Active Pharmaceutical Ingredients Market Size, Share, Industry, Forecast and Outlook (2023-2030)

Active Pharmaceutical Ingredients Market is segmented By Type (Synthetic API, Biotech API), By Nature (Generic API, Innovator API), By Manufacturing type (Captive, Merchant), By Application (Cardiovascular, Diabetes, Oncology, Orthopaedics, Neurology, NSAIDS, Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023 - 2030 

Active Pharmaceutical Ingredients Market Overview

The global active pharmaceutical ingredients market reached USD 197.2 billion in 2022 and is expected to witness lucrative growth by reaching up to USD 313.7 billion by 2030. The global active pharmaceutical ingredients market is expected to exhibit a CAGR of 6.1% during the forecast period (2023-2030). APIs find application in high-quality drugs that treat diseases pertaining to oncology, cardiology, CNS and neurology, orthopedic, pulmonology, gastroenterology, nephrology, ophthalmology, and endocrinology.

Active Pharmaceutical Ingredients can potentially create a more sustainable healthcare system by introducing more innovative products.

Furthermore, increase in the number of chronic diseases and an increase in the number of geriatric populations around the world, is driving up the active pharmaceutical ingredient market size. Due to the expansion of research in these fields, the market is seeing an increase in demand from North American regions with significant competitors like Aurobindo Pharma, Teva Pharmaceutical Industries Ltd, Pfizer Inc and others actively operating in the market.

Active Pharmaceutical Ingredients Market Scope

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Active Pharmaceutical Ingredients Market Dynamics

Rise in the Geriatric Population will help to Drive the Market Growth

A considerable proportion o ly population suffers from one or more chronic conditions, including as heart disease, cancer, type 2 diabetes, or arthritis, which increases the need for HI policies among this age group. 

For instance, according to Eurostat, the EU population in January 2022, was estimated to be 446.7 million, out of which 21.1% were Older individuals aged 65 or over indicating an increase of 0.3 percentage points (pp) to the previous year and an increase of 3.1 pp compared with a decade earlier. In addition, according to a new report by the United Nations (UN), the number of individuals aged 65 years or above globally is anticipated to increase two folds in the next 30 years. The geriatric population is expected to attain 1.6 billion in 2050, making up over 16% of the world population. By thus increasing the geriatric population will drive the market growth.

The Launches of New Drugs and Approvals Helps to Boost the Market Growth

The launches of new drugs and biological products, acquisitions, collaborations, and regional expansions are some of the strategic initiatives to maintain stability in the market. For instance, on November 01, 2023, Lonza, a trusted partner in the pharmaceutical, biotech, and nutraceutical industries, has introduced a novel capsule to deliver acid-sensitive active pharmaceutical components to the gut. 

The capsugel enprotect capsule does not dissolve in the stomach and instead releases its contents in the intestine. By eliminating the need for extra capsule coating or sealing, Capsugel enprotect capsules greatly simplify the drug product manufacturing process.

Additionally, on August 31, 2021, Teva Pharmaceuticals, a subsidiary of Teva Pharmaceutical Industries Ltd, and MedinCell announced that the FDA has approved the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. Thus launches and approvals of new drugs helps market growth.

Drug Price Control Policies Across Various Countries will Hamper the Market Growth

The high manufacturing cost of APIs is one of the major challenges faced by market players. Manufacturers often have to make costly investments for improvements in their manufacturing facilities to ensure compliance with standards such as the cGMP. This includes the renovation of production facilities, inculcating familiarity with qualification requirements and processes, and building a dossier of product efficacy and safety tests that meet the requirements of regulatory authorities. 

Furthermore, the costs of obtaining regulatory approvals are relatively higher for firms with small volumes. The chemical synthesis of APIs also often requires expensive and uncommon building blocks and raw materials, which further adds to API manufacturing costs. These factors are hampering the growth of the market in the forecast period.   

Active Pharmaceutical Ingredients Market Segment Analysis

The global active pharmaceutical ingredients market is segmented based on type, application, nature, manufacturing type and region.

Cardivascular Segment Accounted for Approximately 24.7% of the Active Pharmaceutical Ingredients Market Share

The cardiovascular segment holds a significant share due to the vast population using various CVD drugs owing to the high prevalence of cardiovascular diseases. For instance, according to WHO, cardiovascular diseases (CVDs) are the largest cause of death worldwide, accounting for 17.9 billion deaths per year. CVDs are a collection of heart and blood vessel disorders that include coronary heart disease, cerebrovascular disease, rheumatic heart disease, and others. Heart attacks and strokes account for more than four out of every five CVD deaths, and one-third of these deaths occur in adults under the age of 70. 

Unhealthy food, physical inactivity, cigarette use, and problematic alcohol consumption are the most major behavioural risk factors for heart disease and stroke. Individuals experience elevated blood pressure, elevated blood glucose, elevated blood lipids, and overweight or obesity as a result of behavioural risk factors. As a result of the rise in the number of cardiovascular disorders, the market is expanding.

Source: DataM Intelligence Analysis (2023)

Global Active Pharmaceutical Ingredients Market Geographical Share

North America Accounted for Approximately 38.4% of the Market Share in 2022

North America currently dominates the market for active pharmaceutical ingredients and is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future, owing to the increasing incidences of disease and due to the rising incidence of cancer and other lifestyle-induced diseases, which stimulates R&D, thereby boosting the market.

For instance, according to CDC, in the United States in 2020, there were 1,603,844 new cancer cases reported and 602,347 cancer deaths. There were 403 new cancer cases reported for every 100,000 individuals, and 144 people died from cancer. Since 1938, cancer has been the second biggest cause of mortality in the United States, trailing only heart disease. Cancer is responsible for one out of every five deaths in the United States, and one out of every three persons will develop cancer during their lifetime.

Source: DataM Intelligence Analysis (2023)

Active Pharmaceutical Ingredients Market Key Players

The major global players in the active pharmaceutical ingredients market Aurobindo Pharma, Teva Pharmaceutical Industries Ltd, Pfizer Inc., Novartis AG, BASF SE, Boehringer Ingelheim GmbH, Dr. Reddy’s Laboratories Ltd, Lupin Ltd, Mylan NV, Sun Pharmaceutical Industries Ltd and among others.

COVID-19 Impact on Active Pharmaceutical Ingredients Market

The COVID-19 pandemic had a favorable impact on the market as the countries and major players are manufacturing huge amounts of ingredients to maintain the demand for the treatment of COVID-19. The outbreak of COVID-19 has led drug manufacturers to redirect their models to focus on a larger pool of patients. For instance, the United States requested that hydroxychloroquine (HCQ) be imported from India as a treatment for coronavirus. 

The virus has also disrupted the drug supply chain in Canada and may cause problems for patients in the country. Canadian pharma majors expand their programs with countries other than China to gain access to new regions. On March 24, 2020, the WHO announced that it had initiated a global mega-trial of the four most promising drugs against COVID-19. The economic and social burden of pandemics has prompted government bodies to increase funding for vaccine development on a global scale.

Russia Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global active pharmaceutical ingredients market, owing to the low prevalence and absence of key market players in this region. However, the impact of the import and export of raw materials is expectedto have little influence over the global active pharmaceutical ingredients market growth over the forecast period.

Artifical Intelligence Impact A nalysis

To ensure safety and effectiveness, API products must meet stringent stability requirements. Artificial intelligence in manufacturing can help to improve product stability by recognising and correcting problems as they occur. This can assist ensure that changes in the production process do not influence the active medicinal components in the final product.

By Type

• Synthetic API
• Biotech API

By Application

• Cardiovascular
• Diabetes
• Oncology
• Orthopaedics
• Neurology
• NSAIDS
• Others

By Nature

• Generic API
• Innovator API

By Manufacturing type

• Captive
• Merchant

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• In June 14, 2023, C2 PHARMA, a manufacturer and supplier of ophthalmic and specialised active pharmaceutical ingredients (APIs), announced the clearance of a C-Drug Master Filing (DMF) for Digoxin, an API supplied by Nobilus Ent, a Polish manufacturing partner. 
• In November 18, 2022, Bajaj Healthcare Ltd has successfully completed the pre-approval examination of its active pharmaceutical ingredients plant in Vadodara, Gujarat, by the US Food and Drug Administration. The USFDA pre-approval examination of the manufacturing facility was conducted satisfactorily, with zero Form 483 observations, according to the company, which manufactures APIs (active pharmaceutical ingredients), intermediates, and formulations.
• On December 14, 2022, Eli Lilly and Company and EVA Pharma established a partnership to provide a sustainable supply of high-quality, inexpensive human and analogue insulin to at least one million individuals suffering from type 1 and type 2 diabetes in low- to middle-income countries (LMICs), the majority of which are in Africa.

Why Purchase the Report?

• To visualize the global active pharmaceutical ingredients market segmentation based on application, type, nature, manufacturing type and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous data points of active pharmaceutical ingredients market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global active pharmaceutical ingredients market report would provide approximately 53 tables, 54  figures and 195 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies