Medical network - on February 17, according to figures from the abroad, global (ostoporosis, OP) in patients with osteoporosis has more than 200 million people. With the arrival of the ageing of the world, many older per capita have varying degrees of osteoporosis. After menopause female incidence of about 40%, the incidence of male was 15%.
Osteoporosis is a kind of endocrine, nutrition, immune, genetic metabolic disease caused by a variety of complex factors, were gradually reduce bone mineral content and bone strength loss, bone destruction, micro structure is characterized by osteopsathyrosis enhancement and the increased risk of bone fracture.
The disease can be divided into primary, secondary, and idiopathic three categories. Primary osteoporosis also known as degenerative osteoporosis, the majority of patients belong to this type, mainly due to increasing age. Osteoporosis in the elderly, and greater incidence of malignant tumors in patients with postmenopausal women. With the development of osteoporosis, which can lead to systemic skeletal disease, caused by bone pain, lumbar back deformity and spinal deformation, also can cause vertebrae and fracture of the distal radius, also known as the "invisible epidemic" devour the elderly health. Serious consequences is osteoporotic fracture (brittle fracture), namely under mild trauma or everyday activities can fracture, leading to the sick rate and increased mortality.
Osteoporosis has the serious influence the health and life quality of old people, also to the national health care investment and the general family bring heavy economic burden. "2013 China's prevention and cure of osteoporosis fracture blue book, according to the Chinese people over the age of 50, osteoporosis, total prevalence rate of 15.70%. 2012 statistical yearbook data show that China's current age 50 and older elderly population reached 338 million, this also means that our country has more than 5000 elderly people over the age of 50 mouth of osteoporosis patients, is expected to reach more than 150 million people by 2025.
Osteoporosis drug use is definitely a huge market. So, at present our country osteoporosis overall market situation? What are the opportunities? Research and development status of domestic company? What are the problems?
According to the Chinese medical association of osteoporosis and bone mineral salt diseases branch issued by primary valuation guidance of diagnosis and treatment of osteoporosis, the mechanism of action of osteoporosis drugs mainly divides into: inhibit bone absorption, promote bone formation, and the dual function of three types. Minerals (VMS) and its supplements, such as calcium, not in the scope of this article.
Market analysis
Double phosphonic acids accounted for a third
According to m Intranet "China city public hospital chemical medicine terminal monitoring analysis system" (HDM) data, 2015 samples of the key cities for the domestic hospital osteoporosis drugs market has amounted to 2.306 billion yuan, including double phosphonic acid salts drug use amount is 688 million yuan, year-on-year growth of 1.43%. Double phosphate occupy about 30% of the share.
Double phosphonic acid salts TOP 5 varieties are: thiazole class to phosphonic acid, phosphonic acid sodium, Allen phosphonic acid sodium, para meters phosphonic acid, Allen phosphonic acid VD3, accounted 96.68% share of the double phosphonic acid salts drugs.
Double phosphonic acid salt as calcification inhibitors, is the earliest application for phosphonic acid sodium is the only double phosphonic acid salt is used for such purposes, are used to reduce after spinal cord injury ectopic calcification, or added to toothpaste to prevent tartar.
The clinical application of dual phosphonic acid salt in the treatment of osteoporosis development began in the 1990 s, has experienced three generations of development. The first generation of the representation of the drug is for phosphonic acid sodium and chloride phosphonic acid disodium salt; Representative drug is para meters of the second generation product phosphonic acid sodium, the class phosphonic acid sodium; Third generation product: the representation of the drug is Allen phosphonic acid sodium, the plug phosphonic acid sodium, the azole phosphonic acid, phosphonic acid sodium English card. Is this a few representative drugs have been listed in the country. Besides azole to phosphonic acid, however, most of the listed in around 2000 pairs of phosphonic acid salts are faced with the patent expiration situation.
To compare, from the aspects of efficacy of azole phosphonic acid to phosphonic acid and the class is the best in the double phosphonic acid salts, and Allen phosphonic acid and the plug phosphonic acid is a bit worse in the first two, this also can see from the sort of the sales.
By the above information as you can see, the double phosphonic acid salt is still osteoporosis drugs were most often the category of the doctors' prescriptions.
Azole to dominate phosphonic acid double phosphonic acid salts
In the double phosphonic acid salt, azole to phosphonic acid occupied 58% market share, in the category of double phosphonic acid salt dominant.
Reclast/Aclasta (azole phosphonic acid) was developed by novartis global fourth listed for double phosphonic acid salts drugs for the treatment of osteoporosis. Main formulations of the products for intravenous injection, one year one shot dosing frequency great convenience to patients, and related clinical trials also proved the effectiveness of the drug. Azole to phosphonic acid, however, has not been treatment guidelines recommended as first-line drugs, moreover the product sales in the United States because of other products (such as Allen sodium phosphate, sodium, plug phosphonic acid, phosphonic acid sodium) the class of the generics market and gradually decline.
Azole phosphonic acid initially in the United States in 2001 was to Zometa (4 mg) brand name approved, mainly used in the treatment of hypercalcemia caused cancer. In 2007, in the United States and Europe, azole to phosphonic acid with brand name Reclast (5 mg) is approved for osteoporosis after menopause women. In 2008 and expanded Reclast indications to prevent women and men of hip fractures. In 2009, the United States, approved by FDA Reclast) for the treatment of osteoporosis and its injection frequency is once every two years; In the same year Reclast by European EMA approved for a man caused by steroids and symptoms of postmenopausal osteoporosis.
4 mg injection with azole phosphonic acid by novartis domestically listed in 2004, and 5 mg for osteoporosis azole phosphonic acid injection in 2009 was approved in China. Azole phosphonic acid in more than 10 domestic generic manufacturers, such as the weather is fine, hengrui, etc.
The original article absolute advantage
Although most of phosphonic acid salts drug patents have expired, in addition to a few varieties, however, foreign companies on the item's dominant market share.
Azole phosphonic acid is currently the only one in double phosphonic acid salt in Europe and the United States patent has not yet expired, azole to phosphonic acid in the European patent expired in 2021, in the United States patent expired in 2028. However, due to the impact of the generics market similar products, its sales abroad have varying degrees of decline, fell 4% compared with 2014 in 2015. In contrast, azole phosphonic acid in China in 2015 to around 7% of the growth rate of growth.
Look from the market share of a single drug, in addition to the class phosphonic acid, para meters phosphonic acid and calcitriol held by local enterprises, several other pairs of phosphonic acid salt is dominated by foreign companies. For example: novartis thiazole phosphonic acid by more than 70% of the share, Allen phosphonic acid by Merck accounted for more than 80% of market share, phosphonic acid chloride by bayer accounted for more than 80% of market share. This kind of situation and foreign patents expire after corresponding products market share a sharp drop in form relatively bright contrast. Similarly, calcitonin salmon calcitonin in class, novartis still accounts for about 70% of the share, estradiol bayer occupies 98% market share, for drug by Dutch organon occupy more than 80% market share, raloxifene by lilly occupy about 80% market share.
The domestic research and development
Generic weak
In the field of osteoporosis, for some listed varieties for many years, the domestic enterprise of generic fatigue, no diseases such as cancer, diabetes, anti-infection and so on domestic most drug firms receiving attention.
In addition to the double phosphonic acid salts, after 2000 listed on the global osteoporosis drugs are: lilly peptide (2002), the tenet of servier rainie acid strontium (2004), of amgen's single resistance (2010).
Tenet palmer peptide in domestic haven't domestic market, at present only squire in shenzhen and Shanghai united self companies in 2014 and 2015, submit the clinical application.
Rainie acid strontium today, only the original servier in domestic market, domestic generic declaration is mostly old 3.1 class before 2010, the shandong hengrui in 2006, got the approval documents of clinical, but 10 years on, the product still not declared for production. Presumably, the preparation of the product and clinical still has the certain difficulty.
To single resistance is the first in the field of osteoporosis biological therapy, the product to achieve $2010 in 513 million sales revenue, although the mechanism of action of single resistance than double phosphonic acid salt is not new, but two years the use of a dose, do offer greater convenience to patients, and better adherence. Compared to other second-line drugs, especially in those patients with high risk of fracture for second-line drugs, and the effectiveness of the sheet resistance and better tolerability. But, is such a product, the original is not at home for import declaration, no declaration of related biological analogs.
As for the listed earlier raloxifene (1998), only hengrui listed in domestic enterprises, and the 6 kind of generic drugs to declare only chongqing st cfna was carried out in 2014 BE application.
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In view of the above situation, I guess there are two main reasons: first, osteoporosis category industry usually are not cognitive therapy, easy to be ignored; Second, in view of some peptides, single class, and volatile compounds, domestic enterprises there are still some technical hurdles to breakthrough.
Independent research and development awareness is low
Foreign current anti osteoporosis drug development late clinical concentration of peptides, single class, few domestic enterprises follow up; And small molecule drugs yesterday Finn and declaration of cluster is facing. Domestic independent research and development on drugs in the field of interest is low.
In the field of osteoporosis, recently listed and late clinical projects mainly focus on:
Pfizer's lot yesterday Finn (Viviant) is the main target estrogen receptor; The Radius the Health development of peptide drugs Abaloparatide BA058 (SC), targets for parathyroid hormone; Development of biological medicine Natpara similar NPS company (recombinant human parathyroid hormone).
Merck had high hopes of odanacatib, inhibit cathepsin K (cathepsin K) play a role, the protease plays a key role in bone resorption. The mechanism of action of this is a kind of new, original odanacatib have wanted to be the first of the mechanism of action listed drugs, but because of according to Ⅲ phase of clinical trial data, odanacatib increased the risk of atrial fibrillation and stroke, Merck announced in September 2016, therefore give odanacatib clinical development, leading to high the product.
Tarsa developed calcitonin (Ostora), main is a kind of polypeptide and UCB Romosozumab with amgen joint development. Romosozumab is currently in anti osteoporosis most have clinical attractive products on the market, the current clinical data, its curative effect is better than the current world osteoporosis drug to market, and Romosozumab role green-field anabolic pathways, it is very beneficial for patients with bone generation needs.
The above products in addition to the more than yesterday, odanacatib, are protein drugs, there is no relevant domestic enterprises to copy to follow up.
The ever more Finn is imported by Pfizer in 2011 clinical application, so far, has not production report; But the generic declare there are as many as 11, including the qilu pharmaceutical and public companies such as the weather is fine.
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Comprehensive the above information, the field of osteoporosis drug research and development direction of macromolecular project now, but slower domestic follow up; For small molecules, the domestic response faster. Query salty reach V3.2, found that there are no independent research and development in domestic against osteoporosis drug class 1 new drug for declaration, showed the new drug research and development enterprise to lack of attention in the field.
conclusion
Osteoporosis drug market in China is not small, than the crowded diabetes medication, tumor drug market, osteoporosis is more likely to cultivate in the field of research and development of domestic domestic and foreign enterprises compete of generic drugs.
However, the domestic enterprises to focus on the direction in the field of osteoporosis, or is not exactly curative effect of traditional Chinese medicine, after either generic may not be able to open the market direction.
If the mechanism is not our advantage, at least to fast follow up foreign late clinical has the prospect of research and development projects, under the premise of quality assurance in technology to get the corresponding first-mover advantage.
In addition, the relevant generic drug post-marketing not rest easy, high-value, need to market, for domestic generics market positioning and the corresponding marketing strategy, on the basis of equivalent quality, with corresponding cost advantage to occupy the domestic market, in order to beat foreign enterprises dominant pattern on the share. |
