Humira Biosimilar Market to surpass $3,871.4 Million by 2030, Globally, at a CAGR of 25.9%, says Coherent Market Insights (CMI)

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The biosimilar is developed to have the same therapeutic effects as Humira, offering an alternative treatment option with potentially reduced costs. It is designed to treat various inflammatory conditions, such as rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis.

Burlingame, July 28, 2023 (GLOBE NEWSWIRE) — The global Humira biosimilar Market is approximated to be $772.1 million in 2023, and it is projected to reach $3,871.4 million by 2030 at a CAGR of 25.9%., as per the recent study by Coherent Market Insights, Inc. Haldima, a latest biosimilar of Humira will receive approval from the Food and Drug Administration, which will offer patients another option of treatment. This biosimilar is designed for use in same way as Humira, which is to provide relief from rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and Crohn’s disease. There are other different biosimilar of Humira available in the market. With increasing prevalence of autoimmune diseases, the demand for these medications is increasing all over the world.

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Key Trends and Analysis of the Global Humira Biosimilar Market:

Increasing market entry and regulatory approvals of new biosimilars is a growing trend in the global Humira biosimilar market. Regulatory authorities around the world have create guidelines and pathways for approval as well as market entry of biosimilars, which also includes those of Humira. In recent years, there has been a rise in number of regulatory approvals for Humira biosimilars. This is leading to increased availability and adoption of these biosimilars. This trend is likely to boost growth of the market in the coming years.

Global Humira Biosimilar Market – Drivers

Rising prevalence of autoimmune diseases to boost growth of the market

Prevalence of autoimmune diseases such as psoriasis, Crohn’s disease, and rheumatoid arthritis is increasing all over the world. Due to this rise in prevalence, the demand for accessible and effective treatment for these conditions is increasingly rapidly incuding Humira biosimilars that are proven treatments for autoimmune conditions. Thus, this factor is expected to augment growth of the global Humira biosimilar market over the forecast period.

Favorable regulatory policies to fuel the market growth

Regulatory agencies in different regions have created pathways and guidelines for the approval and market access of biosimilars. With these frameworks development, commercialization, and evaluation of Humira biosimilars is facilitated and get clarity. Favorable regulatory environments further allow pharmaceutical firms for investing in biosimilar development. Thus, this is anticipated to accelerate growth of the global Humira biosimilar market over the forecast period.

Humira Biosimilar Market Report Coverage

Report Coverage Details
Base Year: 2023   Market Size in 2023: US$ 772.1 Mn
Historical Data for: 2017 to 2021 Forecast Period: 2023 – 2030
Forecast Period 2023 to 2030 CAGR: 25.9%   2030 Value Projection: US$ 3,871.4 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East & Africa:  GCC Countries, Israel,  South Africa, North Africa, and Central Africa and Rest of Middle East
Segments covered:
  • By Product Type: Biosimilar Humira (Adalimumab), Interchangeable Biosimilar Humira
  • By Indication: Rheumatoid Arthritis, Psoriasis, Crohn’s Disease, Ulcerative Colitis, Ankylosing Spondylitis, Juvenile Idiopathic Arthritis, Other Autoimmune Conditions
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
  • By Patient Age: Adult Patients, Pediatric Patients
  • By Application: Rheumatology, Dermatology, Gastroenterology, Other Therapeutic Areas
  • By Administration: Subcutaneous (SC) Injection, Intravenous (IV) Infusion
  • By Dosage Strength: 40 mg/0.8 mL, Other dosage strengths
  • By End-User: Hospitals, Specialty Clinics, Others
  • By Packaging Type: Pre-filled Syringes, Autoinjectors, Vials
Companies covered: Amgen Inc., Samsung Bioepis Co., Ltd., Sandoz International GmbH (Novartis AG), Mylan N.V., Boehringer Ingelheim International GmbH, Pfizer Inc., Fresenius Kabi AG, Coherus BioSciences, Inc., Biogen Inc., AbbVie Inc., Celltrion Inc., Amneal Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc., Merck & Co., Inc., Viatris Inc.
Growth Drivers:
  • Patent Expiration
  • Cost Savings
  • Increasing Prevalence of Autoimmune Diseases
  • Favorable Regulatory Environment
Restraints & Challenges:
  • Complex Regulatory Processes
  • Intellectual Property and Patent Litigation
  • Physician and Patient Awareness and Acceptance

Global Humira Biosimilar Market – Restrain

Complexity of regulatory processes to hinder the market growth

The regulatory processes for approval of biosimilars can be complicated and time taking. The requirements to demonstrate similarities to the reference product and ensuring efficacy and safety can be challenging for manufacturers of biosimilars. Such regulatory processes delay the market entry as well as availability of biosimilars into market. Thus, this factor is expected to limit growth of the global humira biosimilar market over the forecast period.

Global Humira Biosimilar Market – Opportunities

Growing access to treatment is creating multiple opportunities in the global humira biosimilar market over the forecast period. The availability of these biosimilars offers improved access to treatment for patients suffering from autoimmune diseases. Biosimilars offer low-cost alternatives to the reference biologic drug, which makes treatment accessible to a broad range of populations. Thus, this in turn is creating lucrative opportunities in the global humira biosimilar market over the forecast period.

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Global Humira Biosimilar Market – Key Developments

In November 2019, Coherus Biosciences entered into collaboration with Innovent Biologics for the commercialization biosimilar candidates, which includes a Humira biosimilar in the Chinese market.

In October 2018, Samsung Bioepis collaborated with Biogen to jointly commercialize multiple biosimilars including Humira biosimilars.

In July 2018, AbbVie entered into a settlement agreement with Mylan for the launch of Humira biosimilar of Mylans in the U.S.

Key Market Takeaways:

Global Humira biosimilar market is expected to exhibit a CAGR of 25.9% during the forecast period. The Humira biosimilar market is growing rapidly in response to the costs savings offered by biosimilars. As compared to biologic drugs, these biosimilars are more cost-effective alternatives. With the rise in demand for affordable healthcare, the global Humira biosimilar market is likely to show substantial growth in the near future.

On the basis of Type, Biosimilar Humira (Adalimumab)Segment is expected to dominate the market during the forecast period and this is attributed to the ability to treat different conditions such as rheumatoid arthritis, Crohn disease, juvenile idiopathic arthritis, hidradenitis suppurativa, chronic plaque psoriasis, and more

On the basis of Indication, Rheumatoid Arthritis Segment is expected to dominate the market during the forecast period and this is attributed to the high prevalence of the disease among global population.

On the basis Distribution Channel, hospital Pharmacies Segment is expected to dominate the market during the forecast period and this is attributed to the increased demand from hospital pharmacies with growing patient pool in the hospital.

On the basis Patient Age, Adult Patients Segment is expected to dominate the market over the forecast period and this is attributed to the high prevalence of autoimmune diseases in adult patients, leading to increasing demand.

On the basis Application, Rheumatology Segment is expected to dominate the market during the forecast period and this is attributed to the increasing high prevalence of rheumatology diseases around the world.

On the basis of Administration, Subcutaneous (SC) Injection Segment is expected to dominate the market during the forecast period and this is attributed to the highly effective way of administrating the drug and the injected drug is diffused slowly at a sustained rate of absorption.

On the basis Dosage Strength, 40 mg/0.8 mL Segment is expected to dominate the market during the forecast period and this is attributed to the efficiency of the drug strength to give desired effect.

On the basis End User, Hospitals Segment is expected to dominate the market over the forecast period and this is attributed to the increase in number of patients suffering autoimmune diseases.

On the basis Packaging Type, Autoinjectors Segment is expected to dominate the market during the forecast period and this is attributed to the ease of use of autoinjectors without requiring examination of medical professionals.

On the basis of Geography, North America is expected to hold a dominant position over the forecast period, due to strong presence of major market players in the region. With increasing regulatory approvals of novel Humira biosimilars in the region, the market is likely to gain significant growth in the region over the forecast future.

Competitive Landscape:

Key players operating in the global Humira biosimilar market include Viatris Inc., Amgen Inc., Merck & Co., Inc., Samsung Bioepis Co., Ltd., Lupin Pharmaceuticals, Inc., Sandoz International GmbH (Novartis AG), Amneal Pharmaceuticals, Inc., Mylan N.V., Celltrion Inc., Boehringer Ingelheim International GmbH, AbbVie Inc., Pfizer Inc., Biogen Inc., Fresenius Kabi AG, and Coherus BioSciences, Inc.

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Detailed Segmentation:

  • Global Humira Biosimilar Market, By Product Type:
    • Biosimilar Humira (Adalimumab)
    • Interchangeable Biosimilar Humira
  • Global Humira Biosimilar Market, By Indication:
    • Rheumatoid Arthritis
    • Psoriasis
    • Crohn’s Disease
    • Ulcerative Colitis
    • Ankylosing Spondylitis
    • Juvenile Idiopathic Arthritis
    • Other Autoimmune Conditions
  • Global Humira Biosimilar Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
  • Global Humira Biosimilar Market, By Patient Age:
    • Adult Patients
    • Pediatric Patients
  • Global Humira Biosimilar Market, By Application:
    • Rheumatology
    • Dermatology
    • Gastroenterology
    • Other Therapeutic Areas
  • Global Humira Biosimilar Market, By Administration:
    • Subcutaneous (SC) Injection
    • Intravenous (IV) Infusion
  • Global Humira Biosimilar Market, By Dosage Strength:
    • 40 mg/0.8 mL
    • Other dosage strengths
  • Global Humira Biosimilar Market, By End User:
    • Hospitals
    • Specialty Clinics
    • Others
  • Global Humira Biosimilar Market, By Packaging Type:
    • Pre-filled Syringes
    • Autoinjectors
    • Vials
  • Global Humira Biosimilar Market, By Region:
    • North America
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country:
        • GCC Countries
        • Israel
        • Rest of Middle East
    • Africa
      • By Country/Region:
        • South Africa
        • Central Africa
        • North Africa

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About Us:

Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients.

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