Biosimilars: Global Markets

Report Scope

Biosimilar drugs have gained immense popularity because of their impact on the lives of many patients. These drugs belong to several drug classes including hormones, interferons, growth factors (colony stimulating factors, erythropoietin) and monoclonal antibodies, among others. The use of these drugs has aided in the affordable treatment of many life-threatening diseases ranging from cancer and diabetes to chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and others. The high cost of branded biologics has made biosimilars a lucrative alternative for affordable treatment. According to a BCC Research report on biosimilars (BIO090C), the global market for biosimilars is expected to reach close to $20.8 billion by 2022, growing at a CAGR of 30.5%. Other drivers for this market include rising aging populations, patent expirations of many blockbuster drugs, and better healthcare provisions.

This updated report for BCC Research provides in-depth analysis of the market for biosimilars in a global context, including market forecasts and sales through 2025. This study surveys the market for biosimilars in all the geographic regions including North America, Europe, the developed rest of the world (RoW), and emerging markets. The emerging markets include countries like India, China, Taiwan, Africa and Latin America.

The report provides an analysis of the market for biosimilars in various segments, for instance, by type, by region and by application/disease category. The report will include a detailed overview about the subject wherein the classification of biosimilar drugs along with their approval mechanisms, clinical trials and applications under review are elaborated upon.

The report also provides relevant patent analysis in both the U.S. and the European Union and comprehensive profiles of companies that lead the biosimilar drugs industry. The industry structure, focusing on the important biosimilar drug manufacturers/suppliers and their market shares and product offerings, is analyzed. This report also discusses the current market situation by elaborating upon the market drivers, restraints, challenges and opportunities. Separate chapters discuss the regulatory aspects and clinical trials. The latest news pieces including new products, new indications, mergers and acquisitions in the market are also dealt with in sufficient detail.

Excluded from this report are biobetters, generics of small molecule drugs and the biogenerics pertaining to vaccines and blood products. The different requirements for approval and bioequivalence between generics and biosimilars put them in an entirely different regime.

Report Includes

- 69 data tables and 73 additional tables

- An updated review and industry insights of the global biosimilars market

- Analyses of the global market trends, with data from 2018 to 2020, and projections of compound annual growth rates (CAGRs) through 2025

- Highlights of the emerging market regulations, clinical trials, and new products launches; and their impact on the stakeholders in this market

- Discussion of the biosimilars industry structure, opportunities and complexities, regulatory updates and penetration of biosimilar product classes in various regions worldwide

- Estimation of current market size and potential growth forecast for biosimilars market, and corresponding market share analysis by product type, application/disease category and geographic region

- A detailed review of patents issued for biosimilars by different assignee categories

- Impact analysis of COVID-19 pandemic on the growth of biosimilars market as compared to overall pharmaceuticals industry with respect to clinical trials/approvals

- Company profiles of the major market players, including Amgen Inc., Boehringer Ingelheim, Cipla Ltd., Dr Reddy's Laboratories Ltd., Lupin Ltd., Pfizer Inc. and Zydus Cadila

Summary

Biosimilars or follow-on biologics have attracted many biopharmaceutical companies and new entitiesto enter this market. The huge economic potential boosted by billions of dollars of market revenues of branded biologics has lured these developers. Further, the massive cost savings from the use of biosimilar drugs in the treatment of cancer and other chronic diseases have also motivated the healthcare systems, payers and regulatory agencies to approve and adopt these drugs.

In the last five years, the market for biosimilars has changed in many ways. Particularly, in the U.S., the first approval came only in 2015, and the market has since grown to include more than 30 biosimilar drugs. Inclusion of insulin and other drugs in the biological pathway has paved the way for new biosimilar entries in this market. A rise in competition due to multiple products has also worked in the industry's favor, allowing price reduction at launches (close to 57% for Amgen's Avsola, infliximab biosimilar), making the drugs available to much-needed populations. The developed markets have also seen increased adoption of biosimilars driven by growth in physician and payer education, inclusion of

biosimilars in preferred drug lists, and increases in coverage, in general. It was however noted that the adoption of biosimilar drugs has been variable with respect to different drug classes. Filgrastim biosimilars have witnessed extraordinary growth with a market share reaching almost REDACTED, compared to infliximab biosimilars that have captured only REDACTED market share in the U.S. until 2020. A number of factors are responsible for this disparity, including the type of diseases covered by the drug, branded drug manufacturer tactics, patent scenario and stakeholder awareness, among others.

As the market for biosimilar drugs matures, there is a shift in the drug pipelines of most of the biosimilar developers. While some biosimilar drugs from the second wave of biosimilars, such as adalimumab and etanercept, are awaiting approval in the U.S. due to patent litigations and settlements with the originator drug manufacturers, many new drugs considered as third-wave biosimilars (patent expirations on or after 2020) are now in Phase III clinical studies. Some popular drugs in this category are Prolia, Stelara, Eylea and Lucentis.

A continuing trend in the global biosimilars space has been collaborations and partnerships with local and multi-national companies. Leading developers have inked strategic commercialization and marketing arrangements with domestic companies to enable market approvals and commercialization in those territories. Technical capabilities, manufacturing expertise, regulatory knowledge and vast experience in generics markets are some of the drivers of these partnerships.