Medical Device Industry Series Report: New Growth Point for IVD Detonation Industry

Investment points:

Why choose the IVD industry? 30 billion + blue ocean market (2014): "New technology tends to mature + new medical reform to enhance the value of inspection services" to drive the industry to maintain rapid growth of 16-20% in the next three years. In 2013, the market size of China's in vitro diagnostic products was 26.154 billion yuan, an increase of 37.85% compared with 2012. Although the traditional market is maturing, the growth rate in 2014 has dropped to 17%. We believe that the in vitro diagnostic industry will remain in the next three years. 20% rapid growth, because: 1) new technology into maturity (molecular diagnosis, breakthrough in new technologies for precision medicine ) and the replacement of old products (chemiluminescence for the replacement of enzyme-linked immunoassay) to generate new demand; 2) benefit new Medical reform, the diagnostic service industry has gained a rare historical opportunity. Since 2015, excellent IVD companies including Mike, Meikang, Wanfu and Runda have landed in the capital market, which has once again aroused everyone's concern for the IVD industry. This report is based on the characteristics of various industry barriers and technology updates in the IVD field. A comparative analysis of domestic enterprises by mergers and acquisitions and technical perspectives. We believe that China's IVD industry is currently in a state of multiple, small, scattered and weak. In the future, the industry will demonstrate the process of increasing concentration and upgrading technology. Enterprises with strong industrial integration capabilities and technological advantages are expected to benefit from this process.

Medical Device Industry Series Report: New Growth Point for IVD Detonation Industry

Chemiluminescence, molecular diagnostics, and POCT are the most growth segments in the future. Enterprises with R&D and channel advantages are expected to benefit from the technological upgrading process. The market share of biochemical diagnosis decreased from 27% to 19%, the market share of immunochemistry increased from 33% to 38%, and the molecular diagnosis increased from 5% to 15%. POCT in emerging fields developed rapidly.

Biochemical diagnosis: homogenization competition, optimistic about self-produced raw materials, reagents and equipment integration enterprises. The technical barriers in this industry are low, the import substitution has been basically completed, the technology is mature, the homogenization is serious, and the space for localization of products has slowed down, causing the growth rate to slow down to around 7%. We believe that the focus of the development of biochemical diagnosis will shift to costs, channels, On the basis of competition in marketing methods and quality control, we are optimistic about the self-produced raw materials, the linkage sales of reagents and instruments, and the biochemical enterprises with channel advantages.

Immunodiagnosis: Chemiluminescence technology is expected to replace enzymes as the mainstream detection method. Chemiluminescence diagnostic products will gradually replace the main domestic enzyme-linked immunodiagnostic products with the advantages of high sensitivity, high specificity, high degree of automation and fast detection speed. The large environment of medical insurance control fees and the independent research and development of chemiluminescence products will enable immunodiagnosis. In the wake of explosive growth, domestic companies that have the advantage of technology and price advantage are the first to benefit.

Molecular diagnosis: Under the background of precision medicine , new technologies drive the industry to grow by 20-30%. Benefiting from the advancement of personalized medicine and big data applications, the molecular diagnostic growth rate can reach 20-30%. With the increase of people's health awareness, the proportion of national medical insurance reimbursement increases, the molecular diagnostic market is expected to expand on a large scale, the quantitative fluorescent PCR technology of domestic products in nucleic acid detection has basically reached the international level, and the gene chip technology and tumor gene detection technology are close to the international level. Because molecular diagnostic products are expensive, we are optimistic about molecular upgrades and molecular diagnostics companies that generate price advantages in industrial clusters.

Through the analysis of the industrial chain and competitiveness of in vitro diagnosis, we believe that the technology platform is the moat of the in vitro diagnostic industry, and also the core competitiveness of the enterprise. The acquisition of mergers and acquisitions to quickly acquire new technologies + strengthen independent research and development strength is an important way to improve the in-depth technology platform.

Screening domestic outstanding companies from Roche Diagnostics and Illumina Growth Path.

Roche Diagnostics has expanded its product line through a series of mergers and acquisitions that conform to the development trend of the industry to achieve coverage in multiple segments; (2) Leading the market for R&D innovation, thus achieving today's global overlord in vitro diagnosis.

Illumina is an excellent supplier of products, technologies and services in the field of genetic variation and biological functional analysis. It accounts for more than 70% of the global market share in gene sequencing . "Technology + Execution + Capital" has achieved its unshakable status. .

From this we conclude the success factors in the in vitro diagnostic industry: strategic mergers and acquisitions and leading R&D capabilities are indispensable elements for leading companies. As a comprehensive platform company such as Roche, product expansion mergers and acquisitions that conform to industry trends, integration with its own platform advantages, and research and development capabilities based on demand are indispensable factors; and as a specific type such as Illumina Enterprises, based on high-tech sub-sectors, through high-input high-quality research and development and technology mergers and acquisitions in the same field, and eventually become the absolute king of the segment.

Considering the enterprise product layout, outsourcing M&A capability and independent R&D strength, we recommend focusing on the self-produced agent dual-driver to bring the complete product line of Mike Bio), the realization of reagent instrument integration and high-end M&A capability, and benefit from the individual. Chemical medicine is based on the molecular diagnosis of the Daan gene.

Risk warning: product development is lower than expected risk; product approval risk; quality control risk.

Acknowledgement: Thanks to the intern and the graduate student of East China University of Science and Technology Xie Muqing for his contribution to the report.

First, why choose the IVD industry?

1. China's market scale exceeds 30 billion yuan, and CAGR far exceeds the world's 7% growth rate.

According to Frost & Sullivan's market research report and the China Medical Health Blue Book published by the China Pharmaceutical Industry Information Center in 2015, the market size of China's in vitro diagnostic products reached 26.154 billion yuan in 2013, an increase of 37.85% compared with 2012 and 30.6 billion yuan in 2014. The growth rate has dropped to 17%. It is predicted that the market size will reach 72.3 billion yuan in 2019, and the compound annual growth rate is about 18.7%. We believe that the in vitro diagnostic industry will maintain a rapid growth rate of 16-20% in the next three years. :1) New technology enters maturity (molecular diagnosis, breakthrough in new technologies for precision medicine) and old products (synthesis of chemiluminescence for enzyme-linked immunosuppression) to replace new demands; 2) Benefit from new medical reform, value of diagnostic service industry Improve the rare historical opportunity period.

Medical Device Industry Series Report: New Growth Point for IVD Detonation Industry

2. The implementation of new medical reforms has increased the demand for in vitro diagnostic products.

The positive effects of the new medical reform on the in vitro diagnostic industry mainly include four aspects: First, the medical reform fund is invested in the procurement of grassroots equipment. On January 21, 2009, the State Council passed the medical reform plan, and decided that the government at all levels should invest 850 billion yuan within three years, focusing on five reforms such as the basic medical security system. About 30-40 billion yuan will be invested in grassroots equipment procurement. The demand for advanced practical products and high-end products has increased; second, the coverage of medical insurance has gradually increased, and the number of medical and health care institutions has maintained steady growth. In 2013, the total number of medical treatments in the national medical and health institutions reached 7.314 billion, an increase of 426 million, an increase of 6.2%. It is expected that the number of medical treatments will continue to increase in the next five years. The steady growth of medical treatment has led to a steady increase in the demand for in vitro diagnostics; third, the elimination of drug additions. Inspection services will be a major source of profit for hospitals. In vitro diagnostic reagents as the cost end of the hospital (different from the income end of the drug), the hospital will be more inclined to choose diagnostic products with cost-effective advantages; Fourth, encourage the development of non-public medical institutions. We will liberalize the service prices of non-public medical institutions and promote medical marketization, thereby further promoting the development of new diagnostic and therapeutic technologies and promoting the advancement of diagnostic services. In the past ten years, the number of private hospitals has shown a rapid growth. In 2014, the number of private hospitals reached 12,166, almost the same as the number of public hospitals, an increase of 10.3% compared with 2013.

Medical Device Industry Series Report: New Growth Point for IVD Detonation Industry

3. The policy is beneficial to guide the industry's concentration and technology upgrade.

In vitro diagnosis is an important emerging industry in China. During the “Twelfth Five-Year Plan” period, it was strongly supported by the policy. Under this background, more enterprises began to enter the in vitro diagnostic industry. In the first half of 2015, nearly 20 traditional pharmaceutical companies passed or The company will enter the in-vitro diagnostic industry through the acquisition of joint ventures. The increasingly fierce competition will prompt enterprises to continuously improve their competitiveness, and improve the domestic in-vitro diagnostic level as a whole, which is conducive to the development of China's in vitro diagnostic industry.

Medical Device Industry Series Report: New Growth Point for IVD Detonation Industry

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