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The growth of the global infliximab drug market is driven by the rising number of rheumatoid arthritis cases, which was close to 35 million in 2021. The prevalence of rheumatoid arthritis disease is likely to grow at a CAGR of 1.0% in the forecast period of 2023-2031 and the number of cases is likely to reach nearly 38 million by 2030.
In September 2021, Sandoz announced a marketing agreement with Bio-Thera Solution for the Biosimilar Bat1706. This contract will improve the tumour portfolio of the company and will add further growth to the infliximab drug market expansion.
In July 2021, Biocon Ltd (Biocon Biologics), in collaboration with Viatris, obtained Food and Drug Administration approval for the first SEMGLEE biosimilar (insulin glargine injection) for the treatment of diabetes.
Infliximab (Remicade) was the first monoclonal antibody produced by Janssen Biotech, Inc. Infliximab is the biosimilar version of Remicade. It was first approved by the United States Food and Drug Administration (FDA) in 1998 in collaboration with Merck & Company.
The drug is widely used in the treatment of active plaque psoriasis rheumatoid arthritis, ulcerative colitis, and Crohn's disease in children and adults.
Inflectra (infliximab dyyb) was launched under the brand name Remicade developed by Celltrion Healthcare and Pfizer Hospira in the European market after receiving an approval from EMA’s CHMP in June 2013.
Moreover, the United States Food and Drug Administration (FDA) has now released Remicade's biosimilar Inflectra.
According to the global infliximab drug market research report, the market can be categorised into the following segments:
Market Breakup by Product Type
Market Breakup by Route of Administration
Market Breakup by Application
Market Breakup by Distribution Channel
Market Breakup by Region
The increasing prevalence of rheumatoid arthritis has been driving the growth of the infliximab drug market. Infliximab (Remicade) biosimilar sales will grow further in the coming years due to the rising cases of rheumatoid arthritis and the early loss of patent exclusivity. A growing number of autoimmune diseases and a decline in the price of biosimilar Infliximab (Remicade) are driving the adoption and consumption of the drug in European market.
In the regional nodal countries, the development of FDA-approved manufacturing facilities and faster approval procedures are the contributing factors to the growth of the drugs market.
In addition, clear labelling and transparent labelling to ensure that medicines are accurately prescribed and dispensed and to improve post-market control will greatly contribute to the confidence of prescribers and lead the infliximab drug market in the coming years.
The availability of adequate FDA-approved manufacturing facilities in regional nodal countries and faster approval procedures are significantly aiding the market growth.
However, long-term adoption of infliximab biosimilars may be difficult due to safety concerns associated with manufacturing facilities and potential side effects of drug use.
Infliximab biosimilars are driven by factors such as an increase in the prevalence of autoimmune diseases, especially rheumatoid arthritis and plaque psoriasis, the expiration of the branded version's patent early, a lower price in the European market and quicker response times.
The introduction of biosimilar versions could greatly improve access to essential drugs for patients and relieve the financial burden on the healthcare system.
There are also serious drug-related side effects associated with Infliximab biosimilars that can lead to hospitalisation or death. Tuberculosis, bacterial sepsis, and histoplasmosis are some of these infections.
To ensure that both healthcare professionals and patients are informed, pharmaceutical manufacturers must include "box alerts." Furthermore, infliximab's complex molecule and lack of FDA-approved manufacturing facilities also limit the market growth in developing countries.
The North American market is dominated by infliximab due to the developed healthcare infrastructure. During the forecast period, the Asia Pacific region will witness high growth due to increased research and development activity.
The drug Infliximab is a potential treatment platform for many diseases. Infliximab is used clinically to treat a variety of conditions.
The chimeric IgG1 monoclonal antibody, infliximab (Remicade), targets tumor necrosis factor alpha (TNFa) in humans. A continuous infusion of recombinant cells produces infliximab. An injectable powder preparation is used for making intravenous injection solutions.
With high affinity, infliximab inhibits the binding of TNF to its receptor and neutralizes its biological activity.
Infliximab does not neutralize lymphotoxin-α, a related cytokine that uses the same TNFα receptor.
Among the biological effects of TNFa are the release of inflammatory cytokines such as interleukins (IL) 1 and 6, the activation of leukocytes, and increased endothelial layer permeability. Activation results in increased expression of adhesive molecules in leukocytes. In addition to acute contrast, other degrading enzymes of the tissues are produced by the liver proteins and cartilage cells.
The functional activity of TNF alpha is prevented by infliximab using neutrophils, endothelial cells, B lymphocytes, human fibroblasts and T lymphocytes.
A few biosimilars are approved for therapeutic use by regulatory authorities. Inflectra, Renflexis and Ixifi are three FDA-approved biosimilars of infliximab for rheumatoid and Crohn’s disease indications. All these biosimilars are injected intravenously and are sold under different brands.
Inflectra will be Celltrion's first biosimilar monoclonal antibody (mAb) and the second biosimilar to be marketed in the United StatesThis drug is approved for the treatment of moderately to severely active Crohn's disease in adults and children.
The invention and development of new biosimilars is essential to provide robust and cost-effective treatments. These economic benefits, therefore, contribute to improving access to health services. New biosimilar therapeutics targeting infliximab will drive the development of the infliximab drug market in the coming year.
A biosimilar should be substantially similar to the original reference product in efficacy and safety. Conduct research and confirmatory clinical studies to confirm similarity to the reference product are ongoing.
Infliximab is primarily used to treat follicular lymphoma and rheumatoid arthritis. Therefore, infliximab biosimilar studies were primarily conducted in patients with signs of plaque psoriasis and rheumatoid arthritis disease.
Biosimilars undergo different clinical trials than their biological counterparts. In biosimilar trials, there is an exemption for in-vivo clinical studies. To ensure that the newly developed product is as effective and safe as the reference product, pharmacological and pharmacokinetic studies are performed.
The clinical trials for biosimilars are a bit different from their biological ones. The two approved infliximab biosimilars, that is, BCD 055 successfully passed the last phase of clinical trials. The Phase III study for CT-P10 is ongoing on patients with rheumatoid arthritis.
Apart from the three approved infliximab biosimilars, many more potential biosimilars are in the last stage of clinical development. The approval of these biosimilars will lead to the infliximab drug market expansion.
A proposed biosimilar of infliximab is in the final stage of clinical trials and under regulatory scrutiny. The invention of new infliximab biosimilars could help deliver better treatments at a lower cost.
These new targeted therapies are likely to attract the attention of major corporations and investors and will have a direct impact on the development of this field. This will enable patient access and accelerate the infliximab drug market in the coming year.
The report gives an in-depth analysis of the key players involved in the infliximab drug market, sponsors manufacturing the drugs, and putting them through trials to get FDA approvals. The companies included in the market are as follows:
|Scope of the Report||
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
|Breakup by Product Type||
|Breakup by Product Type||
|Breakup by Application||
|Breakup by Distribution Channel||
|Breakup by Region||
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1.1 Objectives of the Study
1.1.1 Research Objectives
1.1.2 Key Findings of the Report
1.2 Limitations of the Study and Scope for Future Research
2 Research Methodology
3 Executive Summary
4 Global Infliximab Drug Overview
4.1.3 Adverse Events
5 Patient Profile
5.1 Patient Profile Model
5.2 Patient Psychology and Emotional Impact Factors
5.3 Risk Assessment and Treatment Success Rate
6 Global Infliximab Drug Market
6.1 Global Infliximab Drug Market Overview
6.2 Global Infliximab Drug Market Analysis
6.2.1 Market Overview
18.104.22.168 Global Infliximab Drug Historical Market by Value (2016-2022)
22.214.171.124 Global Infliximab Drug Market Forecast by Value (2023-2031)
6.3 Global Infliximab Drug Market by Product Type
6.3.1 Market Overview
126.96.36.199 Brands Drugs
188.8.131.52 Generic Drugs
6.4 Global Infliximab Drug Market by Route of Administration
6.4.1 Market Overview
6.5 Global Infliximab Drug Market by Application
6.5.1 Market Overview
184.108.40.206 Rheumatoid Arthritis
220.127.116.11 Crohn’s Disease
18.104.22.168 Ulcerative Colitis
6.6 Global Infliximab Drug Market by Distribution Channel
6.6.1 Market Overview
22.214.171.124 Hospital Based Pharmacies
126.96.36.199 Online Pharmacies
188.8.131.52 Retail Pharmacies
6.7 Global Infliximab Drug Market by Geography
6.7.1 Market Overview
184.108.40.206 North America
220.127.116.11 Asia Pacific
18.104.22.168 Latin America
22.214.171.124 Middle East and Africa
6.8 North America
6.8.1 Historical Trend (2016-2022)
6.8.2 Forecast Trend (2023-2031)
6.8.3 Break Up by Country
126.96.36.199 United States of America
6.9.1 Historical Trend (2016-2022)
6.9.2 Forecast Trend (2023-2031)
6.9.3 Break Up by Country
188.8.131.52 United Kingdom
6.10 Asia Pacific
6.10.1 Historical Trend (2016-2022)
6.10.2 Forecast Trend (2023-2031)
6.10.3 Break Up by Country
6.11 Latin America
6.11.1 Historical Trend (2016-2022)
6.11.2 Forecast Trend (2023-2031)
6.11.3 Break Up by Country
6.12 Middle East and Africa
6.12.1 Historical Trend (2016-2022)
6.12.2 Forecast Trend (2023-2031)
6.12.3 Break Up by Country
184.108.40.206 Saudi Arabia
220.127.116.11 United Arab Emirates
18.104.22.168 South Africa
7 Risks and Current Scenario Assessment
7.1 Biosimilars in the Market
7.2 Risk Assessment
7.3 Emerging Therapies and Alternatives
7.4 Investment Scenarios
8 Challenges & Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop-out rate
8.3 Awareness and Prevention Gaps
9 Regulations and Current Developments
9.1 Regulatory Framework
9.1.1 US DMF
9.1.2 EU GMP
9.1.4 INDIA CDSCO
9.2 Patent Landscape
9.2.1 Patent Expiry
9.2.2 New Drug Application
9.2.3 Abbreviated New Drug Application (ANDA)
9.2.4 Timelines from Drug Development to Commercial Launch
10 Global Infliximab Drug Market Dynamics
10.1 Market Drivers and Practices
10.2 Drug Adoption Analysis
10.3 SWOT Analysis
10.4 Porter’s Five Force
10.5 Key Demand Indicator Analysis
10.6 Key Price Indicator Analysis
11 Supplier Landscape
11.1 Company Profile
11.1.1 Zydus Cadila
22.214.171.124 Company Overview
126.96.36.199 Product Portfolio
188.8.131.52 Demographic Reach and Achievements
184.108.40.206 Mergers and Acquisitions
220.127.116.11 Company Overview
18.104.22.168 Product Portfolio
22.214.171.124 Demographic Reach and Achievements
126.96.36.199 Mergers and Acquisitions
11.1.3 Samsung Bioepis
188.8.131.52 Company Overview
184.108.40.206 Product Portfolio
220.127.116.11 Demographic Reach and Achievements
18.104.22.168 Mergers and Acquisitions
22.214.171.124 Company Overview
126.96.36.199 Product Portfolio
188.8.131.52 Demographic Reach and Achievements
184.108.40.206 Mergers and Acquisitions
220.127.116.11 Company Overview
18.104.22.168 Product Portfolio
22.214.171.124 Demographic Reach and Achievements
126.96.36.199 Mergers and Acquisitions
188.8.131.52 Company Overview
184.108.40.206 Product Portfolio
220.127.116.11 Demographic Reach and Achievements
18.104.22.168 Mergers and Acquisitions
22.214.171.124 Company Overview
126.96.36.199 Product Portfolio
188.8.131.52 Demographic Reach and Achievements
184.108.40.206 Mergers and Acquisitions
11.1.8 Epirus Biopharmaceuticals
220.127.116.11 Company Overview
18.104.22.168 Product Portfolio
22.214.171.124 Demographic Reach and Achievements
126.96.36.199 Mergers and Acquisitions
11.1.9 Janssen Biotech, Inc.
188.8.131.52 Company Overview
184.108.40.206 Product Portfolio
220.127.116.11 Demographic Reach and Achievements
18.104.22.168 Mergers and Acquisitions
11.1.10 NAPP Pharmaceuticals
22.214.171.124 Company Overview
126.96.36.199 Product Portfolio
188.8.131.52 Demographic Reach and Achievements
184.108.40.206 Mergers and Acquisitions
11.1.11 Nippon Kayaku
220.127.116.11 Company Overview
18.104.22.168 Product Portfolio
22.214.171.124 Demographic Reach and Achievements
126.96.36.199 Mergers and Acquisitions
188.8.131.52 Company Overview
184.108.40.206 Product Portfolio
220.127.116.11 Demographic Reach and Achievements
18.104.22.168 Mergers and Acquisitions
12 Recommendations and Discussion
13 Global Infliximab Drug Distribution Model (Additional Insight)
13.2 Potential Distributors
13.3 Key Parameters for Distribution Partner Assessment
14 Pricing Models and Strategies (Additional Insight)
14.1 Cost Model
14.1.1 Manufacturing Cost Analysis
14.1.2 Procurement Cost Analysis
14.2 Pricing Strategies
14.2.1 Competitor pricing Analysis
14.2.2 Key assessment of product attributes
14.2.3 Pricing Benchmark
The factors stimulating the development of the infliximab drug market are increased government initiatives, optimal biosimilars costs and a rise in R&D expenditure in biopharmaceutical companies.
Fewer drug approvals, stringent government regulations, and lack of awareness are the suspected reasons for hindering the growth of this market.
Infliximab and its biosimilars are primarily used to treat rheumatoid arthritis, lymphoma and leukaemia.
The top companies involved are Zydus Cadila, Pfizer, Samsung Bioepis, Celltrion, Sandoz, AbbVie, Hospira, Epirus Biopharmaceuticals, among others.
The chimeric IgG1 monoclonal antibody, infliximab (Remicade), targets tumour necrosis factor alpha (TNFa) in humans. A continuous infusion of recombinant cells produces infliximab. An injectable powder preparation is used for making intravenous injection solutions.
Inflectra, Renflexis and Ixifi are three FDA-approved biosimilars of infliximab for rheumatoid and Crohn’s disease indications.
The generic/trade name for infliximab is Remicade.
A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original drug.
Biosimilars are available at low costs and thus, have the potential to enhance treatment accessibility.
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