The global optical imaging market is witnessing continuous technological developments and product innovations. The Americas was the major revenue contributor to the global optical imaging market in 2016, with the US dominating the market in the region. It was followed by EMEA. There is, however, a huge opportunity for the market in APAC to rise at a faster rate and increase its revenue contribution during the forecast period.

According to Orphan Drug Designation program of the US Food and Drug Administration (FDA), orphan diseases are defined as rare diseases that affects less than 2,00,000 Americans. The global orphan drugs market is expected to benefit from patent extensions like Orphan Drug Exclusivity (ODE), increasing focus of vendors on orphan drug products, and financial incentives provided by government in form of tax credits and waived FDA fees. For instance, the FDA grants a seven-year patent exclusivity to orphan drugs to treat a rare disease. Therefore, any other drug with the same indication cannot be approved by the FDA during these seven-years period. In addition, they also provide tax credits up to 50% of the total R&D cost after the drug receives the orphan drug designation. This credit can be used by the sponsor during the R&D phase of any drug irrespective of the drug designation. The orphan designated drugs are also exempted from paying the FDA fees. Thus, these financial incentives and grants for orphan drug attract many vendors to invest in developing drugs for rare diseases and make huge profits.

Diabetic retinopathy and glaucoma can cause blindness. Hence, in many developed countries such as the US and the UK, governments conduct routine eye screening programs that helped reduce the number of blind people. According to the Government of the UK in March 2014, every year 2.5 million people are invited for screening. Government data in 2014 found that around 74,000 people were referred for hospital eye services. Among which, 4,600 people were suffering from diabetes and were sent to specialty services to prevent sight loss.

With the developments in the orthopedic market, there has been an emergence of product offerings, which facilitate robotic and computer-assisted surgeries. Such products are gaining traction due to the increase in the demand for musculoskeletal disorders across all the age groups, and the increased demand for procedures that enhance precision and eliminate any revisions. As opposed to open surgeries, the forecast period is expected to see a burgeoning demand for minimally invasive surgeries (MIS), which improve functional outcomes and reduce recovery times and hospital stays for patients.

本报告为笔者创新药系列报告第三篇，我们深入分析了近几年创新药产业环境的巨变，发现制约我国创新药产业发展的因素均大为改观。我们前期报告预期的创新大时代已经来临。

我们对行业维持谨慎乐观，预计中成药增速 2018 年回升至 10-12%，中药饮片得益于需求扩张 2018 年增速升至 18-20%。中药行业宏观利好看似繁多，但未下渗至配套措施，我们预计微观结构将呈现冷暖分化：医保控费、两票制对行业产生负面冲击，而经典名方免临床、配方颗粒拟放开为企业带来新希望。主题机会上，建议关注经典名方、消费升级、中药配方颗粒，投资标的上，推荐康美药业、片仔癀、云南白药，建议关注中国中药。

政策鼓励和规范生物类似药研发力度加大，将加速目前在研产品优胜劣汰，安科生物和复星医药等领先企业产品上市后可以通过价格优势或者进入医保目录提高渗透率，快速实现进口替代。

上周医药板块整体表现居中，CFDA 相继发布了《鼓励药品创新实行优先审评审批的意见》、一致性评价首批首批名单、中国上市药品目录集等，我们建议持续关注一致性评价进展，同时继续推荐各版块龙头企业。

回顾 2017 年，受控费政策持续影响，医药生物行业指数整体表现较弱，全年涨幅 3.56%，跑输上证综指和沪深 300 指数。医药供给侧改革深化，带来产业结构调整和升级，产业链各环节集中度提升，龙头显著受益。

2017 收官，政策和行业趋势明朗，医药政策拐点充分显现；2018 到来，积极布局创新药、高品质仿制药、医疗服务三大方向。回顾 2017 年医药板块整体绝对收益率 3.6%、跑输沪深 300 约18.2%，在所有申万一级行业中排名第 10 位，处于中间位置。

从 2017 年下半年开始，新药审批和一致性评价均显著提速，我们认为 2018 年将是医药行业全面向上的拐点年，顶层制度改革和居民对品牌的认可将驱动行业良币驱逐劣币，医药行业的“消费升级”加速到来。在医院端，“好药”是核心，药审政策的趋紧以及医保的倾斜，都使得高品质的“好药”逐步胜出；在居民端，“品牌”是核心，无论是 OTC，医疗服务还是药品零售，品牌的溢价效应都在逐步体现。我们看好 2018 年的板块投资机会。

第一批通过一致性评价的药品名单公布，华海药业、海正辉瑞有多个品规进入。总局发布了关于鼓励药品创新实行优先审评审批的意见，药品创新鼓励力度不减，优先审评审批对于肿瘤、肝病、儿童药等领域创新药首仿品牌以及美国、欧盟临床验证药品有所侧重。