Frost & Sullivan releases the 'Current Situation and Development Trends Report on the Medical Device CRO Industry' (with full text available for download)

A Contract Research Organization (CRO) is an academic or commercial third-party institution that provides specialized services to medical device R&D enterprises, pharmaceutical companies, healthcare institutions, or government agencies through contracts during the research and development of basic and clinical medicine.

Medical device CROs accept commissions from medical device R&D enterprises through contracts, providing customized services including R&D trials, testing and inspection, clinical trials, registration applications, post-market management, etc.

Medical device CRO institutions typically consist of specialized talents familiar with the entire process of medical device research and development, registration, testing, etc. They possess standardized service procedures to meet the unique experimental needs and regulatory requirements of medical device development. These institutions assist clients in optimizing technology and design, reducing R&D costs, shortening product launch cycles, and lowering failure risks.

Medical device CRO services cover a wide range, mainly including preclinical research and development testing services, animal experiment services; clinical trial services; registration phase application services; post-market production system regulatory services, as well as product iterative R&D services. The service content covers the entire lifecycle of medical devices.

Source: Analysis by Frost & Sullivan

As a third-party outsourcing organization dedicated to serving the medical device industry, Medical Device CRO is deeply rooted in this field.

Medical device CROs possess a specialized and experienced team, provide full lifecycle services, integrate enterprise experimental needs, build large-scale platforms, and cooperate deeply with various entities in the innovation chain to accelerate the layout of innovation resources. The service advantages of medical device CROs can effectively help medical device enterprises shorten the product R&D and market launch cycles, assist in verifying the safety and effectiveness of products, reduce failure risks, lower R&D costs, and facilitate the transformation of innovative achievements for medical device enterprises.

Source: Analysis by Frost & Sullivan

The Report details the definition, development history, industrial chain, service scope, types of medical devices served, main experimental technology platforms and technical capabilities, as well as service advantages of medical device CROs. For more detailed content, please refer to the full report.

Medical devices are related to the health and safety of the people, as well as the overall economic and social development of the country. To ensure the safety and effectiveness of medical devices, protect human health and safety, and promote the development of the medical device industry, China's regulatory environment for the medical device industry has become stricter, providing a favorable development environment for medical device CROs. At the same time, strict regulatory policies have strengthened the compliance demands of medical device enterprises for various aspects such as R&D, production, and quality management systems, enhancing the demand for medical device CRO services from these enterprises.

In terms of service outsourcing policies, the state has introduced a series of incentive support measures to encourage enterprises to develop service outsourcing businesses in healthcare and other fields. It has proposed development strategies such as deepening the coordinated development of the service outsourcing industry with various industries, digital transformation, and enhancing R&D innovation. At the same time, local governments implement the central general policy for outsourcing service support and formulate local policies and measures that suit the local market conditions, which is beneficial to the development of the medical device CRO industry.

With the introduction of policy documents such as the 'Good Clinical Practice for Medical Devices', 'Technical Review Guidelines for Animal Studies on Medical Devices', 'Technical Guidance Principles for Clinical Evaluation of Medical Devices', and the 'Regulations on the Supervision and Administration of Medical Devices', enterprises' demand for medical device CRO services has been continuously strengthening. This has broadened the scope of services provided by medical device CROs and encouraged their diversified development.

Medical device CROs, as important practitioners of medical device standards, provide professional compliance services related to medical device standards during the product design and development process, including product testing, importation of product design standards, and support for product standard compliance. The continuous advancement of medical device standardization has played a positive role in promoting the high-quality and healthy development of medical device CROs. At the same time, medical device CROs are also accumulating experience through continuous practice, participating in the formulation and revision of standards, and supporting the medical device standardization process in reverse.

The Report details the support policies for China's medical device CRO industry, analyzing from multiple dimensions such as macro-regulatory policies, service outsourcing policies, and the standardization process of medical devices. For more detailed content, please refer to the full report.

According to data released by the National Bureau of Statistics, in 2000, China's population aged 65 and above reached 88.21 million, accounting for 7% of the total population, marking the beginning of China's aging society. By 2021, the number of people aged 65 and above in China reached 200 million, accounting for 14.2% of the total population, indicating a continuous deepening of population aging and an increasingly severe situation. According to survey data published by researchers from the Chinese Center for Disease Control and Prevention, among China's elderly population aged 60 and above, the proportion of those suffering from one or more chronic diseases is 75.8%. Against the backdrop of China's aging population and extended life expectancy, the base of chronic disease patients continues to expand. The number of patients with common chronic diseases such as hypertension, coronary heart disease, diabetes, chronic obstructive pulmonary disease, and hyperlipidemia reached 330 million, 210 million, 140 million, 110 million, and 90 million respectively in 2021.

Chronic diseases have a long course and carry the risk of causing serious complications, with high disability and mortality rates. The large group of chronic disease patients places a heavy burden on society, releasing demand for medical devices that are the foundation for diagnosing and treating diseases. Driven by population aging and increasing demand for medical devices, China's medical device industry and medical device CRO industry will continue to develop.

Source: Literature search, Frost & Sullivan analysis

At the same time, with the improvement of residents' economic levels and the development of health education, the consumption structure of Chinese residents has continued to optimize. Driven by the increase in per capita disposable income, the implementation of hierarchical diagnosis and treatment policies, and the development of medical security services, the affordability of healthcare services for Chinese residents has continuously improved. The number of outpatient visits has increased, raising society's higher requirements for the facility configuration of medical institutions and the safety and effectiveness of medical devices. The importance of medical device CROs has gradually become prominent.

The Report details the medical needs of Chinese patients, analyzing from multiple dimensions such as the trend of population aging, the epidemiology of chronic diseases, the affordability of residents' healthcare services, and the total number of outpatient and inpatient visits to healthcare institutions. For more detailed content, please refer to the full report.

With the continuous expansion of R&D investment in China's medical device field, the innovative vitality of domestic medical device enterprises has been unleashed, continuously breaking through technical barriers. At the same time, the state is also constantly encouraging independent innovation of high-quality domestic medical devices, introducing a number of supportive policies to encourage medical institutions to allocate domestic medical devices, helping them break through market access barriers. Under the wave of independent innovation and domestic substitution, China's medical device industry has achieved rapid and high-quality development.

In 2021, the National Medical Products Administration (NMPA) approved a total of 1,429 first registration applications for Class III medical devices, including 1,131 domestic products, accounting for 79.1%. In 2018, the NMPA revised and issued the 'Special Review Procedure for Innovative Medical Devices', which has set up a special approval channel for medical devices with Chinese invention patents, domestically original technologies, internationally leading levels, and significant clinical application value. By the end of 2021, a total of 134 innovative medical devices had been approved, including 127 domestic products, accounting for 94.7%. From scratch, from imitation to innovation, the importance of domestic medical devices in the field of innovative medical devices has been continuously increasing, continuously promoting the process of domestic substitution.

Source: National Medical Products Administration, Frost & Sullivan analysis

With the emergence of high-quality domestic medical device products, industry competition has intensified. The market has put forward higher requirements for the safety, effectiveness, and lifecycle management of domestic medical devices, giving rise to a huge demand for medical device CRO services.

Source: Analysis by Frost & Sullivan

The Report details the process of independent innovation and domestic substitution of medical devices in China, analyzing from multiple dimensions such as policies, approval status of domestic medical devices, R&D investment by domestic medical device enterprises, and foreign trade of medical devices. For more detailed content, please refer to the full report.

With the continuous improvement of China's scientific and technological level and national policies supporting independent innovation and domestic substitution, the medical device industry has continuously broken through technical barriers and achieved high-speed and high-quality development. In 2021, the market size of medical devices in China was approximately RMB 8348 billion, with a compound annual growth rate of up to 17.7% from 2017 to 2021. At the same time, driven by factors such as increased per capita disposable income, enhanced healthcare awareness, and population aging, the demand for medical device products in China has significantly increased, driving the continuous growth of the market size. It is estimated that the market size of medical devices in China will reach RMB 1244.2 billion and RMB 1660.6 billion in 2025 and 2030 respectively, with a compound annual growth rate of 10.2% from 2021 to 2025 and 5.9% from 2025 to 2030.

The rapid growth of the medical device market scale will attract more medical device enterprises to participate in industry competition. With the release of volume-based procurement policies, medical device enterprises will continue to increase investment in research and development and product technology updates and iterations to ensure their core competitiveness. As a key link in the medical device industry chain, medical device CROs provide professional services covering the entire life cycle of medical device products, meeting the needs of medical device enterprises for shortening the R&D cycle, controlling R&D costs, and reducing failure risks. Under the influence of the rapid development of China's medical device industry, the Chinese medical device CRO industry will also witness significant growth.

The Report details the market scale of medical devices in China and the demand from medical device enterprises. It analyzes from multiple dimensions such as the market scale of medical devices in China and the focus of demand among different types of medical device enterprises. For more detailed content, please refer to the full report.

Source: Company website, Frost & Sullivan analysis

With the vigorous development of China's medical device industry, the release of relevant supportive national policies, and capital assistance, products in the Chinese medical device industry are diversifying. Clinical trials and approval processes are gradually becoming standardized, and the service demand and scope of medical device CROs will continue to expand. Large-scale medical device CROs will seize the opportunity, leverage their resource advantages, actively develop preclinical animal experiments and testing services, allocate operational resources such as animal laboratories and testing equipment, layout full life cycle services for medical device products, and enhance their professional technology and core competitiveness.

Medical device enterprises usually consider factors such as CRO project experience, service areas, and professional teams when selecting outsourcing service providers. They tend to choose medical device CROs that match each other in specialized fields and have higher professional capabilities. Therefore, driven by downstream demand, China's medical device CROs will continue to delve into specialized medical device service areas, continuously enhancing their technical reserves and service levels.

At the same time, with the rapid development of China's medical device industry, medical device CROs are also actively exploring emerging niche markets for medical devices, continuously expanding their service scope, enhancing core competitive advantages, and increasing their market share. Taking the field of in vitro diagnostic reagents (IVD) as an example, the IVD industry is an important segment of China's medical device industry, with rapid development. From 2017 to 2021, the market scale of IVD in China increased by as high as 22.9%, reaching RMB 129.6 billion in 2021. It is estimated that by 2025, the domestic IVD market will continue to expand, reaching RMB 245.7 billion.

Source: Analysis by Frost & Sullivan

In the future, China's medical device CROs will continue to delve into their existing professional specialty service areas while actively expanding into other niche segments of medical devices, thereby broadening the scope of related services and seeking more business opportunities.

With the continuous improvement of regulatory policies in China's medical device industry and the sustained growth in demand from medical device enterprises, the technical capabilities of medical device CROs will continue to expand into the field of medical device material characterization. They will further deepen their technical capabilities related to preclinical animal experiments to better meet regulatory requirements and the needs of medical device enterprises.

The characterization and performance of medical device materials are important reference materials in the evaluation of the biological safety and clinical effectiveness of medical devices. In the future, medical device CROs will continuously expand their technical capabilities in the field of medical device material characterization, providing new services such as chemical characterization testing and physical characterization testing.

Animal experiments are an important evidence module for evaluating the safety and effectiveness of medical devices. Preclinical large animal experiments can better simulate the clinical use of medical devices to assess their safety and effectiveness, and are commonly used in preclinical studies.

Source: Analysis by Frost & Sullivan

In the future, more medical device CROs will provide preclinical animal experiment-related services, continuously deepening their capabilities in areas such as animal model technology and clinical surgical techniques to meet the diverse needs of downstream medical device enterprises.

The CRO services for medical devices will extend upstream along the industrial chain, helping medical device companies design laboratory solutions, build R&D experimental systems, assist medical institutions with clinical institution registration, provide scientific instruments, experimental animals, biological reagents, and materials for medical device companies, thereby enhancing the status and value of CROs in the medical device industry.

At the same time, the implementation of the medical device registrant system will also promote the extension of medical device CRO service content downstream along the industrial chain, providing innovative services such as product design and production, product tracking, and post-market sales promotion.

Source: Analysis by Frost & Sullivan

In the future, medical device CROs will continuously break through traditional service boundaries and continue to expand the scope of services upstream and downstream of the industrial chain. The vertical expansion of medical device CRO service content will help medical device CROs reach customers earlier, activate more customer needs, and enhance customer loyalty. By unblocking the industrial value chain, it will promote mutual complementarity and transformation within the CRO's own business, boosting the rapid growth of the overall business.

Currently, China's scientific and technological revolution and industrial transformation are progressing smoothly. General Secretary Xi Jinping has repeatedly proposed 'to deploy the innovation chain around the industrial chain, promote precise alignment between the innovation chain and the industrial chain', to drive the deep integration of China's industrial chain with the innovation chain, and to facilitate technological innovation and market application in frontier basic research in the medical field.

Under the guidance of the national general policy, the medical device CRO industry has also continuously strengthened strategic cooperation with all sectors within the medical device innovation chain. By establishing strategic cooperative relationships with government agencies, medical institutions, industrial parks, universities, research institutions, medical device companies, investment firms, and other organizations, it has gathered comprehensive resources from politics, medicine, industry, academia, research, enterprises, and investment. It takes on more strategic planning responsibilities, collaborates with all entities in the innovation chain, and promotes the innovative development of the medical device industry.

Source: Analysis by Frost & Sullivan

Currently, the concentration of China's medical device CRO industry is relatively low. Most medical device CROs are small and medium-sized enterprises with different focuses in service scope. The foreign medical device CRO industry developed earlier, experiencing a large number of mergers and acquisitions, resulting in a higher market concentration. Taking the American company NAMSA as an example, since its establishment in 1967, it has continuously sought and acquired medical device CROs in specific professional fields to broaden its service scope and enhance its professional service capabilities. A series of mergers and acquisitions by NAMSA have significantly improved its business capabilities, continuously expanded its market share, and made it a leading enterprise in the international medical device CRO market.

Source: Company website, analysis by Frost & Sullivan

With the continuous development of the medical device CRO industry, future mergers and acquisitions related to medical device CRO in China will continue, changing the current situation of low industry concentration and promoting industry integration.

The Report provides a detailed analysis of the future development trends of China's medical device CRO industry. For more detailed content, please refer to the full report.

The Report details the financing events of Chinese medical device CRO companies and mergers and acquisitions in the global medical device CRO industry. For more detailed content, please refer to the full report.

Yipin Technology is a medical device technology service platform with laboratory resources as its core competitiveness. The company focuses on the rapidly developing medical devices and biomedicine industries, providing full-cycle services including R&D design verification, inspection testing, animal experiments, clinical trials, and registration applications for medical devices. It aims to cover all categories of active and passive medical devices, biomedical materials, in vitro diagnostic equipment, sterilization and disinfection equipment. It offers one-stop solutions for domestic and foreign manufacturing enterprises and research institutions, assisting in quickly bringing safe and effective products to the global market.

Yipin Technology's heavy-asset contract R&D outsourcing laboratory has successively obtained qualifications such as CMA and CNAS in China, as well as A2LA and IAS in the United States. The biotechnology laboratory can implement the FDA GLP system and provide rigorous and scientific R&D outsourcing services and test reports for markets in China, the US, and Europe. It can meet various R&D and testing needs of enterprises from R&D to clinical registration. Yipin Technology collaborates with other parties to build a medical device innovation center, providing technical support and experimental testing services for medical device innovation. At the same time, it participates in establishing provincial-level biomaterial research platforms, conducting cutting-edge academic research, and promoting the popularization, clinical application, and industrial development of biomaterials.

TigerMed's wholly-owned subsidiary, TigerJET, was established in 2000. It provides regulatory affairs and clinical research CRO services for medical devices (including in vitro diagnostic products), covering the entire life cycle of various medical device fields. Relying on the Tiger Group, TigerJET has set up 138 service outlets in major cities on the Chinese mainland, Hong Kong, China, and Taiwan. In addition, it has also established overseas service outlets in 15 countries and regions including South Korea, Japan, Malaysia, the United States, Europe, etc.

Aozhida was established in 2004 and is a global medical device industry technology service provider. It provides the medical device industry with platforms for scientific research transformation and manufacturing (CDMO), global registration and clinical trials (CRO), industrial service platforms (industrial planning, professional education, park management), industrial investment platforms, and medical device cloud platforms.

Mediscren Technology was founded in 2011 and is a comprehensive service provider specializing in the research, development, production, registration application, and clinical trial of medical devices (including in vitro diagnostic reagents). The company's headquarters are located in Beijing, with branch offices and representative offices in Tianjin, Shanghai, Guangzhou, Shenzhen, Wuxi, Chengdu, Zhengzhou, Shenyang, and other places. It can provide one-stop regulatory consulting services for global medical device customers before their products are launched in China.