Case studies of medical devices CRO industry

Medical Device CRO in the market introduction phase, equipment development and product registration as a driving factor. Domestic CRO business services focused on medical research, medical devices CRO fewer participants, the market is yet to be developed, we believe CRO by the pharmaceutical sector extended to the field instrument is an evolving process. From the stage of development of the industry, the medical devices CRO market is still in the introduction phase, the future development of the industry in equipment and promote product registration, is expected to usher in rapid development. Upstream medical devices CRO to provide clinical data medical device medical institutions (for both upstream and downstream manufacturers of medical devices), downstream of the medical device companies. Medical Device CRO business is largely dependent on the development of medical device industry.

Domestic equipment market CAGR of 20.46%, the product registered as rise. China's medical equipment and pharmaceuticals output of about 0.2: 1, a reference to developed countries: a huge space for development. 2001-2014, China's medical device industry market size increased to 255.6 billion yuan from the 17.3 billion yuan, the compound growth rate over 23%. We expected 2010--2017 domestic medical equipment market sales of compound growth rate of 20.46%, well above the 5.09% level in the world. Compared to Europe, China's large population base, easier to recruit subjects and obvious cost advantages, only about half of the United States, Germany 1/3, create favorable conditions for R & D equipment. CFDA According to statistics, China's medical device product registration number increased from 2007 10974-2013 29073 years, the annual compound growth rate of 18%, driven by further expansion devices CRO industry.

Domestic policy on medical equipment station outlet, leading devices CRO usher development opportunities. Innovative Medical Devices special approval process, the selection of items of domestic medical equipment, and promote the healthy development of the pharmaceutical industry guidance and a series of policy clearly support the development of national brands and domestic equipment, medical equipment station on domestic policy vent. On the other hand, many categories of medical devices, clinical normative serious lack of standardization of clinical trials with the acceleration of the instrument of reform, a large number of SMEs in the batch equipment products face the risk of failure registration, rapid increase in demand for CRO equipment. Through five forces model analysis, instrument CRO industry potential entrants and substitute products are at less risk, lower demand, upstream bargaining power in general, better competition, leading enterprises to usher in development opportunities.

Austrian Farm (835575.OC) domestic equipment CRO leader, intends to create one-stop service platform. The company is the first to focus on one of the professional field of medical devices CRO, at home and abroad nearly 3,000 medical device companies to provide services. The company has innovative application software systems and management platform, extensive industry experience, rigorous and comprehensive service network SOP and multi-center, to build a one-stop service platform. The company's revenue comes mainly from clinical trials and registration of technical services and quality management systems and technical services. 2013-2015, the company revenues were 14.84 million, 28.93 million, 28.04 million, of which clinical trial technology and services accounting for respectively 43.46%, 57.69%, 70.28%, and registered quality management system and technical services accounting for respectively 44.68% , 39.75%, 26.97%, training classes and services accounting for respectively 11.93%, 2.56%, 2.76%.

Induced Public Technology (833360.OC) strengthen regional advantages, take different routes. Company focused on the field of medical devices CRO, the main business area in Hubei Province. 2013-2015, the company's business income accounted for in Hubei Province were 64.86%, 60.00%, 65.85%, respectively, in Hubei Province outside accounting 35.14%, 40.00%, 34.15%. The company differs from the traditional instrument CRO enterprises, mainly to provide technical advice and regulations for the three types of enterprises: ① domestic medical equipment innovation and entrepreneurship for SMEs; ② the transition into the medical device industry enterprises; ③ outside (first) to enter the Chinese market, small and medium sized medical equipment enterprise. At the same time, some of the larger companies in the medical device company providing regulatory or clinical outsourcing services.

Yongming Medicine (430306.OC) cardiovascular CRO started, integration of industrial chain and the "Internet +" to leap forward again. Founded in 2009, focused on cardiovascular drugs and medical devices in the field of clinical CRO full-service agency. August 2015, the company acquired through the vertical integration of industrial chain Sheng Lin Beijing Dakota Trade Co., Ltd. 100% stake in the Beijing Shenglin of cardiac pacemakers, pacemaker and other revenue consolidation range, a substantial thickening of the company performance. September 2015, the company sinks subscribe Yixing Zhi (Beijing) Technology Co., Ltd. 30% stake in the target company will indirectly through the Internet and corporate entities in the field of cardiovascular product line of business combination, intended to create the cardiovascular field "Internet +" closed loop.