Immunology Biosimilars Market Size, Share and Global Trend By Disease (Inflammatory Bowel Disease, Arthritis), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), Regional Forecast, 2024-2032

A Biosimilar is a biotherapeutic product that is similar in terms of quality, safety, and efficacy to an already licensed reference biopharmaceutical product, also known as a biologic drug. But, biologic drugs are costlier though effective and are leading to greater costs per patient and a number of patents of biologics are expiring. Biosimilars are used for a number of disorders relating to the immune system, such as various types of arthritis like rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, psoriasis, hidradenitis suppurativa, and ulcerative colitis.

The market is expected to grow because the Immunology Biosimilars pipeline shows remarkable and sustained growth. Due to the demand for better therapeutics as compared to generic drugs, the immunology Biosimilars Market is growing, because it is cheaper than the biologics. The Immunology biosimilars market is expected to grow due to the patents of the number of biologics expiring or already expired. Some of them are Rituxan (rituximab), Humira (adalimumab), Enbrel (etanercept) and Remicade (Infliximab). 

The growth in the number of products in the advanced stages of R&D along with a number of recent regulatory approvals are further expected to boost the market. Due to the comparatively lesser cost of the biosimilars compared to the biologics and the effectiveness of the biosimilars compared to the conventional treatment options are further driving the market growth positively. 

The factor that is expected to inhibit the growth of the market is the complex manufacturing process of the immunology biosimilars. Another main factor that can limit the growth of the market is the stringent regulatory scenario for immunology biosimilars. Apart from the stringent regulatory scenario, the approvals process for the immunology biosimilars also includes a few additional tests, so that the immunology biosimilars can be termed interchangeable to their biologics counterparts. 

Key Players Covered 

Some of the major companies that are present in the global Immunology Biosimilars market are Novartis AG, Pfizer Inc., Mylan N.V., AbbVie Inc., STADA Arzneimittel AG, Celltrion, Inc., KBI Biopharma, Inc., Amgen Inc, and other players. 

SEGMENTATION 

At present, inflammatory bowel disease and arthritis account for the largest proportion of the market and this due to the increased demand for biosimilars as the cost-effective treatment option for these diseases. 

Key Insights 

• Opportunity assessment for immunology biosimilars in untapped markets
• Regulatory scenario for key countries
• Pipeline analysis
• Overview of new product launches of immunology biosimilars 

Regional Analysis 

The global immunology biosimilars market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America followed by Europe are the two largest markets for immunology biosimilars at present and they are expected to account for a large proportion of the market in the forecast period as well. This is because due to the increasing approvals of immunology biosimilars in the region due to the extensive research & development and the ongoing approvals for the immunology biosimilars. In the Asia Pacific region, Japan is expected to provide the largest market opportunity. This because of the increasing adoption of biosimilars in the region and as of April 2016, eight biosimilars have been approved in Japan and also due to their increasing applications in rheumatoid arthritis. 

Key Industry Developments

• In November 2018, the FDA announced the approval of Celltrion and Teva’s rituximab biosimilar called Truxima (rituximab-abbs), which is an immunotherapy and also has indications for the treatment of cancer
• In November 2018, the immunology biosimilar of UDENYCA (pegfilgrastim-cbqv) was approved by the FDA. This immunology biosimilar was developed by Coherus Biosciences and KBI Biopharma, Inc. and its reference product is Neulasta
• In October 2018, FDA announced the approval for the immunology biosimilar of HUMIRA (Adalimumab), to Sandoz/Novartis AG for its biosimilar product of Hyrimoz