Reports - Active Pharmaceutical Ingredients (API) Market
Active Pharmaceutical Ingredients (API) Market Size, Share & Trends Analysis Report by Potency (Traditional API, HPAPI) by Type of Synthesis (Synthetic API, Biotech API) by Type of Drug (Prescription Drugs, Over the counter drugs) by Therapeutic Application (Communicable Diseases, Oncology, Diabetes, Cardiovascular Diseases, Pain Management, Respiratory Diseases, Other Therapeutic Applications) by Region (North America, Europe, Asia Pacific, Latin America, Middle East & Africa) - Global Industry Assessment (2018 - 2023) & Forecast (2024 - 2032)
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USD 209.80 Billion
USD 445.7 Billion
7.15%
North America
Asia Pacific
2024
2021 - 2023
2025 - 2035
By Potency, By Type of Synthesis, By Type of Drug, By Therapeutic Application, By Region
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The global Active Pharmaceutical Ingredients (API) Market is valued at USD 209.80 Billion in 2024 and is projected to reach a value of USD 265.7 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 7.15% between 2025 and 2035.
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North America Dominated Sales with a 40.2% share in 2024. North America is anticipated to hold a significant market owing to factors such as the prevalence of chronic diseases such as cancer, diabetes, cardiovascular and neurological diseases coupled with the ageing population. For instance, in July 2022 by the Canadian Institute for Health Information indicates that over 2.4 million Canadians suffer from cardiac disease in 2022. This increases the need for APIs in the production of cardiovascular and cancer medications, which is expected to drive market expansion in North America.
The regions presence of major market participants and the high cost of healthcare are expected to contribute to the markets growth.
People work with active pharmaceutical ingredients (APIs) and their intermediates understand and abide by Part C, Division 2 of the Food and Drug Regulations (the Regulations), which deals with good manufacturing practices (GMP), the Government of Canada released guidelines for active pharmaceutical ingredients (GUI-0104) in February 2022. Fabricators, packagers/labelers (including repackages/re-labelers), testers, importers, distributors, and wholesalers are all covered by this manual. Over the course of the projection period, it is anticipated that government endeavor will raise the demand for finished goods and expand the Active Pharmaceutical Ingredients (API) market.
Furthermore, it is anticipated that expanding manufacturing facilities and stepping up business initiatives to boost API production will support market expansion. For instance, Eurofins stated in January 2023 that it had enlarged and moved its API development laboratory to a new location in Ontario, Canada.
Piramal Pharma declared in May 2022 that a new active pharmaceutical ingredient (API) factory at its Aurora, Ontario, location had successfully finished its first production runs after coming online. As a result, the market is anticipated to expand during the course of the forecast period due to growing government initiatives, an increase in the prevalence of cardiovascular and cancer disorders, and expanding corporate manufacturing facility expansion activities.
The U.S. Active Pharmaceutical Ingredients (API) market, valued at USD 26.84 Billion in 2023 to USD 55.07 Billion in 2032, is anticipated to grow at a CAGR of 8.3% from 2024 to 2032. The U.S. Active Pharmaceutical Ingredients (API) market is driven by technological advancements, regulatory updates, and rising prevalence of chronic diseases, making it a pivotal player in the pharmaceutical industry.
For instance, the American Cancer Society released estimates for 2024 that indicate there would be roughly 2,001,140 new cases of cancer identified in the US in 2024, including 353,820 cases linked to the digestive system, 313,510 cases connected to the breast, and 252,950 cases related to the respiratory system. Similarly, the rising prevalence of chronic diseases like Alzheimers, estimated to affect 6.2 million Americans over 65 and projected to reach 12.7 million by 2050, fuels demand for specific APIs like donepezil, further shaping market dynamics and growth trajectories.
Boasting a diverse array of manufacturers catering to both domestic and international needs, the market prioritizes innovation and adherence to stringent FDA regulations. This emphasis on quality is bolstered by significant investments in research and development, particularly in specialized APIs and biologics, to meet the changing healthcare landscape.
The cardiovascular diseases segment dominated the Active Pharmaceutical Ingredients (API) market with the largest share of 22.2% in 2023. The Active Pharmaceutical Ingredients (API) market, segmented by the Therapeutic Application, is bifurcated into Communicable Diseases, Oncology, Diabetes, Cardiovascular Diseases, Pain Management, Respiratory Diseases and Other Therapeutic Applications.
The cardiovascular diseases category had the highest revenue share because of the increasing prevalence of cardiovascular problems and the extensive use of various CVD drugs.
Cardiovascular diseases (CVDs) are the leading cause of death globally due to poor eating habits, obesity, physical inactivity, growing alcohol and tobacco consumption, and improper eating habits. For instance, 17.9 million deaths globally were linked to CVDs, according to WHO estimates. 55% of these deaths were caused by heart attacks and strokes.
Drugs for cardiovascular disease are necessary for both treating and preventing it. Based on data from 84 of the countries covered by the World Medicines Situation Report, cardiovascular medications were the second most often used class of medication in the non-hospital sector. By 2024, sales of branded cardiovascular drugs are expected to exceed US$90 billion.
For the treatment or prevention of CVDs, 400 active pharmaceutical ingredients (APIs) or API combinations are listed in the British National Formulary (77/2019) and the WHO Anatomical Therapeutic Chemical (ATC) classification list5. Because cardiovascular problems are more common, there is a greater need for active pharmaceutical ingredients.
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The global need for safe and effective medications is being driven by the rising incidence and burden of infectious diseases, genetic disorders, and chronic diseases. This, in turn, is pushing up demand for active pharmaceutical ingredients. For example, the International Diabetes Federation (IDF) released statistics for 2022, which indicate that the number of diabetes patients will increase to 643 million by 2030 and 784 million by 2045. Furthermore, the Australian Bureau of Statistics revealed in December 2023 that approximately 1.3 million Australians, or 5.3% of the population, had diabetes in 2022.
Businesses are being compelled to take strategic measures for the production and development of APIs due to the growing development and clinical trials of biologic and biosimilar medications for novel therapeutic classes, which is anticipated to fuel market expansion. For instance, Aurobindo Pharmas wholly owned subsidiary CuraTeQ Biologics invested over INR 300 (USD 3.82) crore in September 2022 to expand the capacity of biologics manufacturing facilities. The business was also given permission to start contract manufacturing activities for biologicals. Similarly, Novartis invested $300 million in September 2022 to expand its capacity for biological medicine development and production. It is projected that increased acceptance of biologics would result from investments in bettering biologic manufacturing and increasing biologic approvals, which will raise the need for APIs for development.
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The emphasis on precision medicine propels demand for APIs tailored to individual patients, driving innovation in drug development and personalized treatments
Precision medicine involves tailoring medical treatments to individual patients based on their genetic makeup, environment, and lifestyle. By directing treatments toward the patients who stand the best chance of benefiting from them, this strategy seeks to enhance treatment outcomes and reduce side effects. Demand for certain APIs that facilitate the creation of customized medications is driven by the focus on precision medicine in theActive Pharmaceutical Ingredients (API) market. In order to find APIs that may be utilized in precision medicine treatments, pharmaceutical companies spend in research and development. This opens up chances for API producers to produce and provide these specialized chemicals.
Stringent drug price controls constrain profitability and investment in the Active Pharmaceutical Ingredients (API) market, potentially hindering research and development efforts
Drug price control policies, implemented by governments and regulatory agencies, aim to contain healthcare costs and ensure access to affordable medications. However, these regulations may present difficulties for manufacturers of APIs and pharmaceuticals, especially if they result in lower profit margins and pricing pressure. The expansion of the Active Pharmaceutical Ingredients (API) industry is hindered by unfavorable medication price control laws that restrict the pricing flexibility of APIs and finished pharmaceutical products.
The rise of biosimilars presents a growth opportunity for API manufacturers, as demand increases for ingredients used in the production of cost-effective alternatives to biologic drugs
Biosimilars are biological products that are highly similar to an already approved biologic drug, with no clinically meaningful differences in terms of safety and efficacy. Biosimilars offer cost-effective alternatives to expensive biologic drugs, providing patients with increased access to essential treatments. Specialized APIs are needed for the creation of biosimilars, which creates a demand for producers who can produce these chemicals in large quantities while maintaining regulatory compliance. For instance, Biocon Biologics and Yoshindo, a Japanese pharmaceutical firm, signed a strategic out-licensing deal in October 2022 to market Ustekinumab and Denosumab, two of Biocon Biologics' pipeline biosimilar assets, in Japan. Additionally, bevacizumab (Abevmy), a biosimilar to Avastin (Roche), was introduced in May 2022 in Canada by Biocon Biologics and Viatris to treat various cancers. As biosimilar adoption continues to grow worldwide, API manufacturers have the opportunity to expand their product portfolios and capture a larger share of the market.
The competitive landscape of the Active Pharmaceutical Ingredients (API) market is marked by intense competition fueled by a combination of factors such as stringent regulatory requirements, increasing demand for generic drugs, and the emergence of complex biologic drugs. Established players like Teva Pharmaceutical Industries, Pfizer, and Novartis dominate with their extensive manufacturing capabilities and global presence, while also investing heavily in research and development to maintain a competitive edge. Simultaneously, contract manufacturing organizations (CMOs) such as Lonza Group and Catalent leverage their expertise in API production to cater to the growing demand for outsourcing services, offering cost-effective solutions and flexible manufacturing capacities.
The key players in the global Active Pharmaceutical Ingredients (API) market include - Pfizer among others.
Sterling Pharma Solutions Acquires Novartis API Manufacturing Facility in Ireland
Pfizer and Acuitas Ink Agreement for Lipid Nanoparticle Delivery Method for mRNA Vaccines
The global Active Pharmaceutical Ingredients (API) market can be categorized as Type, Potency, Type of Synthesis, Product, Expression Systems, Type of Drug, Therapeutic Application and Region.
Source: www.vantagemarketresearch.com
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Report Coverage | Market growth drivers, restraints, opportunities, Porter’s five forces analysis, PEST analysis, value chain analysis, regulatory landscape, technology landscape, patent analysis, market attractiveness analysis by segments and North America, company market share analysis, and COVID-19 impact analysis | |
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