Infliximab Biosimilar Market Size is valued at XX Million in 2024 and is predicted to reach XX Million by the year 2034 at an XX % CAGR during the forecast period for 2025-2034.
Infliximab is chimeric anti-TNF monoclonal antibody approved for the treatment of Chron’s Disease. It is also approved for the treatment of other autoimmune diseases such as Psoriasis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and others. It is marketed under the trade name of Remicade. It is developed by Jansen Biotech (Johnson & Johnson) operated as Centocor and was approved by U.S Food Drug Administration (FDA) in 1998 and by European Medicines Agency in 1999. It was originally approved for the treatment of Crohn’s Diseases however in 2011, it has been approved for various indications including rheumatoid arthritis.
The patent for infliximab has been expired in Europe in February 2015 and it will expire in the US during the end of year 2018. Biosimilars are defined as biotherapeutic product that have similar safety and efficacy as an approved biologic product. Pfizer’s Hospira subsidiary in partnership with Celltrion launched first biosimilar of infliximab i.e. Inflectra in the U.S. on April 2016 and in Europe in June 2013, thus entry of biosimilar into the market have boosted the growth of infliximab biosimilar market. Also, rising incidence and prevalence of autoimmune disease, emergence of new market players, increase in infliximab accessibility and price erosion have boosted the growth of the infliximab biosimilar market. However, stringent regulatory process for the product approval of biosimilars restrain the growth of the market. Furthermore, complex nature of the molecule, patent term extension, unavailability FDA certified manufacturing facilities and low switching tendency from brand to biosimilar hampers the growth of infliximab biosimilar market.
The infliximab biosimilars market is segmented by brand into Avsola (infliximab-axxq), Flixabi (SB2), Inflectra (infliximab-dyyb), Ixifi (infliximab-qbtx), Remicade, Zessly, Infimab (BOW015), NI-071, Infliximab BS, CMAB008 and other pipeline products. It is segmented by application into Crohn’s disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis and other related conditions. The market is also categorised by distribution channel into hospital pharmacy, online pharmacy, retail pharmacy and other direct distribution channels.
At regional level, the global infliximab biosimilar market is segmented into Asia Pacific, Europe, North America, Latin America, and Middle East & Africa. Europe dominate the infliximab biosimilar market owing to factors such as less stringent regulatory requirement compared to US FDA, early entry of infliximab biosimilar in European market, early loss of patent exclusivity and entry of new participants. Also, rising incidence and prevalence of chronic diseases and increase in geriatric population have boosted the growth of the infliximab biosimilar market in Europe. North America hold second position in global infliximab biosimilar market owing to strong infliximab biosimilar product pipeline, increased research and development expenditure and rising government initiatives. Asia Pacific is third promising revenue contributor which is expected to grow at rapid pace during forecast period. Countries such as Japan, India, and China are major contributor to the infliximab biosimilar market. Emerging and huge population base countries such as China and India offer tremendous market opportunities.
| Report Attribute | Specifications |
| Market Size Value In 2024 | USD XX Million |
| Revenue Forecast In 2034 | USD XX Million |
| Growth Rate CAGR | CAGR of XX % from 2025 to 2034 |
| Quantitative Units | Representation of revenue in US$ Million and CAGR from 2025 to 2034 |
| Historic Year | 2021 to 2024 |
| Forecast Year | 2025-2034 |
| Report Coverage | The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
| Segments Covered | By Brand, Applications, Distribution Channel |
| Regional Scope | North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
| Country Scope | U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South Korea; South East Asia |
| Competitive Landscape | Amgen, Samsung Bioepis, Celltrion, Pfizer, Johnson & Johnson, Sandoz (Novartis division), Epirus Biopharmaceuticals, Nichi-Iko Pharmaceutical, Mabpharm, Biogen, Merck (MSD), Ranbaxy Laboratories (now Sun Pharma), Sorrento Therapeutics (partner), Other players. |
| Customization Scope | Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
| Pricing and Available Payment Methods | Explore pricing alternatives that are customized to your particular study requirements. |
Infliximab Biosimilar Market By Application
Infliximab Biosimilar Market By Distribution Channel
Infliximab Biosimilar Market By Region
Europe
North America:
Asia Pacific:
RoW
This study employed a multi-step, mixed-method research approach that integrates:
This approach ensures a balanced and validated understanding of both macro- and micro-level market factors influencing the market.
Secondary research for this study involved the collection, review, and analysis of publicly available and paid data sources to build the initial fact base, understand historical market behaviour, identify data gaps, and refine the hypotheses for primary research.
Secondary data for the market study was gathered from multiple credible sources, including:
These sources were used to compile historical data, market volumes/prices, industry trends, technological developments, and competitive insights.
Primary research was conducted to validate secondary data, understand real-time market dynamics, capture price points and adoption trends, and verify the assumptions used in the market modelling.
Primary interviews for this study involved:
Interviews were conducted via:
Primary insights were incorporated into demand modelling, pricing analysis, technology evaluation, and market share estimation.
All collected data were processed and normalized to ensure consistency and comparability across regions and time frames.
The data validation process included:
This ensured that the dataset used for modelling was clean, robust, and reliable.
The bottom-up approach involved aggregating segment-level data, such as:
This method was primarily used when detailed micro-level market data were available.
The top-down approach used macro-level indicators:
This approach was used for segments where granular data were limited or inconsistent.
To ensure accuracy, a triangulated hybrid model was used. This included:
This multi-angle validation yielded the final market size.
Market forecasts were developed using a combination of time-series modelling, adoption curve analysis, and driver-based forecasting tools.
Given inherent uncertainties, three scenarios were constructed:
Sensitivity testing was conducted on key variables, including pricing, demand elasticity, and regional adoption.