测、心脏标识物检测、传染病检测、糖化血红蛋白测定、凝血测试等领域。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国POCT各细分领域所处发展阶段|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/8d5a6655e40496e80b103c740296134c_26.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>我国POCT各细分领域所处发展阶段</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>与传统大型检测设备相比，POCT 仪器具有以下特性。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| POCT仪器特征|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/580fcb7f8f461df947a6a49b339abf03_27.jpg" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：公司招股说明书，川财证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span><span></span></section><section><p><strong>POCT行业现状和趋势</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>全球POCT市场规模较大，增长稳健。</strong>根据TriMark发布的报告，全球POCT市场规模到2018年预计达到159亿美元，10年翻了一倍，年均复合增长率为7.5%。在全球POCT市场中，欧美发达国家占据80%的市场份额，亚洲占POCT市场的15%左右。</p><p><br /></p><p><strong>我国POCT市场刚刚起步，快速发展。</strong>由于庞大的人口基数和日益增加的健康理念，我国POCT市场增速远高于全球水平。据测算，到2018年，我国POCT市场将达到8.6亿美元，十年翻了2.5倍，2008-2018年均复合增长率为13.5%。中国POCT 市场处于发展初期，医院等终端渗透率较低。跨国巨头在POCT市场上占据着主导地位，国内公司规模相对较小。主要代表企业有美国的艾美利尔（Alere）、雅培、碧迪以及罗氏四大巨头。国内POCT企业同国外公司相比，普遍规模小，品种单一，目前还未出现强势的行业领导者，主要有万孚生物、三诺生物等。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国POCT各细分领域竞争格局情况|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/2aa7c4d42e4f678e2a790ca9279188e0_28.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源:Rncos，安信证券研究中心</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国POCT市场格局情况|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/02dcfb166cc81f24b0114b2773e7e324_29.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：川财证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>血糖检测和心血管领域检测成为POCT备受关注的领域。</strong>进行血糖检测是实现预防和控制糖尿病的有效手段，而POCT小型化、便携式的特点满足了对于家庭检测、自我检测的需求。通过POCT进行检测，糖尿病患者可以快速、随时掌握自身血糖水平，对自身进行健康管理和后续治疗方案的制定提供依据糖尿病检测主要包括血糖检测和糖化血红蛋白检测。在糖尿病检测领域外资品牌合计约占70%的市场，其中强生占据31%市场份额，进口替代空间巨大，国内品牌常见的有三诺和怡成，其中，三诺是国内最大血糖仪生产商，凭借着收购美国Trividia Health Inc.（原美国尼普洛诊断有限公司），获得多款国际领先的血糖仪和辅助护理产品线，成为全球第六大血糖仪企业。</p><p><br /></p><p>由于抢救心血管类病人在时效性上的要求比其他疾病救治高的多，而POCT凭借检测速度快的最大特色满足了这一需求，因此心血管类检测成为POCT发展最快的应用。心脏标志物检测国内上市企业覆盖较少，艾美利尔在国内心脏标志物检测市场具有占据较大市场份额，其心血管类检测产品覆盖冠心病、心衰、血栓等多个方面，产品线丰富。由于心脏标志物检测具有较高的技术壁垒，而国内上市体外诊断公司中，很少有公司业务涉及应用POCT进行心脏标志物检测。润达医疗收购了RBM公司43.1%的股权，开始进军心脏标志物快速检测领域，未来发展空间不可估量。 </p><p><br /></p><p><strong>体外诊断公司积极进军POCT领域。</strong>目前，A股上市公司中以POCT为主营业务的主要有三诺生物和万孚生物两家。但由于POCT市场的快速发展，且在应用领域与传统体外诊断重合，有越来越多的体外诊断公司甚至是医疗器械公司将业务延伸进入到该领域，结合公司本身技术优势，专注于某个细分领域的市场开拓。在各细分子领域中，在最大细分行业血糖检测进行布局，可以获得较大市场份额的优势，如三诺生物，鱼跃医疗等；而在发展速率较快的传染病、心血管、肿瘤标志物等领域布局，将获得增长速率较快的优势，如万孚生物等。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 体外诊断进军POCT|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/ca8e076cfe838bd1ce7edd5dc2b85d0b_30.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：东兴证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span><span></span></section><section><p><strong>POCT国内投资标的分析</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span></section><section><p><strong>三诺生物</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>2002年成立，2012年3月创业板上市，专注于研究生物传感技术快速检测慢性疾病产品的高新技术企业，致力于推动糖尿病健康事业的发展，在中国长沙建有亚洲最大的血糖仪及试条生产基地。公司主要产品为微量血快速血糖测试仪及配套血糖检测试条，构成血糖监测系统，用于血糖监测。</p><p><br /></p><p>截止2017年半年报，公司共有29款POCT 产品，已覆盖多个POCT 领域，与去年同期相比增加8项，在申请产品9项。</p><p><br /></p><p><strong>公司股权结构</strong>相对集中，李少波和车宏莉是公司联合创始人，并签署《一致行动协议》，两人分别持股31.14%、25.47%。公司分别于2013年12月和2017年7月进行了两轮股权激励。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 三诺生物公司股权结构|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/08d4bbd2355afed2a42a1035a35f86ba_31.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：川财证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>三诺生物公司并购史</strong></p><p>2016年1月,公司通过参股公司心诺健康完成了对美国尼普洛诊断有限公司（后更名为Trividia）的收购。Trividia 是世界第六大血糖监测系统供应商， TRUE 系列产品是血糖监测领域的知名品牌，市场认可度较高。</p><p><br /></p><p>2016年7月，公司通过参股公司三诺健康收购PTS。PTS 是世界第三大从事血脂检测的公司，其主要产品为CardioChek 系列血脂、血糖监测系统和A1CNow 系列糖化血红蛋白（HbA1c）监测仪。</p><p><br /></p><p>2018年1月23，三诺生物公布参与竞购强生的糖尿病护理业务，交易价格或达40亿美元。</p><p><br /></p><p>PTS 拥有光化学检测平台，而三诺生物与Trividia 都是电化学检测平台，三诺生物另外还拥有免疫荧光平台，三大检测平台的搭建至此齐备。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 三诺生物公司发展历程|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/2a68772018d543a3e8f1ce7789be20ca_32.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：川财证券研究所</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国血糖仪OTC市场竞争格局|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/6d09c67315f83cdf5cf6863aba9bbf49_33.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：川财证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 我国血糖仪医院市场竞争格局|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/3ae66a617d4eb9cd7dff5d0bfa08d14a_34.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：川财证券</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><span></span><span></span></section><section><p><strong>万孚生物</strong></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>公司成立于1992年，2015年创业板上市，是国内最早成立的POCT企业，多年来一直专注于POCT领域。经过多年的研发，公司已经从定性胶体金斑点膜渗率技术平台，发展了胶体金免疫层析技术平台、荧光乳胶定量技术平台、电化学技术平台、生物传感器技术平台、化学发光技术平台等，与此同时，公司还进行微流控、磁珠定量技术的研发布局。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 万孚生物是POCT行业中产品线最为齐全的|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/57621c2098fb42d2150d376194a44426_35.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：各公司公告、安信证券研究中心</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>万孚生物公司股权结构：</strong>公司控股股东和实际控制人为自然人李文美和王继华，两人为夫妻关系，分别持股24.83%、14.88%。2015年公司通过百诺泰实施管理层激励。2017年9月，公司实施员工持股计划，实施限制性股票激励。<br /></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 万孚生物公司股权结构|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/9f0e6c19d31ffbc9d7b965fd8485b067_36.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：同花顺</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>公司并购史：</strong>公司通过内部员工创业合伙和收编经销商的方式来加强渠道资源。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 以拓展销售渠道为目的的外延并购一览表|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><strong>向左滑动查看全图<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/28f3d7bbb6fb931b1785be5bb0d5c7ae_37.png" /></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/52bf2e7cc516c37155a09107c9364333_38.png" /></p></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：各公司公告、安信证券研究中心</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>2017年1月和4月，公司先后两次增资，并购苏州达成51%股权，切入化学发光领域。苏州达成拥有化学发光检测仪器及配套试剂，已经有肿瘤标志物、甲状腺、性腺及糖代谢等30多个试剂批文。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 苏州达成的肿瘤标志物试剂批文齐全|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><strong>向左滑动查看全图<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/60a98f6bbcf3876408d3bcc1c6ecd372_39.png" /></p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><img src="image/20201014/144e7e5413bb311a72bca7b85c2226c2_40.png" /></p></section></section></section></section></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：各公司公告、安信证券研究中心</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p>2016年12月，万孚生物通过增资参股英国AG，布局分子诊断POCT领域。Atlas Genetics是2005年7月创立的一家专注于POCT分子诊断的英国公司，诊断技术是微流控、电化学结合PCR，该公司已经开发出了快速分子诊断POCT测试系统---io系统和利用该系统用于检测性传播疾病（SexuallyTransmitted Infections，STI）和医院获得性感染（Hospital Acquired Infections, HAI）的检测芯片。</p><p><br /></p><p>2017年收购北京莱尔攻，公司持有北京莱尔51%股份，布局循环肿瘤细胞CTC检测。北京莱尔成立于2009年，是国内最早专注从事循环肿瘤细胞（CTC）检测业务的厂商，在循环肿瘤细胞（CTC）检测市场有较高的知名度，产品已在国内超过160家医院应用。</p></section></section></section></section></section></section><section powered-by="gulangu"><section><section><p><br /></p></section></section></section><section powered-by="gulangu"><section><section><section powered-by="gulangu"><section><section><p><strong>| 万孚生物国内外营收占比|<br /></strong></p></section></section></section><section powered-by="gulangu"><section><section><p><img src="image/20201014/d67ff45753a39599cb0c01309d9b0dc3_41.png" /></p></section></section></section><section powered-by="gulangu"><section><section><p>资料来源：各公司公告</p><p><br /></p></section></section></section></section></section></section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><section data-id="1658"><section><section><p><span><strong>相关阅读</strong></span></p></section><p><p><img src="image/20201014/ec237188ae1e9c03eb4d9814f31b18ab_42.gif" /></p></p><p><span>详解生化、免疫、血球、分子和POCT</span></p><p><br /></p><p><span>【从业必读】中国主流IVD上市公司核心秘笈！</span></p><p><br /></p><p><span>【中国首创】POCT"伐木累"之血气新锐</span></p><p><br /></p><p><span>浅谈国内外POCT智能技术的发展</span></p></section></section></section></section></section></section></section></section></section></section></section><p><br /></p><p><p><img src="image/20201014/ddc723b50bcaa3c373cb35a0033daacd_43.jpg" /></p></p>
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发表于 2020-10-14 16:59:21