Tens of billions of markets to be broken! The popularity of "orphan drugs" in China continues to rise

【Pharmaceutical Network Market Analysis】 In the innovative drug market, the popularity of rare diseases continues to rise
.
According to data, from 2020 to 2030, the global rare disease drug market will increase from US$135.
1 billion to US$383.
3 billion, with a compound annual growth rate of 11%.

In order to encourage domestic pharmaceutical companies to increase the research and development and production of rare disease drugs, in recent years, national government departments have successively issued a series of incentive policies
.
For example, in June 2022, CDE issued the "Statistical Guidelines for Clinical Research of Rare Disease Drugs", which elaborates on the key statistical issues in the clinical research of rare disease drugs and provides guidance for sponsors to carry out clinical research on rare disease drugs
.
In January 2022, CDE issued the Technical Guidelines for Clinical R&D of Drugs for Rare Diseases, which provides suggestions for the clinical R&D of rare disease drugs based on the characteristics of rare diseases, and provides a reference
for the clinical trials of rare disease drug science.
With the support of favorable policies, the domestic rare disease drug market has also made many breakthroughs
.
According to data released by the National Health Commission, more than 60 rare disease drugs have been approved for marketing
in China.
It is reported that recently, a number of pharmaceutical companies have also announced new progress
in the field of orphan drugs.
For example, on December 8, Remegen Biopharmaceutical (Yantai) Co.
, Ltd
.
announced that the company's RC118 for injection has obtained two orphan drug certifications issued by the US Food and Drug Administration (FDA), respectively for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer indications 。 Henlius also announced on December 15 that Henlius Europe GmbH, the company's holding subsidiary, recently received a letter from the European Commission (EC) that the company's self-developed Hans-like (serplulimab injection) (Hans-like) for the treatment of small cell lung cancer (SCLC) was granted orphan drug designation
by the European Commission (EC).
At the same time, the policy dividend has also ignited the enthusiasm
of enterprises to participate in the research and development and production of rare disease drugs.
For example, CANbridge, Shufang Pharmaceutical, Langyu Group, Lingyi Biologics and other domestic enterprises have deployed rare disease drugs and received financing support
.
The industry believes that with the emergence of high-value ecosystems such as rare disease drug research and development, innovative biotechnology platforms, Internet technology and innovative medical services, the development of the whole rare disease industry chain will be driven
.
The data predicts that from 2020 to 2030, the global rare disease drug market will increase from $135.
1 billion to $383.
3 billion
.
In addition, data predict that by 2025, the global market for "orphan drugs" (generally refers to drugs used to prevent, treat and diagnose rare diseases) will reach 110 billion US dollars, and the domestic market is expected to reach 30 billion yuan
.
It is reported that in order to reduce the burden of patients, at present, 67% of the domestic listed rare disease drugs have entered the national medical insurance catalog
.
According to data from the National Health Insurance Administration, including the 7 new rare disease drugs added last year, a total of 45 rare disease drugs are currently included in the national drug list, covering 26 rare diseases, and 67% of the domestic listed rare disease drugs are among them
.
In addition to ensuring the normal use of drugs by patients in the hospital, the medical insurance department also enters the negotiated rare disease drugs into pharmacies through "dual channels", so that patients can purchase them more
conveniently.
As of the end of September 2022, a total of 4,695 designated institutions for rare diseases have been equipped in designated institutions across the country during the agreement period, including 2,283 designated hospitals and 2,412 designated retail pharmacies
.
In addition, China has also implemented priority review and approval of rare disease drugs, so that the number and speed of rare disease drugs on the market are rapidly increasing, and the quality of
rare disease diagnosis and treatment has been effectively improved through the establishment of a national rare disease diagnosis and treatment cooperation network.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.