Market Overview

The Biosimilar market is predicted to develop at a compound annual growth rate (CAGR) of 18.32% from 2024 to 2034, when it is projected to reach USD 125.32 billion, based on an average growth pattern. The market is estimated to reach a value of USD 27.46 billion in 2024.

  

SOURCE: We Market Research

The biosimilars market is the segment of the pharmaceutical business focused on developing and promoting biosimilar drugs. Affordably priced biologics that closely resemble reference biologics that have already been approved are known as biosimilars. The biologic medication sector has expanded tremendously as a result of the biologic medicine patents expiring, providing businesses with the chance to produce biosimilars. The global biosimilars market is meeting the demand for more affordable versions of complex biologics while also promoting competition, expanding patient access to state-of-the-art therapies, and igniting innovation in the biopharmaceutical sector.

The biosimilars market is being driven by a number of significant reasons. The expiration of biologics originator patents opens the door to the development of biosimilars, boosting market competition and bringing down healthcare costs. The increasing demand for accessible therapeutic options, especially in regions where healthcare expenses are rising, promotes the adoption of biosimilars. Regulatory frameworks that speed up the approval process for biosimilars improve market access. In addition, the growing prevalence of chronic illnesses is driving demand for reasonably priced biologic treatments, which is propelling the biosimilars market. Pharmaceutical companies can increase their market share by strengthening their R&D capabilities through strategic alliances and teamwork. When combined, these elements promote availability to advanced biologic therapies and create a vibrant atmosphere for the development of biosimilar.

Market Scope

Biosimilar Industry: Dynamics & Restrains

Market Drivers

The increasing prevalence of chronic diseases - A primary driver of the biosimilars market's growth is the increasing number of people suffering from chronic illnesses. Ailments including diabetes, cancer, and autoimmune disorders—which are growing increasingly prevalent as the world's population ages and lifestyles alter—require cutting-edge and reasonably priced treatment alternatives. Biosimilars, or extremely similar versions of biologic medications now on the market, offer a way to achieve therapeutic treatments that are more affordable and efficient. When the patents on several biologics expire, biosimilars become necessary replacements, boosting competition and bringing down healthcare costs. As a result of this market expansion, biosimilars are becoming increasingly important in addressing the growing worldwide burden of chronic diseases. This is in line with the growing desire for sustainable and reasonably priced healthcare solutions.

Biosimilars are generally more affordable than their reference biologics - The cost advantage of biosimilars over their reference biologics is one of the primary drivers of the biosimilars market. Biosimilars give patients access to a wider choice of treatments at a lower cost than those of biologics. The final product will be more cheaply priced because biosimilars are developed with shortened regulatory procedures and lower R&D expenses. Biosimilars are more competitive in the market due to their lower cost, which persuades payers and healthcare providers to accept them as cost-effective alternatives that preserve therapeutic efficacy. The economic attractiveness of biosimilars shapes the dynamics of the biosimilars market and is critical to their wider adoption as healthcare systems seek low-cost solutions to curb growing expenses.

Market restrains

Intellectual Property Issues - Intellectual property issues provide a major barrier to the biosimilars industry. The patents covering reference biologics often create legal barriers that keep competitors developing biosimilars out of the market. Obtaining identical replication is further complicated by complex biologic structures and intricate manufacturing processes. Producers of biosimilars and inventors participate in patent litigation that extends market exclusivity, decreasing competition and hindering timely introduction into the market. Strict IP protection limits the potential cost savings and accessibility benefits that biosimilars may offer by impeding the development of a competitive market. More energy and competition in the biosimilars sector will only come from removing these legal barriers.

We Market Research: Biosimilar Dashboard

Our marketing platform offers a comprehensive dashboard that provides clients with valuable insights into market trends over the years. Included below is a sample image of our dashboard, and specific PDF logins will be furnished to grant access to this insightful tool.

Biosimilar Segmentation

Market- By Product Analysis

By Product, the Biosimilar Market is Categories into Monoclonal Antibodies, Glucagon, Insulin, Erythropoietin, Interferon, and Calcitonin. The Monoclonal Antibodies segment accounts for the largest share of around 49% in 2024.

Many diseases, including multiple sclerosis, rheumatoid arthritis, cancer, and cardiovascular disorders, are treated with monoclonal antibodies. Since monoclonal antibodies specifically target infected cells during treatment, they are widely utilized in the management of cancer, which has caused this category to rise to the top.

The following segments are part of an in-depth analysis of the global Biosimilar market:

Biosimilar Industry: Regional Analysis

Europe Market Forecast

Europe dominate the Biosimilar Market with the highest revenue generating market with share of more than 46%. Europe is leading the way in the use of biosimilars due to its regulatory environment's support and dedication to providing affordable healthcare. The European Medicines Agency (EMA) has been instrumental in the approval process for biosimilars, providing a strong foundation for their market launch. Many biologics' patents are about to expire, which presents a significant opportunity for producers of biosimilars to enter the market. The region's biosimilars industry is still expanding because to the advanced healthcare systems and significant emphasis on cost containment in European nations.

North America Market Statistics

North America is the second-largest market for Biosimilar. In North America, particularly in the US, a growing emphasis on biosimilars is the result of several significant causes. One crucial element is the regulatory help provided by the Food and Drug Administration (FDA). The FDA has been aggressively working to create a transparent procedure for biosimilar approval, which is intended to incentivize companies to participate in the creation of these less expensive alternatives.

Asia Pacific Market Forecasts

Asia Pacific is expected to be the fastest-growing market for Biosimilar during the forecast period. The Asia-Pacific biosimilars industry is impacted by a number of variables that varies from nation to nation. Growing healthcare infrastructure and rising biosimilar awareness are major drivers of market growth in nations like South Korea and India. Japan's regulatory actions have expedited the biosimilars approval process, increasing their accessibility. The adoption of biosimilars is fueled by the region's growing chronic disease prevalence as well as a focus on affordable treatment choices.

Key Market Players

The Biosimilar Market is dominated by a few large companies, such as

·       Pfizer Inc.

·       Novartis AG

·       Orion Pharma AB

·       Biocon.

·       Coherus BioSciences, Inc.

·       Amgen Inc.

·       Samsung Bioepis.

·       Takeda Pharmaceutical Company Limited.

·       Bristol-Myers Squibb Company

·       Merck KGaA

·       Eli Lilly and Company

·       Teva Pharmaceutical Industries Ltd.

·       Bayer AG

·       Others

Recent Developments:

·       July 2020, The FDA approved Fujifilm Kyowa Kirin Biologics' adalimumab biosimilar Hulio, which is indicated for subcutaneous treatment of psoriatic arthritis, adult Crohn's disease, adult rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis, and plaque psoriasis.

·       In May 2020, Fresenius Kabi has been granted approval by the European Medicines Agency and the US Food and Drug Administration (FDA) for its planned pegfilgrastim biosimilar, MSB11455, regulatory submission.