本报告基于中国证券监督管理委员会公开的信息和数据，对2017年度和2018年度中国证监会发行审核委员会审核的医疗器械企业上市申请审核结果及关注问题进行简要分析，旨在提示医疗器械企业在申报上市过程中需要重点关注的问题，有助于申报企业在申报前做好更充分的准备。审核过程关注度较高的方面包括毛利率及营业成本等与同行业可比上市公司对比情况、特定销售模式情况、盈利能力的可持续性以及行业政策变化对公司的具体影响等。

The research service provides an overview of the global DCT market and a 6-year global market revenue forecast from 2021 to 2026. The report covers market drivers, challenges, regulatory trends, partnerships, and investments in the DCT market. The regional segmentation assumes adoption of decentralized trials based on discussions with industry participants and associated regional trends across United States and Canada, Europe, and Rest of the World (RoW). For the purpose of this study, decentralized trials are defined as those that utilize either clinical IT solutions, such as remote patient recruitment/enrollment and monitoring, clinical data management, clinical trial operations management, at-home supply of therapeutic interventions, or at-home monitoring services offered by nurses to draw blood and conduct assessments not suitable for virtual methods.

The report provides dynamics and trends related to the global clinical nutrition market. In addition, it presents the estimations and forecast of the market. Moreover, the study estimates revenue generated from the sales of clinical nutrition products. The revenues are confined to the clinical nutrition options to maintain health. These products aid to improve the metabolic system of the body by providing adequate supplements such as minerals, vitamins, and others.

Digital health is an emerging technology, which uses connectivity, software, computing platforms, and sensors to enhance the quality of healthcare and its outcome. It increases the physical and emotional well-being of the population. This study comprises products only and not services. The study estimates the revenue generated from the sales of digital devices used for health care. The valuations comprise revenue generated from adoption of health, health information technology, wearable patch, telehealth and telemedicine by patients. The study scope focuses on digital health products for quality health care.

This research service analyzes the global prebiotic ingredients market, covering North America, Europe, Asia-Pacific (APAC), and Latin America, the Middle East, and Africa (LAMEA). Global and regional trends are detailed in the study. The study focuses on prebiotic ingredients used across the following end applications: functional food and beverages, dietary supplements, and infant formula.

According to the National Cancer Society, Nutrigenomics is the study of a person’s gene and its interaction with the food consumed by the person. The study lays the foundation for the concept of “personalized nutrition.” The research field is highly dependent on the recent developments and advancements of the technologies that allow the processing of large amounts of data relating to gene variants.

The global pepper sprays market is segmented on the basis of product, distribution channel, and region. By product, it is categorized into fogger, stream, gel, and others. By distribution channel, it is divided into specialty shops and online stores. Region-wise, it is analyzed across North America (the U.S., Canada, and Mexico), Europe (Germany, France, Italy, Spain, the UK, Russia, and Rest of Europe), Asia-Pacific (China, India, South Korea, Indonesia, the Philippines, Thailand, and Rest of Asia-Pacific), and Rest of the World (South Africa, Egypt, Saudi Arabia, and other countries).

Rise in prevalence of cancer, genetic disorders, and viral infections; and increase in awareness about vaccination drive the global mRNA vaccines market Outbreak of COVID-19 and rise in number of prominent market players conducting clinical trials for vaccine development are projected to drive the global market during the forecast period. There has been significant increase in the licensing agreement between manufacturers for the development of mRNA vaccine and therapeutics. Moreover, increase in approval of from various regulatory bodies such as FDA, CE and others are also expected to drive the growth of mRNA vaccines and therapeutic market.

This study analyzes the global market for plastic, glass, aluminum, rubber and paper-based primary pharmaceutical packaging materials that include bottles, blister and strip packs, ampoules and vials, prefilled syringes, cartridges, tubes, canisters, caps and closures, and sachets. These products are greatly valued in the pharmaceutical industry for storing and dispensing oral drugs, drops and sprays, topical medicines and suppositories, and injectables.

Monoclonal antibodies are used to improve & suppress the immune responses in several medical conditions and to treat different diseases such as cardiovascular, cancer, and cerebrovascular diseases. The benefits of monoclonal antibodies include inhibiting cancer cell growth, detecting & killing abnormal cells directly, and delivering radioactive particles to the specific cells, thereby decreasing the risk of side effects from medication. The report provides market dynamics and trends related to the monoclonal antibodies market. The study estimates the revenue generated from the sales of monoclonal antibodies sources. The valuations comprise revenue generated from monoclonal antibodies sources such as murine, chimeric, humanized, and human.

Nucleic acid isolation and purification is the preliminary step in the field of molecular biology research accompanied with recombinant techniques. The nucleic acid isolation process majorly includes enzymatic digestion and mechanical and chemical disruption. On the other hand, purification consists of the combination of precipitation, chromatography, centrifugation, electrophoresis, and separation. The process of nucleic acid isolation aids sample processing by reducing the time, significantly minimizes nucleic acid loss, and enhances experimental process efficiency and effectiveness. The obtained purified product is further used in recombinant technology methods, thereby making it suitable for targeted purposes in the field of omics research. The advantages offered by nucleic acid isolation and purification significantly aid scientists and researchers to obtain high-quality starting material for conducting downstream applications, thereby generating accurate results.

Cancer diagnostics is the process of detecting various biomarkers, proteins, and certain symptoms that result in the detection of presence of cancerous tumor in patients. Effective diagnostic testing is used to confirm or eliminate the presence of disease, monitor the disease process, and plan and evaluate the effectiveness of treatment. Diagnostic procedures for cancer may include imaging, laboratory tests (including tests for tumor markers), tumor biopsy, endoscopic examination, surgery, or genetic testing.

Dialysis is a technique used to remove waste products such as urea and creatinine from blood, which occurs from inappropriate functioning of kidneys and is usually required for people suffering from chronic renal failure. This procedure is performed for treating kidney disorders and is classified into two types—hemodialysis and peritoneal dialysis. In hemodialysis, blood is pumped out of blood vessels and is purified with the help of dialyzer and then returned back to the body through vascular access. In peritoneal dialysis, the principle of the procedure remains same; however, the inner lining of stomach called peritoneum is used as a filter to purify blood. The report includes the revenue generated from the sales of dialysis products and services. In addition, it also includes the revenue generated from the services provided by doctors, nurses, and other healthcare professionals and focuses on the manufacturers of dialysis products and their service providers.

Personal hygiene refers to regular practice of maintaining cleanliness and grooming body. It includes protecting body parts by washing, sanitizing, cleaning, or covering to prevent body from illnesses caused by contamination of germs and viruses. The report provides market dynamics and trends related to global personal hygiene. The study estimates revenue generated from sales of personal hygiene products. Valuations comprise revenue generated from personal hygiene products such as soaps, hand sanitizers, face care products, and bath & shower products such as shampoos, conditioners, and bathing gel.

Ceramide is a type of lipid complex, which can be found in various glycolipids. Natural sources of ceramide include various plants such as rice, wheat, and soybean plants. It is widely used in cosmetics products to improve skin appearance and skin hydration rate. This study provides information on the application of ceramide in cosmetics, food, and other applications. The study is segmented on the basis of type (natural and synthetic), process (fermentation ceramide and plant extract ceramide), and application (cosmetics, food, and others). Additionally, the report also includes key drivers, restraints, and opportunities in the market. The study also includes in-depth information of value chain analysis and patent analysis in the market.

The study provides insights into market metrics (unit sales and earned revenues), latest trends, market projections until 2025, and a roadmap to cutting-edge technologies that will drive the future growth of the CT market. The study offers a detailed landscape of industry drivers, restraints, and segments conducive for market growth. The study analyzes the CT market on a global scale, including North America, Europe, Asia-Pacific (APAC), Middle East, Latin America (LATAM), and Africa.

The manufacturing of pharmaceutical products requires high standards to ensure the strength of the active ingredients, purity, and quality of the final products. These standards ensure safe and efficient finished products for patients. Small changes in any of these factors can alter the overall composition and may have serious side effects. Thus, the checks and the controls which are applied need to be more stringent than the food industry.

印度疫情带来的利好将在三季度体现，行业已进入良好配置区间。2021 年7 月化学原料药板块估值（市盈率，TTM 整体法，剔除负值）为26.51 倍，预计因为估值切换引起。由于受2020Q1 疫情和人民币汇率的影响，去年二季度为原料药行业的业绩高点，且印度疫情二次爆发带来的产业链转移预计将在Q3 显现，因此预计今年Q3 增速环比将有大幅提升，行业即将走出阶段性低谷，二季度末将成为原料药行业配置的重点节点。

总体来看，近两个月医药板块进行了大幅回调，虽然上周有所反弹，但长期来看，在经历上半年的医药牛市后，经短暂调整，部分标的估值已回归合理水平。当市场出现分歧，在新一轮医保谈判或出现政策扰动之际，或是配置的好时机。医药产业的基本面和“追逐国产技术创新，坚定医疗消费升级”的选股思路未发生变化。

本报告期医药生物行业指数跌幅为6.71%，在申万28 个一级行业中位居第27，跑输沪深300 指数（-2.40%）。从子行业来看，医药生物三级行业全线下跌，医疗服务、化学制药、医疗器械跌幅居前，跌幅分别为10.02%、9.49%、8.25%。估值方面，截止2021年8 月27 日，医药生物行业PE（TTM 整体法，剔除负值）为33.92x（上期36.95x）。医药生物申万三级行业医疗服务、生物制品、医疗器械、化学制剂、化学原料药、中药、医药商业PE（TTM 整体法，剔除负值）分别为81.68x、47.37x、26.46x、31.48x、39.66x、27.40x、14.41x。