Biosimilars Market

According to Stratistics MRC, the Global Biosimilars Market is accounted for $23.9 billion in 2023 and is expected to reach $100.2 billion by 2030 growing at a CAGR of 22.7% during the forecast period. Biosimilars, also known as follow-on biologics, are almost exact replicas of the original drugs but are created by a different company. A variety of acute and chronic illnesses and disorders are treated with biosimilars. The human brain's electrical activity is captured using biosimilars.

According to the International Agency for Research on Cancer 2020, the estimated number of new leukemia cases in 2020 was 474,519 globally.



Market Dynamics:

Driver:

Strong product pipeline

Pharmaceutical companies with robust pipelines of biosimilar products are well-positioned to meet the increasing demand for cost-effective alternatives to biologic drugs. A diverse and expansive pipeline allows for a broader range of therapeutic options, covering various therapeutic areas and medical conditions. As more biologic drugs approach patent expiration, a well-developed product pipeline can lead to a steady stream of new biosimilar offerings, enhancing competition and availability in the market.

Restraint:

High developmental costs

Developing a biosimilar is a complex and resource-intensive process that involves extensive research, clinical trials, and regulatory approvals. Companies must demonstrate the biosimilar's comparability to the reference biologic through extensive testing, which requires substantial financial investment. Additionally, navigating the regulatory landscape for biosimilars, which often involves more stringent requirements compared to generic drugs, can further escalate development costs. These high costs deter some pharmaceutical companies from entering the biosimilars market, leading to limited competition and potentially delaying the availability of more affordable biosimilar alternatives for patients.

Opportunity:

Increasing demand for biosimilars

Biosimilars are cost-effective alternatives to expensive biologic drugs, offering similar therapeutic effects and quality. With rising healthcare costs and the need for affordable treatment options, biosimilars have gained traction among healthcare providers and patients. Governments and healthcare systems worldwide are encouraging the use of biosimilars to enhance accessibility to life-saving medications and reduce healthcare expenditure. As more biologic drugs approach patent expiration, the biosimilars market is expected to expand rapidly, providing patients with greater access to critical treatments and creating opportunities for pharmaceutical companies to compete in this growing and dynamic sector.

Threat:

Complexities in manufacturing

Biosimilars are complex biologic compounds made in living cells as opposed to conventional small-molecule medications, making the production procedure for them complex and delicate. Cell lines, fermentation, purification, and post-translational changes are just a few of the many variables that need to be carefully controlled in order to guarantee consistency in quality, effectiveness, and safety. Any manufacturing deviation or inconsistency might affect the final product's resemblance to the reference biologic and potentially jeopardize patient safety. The strict regulatory restrictions and expensive research costs related to biosimilars provide additional difficulties, deterring some businesses from joining the market and limiting the supply of patient-friendly biosimilar substitutes.

Covid-19 Impact:

The COVID-19 outbreak is anticipated to have a negative impact on the growth of the biosimilars market, owing to the implementation of lockdowns in many countries. The COVID-19 pandemic made it impossible for the pharmaceutical sector to concentrate on R&D efforts, particularly the creation of biosimilars. During the epidemic, the whole healthcare sector has concentrated on developing life-saving products. Additionally, pandemic conditions cause delays in product approvals and releases, which further limit the growth of the biosimilars industry.

The recombinant non-glycosylated proteins segment is expected to be the largest during the forecast period

The recombinant non-glycosylated proteins segment is expected to have lucrative growth in the biosimilars market as they represent a crucial class of biologic drugs used to treat various diseases, including cancer, autoimmune disorders, and inflammatory conditions. Biosimilar development for non-glycosylated proteins presents a promising opportunity to offer cost-effective alternatives to expensive reference biologics. As patents for non-glycosylated biologics expire, biosimilar manufacturers can capitalize on this opportunity to provide more affordable treatment options for patients. However, the complexity of manufacturing and demonstrating comparability to the reference products pose challenges in the development and approval processes.

The oncology segment is expected to have the highest CAGR during the forecast period

The oncology segment is anticipated to witness the fastest CAGR growth during the forecast period. With the rising incidence of cancer worldwide, biologic drugs have become essential in the oncology field, but their high costs pose challenges for many patients. Biosimilars offer a promising solution by providing more affordable alternatives to expensive biologics used in cancer therapies. As patents for various oncology biologics expire, biosimilar developers have focused on developing comparable versions, expanding the options available to healthcare providers and patients.

Region with largest share:

During the forecast period, it is expected that the North American Biosimilars market will continue to hold a majority of the market share. Due to its advanced healthcare infrastructure and growing focus on cost-effective treatment options. With several biologic drugs losing patent exclusivity, the region has seen an increase in biosimilars approvals and market entry. Regulatory frameworks, such as the Biologics Price Competition and Innovation Act (BPCIA) in the United States, have paved the way for biosimilars development and commercialization. Moreover, collaborations between pharmaceutical companies and healthcare providers have further facilitated biosimilars adoption.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period. The increasing prevalence of chronic diseases, rising healthcare costs, and the expiration of biologic drug patents has fuelled the demand for cost-effective treatment options. Governments in countries like India, South Korea, and China are actively promoting the adoption of biosimilars to enhance healthcare accessibility and affordability. Additionally, a supportive regulatory environment and streamlined approval processes have encouraged both domestic and international pharmaceutical companies to invest in biosimilar development.



Key players in the market

Some of the key players in Biosimilars market include Coherus Biosciences Inc., Boehringer Ingelheim International GMBH, Eli Lilly and Company, Fresenius Kabi Ag, Samsung Bioepis Co. Ltd, Amgen Inc., LG Life Sciences (LG Chem), Celltrion Healthcare, Biocad, Dr. Reddy’s Laboratories LTD., Viatris Inc., Intas Pharmaceutical Ltd, Biocon Limited, Teva Pharmaceutical Industries Ltd, Pfizer Inc., Stada Arzneimittel AG and Novartis AG.

Key Developments:

In May 2023, Boehringer Ingelheim received U.S. FDA clearance for Cyltezo Pen, a novel autoinjector choice for Cyltezo (adalimumab-adbm), an FDA-approved interchangeable biosimilar to Humira.

In January 2023, Amgen Inc. launched AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab) in United States.

In October 2022, Biocon and Yoshindo Inc., entered into an agreement for commercializing Biocon’s pipeline products ustekinumab and bDenosumab in Japan.

Drug Classes Covered:
• Recombinant Non-Glycosylated Proteins
• Recombinant Glycosylated Proteins
• Recombinant Peptides
• Other Drug Classes

Manufacturing Types Covered:
• In-house Manufacturing
• Contract Manufacturing

Technologies Covered:
• Mass Spectroscopy
• Chromatography
• Monoclonal Antibody Technology
• Recombinant DNA Technology
• Nuclear Magnetic Resonance (NMR) Technology
• Electrophoresis
• Bioassay

Applications Covered:
• Hematology
• Oncology
• Chronic Diseases
• Autoimmune Disease
• Blood Disorders
• Growth Hormone Deficiency
• Diabetes
• Other Applications

End Users Covered:
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Other End Users

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances