Drug API Market - Forecasts from 2024 to 2029

The global drug API market is projected to reach US$309.642 billion in 2029 from US$245.053 billion in 2024 at a CAGR of 6.23%.

The active pharmaceutical ingredient (API) is the component of medicine that generates the desired effects. Combination therapies, for example, have several active ingredients that treat different symptoms or function differently. The booming new drug development to cater to the ongoing increase in market demand, followed by innovations in biotech & synthetic drug development, is anticipated to drive market expansion.

APIs have generally been manufactured in-house by pharmaceutical businesses in their home nations. However, in recent years, many companies have outsourced manufacturing to save money. This has resulted in considerable changes in regulating these pharmaceuticals, including implementing more stringent criteria and inspections. However, the market's expansion will likely be hampered by negative medicine price control regimes in several countries, high manufacturing costs, and strict regulatory policies.

The global API market is segmented by drug synthesis type, application, and geography.

Global Drug API Market Drivers:

The favorable investment & collaboration in biological drugs is expected to boost the growth of API globally.

The key factors driving the API drug market are the expanding drug research and development activities for drug manufacturing, the increasing importance of generics, and the increasing consumption of biopharmaceuticals. For instance, in May 2024, Sanofi announced an investment of more than EUR1 billion in Vitry-sur-Seine, Le Trait site, and Lyon Gerland. The company will establish a biologics production facility that will expand its monoclonal antibody production, thereby improving the overall manufacturing of essential medicines.

Likewise, in July 2023, Pfizer Inc. and Flagship Pioneering Inc. partnered to develop a new pipeline of innovative medicines to address the unmet needs of a wide patient population suffering from highly complex diseases. As per the collaboration, both companies would invest nearly US$50 million to develop 10 single-asset programs that would leverage Flagship’s network of 40 human health companies and biotech platforms.

The rising frequency of chronic diseases is predicted to boost medicine demand, which will drive the API drug market forward. Cardiovascular illnesses are the biggest cause of death worldwide, with an estimated 17.9 million people each year, according to the World Health Organization (WHO).

The booming demand for innovative drugs to fight diseases is expected to bolster overall API usage in the coming years.

Active Pharmaceutical Ingredients undergo rigorous testing to ensure they have the desired effect on the patient’s condition without causing harm. Hence, health-related APIs are ideal for pharmacological activities, diagnosis, treatment, and prevention of certain diseases that affect the body's functioning. Complex diseases such as Alzheimer’s, especially in the elderly population, negatively impact their motor skills.

According to the Alzheimer's Association, the disease is the sixth leading cause of death in the United States, and it primarily affects people over the age of 65, with approximately 5.6 million patients falling into this age bracket. As per the same source, by 2050, a new case of the disease is expected to occur every 33 seconds. The growing prevalence of such diseases will increase the demand for innovative drugs with highly desired functionality and minimal effects, thereby providing a positive outlook to the market scope of active pharmaceutical ingredients.

Global Drug API Market Geographical Outlook

North America is projected to constitute a considerable market share in the given time frame.

Region-wise, the global API drug market is segmented into North America, South America, Europe, the Middle East and Africa, and Asia Pacific. The North American region is poised for considerable growth, fuelled by increased disease rates and an aging population. For instance, according to the Centers for Disease Control and Prevention, approximately 795,000 people in the United States suffer from the effects of stroke each year, with ischemic stroke accounting for 87% of instances.

Major regional economies, mainly the United States and Canada, are experiencing positive growth in new drug development and investment in API medicinal technologies. For instance, in May 2024, Eli Lilly and Company announced an additional investment of US$5.3 billion for its Indiana manufacturing facility. This investment enables the company’s API manufacturing capacity for Mounjaro® (tirzepatide) and Zepbound® (tirzepatide) injections that would be used for treating adults suffering from type 2 diabetes and obesity.

Due to rising healthcare expenditures and a high number of pharmaceutical businesses, Asia-Pacific is predicted to develop at the fastest rate in this market over the forecast period. The existence of economies like China and India, which the world relies on for low-cost API production, benefits the region. This further boosts the growth in the API market in Asia-Pacific.

Moreover, new pharmaceutical and biological product launches, acquisitions, collaborations, and geographic expansions are some of the industry's strategic operations. For instance, Bortezomib is a drug that is used to treat adult patients with multiple myeloma or mantle cell lymphoma who have had at least one previous treatment.

Global Drug API Key Market Developments

• In May 2024, The United States Agency for International Development (USAID) launched a new project to provide US$5 million for sustainably producing, regulating, and exporting active pharmaceutical ingredients and other assured medical products to Kazakhstan and Uzbekistan. USAID’s International Development Group-led Indo-Pacific Opportunity Program and the U.S. Pharmacopeia-led Promoting the Quality of Medicines Plus (PQM+) program will regulate the project.
• In November 2023, Novo Nordisk announced plans to invest more than 42 billion Danish Krone to expand the company’s active pharmaceutical ingredient production capacity at its Kalundborg facility. The investment would bolster the production scale of the product inclusive of GLP-1 products thereby enabling Novo to meet future demand.
• In May 2023, the API Innovation Center announced a cooperation agreement to support the adoption of flexible pharmaceutical manufacturing technologies, improving the scale of critical drugs required in the United States. The agreement will further improve pharmaceutical companies' domestic API manufacturing.
• In January 2023, Agilent Technologies announced an investment of US$275 million to double its therapeutic nucleic acid manufacturing capacity, which produces active pharmaceutical ingredients for drugs targeting cardiovascular, cancer, and other infectious diseases.

The Global Drug API market is segmented and analyzed as follows:

By Synthesis Type

• Biotech Drugs
• Synthetic Drugs

By Drug Type

• Generic Drug
• Branded Drug

By Application

• Cardiology
• Pulmonology
• Oncology
• Ophthalmology
• Neurology
• Orthopedic
• Other Applications

By Geography

• North America
• United States
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• Israel
• Others
• Asia Pacific
• China
• Japan
• South Korea
• India
• Others