CRO's favorite service of the TOP10 pharmaceutical companies! Roche, Eli Lilly, Takeda...

The Human Genetic Resources Office (hereinafter referred to as the "Genetic Resources Office") has a significant impact on the progress of clinical research, and the sponsor or CRO or set up a special team to approve the genetic Resources Office.

This is related to the pipeline strategy of pharmaceutical enterprises in recent years, "to go out, but also to invite in", the extensive development of global multi-center clinical research and pharmaceutical enterprises are becoming popular, which seems to be the only way for the development and growth of Chinese pharmaceutical enterprises.

Recently, according to the data released by the 2022 Genetic Office, the Top 10 CRO favorite service of the bid prescription enterprise has been released! Companies such as Roche, Eli Lilly and Takeda made the list.

TOP10 CRO favorite service sponsor prescription company

According to statistics, the top 10 CROs with the most experience in applying for clinical research in the Department of Genetics are:

Aikunwei, Tige, Kunling, Leica, Kangde Hongyi, Bristell, Jingding, Nordstrom, Collin Likang and Kuntuo are probably the top ten CRO companies in China.

1. Aikunwei's clinical research orders are highly concentrated and high-end.

The TOP four research sources are all the top foreign sponsors, Roche, Eli Lilly, Merck Serono and Takeda. These four research sources account for 50% of its total research, among which Roche accounts for 30%, which shows the advantages of Ikunwei in the field of tumor research.

2. Tiger research sources are the most dispersed and healthy.

Tiger's status as the "big brother" of domestic clinical research is beyond doubt. Tiger, the second largest in the number of genetic research, has become the CRO with the most dispersed source of orders with 29 sponsors accounting for 50% of its total number of studies, which is enough to show that Tiger's brand influence is huge and favored by many sponsors.

3. Kunling is more interested in Biotech.

The top five sponsors of clinical research of Kunling are all Biotech, including Shanghai Haihe, Jiahe Bio and Shenzhou Cell, etc. As the capital market is cooling and Biotech companies are facing difficulties in financing, does the client portrait of Kunling need to be repainted?

4. Leica Brocade helps traditional big Pharma.

Haisco is one of the more successful cases of transforming traditional pharmaceutical enterprises into innovative pharmaceutical enterprises through new drug research and development. After the commercialization of its self-developed class 1.1 new drug cyclopropofol, it has achieved rapid growth, and the market value of the enterprise has made steady progress in the secondary market.

5. Conde Wing is still a big MAC without foreign companies.

There were few foreign sponsors (except Roche Diagnostics) in the top five sponsors of the application for the study of K&D Wing.

6. Bristol-myers fully grasps the "20-80 principle".

50% of the genetic research applications come from Takeda Pharmaceutical, and Takeda pharmaceutical has made rapid progress in new drug research and development in recent years, and has become the world's top ten pharmaceutical companies after its merger with Charmer four years ago.

7. Ranked the seventh Jingding, mainly sponsored by foreign companies and prescription companies, and the most advanced in the spiritual field.

8. Senius, ranked eighth, serves a sponsor to prop up "half the sky".

9. Kroenosg and Corineneca, ranked ninth and tenth, are the domestic sponsors in the cooperation focus of domestic research contract organization.

The TOP 19 CRO accounted for half of the research applications in the Genetics Office

There is very little data on CRO orders in China, as can be seen from the data released by the Genetics Office.

From January to October 2022, 19 CRO research applications accounted for 50%, 88 CRO research applications accounted for 80%, and 5% of CRO companies contributed 50% of the research volume.

In other words, the clinical research requiring the approval of the genetic office is more concentrated in the leading domestic CRO and multinational CRO enterprises (see Figure 1).

Aikunwei and Tige were in the first echelon, far exceeding other CROs. Kunling, Kang Dehongyi and Norsig also performed well, which to a certain extent indicated their status in the field of clinical research.

Different from the bid prescription companies, foreign background CRO does not have an advantage. From the perspective of leading CRO, Ai Kunwei, Tige and Kunling are the top three genetic research applications. From the perspective of the number of 19 CROs, foreign CROs did not reflect their quantitative advantages.

In fact, CRO with domestic background has a greater advantage in conducting clinical research in China. They are familiar with the policy environment, have greater support for PI, and have good cooperation with institutions. What needs to be strengthened is standardization and systematization. After all, the earliest domestic-funded CROs were only established for more than 20 years.

In terms of research experience and systematization, it is also necessary to learn from foreign CROs with decades of experience.

Of course, there are also well-organized CROs in China. For example, Kunling started a faster journey after its name was changed in 2021. In July 2022, it announced the completion of $150 million financing, which will be committed to continuous expansion in China and overseas, innovative business development, and mergers and acquisitions.

CRO is still the mainstay of clinical research

The layout of pharmaceutical enterprises should consider the unmet treatment needs, and more importantly, the future of commercialization, which will gradually make new drug research and development and investment rational.

With the rapid development of innovative drugs in China, the global multi-center clinical research is an important part of the globalization layout, which also leads to the hot application results of genetic research.

According to relevant data, as of October 2022, the Genetics Office announced 19 batches of international cooperative scientific research projects, a total of 3632, with an average of more than 300 approvals per month and an average of 16.5 approvals per day (see Figure 2).

The Office of Genetics has strict procedures and steps for the approval of clinical research applications. Although the approval process was simplified as early as 2021 to accelerate the approval speed, it now seems that the strong demand for research and development still poses great challenges to the approval.

Among the 3,632 research projects, CRO applications accounted for 52%, accounting for more than half, which is still the main force in the field of clinical research (see Figure 3).

On the other hand, we can see that a large part of the sponsors choose to build their own clinical research teams, which may have several considerations. First, the research and development pipelines of large domestic Pharma are abundant, and self-built teams can reduce costs and increase efficiency, such as Qilu Pharmaceutical, Zhengda Tianqing;

Second, the self-built team can control the progress of clinical research; Third, some small pharmaceutical companies do not have the ability to pay high research fees to CRO, so they choose their own "hard".

Although the sponsors choose to build their own team, this is not the trend, from foreign large pharmaceutical companies continue to choose to outsource research orders, we can learn a little.

On the one hand, the research efficiency of the clinical research team operated by the sponsor is lower than that of the contracted CRO. On the other hand, self-built clinical research teams need the ability of enterprises to have a clear and sustainable business strategy.

From the decades of experience of the world's leading CROs, China's CROs are in their infancy and will still become an important force in clinical research for a long time.

Summary

China's CRO started relatively late, and with the upgrading demand of the pharmaceutical industry, new drug research and development has gradually emerged.

On the one hand, the application of innovative drugs increased significantly after 2015, which promoted the blowout of CRO number and the development of CRO in China to a certain extent.

On the other hand, the data of clinical research organization orders are relatively scarce, and the data released by the Office of Genetics has certain reference significance.