North America was the Largest Region in 2022

DUBLIN, Feb. 22, 2023 /PRNewswire/ —  The “Pharmaceutical API Manufacturing Global Market Report 2023” report has been added to  ResearchAndMarkets.com’s offering.

This report provides strategists, marketers and senior management with the critical information they need to assess the market.

The global pharmaceutical API manufacturing market is expected to grow from $179.05 billion in 2021 to $195.29 billion in 2022 at a compound annual growth rate (CAGR) of 9.1%. The pharmaceutical API manufacturing market is expected to reach $250.66 billion in 2026 at a CAGR of 6.4%.

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Major players in the pharmaceutical API manufacturing market are Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Boehringer Ingelheim, PfizerInc., Aurobindo Pharma, Novartis AG, Dr. Reddy’s Laboratories, Merck & Co.Inc., BASF SE., 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., and F. Hoffmann-La Roche Ltd.

The pharmaceutical active pharmaceutical ingredients (API) manufacturing market consists of sales of tablet, capsule, cream, and injectable. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

Pharmaceutical active pharmaceutical ingredients (API) manufacturing refers to the production of the active substances that give a pharmaceutical medicine its desired impact on the body to treat a condition. Chemical components must be processed in order to make APIs. A biologic drug’s active component is referred to as a bulk process intermediate.

North America was the largest region in the pharmaceutical API manufacturing market in 2022. Middle East is expected to be the fastest growing region in the forecast period. The regions covered in the pharmaceutical API manufacturing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The main therapy areas of pharmaceutical API manufacturing are cardiovascular disorders, metabolic disorders, neurological disorders, oncology, musculoskeletal disorders, NSAIDs, and other therapeutics uses. Cardiovascular diseases are a group of heart and blood vessel disorders. The various API type includes chemical API and biological API that are used to produce innovative drugs, generic prescription, and over-the-counter (OTC) drugs.

The rise in the 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 October 2022, according to an article shared by WHO, a Switzerland-based specialized agency of the United Nations responsible for international public health, 80% of senior citizens will reside in low- and middle-income nations by 2050. The population is aging considerably more quickly than in the past. In 2020, there will be more persons over the age of 60 than under five-year-olds. Therefore, rise in aging population is driving the growth of the pharmaceutical API manufacturing market.

Stringent regulations for approval of pharmaceutical drugs act as a restraint on the pharmaceutical API manufacturing market. Various regions have their own set of rules, guidelines, and regulations set by their respective drug 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 drug approvals, thereby negatively affecting the pharmaceuticals API manufacturing market.

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 that 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, automatic loading and unloading system for freeze dryers to manufacture hazardous products. The system uses a linear magnetic driving mechanism that functions without racks and belts to reduce particle generation and this improves the hygiene in API manufacturing.

Also, ILC Dover, a pharmaceutical company, developed the 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.

In March 2021, Piramal Pharma Ltd., an India-based healthcare solutions company, acquired Hemmo Pharmaceuticals for an amount of $105.8 million. This acquisition is expected to expand PPS’s expand its capacity to provide integrated services to its clients globally by gaining access to the expanding peptide API industry. The deal would also increase peptide API manufacturing and development capabilities. Hemmo Pharmaceuticals is an India-based developer and manufacturer of peptide APIs.

The countries covered in the pharmaceutical API manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

Key Topics Covered:

1. Executive Summary

2. Pharmaceutical API Manufacturing Market Characteristics

3. Pharmaceutical API Manufacturing Market Trends And Strategies

4. Pharmaceutical API Manufacturing Market – Macro Economic Scenario

4.1 COVID-19 Impact On Pharmaceutical API Manufacturing Market

4.2 Ukraine-Russia War Impact On Pharmaceutical API Manufacturing Market

4.3 Impact Of High Inflation On Pharmaceutical API Manufacturing Market

5. Pharmaceutical API Manufacturing Market Size And Growth

5.1. Global Pharmaceutical API Manufacturing Historic Market, 2017-2022, $ Billion

5.1.1. Drivers Of The Market

5.1.2. Restraints On The Market

5.2. Global Pharmaceutical API Manufacturing Forecast Market, 2022-2027F, 2032F, $ 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, 2017-2022, 2022-2027F, 2032F, $ 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, 2017-2022, 2022-2027F, 2032F, $ Billion

• Chemical API
• Biological API

6.3. Global Pharmaceutical API Manufacturing Market, Segmentation By Drug Type, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ 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, 2017-2022, 2022-2027F, 2032F, $ Billion

7.2. Global Pharmaceutical API Manufacturing Market, Split By Country, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion

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