In 2019, the global market for psoriasis treatment drugs will reach 9.02 billion US dollars, with biological drugs as the main market

Source: on November 19, 2015, psoriasis is an immune-mediated chronic skin disease, which afflicts 2-3% of the global population Psoriasis is characterized by excessive proliferation of keratinocytes, which leads to pruritus, scales and red plaques Plaque psoriasis is the most common, accounting for 80% - 90% of psoriasis Among them, 80% of patients are mild to moderate psoriasis, 20% of patients are moderate to severe psoriasis, and at least 5% of these patients' body surface area is affected At present, there are many drugs for symptomatic treatment, and a series of drugs have been approved for the symptomatic treatment of psoriasis In patients with mild to moderate psoriasis, local topical drugs are usually used to regulate gene transcription, inhibit cell proliferation and promote keratinocyte differentiation The main external preparations include: corticosteroids, vitamin A acid tazarotene, calcineurin inhibitor tacrolimus, vitamin D analogue carbotriol, and compound preparations composed of carbotriol and betamethasone propionate For patients with more severe psoriasis, in addition to light therapy, oral systemic therapy drugs such as methotrexate, tretinoin or cyclosporine are also used Recently, otezla, the phosphodiesterase-4 inhibitor of cel gene, has become the first oral drug approved for the treatment of psoriasis in 20 years The drug was approved for marketing in the United States and the European Union in September 2014 and January 2015 The first biological drug approved for the treatment of psoriasis was Amgen's tumor necrosis factor enril (etanercept, Enbrel), which was approved in 2004 Tumor necrosis factor (TNF) is a kind of proinflammatory cytokines, which is highly expressed in psoriasis, and has a strong correlation with the severity of the disease The other two TNF drugs that were approved in 2005 were mosadong, REMICADE of Janssen biotechnology group, and sumilab, Humira of Aberdeen in 2006 Because of its superior safety and effectiveness, sumilab (adamumumab, Humira) has become the drug choice for patients with severe psoriasis However, since TNF is associated with infection and malignancy, doctors need to carefully weigh the efficacy and risk when prescribing these drugs Other biological drugs target proinflammatory cytokines such as interleukin-12, interleukin-17, and interleukin-23 In 2009, ytekimab and ustekinumab of Janssen biotechnology group have been approved by FDA The drug combines with P40 subunit shared by IL-12 and IL-23, and is the first and only drug approved for the treatment of psoriasis However, Novartis sukingumab (secukinumab, cosentyx) was not approved by FDA until January 2015 It is the first monoclonal antibody targeting IL-17 in the world, which is used for systemic treatment of moderate and severe psoriasis IL-17 is a cytokine derived from T cells, which is involved in the induction and mediation of inflammation, while IL-23 promotes the production of IL-17 cells Although these two mAbs are effective, they are expensive for psoriasis patients A series of new drugs for the treatment of psoriasis are under development, among which there are many drugs with innovative targets and mechanisms Two topical drugs are expected to go on the market In April 2015, Dr Promius Pharma, an American subsidiary of India pharmaceutical company, submitted a DFD-01 application to FDA, a corticosteroid spray or emulsion used to treat moderate and severe psoriasis In May 2015, maruho pharmaceutical of Japan filed an application for m8010 in Japan, which is an external drug composed of the vitamin D3 derivative Masha ossifying alcohol and the corticosteroid buprenbetamethasone, which will be used for the treatment of psoriasis vulgaris There are also a number of local external drugs have entered the end of the R & D pipeline Benvitimod of GlaxoSmithKline is a small non steroidal anti-inflammatory drug, which can significantly inhibit the expression of factors such as interleukin-2, interleukin-13, interleukin-17 and tumor necrosis factor It seems that the drug can inhibit the activation and migration of T cells, but the specific mechanism is not clear Benzenomod has entered the final stage of clinical trials for the treatment of psoriasis, in which China is in phase III and Canada is in phase II Two corticosteroids in Therapeutics Inc are in the III phase of the treatment of moderate to severe plaque psoriasis, where 122-0551 is an unknown emulsion of glucocorticoid receptor agonists, and the other is chlorproso's external lotion Chloroproso is a small molecule drug, and the widely used formulations are cream and ointment The drug is an inhibitor of phospholipase A2, which participates in the inflammatory process related to psoriasis Following the steps of otezla and apremillast, the phosphodiesterase-4 inhibitors of sell gene, are vitamin D derivatives of maruho pharmaceutical and pefcalcitol, the phosphodiesterase-4 inhibitors of maruho pharmaceutical in Japan They have entered the phase III clinical stage of plaque psoriasis in the United States and Europe, and also entered the phase II clinical stage in Japan Another drug is las-41008 from almirall, Spain, which is an oral preparation of dimethyl fumarate Dimethyl fumarate, as an immunomodulator, is believed to regulate proinflammatory cytokines through the signal pathway of nuclear factor E2-related factor 2 (Nrf2) The German right of the drug has been authorized to Baijian Aidi for the treatment of psoriasis, the trade name is Fumaderm Las-41008 and fp-187, another controlled-release preparation of dimethyl fumarate developed by forward Pharma, a Danish biopharmaceutical company, are respectively in phase III and phase II clinical trials for the treatment of plaque psoriasis in Germany The whole body treatment of biological drugs - targeted pro-inflammatory cytokines a pile of targeted pro-inflammatory cytokines of biological drugs is in the late stage of development Among them, the leading one is illekizumab, an IL-17 monoclonal antibody, which has been applied for the treatment of plaque psoriasis in the United States and has entered the phase III clinical stage of psoriatic arthritis Brodalumab, originally researched by Amgen and expected by Amgen and AstraZeneca, but after Amgen announced to withdraw from the cooperation with AstraZeneca on June 29, 2015, AstraZeneca also announced to enter into cooperation with varante pharmaceutical on September 2, 2015, and authorized the exclusive right of development and commercialization of the drug to varante pharmaceutical Under the agreement, valante will pay US $100 million in upfront payment, US $170 million in pre IPO milestone payment and US $175 million in post IPO sales related milestone payment, totaling US $445 million According to the agreement, valante pharmaceutical will have the global exclusive right to develop and commercialize brodalumab (except for Japan and some other Asian countries, which are held by Japan Pharmaceutical Enterprise consortia and fermentation Kirin), and will also bear all development costs related to the regulatory approval of brodalumab Brodalumab targets IL-17 receptor and is in the phase III clinical stage of various inflammatory diseases including psoriasis Brodalumab showed excellent curative effect in stage III clinical (amagine-2) The index of complete cure rate of psoriasis - 100% skin clearance rate (pasi-100) reached 25.7% - 44%, which was higher than that of sidanor (uticamab, ustekinumab) of Janssen biotechnology group, the latter was 21.7%, the blank control group was 0.6% Kylin has applied for listing in Japan Another promising target is the P19 subunit of IL-23 There are two drugs targeted at the target, namely, guselkumab (cnto1959) of Janssen biotechnology group, MSD and tildrakizumab of India sun pharmaceutical The difference between the two mAbs is that they do not affect the immune response of helper T cell 1, so they are safer Guselkumab comes from the human antibody library and is in the phase III clinical stage of plaque psoriasis and erythroderma psoriasis Guselkumab's phase II clinical (x-pore) is superior to sumilab (adamumumab, Humira) in the treatment of plaque psoriasis Tildrakizumab is also in phase III clinical practice, and two studies for moderate and severe plaque psoriasis are expected to be completed in 2019 According to IMS Midas of Ames market research company, the global market for psoriasis treatment drugs reached 7.49 billion US dollars in 2014, showing the substantial growth since 2010 US $4.2 billion, with a compound growth rate of 15.6% in 2010-2014 The top five products, such as amoximab and Humira, account for 82% of the market of psoriasis drugs Among them, the sales volume of amoximab and Humira, the leading figures, was US $2.05 billion in 2014, accounting for 27.3% of the market of psoriasis treatment drugs; the top one was sidano (utectab and ustekinumab) of Janssen biotechnology group, with a sales volume of US $1.94 billion in 2014, accounting for 26.0% of the market of psoriasis treatment drugs In 2014, the sales volume of enri (enacep, Enbrel) was US $1.47 billion, accounting for 19.6% of the market of psoriasis treatment drugs; in 2014, the sales volume of detubation of Leo Pharmaceutical (betamethasone and Daivobet) was US $444 million, accounting for 5.9% of the market of psoriasis treatment drugs In 2014, the sales volume was US $214 million, accounting for 2.9% of the psoriasis treatment drug market The U.S is still the main force in the global psoriasis treatment drug market, accounting for 62% of the global psoriasis treatment drug market The global market for psoriasis treatment drugs will reach US $9.02 billion in 2019, with a compound annual growth rate of 3.8% in 2014-2019, mainly driven by high prices of biological drugs However, as a series of patented biopharmaceuticals are about to expire in the mainstream market of psoriasis treatment drugs such as the United States and Europe, the growth of the global market of psoriasis treatment drugs will be impacted by biological analogues For example, the two biological analogues of mosadon and REMICADE, respectively remsima of celltrion, a Korean manufacturer of biological products, and infactra of heshengrui, the world's largest manufacturer of injection preparations, have been listed in many countries, including Europe and Japan, and have entered the FDA review stage Biological analogues of Amgen's enri (enacep, Enbrel) and Aberdeen's Sumeria (adamumumab, Humira) will also be launched in the near future The lack of response to existing therapeutic drugs and the absence of diagnostic markers for psoriasis are important defects of therapeutic drugs for psoriasis The updated molecular entity, along with the available biomarkers, will bring hope for the precise treatment of psoriasis