USD 15.6 billion
Biosimilars Market Size, Share, Growth Analysis, By Drug Type(Monocional Antibodies (Infliximab, Trastuzumab, Rituximab, Adalimumab), By Indication(Oncology, Inflammatory & Autoimmune Disorders, Chronic Diseases, Blood Disorders), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35H2167 |
Region:
Global |
Published Date: August, 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).
Biosimilars are very similar to any other approved medicine but are much more cost-effective as compared to the originator drug. Surging demand for affordable healthcare around the world and high investments in the development of novel biosimilars are projected to drive market growth in the future. High incidence of cancer and diabetes along with other chronic diseases is also creating new business opportunities for biosimilars companies. Supportive government and regulatory initiatives to promote biosimilars development are also projected to bolster the demand for biosimilars in the long run. However, stringent regulatory mandates, legal issues with patent infringement, and high costs of development are slated to hamper the overall biosimilars market growth potential across the study period and beyond.
Market Snapshot - 2024-2031
Global Market Size
Largest Segment
Oncology
Fastest Growth
Oncology
Growth Rate
23.5% CAGR
Global Biosimilars Market ($ Bn)
Country Share for North America Region (%)
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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 monoclonal 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
High incidence of diabetes allows insulin to emerge as the dominant drug type in this market. Increasing emphasis on improving diabetes management and making it more cost-effective has led to the development of insulin biosimilars. Working like other insulin products, insulin biosimilars increase the accessibility of insulin to people with limited spending potential. Due to its low cost, the demand for insulin biosimilars is increasing rapidly worldwide.
Growing demand for low-cost therapeutic alternative for the treatment of multiple chronic diseases is projected to bolster the sales of monoclonal antibodies. Low toxicity and high specificity in treating chronic disorders is what make monoclonal antibodies highly popular. Low risk of side effects and better chances of survival for patients are also helping this segment hold a high market share.
Analysis by Indication
Surging cancer cases around the world have contributed to the high market share of oncology indication. Growing investments in oncology research and high demand for low-cost cancer therapeutics are contributing to the dominance of this segment. Highly affordable nature of biosimilar oncology drugs as compared to expensive immunotherapy is what helps this segment hold a prominent chunk of the global market share. Rising investments in research and development of new oncology biosimilars will also promote market growth going forward.
Rising incidence of autoimmune and inflammatory disorders around the world is also creating new opportunities for biosimilar companies. Most of these diseases require expensive biologic therapies to treat them thereby making treatment inaccessible to patients with limited spending potential. Use of biosimilars to treat autoimmune diseases costs relatively less and makes the treatment more accessible to all patients, which is why this segment is projected to pay off big time for biosimilar companies in the future.
Global Biosimilars Market By Indication
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Biosimilars Market Regional Insights
High incidence of chronic diseases and growing investments in the development of biosimilars are helping North America to dominate the global market. The United States is projected to spearhead biosimilars demand in this region owing to favorable regulatory environment and high investments in medical R&D. The presence of key pharmaceutical companies and rising prescription of biosimilars by healthcare professionals in this region will also boost market growth in the future.
Growing investments in healthcare infrastructure development and rising demand for affordable healthcare are creating new opportunities for biosimilars companies in the Asia Pacific region. China, Japan, and India are slated to be the key markets that help Asia Pacific region become the fastest growing market in the world. Rapidly increasing patient pool, growing awareness regarding benefits of biosimilars use, and increasing investments in medical R&D are slated to help this region boost market growth in the future.
Global Biosimilars Market By Region
- Largest
- Fastest
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Biosimilars Market Dynamics
Drivers
Patent Expiration of Biologic Drugs
- Major drugs that are used extensively for the treatment of various diseases are facing patent expiry in recent years and this is opening new opportunities for biosimilar adoption. Completion of the exclusivity period for different biologics is also expected to boost sales of biosimilars.
Low Costs of Biosimilars
- Healthcare expenditure has only been increasing in recent years and this is why healthcare accessibility has significantly reduced. Rising emphasis on improving healthcare accessibility and developing low-cost drugs and treatments is estimated to favor the demand for biosimilars in the long run.
Restraints
High Costs of Development
- Developing biosimilars is a time-consuming and expensive process as it involves multiple clinical trials to ensure regulatory compliance. This expensive development reduces the profit margin for biosimilars companies and thereby acts as a key restraint for market growth.
Regulatory and Legal Hurdles
- Biosimilars are subject to strict regulatory mandates and legal hurdles in the form of patent litigations. All of these factors make it difficult for biosimilars companies to bring their product to the market and also significantly increase the time-to-market and slow down biosimilars sales.
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Biosimilars Market Competitive Landscape
Investing in the research and development of advanced biosimilar products for the treatment of different indications will be a priority for all biosimilars companies. Launching new products will be crucial for biosimilars providers to stay competitive in this market. Collaborations will also help companies reduce their time-to-market and fast-track launches. Targeting the diabetes and oncology indications will pay off big time in the long run.
Top Player’s 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)
- 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)
- AMPHASTAR PHARMACEUTICALS, INC. (US)
Recent Developments
- In September 2023, Meitheal Pharmaceuticals, a leading pharmaceutical company based in the United States, announced that it had signed an exclusive agreement with Dongbao Pharmaceutical to develop 3 new insulin biosimilars for the United States market.
- In March 2024, Biocon Biologics reached a settlement to launch Yesafili biosimilar in the Canadian market. The company settled with Bayer and Regeneron Pharmaceuticals to resolve the patent infringement issues.
Biosimilars Key Market Trends
- Entering Emerging Markets: The demand for affordable healthcare is highest in developing and underdeveloped economies, which is why biosimilars companies should expand their business in these countries. Limited patient spending potential and rising awareness regarding benefits of biosimilars will contribute to increased sales in these new emerging markets going forward.
Biosimilars Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, rising prevalence of chronic diseases and high demand for affordable drugs are projected to boost sales of biosimilars over the coming years. However, high costs of development and stringent regulations are slated to impede biosimilars demand outlook in the future. The North American region is estimated to secure the top spot when it comes to biosimilars market share owing to presence of key pharmaceutical and biotechnology companies. Entering underdeveloped and developing countries will be a key strategy for biosimilars providers in the long run.
| 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.
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