Fueled by the product’s ability to facilitate cost-effective treatment options by overcoming astronomical medicine prices, the global biosimilars market is shaping up to become one of the medical industry’s fastest-growing investment avenues.
According to Equity Bulls, indeed, the potential presented by biosimilars is quite lucrative with many pharmaceutical companies keen on capitalizing on these drugs. This is primarily being done to take themselves past molecule generics-driven sector that is full of intense competition and subject to price pressures.
Typically, a biosimilar is a less expensive drug that is demonstrated to be quite similar to a patented biologic medicine authorized by regulators for sale. While it may seem like patent infringement, biosimilars contain inactive components that differentiate them from the original drug and are often manufactured when the original drug’s patent & data protection have expired.
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When introduced to the market, a biosimilar takes away the originator drug’s business due to its affordability and its ability to perform same as the reference drug. This would consequently boost product adoption and bring about a change in biosimilars industry statistics. As a matter of fact, the market is slated to witness additional goals in forthcoming years as more patents keep expiring.
Global biosimilars industry | Impact of India’s expanding biopharmaceutical sector
Over the past few decades, India has firmly consolidated its reputation in the global pharmaceutical market. In fact, the nation is expected to become the world’s sixth largest pharmaceuticals market by 2020.
The Reputation: Indian pharmaceutical firms are specifically known for manufacturing generics, which follow same principles as biologics; wherein identical copies or duplicates of known drugs that branded & marketed under a different name are manufactured and sold in the market once the original drug’s patent expires.
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The Potential: Several Indian pharmaceutical companies, supported by their experience in manufacturing generics, are beginning to make a move into the global biosimilars market. Reliable reports claim that most Indian pharmaceutical firms are beginning to accrue a substantial percentage of their revenue from biosimilars. This has, in consequence, provided a major impetus to the regional biosimilars industry statistics.
The Projection: The future of India biosimilars market is often reflected in the way global pharmaceutical companies forge partnerships with Indian firms. The most notable one is the agreement between U.S. pharma company Mylan N.V. and India’s Biocon. The partnership has seen substantial progress in obtaining approvals for biosimilars across Europe and the U.S in 2018, which helped Biocon witness a 36% revenue growth – approximately $120 million – through its biosimilars business.
Such ventures are expected to become more commonplace in the years to come, as patents expire and further growth opportunities arise, propelling biosimilars market statistics.
Global biosimilars industry | Potential of the relatively untapped U.S. healthcare sector
While the penetration of biosimilars across the European Union is considerably extensive, moving further west to the U.S. reveals that the impact of biosimilars in the regional healthcare industry is fairly limited.
According to Kemwell Biopharma, this disparity between the equally developed regions can be attributed to the fact that unlike the EU, USA didn’t implement any regulatory framework that would evaluate biosimilars until 2009, when it enacted the Biologics Price Competition and Innovation (BPCI) Act.
The Conditions: Even with the 2009 act, Reuters reported that 2015 was the first instance of a biosimilar entering the U.S. healthcare sector; when Novartis’ generics unit Sandoz unveiled the Zarxio biosimilar, which is based on Neupogen by Amgen.
The product’s entry into the nation was slowed down by slow evaluation processes and because Amgen tried to block the product’s launch in court.
The Pressure: Since then skyrocketing drug prices as well as additional pressure from the Trump administration has brought the U.S. Food & Drug Administration (FDA) into the spotlight with current FDA commissioner, Dr. Scott Gottlieb also actively advocating change.
The Impact: These events are expected to bring about a major change in biosimilars industry statistics, aiding the vertical in gaining a noticeable foothold in the American healthcare sector. The industry would continue to observe growth in the region, as the FDA attempts to enforce regulations that ensure quicker biosimilars approvals in the nation.
The Projection: The world’s biopharmaceutical sector is expected to leverage the prevailing conditions in the American healthcare industry and capitalize on the opportunities that would be created by FDA’s efforts in getting quicker biosimilars approvals.
In 2018, Forbes reported that in the U.S., by 2020, patents for nine of the nation’s top 20 best-selling biologics are expected to expire, creating additional opportunities for the market players. In fact, the U.S. biosimilars market is slated to grow with an impressive 38.1% CAGR in the forthcoming years.
In a nutshell, fueled by U.S. regulators’ efforts in expediting the entry of biopharmaceuticals in the country and by the Indian biopharmaceutical industry’s active participation in heralding industry growth, the global biosimilars market statistics are projected to expand substantially in coming years. A report by Global Market Insights, Inc. estimates that the revenue graph of global biosimilars industry is poised to surpass a valuation of $69 billion by 2025.