Global Biosimilars Market by Application (Growth Hormone, Oncology, Blood Disorders, Chronic & Autoimmune Disorders) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

In 2016, the global biosimilars market was worth USD 4.36 billion. The market is expected to grow at a 34.2% CAGR over the forecast period. Market growth is influenced by the cost-effectiveness and high prevalence of chronic diseases worldwide.

The biosimilar drugs are identical to the approved biologic drugs. They have similar medical properties to original biologic drugs in terms of safety, potency, and efficacy. Market expansion is likely to be fueled by a high prevalence of chronic diseases like diabetes, cancer, and growth hormone deficiency.

According to the National Cancer Institute (NCI), there are expected to be 1,735,350 new cases and 609,640 deaths from cancer in the United States in 2018. There were approximately 14 million cases of cancer and 8.2 million deaths from cancer in 2012. This is why there is such a demand for biosimilars that are cost-effective for treating chronic diseases like cancer. It is expected to increase market growth.

Due to the high-priced patent pharmaceutical drugs, particularly biologics, total healthcare costs have risen. Many countries have put emphasis on drug synthesis that is cost-effective. The United States is the country with the highest healthcare expenditures. Recent efforts have been made to reduce healthcare spending. Price regulation in Japan and a reduced Indian health budget have also increased cost containment requirements. This highlights the need to develop new, better, more efficient, affordable therapies. Hence, biosimilars will be more popular if healthcare costs are reduced.

Biosimilars market growth could be hindered by stringent government regulations regarding the production and development of biosimilars. Different regulatory bodies provide specific guidelines to ensure the safety and effectiveness of any proposed drug. Diverse regulations are available for drug approvals from different regulatory bodies, including the European Medicines Agency (EMA), U.S. Food and Drug Administrations (FDA), and China Food and Drug Administration. Biosimilar drug approval can be complicated and time-consuming due to the existence of many regulations.

Product Insights

Human growth hormone, granulocyte-coloy-stimulating factors, interferons and insulin are all examples of recombinant nonglycosylated protein. Recombinant nonglycosylated protein was the most lucrative segment in 2016 due to its increased regulatory approvals. In November 2016, for example, the European Medicines Agency approved three drugs: Lusduna ("insulin glargine Biosimilar"), Movymia ("teriparatidebiosimilar") and Lusduna ("insulin glargine Biosimilar").

Market growth will also be boosted by the increasing prevalence of chronic diseases like diabetes, cancer, arthritis and Alzheimer's disease. The Centers for Disease Control and Prevention reported that in 2016, nearly 29.0 million Americans were living with diabetes. According to the Canadian Diabetes Association (CADA), diabetes prevalence is increasing in Canada. It is expected that it will reach 5.0 million people by 2025.

The lucrative CAGR for the recombinant glycosylated protein segment is expected to be high during the study period. This growth is expected to be fueled by the patent cliff for biologics products, including monoclonal antibodies and erythropoietin. Roche's Actemra/RoActemra (tocilizumab), was approved in January 2009 by the European Medicines Agency and January 2010 by the U.S. FDA. These drugs were granted patents in the U.S.A in December 2015. They will be withdrawn in Europe in April 2017.

The most favorable market conditions are found in Europe, including France, the U.K. and Germany. Because of the well-developed regulatory framework and the large number of biopharmaceutical businesses, demand for biosimilars in Europe is higher than elsewhere. To be market leaders, these companies are focused on price competition and the development of innovative products.

Application Insights

In 2016, the market for biosimilars was dominated by the oncology sector in terms of revenues. The high incidence of cancer, including stomach, lung, stomach, coloretal, stomach and blood, is why the oncology segment dominated the global market for biosimilars in 2016. According to the World Health Organization, cancer is the second leading cause for death in the world. In 2015, it was responsible for 8.8 million deaths.

Low- and middle-income countries have a high death rate from cancer, with around 70% of all deaths due to the disease. High mortality rates are due to high costs of treatment and drugs for cancer, as well as the inaccessibility of modern healthcare facilities. There is a growing demand for affordable, high-quality and cost-effective therapeutic drugs.

The segment of blood disorders is expected to grow at a profitable rate over the forecast period. Growth is expected to be driven by factors such as the positive outcomes of ongoing biosimilars clinical trials, the prevalence of anemia and hemophilia among other blood disorders, and the availability of blood clots. There is a growing demand for low-cost innovative therapeutic products, which will drive growth.

The largest market share for biosimilars is expected to be held by India, the U.K. and China. These countries have high product adoption due to their favorable regulatory environment, government support and rising prominence to reduce healthcare spending. Biopharmaceutical companies are also focusing on product development and launch in order to meet the unmet medical needs of patients. This will positively impact market growth.

Regional Insights

Europe holds the largest market share in terms revenue. This is due to the existence of a clear regulatory framework for biosimilars, major biopharmaceutical firms such as Johnson & Johnson and Novartis. The region's market growth has been fueled by a well-developed healthcare infrastructure as well as a growing number product launches.

Asia Pacific accounted for the largest market share in 2016, followed by Europe. The region's market growth is due to a growing demand for cheaper therapeutic products and the high prevalence of chronic illnesses in Asia Pacific. Another important factor driving the market is the increased focus on product development in countries like China, India, South Korea.

North America will experience a high CAGR over the forecast period due to increased efforts by manufacturers to capitalize on growth opportunities in Canada and the U.S. In March 2009, the U.S. established a biosimilar regulatory pathway. Since then, the region has seen significant growth, which presents new challenges and opportunities. In March 2015, Zarxio (filgrastim sndz) was approved by the U.S. FDA.

Market Share Insights & Key Companies

There are many large and small-scale producers in the market. 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. are some of the major players in this sector.

Collaborations, new drug development, mergers and acquisitions, as well as regional expansions are all part of the top players' plans to improve their market position. Collaborations and new drug launches help companies increase their revenue share, expand their product portfolio and regional presence. Teva Pharmaceutical Industries Ltd. entered into a strategic partnership with Celltrion Healthcare in October 2016 to market CT-P10 (Celltrion’s monoclonal antibodies biosimilar candidate candidates) in the U.S. and Canada.

Biosimilars Market Report Scope

The Report Covers Certain Segments

This report predicts revenue growth at the global, regional and country level and offers an analysis of industry trends in each sub-segment from 2014 to 2025. Grand View Research has divided the global market report on biosimilars on the basis product, region, and application.

• Product Outlook (Revenue USD Million, 2014-2025)

  • Recombinant non-glycosylated proteins

    • Human Growth Hormones

    • Granulocyte Colony Stimulating Factor (G–CSF)

    • Interferons

    • Insulin

  • Recombinant Glycosylated Proteins

    • Erythropoietin

    • Monoclonal Antibodies

    • Follitropin

• App Outlook (Revenue USD Million, 2014-2025)

  • Oncology

  • Blood Disorders

  • Growth Hormonal Deficiency

  • Chronic and autoimmune disorders

  • Other

• Regional Outlook (Revenue USD Million, 2014-2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • China

    • India

  • RoW

These are the most frequently asked questions about this report

b. Global biosimilars market was valued at USD 10.02 Billion in 2019, and is projected to grow to USD 13.2 Billion by 2020.

b. Global biosimilars sales are expected to increase at a compound annual rate of 19.6% between 2019 and 2027, reaching USD 46.25 Billion by 2027.

b. Recombinant nonglycosylated protein had the highest revenue share at 55.18%, due to greater regulatory approvals and an increase in chronic diseases like diabetes, cancer, arthritis and Alzheimer's disease.

b. Amgen Inc., F. Hoffmann-La Roche Ltd., Sandoz International GmbH, Dr. Reddy's Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Pfizer Inc.; Samsung Bioepis and Biocon; and Mylan N.V. are the major market players in biosimilars market.

b. Biosimilars market growth is largely due to the cost-effectiveness and high prevalence of chronic diseases worldwide.

Up Market Research published a new report titled “Biosimilars Market research report which is segmented by Application (Growth Hormone, Oncology, Blood Disorders, Chronic & Autoimmune Disorders), By Players/Companies Amgen Inc; F Hoffmann-La Roche Ltd; Sandoz International GmbH; Dr Reddy’s Laboratories Ltd; Teva Pharmaceutical Industries Ltd; Pfizer Inc; Samsung Bioepis; Biocon; and Mylan NV”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global Biosimilars Market Report Segments:

The market is segmented by Application (Growth Hormone, Oncology, Blood Disorders, Chronic & Autoimmune Disorders).

Biosimilars Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the Biosimilars Market

Overview of the regional outlook of the Biosimilars Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The Biosimilars Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of Biosimilars Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Growth Hormone

                2. Oncology

                3. Blood Disorders

                4. Chronic & Autoimmune Disorders

7. Market scenario by region, sub-region, and country.
8. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
9. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
10. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the Biosimilars Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the Biosimilars Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.