Jersey City, NJ, April 06, 2023 (GLOBE NEWSWIRE) -- InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Adalimumab Biosimilar Market- (By Product (Amjevita, Cyltezo, Hadlima, Yusimry, Hulio, Hymiroz, Abrilada, Yuflyma, Exemptia, Adalirel, Cipleumab and other pipeline products), by Application (Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Crohn’s Disease, Ankylosing Spondylitis, Ulcerative Colitis, and Psoriasis), Distribution Channel (Hospital Pharmacy, Online Pharmacy and Other Direct Distribution Channels)), Trends, Industry Competition Analysis, Revenue and Forecast To 2031."
According to the latest research by InsightAce Analytic, the global Adalimumab Biosimilar market is valued at US$ 613.28 Million in 2022, and it is expected to reach US$ 3954.75 Million by 2031, with a CAGR of 23.2% during a forecast period of 2023-2031.
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Biosimilars are biological medicines that are the same in terms of safety and effectiveness as licenced originals. They can make the market more competitive and could give more patients access to biologics within the limits of treatment recommendations. For instance, in December 2002, the US Food and Drug Administration authorized Adalimumab as the first human monoclonal antibody.
Adalimumab is a drug used to treat psoriatic arthritis, rheumatoid arthritis, and various other conditions. Adalimumab is a prescription medication that goes by the brand names Exemptia and Humira. Adalimumab treats rheumatoid arthritis, Crohn's disease, psoriatic arthritis, psoriasis, and ulcerative colitis. In addition, Adalimumab is often used to bind TNF (tumour necrosis factor-alpha). TNF causes an inflammatory response that leads to autoimmune disease when it binds to TBF receptors. By binding to TNF, adalimumab reduces the risk of an inflammatory response.
The global adalimumab biosimilars market is anticipated to expand at a rapid rate during the projected period, owing to an increase in the prevalence of arthritis and skin disorders among the global population, which would result in an increase in demand for Adalimumab. As per World Health Organization (WHO), skin disorders are the leading cause of human health impairment. At any given time, it is believed that more than 900 million individuals worldwide suffer from skin disorders. Numerous of these skin illnesses result in lasting disfigurement, stigma, and disability, and their treatment has become a global priority for health organisations.
The biosimilar adalimumab has emerged as a promising treatment option for persistent skin diseases including eczema. This factor has the potential to greatly expand the global adalimumab biosimilars market during the predicted period. In addition, the introduction of new biosimilars would reduce medicine prices globally, resulting in a robust market demand. This is projected to drive the growth of the global adalimumab biosimilar market throughout the forecast period.
North America is supposed to be the major contributor to the Adalimumab Biosimilar market over the forecast years. As per the American Autoimmune Related Diseases Association, over 50 million Americans have an autoimmune disease. Furthermore, the annual healthcare costs for treating these disorders are nearly USD 100 billion. This, combined with an ageing population, will likely offer North America the highest share of the global adalimumab biosimilar market throughout the forecast period. In addition, the Asia Pacific Adalimumab Biosimilar market is supposed to grow significantly during the forecast period. The rising elderly population and increased governmental and private investment in pharmaceuticals drive the Asia-Pacific market. In addition, increasing investments in medical research are also projected to fuel the market.
Recent collaborations and agreements in the market:
- In Jan 2023, Amgen has recently introduced a biosimilar version of Humira by AbbVie in the United States. Amjevita's biosimilar will be priced 55% less than the wholesale purchase cost of Humira, which is $6,923 for a four-week supply. Amgen's objective is to provide patients with broad access by providing health plans and pharmacy benefit managers with two options.
- In June 2022, The application for Sandoz's biosimilar Hyrimoz ®'s concentration formulation 100 mg/mL (HCF) has been accepted for regulatory assessment by the European Medicines Agency (EMA), according to Sandoz (adalimumab). Rheumatoid arthritis, ulcerative colitis, Crohn's disease, plaque psoriasis, and uveitis are just a few of the indications covered by the reference drug* that are included in the application.
- In Feb 2022, The FDA has approved the PAS (Prior Approval Supplement) to the Biologics License Application (BLA) for ABRILADATM (adalimumab-afzb), an interchangeable biosimilar to Humira®, for review, according to a statement from Pfizer Inc. (adalimumab). The REFLECTIONS B538-12 trial, which examined a number of switches between ABRILADA and its reference drug, Humira, both of which were governed with methotrexate in adult patients with moderate to severe rheumatoid arthritis, provided supportive topline data that confirmed the PAS (RA).
- In Oct 2021, Boehringer Ingelheim announced that the U.S. FDA authorised the Cyltezo® (adalimumab-adbm) supplemental Biologics License Application (sBLA) as the first Interchangeable biosimilar with Humira® (adalimumab). In 2017, the FDA authorised Cyltezo® for the treatment of numerous chronic inflammatory illnesses, and this latest clearance certifies it as interchangeable for all of these indications.
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Major market players operating in the Adalimumab Biosimilar market include:
- Amgen,
- Pfizer,
- Sandoz International GmbH,
- Celltrion Healthcare Co., Ltd.,
- Fresenius Kabi,
- Kyowa Hakko Kirin,
- G. Life Sciences,
- Mochida Pharmaceutical,
- Momenta Pharmaceuticals.
- BIOCND
- Baxalta (Shire)
- Organon
- Teva
- Bio-Thera Solutions
- Biocad
- Boehringer Ingelheim
- CinnaGen
- Coherus Biosciences
- Hetero Drugs
- Hisun Pharmaceuticals
- Innovent Biologics
- Neuclone
- Outlook Therapeutics
- Prestige Biopharma
- Reliance Life Sciences
- Samsung Bioepis
- Shanghai Henlius Biotech
- Shanghai Junshi Biosciences
- Torrent Pharmaceuticals
- Zydus Cadila
- Amneal Pharmaceuticals, Inc.
- Hospira Inc.
- Mylan Pharmaceuticals Inc.
- Kashiv BioSciences, LLC
| Adalimumab Biosimilar Pipeline Landscape | |||
| Aprroximate launch | Product Name | Manufacturer/ Company | Approval |
| Jan 2023 | Amjevita | Amgen | FDA, EU |
| July 2023 | Cyltezo | Boehringer Ingelheim | FDA |
| Hadlima | Organon/Samsung Bioepis | FDA, EU | |
| Yusimry | Coherus | FDA | |
| Hulio | Viatris/Biocon | FDA, EU | |
| Sept 2023 | Hymiroz | Sandoz | FDA, EU |
| Nov 2023 | Abrilada | Pfizer | FDA |
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Market Segments
Global Adalimumab Biosimilar Market, by Product, 2023-2031 (Value US$ Mn)
- Amjevita
- Cyltezo
- Hadlima
- Yusimry
- Hulio
- Hymiroz
- Abrilada
- Yuflyma
- Exemptia
- Adalirel
- Cipleumab
- Other pipeline products
Global Adalimumab Biosimilar Market, by Application, 2023-2031 (Value US$ Mn)
- Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Psoriatic Arthritis
- Crohn’s Disease
- Ankylosing Spondylitis
- Ulcerative Colitis
- Psoriasis
Global Adalimumab Biosimilar Market, by Distribution Channel, 2023-2031 (Value US$ Mn)
- Hospital Pharmacy
- Online Pharmacy
- Retail Pharmacy
- Other Direct Distribution Channels
Global Adalimumab Biosimilar Market, by Region, 2023-2031 (Value US$ Mn)
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
North America Adalimumab Biosimilar Market, by Country, 2023-2031 (Value US$ Mn)
- U.S.
- Canada
Europe Adalimumab Biosimilar Market, by Country, 2023-2031 (Value US$ Mn)
- Germany
- France
- Italy
- Spain
- Russia
- Rest of Europe
Asia Pacific Adalimumab Biosimilar Market, by Country, 2023-2031 (Value US$ Mn)
- India
- China
- Japan
- South Korea
- Australia & New Zealand
Latin America Adalimumab Biosimilar Market, by Country, 2023-2031 (Value US$ Mn)
- Brazil
- Mexico
- Rest of Latin America
Middle East & Africa Adalimumab Biosimilar Market, by Country, 2023-2031 (Value US$ Mn)
- GCC Countries
- South Africa
- Rest of Middle East & Africa
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