Remicade Biosimilar Market Size, Share, Growth Report 2032

Remicade Biosimilar Market Size:

The global Remicade biosimilar market size was worth USD 1,628.3 million in 2021 and is estimated to grow to USD 10,257.7 million by 2028, with a compound annual growth rate (CAGR) of approximately 35.9 percent during the forecast period. The report analyzes the Remicade biosimilar market's drivers, restraints/challenges, and their effect on the demands during the projection period. In addition, the report explores emerging opportunities in the Remicade biosimilar market.

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Remicade Biosimilar Market: Overview

A biological product classified as a biosimilar also called a reference biological product, is very similar to a drug that has already received FDA approval. The U.S. FDA and the European Medicines Agency (EMA) license biosimilar medications identical to reference products regarding safety, purity, efficacy, and effectiveness.

Large regulatory agencies can only approve these biosimilar medications for the conditions and indications already authorized for the reference product. For the treatment of many different diseases, there is a high demand for biological products. However, there is a growing market demand for biosimilar products to reduce healthcare costs. The rising prevalence of autoimmune diseases, especially rheumatoid arthritis and psoriatic arthritis, early brand-name Remicade patent expiration, discounted prices across the European market, and quicker response times due to intravenous administration are all driving factors for the market growth.

Additionally, introducing biosimilar versions may reduce the financial burden on healthcare system applications and increase patient access to critical medications. Serious drug side effects that necessitate hospital treatment or even be fatal are obstacles to the Remicade biosimilar industry. These include invasive fungal infections, such as histoplasmosis, bacterial sepsis, tuberculosis, etc.

COVID-19 Impact:

The unexpected outbreak of the COVID-19 pandemic had caused a delay in clinical trials for Remicade biosimilars due to the increased focus on developing vaccination programs against coronavirus infection, negatively impacting the Remicade biosimilar market. There was an unprecedented global demand for these drugs for emergency use in treating acute COVID-19 cases, which prompted calls for the approval of Remicade biosimilars of these drugs to be expedited.

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Key Insights

• As per the analysis shared by our research analyst, the global Remicade biosimilar market value will grow at a CAGR of 35.9% over the forecast period.
• In terms of revenue, the global Remicade biosimilar market size was valued at around USD 1,628.3 million in 2021 and is estimated to grow to USD 10,257.7 million by 2028.
• The rising prevalence of autoimmune diseases, primarily rheumatoid arthritis and psoriatic arthritis, early brand-name Remicade patent expiration, discounted prices across the European market, and quicker response times due to intravenous administration are all driving factors for the market growth.
• By disease indication, the rheumatoid arthritis category dominated the market in 2021.
• Europe dominated the global Remicade biosimilar market in 2021.

Remicade Biosimilar Market: Growth Drivers

Growing demand for biosimilar drugs owing to their cost-effectiveness is likely to pave the way for market growth

Increased demand for biosimilars likely promotes corporate growth in the future. The cost of the Remicade biosimilar medications is 20–30% less than their reference medications, per the American Journal of Managed Care (AJMC). Patients benefit from having access to advanced, effective treatments while saving money. Compared to innovator biologics, the development costs of biosimilars are cheaper.

The price of Remicade biosimilars is reduced by lower R&D expenses. Lower-cost biosimilars reduce the cost of reference biologics due to price rivalry among producers. The decreased unit price of a biologic due to its rival medication and the enhanced accessibility of a variety of Remicade biosimilars for the patients are two ways that these drugs' cost-effectiveness improves total healthcare costs.

Constant focus on expanding biosimilar portfolios by prominent drug makers is a key trend bolstering the global Remicade biosimilar market prospects. Thus, it is anticipated that the later entrance biologics' overall competitive costs will support their demand over the forecast period.

Remicade Biosimilar Market: Restraints

High developmental costs and complex manufacturing processes hamper the market growth

Developing Remicade biosimilars is a difficult and expensive process that needs a lot of money, technical know-how, clinical trial experience, scientific criteria, and quality control procedures. Unlike generic drug developers, Remicade biosimilar producers must invest in clinical testing and post-approval monitoring and control measures comparable to those of the original patent businesses.

The ability to manage variability during the production process, where the final products are similar to their biological products, is another important concern in the production of Remicade biosimilars. Manufacturing Remicade biosimilars should adhere to established quality standards for both safety and efficacy.

Regulatory agencies may ask for more preclinical, clinical evidence to prove that the manufacturing process has no bearing on the product's efficacy or safety and that there is no difference between the biosimilar and the biologic medication.

Remicade Biosimilar Market: Opportunity

Major biologics patents expiration and research into new indications bring up market growth opportunities

Most prior biologic drugs lost patent protection in the last century, and many of today's best-selling drugs are expected to lose patent coverage in the coming years. This opens up new avenues for biosimilar drugs. Nearly 20 oncology biologics patents will expire by 2023, potentially paving the way for more Remicade biosimilars in the field. There are currently a variety of diseases and ailments that are treated with Remicade biosimilars. Oncology, autoimmune diseases, diabetes, and hepatitis are the main target treatment areas for which numerous Remicade biosimilars are under development.

Remicade Biosimilar Market: Challenges

Significant drug-related adverse effects continue to be a market challenge

Serious adverse effects of the medicine that may need hospitalization or possibly be lethal are a barrier to the growth of the global Remicade biosimilars market. These include invasive fungal infections, such as histoplasmosis, bacterial sepsis, tuberculosis, etc. Moreover, the market for Remicade biosimilars is significantly challenged by the accessibility of substitute medications. These medications are structurally altered biologic medications that affect the medication's effectiveness and safety. As a result, complicated biologics whose mode of action is unknown can be dangerous.

Remicade Biosimilar Market: Segmentation

The global Remicade biosimilar market has been segmented into disease indications and region.

Based on disease indication, the market is classified into Crohn’s disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, and plaque psoriasis. In 2021, the rheumatoid arthritis category dominated the global market owing to the increase in the number of cases of this disease.

Recent Developments

• September 2021: Sandoz, a Novartis division, announced a commercialization agreement for the biosimilar BAT1706, bevacizumab, with Bio-Thera Solutions. This agreement aided market expansion and added to Sandoz's top oncology off-patent portfolio. The agreement enables the business to perfectly balance patient care and financial efficiency.
• July 2021: Biocon Ltd (Biocon Biologics), in collaboration with Viatris, Inc., received FDA approval for the first exchangeable biosimilar SEMGLEE (insulin glargine injection) to treat diabetes.

Report Scope:

Remicade Biosimilar Market: Regional Landscape

North America dominated the Remicade biosimilar market in 2021

Due to the existence of top market players in the region, the rapid entry of biosimilars into the market, and the high adoption rate owing to the biosimilars' low price, Europe dominates the global Remicade biosimilars market. For instance, the European Commission (EC), a division of Novartis, authorized Zessly (infliximab), a Remicade biosimilar, for use in Europe in 2019. This is primarily due to the bio-like version being introduced shortly after the patent on the branded version expired. The European Medical Association's useful regulatory framework, high medical reimbursement rates, and technological advancement further contribute to regional expansion.

Remicade Biosimilar Market: Competitive Landscape

Some of the main competitors dominating the global Remicade biosimilar market include - Johnson & Johnson, Janssen Biotech Inc, Merck & Co., Pfizer Inc, Viatris Inc, Celltrion Inc, Alvogen, Biocon Biologics, Napp Pharmaceuticals, and Nippon Kayaku.

Global Remicade Biosimilar Market is segmented as follows:

By Disease Indication

• Crohn’s Disease
• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Ulcerative Colitis
• Plaque Psoriasis

By Region

• North America

  • The U.S.

  • Canada
• Europe
  • France 
  • The UK
  • Spain
  • Germany
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • GCC
  • South Africa
  • Rest of Middle East & Africa