Humira Biosimilar Market Synopsis

Humira Biosimilar Market Size is Valued at USD 0.72 Billion in 2023, and is Projected to Reach USD 4.34 Million by 2032, Growing at a CAGR of 22.1% From 2024-2032.

Humira biosimilar market define the part of pharmeducial industry that is involved in the production of biosimilar drugs which are intended to be used to offer similar therapeutic effects to the Humira that is adalimumab biologic which is used for the treatment of autoimmune diseases including rheumatoid arthritis, psoriasis, and inflammatory bowel disease. The idea of biosimilars is that they have a very similar structure, efficacy, safety and immunogenicity profile to their reference biologics; however slight differences can be present due to the nature of biologics. As patents on Humira will soon expire, several other pharmaceutical companies have launched different biosimilar or are in the process of launching their own biosimilar of Humira so as to increase patient access to such important treatment. Competitive pricing strategy, regulatory factors fro pricing of such products as well as the quality considerations or assurance with a view of bringing to market, high quality products within the various markets of the global market that are safe for use.

• THe biosimilar market of Humira comes to be seen as a large portion of the contemporary pharma market, stimulated by the expiration of the patent law of AbbVie’s $10bn+ blockbuster drug Humira (adalimumab) back in 2016. As one of the most successful drugs within the global market demand for biosimilars has appeared the possibilities for the competition and decrease of costs of auto-immune diseases treatment that includes rheumatoid arthritis, psoriasis and Crohn’s disease. In light of this there is increased expectations that the use of biosimilars is likely to bring down the costs of healthcare largely given that patient will have affordable and effective treatment options. The market competition has grown relatively fast in just a few years, many biosimilars are to be dominated by key players such as Amgen, Boehringer Ingelheim and Sandoz.
• This growth opportunity is expected to start from 2024 and gradually grow to be a few billion-dollar market by the end of the next decade. This is aligned by the uptake of autoimmune diseases as well as the need for biologics as key drivers of the market expansion. Further, stringent healthcare reforms and the increased awareness towards usage of biosimilar, mainly in US and Europe will propel the biosimilars market. Nonetheless, some features may act as barriers to market entry, including the physicians and patient’s reluctance to use biosimilars instead of the initial reference and a convoluted regulatory framework. Bypassing these barriers is going to be cornerstones of biosimilars gradually becoming accepted as ‘go-to’ options in clinical practice.
• These dynamics mean competition is intensified in the Humira biosimilar market while also requiring differentiation through the use of value-add services, such as patient support programmes, and demonstration of biosimilarity through clinical evidence. It is the existing partnership agreement between biosimilar manufacturers and the healthcare providers which will prove to be instrumental in the development of the perception about such products. It is expected that in time the market will expand to allow further players into this arena, which will increase competition and thus push further advancement in the biosimilar industry. All things considered, Humira biosimilar market is a revolutionary change of improving therapeutic access to patients along with reinventing the course of biologic therapies in the future years.

Humira Biosimilar Market Trend Analysis

Growth Trends in the Humira Biosimilar Market

• The market for Humira biosimilar is expected to grow at a healthy pace at the present with its primary driver being the rising need for affordable treatment for different inflammatory diseases including rheumatoid arthritis, psoriasis, and Crohn’s disease among other related illnesses. Humira (adalimumab), an innovative and blockbuster therapy originally discovered by AbbVie, has lost its patent shield so that a plethora of biosimilar contenders have barracked the entry. The entry of many biosimilar products has led to increased competition not only in the pricing aspect but has also extended the product access to the many patients. Since patients with these diseases and healthcare providers look for cheaper options in the treatment of the above ailments, the Humira biosimilar market is expected to grow, with different organizations positioning themselves to manufacture Humira biosimilars.
• However, it is mandatory to note that regulation has dramatically influenced the price as well as the Humira biosimilar market. Biosimilars are the escalated versions of biologics, and the FDA of the United States has unveiled concise measures putting into practice more time-sensitive entry into the market. As a result of this action, there has been increased investment in biosimilars adalimumab formulations, and leading manufactures namely Amgen, Sandoz and Boehring Ingelheim among others have stepped up to gain approvals. However, with the emerging use of these biosimilars, there is need to sensitize health professional on these products’ effectiveness and risks. Higher recognition and utilization of biosimilars in physicians will be instrumental in scaling up biosimilar consumption, which in turn will support the market continued growth in the next years.

Impact of Regulatory Advancements on the Humira Biosimilar Market

• The regulatory aspects have formed an important niche in lieu of the Humira biosimilar market led by a conscious attempt by FDA to provide a definitive pathway for approval of biosimilars. CPL has also praised this proactive strategy as having increased dramatically the rate at which such products can get to market, thus creating an intra-health care system competition that is good for patients and providers. The smooth execution has compelled many manufacturers like Amgen, Sandoz and Boehringer Ingelheim to step up the biosimilar adalimumab formulation usage. While these companies work aggressively to clinch regulatory clearances, the new biosimilars are all set to enter the market to meet the growing need for affordable therapies.
• In realization of these factors, it is high time to stress on the educational activities connected with biosimilars and their efficiency and safety profile among CARE professionals. The knowledge about the advantages and differences between biosimilars and their reference products, as well as the elimination of existing misunderstandings among physicians will contribute to the problem solution as well. Higher levels of adoption by physicians will be the essential factor for sustained growth of biosimilar market in the growth of biosimilar Humira market share. Thereby, the closer links that are made between these alternatives and the treatment of chronic inflammatory diseases enable a larger number of healthcare providers to become aware of these choices and ultimately expand patient access to such therapies.

Humira Biosimilar Market Segment Analysis:

Humira Biosimilar Market Segmented based on By Type of Biosimilar, By Indication and By Distribution Channel

By Type of Biosimilar, Adalimumab Biosimilars segment is expected to dominate the market during the forecast period

• Global adalimumab biosimilars are one of the key segments of the biosimilars market due to increasing pressure on healthcare systems for affordable treatment options for autoimmune diseases. Being one of the first fully human monoclonal antibodies, adalimumab has become a staple of modern treatment for various diseases including rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis. This has happened due to the expiration of patents and introduction of biosimilar to reduce competition and ultimately may reduce the costs of the biosimilars to patients and the healthcare systems. This expanded financial access to the product enhances patient access to mainly necessary therapies that were unavailable as a result of high costs related to the reference product.
• The benefits of cases such as adalimumab biosimilars are enhanced by factual evidence that well proves the effectiveness of such products. Clinical and other research studies currently and steadily revealing that these biosimilars are as effective as their reference originals. With increasing utilization experience, both the healthcare providers and patients have become more receptive on the biosimilars. More than that, the acceptance to the biosimilars like adalimumab not only expands patients’ access to their required treatments but also drives improvements in general competitive environment and helps to develop healthier market and, consequently, improved results for patients.

By Distribution Channel, Hospital Pharmacies segment held the largest share in 2023

• Due to the latter, the role of the hospital pharmacies is crucial in the distribution of biosimilars, resulting from the key focus on providing enhance care for patients with complication and chronic diseases. Since hospital pharmacies are directly responsible for the distribution of biologics, they most often have expertise and knowledge that are critical for operating with such treatments. Hospital pharmacists have interactions with patients’ medical records which make them able to make sound decisions on the drugs to be prescribed and how to do so. Apart from increasing the safety and effectiveness of those treatment regimens, such access also contributes to the development of treatment plans that meet each patient’s requirements.
• One of the powerful ways that biosimilars are incorporated into hospital formularies is through administering influences on prescribers. This way, physicians find pharmacists as valuable sources of detailed information and recommendations regarding biologic therapy processes. Since management of healthcare costs is a key issue that continues to be addressed by healthcare facilities, the use of biosimilars is anticipated to grow. This trend is particularly useful where there are high-cost biologic medicines to which cheaper biosimilar are available to provide huge saving for patient as well as the healthcare system. Finally, there is the role of hospital pharmacies to encourage its utilisation in management of diseases due to the increased availability of biosimilar products in extending patient care.

Humira Biosimilar Market Regional Insights:

North America is Expected to Dominate the Market Over the Forecast period

• In North America, especially in the United States of America the availability of many biosimilars of Humira has impacted on this market through increasing its competitiveness and adoption by health care providers and patient. As it has been discussed earlier, the development of biosimilars is supported by a favourable legal environment in the USA and the effective FDA regulations for biosimilar approvals. These services have prompted other important actors to invest in the market thus allowing for a rich offering of the biosimilars. Also, the educational programs for healthcare professionals have helped greatly to increase acceptance of the biosimilars notion among the practitioners that in fact results in accepting by the prescribing physicians and patients.
• However, it is important to understand that the development of the market is not without many problems that have made its first breakthrough difficult. These aspects may lead to challenges in attaining approval especially for new entrants in the industry, while patent litigation’s have also be a challenge to some biosimilars. These facts have made many healthcare providers to be selective when using biosimilars as options of the originator products. All of these issues will have to be resolved to guarantee the sustainable development of the Humira biosimilar market in the USA because stakeholders face numerous requirements and restrictions on biosimilars’ safety and effectiveness.

Active Key Players in the Humira Biosimilar Market

• Amgen
• Sandoz
• Pfizer
• Boehringer Ingelheim
• Mylan (now part of Viatris)
• Samsung Bioepis
• Biocon
• Hikma Pharmaceuticals
• Other Key Players

Chapter 1: Introduction
 1.1 Scope and Coverage

Chapter 2:Executive Summary

Chapter 3: Market Landscape
 3.1 Market Dynamics
  3.1.1 Drivers
  3.1.2 Restraints
  3.1.3 Opportunities
  3.1.4 Challenges
 3.2 Market Trend Analysis
 3.3 PESTLE Analysis
 3.4 Porter's Five Forces Analysis
 3.5 Industry Value Chain Analysis
 3.6 Ecosystem
 3.7 Regulatory Landscape
 3.8 Price Trend Analysis
 3.9 Patent Analysis
 3.10 Technology Evolution
 3.11 Investment Pockets
 3.12 Import-Export Analysis

Chapter 4: Humira Biosimilar Market by Type of Biosimilar
 4.1 Humira Biosimilar Market Snapshot and Growth Engine
 4.2 Humira Biosimilar Market Overview
 4.3 Adalimumab Biosimilars & Combination Products
  4.3.1 Introduction and Market Overview
  4.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  4.3.3 Key Market Trends, Growth Factors and Opportunities
  4.3.4 Adalimumab Biosimilars & Combination Products: Geographic Segmentation Analysis

Chapter 5: Humira Biosimilar Market by Indication
 5.1 Humira Biosimilar Market Snapshot and Growth Engine
 5.2 Humira Biosimilar Market Overview
 5.3 Rheumatoid Arthritis (RA)
  5.3.1 Introduction and Market Overview
  5.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.3.3 Key Market Trends, Growth Factors and Opportunities
  5.3.4 Rheumatoid Arthritis (RA): Geographic Segmentation Analysis
 5.4 Psoriasis
  5.4.1 Introduction and Market Overview
  5.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.4.3 Key Market Trends, Growth Factors and Opportunities
  5.4.4 Psoriasis: Geographic Segmentation Analysis
 5.5 Crohn’s Disease
  5.5.1 Introduction and Market Overview
  5.5.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.5.3 Key Market Trends, Growth Factors and Opportunities
  5.5.4 Crohn’s Disease: Geographic Segmentation Analysis
 5.6 Ulcerative Colitis & Other Indications
  5.6.1 Introduction and Market Overview
  5.6.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  5.6.3 Key Market Trends, Growth Factors and Opportunities
  5.6.4 Ulcerative Colitis & Other Indications: Geographic Segmentation Analysis

Chapter 6: Humira Biosimilar Market by Distribution Channel
 6.1 Humira Biosimilar Market Snapshot and Growth Engine
 6.2 Humira Biosimilar Market Overview
 6.3 Hospital Pharmacies
  6.3.1 Introduction and Market Overview
  6.3.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.3.3 Key Market Trends, Growth Factors and Opportunities
  6.3.4 Hospital Pharmacies: Geographic Segmentation Analysis
 6.4 Retail Pharmacies & Online Pharmacies
  6.4.1 Introduction and Market Overview
  6.4.2 Historic and Forecasted Market Size in Value USD and Volume Units (2017-2032F)
  6.4.3 Key Market Trends, Growth Factors and Opportunities
  6.4.4 Retail Pharmacies & Online Pharmacies: Geographic Segmentation Analysis

Chapter 7: Company Profiles and Competitive Analysis
 7.1 Competitive Landscape
  7.1.1 Competitive Benchmarking
  7.1.2 Humira Biosimilar Market Share by Manufacturer (2023)
  7.1.3 Industry BCG Matrix
  7.1.4 Heat Map Analysis
  7.1.5 Mergers and Acquisitions
  
 7.2 AMGEN
  7.2.1 Company Overview
  7.2.2 Key Executives
  7.2.3 Company Snapshot
  7.2.4 Role of the Company in the Market
  7.2.5 Sustainability and Social Responsibility
  7.2.6 Operating Business Segments
  7.2.7 Product Portfolio
  7.2.8 Business Performance
  7.2.9 Key Strategic Moves and Recent Developments
  7.2.10 SWOT Analysis
 7.3 SANDOZ
 7.4 PFIZER
 7.5 BOEHRINGER INGELHEIM
 7.6 MYLAN
 7.7 SAMSUNG BIOEPIS
 7.8 BIOCON
 7.9 HIKMA PHARMACEUTICALS
 7.10 OTHER KEY PLAYERS
 7.11 OTHERS

Chapter 8: Global Humira Biosimilar Market By Region
 8.1 Overview
 8.2. North America Humira Biosimilar Market
  8.2.1 Key Market Trends, Growth Factors and Opportunities
  8.2.2 Top Key Companies
  8.2.3 Historic and Forecasted Market Size by Segments
  8.2.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.2.4.1 Adalimumab Biosimilars & Combination Products
  8.2.5 Historic and Forecasted Market Size By Indication
  8.2.5.1 Rheumatoid Arthritis (RA)
  8.2.5.2 Psoriasis
  8.2.5.3 Crohn’s Disease
  8.2.5.4 Ulcerative Colitis & Other Indications
  8.2.6 Historic and Forecasted Market Size By Distribution Channel
  8.2.6.1 Hospital Pharmacies
  8.2.6.2 Retail Pharmacies & Online Pharmacies
  8.2.7 Historic and Forecast Market Size by Country
  8.2.7.1 US
  8.2.7.2 Canada
  8.2.7.3 Mexico
 8.3. Eastern Europe Humira Biosimilar Market
  8.3.1 Key Market Trends, Growth Factors and Opportunities
  8.3.2 Top Key Companies
  8.3.3 Historic and Forecasted Market Size by Segments
  8.3.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.3.4.1 Adalimumab Biosimilars & Combination Products
  8.3.5 Historic and Forecasted Market Size By Indication
  8.3.5.1 Rheumatoid Arthritis (RA)
  8.3.5.2 Psoriasis
  8.3.5.3 Crohn’s Disease
  8.3.5.4 Ulcerative Colitis & Other Indications
  8.3.6 Historic and Forecasted Market Size By Distribution Channel
  8.3.6.1 Hospital Pharmacies
  8.3.6.2 Retail Pharmacies & Online Pharmacies
  8.3.7 Historic and Forecast Market Size by Country
  8.3.7.1 Bulgaria
  8.3.7.2 The Czech Republic
  8.3.7.3 Hungary
  8.3.7.4 Poland
  8.3.7.5 Romania
  8.3.7.6 Rest of Eastern Europe
 8.4. Western Europe Humira Biosimilar Market
  8.4.1 Key Market Trends, Growth Factors and Opportunities
  8.4.2 Top Key Companies
  8.4.3 Historic and Forecasted Market Size by Segments
  8.4.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.4.4.1 Adalimumab Biosimilars & Combination Products
  8.4.5 Historic and Forecasted Market Size By Indication
  8.4.5.1 Rheumatoid Arthritis (RA)
  8.4.5.2 Psoriasis
  8.4.5.3 Crohn’s Disease
  8.4.5.4 Ulcerative Colitis & Other Indications
  8.4.6 Historic and Forecasted Market Size By Distribution Channel
  8.4.6.1 Hospital Pharmacies
  8.4.6.2 Retail Pharmacies & Online Pharmacies
  8.4.7 Historic and Forecast Market Size by Country
  8.4.7.1 Germany
  8.4.7.2 UK
  8.4.7.3 France
  8.4.7.4 Netherlands
  8.4.7.5 Italy
  8.4.7.6 Russia
  8.4.7.7 Spain
  8.4.7.8 Rest of Western Europe
 8.5. Asia Pacific Humira Biosimilar Market
  8.5.1 Key Market Trends, Growth Factors and Opportunities
  8.5.2 Top Key Companies
  8.5.3 Historic and Forecasted Market Size by Segments
  8.5.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.5.4.1 Adalimumab Biosimilars & Combination Products
  8.5.5 Historic and Forecasted Market Size By Indication
  8.5.5.1 Rheumatoid Arthritis (RA)
  8.5.5.2 Psoriasis
  8.5.5.3 Crohn’s Disease
  8.5.5.4 Ulcerative Colitis & Other Indications
  8.5.6 Historic and Forecasted Market Size By Distribution Channel
  8.5.6.1 Hospital Pharmacies
  8.5.6.2 Retail Pharmacies & Online Pharmacies
  8.5.7 Historic and Forecast Market Size by Country
  8.5.7.1 China
  8.5.7.2 India
  8.5.7.3 Japan
  8.5.7.4 South Korea
  8.5.7.5 Malaysia
  8.5.7.6 Thailand
  8.5.7.7 Vietnam
  8.5.7.8 The Philippines
  8.5.7.9 Australia
  8.5.7.10 New Zealand
  8.5.7.11 Rest of APAC
 8.6. Middle East & Africa Humira Biosimilar Market
  8.6.1 Key Market Trends, Growth Factors and Opportunities
  8.6.2 Top Key Companies
  8.6.3 Historic and Forecasted Market Size by Segments
  8.6.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.6.4.1 Adalimumab Biosimilars & Combination Products
  8.6.5 Historic and Forecasted Market Size By Indication
  8.6.5.1 Rheumatoid Arthritis (RA)
  8.6.5.2 Psoriasis
  8.6.5.3 Crohn’s Disease
  8.6.5.4 Ulcerative Colitis & Other Indications
  8.6.6 Historic and Forecasted Market Size By Distribution Channel
  8.6.6.1 Hospital Pharmacies
  8.6.6.2 Retail Pharmacies & Online Pharmacies
  8.6.7 Historic and Forecast Market Size by Country
  8.6.7.1 Turkey
  8.6.7.2 Bahrain
  8.6.7.3 Kuwait
  8.6.7.4 Saudi Arabia
  8.6.7.5 Qatar
  8.6.7.6 UAE
  8.6.7.7 Israel
  8.6.7.8 South Africa
 8.7. South America Humira Biosimilar Market
  8.7.1 Key Market Trends, Growth Factors and Opportunities
  8.7.2 Top Key Companies
  8.7.3 Historic and Forecasted Market Size by Segments
  8.7.4 Historic and Forecasted Market Size By Type of Biosimilar
  8.7.4.1 Adalimumab Biosimilars & Combination Products
  8.7.5 Historic and Forecasted Market Size By Indication
  8.7.5.1 Rheumatoid Arthritis (RA)
  8.7.5.2 Psoriasis
  8.7.5.3 Crohn’s Disease
  8.7.5.4 Ulcerative Colitis & Other Indications
  8.7.6 Historic and Forecasted Market Size By Distribution Channel
  8.7.6.1 Hospital Pharmacies
  8.7.6.2 Retail Pharmacies & Online Pharmacies
  8.7.7 Historic and Forecast Market Size by Country
  8.7.7.1 Brazil
  8.7.7.2 Argentina
  8.7.7.3 Rest of SA

Chapter 9 Analyst Viewpoint and Conclusion
9.1 Recommendations and Concluding Analysis
9.2 Potential Market Strategies

Chapter 10 Research Methodology
10.1 Research Process
10.2 Primary Research
10.3 Secondary Research