Biosimilars Market Size, Share, Growth, Trends, Consumption, Revenue, Company Analysis, Regional Insights and Forecast 2021-2028

Published Date : Nov 2020 | No. of Pages : 200 Pages | Category : Healthcare

Global Biosimilars market size surpassed at US$ 20 bn in 2019 and to reach valuation of around US$ 61.5 billion by 2028 with a CAGR of 23.5% from 2021 to 2028.

The growth of the market can be attributed to various factors, including significant product pipeline, focus of market players on expanding their presence in emerging markets, rise in prevalence of non-communicable diseases, cost savings offered by biosimilars, patent expiries of major biologics, and increase in adoption rate of biosimilars.

Biosimilars can be defined as a biologic medical product, which is considered to be similar to already approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the same standards of pharmaceutical quality that apply to all biologic medicines.

Biosimilars are the copy versions of biologics, which have reached the end of patent protection. The patent expiries of major biologics are expected to contribute to the growth of the biosimilars market. As a result of increasing approvals and sales of biosimilars, biologics, which had a steady or growing demand, witnessed a strong decline in their sales.

The global burden of chronic diseases has been increasing globally. Aging population and changing societal behavior are the key factors contributing to the increase in prevalence of chronic diseases. Major chronic diseases include diabetes, hypertension, stroke, respiratory diseases, oral diseases, obesity, arthritis, and cancer.

The approvals of biosimilars have been increasing globally, owing to changing regulations and increasing pressure on the healthcare system to facilitate treatment to all patients. Biosimilars or copy biologics are being increasingly adopted by physicians, authorities, and patients, owing to much-needed improvements to access therapeutically-viable treatments for various diseases.

Increase in Approvals of Biosimilars to Drive Global Market

The U.S. has witnessed a wave of biosimilar approvals in 2019. According to the Antibody Society in the U.S., over 16 antibody biosimilar therapeutics were approved  from 2015 to 2019. Drugs approved in 2019 include Trazimera, Kanjinti, and Ruxience.

As per the FDA’s Biosimilars Action Plan, new policies are being made to make the development of biosimilars more efficient and provide significant opportunities to biosimilar manufacturers. This is anticipated to propel the rate of biosimilar approvals in the U.S., contributing to the growth of the biosimilars market. 

High Demand for Recombinant Non-glycosylated Protein Biosimilars

In terms of product, the recombinant non-glycosylated proteins segment is likely to account for a major share of the global biosimilars market. Moreover, the insulin sub-segment of the recombinant non-glycosylated proteins segment dominated the market in 2020. It is likely to grow at a high CAGR during the forecast period, due to increase in prevalence of diabetes globally. According to the International Diabetes Federation, over 463 million adults aged between 20 years and 79 years lived with diabetes in 2019.

Biosimilars for Oncology Indication to Dominate Global Market

In terms of indication, the global biosimilars market has been divided into chronic diseases, oncology, autoimmune diseases, infectious diseases, blood disorders, growth hormone deficiency, and others. The oncology segment held the largest market share in 2020 and the trend is anticipated to continue during the forecast period. The robust growth of the segment can be attributed to rise in prevalence of cancer cases globally. According to the World Cancer Research fund, over 18 million cancer cases were reported in 2020. In addition, the patent expiration of a range of cancer biologic drugs, leading to the growing usage of biosimilars, owing to their lower costs contributes to the growth of the segment in the forecast period.

Innovations in mAbs Increase Cancer Treatment Options

Innovations in monoclonal antibodies (mAbs) are expected in the biosimilars market landscape in the near future. Healthcare companies are increasing their efficacy in hybridoma-based technology to develop improved mAbs with the help of genetic engineering. Monoclonal antibodies are a key source of revenue in the recombinant glycosylated proteins segment. As such, among product types, the recombinant glycosylated proteins segment of the biosimilars market is estimated to reach a value of US$ 23.6 Bn by 2028. Hence, manufacturers are aiming at the integration of humanized mAbs based on grafting the murine complementary regions into the human immune globulin backdone.

Monoclonal antibodies are being pervasively used for the treatment of cancer, diabetes, and autoimmune diseases. Manufacturers in China are facing fierce competition to gain approvals for biosimilar mAbs. For instance, in December 2019, Shanghai Henlius Biotech - a producer of advanced mAb products, announced the approval of China’s first-of-its-kind Rituximab biosimilar HLX01 for the treatment of non-Hodgkin’s lymphoma.

Low-cost Biosimilar Insulin in Offing

The global biosimilars market is largely consolidated with five major players accounting to more than ~50% of the market share. This poses as a challenge for emerging players to gain prominence in the biosimilars market. Moreover, unfavorable regulatory landscape as suggested by the FDA in the U.S. poses as a challenge for drug manufacturers.

Currently, the biosimilars market in North America is projected for exponential growth during the forecast period. The U.S. being one the most developed economies in North America is faced with several restraints in the current developmental programs for protein products, including insulin, due to stringent and time-constrained regulatory norms imposed by the FDA. Hence, manufacturers in the biosimilars market are increasing R&D activities to produce affordable biological products before the 2020 deadline issued by the FDA.

Insulin is an important recombinant non-glycosylated protein that is creating incremental opportunities for companies in biosimilars market, due to high prevalence of diabetic patients.

Companies Seek Approval for Orphan Biosimilars

Companies in the biosimilars market are tapping into opportunities in orphan biosimilars. Biosimilars are gaining popularity as affordable treatment options for patients in need of biologics. Due to the high prevalence of rare diseases, companies have a renewed purpose to steer innovation in biosimilars. Thus, manufacturers are increasing efforts to fulfill unmet needs of patients with rare diseases by increasing the availability of low-cost biosimilars.

Development of new orphan biosimilars is in the pipeline for most healthcare companies. They are increasing efforts to gain approvals on new biologic products. For instance, Amgen - a U.S. multinational biopharmaceutical company, revealed that the company has gained approval for its biosimilar medicine, which is a version of Johnson and Johnson/MRK’s Remicade (infliximab).

Manufacturers in the biosimilars market are commercializing orphan biosimilars for the treatment of rare blood diseases involving blood clotting and impaired bone marrow function. Hence, companies are increasingly focusing on the development of biosimilars for blood disorders, since the segment is anticipated for exponential growth during the forecast period.

Prominent Regions

In terms of region, the global biosimilars market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Europe dominated the global biosimilars market in 2020. This can be attributed to the significant price reduction in biosimilars as compared to biologics, and country policies in Europe enabling the penetration of biosimilars to enhance patient access to affordable treatment, contributes to the growth of the market in Europe.  

The biosimilars market in Asia Pacific is likely to expand at a rapid CAGR from 2021 to 2028. Increase in population of Asian countries, rise in urbanization, surge in aging population, lifestyle changes, and growing incidence of non-communicable diseases such as diabetes, cancer, and autoimmune diseases are driving the biosimilars market in Asia Pacific. Furthermore, various countries in South Asia have been assigning a major portion of their medical research budget for the development of biosimilars.  

Key Strategies

  • The global biosimilars market is consolidated in terms of number of players. Key players operating in the global biosimilars market include Pfizer, Inc., Intas Pharmaceuticals Ltd., Biocon, Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Sandoz International GmbH (A Novartis Division), Celltrion Inc., Amgen, Inc., STADA Arzneimittel AG, and Apotex Inc. (Apobiologix).
  • These players have adopted various strategies such as product portfolio expansion, investment in research & development, collaborations, and product launches to establish a strong geographic presence. For instance, in November 2019, Pfizer received the U.S. FDA approval for its ABRILADA, a biosimilar to Humira, for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

Market Segmentation

 Biosimilars Market, by Product

  • Recombinant Glycosylated Proteins
    • Monoclonal Antibodies
    • Erythropoietin
    • Others
  • Recombinant Non-glycosylated Proteins
    • Insulin
    • Granulocyte Colony Stimulating Factor
    • Recombinant Human Growth Factor
    • Interferons 
  • Recombinant Peptides

Biosimilars Market, by Indication

  • Chronic Diseases
  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Blood Disorders
  • Growth Hormone Deficiency
  • Others

Biosimilars Market, by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • Israel
    • South Africa
    • Rest of Middle East & Africa

Report Scope

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 2028. 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 2028. 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.

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:

  • History Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

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 (2021-2028);
  • 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.

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