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Active Pharmaceutical Ingredients Market: International Regulation for APIs Helps Improve Drug Standards

September 20th, 2021 Transparency Market Research Releases

Active Pharmaceutical Ingredients (API) Market: Introduction

According to the report, the global active pharmaceutical ingredients (API) market was valued at US$ 168 Bn in 2020 and is projected to expand at a CAGR of ~6% from 2021 to 2031. An active pharmaceutical ingredient (API) is any substance or mixture of substances used in a finished pharmaceutical product (FPP) that is intended to provide pharmacological action or to otherwise have a direct impact in the diagnosis, remedy, mitigation, therapy, or prevention of disease, or to have a direct effect in repairing, correcting, or altering physiological functions in humans. The growth of the global active pharmaceutical ingredients (API) market can be ascribed to increase in incidence & rise in prevalence of various diseases; and surge in funding from government organizations and large corporates for developing active pharmaceutical ingredients (API).

North America dominated the global active pharmaceutical ingredients (API) market in 2020 and the trend is anticipated to continue during the forecast period. Presence of major market players, significant healthcare expenditure, and early availability of new products drive the market in North America. Additionally, large patient base in the U.S. and surge in the number of active pharmaceutical ingredient (API) suppliers propel the market in the country.

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Asia Pacific is expected to be the second largest market for active pharmaceutical ingredients (API) during the forecast period. The market in the region is likely to expand at a high CAGR during the forecast period.

Rise in Incidence & Prevalence of Diseases, Increase in Entry of Various Companies, and Surge in Launch of New APIs to Drive Global Market

The active pharmaceutical ingredients (API) market is projected to grow at a rapid pace during the forecast period, owing to rise in cases of various chronic diseases. The increase in incidence of chronic diseases drives the global active pharmaceutical ingredients market. In the past few decades, the incidence of chronic diseases, including diabetes, chronic obstructive pulmonary disease (COPD), coronary artery disease, arthritis, asthma, hepatitis, and cancer has increased significantly in major regions across the globe. This could be attributed to the increase in the geriatric population across the world (by 2050, more than 20% of the global population is anticipated to be aged over 65 years), changing lifestyles, and dietary changes as a result of rapid urbanization.

According to the International Diabetes Federation, 463 million people across the world were diagnosed with diabetes in 2019. Moreover, the number of new cancer cases per year is expected to increase to 23.6 million by 2030. Apart from cancer, a number of other diseases has shown rise in prevalence rates. Rise in prevalence of cancer, cardiovascular diseases, and diabetes; surge in sedentary lifestyle, and increase in geriatric population are the key drivers of the active pharmaceutical ingredients (API) market.

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The increase in launch of various APIs drives the global active pharmaceutical ingredients (API) market. For instance, in 2018, Pfizer announced the launch of Retacrit, a biosimilar of Amgen’s Epogen for the treatment of anemia.

In House Manufacturing to Dominate Global Market

In terms of manufacture type, the global active pharmaceutical ingredients (API) market has been segmented into in house manufacturing and contract manufacturing. The in house manufacturing segment dominated the global active pharmaceutical ingredients (API) market in 2020 and the trend is projected to continue during the forecast period. Global players, such as Merck KGaA, prefer in-house production of APIs. This is a major factor driving the segment. These players believe that in house manufacture provides control of the process from start to finish. It offers the flexibility to adapt as and when required. This is especially useful when a company wants to respond to the market quickly and make a consumer-led change to the product, as it does not have to go through another company or rely on anyone else. These factors are anticipated to boost the growth of the segment during the forecast period.

Labor costs constitute majority of the cost of any manufacturing process. Outsourcing manufacturing eliminates the responsibility and costs involved in hiring the staff required to do the job properly. This is a major factor likely to drive the demand for contract manufacturing in the near future.

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Branded or Innovative Prescription Drugs to be Highly Lucrative

Based on drug type, the global active pharmaceutical ingredients (API) market has been categorized into branded or innovative prescription drugs, generic prescription drugs, and OTC drugs. The branded or innovative prescription drugs segment accounted for a prominent share of the global active pharmaceutical ingredients (API) market in 2020. According to TMR Research, medicine use has continued to rise, with people in the U.S. filling 5.8 billion prescriptions in 2018, an increase of 2.7% over the previous year. This was largely driven by more patients receiving existing branded drugs and using newly launched drugs.

Synthetic to be Highly Attractive API

In terms of API type, the global active pharmaceutical ingredients (API) market has been classified into synthetic, biological, and plant extracts. The synthetic segment accounted for a significant share of the global active pharmaceutical ingredients (API) market in 2020. This can be attributed to higher availability of raw materials and easier protocols for the synthesis of these molecules.

Cardiovascular to be Major Application of API

Based on application, the global active pharmaceutical ingredients (API) market has been divided into anti-infective, cardiovascular, neurological, metabolic disorder, respiratory, oncology, and others. The cardiovascular segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. Drug therapy is a major treatment modality in cardiovascular disease. Hypertension and cardiovascular diseases (CVD) are quite common conditions, and account for significant medical disability and death worldwide. New classes of cardiovascular drugs would be effective for the treatment of hypertension and CVD and decrease their socioeconomic consequences. New drug approval is one of the prominent factors that drives the demand for APIs. These factors are expected to propel the segment during the forecast period.

High Use of API in Pharmaceutical & Biotechnology Industry

In terms of end user, the global active pharmaceutical ingredients (API) market has been categorized into pharmaceutical & biotechnological industry, CROs, CMOs, and others. The pharmaceutical & biotechnological industry segment accounted for a major share of the global active pharmaceutical ingredients (API) market in 2020. A large number of pharmaceutical & biotechnology companies and their preference for in-house manufacturing of finished dose products drives the segment. Additionally, pharma companies are opening their own manufacturing plants in emerging markets instead of imports to sell products, which drives the segment.

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North America to Dominate Active Pharmaceutical Ingredients (API) Market

In terms of region, the global active pharmaceutical ingredients (API) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global active pharmaceutical ingredients (API) market in 2020, followed by Asia Pacific. Rise in prevalence of lifestyle diseases and increase in healthcare expenditure are anticipated to boost the market in North America during the forecast period.

The active pharmaceutical ingredients (API) market in Asia Pacific is anticipated to expand at a significant CAGR from 2021 to 2031. Favoraable government initiatives, changing lifestyles leading to the development of diseases, rise in investment in R&D, and technological developments in drug manufacturing processes boost the market in the region.

Competition Landscape of Active Pharmaceutical Ingredients (API) Market

The global active pharmaceutical ingredients (API) market is fragmented in terms of number of players. Key players operating in the global market include Merck & Co., Inc., Teva Pharmaceutical Industries Ltd., Sanofi, Pfizer, Inc., Novartis AG, Mylan N.V., Lonza, WuXi AppTec Co., Ltd., Piramal Pharma Solutions, Hisun USA, Inc., Ipca Laboratories Ltd., AbbVie, Inc., Alembic Pharmaceuticals Limited, BASF SE, Biocon Ltd., Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Cambrex Corporation, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, and GlaxoSmithKline plc.

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About Us

Transparency Market Research is a global market intelligence company providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for several decision makers. Our experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts so that it always reflects latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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