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(Health-NewsWire.Net, May 18, 2021 ) This study involved four major activities in estimating the current size of the active pharmaceutical ingredients market. Exhaustive secondary research was carried out to collect information on the market, its peer markets, and its parent market.
The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.
RESTRAINT: High manufacturing costs
The high manufacturing cost of APIs is one of the major challenges faced by market players. Manufacturers often have to make costly investments for improvements in their manufacturing facilities to ensure compliance with standards such as the cGMP. This includes the renovation of production facilities, inculcating familiarity with qualification requirements and processes, and building a dossier of product efficacy and safety tests that meet the requirements of regulatory authorities. Furthermore, the costs of obtaining regulatory approvals are relatively higher for firms with small volumes. The chemical synthesis of APIs also often requires expensive and uncommon building blocks and raw materials, which further adds to API manufacturing costs.
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OPPORTUNITY: Emerging biosimilars market.
The rising incidence of various diseases, the increasing number of off-patent biologic drugs, positive outcomes in ongoing clinical trials for biosimilars, and the rising demand for biosimilars in different therapeutic applications (such as rheumatoid arthritis and blood disorders) are the major factors driving the growth of the biosimilars market. Biosimilars are generic versions of patented biologic drugs; hence, they do not need to comply with the stringent requirements of various regulatory authorities (making them cost-effective as compared to patented biologics). The expiration of patents and other intellectual property rights for originator biologics over the next decade is expected to open up opportunities for biosimilars to enter the market.
COVID-19 impact on the active pharmaceutical ingredients market
With the WHO declaring the COVID-19 outbreak a pandemic, a mix of established pharmaceutical and biopharmaceutical companies, as well as small startups, have stepped forward to develop treatments that target the infection. In just a few weeks, scientists found a list of molecules that target COVID-19. Currently, around 155 molecules are under clinical investigation, and 45 molecules are under preclinical development to be targeted against COVID-19.
In this list, there are four promising drugs (Remdesivir, Chloroquine & Hydroxychloroquine, Lopinavir & Ritonavir, and Lopinavir with Ritonavir plus Interferon beta-1a) that have been repurposed for use against COVID-19. On March 24, 2020, the WHO announced that it had initiated a global mega trial of the four most promising drugs against COVID-19. Countries are in a global race to develop and mass-produce an efficient vaccine to fight COVID-19. The economic and social burden of pandemics has prompted government bodies to increase funding for vaccine development on a global scale. According to the WHO, as of June 2020, there were over 140 vaccines in various stages of development.
Of these, 13 are now in the human clinical trial stage, while others remain at the very early stages of preclinical testing. Increase in funding and research for development of pharmaceutical products will drive growth for the market. However, coronavirus outbreak has disrupted business and economic activities globally.in the first quarter of 2020 It is expected to have a short-term impact on the active pharmaceutical ingredients market to a certain extent.
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The global active pharmaceutical ingredients market is highly consolidated. Prominent players in the active pharmaceutical ingredients market include Pfizer Inc. (US), Novartis International AG (Switzerland), Merck & Co. (US), Teva Pharmaceutical Industries Ltd. (Israel), Mylan N.V. (US), Boehringer Ingelheim (Germany), F. Hoffmann-La Roche AG (Switzerland), Sanofi (France), AbbVie (US), Eli Lilly and Company (US), AstraZeneca (UK), Bristol-Myers Squibb (US), and GlaxoSmithKline plc (UK).
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