Report Highlights
The global market for biosimilars reached $1.7 billion in 2010 and $2.5 billion in 2011. The market is expected to reach $3.6 billion by 2016, a compound annual growth rate (CAGR) of 7.7%.
Report Scope
The market definition is important to consider in this report. There are several copies of biologic drugs sold for many years in semi- and unregulated markets before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes in these regions for the approval of these products are considerably less stringent compared to that of EMA. However, these companies are targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Hence, the approach taken for this report is to include all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development. The scope of this report includes the product segments such as somatropin, erythropoietin, Colony Stimulating Factors (CSFs), interferons, interleukins, insulin and insulin analogues, follicle stimulating hormones (FSHs), monoclonal antibodies (MAbs), and low molecular weight heparins (LMWH). It is often argued that LMWH is not essentially a biosimilar product since it is derived from dead tissues. However, considering the complexity of LMWH, EMA has developed specific guidelines for LMWH; hence, this is included as one of the product segment in this report. The global market size estimation includes the above mentioned product segments.
Both EMA and World Health Organization (WHO) exclude vaccines from consideration as biosimilars. The EMA guideline says: “Due to complexity and the likelihood that they cannot be thoroughly characterized at the molecular level, vaccines must be considered on a case-by-case basis.” Besides vaccines, plasma-derived products and their recombinant analogues are also excluded from biosimilar guidelines by EMA due to their complex and variable physicochemical, biological and functional characteristics. Therefore, vaccines and blood products are not included as product segments in this report. Other biologic drug segments excluded in the market estimation of this report include streptokinase, hyaluronidase, etc., since biosimilar guidelines neither exist at present nor under development by EMA.
This report contains:
- An overview of biosimilar product classes in various regions worldwide.
- Biosimilar products approved by EMA.
- A look at the biosimilar pipeline worldwide.
- Detailed analysis of the emerging regulatory framework in regulated markets.
- Comparison of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.
- Detailed analysis of the market and key players in Europe and country-by-country analysis of key markets in Europe and the market forecasts for the region for various product classes
- Detailed analysis of U.S. market regulation, key players and emerging trends.
- Detailed analysis of the APAC market with analysis of key national markets (including Australia, Singapore, Korea, India, China and Japan), local players, investment trends and regulatory developments.
- Detailed analysis of the rest of world (ROW) market size, trends, country analysis of promising markets (including Brazil, Russia, and Canada), regional players, and emerging regulatory and market trends.
- Technology trends and patent analysis.
- Profiles of over 70 key players.
- Global and regional sales projections through 2016 for various product classes and regions.
Analyst Credentials
Syamala Ariyanchira is actively involved in technology assessment, strategic planning, competitor analysis, due diligence, and market analysis. She combines her technical background with current business sector issues with ease. Her clients include investment firms, government agencies, and chemical and pharmaceutical companies. She holds a Ph.D. from Indian Institute of Science, Bangalore, India, and has over sixteen years of experience in the industry.
Related Reports
Antibody Drugs: Technologies and Global Markets
The global market for therapeutic monoclonal antibodies (mAbs) was estimated at $44.6 billion in 2011. With the rollout of at least eight new therapeutic mAb products and expanded indications for existing products expected during the forecast period, the global mAb market is expected to rise at a compound annual growth rate (CAGR) of 5.3% to nearly $58 billion in 2016.
2011 Biotechnology Research Review
Highlights from various reports on biotechnology markets published by BCC Research in 2011.
Therapeutics for Immune System Disorders
In 2010, the global market for drugs for the treatment of immune disease was estimated to be approximately $72.2 billion. The market size is forecast to grow at a compound annual growth rate (CAGR) of 2.6% to reach $82.2 billion by 2015.
Biologic Therapeutic Drugs: Technologies and Global Markets
The global biologics market is valued at an estimated $149 billion in 2010 and is expected to reach $239 billion by 2015, a compound annual growth rate (CAGR) of 9.9% from 2010-2015. Driving this growth is the need for a more extensive drug pipeline, attractive targets against challenging diseases, a push to pursue biosimilars, and enabling manufacturing technologies that reduce the cost to produce profitable products.
Track the Latest Global Tariff Developments
In today's fast-paced global economy, tariffs are no longer static—they are dynamic levers shaped by geopolitical realignments, supply chain vulnerabilities, inflationary pressures, and sustainability-driven trade reforms. As governments worldwide recalibrate their trade strategies, businesses are left to navigate a maze of shifting rules, rising costs, and regulatory uncertainty.
Our analysis empowers you with real-time updates and in-depth expert analysis on all facets of global tariff activity. From new trade agreements and sanctions to abrupt tariff hikes and retaliatory duties, we monitor developments across borders, sectors, and industries—so you don't have to.
Whether it's the ongoing U.S.–China trade dynamics, the evolving EU Carbon Border Adjustment Mechanism (CBAM), or the emerging policies in India, ASEAN, and Latin America, we provide full-spectrum coverage. We also track multilateral trade negotiations, World Trade Organization (WTO) rulings, and sector-specific duty structures—ensuring you are always ahead of global trade shifts.
With our analysis, you can stay informed, identify risks, and confidently respond to tariff changes—no matter where you operate.
Ready to see what tariff means for your business?
Consult with our experts or request your custom Tariff Impact Brife today
Stay Informed, Stay Competitive
In today's interconnected and unpredictable global economy, staying ahead of tariff shifts is not just important—it's essential. BCC Research provides decision-makers with trusted, research-driven insights that turn uncertainty into opportunity.
Our in-depth market analysis and trade intelligence help you decode how tariff changes impact your specific sector—manufacturing, healthcare, technology, agriculture, or energy. We break down complex data into actionable knowledge through comprehensive reports, expert commentaries, and sector-focused forecasts.
Our analysis includes:
- Thorough breakdowns of current and proposed tariff policies and how they affect regional and global trade flows.
- Sector-specific implications, helping you understand the strategic impact on sourcing, pricing, and competitiveness.
- Forward-looking insights to support risk management, planning, and response strategies for evolving trade conditions.
With BCC Research, you gain more than just information—you gain clarity and confidence to make well-informed decisions in a volatile trade environment.
Don't let tariffs catch you off guard—let our insights guide your strategy.
Recent Reports
Global Irritable Bowel Syndrome and Inflammatory Bowel Disease Therapeutics Market
The global market for irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) therapeutics is expected to grow from $33.3 billion in 2025 and is projected to reach $52.6 billion by the end of 2030, at a compound annual growth rate (CAGR) of 9.6% during the forecast period of 2025 to 2030.
Global DNA Forensics Market
The global market for DNA forensics is projected to grow from an estimated $3.3 billion in 2025 to $4.7 billion by the end of 2030, at a compound annual growth rate (CAGR) of 7.7% from 2025 to 2030.
Global Blood Platelet Market
The global market for blood platelets is expected to grow from $3.2 billion in 2025 and is projected to reach $4 billion by the end of 2030, at a compound annual growth rate (CAGR) of 4.6% during the forecast period of 2025 to 2030.
Digital Biomarkers: Global Markets
The global market for digital biomarkers is estimated to grow from $5 billion in 2025 to $18.8 billion by the end of 2030, at a compound annual growth rate (CAGR) of 30.4% from 2025 through 2030.
Whole Genome Sequencing: Global Markets
The global market for whole genome sequencing is expected to grow from $3 billion in 2025 and forecast to reach $6.1 billion by the end of 2030, at a compound annual growth rate (CAGR) of 15.1% from 2025 to 2030.
Top Trending Reports
Sensors: Technologies and Global Markets
The global market for sensors was valued at $195.1 billion in 2024 and is estimated to increase from $212.5 billion in 2025 to reach $323.3 billion by 2030, at a compound annual growth rate (CAGR) of 8.7% from 2025 through 2030.
Global Cell Line and Membrane Market
The global market for cell lines and membranes was valued at $5.7 billion in 2024 and is estimated to increase from $6.3 billion in 2025 to reach $11.4 billion by 2030, at a compound annual growth rate (CAGR) of 12.5% from 2025 through 2030.
Water and Wastewater Treatment Technologies: Global Markets
The global market for water and wastewater treatment technologies is expected to grow from $350.7 billion in 2025 and is projected to reach $591.2 billion by the end of 2030, at a compound annual growth rate (CAGR) of 11.0% during the forecast period of 2025 to 2030.
Global Edge AI Market
The global market for edge AI was valued at $8.7 billion in 2024 and is estimated to increase from $11.8 billion in 2025 to reach $56.8 billion by 2030, at a compound annual growth rate (CAGR) of 36.9% from 2025 through 2030.
2024 Medical Devices Research Review
The medical device industry is a multi-billion-dollar industry whose outlook is supposed to rise in the coming years These devices treat and diagnose a multitude of patient conditions and work much better than drugs.
Become A Member
BCC Research offers a comprehensive library of reports, granting members unlimited access to data, insights, and market intelligence for informed business decisions, while actively supporting members in their evolving journeys and prioritizing high-quality, relevant topics based on continuous engagement with the research community.
Find Out MoreCustom Consulting
BCC Research emphasizes the importance of organizations leveraging highly customized market insights aligned with specific strategic business objectives through direct engagement with primary sources and proprietary forecasting models for profitable decision-making in maximizing growth opportunities and minimizing risks.
Customize NowScorecard
The Venture Scorecard provides commercialization offices and decision makers with expert analysis, offering strategic insights crucial for aligning objectives with market realities at various stages of commercializing new products or evaluating investment opportunities, from opportunity assessment to growth planning.
Find Out MoreInnovation Spotlight
Our industry experts offer strategic guidance to maximize the market potential of commercialized products, patents, and IP by providing insights into market trends, competitive dynamics, and effective positioning, using the Innovation Spotlight service for enhanced exposure to thought leaders and the wider community.
Find Out More