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Pharmaceutical API Manufacturing Global Market Research Report 2021: Focus on Chemical API, Biological API, Innovative Drugs, Generics, OTC -

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DUBLIN, December 08, 2021--(BUSINESS WIRE)--The "Pharmaceutical API Manufacturing Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to's offering.

The global pharmaceutical API manufacturing market is expected to grow from $170.06 billion in 2020 to $177.32 billion in 2021 at a compound annual growth rate (CAGR) of 4.3%. The market is expected to reach $215.9 billion in 2025 at a CAGR of 5%.

Major players in the pharmaceutical active pharmaceutical ingredients (API) manufacturing market are Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Boehringer Ingelheim), Pfizer, Inc. and Aurobindo Pharma.

Active pharmaceutical ingredient is a chemical which is responsible for the pharmacological activity in the living body and are used as a major base for preparation of drugs.

The pharmaceutical active pharmaceutical ingredients (API) manufacturing market consists of sales of pharmaceutical active pharmaceutical ingredients and related services. Active pharmaceutical ingredients are used to produce drugs which treat various diseases such as cardiovascular diseases, rare genetic disorders, infections, metabolic disorders, cancers, respiratory diseases and others.

Stringent regulations for approval of pharmaceutical drugs acts as a restraint on the pharmaceutical API manufacturing market. Various regions have their own set of rules, guidelines, and regulations set by their respective drugs regulatory bodies.

For example, in Japan, the manufacturers have to register an API with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) through the country's Drug Master File (DMF) system. Products like APIs and new excipients i.e. inactive substances used in a drug should be registered compulsorily. The API manufacturer is also responsible for DMF registration, even if they don't have their office in Japan. They should appoint an in-country caretaker (ICC) to apply on their behalf.

Also, if there are any changes to be made to DMF products, either an application for change in registration or a minor change notification should be submitted by the ICC to the PMDA. This whole process delays the drugs approvals, thereby negatively affecting the pharmaceuticals API manufacturing market.

The rise in aging population is one of the major drivers of the pharmaceutical API manufacturing market. As the aging population increases, the demand for pharmaceutical drugs also increases. API acts as a specialty drug in these medicines to cure a particular disease.

For instance, in 2019, number of people over the age of 65 were 703 million, in 2050, the number of elderly people is expected to double to 1.5 billion. This led to increase demand for pharmaceutical drugs, significantly impacting the pharmaceutical API manufacturing market growth.

Many companies use modern technologies such as process control, and powder handling to optimize API manufacturing. These technologies include advances in Lyophilization i.e. freeze-drying process. It is a low-temperature dehydration process which involves freezing the product, lowering pressure and then removing the ice formed.

For instance, Telstar, a company that manufactures efficient integrated systems for pharmaceutical and manufacturing processes, developed LyoGistics Zero, an automatic loading and unloading system for freeze dryers to manufacture hazardous products. The system uses a linear magnetic driving mechanism which functions without racks and belts to reduce particle generation and this improves the hygiene in API manufacturing.

Also, ILC Dover, a pharmaceutical company, developed JetBreaker system, a semi-automatic powder handling system that separates powdered media and buffers powders so that they can be mixed better in a solution.

Key Topics Covered:

1. Executive Summary

2. Pharmaceutical API Manufacturing Market Characteristics

3. Pharmaceutical API Manufacturing Market Trends and Strategies

4. Impact Of COVID-19 On Pharmaceutical API Manufacturing

5. Pharmaceutical API Manufacturing Market Size and Growth

5.1. Global Pharmaceutical API Manufacturing Historic Market, 2015-2020, $ Billion

5.1.1. Drivers Of the Market

5.1.2. Restraints On the Market

5.2. Global Pharmaceutical API Manufacturing Forecast Market, 2020-2025F, 2030F, $ Billion

5.2.1. Drivers Of the Market

5.2.2. Restraints On the Market

6. Pharmaceutical API Manufacturing Market Segmentation

6.1. Global Pharmaceutical API Manufacturing Market, Segmentation by therapy Area, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

  • Cardiovascular disorders

  • Metabolic disorders

  • Neurological disorders

  • Oncology

  • Musculoskeletal disorders

  • NSAIDs

  • Other therapeutics uses

6.2. Global Pharmaceutical API Manufacturing Market, Segmentation by API Type, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

  • Chemical API

  • Biological API

6.3. Global Pharmaceutical API Manufacturing Market, Segmentation by Drug Type, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

  • Innovative Drugs

  • Generic Prescription

  • Over-the-counter (OTC) Drugs

7. Pharmaceutical API Manufacturing Market Regional and Country Analysis

7.1. Global Pharmaceutical API Manufacturing Market, Split by Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7.2. Global Pharmaceutical API Manufacturing Market, Split by Country, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

Companies Mentioned

  • Teva Pharmaceutical Industries Ltd.

  • Sun Pharmaceutical Industries Ltd.

  • Boehringer Ingelheim

  • Pfizer Inc.

  • Aurobindo Pharma

  • Novartis AG

  • Dr. Reddy's Laboratories

  • Merck & Co.Inc.


  • Bayer Healthcare

  • Mylan N.V.

  • Albemarle Corporation

  • Actavis plc

  • Hospira Inc.

  • Ranbaxy Laboratories

  • Virbac

  • Zoetis

  • Heska Co.

  • AbbVie Inc.

  • AstraZeneca plc

  • Eli Lilly and Company

  • GlaxoSmithKline plc

  • Sanofi

  • Bristol-Myers Squibb

  • CiplaInc.

  • F. Hoffmann-La Roche Ltd.

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