Global Polyarticular Juvenile Idiopathic Arthritis Drugs Market - 2022-2029
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.
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