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The Biosimilars Market Will Exhibit Exceptional Growth Owing to Enhanced and Improved Legal Framework Surrounding Drug Approvals

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Ankitha Bommidi
The Biosimilars Market Will Exhibit Exceptional Growth Owing to Enhanced and Improved Legal Framework Surrounding Drug Approvals

The biosimilars market growth will be positively impacted by increased litigation and high approval rate through to 2025. Biosimilars approval rate has steadily increased in the US ever since the country passed its first biosimilar in 2015. As of July 2019, 23 biosimilars have been approved by the US Food and Drug Administration. This development has taken place majorly owing to improved clarity in the reviewing process of the FDA and the legal framework that surrounds the litigation process. Drug approvals are often prone to patent disputes which have become a prioritized area for most countries to improve. The US, for example, introduced its Biosimilars Action Plan in 2018 which featured approval process and scientific clarity as the primary objectives. A clearer legal framework assists pharmaceutical industry players in obtaining faster approvals and resolving patent disputes quicker, thus ensuring market growth. Additionally, the APAC region will prove to be a potentially beneficial region for the biosimilars market growth despite Europe featuring a rather mature market. Key countries of the APAC region such as India, China, and South Korea are largely generics-driven for their cost-effectiveness. This will be advantageous to the biosimilars market with key players experiencing rapid commercialization, development, and distribution of biosimilars. India, for example, approved its first biosimilar before the US and Europe. In 2000, India approved its first biosimilar for Hepatitis B and since then, 70 biosimilar products have been approved in the country, with more than 25 developed indigenously. The Biosimilars Market has been estimated to exhibit growth with an exceptional CAGR of 38% during the forecast period 2019-2025. Additionally, the market earned a revenue of $5.5 billion in 2018. The report covers Biosimilars market size by Product Type and applications, Biosimilars market share by top 5 companies and also the market share by start-ups during the forecast period.

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Report Price (Single User): US $3850

Europe Leading the Global Biosimilars Market

Europe has emerged as the geographical leader of the biosimilars market. In 2018, the region held a 74% share of the total revenue earned by the market globally. The high demand in Europe for biosimilars can be credited to both the governments and the pharmaceutical industry. In 2005, the European Union established a regulatory framework that solely deals with the approval and production of high-quality biosimilars in the continent. This framework is updated regularly and has been pivotal in ensuring the growth of biosimilars use in European countries. Through this science-based regulatory framework, the European Union approved its first biosimilar called Omnitrope in 2006. Since then, Europe has experienced a high inflow of biosimilar approvals. 16 new biosimilars were approved and granted authorization for marketing in 2018 alone. One of the key players of the biosimilars market, Novartis International AG, held the majority in these approvals and had 5 new biosimilar products approved. The regulatory environment will continue to contribute to the growth of the biosimilars market by improving and increasing approvals. Furthermore, the European Medicines Agency (EMA) has also played a key role in the growth of the biosimilars market in Europe. The EMA has not only helped in carving out an effective framework but also educated the European population about biosimilars. In September 2018, the EMA published new educational materials on biosimilars that were centered on patients. These educational materials have played an important role in increasing patient access to biosimilars, thereby increasing the market growth. Through these informative materials, European patients have become aware of biosimilars and where they can obtain them.

High Cost of Biologic Drugs Will Fuel Growth of the Biosimilars Market

Chronic diseases are steadily plaguing the growth of life expectancy in the human population. Furthermore, the medical costs associated with the prevention and treatment of chronic illness continues to be persistently high. These costs are increasingly exorbitant for patients suffering from complex diseases that have limited treatment options which are often highly expensive. These options prominently include biologics which are drugs composed of large-sized proteins. The types of biologics range from drugs to therapies such as vaccines, gene therapies, plasma treatments, and others. According to the National Center for Biotechnology Information, the average cost of biologics in the United States of America is around $10,000-$30,000 per year. Furthermore, the most expensive biologics can cost around $500,000 per year owing to patent protection, research investments, and approval costs. The demand for biologics despite this remains high for their efficacy in treating complex diseases and serious conditions such as cancer, rheumatoid arthritis, diabetes, and others. The biosimilars market will serve as a resolve to the high costs associated with biologics, thereby attaining growth in the process.

Monoclonal Antibodies- The monoclonal antibody is the most expensive biologics to exist and is predominantly used for the treatment of cancer. These antibodies are produced artificially inside laboratories to mimic or enhance the body’s immune system. The segment of biologics for oncology diseases has emerged as the most promising for this market. According to IndustryARC, the segment will grow with a CAGR of 41% during the forecast period 2019-2025. The comparatively lower costs for consumers associated with monoclonal bodies have contributed to their success in the healthcare industry. For example, in 2015, the US Food and Drug Administration approved the first biosimilar to be manufactured in the country. This biosimilar called Zarxio cost around $1000 which was a remarkable difference over its pharmaceutical counterpart priced at $3000 for approximately ten injections. Similarly, despite lengthy approval rates associated with biosimilars, industry experts have predicted high financial savings in the healthcare industry owing to the biosimilars market. According to ExpressScripts, a pharmacy benefit management company based in the US, the United States will approximately save $250 billion by the end of 2024 with the introduction of a mere 11 biosimilars in the country. Financial savings of this magnitude will be pivotal in ensuring the growth of the market in the forecast period.

Key Players of the Global Biosimilars Market and Recent Developments

Despite biosimilars’ visible success in considerably reducing the costs of treating complex diseases, key players of the market will experience several challenges in the forecast period. Some of the challenges that lie ahead are slow approvals for biosimilars, time invested in emulating biologics, and others. Key market players will shift their focus towards spreading awareness about biosimilars. Automatic substitution is a key area that will help in the growth of this market. By capitalizing on the timely and effective marketing of biosimilars, key players can educate both the doctors and purchasers, thereby fuelling the growth of the market. These key companies of the biosimilars market include Stada Arzneimittel AG, Boehringer Ingelheim, Amgen Inc, Merck & Co. Inc., Allergan Plc., Eli Lilly and Company, Dr. Reddy's Laboratories, Pfizer Inc., Samsung Bioepis Co., Ltd., Celltrion Healthcare Co., Ltd., Novartis International AG, and Biogen Inc.

In May 2019, STADA Arzneimittel AG announced a strategic partnership with Xbrane Biopharma AB for expanding biosimilars development. The focus of this partnership will be on manufacturing biosimilar products with estimated patent expirations in 2025-2030.

In June 2019, the US Food and Drug Administration approved KANJINTI, a biosimilar for treating metastatic breast cancer and gastroesophageal junction adenocarcinoma. This will add another biosimilar to Amgen’s portfolio which stood at 9 in number before this approval.

In July 2019, Sandoz, Novartis AG’s division dedicated to biosimilar development announced their first patient enrollment for treating osteoporosis. This biosimilar is called Denosumab and will majorly help postmenopausal women in managing osteoporosis symptoms.

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Related Reports:

A. Biologics And Biosimilars Market
https://www.industryarc.com/Research/Biologics-And-Biosimilars-Market-Research-502754

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