Biosimilars Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

The global Biosimilars market size is expected to be worth around US$ 66.47 billion by 2030, according to a new report by Vision Research Reports.

The global Biosimilars market size was valued at US$ 6.36 billion in 2020 and is anticipated to grow at a CAGR of 36.2% during forecast period 2021 to 2030.

Growth Factors

Major biological drugs are approaching the patent cliff. This is the most significant driving factor for the market. For instance, Roche’s MabThera/Rituxan (rituximab), a monoclonal antibody biologics was approved by the U.S. Food and Drug Administration (FDA) in November 1997 and its U.S. patent expired in September 2016. Several companies such as Amgen, Boehringer Ingelheim, and Pfizer are focusing on the development of biosimilar drugs of rituximab.

Furthermore, the lower cost of biosimilars compared to patented biologics and positive outcomes in clinical trials are expected to boost market growth. For instance, in July 2016; Allergan plc and Amgen stated results from a Phase 3 clinical study of ABP 980 compared with trastuzumab, a recombinant DNA-derived humanized monoclonal antibody. This drug was approved for early and metastatic breast cancer and metastatic gastric cancer in many regions. Currently, there is a boom in the pharmaceutical industry for the development of biosimilar drugs, which is a cost-saving alternative to biologic drugs. Amgen Inc.; Sandoz International GmbH; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Biocon; Samsung Bioepis; and Mylan N.V are some of the companies focusing on the development and production of biosimilars.

Total healthcare costs have increased due to high-prices patented pharmaceutical drugs, especially biologics. Governments of several countries are emphasizing on cost-effective drug synthesis. The U.S. is known as the country with the highest health expenditure. It has recently put emphasis on cutting healthcare expenditures. Similarly, price regulation in Japan and reduced health budget in India, have raised cost containment demands. This brings into the light the need for developing new, improved, efficient, and affordable therapeutics. Thus, efforts to bring down healthcare expenditures are projected to boost the market for biosimilars.

Stringent government regulations for the development and production of biosimilars could hinder biosimilars market growth. Specific guidelines are provided by various regulatory authorities to maintain the safety profile and effectiveness of proposed drugs. Different regulatory bodies including European Medicines Agency, U.S. Food and Drug Administration (FDA), and China Food and Drug Administration have diverse regulations for drug approvals. The presence of different regulations make biosimilar drug approval process highly tedious and time-consuming.

Report Highlights

Recombinant non-glycosylated proteins include human growth hormone, granulocyte colony-stimulating factor, interferons, and insulin. recombinant non-glycosylated proteins was the largest revenue-generating segment due to increased regulatory approvals. For instance, in November 2016, the European Medicines Agency approved three drugs: Lusduna (insulin glargine biosimilar) and Movymia and Terrosa (teriparatide biosimilar).

In addition, increasing incidence of chronic diseases such as diabetes, cancer, arthritis, Alzheimer’s disease, chronic kidney disease, and chronic pain is expected to boost the market growth. According to the Centers for Disease Control and Prevention (CDC), in 2016, around 29.0 million individuals in the U.S. were suffering from diabetes. As stated by the Canadian Diabetes Association, the prevalence of diabetes is growing in Canada and it is projected to reach around 5.0 million by 2025.

The recombinant glycosylated proteins segment is expected to witness lucrative CAGR during the study period. Patent cliff of biologics products including erythropoietin and monoclonal antibodies is anticipated to propel this growth. For instance, Roche’s Actemra/RoActemra (tocilizumab) was approved by the European Medicines Agency in January 2009 and by the U.S. FDA in January 2010. Patents of these drugs expired in the U.S. in December 2015 and it will expire in Europe in April 2017.

European countries including Germany, U.K., and France have the most favorable market conditions for biosimilars. Demand for biosimilars is high in European countries as compared to other regions owing to the availability of a well-developed regulatory framework coupled with the presence of a large number of biopharmaceutical companies. These companies focus on price competition and innovative product development to command market dominance.

The oncology segment dominated the global market for biosimilars in terms of revenue in 2020. This is due to the high prevalence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer. According to the World Health Organization (WHO), cancer is the second leading cause of deaths around the world. It was accountable for around 8.8 million deaths in 2015.

The death rate due to cancer is high in low- and middle-income countries with about 70% deaths caused by cancer. The high cost of cancer drugs and treatment and the unavailability of advanced healthcare facilities are some of the major factors responsible for the high mortality rate. Therefore, there is an increasing demand for low-cost therapeutic drugs that are highly effective and less expensive.

The blood disorders segment is projected to grow at a lucrative rate during the forecast period. Factors such as the positive outcome of the ongoing biosimilars clinical trials and prevalence of anemia, hemophilia, and blood clots among other blood disorders are expected to propel growth in the near future. Thus, there is a rising demand for innovative therapeutic products at low cost which is expected to drive growth.

Germany, U.K., China, and India are projected to account for the largest share in the market for biosimilars. The favorable regulatory environment, government support, and increasing prominence to cut down healthcare expenditures in these countries are some of the key reasons for high product adoption in these regions. In addition, biopharmaceutical companies are focusing on new product development and its launch to cater to the unmet needs of patients, which is expected to positively impact market growth.

Europe has held the largest market share in terms of revenue due to the presence of a well-defined regulatory framework for biosimilars and major biopharmaceutical companies such as Johnson & Johnson, Novartis, AstraZeneca, Pfizer, Merck, Sanofi, and GlaxoSmithKline. Furthermore, well-developed healthcare infrastructure and a growing number of product launches have fueled the regional market growth.

Europe was followed by Asia Pacific, which accounted for a major market share in 2020. Growing demand for less expensive therapeutic products and a high prevalence of chronic diseases in Asia Pacific are contributing to the regional market growth. Increasing focus on product developments in countries including China, India, and South Korea is another major factor market drivers.

Key Players

Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; Mylan N.V.

Market Segmentation

• Product Outlook 

  • Recombinant Non-Glycosylated Proteins

    • Human Growth Hormones

    • Granulocyte Colony-Stimulating Factor (G-CSF)

    • Interferons

    • Insulin

  • Recombinant Glycosylated Proteins

    • Erythropoietin

    • Monoclonal Antibodies

    • Follitropin

• Application Outlook

  • Oncology

  • Blood Disorders

  • Growth Hormonal Deficiency

  • Chronic and Autoimmune Disorders

  • Others

• Regional Outlook

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • China

    • India

  • RoW

The Biosimilars market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Biosimilars market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Biosimilars market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Biosimilars market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Biosimilars market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Biosimilars capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Biosimilars by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Biosimilars market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Biosimilars market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Biosimilars market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Biosimilars industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Biosimilars market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Biosimilars market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Biosimilars market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Biosimilars market. These factors have benefited the growth of the global market for Biosimilars. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Biosimilars. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Biosimilars are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

• To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
• Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
• Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
• To define, describe and forecast the market by type, application and region.
• To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
• To identify significant trends and factors driving or inhibiting the market growth.
• To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
• To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
• To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
• To strategically profile the key players and comprehensively analyze their growth strategies.