Biosimilars Market size was valued at USD 29.51 Billion in 2023 and is expected to reach USD 108.8 Billion By 2031 and grow at a CAGR of 17.7% over the forecast period of 2024-2031.
The market for medicinal medicines known as biosimilars is referred to as the biosimilars market. The term "biosimilar" refers to biological medications that are very similar to an original or "reference product," a reference biologic medication that has previously received approval. These medications are often manufactured by living things and have intricate molecular structures. Biosimilars are created with the goal of being as effective, safe, and high-quality as the reference product. They are frequently employed as more cost-effective substitutes and are meant to have therapeutic benefits that are equivalent to those of the reference product. Once the exclusivity term and patent protection of the reference biologic medication have expired, biosimilars may be created. Recent years have seen a significant expansion of the biosimilars business as a result of the rise in demand for affordable biologic alternatives.
As a supplemental form of chemotherapy, biosimilars play a significant role in the treatment of cancer. For instance, a top pharmaceutical firm, Novartis, produces a biosimilar drug called Ziextenzo (Pegfilgrastim-bez Injection), which is intended to lower the risk of infection in patients with certain tumours who are receiving chemotherapy drugs that may lower neutrophil counts. The prevalence of autoimmune conditions, including rheumatoid arthritis and ankylosing spondylitis, is rising, fueling the expansion of the biosimilars market. For instance, 7.2% of the population had positive screening results for ankylosing spondylitis, according to research published in the "Scandinavian Journal of Rheumatology" in 2020 and titled "Prevalence of Ankylosing Spondylitis in Spain". For the treatment of chronic pain in arthritis, biosimilars such as infliximab-axxq (Avsola), infliximab-box (Ixifi), infliximab-days (Inflectra), and infliximab-abda (Renflexis) are used. Additionally, the number of orthopaedic hospitals and diagnostic facilities is growing, which helps with illness diagnosis and treatment rates.
Drivers
The development and commercial entrance of biosimilars are made possible when the patents on the reference biologic medicines expire.
Increasing Demand for Biopharmaceuticals.
The need for biological medications has grown as chronic illnesses, including diabetes, autoimmune disorders, and cancer, become more common. By providing affordable alternatives, biosimilars can meet this need and increase patient access to these treatments.
Restrain
The clearance procedure can still be difficult and time-consuming, despite the fact that regulatory bodies have created criteria for biosimilars.
Legal Concerns with Intellectual Property.
The market for biosimilars may be impacted by legal issues and intellectual property rights. Manufacturers of reference biologics may use legal means to safeguard their patents and exclusivity, delaying or impeding the development of biosimilar competitors. Patent litigation and intellectual property challenges may delay the time it takes for biosimilars to enter the market and create market uncertainty.
Opportunity
Comparing biosimilars to the original biologics, considerable cost reductions are possible.
Growing Number of Patent Expirations.
The patent life of many biologic medications is coming to an end, opening up the possibility of biosimilars. As more patents expire, it becomes easier for producers of biosimilars to enter the market and offer more cost-effective substitutes, which promotes market expansion.
Challenge
The success of biosimilars depends on gaining the respect and approval of medical professionals and patients.
Challenges with Pricing and Reimbursement.
Different nations and healthcare systems have different pricing and reimbursement patterns. Manufacturers of biosimilar products struggle to set competitive prices for their goods while taking production costs, market competition, and reimbursement rules into account. The commercial feasibility and profitability of biosimilars may be affected by pricing pressures and discussions with payers.
Global business interruptions and economic instability have occurred due to the ongoing geopolitical tensions due to Russia's invasion of Ukraine, including sanctions. and other limitations imposed on the Russian government and enterprises While we don't have any affiliates or employees in either Russia or Ukraine, we do provide different medications to patients in that country through a distributor, and we're currently working on clinical trials with locations there as well. The conflict can have an effect on the trial's schedule and price. New government restrictions on the export of specific manufacturing inputs to Russia may also hinder or delay our ability to obtain approval for new products.
The conflict's effect on our business operations and financial performance is still unknown and will depend on subsequent developments, such as the severity and duration of the conflict, how it will affect local and global economic conditions, and whether it will expand to or have an influence on nations other than Russia and Ukraine. Less than 2.4% of the total product revenue for the years ending in 2022 and 2021 came from sales in these regions. The company will keep an eye on the war between Russia and Ukraine and evaluate any potential effects on our business, supply chain, partners, or clients, as well as any elements that might have a negative influence on our operational results.
Impact of Ongoing Recession
People and households may encounter financial difficulties during a recession, including decreased disposable income and restricted access to healthcare services. For Biosimilars patients looking for medications, affordability becomes a top priority because the high costs of these drugs can be extremely burdensome. The demand for biosimilar medications may decline, which could have an impact on the market expansion. Pharmaceutical companies may experience greater pricing pressure during economic downturns. To control healthcare costs, governments and insurance companies may negotiate lower reimbursement rates or demand discounts for biosimilar medications. Pricing pressures can affect drug makers' profitability and their capacity to make research and development investments, thereby slowing the development of new treatments.
Economic downturns can put a strain on healthcare systems and limit access to treatments. This may have an impact on how biosimilars are identified, treated, and managed, delaying the start of the right medicines or subsequent care. Particularly in areas with limited resources, access to specialised neurologists, Biosimilars clinics, and supportive services may also be restricted. Reductions in financing for R&D initiatives might result from economic downturns. Pharmacies may have trouble getting funding for cutting-edge medication research programmes and clinical studies. The pipeline of new Biosimilars medications may be affected by the slowdown in research and development, thereby reducing long-term therapy options for patients.
By Type
Human growth hormone
Erythropoietin
Monoclonal antibodies
Insulin
Granulocyte-Colony Stimulating Factor
By Application
Blood disorders
Oncology diseases
Chronic and autoimmune diseases
North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
South Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of the Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America
North America: The development and uptake of biosimilars have been spearheaded by the North American market, which principally consists of the United States and Canada. The regulatory framework for biosimilars in the US is well-established, and a number of them have been given the go-ahead. Due to patent disputes, complicated payment systems, and issues with physician and patient acceptability, market adoption has nonetheless been somewhat gradual.
Asia-Pacific: For biosimilars, the Asia-Pacific area, which includes nations like China, India, South Korea, and Japan, offers a considerable possibility for expansion. These nations have expanding healthcare demands, increased chronic illness prevalence, and an expanding need for low-cost biologic treatments. In these nations, the regulatory frameworks for biosimilars are changing as more emphasis is placed on creating standards, expediting approvals, and fostering domestic manufacturing capacity. Large patient populations, rising healthcare spending, and government attempts to improve patient access to biological therapies are some of the reasons driving the market potential in the Asia-Pacific region.
The major key players are Dr Reddy’s Laboratories, Eli Lilly and Company, Pfizer Inc., Intas Pharmaceutical Ltd, Biocon Ltd, Merck & Co. Inc., Amgen Inc., Teva Pharmaceutical Industries Limited, Kashiv BioSciences, reliance life sciences and final reports list additional participants.
Amgen Inc: Amgen Inc. released AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab), in the US in 2023.
Biocon Ltd: A contract for the commercialization of Biocon's pipeline drugs ustekinumab and denosumab in Japan was signed by the companies in 2022.
| Report Attributes | Details |
| Market Size in 2023 | US$ 29.51 Bn |
| Market Size by 2031 | US$ 108.8 Bn |
| CAGR | CAGR of 17.6 % From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Type (Human growth hormone, Erythropoietin, Monoclonal antibodies, Insulin, Granulocyte-Colony Stimulating Factor, Others) • By Application (Blood disorders, Oncology diseases, Chronic and autoimmune diseases, Others) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Dr Reddy’s Laboratories, Eli Lilly and Company, Pfizer Inc., Intas Pharmaceutical Ltd, Biocon Ltd, Merck & Co. Inc., Amgen Inc., Teva Pharmaceutical Industries Limited, Kashiv BioSciences, reliance life sciences |
| Key Drivers | • The development and commercial entrance of biosimilars are made possible when the patents on the reference biologic medicines expire. • Increasing Demand for Biopharmaceuticals. |
| Market Opportunities | • Comparing biosimilars to the original biologics, considerable cost reductions are possible. • Growing Number of Patent Expirations. |
Ans: The Biosimilars market is to grow at 17.6% Over the Forecast Period 2023-2030.
Ans: The Biosimilars market is to Hit USD 91.81 Billion by 2030.
Ans: The major key players are Dr Reddy’s Laboratories, Eli Lilly and Company, Pfizer Inc., Intas Pharmaceutical Ltd, Biocon Ltd, Merck & Co. Inc., Amgen Inc., Teva Pharmaceutical Industries Limited, Kashiv BioSciences, reliance life sciences and others
Ans: The Biosimilars Market size was valued at USD 25.10 Billion in 2022
Ans: The U.S. Food and Drug Administration (FDA) has currently approved 41 biosimilars.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1Impact of the Ukraine-Russia War
4.2 Impact of Ongoing Recession
4.2.1 Introduction
4.2.2 Impact on major economies
4.2.2.1 US
4.2.2.2 Canada
4.2.2.3 Germany
4.2.2.4 France
4.2.2.5 United Kingdom
4.2.2.6 China
4.2.2.7 Japan
4.2.2.8 South Korea
4.2.2.9 Rest of the World
4.3 Supply Demand Gap Analysis
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Global Biosimilars Market Segmentation, By Type
8.1 Human growth hormone
8.2 Erythropoietin
8.3 Monoclonal antibodies
8.4 Insulin
8.5 Granulocyte-Colony Stimulating Factor
9. Global Biosimilars Market Segmentation, By Application
9.1 Blood disorders
9.2 Oncology diseases
9.3 Chronic and autoimmune diseases
10. Regional Analysis
10.1 Introduction
10.2 North America
10.2.1 North America Biosimilars Market by Country
10.2.2 North America Biosimilars Market by Type
10.2.3 North America Biosimilars Market by Application
10.2.5 USA
10.2.5.1 USA Biosimilars Market by Type
10.2.5.2 USA Biosimilars Market by Application
10.2.6 Canada
10.2.6.1 Canada Biosimilars Market by Type
10.2.6.2 Canada Biosimilars Market by Application
10.2.7 Mexico
10.2.7.1 Mexico Biosimilars Market by Type
10.2.7.2 Mexico Biosimilars Market by Application
10.8 Europe
10.8.1 Europe Biosimilars Market by Country
10.8.2 Europe Biosimilars Market by Type
10.8.3 Europe Biosimilars Market by Application
10.8.6 Germany
10.8.6.1 Germany Biosimilars Market by Type
10.8.6.2 Germany Biosimilars Market by Application
10.8.7 UK
10.8.7.1 UK Biosimilars Market by Type
10.8.7.2 UK Biosimilars Market by Application
10.8.8 France
10.8.8.1 France Biosimilars Market by Type
10.8.8.2 France Biosimilars Market by Application
10.9.9 Italy
10.3.9.1 Italy Biosimilars Market by Type
10.3.9.2 Italy Biosimilars Market by Application
10.3.10 Spain
10.3.10.1 Spain Biosimilars Market by Type
10.3.10.2 Spain Biosimilars Market by Application
10.3.11 The Netherlands
10.3.11.1 Netherlands Biosimilars Market by Type
10.3.11.2 Netherlands Biosimilars Market by Application
10.3.12 Rest of Europe
10.3.11.1 Rest of Europe Biosimilars Market by Type
10.3.11.2 Rest of Europe Biosimilars Market by Application
10.4 Asia-Pacific
10.4.1 Asia Pacific Biosimilars Market by Country
10.4.1 Asia Pacific Biosimilars Market by Type
10.4.3 Asia Pacific Biosimilars Market by Application
10.4.6 Japan
10.4.6.1 Japan Biosimilars Market by Type
10.4.6.2 Japan Biosimilars Market by Application
10.4.7 South Korea
10.4.7.1 South Korea Biosimilars Market by Type
10.4.7.2 South Korea Biosimilars Market by Application
10.4.8 China
10.4.8.1 China Biosimilars Market by Type
10.4.8.2 China Biosimilars Market by Application
10.4.9 India
10.4.9.1 India Biosimilars Market by Type
10.4.9.2 India Biosimilars Market by Application
10.4.10 Australia
10.4.10.1 Australia Biosimilars Market by Type
10.4.10.2 Australia Biosimilars Market by Application
10.4.11 Rest of Asia-Pacific
10.4.11.1 APAC Biosimilars Market by Type
10.4.11.2 APAC Biosimilars Market by Application
10.5 The Middle East & Africa
10.5.1 The Middle East & Africa Biosimilars Market by Country
10.5.2 The Middle East & Africa Biosimilars Market by Type
10.5.3 The Middle East & Africa Biosimilars Market by Application
10.5.6 Israel
10.5.6.1 Israel Biosimilars Market by Type
10.5.6.2 Israel Biosimilars Market by Distribution Channel
10.5.6.3 Israel Biosimilars Market by Application
10.5.7 UAE
10.5.7.1 UAE Biosimilars Market by Type
10.5.7.2 UAE Biosimilars Market by Application
10.5.8 South Africa
10.5.8.1 South Africa Biosimilars Market by Type
10.5.8.2 South Africa Biosimilars Market by Application
10.5.9 Rest of Middle East & Africa
10.5.9.1 Rest of Middle East & Asia Biosimilars Market by Type
10.5.9.2 Rest of Middle East & Asia Biosimilars Market by Application
10.6 Latin America
10.6.1 Latin America Biosimilars Market by Country
10.6.2 Latin America Biosimilars Market by Type
10.6.3 Latin America Biosimilars Market by Application
10.6.6 Brazil
11.6.6.1 Brazil Biosimilars Market by Type
10.6.6.2 Brazil Biosimilars Market by Application
10.6.7 Argentina
10.6.7.1 Argentina Biosimilars Market by Type
10.6.7.2 Argentina Biosimilars Market by Application
10.6.8 Rest of Latin America
10.6.8.1 Rest of Latin America Biosimilars Market by Type
10.6.8.2 Rest of Latin America Biosimilars Market by Application
11. Company profile
11.1 Dr. Reddy’s Laboratories
11.1.1 Market Overview
11.1.2 Financials
11.1.3 Product/Services/Offerings
11.1.4 SWOT Analysis
11.1.5 The SNS View
11.2 Eli Lilly and Company
11.2.1 Market Overview
11.2.2 Financials
11.2.3 Product/Services/Offerings
11.2.4 SWOT Analysis
11.2.5 The SNS View
11.3 Pfizer Inc.
11.3.1 Market Overview
11.3.2 Financials
11.3.3 Product/Services/Offerings
11.3.4 SWOT Analysis
11.3.5 The SNS View
11.4 Intas Pharmaceutical Ltd
11.4.1 Market Overview
11.4.1 Financials
11.4.3 Product/Services/Offerings
11.4.4 SWOT Analysis
11.4.5 The SNS View
11.5 Biocon Ltd
11.5.1 Market Overview
11.5.2 Financials
11.5.3 Product/Services/Offerings
11.5.4 SWOT Analysis
11.5.5 The SNS View
11.6 Merck & Co. Inc.
11.6.1 Market Overview
11.6.2 Financials
11.6.3 Product/Services/Offerings
11.6.4 SWOT Analysis
11.6.5 The SNS View
11.7 Amgen Inc.
11.7.1 Market Overview
11.7.2 Financials
11.7.3 Product/Services/Offerings
11.7.4 SWOT Analysis
11.7.5 The SNS View
11.8 Teva Pharmaceutical Industries Limited
11.8.2 Financials
11.8.3 Product/Services/Offerings
11.8.4 SWOT Analysis
11.8.5 The SNS View
11.9 Kashiv BioSciences
11.9.1 Market Overview
11.9.2 Financials
11.9.3 Product/Services/Offerings
11.9.4 SWOT Analysis
11.9.5 The SNS View
11.10. reliance life sciences
11.10.1 Market Overview
11.10.2 Financials
11.10.3 Product/Services/Offerings
11.10.4 SWOT Analysis
11.10.5 The SNS View
12. Competitive Landscape
12.1 Competitive Benchmarking
12.2 Market Share Analysis
12.3 Recent Developments
13. Use Cases and Best Practices
14. Conclusion
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