Global biosimilars market – a myriad of promises

Shushmul Maheshwari


Biosimilars, also known as ‘biogenerics’ or ‘follow-on biologics’, have become the talk of the industry in recent years, following the patent expiry of numerous innovative products. Factors, such as rising healthcare costs, high pharmaceutical expenditure, more expensive drugs, and the rapidly increasing elderly population have been driving the incessant growth of the industry. In fact, over the years, the biosimilars market have gained a rapid impetus and escalated user acceptance globally.

Western countries including the US and Canada hold a great potential for the growth of biosimilar industry in the coming years. The industry largely counts on the US market, which is on the verge of patent expiration of many popular biologics during 2012-2019. Aligned with the US, Canada also has an increased aging population, thus urging the increased requirement for biotech drugs for the treatment of medical conditions whose incidence increases with age. Hence, the need to allow cheaper biosimilars in the market has been more intense in Canada. As far as Mexico is concerned, factors, such as growth in hospital drug expenditure, a rise in drug consumption, increased spending power with aging population, and increasing prescription drug price are expected to be responsible for the budding biosimilars market.

“…the need to allow cheaper biosimilars in the market has been more intense in Canada.”

Further in the west, Europe has made significant progress in establishing a clear legal pathway for the approval of biosimilars and is welcoming these products owing to the high cost of biological drugs along with the need to cut expenses in the pharma market. Despite many companies have inhibitions regarding the worth in developing a biosimilar, competition in the industry still prevails.

Coming to the Asia-Pacific countries, many companies in India and China are preparing themselves for dominating the market, owing to their high competitiveness in production costs and proximity to the emerging markets. China might take up a major share of the global biosimilars market, owing to its competitive edge in terms of manufacturing and expertise. In India, biosimilars are bringing huge opportunities particularly for companies, such as Dr Reddy’s Labs, Biocon, and Ranbaxy who are actively concerned in this space. As per our new report, “Global Biosimilars Market Analysis”, India is aiming to upgrade its current 1.4% share in the global biopharma market to 10% by 2020.

Although the companies are gearing up for market entry in the biosimilars sector, there exists a strict regulatory framework for the approval of biosimilars in the market. Our study on the industry indicates that in the US, there is a 12-year “market exclusivity”, period according to which, biosimilar manufacturers cannot produce copies of the biologic drugs for 12 years, after receiving approval from the US Food and Drug Administration (FDA). This market exclusivity period is longer than the 10-year exclusivity period granted to innovator companies in Europe, where the European Medicines Agency issues the biosimilar guidelines. In the Asia-Pacific region, Japan constitutes the Ministry of Health, Labor, and Welfare to issue guidelines for the approval of biosimilars while Indian regulators are also planning for a guideline (under the aegis of DBT) to create a pathway for biosimilar approvals for making an entry into the drug market.

“India is aiming to upgrade its current 1.4% share in the global biopharma market to 10% by 2020.”

As far as the products are concerned, various biosimilar products being marketed currently include Erythropoietin, Human Growth Hormone, Recombinant Human Insulin, G-CSF, and Interferon. Industry statistics indicate that in 2010, Epoetin alfa (Erythropoietin Biosimilar) occupied more than 40% of the market share, followed by Filgrastim (G-CSF Biosimilar) with 33% market share, and Somatropin (Human Growth Hormone Biosimilar) with 25% market share.

Coming over to the competitive landscape, a broad range of companies varying in size from small startups to most important generic manufacturers are competing for establishing position in the biosimilars market. A good number of these companies are situated in Europe with Hexal, Biopartners, Ratiopharm, Sandoz, and Teva as early industry leaders and India with Biocon, Dr. Reddy’s Laboratories, and Ranbaxy dominating the several smaller players. As per our research, American companies such as AstraZeneca, Eli Lilly &amp, Company, and Merck have also started expressing concern in follow-on biologics (FOBs).

Biosimilar Products launched by Key Players

Table 1: Biosimilar Products launched by Key Players

Road ahead

The forthcoming era of drug approvals and patent expirations in the coming years is all set to push the biosimilar industry to enormous heights. Lipitor (atorvastatin – Pfizer), Zyprexa (olanzapine – Eli Lilly), and Levaquin (levofloxacin – Johnson &amp, Johnson) include the key patent expiries. The product approvals in the global biosimilars industry have gained momentum and major ones include the approval of Cresp (Dr. Reddy’s Laboratories), Nivestim (Hospira, Inc.), and BASALOG (Biocon). Another aspect of developments in this industry are the collaborations and acquisitions that are taking place worldwide, with the objective to deliver high-quality, affordable biosimilars, thereby, reducing the mounting healthcare costs in both the developed and emerging economies.

Global Biosimilars Market (Million US$), 2010 &amp, 2015

Figure 1: Global Biosimilars Market (Million US$), 2010 &amp, 2015

Source: IMS Health

As per our report, the global biosimilars market is expected to grow at a CAGR of around 52% during 2010–2015, owing to the increasing demand for low-cost biological drugs, patent expiries, and product approvals in the coming years. The alliance of big biotech and pharma companies to introduce biosimilar programs with the FDA laying out a regulatory pathway for therapies is also expected to drive the optimistic industry expansion. Further, it is noteworthy that there has been a tremendous increase in the approval of biosimilars by the FDA. The prospect of marketing new versions of accessible biologics whose patents have expired is driving the attention of manufacturers, specifically as innovative products will be going off patent in the coming years. It has been observed that even the Venture capitalists are eager to participate in the upcoming era of biosimilar products.

However, certain barriers to market entry include companies facing the challenges of higher development cost, greater time in development, quality requirements, as well as demanding and uncertain approval and patent procedures. Considering all these factors, only a selection of top biosimilars players are anticipated to acquire the capabilities to make an initial impact on the market.

About the Author:

Shushmul Maheshwari is the Chief Executive of RNCOS, a market research &amp, Information analysis company with global presence. He has spent more than 19 years working in the senior management teams of both, Indian and multinational companies. He has gained expertise in research &amp, analysis field and actively participated in various national and international conference &amp, discussions organized by business &amp, trade-related associations.


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