Global sales of pharmaceutical intermediates closed in on US$ 26 billion 2018, which is likely to see modest Y-o-Y growth in 2019, by an estimated 3.6% rate. More than 70% of the pharmaceutical intermediates consumed, were generic. A moderate demand growth outlook has been projected for branded pharmaceutical intermediates.
Prominently driven by high sales of chiral intermediates, bulk drug intermediates will continue to account for over 3/5th of overall sales, followed by chemical intermediates. The report highlights pivotal role of CROs (contract research organizations) and CMOs (contract manufacturing organizations) in shaping the pharmaceutical intermediates market, as they collectively contribute more than 60% to the market value. Pharma and biotech companies are also likely to develop as key end users of pharmaceutical intermediates in the near future.
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Application in Analgesics Account for a Third of Global Revenue
Increasing prevalence of the chronic diseases, coupled with the improved rate of early diagnosis, is heavily contributing to the towering drug demand. The report opines that prevalence rate of CVDs (cardiovascular diseases) and diabetes will particularly bolster pharmaceutical intermediates consumption. Over 1/3rd of the pharmaceutical intermediates market revenues is accounted by application in analgesics, followed by cardiovascular drugs and oral antidiabetic drugs, as reported by the study.
Moreover, the increasing rate of seeking treatment is also likely to boost the demand for drugs. According to the report, global pandemics, such as H1N1, Ebola, and others are also accounting for fostering drug demand – thereby pushing consumption of a wide range of APIs and pharmaceutical intermediates.
Manufacturing Companies to Strategize on Increasing Drug Approvals
A couple of years ago, the Center for drug evaluation and research (CDER) approved more than 45 novel drugs, compared to 22 in 2016. The average novel drug approval each year, is around 31 and, and thus FMI’s analysis finds that the year 2017 witnessed a significant rise in the number of drug approvals. With the number of drug approvals on a constant rise, it is highly likely that the demand for pharmaceutical raw materials such as pharmaceutical intermediates and APIs will also witness gains in the years to come.
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To cater to billowing demand in drug formulations, a number of players prominently active in the global pharmaceutical intermediates landscape are maintaining focus on expanding production capacity. Merck KGaA, for an instance, has announced production capacity expansion in Aubonne, Switzerland. The new production facility is supposed to be fully functional by the end of 2023, as reported. The production capacity will be enhanced by over 50% of the existing.
Pharmaceutical intermediates manufacturers seeking cGMP (Current Good Manufacturing Practice regulations) approval from various western regulatory bodies. Key manufacturers of pharmaceutical intermediates, particularly those based in the East and South Asian regions, are focused on their efforts in gaining FDA or EMA (European Medicine Agency) regulatory approvals for their manufacturing plants.
FMI’s research marks that the production costs associated with pharmaceutical intermediates, APIs, and final drug formulations is around 50-60% less when based in emerging Asian markets, compared to that in North America and Europe. This cost benefit according to the report will continue to attract foreign investments from pharmaceutical and biopharmaceutical companies based in overseas. On the other side, leading exporters of pharmaceutical intermediates are focusing on blending the lower production costs and high quality.
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The report tracks some of the key companies operating in the Pharmaceutical Intermediates market, including Chiracon GmbH, Aceto Corporation, Midas Pharma GmbH, BASF SE, Codexis, Inc., A.R. Life Sciences Private Limited, Dishman Group, ZCL Chemicals Ltd., Pfizer, Inc., Arkema Inc and Cambrex Corporation among others.