Biosimilar Market

Biosimilar Market Outlook (2024 to 2034)

Worldwide revenue from the biosimilar market is estimated at US$ 43.8 billion in 2024 and has been analyzed to increase at a CAGR of 8.9% to reach US$ 102.68 billion by 2034.

Biosimilars, also known as follow-on biologics, are created by a different business yet are almost exact replicas of the original medicine. Several acute and chronic illnesses and disorders are treated with biosimilars. Biosimilars are utilized to capture the electrical activity that the human brain produces.

Particularly in low- and middle-income countries where cost is a significant barrier to treatment, the use of biosimilars in cancer treatment has the potential to expand patients' access to potentially life-saving medicines. Additionally, biosimilars might lessen the financial strain on healthcare systems so that more people can get the necessary medical care. Because they provide more accessible and cheaper alternatives for these essential medicines, biosimilars have grown in importance in the treatment of cancer.

Biosimilars and biologics are transforming healthcare through novel therapeutic approaches, improved patient outcomes, and increased accessibility. Consequently, there is a notable increase in demand for them globally.
Biosimilar biologics and biosimilar biologic medications are gaining popularity owing to their increased efficacy and cost.

Because biologics provide focused medicines that explicitly target disease pathways, they have transformed the way that many illnesses are treated. Biologics and biosimilars, in contrast to conventional small-molecule medications, which frequently cause side effects that are not intended, are made to precisely target pathways, reducing unwanted responses.

Generic biologics that are no longer covered by patents are known as biosimilars. The market for biosimilars is anticipated to be propelled by well-known biologics' patent expiry. Sales of biologics have significantly decreased due to the increasing approval and sales of biosimilars. This is contributing to the expansion of the biosimilar market size.

Globally, the prevalence of chronic illnesses has been increasing. The aging population and shifting lifestyles of individuals can be partly blamed for the rise in the incidence of chronic illnesses. Among the prevalent chronic illnesses are diabetes, hypertension, stroke, cancer, obesity, arthritis, and disorders of the mouth and respiratory system. Conversely, rheumatoid arthritis and cancer are being widely treated with biosimilar monoclonal antibodies, leading to biosimilar market growth.

Report Attribute	Detail
Biosimilar Market Size (2024E)	US$ 43.8 Billion
Forecasted Market Value (2034F)	US$ 102.68 Billion
Global Market Growth Rate (2024 to 2034)	8.9% CAGR
Canada Market Growth Rate (2024 to 2034)	8.6% CAGR
China Market Value (2034F)	US$ 12.41 Billion
North America Market Share (2024E)	38.9%
East Asia Market Share (2034F)	20.4%
Key Companies Profiled	Amgen; PFIZER Inc.; Novartis; Biocon Ltd.; Coherus BioScience; Teva Pharmaceuticals; Abbvie; Viatris; Fresenius Kabi; Sanofi SA; Mylan; Amneal Pharmaceuticals, Inc.

What are the Projections for the Biosimilar Business Going Forward?

“R&D Investments in Medical Technologies Leading to Innovative Healthcare Solutions”

One of the primary drivers of market expansion is the rising prevalence of acute and chronic illnesses worldwide, driven by various internal and external factors. The growing incidence of Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis, along with an increasing patient population, especially in emerging nations, is fostering the biosimilar market growth.

Increased investment in R&D capabilities, particularly in both established and emerging nations, focusing on medical equipment and technologies, will further provide lucrative market expansion opportunities. Advances in research and development have led to improvements in healthcare facilities' quality and medical technology. The range of screening exams for research capabilities has also significantly broadened.

Enhanced federal government support is expected to accelerate market growth. Additionally, the expansion of the healthcare sector, driven by both public and private entities, particularly in emerging nations, will create profitable growth opportunities for the personal health devices market.

Market growth is being further supported by the increased adoption of bioidentical hormone replacement therapy by government healthcare institutions. Demand for biological medications has risen due to the aging population and the growing prevalence of chronic illnesses. Biosimilars can help meet this demand and improve patient access to these essential medications.

“Increased Awareness and Understanding of Biosimilars among Public”

Growing public awareness of biosimilars is leading to increased adoption. Biosimilars are widely used in preventing and treating various chronic illnesses, including renal failure, rheumatoid arthritis, diabetes, cancer, autoimmune disorders, cardiovascular diseases, growth hormone deficiency, and infectious diseases. The market for biosimilars is expected to gain momentum in the coming years due to rising healthcare concerns.

Preference for biosimilars over conventional biologics is becoming increasingly prevalent in global markets. This trend is driven by the cost-effectiveness of biosimilars compared to the original biologic medications. Additionally, the growing aging population is expected to drive the demand for biosimilars in the coming years.

Many governmental and commercial organizations are launching campaigns to promote the use of biosimilars instead of traditional biologics and synthetic pharmaceutical products. These efforts are expected to support biosimilar producers' revenue generation potential during the forecast period.

The rapid expansion of the pharmaceutical industry, combined with the rising cost of existing biological pharmaceuticals, should provide favorable growth prospects for the biosimilar market.

What is Hampering Market Expansion to Some Extent?

“High Production Cost and Complex Production Process”

Relatively higher production costs of biosimilars continue to hinder their widespread manufacturing. Additionally, the complexity of the production process is expected to limit the biosimilar market growth drivers.

Sales of biosimilars are likely to be constrained by the availability of affordable generic medications. One clear barrier for market participants is the need to establish biosimilarity through comprehensive analytical characterization. Each biosimilar must be reviewed by relevant regulatory agencies to ensure similarity in terms of safety and efficacy before obtaining regulatory approval. Moreover, subsequent price reductions and competitive pricing in the industry are likely to pose challenges for the marketing of biosimilars.

Country-wise Evaluation

The market in South Korea is projected to expand at a CAGR of 9.6% between 2024 and 2034. The country is projected to account for 19.4% of the East Asia biosimilar market share by the end of 2034.

What is Benefitting Biosimilar Manufacturers in the United States?

“Adoption of Biosimilars Contributing to Reduced Direct Spending on Biologics”

Attribute	United States
Market Value (2024E)	US$ 14.44 Billion
Growth Rate (2024 to 2034)	9% CAGR
Projected Value (2034F)	US$ 34.27 Billion

Clinical and financial benefits of biosimilars are proving to be quite promising for the United States’ healthcare system.

• By the end of 2026, the RAND Corporation estimates that widespread global adoption of these medications could reduce direct spending on biologics by US$ 54 billion.

Various drug manufacturers are engaging in strategic partnerships, collaborations, and acquisitions for research, production, or commercialization to gain a competitive edge, which is one of the key biosimilar market trends in the United States. These partnerships aim to provide patients in a range of therapeutic areas with access to high-quality, reasonably priced medications.

• For example, to strengthen its position through its pipeline of future biosimilar drugs and its portfolio, Biocon Biologics entered into a definitive agreement in February 2022 to purchase the biosimilars business of Viatris, a global franchise specializing in oncology, immunology, and endocrinology.

Why are More Businesses Heading to China?

“Enhanced Production Efficiencies Enabling Better Patient Access to Essential Treatments”

Attribute	China
Market Value (2024E)	US$ 4.73 Billion
Growth Rate (2024 to 2034)	10.1% CAGR
Projected Value (2034F)	US$ 12.41 Billion

Development and production of biosimilars and biologics have advanced significantly in China's pharmaceutical industry, offering substantial potential for expansion, innovation, and improved patient access to life-saving treatments. Advances in biotechnology and manufacturing techniques have enabled the nation to produce biologics and biosimilars more effectively and economically.

Category-wise Evaluation

Based on application, the growth hormone deficiency segment is expected to reach a valuation of US$ 1.84 billion in 2024.

What Makes Recombinant Glycosylated Proteins Stand Out in the Market?

“Effectiveness in Treating Wide Range of Illnesses”

Attribute	Recombinant Glycosylated Proteins
Segment Value (2024E)	US$ 33.26 Billion
Growth Rate (2024 to 2034)	8.8% CAGR
Projected Value (2034F)	US$ 77.39 Billion

Significant portion of the biosimilar market is occupied by recombinant glycosylated proteins, which are quickly becoming a well-known product class. These proteins are gaining recognition in the industry due to their advanced therapeutic potential and ability to treat a wide range of illnesses. Their increasing popularity signifies a promising development in the variety of products offered by the biosimilar sector.

How is Use of Biosimilars Making Cancer Therapies More Accessible?

“Biosimilars Seen as Cost-Effective Alternative to Expensive Biologics”

Attribute	Oncology
Segment Value (2024E)	US$ 20.41 Billion
Growth Rate (2024 to 2034)	9.6% CAGR
Projected Value (2034F)	US$ 50.91 Billion

Use of biosimilars is significantly advancing cancer treatment by making therapies more widely available and affordable. Biosimilars hold great promise for increasing patient access to life-saving medications, especially in low- and middle-income countries where the cost of care is a major obstacle. The growing use of biosimilars in cancer therapy is truly revolutionary.

Market Landscape

Key players in the biosimilar industry are actively adapting themselves to the evolving market trends such as the application of fusion biosimilars and oncology biosimilars.

• In January 2024, Gilead Sciences and Arcus Biosciences announced an updated partnership agreement and a separate equity investment. Gilead invested US$ 320 billion in Arcus common shares at US$ 21 per share.
• In May 2023, Biocon Biologics and Viatris Inc. announced the introduction of Abevmy in Canada. This medication is a bevacizumab biosimilar of Avastin, originally developed by Roche, and has been approved by Health Canada for use in cancer treatment.
• In March 2022, Amneal Pharmaceuticals, Inc. declared that the U.S. government had accepted the Biologics License Application (BLA) for filgrastim-ayow, a biosimilar referencing Neupogen.
• In May 2022, the United States Food and Drug Administration (FDA) approved Amneal Pharmaceuticals, Inc.'s Biologics License Application (BLA) for pegfilgrastim-pbbk, a biosimilar referencing Neulasta.

Fact.MR provides detailed information about the price points of key biosimilar manufacturers positioned across the world, sales growth, production capacity, and speculative technological expansion in this new biosimilar market report.

Key Segments of Biosimilar Market Research

• By Product Type :

  • Recombinant Glycosylated Proteins
  • Recombinant Non-Glycosylated Proteins

• By Application :

  • Hematology
  • Growth Hormone Deficiency
  • Oncology
  • Diabetes
  • Autoimmune Disease
  • Others

• By Distribution Channel :

  • Hospital Pharmacies
  • Online Pharmacies
  • Retail Pharmacies

• By Region :

  • North America
  • Latin America
  • Eastern Europe
  • Western Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa