Anti-inflammatory and Anti-rheumatic Drug Market Surpasses RMB 20 Billion for the First Time! Five Products Already Passed Consistency Evaluation

Recently, Hunan Sailong Pharmaceutical, a wholly-owned subsidiary of Sailong Pharmaceutical, received production approval for its anti-inflammatory and anti-rheumatic drug, parecoxib sodium for injection. It will compete with ten pharmaceutical companies, including Pfizer, Kelun Pharmaceutical, Hengrui Medicine, and Chia Tai Tianqing, for market share. According to data from Menet, China’s anti-inflammatory and anti-rheumatic drug market surpassed RMB 20 billion for the first time in 2018, with five varieties having passed the consistency evaluation by various enterprises. In 2018, four of the top 20 products at terminal public medical institutions in China were coxibs, and domestic pharmaceutical companies occupied eight of the top ten brand positions.

1.3 Billion Injectable Drugs Welcome Another Competitor

Pfizer's 80% Market Share Gradually "Eroded"

On August 13, Sailong Pharmaceutical announced that its wholly-owned subsidiary, Hunan Sailong Pharmaceutical, had recently received the Drug Registration Approval for Parecoxib Sodium for Injection (40 mg) issued by the National Medical Products Administration. Parecoxib Sodium for Injection is a non-steroidal anti-inflammatory drug (NSAID) and currently the only globally available injectable selective cyclooxygenase-2 (COX-2) inhibitor. It is primarily used for the management of postoperative pain in various departments, including general surgery, gynecology, orthopedics, and stomatology.

Figure 1: Sales of Parecoxib Sodium for Injection at Public Medical Institution Terminals in China, 2013–2018 (Unit: RMB 10,000)

(Source: Menet - Competitive Landscape of China's Public Medical Institution Terminals)

Parecoxib Sodium for Injection was jointly developed by Pfizer and Pharmacia. It was first launched in Europe in 2002 and approved for entry into the Chinese market in April 2008. According to data from Menet, in recent years, sales of Parecoxib Sodium for Injection at the terminal end of public medical institutions in China have maintained steady growth. With the successive market launch and sales of generic products from manufacturers such as Hunan Kelun Pharmaceutical and Qilu Pharmaceutical, sales of Parecoxib Sodium for Injection experienced rapid growth in 2018, surpassing RMB 1 billion for the first time, representing a year-on-year increase of 45.55%.

From the perspective of the competitive landscape at the terminal of Chinese public medical institutions in 2018, Pfizer, the original manufacturer, ranked first with a market share of 85.88%, followed closely by Hunan Kelun Pharmaceutical with a market share of 12.6%. As more and more generic drug companies are approved for listing, the market share of the original manufacturer will gradually be "eroded."

Table 1: Approval Status and Consistency Evaluation Progress of Generic Parecoxib Sodium for Injection

(Source: Menet MED China Drug Review Database 2.0)

Currently, there are 11 pharmaceutical companies (including the originator) in the Chinese market holding production approvals for Parecoxib Sodium for Injection. In late November 2017, Hunan Kelun Pharmaceutical’s product was approved for marketing as the first generic version, achieving sales revenue of RMB 160 million in 2018. Seven pharmaceutical companies, including Kelun, Hengrui, Qilu, and Aosaikang, have submitted supplementary applications for consistency evaluation of this product. In addition, nine pharmaceutical companies, including Kunyao and Fudan-Zhangjiang, have submitted new drug applications for their products under Generic Category 4; once approved for marketing, these will be deemed to have passed the consistency evaluation. Which company will be the first to pass the consistency evaluation for Parecoxib Sodium for Injection? We await the outcome with anticipation.

Anti-inflammatory and Anti-rheumatic Market Exceeds 20 Billion for the First Time

Four Coxib Drugs Enter the Top 20

Figure 2: Domestic Market for Anti-inflammatory and Antirheumatic Drugs in China, 2015–2018 (Unit: RMB 100 million)

(Source: Menet Database)

High Disease Incidence Drives Market Expansion for Related Medications: According to data from Menet, the domestic market (comprising China’s public medical institutions and urban retail pharmacies) for anti-inflammatory and antirheumatic drugs has expanded year by year in recent years, surpassing RMB 20 billion for the first time in 2018. Among these channels, China’s public medical institutions remain the primary sales arena for anti-inflammatory and antirheumatic drugs.

Among the top 20 anti-inflammatory and antirheumatic drugs at public medical institution terminals in China in 2018, six varieties achieved annual sales exceeding RMB 1 billion each, collectively accounting for nearly half of the market share. Flurbiprofen axetil injection ranked first with a market share of 12.64%. Four of the 20 varieties belonged to the coxib class of drugs.

Figure 3: Sales of Coxibs Among the Top 20 Anti-inflammatory and Antirheumatic Drugs at Public Medical Institution Terminals in China in 2018 (Unit: 10,000 Yuan)

(Source: Competitive Landscape of Terminal Public Medical Institutions in China, Menet Network)

Coxibs are a class of drugs widely used in the clinical treatment of arthritis. Compared with traditional nonsteroidal anti-inflammatory drugs (NSAIDs), coxibs cause fewer adverse effects on the digestive system. Currently, the commonly used coxibs in clinical practice in China include parecoxib, celecoxib, imrecoxib, and etoricoxib.

Celecoxib Capsules, developed by Pfizer, are the world’s first selective non-steroidal anti-inflammatory analgesic. Currently, only the originator’s product is marketed and sold in the domestic market. The number of accepted applications for generic versions has reached 68, involving companies such as CSPC Ouyi, Sichuan Guowei, and Qilu Pharmaceutical. Over the past two years, sales of celecoxib at public medical institutions in China have progressively lagged behind those of parecoxib. However, with the gradual launch of generic drugs, the market for celecoxib may expand.

Imrecoxib Tablets, a Class 1 new drug independently developed by the Chinese pharmaceutical company Hengrui Medicine, were approved for marketing by the National Medical Products Administration in June 2011. As the first domestic proprietary brand of coxib drugs, coupled with Hengrui’s extensive marketing network, Imrecoxib has experienced rapid growth in sales at public healthcare institutions in China in recent years, with promising future prospects.

Chia Tai Pharmaceutical, Hisun... Domestic Pharma Companies Dominate the Screen

Five Major Varieties Have Already Passed the Evaluation by Enterprises

Table 2: Top 10 Brands of Anti-inflammatory and Anti-rheumatic Drugs at Public Medical Institution Terminals in China in 2018 (Unit: 10,000 Yuan)

(Source: Menet’s Competitive Landscape of China’s Public Medical Institution Terminal Market)

Among the top 10 brands of anti-inflammatory and anti-rheumatic drugs at the terminal of public medical institutions in China in 2018, except for Pfizer's Parecoxib Sodium for Injection and Celecoxib Capsules, the remaining eight were all domestic pharmaceutical company brands; these ten brands collectively accounted for 50.34% of the market share, with Beijing Tide Pharmaceutical's Flurbiprofen Axetil Injection leading by a wide margin.

Table 3: Anti-inflammatory and antirheumatic drugs that have passed the evaluation by existing enterprises

(Source: Menet MED China Drug Review Database 2.0)

According to the MED China Drug Review Database 2.0 of Menet, currently there are 7 application numbers (5 drug varieties) of anti-inflammatory and antirheumatic drugs that have passed or are deemed to have passed the consistency evaluation. Among them, Zhuhai Rundu Pharmaceutical's Ibuprofen Sustained-Release Capsules and Zhejiang Hisun Pharmaceutical's Glucosamine Sulfate Capsules submitted applications as supplementary applications for consistency evaluation and passed the evaluation after approval; the remaining 3 varieties were all declared for market launch under Class 3 generic drugs, and were deemed to have passed the consistency evaluation after being approved for production.

Among the five varieties that have passed the consistency evaluation, three were listed in the Top 10 anti-inflammatory and anti-rheumatic drugs at the terminal of Chinese public medical institutions in 2018. Flurbiprofen axetil injection ranked first with a market share of 12.64%, followed closely by glucosamine sulfate capsules with a market share of 9.74%, while ketorolac tromethamine injection ranked seventh with a market share of 3.95%.

Source: Menet Database, Announcements of Listed Companies

Note: Data statistics are current as of August 20. Any omissions or errors are welcome to be corrected. In Menet’s “Competitive Landscape of Chemical Drugs and Chinese Proprietary Medicines at Terminal Channels in Urban Physical Pharmacies in China,” the term “urban” refers to a statistical scope covering 298 prefecture-level cities and above, namely physical pharmacies in all prefecture-level and higher-tier cities in China (excluding physical pharmacies in counties, townships, and villages). The aforementioned sales figures are calculated based on the average retail price of products at the terminal level.

Original Title: Anti-inflammatory and Anti-rheumatic Market Exceeds 20 Billion for the First Time! Three of the Top 10 Products Have Passed Evaluation, with Domestic Pharmaceutical Companies like Chia Tai Tianqing Pharmaceutical and Hisun Dominating the Screen