Number of pages: 100 | Report Format: PDF | Published date: February 20, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
According to the deep-dive market assessment study by Growth Plus Reports, the global adalimumab biosimilars market was valued at US$ 3.53 billion in 2021 and is expected to register a revenue CAGR of 20.1% to reach US$ 18.35 billion by 2030.
Adalimumab Biosimilars Market Fundamentals
Adalimumab is the first humanized monoclonal antibody that has been approved for the treatment of autoimmune disorders. Adalimumab is an anti-TNF (tumor necrosis factor) medication that reduces inflammation by blocking the effect of TNF. The medicine is available in single-dose prefilled pens (Abrilada pens), single-dose 1 ml prefilled glass syringes, and single-dose institutional usage vials. A single-dose 1 ml prefilled glass syringe is contained within the pen. Though approved, it is not yet commercialized in the United States. It is used to treat rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and psoriasis, among other conditions. It was identified using the phage display technique and was named D2E7. It also went through various manufacturing processes at BASF Bioresearch Corporation and was created by BASF Knoll. Abbott announced the acquisition of BASF Bioresearch Corporation in December 2000.
Despite the number of product introductions, biosimilar uptake in the United States has been variable, particularly when compared to Europe. However, the industry may reach a tipping point by 2023, when adalimumab biosimilars prepare to compete with the brand-name monster, AbbVie’s Humira. In 2021, AbbVie’s revenue for the blockbuster medicine was $20.7 billion. Humira is the first major specialty medicine with biosimilars in the market, mostly controlled through the pharmacy benefit. Amgevita, Amgen’s adalimumab biosimilar, is likely to be released soon. The FDA has approved eight adalimumab biosimilars, with the majority expected to launch within a year of Amgen’s Amgevita.
Adalimumab Biosimilars Market Dynamics
The adalimumab biosimilar market is expected to rise rapidly during the forecast period. Adalimumab is one of the world’s best-selling drugs. The entry of adalimumab biosimilar players into the market is likely to drive the revenue growth of the global adalimumab biosimilars market. For instance, the FDA authorized Boehringer Ingelheim’s Cyltezo adalimumab biosimilar medicine for numerous indications in 2017. Furthermore, the presence of strong pipeline compounds, such as FKB-327, GP-2017, and Amgevita, as well as the increased incidence of autoimmune illnesses, such as rheumatoid arthritis, is projected to drive demand for adalimumab biosimilars. Growing demand for biosimilar medications and increasing adoption of cost-effective therapy in low and middle-income nations is expected to propel the adalimumab biosimilars market during the forecast period.
However, the stringent regulatory process for biosimilar clearance is a major hindrance to the revenue growth of the adalimumab biosimilars market. Furthermore, the techniques utilized by patent-holder businesses to combat biosimilar competition may further impede the expansion of the adalimumab biosimilar industry. For instance, in Aug 2017, Abbvie filed a complaint against Boehringer Ingelheim for a biosimilar version of Humira.
Adalimumab Biosimilars Market Ecosystem
The global adalimumab biosimilars market has been analyzed from four perspectives: product, application, distribution channel, and region.
Adalimumab Biosimilars by Product
Based on the product, the global adalimumab biosimilars market has been segmented into amgevita, hyrimoz, imraldi, hulio, and others (abrilada, cyltezo, hadlima, and mabura).
The amgevita segment is expected to account for the largest revenue share during the forecast period. For instance, Amgen announced in November 2021 that it is seeking interchangeability certification for its low-concentration adalimumab biosimilar (Amjevita). Amjevita received FDA approval in September 2016 and is set to be the first adalimumab biosimilar to market in the United States in January 2023.
Adalimumab Biosimilars by Application
Based on application, the global adalimumab biosimilars market has been segmented into rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and others.
The rheumatoid arthritis segment is expected to dominate the global adalimumab biosimilars market during the forecast period, due to the increasing prevalence of rheumatoid arthritis. Increasing patient knowledge of arthritis disorders and the influx of new biopharmaceuticals into the global market are expected to boost the adoption of adalimumab biosimilars. For instance, according to a February 2022 article titled The Prevalence and Statistics of Arthritis, the prevalence of arthritis in the United States has risen and is expected to continue to rise as the baby boomer generation matures.
Adalimumab Biosimilars by Distribution Channel
Based on the distribution channel, the global adalimumab biosimilars market has been segmented into hospital pharmacy, retail pharmacy, and online pharmacy.
The hospital pharmacy accounts for the largest revenue in the market, attributable to the rising number of hospitals, government investments, technical advancement in the hospital industry, and increasing prevalence of arthritis requiring hospitalization.
Adalimumab Biosimilars by Region
Based on the region, the global adalimumab biosimilars market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World.
Europe is a substantial revenue growth contributor to the global market for adalimumab biosimilars. This is due to a less stringent regulatory product approval process than the United States FDA and the high demand for biosimilar pharmaceuticals in the region. Moreover, the Europe market is driven by a robust pipeline product portfolio and an increased emphasis on research & development efforts. In Europe, five novel adalimumab biosimilars were approved in 2018, namely, ABP501 (Amgevita), SB5 (Imraldi), GP2017 (Hyrimoz), FKB327 (Hulio), and MSB11022 (Idacio). ABP501 was the first adalimumab biosimilar approved by the European Commission. Amgen sells it under the brand name AMGEVITA. During the forecast period, these novel biosimilars are expected to boost the revenue growth of the Europe adalimumab biosimilars market.
Asia Pacific is the third most promising region in revenue contribution. It is predicted to show rapid revenue growth during the forecast period. Japan, India, and China are key contributors to the Asia Pacific adalimumab biosimilar industry. Emerging economies with expanding healthcare expenditures and large population bases in countries, such as China and India, present significant prospects. For instance, Biocon Ltd, an India-based biopharmaceutical company specializing in the development of biological pharmaceuticals, paid $3.34 billion for Viatris, Inc’s biosimilar assets in February 2022. Biocon established itself as a distinct, vertically integrated global biosimilar leader with this acquisition, directly accelerating the commercialization of its portfolio of existing and future biosimilars and expanding its product reach globally.
Adalimumab Biosimilars Market Competitive Landscape
The prominent players in the global adalimumab biosimilars market include:
Adalimumab Biosimilars Market Strategic Developments
Europe is the key revenue growth region in the global adalimumab biosimilars market.
The amgevita product segment leads the global adalimumab biosimilars market.
Adalimumab is the first humanized monoclonal antibody that has been approved for the treatment of autoimmune disorders. Adalimumab is an anti-TNF (tumor necrosis factor) medication that reduces inflammation by blocking the effect of TNF.
The adalimumab biosimilars market is expected to be valued at 18.35 billion by 2030.
The adalimumab biosimilars market is expected to register a revenue CAGR of 20.1% during the forecast period.
*Insights on financial performance are subject to the availability of information in the public domain