Intermediates, Fine and Specialty Chemicals

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What is a pharmaceutical intermediate?

Pharmaceutical intermediates are fine chemicals of intermediate compounds that are produced in the process of manufacturing active pharmaceutical ingredients (APIs). Intermediates are the by-products of reactions in the API production process. Each reaction during the production process may produce several intermediates depending on the analysis, and these intermediates can serve as precursors to other active pharmaceutical ingredients. The conversion of intermediates to active ingredients can be achieved through further refinement processes. Like APIs, intermediates can also be used in bulk drugs for therapeutic purposes.

Difference between an API and an Intermediate

How does an API differ from a pharmaceutical intermediate? These terms may be confused and used interchangeably, especially by newbies in the pharmaceutical industry. Although APIs and intermediates are both pharmacologically active, they differ in function, composition and structure.

What are the major differences between API and Intermediates?

Many factors and analysis differentiate active ingredients and chemical compound from pharmaceutical intermediates. Active ingredients and speciality chemicals are the final products of raw materials, while chemical intermediate make up the by-products produced during the manufacturing process of APIs. Unlike APIs, which are usually safe and administered for therapeutic purposes after due research, intermediates may either be therapeutic, toxic or even APIs. However, APIs produced as by-products that are not officially approved, cannot be administered or used as active ingredients. Also, intermediates do not need to be approved or regulated to be utilized, unlike active ingredients that contain specialty chemical.

What is API in pharmaceuticals?

APIs – Active pharmaceutical ingredients, are the active substances or combination of active substances contained in drugs, that produce the intended pharmacological, biological or therapeutic effect. They serve as the active ingredient of drugs and provide pharmacological activity, or aid diagnosis, treatment, cure, mitigation, or prevention of diseases. Drugs are primarily made up of active pharmaceutical ingredients as the core, and excipient which are either inert or biologically inactive.

Innovations in pharmaceutical intermediates

The pharmaceutical industry is continuously evolving and reshaping itself. Several pharmaceutical companies and market players are adapting innovations in pharmaceutical intermediate sales as the demand for them is rapidly increasing. The growing demand is as a result of several factors such as the surge in chronic diseases, etc., and this has positively impacted the global pharmaceutical intermediate market size. As drug making activities increase around the globe, innovations are being birthed, and the demand for pharmaceutical intermediates manufacturers is on the rise. Due to the implementation of regulated drug-making activities, good manufacturing practices (GMP) in pharmaceutical companies, the global pharmaceutical and packaging market has experienced a surge.

What trends have driven innovations in pharmaceuticals intermediates?

Based on reports, in 2018 forecast period, the global pharmaceutical intermediates market share had an estimated gross margin value of US $ 27, 356.1 million. Its estimated value is anticipated to reach US$38,457.2 million by 2024, with a CAGR of 6.1%, during the 2019-2024 forecast period. Top manufacturers are continually making massive investments into pharmaceutical researches and the development of new pharmaceutical intermediates. Alongside other trends, this gives the market an added advantage.

Some other significant trends driving innovations and growth rate of the global pharmaceutical market size include the rising demand for generic drugs, increasing prevalence of chronic and terminal diseases, patent expiry, and the increasing production of APIs, and intermediate operation among others.

How have pharmaceutical intermediates developed?

Given the massive growth of the market, investments into research, and the continuously advancing biotechnology, pharmaceutical intermediates have experienced some significant developments over the past few years. New intermediates are being discovered, as well as new product development and manufacturing processes such as continuous flow process. These discoveries have made intermediates safer and potent for consumption and have also established new scopes of application.

What are the challenges to pharmaceutical intermediates market growth?

Just as there are key trends motivating innovations and growth of the global pharmaceutical intermediate market, there are also trends that present as challenges. Strict regulatory policies for one, serve as significant setbacks to the growth rate of this market size. Also, strong competition between companies in the industry as well as pricing challenges are adversely affecting the growth of the global pharmaceutical intermediate market. Also, in recent times, the COVID-19 pandemic has also affected pharmaceutical intermediates sales and market share growth.

Top manufacturers of pharma intermediates

The pharmaceutical ingredient market share has a broad pool of competitor pharmaceutical companies at different levels. However, some have strategically worked their way to becoming a top API manufacturer of pharma intermediates in the pharmaceutical industry. These leading manufacturers have played vital roles in the growth of the global intermediate market through stocks. Some of these manufacturers include Aceto Corporation, Vertellus Holdings LLC, Dishman Group, Cycle Pharma, Sanofi Winthrop Industries SA, BASF SE, Teva Pharmaceuticals, AR Life Sciences Private Limited, Midas Pharm etc.

Where can you find the top manufacturers of pharma intermediates?

Although pharmaceutical intermediates are manufactured in several countries and regions across the globe, there are focal points where top manufacturers are located. These regions contribute some of the largest quotas to the growth of the intermediate pharmaceutical market. The major regions include Asia Pacific, North America, Latin America, MEA, and Europe, with the expectance that North America will contribute the largest to the market revenue in the near future.

In addition to this, Asia Pacific and Latin America are also expected to influence the market's growth positively. There are anticipations that top manufacturers in Japan, China, and India will also impact market growth positively.

What do the top manufacturers of pharma intermediates have in common?

Most top players in the pharma intermediate global market have a lot of things in common, keeping them at the top of the supply chain and contributing to the growth rate of the worldwide market. Top manufacturing companies of pharmaceutical intermediates make massive investments into innovations, research, and new pharma intermediate development. They take advantage of recent market trends, rising demands, and opportunities to produce relevant pharmaceutical products. Top manufacturers are consistently evolving with time and technology, and they partake in industry consolidation.

Which supplier selection criteria are relevant for drug intermediates and API?

The majority of pharmaceutical giants outsource for APIs and drug intermediates for drug development. Given this, the competition among manufacturers is too high, and this can affect company evaluation and selection of the right suppliers. The wrong choice of suppliers can negatively influence the supply chain performance and overall performance of the pharmaceutical company.

Therefore, factoring supplier selection criterion before making purchases is essential. Some of the most important criteria for selection of API and drug intermediate suppliers include regulatory compliance (DMF status), cost, quality, supplier profile, risk, reliability, and financial profile of the supplier.

Key players of the pharmaceutical intermediates market

The pharmaceutical intermediates market comprises of many key players who have positively impacted the growth of the global market. Although some of these manufacturing companies independently produce pharma intermediates, a few others handle the production and development of intermediates as well as APIs.

Who are the key players in the global active pharmaceutical ingredients (APIs) market?

The global pharmaceutical market comprises a variety of pharma products in the pharmaceutical industry. APIs are one of the most prominent products, and several top manufacturing companies are key players in the active pharmaceutical ingredients market. Some of these key players include Pfizer Inc., Novartis International AG, Teva Pharmaceuticals, Aurobindo, Sun Pharmaceutical Industries Ltd., etc.

What factors have determined who the key players in the pharmaceutical intermediates market are?

Several factors have influenced and determined who the key players in the pharmaceutical intermediates market within different forecast period. These factors apply everywhere, regardless of the location of these top manufacturing companies. Factors that determine the key players include demographics or population science, technology, social behaviour and culture of the local community, politics (local, national and international), national and global regulating laws and policies, and the natural environment (raw material, pollution, energy prices, biotechnology), etc.

What are the differential strategies adopted by the key players to hold a significant share in the global pharmaceutical intermediates market?

Top manufactures of pharma intermediates have achieved their growth through the acquisition of smaller or other pharma – related companies and via mergers to establish their presence in the market. Also, top pharmaceutical intermediate companies are expanding their businesses through product portfolio expansion and development across the globe. Through these strategies, these key players can maintain a significant share in the global pharmaceutical intermediates market.

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