Active Pharmaceutical Ingredients (API) Market Research Applications, Type, Deployment, Organization Size, Verticals Forecast 2031

International Regulation for APIs Helps Improve Drug Standards

Active pharmaceutical ingredient (API) refers to the active component in a drug. In simple terms, API is part of any drug that produces the intended effects. Drugs are usually formed from several components. The API acts as the primary ingredient. Other ingredients are commonly called excipients, and these elements are required to be biologically innoxious, often forming a changeable fraction of the drug product. The procedure for optimizing and compositing this mixture of ingredients used in the medicine is referred to as formulation. Some drugs have multiple active APIs to treat various symptoms or act in complex ways. Most of the production of APIs has been carried out by the local pharmaceutical companies. However, in previous years, many businesses have opted to transfer manufacturing overseas to cut costs. The increasing demand for pharmaceutical drugs is expected to expand the global active pharmaceutical ingredients (API) market during the forecast period.

Defectively produced and contaminated active ingredients have been associated with adverse health outcomes, extending to death, in several incidents over the past decades. Therefore, most nations across the globe are now regulating active ingredients. Regulating active ingredients can help improve the quality and safety of drugs for consumers, can extend the pharmaceutical drug supply system across the globe, and will bring the active pharmaceutical ingredients (API) market into line with its international regulatory partners. Moreover, producers use specific measures to determine the strength of API in each drug. The measure can vary extensively from one brand to another. Every brand might use different test techniques that can result in various strengths. Nevertheless, the growing incidents of chronic diseases are expected to increase the global demand for the active pharmaceutical ingredients (API) market.

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Supply Chain Restrictions on China Hampered Global API Production

During the COVID-19 crisis, pharmaceutical companies are fighting with the prompt hurdles arising from the disruption in supply chains and the mandate to change business functioning. It was anticipated that if the COVID-19 pandemic continues for a medium/long span of time, it may impact the supply of active material and ingredients from the Asia Pacific with all the import and export of pharmaceuticals globally. The global reliance on China for APIs in various biologics and generic drugs was halted with the operations of the manufacturing as directed by the government. The closure of manufacturing in India and China led to a decline in the global supply of drugs when the demand was at an all-time high. This has led to several countries rolling out programs for domestic API production. Moreover, nations across the EU have reassessed their healthcare standards for tackling the virus and securing a constant inflow of API production.

As the end of this crisis approaches, many manufacturers of active pharmaceutical ingredients are returning their focus on their pre-COVID projects, especially in the essential drugs segment. Leading pharmaceutical businesses are adopting new business models and offering solutions based on key performance indicators by nation. Healthcare expenses of society and current COVID-19 crisis have driven pharmaceutical producers to realign their standards to provide to a large patient pool. However, the impact of coronavirus is anticipated to considerably decrease organizational income and capital expenditures, as the shock solidified various organizations. This is most likely to result in increased investment from API manufacturers for the production, marketing, and promotion of their products. Nevertheless, with rapid production and distribution of COVID-19 vaccines, the global trade is set to reduce its limits for the global active pharmaceutical ingredients (API) market.

Synthetic API Likely to Witness Higher Demand

An API process is linked to a series of operations that result in the development of an active pharmaceutical ingredient. Major procedures or steps in the API process may include multi-step drug synthesis and fermentation, purification, crystallization, drying, milling, packing, labeling, and testing. Some drugs treated similarly to an API may be a bulk-finished product. Moreover, active pharmaceutical ingredients in pediatric formulations have drawn significant attention from regulatory agencies across the world, due to safety concerns. In drug pipelines, small molecule drugs are trending in popularity presently. The small molecule drugs have the maximum number of regulatory approval, and the growing trend is anticipated to continue in the upcoming future. This is likely to benefit the active pharmaceutical ingredients (API) market.

The market share of synthetic API processes has surpassed the biological process. However, the biological API production is growing faster than the synthetic process during the projected timeline. In addition, factors such as increase in aging populations in most of the western world and prevalence of chronic disease are contributing to the growth of the active pharmaceutical ingredients (API) market. Bio-production is growing more widespread as a way to manufacture safer and more efficient drugs. Innovative and inventive methods for curing cancer, cystic fibrosis, asthma, blindness, and heart disease are increasing the demand for biological drugs. Bio-pharmaceuticals operate with the body to defend itself, while synthetic drugs often simply shield the consequences of a disease. Furthermore, in 2020, the cardiovascular segment accounted for a major share of the global active pharmaceutical ingredients (API) market.

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Hypertension and cardiovascular diseases are common diseases and account for significant medical disability and deaths worldwide. The growing demand for pharmaceutical products to treat the increasing number of patients is proving propitious for the global active pharmaceutical ingredients (API) market during the forecast period.

Due to all the above-mentioned factors, the global active pharmaceutical ingredients (API) market is expected to reach the market value of US$ 331.3 Bn in 2031, expanding at a CAGR of 6.4% from 2021 to 2031.

Active Pharmaceutical Ingredients (API) Market: Overview

An active pharmaceutical ingredient (API) is any substance or mixture of substances used in the 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 global active pharmaceutical ingredients (API) market has experienced significant growth in the last decade, due to increase in incidence of chronic diseases

Increase in Abbreviated New Drug Applications (ANDA) drives demand for active pharmaceutical ingredients (API). In order to market a generic drug, a company needs to file Abbreviated New Drug Application (ANDA). An ANDA approval implies that the generic drug is comparable to the original drug in terms of dosage form, strength, route of administration, quality, performance characteristics, and intended use.

However, companies cannot manufacture a drug unless the patent of a drug expires. Hence, as billion dollar drugs lose patents, other drug manufacturers grab the opportunity to manufacture low cost generics and file for ANDA to the U.S. FDA.

The pharmaceutical industry has suffered significantly due to patent expiry of blockbuster drugs in the past few years. Demand for low cost substitutes is high in low- and middle-income countries in Asia Pacific, Africa, and Latin America. This increases the number of API manufacturers, as pharmaceutical drug manufacturers did not have enough in-house capacity to meet the demand.

Currently, majority of API manufacturers is concentrated in Asia Pacific, primarily India, China, and Taiwan. Teva Active Pharmaceutical Ingredients (TAPI), Aurobindo, and Sun Pharma are the leading API manufacturers in the region.

Increase in incidence of chronic diseases drives the global active pharmaceutical ingredients (API) market. According to the International Diabetes Federation, in 2019, 463 million people across the world were diagnosed with diabetes. 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 have 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.

Lung cancer is the leading cause of cancer deaths in Asia Pacific. China alone accounts for over 50% of all cancer cases in the region. Changes in lifestyle and socio-cultural factors are the leading causes of cervical cancer. Major countries affected by breast cancer in Asia Pacific are India, Thailand, and China.

Small molecule drugs account for major share of the current drug pipeline. Despite new biologic entities entering the market, small molecules are experiencing a surge in usage in the clinical pipeline. Maximum number of FDA approvals in the last decade have been for small molecule drugs, and the trend is likely to continue during the forecast period.

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Market Segmentation: Active Pharmaceutical Ingredients (API) Market

In terms of manufacturer type, the global active pharmaceutical ingredients (API) market has been classified into in house manufacturing and contract manufacturing. The in house manufacturing segment is anticipated to dominate the global active pharmaceutical ingredients (API) market during the forecast period.

Based on drug type, the global active pharmaceutical ingredients (API) market has been categorized into branded or innovative prescription drugs, generic prescription drugs, and over-the-counter (OTC) drugs. The branded or innovative prescription drugs segment dominated the global active pharmaceutical ingredients (API) market in terms of revenue in 2020.

In terms of API type, the global active pharmaceutical ingredients (API) market has been divided into synthetic, biological, and plant extracts. The synthetic segment dominated the global active pharmaceutical ingredients (API) market in terms of revenue in 2020.

Based on application, the global active pharmaceutical ingredients (API) market has been segregated into anti-infective, cardiovascular, neurological, metabolic disorder, respiratory, oncology, and others. The cardiovascular segment dominated the global active pharmaceutical ingredients (API) market in terms of revenue in 2020.

In terms of end user, the global active pharmaceutical ingredients (API) market has been split into pharmaceutical & biotechnological industry, CROs, CMOs, and others. The pharmaceutical & biotechnological industry segment dominated the global active pharmaceutical ingredients (API) market in terms of revenue in 2020.

Each of the segments has been analyzed in detail for market trends, recent trends, and developments, drivers, restraints, opportunities, and useful insights. The report provides current and expected revenue (US$ Bn) for each of these segments from 2017 to 2031, considering 2020 as the base year. The compound annual growth rate (% CAGR) has been provided for each segment and market from 2021 to 2031, along with market size estimations.

Regional Overview: 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. The regions have been divided into major countries and sub-regions.

The current and expected market revenue (US$ Bn) of these regional markets and their major countries have been provided in the report from 2017 to 2031, with their CAGRs from 2021 to 2031

The study also offers a list of recommendations, highlights, and useful insights of the global active pharmaceutical ingredients (API) market, which would help new companies willing to enter the market and existing companies to increase market shares and in the decision-making process

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Major Players

The active pharmaceutical ingredients (API) market report concludes with the company profiles section, which includes key information about major players in the global active pharmaceutical ingredients (API) market

Leading players analyzed in the active pharmaceutical ingredients (API) market report 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

GlaxoSmithKline plc.

Each of these players has been profiled in the active pharmaceutical ingredients (API) market report based on parameters such as company overview, financial overview, business strategies, product portfolio, business segments, and recent developments

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