USD 15.6 billion
Biosimilars Market Size, Share, Growth Analysis, By Indication(Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders, Growth Hormones Deficiency, Others), Drug Type(Monocional Antibodies, Insulin, rhGH, Anticoagulants, Others), and Region - Industry Forecast 2024-2031
Report ID:
SQMIG35H2167 |
Region:
Global |
Published Date: June, 2024
Pages:
165
|Tables:
70
|Figures:
75
Biosimilars Market Insights
Global Biosimilars Market size was valued at around USD 23.45 billion in 2022 and is expected to rise from USD 27.30 billion in 2023 to reach a value of USD 92 Billion by 2031, at a CAGR of 16.4% over the forecast period (2024-2031).
The biosimilars market is expected to grow phenomenally with the expected expiry of important biological patents and an increasing imperative to cut healthcare costs. Opportunities for biosimilars entering the market, as patent protection for many blockbusters biologic medicines expires, has taken place in the therapeutic areas of oncology, immunology, and endocrinology. Governing bodies and regulatory organizations, too, are encouraging biosimilar intake with quicker approval times and substitution policies. The European Union has been at the forefront of this movement, with a well-grounded structure of regulations within this region, thus securing higher rates of adoption compared to other regions.
However, there are several pitfalls in the biosimilars market that can affect growth. One of the major challenges is the capital expenditure in this sector, required to develop and manufacture biosimilars and navigate complex and stringent regulatory requirements in this area, which can then practically deter smaller companies from investing in this system. Extensive clinical trials to demonstrate similarity are time-consuming and costly. The existing stronghold of original biologics, based on brand loyalty and trust established among stakeholders, is another challenge for market entry. To combat this, biosimilar manufacturers are also increasingly resorting to strategic alliances and collaborations to tap the existing market presence and distribution networks. In addition, the acceptance of biosimilars and the assimilation of this understanding in physicians and patients are important for growing further and creating competition in this market. Although the opportunities in the biosimilar market are tremendous, it will need further research that could regulate the market dynamics to grow expressly.
US Biosimilars Market is poised to grow at a sustainable CAGR for the next forecast year.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Oncology
Fastest Growth
Oncology
Growth Rate
23.5% CAGR
Biosimilars Market ($Bn)
Biosimilars Market, by country(%)
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Biosimilars Market Segmental Analysis
The biosimilars market is segmented into Drug Type, Indication, and region. Based on Drug Type, the market is segmented into Monocional Antibodies (Infliximab, Trastuzumab, Rituximab, Adalimumab, and Others), Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Recombinant Human Growth Hormone, Etanercept, Follitropin, Teriparatide, Interferons, Anticoagulants, and Others. Based on Indication, the market is segmented into Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders, Growth Hormones Deficiency, Infectious Diseases, and Others. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa.
Analysis by Drug Type
Based on our analysis, the monoclonal antibodies segment dominated the biosimilars market in 2022, driven by their critical role as therapeutics in cancer and autoimmune disease. This segment is dominated by the high demand for low-cost therapeutic alternatives.
The insulin segment is poised to record the highest CAGR during the forecast period. Such expected growth can be attributed to the growing prevalence of diabetes across regions and the accompanying imperative for insulin at low prices. As healthcare systems work towards balancing cost and enhancing patient access, the insulin biosimilars market too will achieve great growth with the support of regulatory policies and biopharmaceutical manufacturing technology upgrades.
Analysis by Indication
In the biosimilars market, oncology is expected to be the most dominant segment in 2023, with the highest incidence and prevalence of cancer globally. The big amount of money associated with treatments related to cancer has made biosimilar oncology drugs provide relatively affordable options for cancer therapy, thus ensuring high levels of adoption and hence market dominance.
It is also projected that inflammatory & autoimmune disorders segment will be growing at a maximum CAGR in the forecast period. This can be attributed to a higher patient population suffering from diseases such as rheumatoid arthritis, psoriasis, and Crohn's disease, further upping the concern of the respective patients towards the effective treatment of the condition, whose therapeutics include high-cost biologic therapies. The arrival of biosimilars in this segment offers significant cost savings and increased patient access, contributing to rapid market expansion.
Biosimilars Market, by Indication($Bn)
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Biosimilars Market Regional Insights
In 2022, the North America region is expected to dominate the biosimilars market. It is also expected that North America will continue to grow significantly in the biosimilars market in the forthcoming years. This expansion is attributed to the rising incidence of chronic diseases like cancer as well as increased funding in research and development by industry players. The presence of numerous key market competitors such as Novartis, Pfizer Inc., Biogen as well as Coherus Biosciences Inc. also contribute significantly towards the growth of the market. These firms are improving and diversifying their products, thus enabling the market to grow faster. Moreover, continued favourable regulation, and a growing trend in physician appreciation of biosimilars also plays a significant role in the domination of North America for this market.
On the other hand, Asia-Pacific has been predicted to grow at the highest CAGR during the forecast period. This growth rate can be attributed to the following factors; there is increased incidence of chronic diseases; the global health expenditure is on the rise and governments are encouraging biosimilars through government policies and legislation. The region’s Biopharmaceutical industry is in its growth phase, along with the availability of a large patient pool, is a major growth opportunity for Biosimilar manufactures. Companies in Asia-Pacific region especially China, India, and South Korea are projected to play crucial role in biosimilar market because of a strong manufacturing base and growing emphasis on research and development. Therefore, over the next few years, the Asia-Pacific market remains a stiff competition area for the development and sales of biosimilars.
Biosimilars Market, By Region
- Largest
- Fastest
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Biosimilars Market Dynamics
Biosimilars Market Driver
Rising Demand for Biosimilars Due to their Affordability
- Biosimilars is playing a key role by being affordable in comparison of original biological drugs. Therefore, this makes biosimilars appealing option for healthcare systems to reach out as many patients as possible with important therapies with low cost. Reducing these costs results in availability of the treatment as most of the biosimilars cost around 15-30% below their patent brand counterparts. As a result, low rates allow doctors redistribute funds effectively and making treatments available.
Increasing Incidence of Chronic Illness Drives the Market Growth
- Increasing prevalence of chronic diseases that include cancer, diabetes, and autoimmune disorders drives the biosimilars market as demand for efficacious and cost-effective treatments goes up. Our analysis reveals that the US elder population (people aged around 50 years and older) is projected to increase by 61.11%, from 137.25 million in 2020 to 221.13 million by 2050. The number of this age group with at least one chronic disease will nearly double, rising by 99.5%, from 71.522 million in 2020 to 142.66 million by 2050. The upsurge in the prevalence of chronic diseases would, in turn, create a dire need for biosimilars and aid markets growth to a further extent.
Restraint
Regulatory Challenges Restraining Market Growth
- Biosimilars have very specific regulations with large differences in different countries which remains as big obstacle for companies. Thus, the existence of these dual systems increases significant time and effort, frequentlypostponing market access and raising development expense. Individual requisites vary from one regulatory authority to another, and these include a series of clinical trials and a comprehensive analytical characterization. The current state where there is no harmonization to occur can result in duplication of effort and high compliance costs which will deter the small firms from venturing into the market. Furthermore, such a setting can also mean constant alteration of the policies and regulations, which brings about uncertainty on the part of the firm, not to mention the lengthy procedures involved. Hence, regulatory hurdles are a major factor restricting the biosimilars industry and the ability to launch new biosimilars at a faster rate and a lower cost.
Limited Cost Savings for Companies in the Biosimilar Industry
- Although in general, biosimilars are more affordable than biologics, the foreseen cost savings may not be huge. In fact, this modest cost differential can make it difficult to justify the switch based on economic reasons that some healthcare systems would have expected from the biosimilars. This price reduction potential for the biosimilars will be curtailed by high development costs, expenses due to compliance with regulatory requirements, and competition pressure in the market. This could therefore make it challenging for healthcare providers to change from established biologics to biosimilars based on cost alone; some broader assessment of benefits in terms of access and/or therapeutic benefit may well be required.
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Biosimilars Market Competitive Landscape
Companies in the global biosimilar market could contribute money to mergers and acquisitions, product launches, changes in technology, and R&D projects. Major corporations may also spend money on new product development and marketing in the next few years. The market's greatest share belonged to Amgen Inc. It created a market for the breakthrough medicine "Mvasi," and the increased countrywide prescription rate is the primary driver of the firm's supremacy in 2021.
Biosimilars Market Top Players Company Profiles
- Pfizer Inc. (US)
- Amgen Inc. (US)
- Samsung Bioepis (South Korea)
- Novartis AG (Switzerland)
- Celltrion Inc. (South Korea)
- Viatris Inc. (US)
- Coherus BioSciences (US)
- Biogen (US)
- Mylan (US)
- Teva Pharmaceutical (Israel)
- Eli Lilly (US)
- Merck & Co (US)
- Biocon (India)
- FHoffman-La Roche Ltd. (Switzerland)
- Dr. Reddy’s Laboratories (India)
- Sandoz International GmbH (Germany)
- AbbVie Inc (US)
- Fresenius Kabi (Germany)
- Formycon (Germany)
- Alvotech (Iceland)
Biosimilars Market Recent Development
-
In June 2023, Samsung Bioepis and Biogen Inc. announced the launch of BYOOVIZ (ranibizumab-nuna) in the US. The biosimilar referencing LUCENTIS (ranibizumab) is priced 40% lower than its biologic. It offers affordable and effective treatment to rental disorder patients. BYOOVIZ is also the first ophthalmology biosimilar launched in the US, which is aimed at enhancing the accessibility of anti-VEGF treatments.
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In February 2023, Pfizer Inc. announced that its supplemental application for the interchangeability of ABRILADA (adalimumab-afzb) with Humira (adalimumab) was accepted for review by the FDA. The interchangeability designation would enable ABRILADA to support the growing use of biosimilars while broadening the accessibility to quality and affordable treatment for chronic inflammatory issues.
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In February 2022, Biocon Biologics has agreed to acquire Viatris' biosimilars business, a global franchise focused on oncology, immunology, and endocrinology, with the goal of strengthening its position through its portfolio and future pipeline biosimilar drugs.
Biosimilars Key Market Trends
- Catalysing Global Biosimilars Growth: Innovating Affordability and Efficiency: If patients are the main winners, then lower biosimilar prices will have a big impact on the demand for biosimilars worldwide. The most recent trend among manufacturers in emerging biosimilar marketplaces is the innovation's notable cost reductions. Over the course of the forecast period, this will continue to be a typical tendency, which will eventually drive the growth of the global biosimilars market. Furthermore, biosimilar manufacturers would most likely experiment with different manufacturing quantities or volumes. The capacity to create value by manufacturing numerous biosimilar medications at one location may prove advantageous for biosimilar makers throughout the anticipated period.
Biosimilars Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by the robust Secondary Desk research.
According to our analysis, the Oncology sector dominated the Biosimilars Market in 2021 owing to the high incidence of cancers worldwide. In 2021, Monoclonal antibodies dominated the Biosimilars Market share due to the rise in the number of various U.S. FDA certificates and new product launches. In 2021, North America is to be the fastest-growing market over the forecast period.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 23.45 billion |
| Market size value in 2031 | USD 92 Billion |
| Growth Rate | 16.4% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Biosimilars Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Biosimilars Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Biosimilars Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Biosimilars Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Biosimilars Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Biosimilars Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Biosimilars Market Report Snapshots
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