Small-sized patch products are increasingly gaining traction in a large market—Tibetan medicine brand Qizheng Xiaotong Tie is leading the market.

　　Source of information: China National Journal of Traditional Chinese Medicine

　　In recent years, as the domestic and international pharmaceutical markets have become increasingly aligned, two technologies—foreign transdermal drug delivery systems and domestically produced traditional Chinese medicine patch formulations—have gradually merged in China. These technologies have proven effective in managing pain in the central nervous system, providing localized analgesia for bones and skin, treating hypertension and angina, and supporting hormone replacement therapy. To enhance the percutaneous absorption of such drugs, researchers are now exploring approaches including thermally assisted controlled-release, electrically based iontophoresis, ultrasound, photo-mechanical wave-induced micro-pore formation in the skin, and velocity-based drug delivery methods. In the coming years, patch formulations are expected to gradually attain a certain level of market scale.

　　Changes in the landscape of plaster products

　　In the process of upgrading and replacing traditional Chinese patent medicine patch products, patch formulations—such as chemical drug patches, transdermal patches, sustained-release transdermal patches, and plasters—are becoming an increasingly growing market. According to data from the National Medical Products Administration’s database, China now has more than 800 approved production licenses for patch-based pharmaceutical products. Moreover, over 20 varieties of imported patch products have been registered, and nearly 30 foreign-invested companies are actively involved in this sector.

　　Currently, the domestically produced varieties that are most widely available include Musk Zhuanggu Paste, Joint Pain Relief Paste, Traumatic Dampness Pain Relief Paste, Dogskin Paste, and Traumatic Dampness Pain-Relieving Paste. The number of manufacturers producing these five varieties has exceeded 200. Beijing Tongrentang, Tianjin Darentang Jingwanhong Pharmaceutical, Harbin Pharmaceutical Group’s No. 6 Pharmaceutical Factory, Guilin Tianhe Pharmaceutical, Wuhan Jianmin Pharmaceutical, Henan Lingrui Pharmaceutical, Hangzhou Zhuyangxin Pharmaceutical, and Guangzhou Baiyunshan He Jigong Pharmaceutical are among the leading manufacturers of topical plaster products.

　　Over the past two years, domestic Chinese companies have gradually stepped up their efforts in R&D for high-end products. Although the high-end market for transdermal patch products has largely been dominated by foreign-funded enterprises, domestically produced transdermal patches are undergoing a transformative shift. Since 2010, several such products—including Beijing Taid Pharmaceutical Co., Ltd.’s flurbiprofen plaster, Beijing Zizhu Pharmaceutical’s testosterone patch, Wuhan Bingbing Pharmaceutical’s indomethacin plaster, Guizhou Yuanhe Pharmaceutical’s Yixue’an plaster, Fushun Pengjian Pharmaceutical’s amlexanox oral patch, and Henan Lingrui Pharmaceutical’s fentanyl transdermal patch—have obtained production approvals from the National Medical Products Administration and have since been launched onto the market.

　　It is worth noting that more than 20 domestic pharmaceutical manufacturers produce transdermal patches for children. The main products include Ding Gui Er Qi Patch, Pediatric Anti-Diarrheal Patch, Er Xie Kang Film Patch, Pediatric Diarrhea Patch, Jian Er Xiao Ji Patch, Pediatric Spleen-Strengthening Paste, Pediatric Heat-Clearing and Lung-Opening Paste, and Pediatric Warm-Belly Paste—among over ten different varieties. These pediatric transdermal patches effectively address the difficulties associated with oral medication administration, exhibit strong adaptability, and offer high safety profiles, making them promising candidates for further development.

　　The patch market is gradually gaining momentum.

　　Currently, most of the topical patch products used in clinical practice are characterized by high safety profiles, mild side effects, and supportive therapeutic roles. In the newly released 2012 National Essential Medicines List, all five patch products included are intended for orthopedic and trauma-related conditions. Classic medications include Yunnan Baiyao Patch and Goupi Paste. Newly added to the National Essential Medicines List are Xiantong Patch, Compound Nansheng Pain Relief Paste, and Tongluo QuTong Paste—four of which are exclusive formulations. The positive impact of these additions on market expansion remains to be seen.

　　Since patch-type OTC drugs account for a significant share, many of these medications enter the consumer market primarily through retail channels. Consequently, hospital statistical systems tend to focus mainly on two subcategories: topical medications for joint and muscle pain, and analgesic medications for the nervous system. Meanwhile, the antihypertensive drug clonidine patch and the testosterone patch for male menopausal syndrome are currently in the early stages of market development.

　　Data from the Chinese Hospital Drug Monitoring System for Traditional Chinese Medicine and Chemical Drugs (referred to as the HDM System) show that in 2012, the sales volume of patch-type pharmaceutical products in sampled hospitals nationwide reached nearly 200 million yuan, representing a year-on-year increase of 21.93%. The top five products were Qizheng Xiaotong Paste, Fentanyl Transdermal Patch, Piroxicam Patch, Indomethacin Babu Ointment, and Tianhe Gutong Patch. These five products accounted for more than 80% of the patch market in sampled hospitals, indicating a high degree of market concentration, with exclusively marketed products drawing particular attention.

　　Qizheng Pain-Relieving Patch from Tibetan Medicine Leads the Market

　　Xiaotong Paste is a traditional Chinese medicine patch developed and exclusively marketed by Tibet Qizheng Tibetan Medicine Co., Ltd. Its medicinal functions include promoting blood circulation, resolving blood stasis, reducing swelling, and relieving pain. Clinically, it is used for acute and chronic sprains and strains, trauma-induced bruises and pain, osteophytes, rheumatic and rheumatoid arthritis pain; it also shows good efficacy in treating stiff neck, periarthritis of the shoulder, lumbar muscle strain, and chronic pain conditions. In 2010, among sampled hospitals, its sales exceeded those of fentanyl transdermal patches, placing it first and maintaining its leading position ever since. According to HDM system data, in 2012, the market sales of Qizheng Xiaotong Paste in domestic sampled hospitals had already surpassed 60 million yuan, representing a year-on-year increase of 13.56% and an average annual growth rate of 21.37% over the past five years. Among the competitive landscape in 16 sampled cities in 2012, Beijing, Shanghai, Jinan, Nanjing, and Hangzhou—ranking in the top five—saw Qizheng Xiaotong Paste occupy market shares of 34.87%, 10.78%, 8.84%, 8.76%, and 8.68%, respectively, while the remaining 11 cities accounted for 28%. Following its inclusion in the 2012 edition of the National Essential Medicines List, the clinical use of Qizheng Xiaotong Paste will enter a new stage.

　　Fentanyl transdermal patches face intense competition.

　　The fentanyl transdermal patch was the first drug registered in China by Belgium’s Janssen-Cilag, marketed under the brand name Durogesic. It was introduced into clinical practice in China in 1999. Fentanyl is primarily used to relieve chronic pain in 80% of patients with advanced cancer and has demonstrated good efficacy. Subsequently, the fentanyl transdermal patch developed by Changzhou Siyao received approval, and in 2012, the National Medical Products Administration also approved the fentanyl transdermal patch produced by Henan Lingrui. As an anesthetic drug, the fentanyl transdermal patch is classified as a specially managed pharmaceutical product under national regulations, placing extremely high demands on the technical and management capabilities of companies seeking market access. Reportedly, only one to three companies are permitted to manufacture this particular product. The entry of domestic pharmaceutical companies into this field signifies their potential access to a vast and lucrative market.

　　In 2013, China reported an incidence rate of cancer at 285.91 per 100,000 people. The growing clinical demand has driven the expansion of both oncology therapeutics and supportive care drug markets. The fentanyl transdermal patch, listed as a Class B drug in the 2009 National Reimbursement Drug List, is the only patch-form medication among cancer pain relief drugs. In recent years, foreign countries have approved the expanded use of fentanyl transdermal patches for the treatment of non-cancer chronic pain. Following the "Guidelines for the Use of Strong Opioids in the Treatment of Chronic Non-Cancer Pain," China has added chronic non-cancer pain indications to the fentanyl transdermal patch, thereby further boosting market growth.

　　According to HDM system data, in 2012, the sales volume of fentanyl transdermal patches in domestic sample hospitals exceeded 50 million yuan, representing a year-on-year increase of 19.83%. Among them, Janssen Xi'an’s Durogesic accounted for 94.53% of the market share, while Changzhou Siyao’s fentanyl transdermal patches accounted for 5.47%. With the launch of Henan Lingrui Pharmaceutical’s fentanyl transdermal patch in 2013, the competitive landscape—which has remained largely unchanged for nearly five years—is expected to be disrupted.

　　Gutong Paste Ointment Covers the Domestic Market

　　Gutong Paste is an exclusive product of Guilin Tianhe Pharmaceutical. It has the effects of dispelling wind and cold, promoting blood circulation and unblocking the meridians, as well as reducing swelling and relieving pain. It is indicated for localized joint pain, swelling, numbness, heaviness, and difficulty in flexion and extension caused by cold-damp obstruction of the meridians combined with blood stasis. This product enjoys a broad market in China, particularly occupying a prominent position in community healthcare due to its cost-effectiveness.

　　According to HDM system data, in 2012, the Tianhe Gutong Plaster achieved a year-on-year growth of 14.99% in domestic sample hospitals, accounting for 7% of the plaster market sales in these sample hospitals. After China Resources Sanjiu acquired 97.18% of the shares of Guilin Tianhe Pharmaceutical, it will be able to further boost the incremental development of Tianhe Pharmaceutical’s Gutong Plaster.