Osteoporosis is a metabolic disease caused by a combination of endocrine, nutritional, immune, and genetic factors, and is characterized by increasing bone fragility and fracture due to a gradual decrease in bone mineral content and bone strength and destruction of the microstructure of bone tissue.
More than 300 million people worldwide are affected by osteoporosis. With the advent of an aging world, many middle-aged and older adults have varying degrees of osteoporosis. The incidence is about 40% in postmenopausal women and about 15% in men. Due to the increasingly aging population, osteoporosis and osteoporotic fractures have become major risk factors threatening public health in China. According to a survey released in October 2020, the prevalence of osteoporosis in China was 19.2% in people aged 50 years and older and 32.0% in people aged over 65 years with 10.7% in men and up to 51.6% in women. By the end of 2020, the number of osteoporosis patients in China was over 150 million and it has kept growing.
The mechanisms of action of osteoporosis medication are divided into three types: inhibition of bone resorption, promotion of bone formation, and dual action of both. The development of clinical application of bisphosphonates in the treatment of osteoporosis began in the 1990s and has undergone three generations of development. The representative drugs of the first generation are etidronate sodium and disodium clodronate; the representative drugs of the second generation are pamidronate sodium and ibandronate sodium; the representative drugs of the third generation are alendronate sodium, risedronate sodium, zoledronic acid and incardronate sodium. At present, these representative drugs have all been marketed in China.
Zoledronic acid was originally developed by Novartis (trade name: ZOMETA®) and was initially approved for marketing in the United States in 2001 under the trade name of Zometa® (4mg), mainly for the treatment of excessive calcium in the blood caused by cancer. In 2007, zaoledronic under the trade name of Reclast® (5mg) was approved by the US and Europe for the treatment of post-menopausal osteoporosis in women. In 2008, Reclast was also indicated for the prevention of hip fractures in women and men. In 2009, Reclast was approved by the FDA for the treatment of osteoporosis and by the EMA of Europe for the treatment of osteoporosis caused by steroid therapy in men and menopausal women.
According to CRI’s market research, 4mg of zoledronic acid injection was marketed by Novartis in China in 2004, while 5mg of zoledronic acid injection for osteoporosis was approved in China in 2009. Subsequently, several companies’ generic zoledronic acid drugs were marketed in China, decreasing Novartis’ share of zoledronic acid market in China.
According to CRI’s market research, in 2020, the sales value of zoledronic acid in China declined to approximately CNY 507 million (USD78 million) because of COVID-19, with a CAGR of approximately -3.9% from 2016 to 2020. Since Novartis’ original drug sells at a much higher price than generic drugs, local Chinese company Chia Tai Tianqing Pharmaceutical then ranked the first in terms of sales value and volume in China’s zoledronic acid market in 2020.
CRI expects that from 2021 to 2025, China’s zoledronic acid market will see growth as COVID-19 is effectively controlled in China.
- Impact of COVID-19 on China’s Zoledronic Acid Market
- Development Environment of Zoledronic Acid in China
- Sales Volume of Zoledronic Acid in China
- Sales Volume and Value of Zoledronic Acid in China by Region
- Major Zoledronic Acid Manufacturers in China and Their Market Shares
- Sales Price of Zoledronic Acid in China
- Prospects of China’s Zoledronic Acid Market, 2021-2025