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Active Pharmaceutical Ingredients Market Expected to Reach US$ 21.9 Bn Globally in 2023

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<strong>Active</strong> <strong>Pharmaceutical</strong> <strong>Ingredients</strong> <strong>Market</strong><br />

<strong>Expected</strong> <strong>to</strong> <strong>Reach</strong> <strong>US$</strong> <strong>21.9</strong> <strong>Bn</strong> <strong>Globally</strong> <strong>in</strong> <strong>2023</strong><br />

Accord<strong>in</strong>g <strong>to</strong> a new market report published by Transparency <strong>Market</strong> Research “<strong>Active</strong><br />

<strong>Pharmaceutical</strong> Ingredient <strong>Market</strong>: Global Industry Analysis, Size, Share, Growth, Trends and<br />

Forecast 2015 - <strong>2023</strong>” the global active pharmaceutical <strong>in</strong>gredient market for was valued at <strong>US$</strong><br />

12.9 bn <strong>in</strong> 2014 and is estimated <strong>to</strong> reach <strong>US$</strong> <strong>21.9</strong> billion by <strong>2023</strong> at a CAGR of 6.3% from<br />

2015 <strong>to</strong> <strong>2023</strong>.<br />

An active pharmaceutical <strong>in</strong>gredient is the <strong>in</strong>gredient <strong>in</strong> a pharmaceutical drug that is<br />

biologically active. Demand for low cost medic<strong>in</strong>es and <strong>in</strong>creas<strong>in</strong>g number of ANDA fil<strong>in</strong>gs are<br />

fuell<strong>in</strong>g the growth of the global active pharmaceutical <strong>in</strong>gredients market.<br />

The active pharmaceutical <strong>in</strong>gredient market is categorized <strong>in</strong><strong>to</strong> manufactur<strong>in</strong>g process, type of<br />

API, drug type and therapeutic areas. The API manufacturers <strong>in</strong>clude those for captive or <strong>in</strong>house<br />

API and contract API. Captive API manufactur<strong>in</strong>g refers <strong>to</strong> production of the active<br />

pharmaceutical <strong>in</strong>gredients for <strong>in</strong>ternal consumption of a pharmaceutical company. Contract<br />

manufactur<strong>in</strong>g <strong>in</strong>volves outsourc<strong>in</strong>g of API manufactur<strong>in</strong>g by the <strong>in</strong>nova<strong>to</strong>r/formula<strong>to</strong>r company<br />

<strong>to</strong> CMOs. Captive manufactur<strong>in</strong>g also known as <strong>in</strong>-house manufactur<strong>in</strong>g held the largest share of<br />

the global active pharmaceutical <strong>in</strong>gredient market <strong>in</strong> 2014. However, the market of captive<br />

manufactur<strong>in</strong>g is decl<strong>in</strong><strong>in</strong>g due <strong>to</strong> high production cost and limited for the manufactur<strong>in</strong>g niche<br />

APIs that offer high operat<strong>in</strong>g profit marg<strong>in</strong>s or for companies that are <strong>in</strong><strong>to</strong> generics and have<br />

their own formulation plants.<br />

The adoption rate of contract manufactur<strong>in</strong>g is <strong>in</strong>creas<strong>in</strong>g due <strong>to</strong> soar<strong>in</strong>g R&D costs and pric<strong>in</strong>g<br />

pressure on f<strong>in</strong>ished products. Improv<strong>in</strong>g quality and time-<strong>to</strong>-market, along with reduction <strong>in</strong><br />

fixed costs are the other important fac<strong>to</strong>rs propell<strong>in</strong>g the growth of the API contract<br />

manufactur<strong>in</strong>g segment. Outsourc<strong>in</strong>g of API production <strong>to</strong> countries such as India and Ch<strong>in</strong>a<br />

have <strong>in</strong>troduced <strong>in</strong>novative production processes and advanced manufactur<strong>in</strong>g technologies <strong>to</strong><br />

rema<strong>in</strong> competitive <strong>in</strong> the market.<br />

The synthetic chemical API segment had the largest share of this market <strong>in</strong> 2014 and has evolved<br />

<strong>in</strong> the past few years due <strong>to</strong> <strong>in</strong>novations <strong>in</strong> the methods of synthesiz<strong>in</strong>g chemical APIs, which<br />

improves their stability and potency., Whereas, the market for biological API is expected <strong>to</strong> have<br />

the highest growth rate <strong>in</strong> the forecast period of 2015 <strong>to</strong> <strong>2023</strong>. The global API market is


transform<strong>in</strong>g, as large pharmaceutical companies are shift<strong>in</strong>g focus <strong>to</strong>ward the biological APIs<br />

segment. Prote<strong>in</strong>-based therapeutics (peptides, prote<strong>in</strong>s, enzymes and antibodies) have emerged<br />

as a major growth eng<strong>in</strong>e <strong>in</strong> the biological API market. Apart from the currently marketed<br />

blockbuster biologics such as Humira and Hercept<strong>in</strong>, several other promis<strong>in</strong>g biologics such as<br />

mepolizumab (GSK), dupilumab (Sanofi/Regeron), alirocumab (Sanofi), evolocumab (Amgen),<br />

brodalumab (Amgen), ixekizumab (Eli Lilly) and secuk<strong>in</strong>umab (Novartis) are expected <strong>to</strong> enter<br />

several geographical markets dur<strong>in</strong>g the forecast period from 2015 <strong>to</strong> <strong>2023</strong>. This fac<strong>to</strong>r has<br />

attracted higher <strong>in</strong>vestments <strong>in</strong> the biologics and biosimilars market.<br />

Based on the drug type, the global API market is segmented <strong>in</strong><strong>to</strong> branded prescription drugs,<br />

generic prescription drugs and OTC drugs. The branded API segment accounted for the largest<br />

share of the global API market <strong>in</strong> 2014. Accord<strong>in</strong>g <strong>to</strong> the USFDA, 44% of the pharmaceutical<br />

products launched <strong>in</strong> the U.S. between 2007 and 2012 were new molecules. This reflected the<br />

frequency of novel molecules enter<strong>in</strong>g <strong>in</strong> the market. Increas<strong>in</strong>g demand for new treatments will<br />

certa<strong>in</strong>ly <strong>in</strong>crease the branded API market <strong>in</strong> the near future. The generic prescription drugs<br />

segment is expected <strong>to</strong> grow at the highest rate <strong>in</strong> the forecast period ow<strong>in</strong>g <strong>to</strong> their low cost.<br />

Currently, the major pharmaceutical companies are also focus<strong>in</strong>g on generic drugs along with<br />

branded drugs due <strong>to</strong> erod<strong>in</strong>g product pipel<strong>in</strong>e and patent expirations. Over-the-counter (drugs)<br />

are considered sufficiently safe and effective and <strong>in</strong>creas<strong>in</strong>g access <strong>to</strong> these medic<strong>in</strong>es through<br />

expansion of distribution channels would further drive this market dur<strong>in</strong>g the forecast period.<br />

The global API market categorizes therapeutics areas segment <strong>in</strong><strong>to</strong> different disorders such as<br />

cardiovascular, metabolic, neurological, oncology, musculoskeletal, non-steroidal anti<strong>in</strong>flamma<strong>to</strong>ry<br />

drugs (NSAIDs), and other therapeutic uses. Cardiovascular, metabolic, and<br />

neurological disorders <strong>to</strong>gether held the largest share of more than 50% <strong>in</strong> 2014.<br />

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