Global Biosimilars Market By Product Type (Monoclonal Antibodies, Recombinant Hormones, Anti-inflammatory Agents, and Other Product Types), Applications (Blood Disorders, Growth Hormonal Deficiency), By Region And Key Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends And Forecast 2023-2032

Report Overview

The global biosimilars market size is expected to be worth around USD 34.4 billion by 2032 from USD 9.5 billion in 2022, growing at a CAGR of 14.1% during the forecast period from 2022 to 2032.

Biosimilars are copies of biological drugs that are identical but not identical to those that have been approved (the biological refer to medicine). A “similar biologic” refers to a biologic product/drug that has been created by genetic engineering and is claimed to be similar to a reference biologic in terms of safety, efficacy, and quality. A biosimilar medicine is a medicine that has the active ingredient of a biological medicine. It is used to treat the same conditions at the same dose.

Biosimilar can be described using the following terms: market-based, regulatory-based (under expedited test), entity based (including product processing), and regulatory-based. Biosimilar can be described using the same terms for follow-up biologics and subsequent entry biologics. Insurance companies and the general public prefer cost-effective options. However, the long-term economic consequences of using biosimilars are not being investigated. The total cost of biosimilar therapy could rise.

Key Takeaways

• Market Growth: The global biosimilars market is projected to reach USD 34.4 billion by 2032, with a remarkable CAGR of 14.1% from USD 9.5 billion in 2022.
• Biosimilars Defined: Biosimilars are biologic drugs that are highly similar to approved reference biologics, offering safety, efficacy, and quality while providing cost-effective treatment options.
• Product Dominance: Monoclonal antibodies are the leading product type, mainly used in treating cancer, rheumatoid arthritis, and cardiovascular diseases. Erythropoietin for anemia is expected to see significant growth.
• Application Leadership: Oncology is the dominant application area for biosimilars, driven by the increasing prevalence of cancer, while hormonal deficiencies are also gaining traction.
• Market Drivers: Advancements in biomedical science, the growing incidence of chronic diseases, and the increasing adoption of biologics are propelling market growth.
• Market Restraints: Limited awareness about biosimilars among healthcare professionals and high development costs, particularly in comparison to generic drugs, hinder market expansion.
• Opportunities: Rising research and development activities, large investments by pharmaceutical companies, and patent expiries of biologics are key growth opportunities.
• Trends: Patent expirations of biologics are driving biosimilar adoption, and controlling manufacturing variability is essential for product quality.
• COVID-19 Impact: The pandemic disrupted the biosimilars market due to supply chain disruptions, manufacturing plant shutdowns, and delays in clinical trials and product approvals.
• Regional Insights: Europe currently dominates the market, while North America is expected to experience significant growth, driven by factors like rapid biosimilar adoption and increasing cancer cases.
• Key Players: Major players in the market include Novartis, Amgen, Pfizer, Viatris, Eli Lilly, and several others, with strategies such as partnerships and mergers to expand their market share.

Product Type Analysis

Monoclonal antibodies and Oncology are dominating the market revenue

Based on type, Monoclonal antibodies were the dominant product in the market, accounting for the highest revenue share. It is expected to continue its dominance over the next years. Monoclonal antibodies can be used to treat cancer, rheumatoid arthritis, multiple sclerosis, and cardiovascular diseases. It is used to treat cancer by targeting the infected cells. In the next few years, erythropoietin will see a promising CAGR.

It is responsible for the production of RBC. It is used to treat anemia. It can also be used to treat kidney-related conditions. It is expected to continue its dominance over the forecast period. This is due to biosimilars being available at lower prices and rising cancer rates. The International Agency for Research on Cancer reported that there were approximately 19.3 million new cases of cancer and 10 million deaths related to cancer in 2020.

The prevalence of breast cancer is increasing in women accounting for approximately 11.7% of all new cases. Lung cancer accounted for 11.4%, while colorectal and colorectal cancers accounted for 10.0%. The segment is experiencing a boom in demand for biosimilar treatments for cancer.

Application analysis

According to the application, the market for biosimilars in the world was dominated by the oncology sector in terms of revenue.

Oncology was the most popular biosimilar market application and had the highest revenue share. It is expected to continue its dominance over the next years. The growth of this segment is due to Biosimilars being widely used in cancer treatment. Market growth is largely driven by the Increasing Prevalence of Cancer and the aging population.

Further driving the market growth is the increasing incidence of breast cancer. The segment’s growth is being driven by the growing demand for biosimilars for cancer treatment. The growth of hormonal deficiencies is expected to see a promising CAGR over the next few years. This segment is growing due to the increasing number of children affected by growth hormone deficiencies.

Key Market Segments

By Product Type

• Monoclonal Antibodies
• Recombinant Hormones
• Immunomodulators
• Anti-inflammatory Agents

By Application

• Blood Disorders
• Growth Hormonal Deficiency
• Chronic and Autoimmune Disorders
• Oncology

Drivers

Biomedical Science Advancements to Fuel Market Growth

Biological drugs are the product of cutting-edge research that allows for the latest scientific breakthroughs. These breakthroughs could lead to new medicines that provide patients with more treatment options. A better understanding of the genetic and molecular basis of diseases has allowed for the development of customized treatments.

For example, recombinant proteins aid the immune system in identifying foreign molecules and binding them. Biologics will continue to expand rapidly due to a drop in productivity for small-molecule therapeutic R&D. Major market players in the pharmaceutical sector continue to focus on the development of innovative drugs for their market position.

The Adoption of Biologics Will Increase with the Growing Incidence of Chronic Diseases

Biosimilars are expected to grow in popularity due to the rising incidence of chronic diseases like asthma, arthritis, and cancer. Biosimilars are being increasingly used to treat chronic diseases such as those caused by long working hours, poor eating habits, and limited physical activity.

Biosimilars increase the immune system’s response to cancer cells, thereby helping the immune system eliminate cancer cells. A United Nations report predicts that by 2030, the global death rate from chronic diseases will rise to 70%. Globally, the burden of chronic diseases is expected to rise to 60%. The rise in chronic disease is expected to drive the market for biosimilars.

Restraints

Lack of Awareness About Biosimilars

The market for biosimilars is not growing because of a lack of awareness among specialists and primary care physicians about biosimilars. Biosimilars are made from cell lines and have the same efficacy as biologics. A lack of knowledge about biosimilars can reduce the chances of prescribing them to patients. This affects the market for new biosimilars.

According to PwC’s Health Research Institute, 55% of 442 physicians surveyed were not familiar with biosimilars, while 35% were hesitant to prescribe them because of concerns about the safety of follow-on biologics. The market for biosimilars is being constrained by a lack of knowledge among specialists and primary care physicians about biosimilars.

The upcoming Challenges with Drug Development, Cost of Development, and Clinical Processing, to restrain the Market Growth

Generic drugs can be 40% to 50% cheaper than biologics and branded pharmaceuticals. Biosimilars, on the other hand, are only 15% to 20% less expensive than biologics. This is due to high development costs and clinical testing as well as high investment in resources. Generic drugs also require less modification, which makes the manufacturing process easier and more cost-effective.

Generic drugs have development costs of around US$ 2 to 3 million. Biosimilars are more expensive. According to Springer Link’s 2021 article, the development and approval of a biosimilar in the United States cost between US$ 100.0 million and US$ 200.0 million. This is substantially more than the cost to develop generic drugs which can range from US$ 1.0 million up to US$ 5.0 million.

Biosimilar development can take anywhere from five to nine years, compared with the development of generic drugs which takes about two years. This time period is very long for both manufacturers and investors. This will likely slow down market growth over the forecast period. The U.S. market is experiencing a slowdown in growth due to the above factors and limited information about efficiency.

Opportunity

Rising Research and Development Activities

Market growth is possible due to the increasing number of research and development activities. Market growth is being driven by the large investments made in research and development by pharmaceutical and biopharma companies.

To drive long-term growth, they are focusing their efforts on research and development. To gain a competitive advantage in the market, and to expand their product portfolios, they are also looking for partnerships and collaborations. The market is seeing significant growth in biotechnology.

Trends

The Patent Expiry of Biologics Directly Increases the Uptake of These Drugs

McKinsey reports that patent protection will be lost for a few blockbuster biologics, with peak annual sales of US$ 60 billion, in the next five years. The market has new opportunities because the top 25 biologics account for 83% of global sales.

The U.S. has seen a wave of biosimilars that have introduced highly effective and powerful drugs, taking full advantage of the expiry of patents on these biologics. In April 2020, prominent companies Merck and Samsung Bioepis announced the trastuzumab-biosimilar Ontruzant on the United States Market.

Biologics therapy is more costly due to the higher Average Sales Price (ASP). These drugs are expected to become more popular in the U.S. market due to the rising prevalence of chronic diseases like cancer and rheumatoid.

According to Dotdash Publishing’s 2021 article, Amgen drug Neulasta for the treatment of neutropenia is more expensive than US$ 10,000 per milliliter, while its biosimilar Ziextenzo costs about US$ 6,500 per milliliter, which represents a 37% savings.

Controlling the variability in expected products when manufacturing biosimilar

Manufacturing variations that are identical to reference products can cause problems. Preclinical and clinical evidence may also be required by regulatory authorities to prove that the manufacturing process had no impact on product safety or effectiveness and that there was no difference between the biosimilar biologic and the original biologic.

Biosimilar producers need to compete with not only other biosimilar producers but also the original biologic producer or generic drug manufacturer. The initial biologic company can launch reformulated pharmaceuticals and second-generation treatments as new biosimilar products hit the market.

This will allow them to compete with the original biologic company. Physicians still perceive biosimilars as unfavorable, which can impact their prescriptions to a certain extent. The global market for biosimilars is also being restricted by patent extensions and lower prices than generic drugs.

Regional Analysis

Europe was the dominant market and had the highest revenue share based on geography

It is expected to continue its dominance over the forecast period. Market growth is being driven by the growing demand for biosimilars. Market growth is positively influenced by the emergence of market leaders, strong product pipelines, and rising product approvals.

North America will experience a promising CAGR over the next few years. Market growth is being driven by factors such as the rapid adoption of biosimilars, rising cases of cancer, numerous market players, and large investments in the research and development of biosimilars.

Key Regions

• North America
  • The US
  • Canada

• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe

• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe

• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC

• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Mexico
  • Costa Rica
  • Rest of Latin America

• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

The major share players in the market such as Binocit, epoetin hexal, and ab seamed are all part of the biosimilars market. This market’s values are factory gate, which is the value of the goods sold by the manufacturer or creator of the goods to any other entity (including downstream manufacturers and wholesalers as well as retailers) or directly to customers.

This market also includes the value of related services sold to the creators of the goods. Market value refers to the revenue that businesses receive from the sale or grant of goods and/or services within a specified market and geographic area. The market is somewhat fragmented due to the presence of many local companies.

These market players want to increase their market share through strategies such as partnerships, investments, acquisitions, mergers, and acquisitions. Companies also spend money on developing better products. They also focus on maintaining competitive pricing.

Fresenius Kabi received approval from the FDA and EMA in May 2020 for its MSB11455 biosimilar. Market growth is facilitated by various strategies such as acquisitions, mergers, and government policies. This creates lucrative opportunities for market players.

Listed below are some of the most prominent biosimilar industry players.

Market Key Players

• Novartis
• Amgen Inc.
• Pfizer Inc.
• Viatris Inc.
• Eli Lilly
• Synthon Pharmaceuticals Inc.
• Teva Pharmaceutical Industries Ltd.
• LG Life Sciences
• Celltrion
• Biocon Biologics Ltd.
• Coherus Biosciences, Inc.
• Bio-Thera Solutions
• Intas Pharmaceuticals Ltd.
• F. Hoffmann-La Roche Ltd.
• Samsung Bioepis Co.
• Hospira
• Merck Serono
• Biogen Idec Inc.
• Genentech

Recent Developments

• Biocon Ltd. (Biocon Biologics, specifically) has entered into a partnership to table SEMGLEE, the very first interchangeable biosimilar insulin glargine yfgn injection, for diabetes treatment. In July 2021, the US FDA approved this biosimilar.
• Novartis AG (Sandoz) in April 2021 signed an agreement with China’s Bio-Thera Solution for the commercialization of BAT1706 (i.e. All over the world, bevacizumab was proposed as a biosimilar to bevacizumab.
• Coherus Biosciences Inc. received approval from the US FDA in December 2021 for “YUSIMRY”, for treating psoriatic and rheumatoid joint pain, psoriasis, ankylosing spondylitis, ankylosing spondylitis, juvenile idiopathic, ulcerative colitis, Crohn’s disease, and psoriatic arthritis.
• Viatris Inc. announced the launch of Abevmy in Canada in May, in collaboration avec Biocon Biologics. This drug is a biosimilar to Avastin. Health Canada is set to approve it for use in oncology.

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