Original Title: [Blue Book of Medical Devices] Current Situation and Development
Trend of Orthopedic Implant Industry in China [Editor's Note] This article is
excerpted from China Medical Device Industry Development Report (2021) B14,
written by Xu Shufu, General Manager of Zhengtian Business Department of Beijing
Natong Technology Group Co., Ltd., and Li Renyao, General Manager of
Orthopaedics Department of Beijing Natong Technology Group Co., Ltd. [Abstract]
The sudden outbreak of COVID-19 at the end of 2019 has caused great losses to
the global medical device market, brought new opportunities and development
directions, and promoted the transformation of the medical device industry from
low-end to high-end. On the one hand, companies have increased their investment
in technological innovation, on the other hand, the smart medical model has
gained unprecedented opportunities for development in the epidemic. At the same
time, in 2020, all provinces in China will carry out purchasing with quantity,
change the profit structure, and then promote the adjustment of market structure
and the centralization of the industry. The promulgation of a series of
regulations on the supervision of medical devices and the implementation of the
unique identification code (UDI) of medical devices indicate the improvement of
the supervision of medical devices and the tightening of quality control in
China, while the registration certificate holder system brings new opportunities
for the development of medical device companies, especially new companies. In
2020, China's orthopedic medical device market reached 29.8 billion yuan, and
the localization rates of trauma, spine and joint reached 72%, 54% and 47%
respectively. With the maturity of domestic enterprises'technology, the
localization rate will be further improved, and innovation is still the source
of power for the sustainable development of orthopaedic medical device market in
China. [Key words] aging; localization rate; purchasing with quantity; digital
orthopaedics [Good News]: Report on the Development of China's Medical Device
Industry (2021), the fifth volume of the Blue Book of Medical Devices, was
created by the China Institute of Drug Administration and published by the
Social Sciences Academic Press, with Wang Baoting and Geng Hongwu as the chief
editors and Yu Qingming, Jiang Haihong and Li Qiang as the deputy editors. The
report was published in September. (Text below) The "14th Five-Year Plan" put
forward by the Fifth Plenary Session of the Nineteenth Central Committee points
out the direction for the development of China's medical device industry, and
also puts forward higher requirements. With the promulgation of a series of
government policies, regulations and regulations, including the Outline of the
"Healthy China" 2030 Plan, the Regulations on the Supervision and Administration
of Medical Devices, the Notice on the Pilot Work of Expanding the Medical Device
Registrant System, and the Pilot Work Program of the Medical Device Unique
Identification System, we have strengthened the supervision of medical devices.
It also provides a good external environment for the innovation and development
of medical devices from the policy aspect. Based on the objective environmental
factors and policy guidance, this paper focuses on the research and analysis of
the development situation, hot spots, new technologies and trends of orthopaedic
medical device industry in 2020, in order to provide reference for the healthy
and sustainable development of the industry. I. Overview of China's Orthopaedic
Medical Devices Market in 2020 (I) Market Overview Expand the full text Large
population base and aging population are the basic national conditions of China
at the present stage. In 2022, the population over 65 years old will account for
14% of the total population, and will reach 28% by the middle of this century
[2]. The elderly are a high-risk group with low bone mass, and osteoporosis is
an important factor leading to fracture. In bone-related orthopedic diseases
(such as osteoarthritis, vertebral compression fracture, osteoporosis, etc.),
the elderly account for nearly 50%, and in fracture patients, the elderly
account for 1/3. In the future, the number of orthopedic patients in China will
continue to grow with the increase of the elderly. With the modern working
lifestyle, the improvement of quality of life and the expansion of sports
groups, the probability of orthopaedic injuries is also increasing, including
fractures caused by traffic accidents, cervical and lumbar diseases, soft tissue
injuries and so on. China's GDP ranks second in the world and grows fastest, but
in terms of government health expenditure, China accounts for less than 5% of
GDP, while the United States accounts for 16.9% of its GDP [3]. With the
proposal of "Healthy China", our government has accelerated the promotion of the
universal health insurance system, and the proportion of health expenditure will
continue to increase. With the expansion of patient scale and the coverage of
medical insurance payment, it is foreseeable that the orthopaedic market in
China will continue to expand in the future. In recent years, with the release
of a series of policies and regulations, our government adjusts the
contradiction between the growing demand of patients and the supply of medical
devices through macro-control, so as to maximize the limited resources to serve
the people. Especially for domestic leading enterprises, based on the low degree
of centralization of Chinese enterprises, under the promotion of a series of
policies such as "two-invoice system" and purchasing with quantity, fee control,
price reduction and domestic penetration will promote the centralization of
leading enterprises in the industry. This is the best opportunity for China's
orthopaedic implant industry to upgrade and penetrate the domestic market. While
strengthening the innovation and development of medical devices, we should also
strengthen the strict supervision of medical devices. China will grasp the
healthy and sustainable development of medical devices from the perspective of
encouragement and supervision. (II) Industry segmentation In 2020, China's
orthopedic implant market reached 29.8 billion yuan, an increase of 10% over the
previous year. The main segments are trauma, spine, joint and sports medicine
(see Table 1). According to the information published on the website of the
National Medical Products Administration, a total of 237 orthopaedic Class II
and Class III registration certificates were approved in 2020, including 202
domestic (including Hong Kong and Taiwan) and 35 imported [4]. 1. Trauma In
2020, a total of 76 registration certificates were approved by NMPA,
titanium
exhaust tubing, including 74 domestic ones and 2 imported ones. Affected by
the COVID-19 epidemic, the growth rate of the trauma market, which is dominated
by elective surgery, such as spine and joints, has slowed down significantly.
Imported trauma showed a negative growth due to factors such as the third-level
hospitals as the main line-ups for anti-epidemic and the purchase of trauma
belts. In the domestic trauma market in 2020, imports accounted for 28%, with a
growth rate of -5%; domestic products accounted for 72%, with a growth rate of
13%. In the future, degradable material solutions will be the main development
direction of the trauma market. 2. Spine In 2020, 71 registration certificates
were approved by NMPA, including 61 domestic and 10 imported. In 2020, there was
no provincial-level purchase with quantity in the domestic spine market, and the
joint market was less affected by price reduction. Also affected by the novel
coronavirus epidemic and the anti-epidemic of the third-level first-class
hospitals, the imported spine showed a negative growth. In the domestic spine
market in 2020, imports accounted for 46%, with a growth rate of -2%; domestic
products accounted for 54%, with a growth rate of 22%. In recent years,
microscopic fusion, 3D printing and navigation robots have become the focus of
attention in the field of spine, and are also the key development direction of
spine in the future. 3. Joints In 2020, there were 54 registration certificates
approved by NMPA, including 43 domestic ones and 11 imported ones; 37
registration certificates related to hip joints, 11 registration certificates
related to knee joints and 6 others. Joints account for the highest share in the
field of orthopaedic subdivision. As joint surgery is mainly elective surgery,
the number of joint surgery has been steadily increased with the improvement of
epidemic control. Affected by the price reduction of purchasing in Yunnan,
Anhui, Jiangsu and Zhejiang,
titanium
round bar, the growth rate of the joint market has slowed down to a certain
extent. In the domestic joint market in 2020, imports accounted for 53%, with a
growth rate of 4%; domestic products accounted for 47%, with a growth rate of
16%. In the future, it will be one of the trends in the joint market to increase
market share through digital solutions, including robot-assisted surgery. 4.
Sports medicine In 2020, Yunyi obtained a total of 32 registration certificates
approved by NMPA, including 23 domestic ones and 9 imported ones. Sports
medicine is the fastest growing segment of the orthopaedic market. Traditional
orthopaedic enterprises and emerging enterprises have laid out the market one
after another. In the domestic sports medicine market in 2020, imports accounted
for 92%, with a growth rate of 23%; domestic products accounted for 8%, with a
growth rate of 66%. At present, sports medicine solutions in the domestic market
mainly focus on traditional anchors, interface screws, titanium plates with
loops and other implants, which are used to solve more than 80% of basic
arthroscopic surgery. Artificial ligament and biological tissue engineering
related products have become indispensable solutions in the future layout of
manufacturers, and are better choices for soft tissue injury repair. Second, the
current hot spot of orthopaedic medical device market in China (I) Policies
& regulations 1. Purchase with quantity In July 2019, the General Office of
the State Council issued the Reform Plan for the Control of High-value Medical
Consumables (No.37 issued by the State Office), which clearly explored the
centralized procurement of high-value medical consumables in accordance with the
principles of purchasing with quantity and linking quantity with price. This
will not only lead to the change of profit structure and the reduction of profit
margin, but also bring opportunities for the improvement of localization and
industry centralization, and domestic leading enterprises will be the biggest
beneficiaries. Since 2019, Yunnan, Anhui, Jiangsu, Zhejiang and Shandong have
successively carried out the work of purchasing with quantity. Among them, the
average decrease of joint purchasing in Anhui has reached 81%, the average
decrease of spine has exceeded 50%, and the highest decrease has reached 95%.
The average decrease of artificial hip prosthesis in Jiangsu is 47%; Shandong
joint procurement, the average decline of more than 86%, while the lowest price
of pottery to pottery products dropped to 4800 yuan, the highest reduction of
trauma reached 94%, the average price of universal locking bone plate was 2200.
In the provinces where purchasing with quantity has been carried out, the
average price drop is about 50%, while the largest single product drop is more
than 85%. From the perspective of bid-winning enterprises, import enterprises
have an average of 1-3 bid-winning enterprises in purchasing with quantity in
each province, while domestic enterprises have been selected more than 10 in
each province, of which leading enterprises have won more than 80%. In 2021, in
the face of the upcoming second batch of national unified procurement with
quantity, orthopaedic enterprises need to actively improve talent management and
innovative technology, develop differentiated products, so as to improve product
quality and brand competitiveness, and maintain their sustainable development.
2、UDI The unique identification of medical devices (UDI) is the identity card of
medical devices and the code to identify the uniqueness of medical devices. UDI
system plays a positive role in realizing the transparency of all aspects of the
whole life cycle of medical devices and improving the traceability of medical
devices. The "Key Tasks for Deepening the Reform of Medical and Health System in
the Second Half of 2020" issued in 2020 (No.25 issued by the State Office) put
forward that some key varieties such as high-value medical consumables should be
selected to implement the unique identification of medical devic es, so as to
link up their codes in registration, sale and use, so as to make them unique. To
realize the unified management of the production and circulation of medical
device consumables. Since the publication of the Pilot Work Program of the
Unique Identification System for Medical Devices National Health Commission in
2019, the pilot work of UDI in China has been officially launched. According to
the current needs of medical and health reform, 69 varieties of 9 categories,
including bone joint implants, spinal implants and joint replacement implants,
were selected as the first batch of medical devices. Select 108 users and 116
production and operation enterprises including 23 orthopaedic enterprises such
as Tianjin Zhengtian Medical Devices Co.,
titanium
plate gr7 ,
titanium bar
gr7, Ltd., Shandong Weigao Haixing Medical Devices Co., Ltd., Beijing Aikang
Yicheng Medical Devices Co and Dabo Medical Technology Co as the first batch of
pilot units for the sole identification of medical devices. Since the pilot work
was carried out, all parties have actively participated in and worked together
to basically build a unique identification system framework and a unique
identification data platform. The pilot orthopedic enterprises have basically
realized the functions of unique identification creation, code assignment and
data upload. The next step is to carry out the global pilot of unique
identification according to the work deployment, and explore and expand the
application of unique identification in medical treatment, medical insurance,
supervision and other fields. The construction of UDI system is a systematic
project to lay a foundation for long-term benefits. Orthopedic implant
enterprises should carry out the implementation of unique identification as
early as possible, actively explore the application mode of UDI in product
traceability and other fields, and give full play to the application value of
UDI. (II) Application of new technologies 1. Biodegradable materials At present,
the main materials of orthopedic implants are metal (titanium,
cobalt-chromium-molybdenum, stainless steel, etc.), PEEK, ceramics,
polyethylene, etc. However, with the gradual maturity of orthopedic implants,
especially for traumatic fractures, the homogeneity of traditional metal
implants among enterprises is obvious, so enterprises need to seek breakthroughs
to maintain their competitiveness. The development or use of new implant
materials has become a consensus among enterprises. Degradable materials have
broad application prospects because they can not only provide initial stability,
but also be degraded and absorbed after fracture healing, avoiding secondary
surgery. (1) Degradable metal material Degradable metal materials have good
mechanical property, mainly including magnesium, iron, zinc and their alloys.
The research of these materials is mainly focused on the internal fixation of
traumatic fractures. Among them, magnesium alloy has good biocompatibility and
its density is close to that of human bone, so it is the most widely studied. At
present, the European Union has approved the world's first magnesium alloy
degradable screw, but the degradation rate of magnesium metal is faster than the
formation rate of new bone, and the degradation products are easy to accumulate
around the tissue. Therefore, the degradation rate of magnesium alloys, the
mechanism and process of corrosion degradation in vivo, and the products need to
be further studied. The mechanical property and biocompatibility of zinc alloys
are similar to those of magnesium, and the metal inertness makes the degradation
rate of zinc alloys suitable. As an inorganic antibacterial material, zinc also
has certain antibacterial properties, and it is one of the essential elements
for human body, so zinc alloys are regarded as a new choice for degradable metal
materials in the future. At present, zinc alloy has been successfully used in
clinical cases of internal fixation of maxillofacial trauma fractures in China.
However, the research of zinc alloy is still in its infancy, and a lot of
research and clinical data are needed to support its safety and osteoinductive
mechanism. (2) Absorbable polymer material Absorbable polymer materials can be
decomposed into CO2 and H2O through a series of enzymes or chemical reactions in
vivo, and do not produce additional elements in vivo, so they have no toxic
effects on human body. Polylactic acid (PLA) is one of the most widely used
absorbable polymer materials in the field of orthopaedics. It has good
biocompatibility and has been widely used in spine, trauma, sports medicine and
other fields. The original polylactic acid material has high brittleness, poor
toughness and residual fragments after degradation, and after copolymerization
with other monomers and process improvement, the extensibility of the material
is increased on the basis of maintaining the strength of the material, the
control of the degradation rate of the material to match with the regeneration
rate of bone tissues can be realized, and the material can be completely
degraded and absorbed. However, due to the poor mechanical property of polymer
absorbable materials, the mature products on the market are mainly
craniomaxillofacial and non-load-bearing bone fixations. With the upgrading of
technology, there is a process of high-strength absorbable polymer materials for
load-bearing parts, but to complete the transformation of products, a large
number of performance and safety validation are needed, which is an important
material in the field of orthopaedics and even biomedical engineering in the
future. Bone graft materials account for more than 50% of biomaterial
applications. At present, there are many kinds of bone graft materials on the
market, and autogenous bone is the most recognized choice for bone graft.
However, due to limited sources and greater trauma, clinical use is limited. In
addition, allogeneic bone and xenogeneic bone also account for a certain
proportion, and the largest share is artificial bone. Traditional artificial
bones mainly include tricalcium phosphate, calcium sulfate, hydroxyapatite, etc.
On this basis, bioactive glass has established its dominant position in the bone
graft market by virtue of its good biocompatibility, osteogenic ability and
degradability. With the increase of choices and the complication of diseases,
the clinical requirements for products are also increasing. Therefore, on the
basis of the existing bioglass, it has become the main direction of research to
increase its toughness and plasticity and improve its osteogenic ability by
adding collagen, hyaluronic acid and other materials. In a word, the application
of absorbable polymer materials is a new trend of orthopaedic materials in the
future and has broad application prospects. 2. Digital orthopaedics The Outline
of the 14th Five-Year Plan mentions that in order to speed up the development of
digitalization and build a digital China, digital technology has also been
vigorously developed in the clinical application of orthopaedics in recent
years. Digital orthopaedics covers surgery from preoperative planning to
intraoperative navigation, as well as postoperative evaluation and
rehabilitation, and the integration of these treatment processes forms a digital
orthopaedic surgery platform. (1) Preoperative assistance Preoperative
assistance includes doctor-patient remote communication and consultation,
preoperative planning and other modules, and precise planning can be achieved
through three-dimensional reconstruction model, simulation training, AR
assistant diagnosis and other technologies. AR-assisted preoperative planning
can change the tradition of analyzing a large number of flat medical image data
before operation, import the image data into AR system, and realize the
information presentation of image data through image segmentation and
three-dimensional visualization technology. And the three-dimensional
reconstruction model can provide more accurate anatomical parameters for a
doctor, so that the doctor can more intuitively and comprehensively understand
the situation faced by the operation; and because a three-dimensional image is
closer to reality than plane data, the three-dimensional reconstruction model
can effectively shorten the learning curve of the doctor. At the same time,
through the virtual cutting function of three-dimensional model, doctors can
repeatedly carry out simulation training and communication. (2) Surgical robot
According to the open data of National Medical Products Administration, in 2020,
domestic enterprises obtained 12 registration certificates for orthopaedic
robots, including 3 navigation robots and the rest rehabilitation training
robots. According to the statistics of Persistence Market Research, in 2018, the
installed capacity of new orthopaedic robots in China was about 26, accounting
for less than 4% of the global total, and by 2019, it had reached 138,
accounting for about 12% of the global total of orthopaedic surgical robots. At
present, there are more than 20 enterprises carrying out robot research in
China, most of which are in the stage of prototype trial and clinical trial.
Surgical robot navigation or assisted surgery can help doctors achieve accuracy,
flexibility and minimally invasive operation, reduce radiation damage to doctors
during operation, and shorten the recovery time of patients after operation. At
present, the number of orthopaedic surgical robots in China is limited, the cost
of surgery is high, and the medical insurance reimbursement policy is imperfect.
Most of the leading international orthopedic enterprises enter the field of
robotics through mergers and acquisitions to consolidate the existing orthopedic
business. At the same time, in the future, robots may be integrated with the use
of orthopedic consumables, and enterprises need to advance the layout to ensure
that follow-up orthopedic products can maintain access to the use of surgical
platforms. With the deepening of clinicians'understanding of robots and the
support of policies for intelligent surgery, the clinical acceptance of surgical
robots is further improving. From the perspective of health economics,
robot-assisted surgery will have great social and economic benefits in the
future. III. Market Development Trend and Forecast According to the
"TheOrthopaedic Industry Annual Report 2020" report [5], in the global
orthopaedic market in 2019, the United States ranked first with a share of $33.1
billion, accounting for 62%; Central Europe ranked second with a share of 24%;
Of the 10% share in the Asia-Pacific region, China and Japan are the larger
single markets; the rest account for 4%. In 2020, in the global orthopedic
market, the joint market share is $16.1 billion, with a growth rate of -17.4%,
including $7.6 billion for knee replacement, $6.4 billion for hip replacement,
and $2 billion for limb joints; $7.9 billion for spine, with a growth rate of
-18.1%, and $7.3 billion for trauma, with an increase rate of -15.4%; Sports
medicine is 4.8 billion, with a growth rate of -17.3%. In the forecast of the
global orthopedic market in 2021, joint replacement is $19.5 billion, with a
growth rate of 21%, including $9.3 billion for knee joint, $7.8 billion for hip
joint, and $2.4 billion for limb joint; $9.6 billion for spine, with a growth
rate of 22%; $7.5 billion for trauma, with an increase of 19%; and $6 billion
for sports medicine, with an increase of 23%. In order to cope with the problem
of continuous expansion of orthopaedic patients caused by aging in China,
through investigating the mode of foreign patients'visits, it is found that the
number of day outpatient operations in the United States has exceeded 80% of the
total number of operations, and in the past 10 years, the number of registered
orthopaedic day outpatient clinics (including hospital outpatient clinics and
independent surgical centers) has increased exponentially. In 2020, nearly 10000
operations were carried out in orthopaedic day clinics, most of the sports
injury operations can be carried out in day clinics, and the number of joint
replacement and spinal orthopedics operations in day clinics is also gradually
increasing. Daytime outpatient service can reduce the average cost of
hospitalization by 20% -40% and the cost of medicine by 37% -55%, alleviate the
contradiction between supply and demand of medical resources, play an important
role in optimizing medical resources and improving medical efficiency, and also
have practical significance for the ongoing reform of medical supply side in
China. At present, the popularization rate of day surgery in China is low, the
payment and reimbursement policies are implemented according to outpatient
regulations, and there is no matching medical insurance payment system. In
addition, the nature of day surgery determines that patients leave the hospital
without full recovery, so the outpatient department carrying out day surgery
should ensure the safety and quality of the operation, do a good job of medical
advice after discharge and prevent possible complications. It can be predicted
that with the construction of medical information and the improvement of day
outpatient facilities, orthopaedic day surgery in China will enter a rapid
development stage, and the corresponding home care and rehabilitation service
market will further develop. Therefore, the field of orthopaedic medical devices
needs to further improve the medical system of "prevention, treatment and
health" to play a role in graded diagnosis and treatment. References [1] Xu
Shufu, General Manager of Zhengtian Business Department of Beijing Natong
Technology Group Co., Ltd., undergraduate; Li Renyao, General Manager of Small
Orthopaedics Business Department of Beijing Natong Technology Group Co.,
ti6al4v,
Ltd., graduate. [2] China Development Report 2020: Development Trends and
Policies of China's Aging Population [3] Publicly available information on OECD
official website [4] National Medical Products Administration public information
[5] "TheOrthopaedic Industry Annual Report 2020" back to Sohu, see more
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