World News: 12:11 GMT Friday 7th December 2018. [Research and Markets via Globe Newswire via SPi World News]
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The active pharmaceutical ingredients market was valued at USD 160.3 million in 2017, is expected to register a CAGR of about 6.1% during the forecast period, 2018-2023.
A huge impact from pharmaceutical industry, increasing adoption of biological and biosimilars, and rising prevalence of cancer are the major factors fueling the growth of the active pharmaceutical ingredients market.
Biosimilars, sometimes referred to as biogenerics, are highly similar versions of biologics - medicines that are made from living microorganisms found in plant or animal cells. Most biologics are very large and complex molecules, or mixtures of molecules, used to treat cancer, Alzheimer's disease, multiple sclerosis, HIV/AIDS, and other serious diseases.
Biosimilars may serve as lower-cost options, and may hold the potential to create a more sustainable healthcare system by making room for innovation, so that more patients continue to receive the best possible care. As per a report by Amgen on biosimilars, in 2015, the first biosimilar approved by the US FDA was Zarxio. Since then, there has been a dramatic increase in applications submitted to the FDA for review, and many more are expected in the near future.
The US healthcare community has firmly taken the first step into a new reality, which includes assessing the addition of biosimilars to the specialty drug portfolio.Other factors driving this market are huge impact from pharmaceutical industry, increasing adoption of biological and biosimilars, and rising prevalence of cancer.
One of the major factors acting as an obstacle is the stringent regulatory framework across several regions. The quality of APIs has a significant effect on the efficacy and safety of medications. Poorly manufactured or compromised APIs have been connected to serious issues, such as illnesses and even death. Even in the case of outsourcing, APIs are subject to stringent regulations and oversight from the country they are shipped to.
For example, API manufacturing plants overseas still go through an inspection by the US Food & Drug Administration. Moreover, the differences in the regulatory requirements in each country have made this an extremely complex market in the recent times. With European Union, several other countries are adopting fierce regulatory requirements and enforcing API inspection system similar to the level of FDA. This is a step towards standardized regulatory framework globally.
These factors restrict the growth of companies in many regions and hinder the growth of this market.Other factors affecting this market are the drug price control policies across various countries, large capital investment, production cost, and the fierce competition between the API manufacturers.
The global API market is segmented by the business mode, type of synthesis, by customer base, and by geography.
By business mode, it is further segmented into captive API and merchant API. The captive API segment of the market studied is defined as APIs used by pharmaceutical companies for in-house production of finished dosage forms. In 2017, this segment held 60% revenue share in the market.
The Asia-Pacific is expected to register a high growth rate compared to other regions during the forecast period, owing to the factors such as increasing healthcare expenditures, growing aging population creating a huge patient pool, and rising economies in this region.
For example, China is considered as the leader in API manufacturing in the APAC region. There are many domestic companies involved in the manufacturing and supplying of API all over the world. Not just in the Asia-Pacific region, China exports the major share of its domestically produced API around the world.
The low price of the API has boosted the China API export market. Moreover, the Japanese Ministry of Health, Labor, and Welfare (MHLW) have taken measure to reduce the healthcare expenditure and decided to promote the use of generic drugs.
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Related Topics: Drug Discovery
Globe Newswire: 12:11 GMT Friday 7th December 2018
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