多關節型青少年特發性關節炎藥物全球市場-2022-2029
市場調查報告書
商品編碼
1140671

多關節型青少年特發性關節炎藥物全球市場-2022-2029

Global Polyarticular Juvenile Idiopathic Arthritis Drugs Market - 2022-2029

出版日期: | 出版商: DataM Intelligence | 英文 180 Pages | 商品交期: 約2個工作天內

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簡介目錄

市場概況

到 2021 年,多關節型幼年特發性關節炎治療市場規模估計為 15.884 億美元,在 2022-2029 年的預測期內達到 6.60% 的複合年增長率 (CAGR)。

幼年特發性關節炎 (JIA) 是兒童和青少年最常見的關節炎類型之一。幼年特發性關節炎是一種慢性炎症性疾病,分為六類:全身性、少突型、多關節型、跟腱炎相關、銀屑病型和未分化型。JIA 在 16 歲之前開始並持續至少 6 週。美國約有 300,000 名兒童患有 JIA。

多關節型幼年特發性關節炎 (PJIA) 影響五個或更多關節,包括手腳的小關節和膝、髖、踝等大關節。PJIA 會影響手指和手部的小關節,但也會影響負重關節和下巴。症狀包括發燒、粉紅色皮疹、眼睛刺激、關節疼痛、關節腫脹以及骨骼發育和生長問題。治療包括止痛藥、非甾體抗炎藥和改善疾病的抗風濕藥。

市場動態

多關節幼年特發性關節炎發病率的增加正在推動市場增長。

據估計,美國約有 300,000 名兒童患有某種形式的關節炎。JIA發病率估計為每年每10萬人4-14例,JRA患病率估計為每10萬人1.6-86.1例。兒童關節炎的發病率從日本的每 100,000 人 0.83 到挪威的每 100,000 人 23 不等。世界範圍內的發病率正在增加。Pruunsild 等人報告說,愛沙尼亞連續第三年增長了 3.5 倍。患病率從台灣的 3.8/100,000 到澳大利亞的一項社區研究中的 400/100,000 不等。

因此,隨著幼年特發性關節炎(JIA)發病率的增加,私人製造商和研究機構正在積極進行治療藥物的研發。幾項臨床試驗正在進行中,以擴大 PJIA 治療的潛力。

流行病學

幼年特發性關節炎是兒童期最常見的慢性風濕性疾病之一。在高收入國家,年發病率估計為每 100,000 人 2-20 例。這些地區的患病率估計為每 100,000 人 16-150 例。一項針對西澳大利亞學童的區域研究報告稱,每 100,000 人中有 400 人患病。總體而言,患病率通常被概括為千分之一的兒童。

不同人群和種族的發病率和流行率數據不同,非洲裔加勒比和亞洲人群的流行率較低。JIA亞型的頻率也存在種族差異。例如,多發性關節炎是歐洲人的常見亞型,但多發性關節炎在印度、哥斯達黎加、新西蘭和南非等許多其他國家占主導地位。

市場細分

全球多關節幼年特發性關節炎治療市場根據藥物類型和分銷渠道進行細分。

按藥物類型來看,治療多關節幼年特發性關節炎的雙羥□酸有望迅速增長。

按藥物類型,多關節型幼年特發性關節炎藥物市場分為改善疾病的抗風濕藥(DMARDs)、生物製劑、非甾體抗炎藥和糖皮質激素。

非甾體抗炎藥:NSAIDs通過抑制環加氧□ (COX) 來干擾前列腺素的合成,從而減輕腫脹和疼痛。NSAIDs用於治療 JIA 的所有亞型。它可以有效緩解疼痛和減少腫脹。常用的非甾體抗炎藥包括□普生、布洛芬、托美汀、雙氯芬酸和消炎痛。

美洛昔康(Movic):美洛昔康屬於非甾體抗炎藥的烯醇家族,在結構上與□羅昔康相關。Movic 用於緩解 2 歲及以上兒童小關節或多關節關節的幼年類風濕性關節炎症狀。

□普生(Aleve、Naprelan、Naprosyn):□普生是一種鎮痛劑和抗炎藥,用於治療關節疼痛和關節炎。□普生適用於治療類風濕性關節炎、骨關節炎、強直性脊柱炎、多關節幼年特發性關節炎、肌腱炎、滑囊炎、急性痛風、原發性痛經和輕度至中度疼痛。有緩解作用。

改善疾病的抗風濕藥 (DMARDs):DMARDs 可以減緩或預防疾病進展,從而防止關節破壞和相關的功能衰退。DMARDs 的成功治療可以消除對其他抗炎和止痛藥的需求。然而,在 DMARD 完全有效之前,可能需要抗炎和鎮痛藥物作為減輕疼痛和腫脹的橋樑。

Sulfasalazine (Azulfidine, EN-tab):在治療對水楊酸鹽和其他非甾體類抗炎藥反應不充分的多關節型幼年類風濕性關節炎的兒科患者中,降低炎症反應並降低炎症反應。全身抑制前列腺素合成.

生物製劑:結合 TNF 並阻斷其與其受體相互作用的 TNF 抑製劑,如依那西普、英夫利昔單抗和阿達木單抗。

依那西普:2019年4月,FDA批准了依那西普的第二種生物仿製藥依那西普-依那西普,用於所有符合條件的生物適應症。Eticovo (etanercept-ykro, Samsung Bioepis) 是 Enbrel (etanercept, Amgen) 的生物仿製藥,推薦用於患有強直性脊柱炎、斑塊型銀屑病、多關節型幼年特發性關節炎、銀屑病關節炎和類風濕性關節炎的患者。它是一種 TNF 抑製劑,用於治療目的.獲得該批准後,Eticovo 成為第二個獲准在美國使用的 Enbrel 生物仿製藥。

Tocilizumab LusiNEX (Tocilizumab, Mysenac) 是一種具有白細胞介素 6 受體 (IL-6R) 拮抗劑活性的生物類似藥。通過與 IL-6R 結合,它可以抑制炎症反應並減輕關節侵蝕。Actemra/Roa Actemra 適用於類風濕性關節炎 (RA)、巨大淋巴結增生 (Castleman 病)、多關節特發性關節炎 (PJIA) 和全身性幼年特發性關節炎 (SJIA)。

阿達木單抗:2022年8月17日,Samsung Bioepis Co., Ltd.和Organon Co., Ltd.收到來自美國的Humira(阿達木單抗)生物類似藥HADLIMA(阿達木單抗-bwwd)的無檸檬酸鹽高濃度製劑。食品和藥物管理局 (FDA). 100mg/ml) 獲得批准。

地理滲透

北美在多關節幼年特發性關節炎藥物的全球市場中佔有最大的市場份額。

由於幼年特發性關節炎患病率的上升和多關節型幼年特發性關節炎藥物的開發不斷增加,北美地區在全球多關節型幼年特發性關節炎藥物市場中佔據主導地位,在 2021 年佔據最大的市場份額。例如,2020 年 4 月,Johnson & Johnson旗下Janssen Pharmaceutical Companies宣布,幼年特發性多關節關節炎(DJIA)和幼年銀屑病關節炎(DJIA)聯合甲氨蝶呤治療 2 歲及以上患者(jPsA)我們已經提交了兩份生物製品許可證向美國食品和藥物管理局 (FDA) 提交的補充申請 (sBLA),尋求批准 SIMPONI ARIA (golimumab) 用於治療用途。

同樣在 2021 年 2 月 24 日,美國上市生物製藥公司AbbVie獲得美國食品和藥物管理局批准 HUMIRA 用於治療 5 歲及以上兒童患者的中度至重度活動性潰瘍性結腸炎(阿達木單抗)。已被批准。

競爭格局

多關節型幼年特發性關節炎藥物市場競爭激烈。由於新藥開發的增加,少數中小企業可能會在預測期內進入市場。為市場增長做出貢獻的主要公司包括Pfizer Inc.、Biocon Ltd.、Coherus BioSciences Inc.、Livzon Pharmaceutical Group Inc.、Myenta Pharmaceuticals Inc.。Momenta Pharmaceuticals Inc.、Mycenax Biotech Inc.、Oncobiologics Inc.、Oncodesign SA、Panacea Biotec Ltd.、Regeneron Pharmaceuticals Inc.、Sandoz International GmbH、UCB SA 等。主要參與者正在採取多種增長戰略,包括產品發布、收購和合作夥伴關係,這些戰略正在促進全球多關節幼年特發性關節炎治療市場的增長。

Pfizer Inc.

概述

Pfizer Inc.是一家總部位於紐約的美國製藥公司。該公司為廣泛的醫學領域開發和生產藥物和疫苗,包括免疫學、腫瘤學、心髒病學、內分泌學和神經學。產品包括降低 LDL 膽固醇的重磅炸彈立普妥(阿托伐他汀)、神經性疼痛和纖維肌痛藥物 Lyrica(普瑞巴林)、口服抗真菌藥物 Diflucan(氟康唑)、抗生素 Zithromax(阿奇黴素)、治療勃起功能障礙的偉哥(西地那非)、和抗炎藥Celebrex(也稱為Cerebra,celecoxib)。

產品介紹

XELJANZ(託法替尼)。在美國,甲氨蝶呤難治的中度至重度活動性類風濕關節炎 (RA)、改善疾病的抗風濕藥物 (DMARD) 和腫瘤壞死因子抑製劑 (TNFi) 難治的活動性銀屑病關節炎 (PSA) 已批准用於中度- 至重度活動性潰瘍性結腸炎 (UC)、活動性多關節病程幼年特發性關節炎 (pcJIA)(□2 歲患者)。

重大發展

2020年9月28日,Pfizer Inc.宣布XELJANZ(託法替尼)獲美國食品藥品監督管理局(FDA)批准,用於治療2歲及以上活動性多關節幼年特發性關節炎(pcJIA)兒童和青少年獲得批准。這次批准的是兩種劑型,一種是片劑,一種是內服,劑量是根據體重來的。該批准使 XELJANZ 成為美國第一個也是唯一一個批准用於治療 pcJIA 的 Janus 激□( JAK )抑製劑。

COVID-19 對數字 X 射線全球市場的負面影響

COVID-19 正在通過直接影響生產和需求、擾亂供應鍊和擾亂市場以及對企業和金融市場產生財務影響來影響全球經濟。全球多關節型幼年特發性關節炎治療市場受到 COVID-19 流行病的影響,由於人數不斷增加,利益相關者呼籲採用新的方法來診斷和治愈受 COVID-19 影響的患者。

2020 年 5 月,台灣合同研究和製造組織 (CDMO) Mycenax 同意向匈牙利的 Gedeon Richter 出售一種托珠單抗 (LusiNEX) 的生物仿製藥。

一種有可能治療與冠狀病毒病(COVID-19)相關的肺炎的研究性生物仿製藥產品將以 1650 萬美元的價格出售。該生物類似藥是基於Roche Actemra開發的托珠單抗製劑。儘管該產品旨在用於類風濕性關節炎的二線治療,但最近的證據表明它可能在對抗 COVID-19 方面具有治療價值。

LusiNEX 目前處於 1 期試驗階段,自 2013 年以來一直在開發中。Gedeon Richter 預計將於 2025 年在歐盟、加拿大、澳大利亞和日本上市銷售。目前美國市場上沒有托珠單抗生物類似藥。羅氏 Actemra 的全球銷售額估計為 24 億美元。

FDA 還在進行一項 3 期研究,以評估靜脈注射托珠單抗(“Actemra”)與 COVID-19並發症住院成人的護理標準的安全性和有效性。已批准臨床試驗。該研究將評估該藥物是否可以減少不受控制的炎症,這種炎症會損害患者的肺部並增加通氣和死亡的風險。在某些 COVID-19 病例中,免疫系統可能變得過度活躍並產生危及生命的細胞因子風暴。武漢的中國醫生去年報告了使用托珠單抗治療少數嚴重肺損傷的 COVID-19 患者的可喜結果。托珠單抗現已納入中國 COVID-19 治療指南。

目錄

第一章 調查方法和範圍

  • 調查方法
  • 市場範圍

第二章主要趨勢和發展

第三章執行摘要

  • 按藥物類型劃分的市場細分
  • 按分銷渠道劃分的市場細分
  • 區域市場細分

第四章市場動態

  • 市場影響因素
    • 促進者
      • 骨科領域病例增加推動市場增長
      • 數字 X 射線設備的技術進步
    • 約束
      • 輻射暴露的副作用風險
    • 商機
  • 影響分析

第五章行業分析

  • 波特五力分析
  • 供應鏈分析
  • 定價分析
  • 監管分析
  • 醫療費用分析

第 6 章 COVID-19 分析

  • COVID-19 的市場分析
    • COVID-19 之前的市場情景
    • COVID-19 的當前市場情景
    • COVID-19 後或未來情景
  • COVID-19 中的價格動態
  • 供需譜
  • 大流行期間與市場相關的政府努力
  • 製造商的戰略舉措
  • 概括

第 7 章 按藥物類型

  • 改善疾病的抗風濕藥
    • 柳氮磺胺□啶
    • 來氟米特
    • 甲氨蝶呤
    • 其他
  • 非甾體抗炎藥
    • 美洛昔康
    • □普生
      • 阿雷夫
      • 那不勒蘭
      • □普生
    • 其他
  • 生物製品
    • 阿巴西普
    • 阿達木單抗
    • 依那西普
    • 英夫利昔單抗
    • 利妥昔單抗
    • 托珠單抗
    • 其他
  • 皮質類固醇
  • 其他

第8章按銷售渠道

  • 醫院藥房
  • 零售藥店
  • 網上藥店
  • 其他

第9章按地區

  • 北美
    • 美國
    • 加拿大
    • 墨西哥
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美地區
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 西班牙
    • 意大利
    • 歐洲其他地區
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 澳大利亞
    • 亞太其他地區
  • 中東/非洲

第 10 章 競爭格局

  • 競爭情景
  • 競爭對手戰略分析
  • 市場/份額分析
  • 併購分析

第十一章公司簡介

  • Pfizer Inc.
    • 公司簡介
    • 產品組合和描述
    • 主要亮點
    • 財務摘要
  • Biocon Ltd.
  • Coherus BioSciences Inc.
  • Livzon Pharmaceutical Group Inc.
  • Momenta Pharmaceuticals Inc.
  • Mycenax Biotech Inc.
  • Oncobiologics Inc.
  • Oncodesign SA
  • Panacea Biotec Ltd.
  • Regeneron Pharmaceuticals Inc.
  • Sandoz International GmbH
  • UCB SA List not Exhaustive

第 12 章 數據管理

簡介目錄
Product Code: DMPH2748

Market Overview

Polyarticular Juvenile Idiopathic Arthritis Drugs Market size was valued at USD 1,588.40 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 6.60% over the forecast period 2022 to 2029.

Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis in kids and teens. Juvenile idiopathic arthritis is a chronic inflammatory disease that includes six categories: systemic, oligoarticular, polyarticular, enthesitis-related, psoriatic, and undifferentiated. JIA begins before 16 years of age and persists for at least six weeks. Around 300,000 children in the U.S. have a form of JIA.

Polyarticular juvenile idiopathic arthritis (PJIA) affects five or more joints and affects both the small joints of the hands and feet, and large joints like the knees, hips, and ankles. PJIA causes inflammation in small joints of the fingers and hands, but weight-bearing joints and the jaw can also be affected. Symptoms include fevers, pink rash, eye inflammation, joint pain, joint swelling, and problems with bone development and growth. Some of the treatment includes painkillers, NSAIDs, and disease-modifying anti-rheumatic drugs.

Market Dynamics

The increasing incidence of Polyarticular juvenile idiopathic arthritis is driving the market growth

Approximately 300,000 children in the United States are estimated to have some type of arthritis. The incidence rate estimates for JIA range from 4-14 cases per 100,000 children annually; for JRA, the prevalence has ranged from 1.6 to 86.1 cases per 100,000. The incidence of childhood arthritis ranges from 0.83 per 100,000 children in Japan to 23 per 100,000 in Norway. The incidence rate is increasing globally. Pruunsild et al. reported a 3.5-fold increase over three consecutive years in Estonia. The prevalence rate varies considerably more, spanning from 3.8 per 100,000 children in Taiwan to 400 per 100,000 in one community-based study in Australia.

Hence, the increasing incidence of juvenile idiopathic arthritis (JIA)is leading to a rise in research and development for its treatment by private manufacturers and research organizations. Several clinical trials are undergoing to expand the potential future of PJIA drugs.

Epidemiology

Juvenile Idiopathic Arthritis is one of the most common, chronic rheumatic diseases of childhood. In high-income countries, the annual incidence is estimated to be 2-20 cases per 100,000 population. The prevalence in these areas is estimated to be 16-150 cases per 100,000 population. According to one community-based survey of school children in Western Australia, it was reported that the prevalence is 400 per 100,000. Overall, the prevalence is often summarized as one per thousand children.

Incidence and prevalence data vary across the different populations and ethnic groups, with a lower prevalence in the Afro-Caribbean and Asian populations. There are also some ethnic differences in the frequency of JIA subtypes: for instance, oligoarthritis is a common subtype in European populations, whilst polyarticular disease predominates in many other countries including India, Costa Rica, New Zealand, and South Africa.

Market Segmentation

The global polyarticular juvenile idiopathic arthritis drugs market is segmented based on Drug Type and Distribution Channel.

By Drugs type, Polyarticular Juvenile Idiopathic Arthritis Drugs Pamoate is expected to witness rapid growth

Based on drug type, the polyarticular juvenile idiopathic arthritis drugs market is segmented into disease-modifying antirheumatic drugs (DMARDs), biologics, NSAIDs, and Glucocorticoids.

Nonsteroidal Anti-inflammatory Drugs: NSAIDs interfere with prostaglandin synthesis through inhibition of the enzyme cyclooxygenase (COX), thus reducing swelling and pain. NSAIDs are used to treat all subtypes of JIA. They may help with pain and decrease swelling. Commonly used NSAIDs include naproxen, ibuprofen, tolmetin, diclofenac, and indomethacin.

Meloxicam (Mobic): Meloxicam is a member of the enolic class of NSAIDs and is structurally related to piroxicam. MOBIC is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older.

Naproxen (Aleve, Naprelan, Naprosyn): Naproxen is used for analgesic and anti-inflammatory properties, treating arthralgia and arthritis. Naproxen is indicated for the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, tendinitis, bursitis, acute gout, primary dysmenorrhea, and for the relief of mild to moderate pain.

Disease-Modifying Antirheumatic Drugs: DMARDs can retard or prevent disease progression and, thus, joint destruction and subsequent loss of function. Successful DMARD therapy may eliminate the need for other anti-inflammatory or analgesic medications; however, until the full action of DMARDs takes effect, anti-inflammatory or analgesic medications may be required as bridging therapy to reduce pain and swelling.

Sulfasalazine (Azulfidine, EN-tabs): Sulfasalazine decreases the inflammatory response and systemically inhibits prostaglandin synthesis. in the treatment of pediatric patients with polyarticular-course juvenile rheumatoid arthritis who have responded inadequately to salicylates or other nonsteroidal anti-inflammatory drugs.

Biologics: The TNF blockers, which bind TNF and thus prevent its interaction with its receptors, include etanercept, infliximab, and adalimumab, among others

Etanercept: In April 2019, the FDA has approved the second biosimilar to etanercept, etanercept-ykro, for all eligible indications of the biological product. Eticovo (etanercept-ykro, Samsung Bioepis), a biosimilar to Enbrel (etanercept, Amgen), is a TNF-inhibitor intended to treat patients with ankylosing spondylitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis. With this approval, Eticovo becomes the second biosimilar to Enbrel approved for use in the United States.

Tocilizumab: LusiNEX (Tocilizumab, Mycenax in-house), a biosimilar act as interleukin-6 receptor (IL-6R) antagonist. By binding IL-6R, it blocks the inflammatory response and alleviates joint erosion. The indication of Actemra/ RoActemra includes Rheumatoid arthritis (RA), giant lymph node hyperplasia (Castleman's disease), polyarticular idiopathic juvenile arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA).

Adalimumab: On 17th August 2022, Samsung Bioepis Co., Ltd. and Organon & Co. announced that The United States Food and Drug Administration had approved the citrate-free, high concentration (100 mg/mL) formula of HADLIMA (adalimumab-bwwd), is a biosimilar referencing HUMIRA (adalimumab).

Geographical Penetration

North America region holds the largest market share in the global polyarticular juvenile idiopathic arthritis drugs market

North American region is dominating the global polyarticular juvenile idiopathic arthritis drugs market and accounted for the largest market share in 2021, owing to the rising prevalence of juvenile idiopathic arthritis and increasing development of drugs for the treatment of polyarticular juvenile idiopathic arthritis. For instance, in April 2020, the Janssen Pharmaceutical Companies of Johnson & Johnson submitted two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (DJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate.

Also, on 24th February 2021, AbbVie, an American- based publicly traded biopharmaceutical company, announced that The United States Food and Drug Administration had approved HUMIRA (adalimumab) for treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.

Competitive Landscape:

The polyarticular juvenile idiopathic arthritis drugs market is competitive. The rising drug development may witness the entry of a few small- or mid-sized companies into the market during the forecast period. Some of the key players which are contributing to the growth of the market include Pfizer Inc., Biocon Ltd., Coherus BioSciences Inc., Livzon Pharmaceutical Group Inc. Momenta Pharmaceuticals Inc., Mycenax Biotech Inc., Oncobiologics Inc., Oncodesign SA, Panacea Biotec Ltd., Regeneron Pharmaceuticals Inc., Sandoz International GmbH, UCB SA, among others. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the Polyarticular Juvenile Idiopathic Arthritis Drugs market globally.

Pfizer Inc.

Overview:

Pfizer Inc. is an American pharmaceutical corporation headquartered in New York City. The company develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, endocrinology, and neurology. Its products include the blockbuster drug Lipitor (atorvastatin), used to lower LDL blood cholesterol; Lyrica (pregabalin) for neuropathic pain and fibromyalgia; Diflucan (fluconazole), an oral antifungal medication; Zithromax (azithromycin), an antibiotic; Viagra (sildenafil) for erectile dysfunction; and Celebrex (also Celebra, celecoxib), an anti-inflammatory drug.

Product Portfolio:

XELJANZ (tofacitinib): It is approved in the U.S. in four indications: adults with moderately to severely active rheumatoid arthritis (RA) after methotrexate failure, adults with active psoriatic arthritis (PsA) after disease-modifying antirheumatic drug (DMARD) failure, adults with moderately to severely active ulcerative colitis (UC) after tumor necrosis factor inhibitor (TNFi) failure, and patients 2 years of age or older with active polyarticular course juvenile idiopathic arthritis (pcJIA).

Key Development:

On 28th September 2020, Pfizer received the United States (US) Food and Drug Administration (FDA) approval for XELJANZ (tofacitinib) for the treatment of children and adolescents two years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA). Two formulations were approved, a tablet and an oral solution, and are dosed based upon weight. This approval makes XELJANZ the first and only Janus kinase (JAK) inhibitor approved in the US for the treatment of pcJIA.

COVID-19 Impact: Negative impact on the global Digital X-ray Market

COVID-19 is affecting the global economy by directly affecting production and demand, disturbing the supply chain and market disruption, and by its financial impact on firms and financial markets. The global polyarticular juvenile idiopathic arthritis drugs market has been impacted by the COVID-19 pandemic, as stakeholders are increasingly searching for newer approaches to diagnosing and curing patients affected by the COVID-19.

In May 2020, Taiwan-based Mycenax, a pharmaceutical contract development and manufacturing organization (CDMO), agreed to sell its tocilizumab biosimilar (LusiNEX) to Hungary-based Gedeon Richter.

A biosimilar under development has the potential for treating coronavirus disease (COVID-19) related pneumonia is changing hands in a US$ 16.5 million deal. The biosimilar is a tocilizumab version that references Roche's Actemra. It is intended for the second-line treatment of rheumatoid arthritis, but recent evidence suggested that it has value as an agent in the war on COVID-19.

LusiNEX is currently being tested in a phase 1 trial and has been in development since 2013. Gedeon Richter is estimated to launch in the European Union, Canada, Australia, and Japan by 2025. Currently, there are no tocilizumab biosimilars on the U.S. market. Roche's Actemra has global sales estimated at $2.4 billion.

In addition, the FDA has approved a phase 3 clinical trial to evaluate the safety and efficacy of intravenous tocilizumab (Actemra) plus standard of care in hospitalized adult patients with pneumonia as a complication of COVID-19. The trial would assess if the agent can reduce uncontrollable inflammation that causes damage to patients' lungs and heightens risks for ventilation and death. In several cases of COVID-19, the immune system becomes overactive and generates a cytokine storm that can be life-threatening. Chinese physicians in Wuhan last year used tocilizumab to treat a small number of patients with COVID-19 with serious lung damage and reported promising results. Tocilizumab is now incorporated into Chinese guidelines for the treatment of COVID-19.

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Scope of the Market

2. Key Trends and Developments

3. Executive Summary

  • 3.1. Market Snippet by Drug Type
  • 3.2. Market Snippet by Distribution Channel
  • 3.3. Market Snippet by Region

4. Market Dynamics

  • 4.1. Market impacting factors
    • 4.1.1. Drivers
      • 4.1.1.1. The prevalence of orthopedic cases will drive the market growth.
      • 4.1.1.2. Technological advancements in digital X-ray devices
    • 4.1.2. Restraints
      • 4.1.2.1. Risk of adverse effects from radiation exposure
    • 4.1.3. Opportunities
  • 4.2. Impact analysis

5. Industry Analysis

  • 5.1. Porter's five forces analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Pricing Analysis
  • 5.4. Regulatory Analysis
  • 5.5. Reimbursement Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of Covid-19 on the Market
    • 6.1.1. Before COVID-19 Market Scenario
    • 6.1.2. Present COVID-19 Market Scenario
    • 6.1.3. After COVID-19 or Future Scenario
  • 6.2. Pricing Dynamics Amid Covid-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During Pandemic
  • 6.5. Manufacturers Strategic Initiatives
  • 6.6. Conclusion

7. By Drug Type

  • 7.1. Introduction
    • 7.1.1. Market size analysis, and y-o-y growth analysis (%), By Drug Type Segment
    • 7.1.2. Market attractiveness index, By Drug Type Segment
  • 7.2. Disease-modifying antirheumatic drug*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis, US$ Million, 2020-2029 And Y-O-Y Growth Analysis (%), 2021-2029
    • 7.2.3. Sulfasalazine
    • 7.2.4. Leflunomide
    • 7.2.5. Methotrexate
    • 7.2.6. Others
  • 7.3. Nonsteroidal anti-inflammatory drugs
    • 7.3.1. Meloxicam
    • 7.3.2. Naproxen
      • 7.3.2.1. Aleve
      • 7.3.2.2. Naprelan
      • 7.3.2.3. Naprosyn
    • 7.3.3. Others
  • 7.4. Biologics
    • 7.4.1. Abatacept
    • 7.4.2. Adalimumab
    • 7.4.3. Etanercept
    • 7.4.4. Infliximab
    • 7.4.5. Rituximab
    • 7.4.6. Tocilizumab
    • 7.4.7. Others
  • 7.5. Corticosteroids
  • 7.6. Others

8. By Distribution Channel

  • 8.1. Introduction
    • 8.1.1. Market size analysis, and y-o-y growth analysis (%), By Distribution Channel Segment
    • 8.1.2. Market attractiveness index, By Distribution Channel Segment
  • 8.2. Hospital Pharmacies*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis, US$ Million, 2020-2029 And Y-O-Y Growth Analysis (%), 2021-2029
  • 8.3. Retail Pharmacies
  • 8.4. Online Pharmacies
  • 8.5. Others

9. By Region

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key region-specific dynamics
    • 9.2.3. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Drug Type
    • 9.2.4. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Distribution Channel
    • 9.2.5. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Country
      • 9.2.5.1. U.S.
      • 9.2.5.2. Canada
      • 9.2.5.3. Mexico
  • 9.3. South America
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Drug Type
    • 9.3.4. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Distribution Channel
    • 9.3.5. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Country
      • 9.3.5.1. Brazil
      • 9.3.5.2. Argentina
      • 9.3.5.3. Rest of South America
  • 9.4. Europe
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Drug Type
    • 9.4.4. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Distribution Channel
    • 9.4.5. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Country
      • 9.4.5.1. Germany
      • 9.4.5.2. U.K.
      • 9.4.5.3. France
      • 9.4.5.4. Spain
      • 9.4.5.5. Italy
      • 9.4.5.6. Rest of Europe
  • 9.5. Asia Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Drug Type
    • 9.5.4. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Distribution Channel
    • 9.5.5. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Country
      • 9.5.5.1. China
      • 9.5.5.2. India
      • 9.5.5.3. Japan
      • 9.5.5.4. Australia
      • 9.5.5.5. Rest of Asia Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Drug Type
    • 9.6.4. Market Size Analysis, And Y-O-Y Growth Analysis (%), By Distribution Channel

10. Competitive Landscape

  • 10.1. Competitive scenario
  • 10.2. Competitor strategy analysis
  • 10.3. Market positioning/share analysis
  • 10.4. Mergers and acquisitions analysis

11. Company Profiles

  • 11.1. Pfizer Inc.*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio and Description
    • 11.1.3. Key Highlights
    • 11.1.4. Financial Overview
  • 11.2. Biocon Ltd.
  • 11.3. Coherus BioSciences Inc.
  • 11.4. Livzon Pharmaceutical Group Inc.
  • 11.5. Momenta Pharmaceuticals Inc.
  • 11.6. Mycenax Biotech Inc.
  • 11.7. Oncobiologics Inc.
  • 11.8. Oncodesign SA
  • 11.9. Panacea Biotec Ltd.
  • 11.10. Regeneron Pharmaceuticals Inc.
  • 11.11. Sandoz International GmbH
  • 11.12. UCB SA List not Exhaustive*

12. DataM

  • 12.1. Appendix
  • 12.2. About us and services
  • 12.3. Contact us