Song Haibo
In Vitro Diagnostic Industry (IVD) is not only significantly involved with people’s health and the advancement of medical and health services, but also works as an essential component to guide the evolution of Clinical Laboratory Provider.
The well-known IVD industry (production, circulation as well as research and development) , management institution of laboratory room for Clinical Laboratory Provider ( clinical examination center at all levels and the third party of certificate authority), and clinical application of Clinical Laboratory (each clinical laboratory department of medical and health institution as well as independent laboratory room) are all the indispensable part of Clinical Laboratory Provider.
The IVD industry is also the engine driving Clinical Laboratory Medicine ‘s towards systematical development, thus the development of IVD industry have an directly favorable influence on Clinical Laboratory Provider’s progress.
¡¡A series of policy and regulation are put forward by the State Council, National Development and Reform Commission, National Health and Family Planning Commission of the People’s Republic of China, China Food and Safety Administration, Ministry of Science and Technology of the People’s Republic of China, which greatly stimulate the development of IVD industry.
But we should also clearly aware the aggravate market competition, and the obvious decline of profit margin of testing products for regular programs. Out of policy element, for instance the national-wide supervision barrier of Clinical Laboratory product and the differential charge for export item and non-important item, cost is added for domestic enterprises’s new product’s research and development, which badly affect the enterprise’s as well as the IVD industry ’s initiative for innovation.
¡¡Due to government’s favorable policy emphasizing on people’s livelihood and medical insurance, as well as the advantageously large population size which excites the expansion of medical and health institution and service by its continuous civilization, by the boost of people’s living standard as well as people’s health impacted by the worsening environment, our country’s IVD industry’s developing in a high speed with an increasing rate averaging 20% annually, much higher than other heath industry’s rate .
¡¡This report is about the IVD industry’s overview in 2013, with its data collected by both National Associated of Health Industry and Enterprise Management Chinese Association for Clinical Laboratory Provider’s member unit and nonmember unit, in the line of the standard required by the related department. We here are sincerely thankful for their support!
¡¡This report’s copyright is belonging to National Associated of Health Industry and Enterprise Management Chinese Association for Clinical Laboratory Provider. Without permission, data, graph, and character therein the report shall not be cited by any unit or personage.
¢ñ. IVD industry's rapid progress in reformation
In the early 80s in 20 century, in the IVD industry, production units are numbered and their product type is simplex; the business units' number is no more than 20, and the clinical examination regents are basically manually compounded. Between the end of 80s and the early 90s, our country's IVD industry developed in high speed, a large group of agency for IVD products' production and import sprung up in China, which constitutes the embryonic form of our country's IVD industry. These enterprises which promoted the commercialized kits into laboratory replace the unstable result history cause of the manual reagent. With the rising by the manufacturing enterprise and the clinical laboratory’s demand for the commercialized reagent, the operating agency still rapid growth. However, at that time, the business enterprise is mostly under state ownership or collective ownership, some province’s clinical examination center and enterprise of health industry initiated by medical and health institutions under government’s favorable policy.
With the in-depth reformation and opening up policy, especially in the 20th century, Chinese government gradually started to administrate the IVD industry in China directly. On May 24th 1993, the National Institutes for Food and Drug Control for the first time held the “national blood product manufacturer blood donor testing technology proseminar”. In 1994, the Ministry of Health issued the No.10 and No.365 documents and started the batch-by-batch examinations for the four kinds of blood testing reagent. From then on, the governmental management of the IVD industry in China drew its curtain. Meanwhile, soundlessly but quickly, lots of IVD enterprises are turning from state-owned economy to private economy. By now, almost all our IVD enterprises are private.
¢ò.Terms explanation and references
1.IVD (In Vitro Diagnosis): The product and service which test the human body from the outside and thus judge body functions and diseases.
2.POCT (point of care testing): The experiments conducted outside traditional and central laboratory.
3.Batch-by-batch examined reagent: it contains the reagent for ABO blood type hepatitis B and hepatitis C virus surface antigen, syphilis and AIDS. Also it requires paid label from the government.
4.IVD industry (clinical laboratory industry): the activities of IVD products manufacture, management, researching and circulation.
5.IVD products classification:
5.1. Based on usage: According to the catalogue of “National Guide to Clinical Laboratory Procedures” published in 1997 by the Ministry of Health, we classify them as Hematology (thrombus and hemostasis, erythronoclastic anemia, chemical staining of bone marrow and blood cell, haematozoon, typology and urinalysis), body fluid testing (urinalysis, stool examination, body fluids and excreta examination), Clinical chemistry examination (protein, sugar, inorganic ions, enzymes, non-protein nitrogen compounds, blood lipid lipoprotein, hormone, analysis of arterial blood gas and acid-base and liver function), Clinical immunology test (non specific immune function, immunoglobulin, complement, CIC, cellular immunity, autoantibody, tumor immunity and infectious disease immunity), microbiological detection (general survey and sensitivity test of antibiont), molecular biology inspection (nuclein, virus and germ).
5.2.Based on products: According to the No.302 document issued by CFDA in 2002 and its medical devices catalogue 6840—“clinical laboratory analyzing instrument”. (However, it’s hard to count, classify and formulate relative date)
5.3. Based on the requirements of “batch-by-batch examination”.
5.4.Self-testing (family) reagent classification.
¢ó.The influence of medical reform and national policies on IVD industry
The 18th Third Plenary Session formulated “the decision on several significant problems of deepening the reform comprehensively”. In this decision, health care reform, which is a significant part of the comprehensive reform, has aroused wild attention of society.
In May 2013, the Sate Council issued “several opinions on encouraging and guiding the investment of private capital into health care industry”.
In October 2013, the Sate Council issued “several opinions on the promotion of health care industry”. These two documents have a positive effect on promoting the development of the health care industry, stimulating consumption on health care, liberalizing the market and simplifying the admittance of lacking medical resource. Greatly it promoted health care reform and expanded health care demands. In this way, IVD industry which serves the health care industry, will face an unprecedented opportunity and space. In the next several years, the IVD industry in China will be still possible in the period of a 15% to 25% growth.
At the meantime, we have also discovered that the IVD industry in China has many problems: the difficulties of product registration, price examination and admittance into NDRL, along with the increasing cost (higher rent, higher HR cost, higher tax, higher input and administrative expenses caused by unnecessary restrictions), greatly effected and restricted the enthusiasm of IVD investors and researchers and reduced the international competitive power of domestic IVD products. Some of the increased cost are caused by the development of society. Some are caused by competition, and some are caused by administrative policies. For now, IVD products in China have the highest registration cost in the world, along with its most complicated registration procedure and the longest registration time. Some of the IVD products are even managed as drugs. This brings not only a higher cost for manufacturers but also a waste of social resources. As mentioned above, since most IVD enterprises in China are now private, the increasing cost and decreasing profits greatly affect their enthusiasm for the investment in IVD research. From the perspective of development, in the course of time it will provoke a continuous decrease of the creative and researching ability in Chinese IVD industry. Although our government offered some encouraging policies, companies that can truly benefit from these policies are limited. So if we want to promote our IVD industry, we should encourage enterprises to improve and create on their own rather than assist them to develop. And these should be unified from both perception and policy.
¢ô. The related data of IVD industry in China 2013:
¡¡¡¡1.Involving national industry standards of IVD: total 199 (information source: Technical Committee of Clinical Laboratory Resting and In Vitro Diagnostic Test System of Standardization Administration of China).
¡¡¡¡2.The total number of registered IVD products are 17432; among Class ¢ó 2119, Class¢ò12585, Class¢ñ2028(information source: CACLP).
¡¡¡¡3.The involved official documents of medical devices and IVD issued by state: from the CFDA set up by the end of 2013, total 257(information source: CACLP).
¡¡¡¡4.The total number of IVD manufacture and circulation enterprises are more than 6800, and workers nearly one hundred thousand; the manufacture enterprises around 900(including foreign products distributor of china general agent). The top five areas which the production company distribution are Shanghai, Beijing, Guangdong, Jiangsu, Zhejiang(information source: CACLP).
¡¡¡¡5.The planning of IVD industry totally have 4, they are biological industry’s Twelfth Five-year Plan, medical device industry’s Twelfth Five-year Plan, Twelfth Five-year Plan of scientific and technological advance, national medium and long-term plan for science and technology development(information source: CACLP).
¡¡¡¡6.In 2013, the IVD patents have 20, it less 61 than 2012(information source: Patent Information Service Platform, CACLP)
¡¡¡¡7.Global IVD Market Ranking(reagents, U.S. Dollar in 2012): U.S. 18.7 billion, Japan 43.5 billion, Germany 3.8 billion£¬France 3 billion, Italy 3billion, China 25.6billion(made in China ), (information source: Institut Merieux, CACLP, Forward-looking Industry Research Institute).
¡¡¡¡8.The annual sales amount of IVD regents and devices are 311.95 billion, among the IVD regents are 161.05 billion(POCT is 4.8 billion), instruments is 150.9 billion.(information source: CACLP)
9.They are 21979 hospitals, 525 blood stations£¬154 sole collection of plasma stations£¬1294 specialized hospitals for disease control and prevention£¬3484CDC.(National health development planning commission, CACLP)
10.Outpatient visits more than 23 trillion, and more than 11000 people in hospital.
After 35 years of IVD industry development, it has formed a certain scale and suitable to the demand of clinical. An increasing differences between enterprises, the industry leaders are take shape in the field of immunity and clinical chemistry, but the ability of research and innovation between developed countries become big.
¢õ. The thinking of the IVD’s development process
In terms of what general instruments and diagnostic reagents, the differences of IVD industry between China and developed countries become small. Foreign enterprise still play the leading roll in the automation, integration and differential diagnostic in the files of clinical laboratory provider.
China IVD industry’s development can’t still go old production mode like the copy product and the general product. So we think the government should give more support in Innovation fund and government support. This is the right method to play a positive role.
Medical product involves basic sciences like optics, electronics, chemistry, biology, computer science, medical science and so on. In the early days, the research and development of intelligent product across many fields and need numbers of interdisciplinary scientists. It is difficult to demarcate the management department, the support department and the industry belonging.(NDRC put it in biophysics and green field. MOST put it in biophysics and medicine to bioengineering).The government should pay attention to the agreed classification of the IVD industry and will use the policy power to develop it.
The IVD patents of 2013 were less than 2012, dropped by 61.The frequently publish of policies and laws for IVD are during the periodicity of the patent applications, and the IVD industry involves many subjects. The low number of patent showed the shortage of the policy stimulation.
The IVD sales volume in our country ranks the 6th in the world, less than Italy (the population is 61 million), is half of Japan (the population is 120 million) and the quarter of USA(the population is 301 million).It shows our gap between the developed countries.
Except the support of the government, we are required to change our minds to reduce the difference. We long for lesser barrier on the supervision and management department. Our national IVD industry should have the same hardware condition as the developed countries’ because the quality can be controlled in the lab. So we should use the market to stimulate the development of IVD industry, that’s the right thought, otherwise, the innovation and independent research and development will be nonsense.
We established a set of IVD registration and management system in 10 years, which promoted the quality and admittance of the products. Our country’s IVD industry got the legal basis and rules, but some of them made unnecessary waste of human and social resources and production costs.
¢ö. IVD industry’s future
The development of IVD industry is trending to be integration, miniaturization, clinic, molecularization, individuation and appropriate technology.
Every medical and health organization is still very positive to found new inspection method and invent new equipment. Income from clinical laboratory accounted for 10% of the hospital’s total one. The cost of inspection is 40% of the income, which makes the different level medical and health organization more passionate. The market power of the IVD industry just comes from this positivity and the social needs of clinical diagnosis and home use IVD product, the new methods and appropriate technology’s promotion.
As an industry combines optics, electronics, bioengineering, Molecular Biology, computer science, materials science, IVD will keep on being in a long period of technology transfer in our national condition. It’s been a long way for us to reach the speed and level of the developed country’s IVD industry. We need more and more national level support, especially the important aspect of the supervision and management and the policy.
All in all, China IVD industry will always keep up with the world and have a rapid development in the future.
CACLP
March 4th, 2014
