Focus on Sustainable Cost Reduction, High Cost of Branded Biologics & Impending Patent Expiries of Major Biologics Drive the Global Biosimilars Market

Growing focus of governments worldwide to build a sustainable healthcare system that promises affordable access to quality care; high cost of branded biologics; impending patent expiries of several blockbuster branded biologics, and the resulting opening up of opportunities for biosimilars are poised to drive the global market for Biosimilars to reach US$23.3 billion by 2022.

Biopharmaceuticals or biologics gained popularity owing to their better efficacy over difficult diseases such as cancer and autoimmune disorders. But given their high prices and focus of global governments on reducing healthcare expenditure, aggressive efforts laid the groundwork for biosimilars. Several blockbuster biopharmaceuticals, including Roche’s Avastin, face patent expiry in the next few years. Though it signals loss of revenues for pharmaceutical giants, patent expiry provides a huge opportunity for companies engaged in developing biosimilars and generic medicines. Biosimilars, the copy products of branded biopharmaceuticals that have gone off patent akin to generic for a chemical drug, have already caught the attention of pharma companies, worldwide.

With the biosimilar sector promising significant cost savings to the healthcare industry, several major markets are welcoming biosimilar legislations. While the EU and Japan pioneered the launch of biosimilars, the regulatory pathway associated with biosimilars was delayed in the U.S. The U.S. biosimilar market scenario, however, took off recently with the approval of Zarxio and Inflectra in 2015 and 2016, respectively. The Asia-Pacific region is expected to witness strong growth, followed by various emerging Latin American countries. A simpler approval process encourages several biosimilar developers to target Asia and other emerging regions. Various manufacturers of biosimilars have already registered their products in India, China, Australia, and South Korea.

The biosimilars market is witnessing an increasing focus on monoclonal antibodies (mAbs), the class that includes some blockbuster biopharmaceuticals that are slated to lose patent protection in the near future. An increasing percentage of biosimilars in current R&D pipelines of companies are mAbs. Several manufacturers are in the race to develop mAb biosimilars for the same biologic, thereby increasing competition in this space. Because all of them cannot achieve blockbuster status, the speed-to-market is of high importance. Monoclonal antibody biosimilars are mainly being developed to tackle the various emerging types of cancer.

As stated by the new market research report on Biosimilars, Europe represents the largest market worldwide. The US represents the fastest growing market, trailing at a CAGR of 76.5% over the review period. Growing number of marketing approvals and wider uptake in care systems and patient circles are creating conducive environment for massive growth of biosimilars in the US.

Major players in the market include Allergan Plc, Amgen Inc., Biocon Ltd., Biopartners GmbH, Boehringer Ingelheim International GmbH, Celltrion Inc., Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, Fresenius Kabi, Intas Pharmaceuticals Ltd., Mylan N.V., Pfizer Inc., Samsung Bioepis Co. Ltd., Sandoz International GmbH, STADA Arzneimittel AG, and Teva Pharmaceutical Industries Ltd., among others.

The research report titled "Biosimilars: A Global Strategic Business Report" announced by Global Industry Analysts Inc., provides a comprehensive review of market trends, issues, drivers, mergers, acquisitions and other strategic industry activities of major market participants. The report provides market estimates and projections for geographic markets, such as the US, Japan, Europe (France, Germany, Italy, UK, Spain, and Rest of Europe), and Rest of World.  

For enquiries e-mail us at rsd@strategyr.com or info411@strategyr.com.

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