Pharmaceutical API Manufacturing Global Market Report 2021: COVID-19 Growth and Change to 2030

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.

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 growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $215.9 billion in 2025 at a CAGR of 5%.

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. 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 API manufacturing market covered in this report is segmented by therapy area into cardiovascular disorders, metabolic disorders, neurological disorders, oncology, musculoskeletal disorders, NSAIDs, other therapeutics uses. It is also segmented by API type into chemical API, biological API and by drug type into innovative drugs, generic prescription, over-the-counter (OTC) drugs.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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.

In January 2019, Bristol-Myers Squibb, a US-based company that discovers and manufactures biopharmaceutical products and drugs for cancer and other diseases acquired Celgene Corporation for $74 billion. With this acquisition, Bristol-Myers Squibb led to develop more innovative medicines and also result in a wider portfolio. Celgene Corporation, a US-based company that discovers, develops and commercializes medicines for cancer and inflammatory disorders.

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.

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