The Active Pharmaceutical Ingredient (API) Market in US is being driven by Increasing number of type II drug master files (DMF)
The Active Pharmaceutical Ingredient (API) Market in US is expected to grow at a CAGR of 9% during 2024 and 2029. During this period, the market is also expected to show a growth of USD 25456.1 million. In the US pharmaceutical industry, there has been a significant shift from captive Active Pharmaceutical Ingredient (API) manufacturing to outsourcing to Contract Manufacturing Organizations (CMOs) and other drug manufacturing entities. Initially, outsourcing was limited to early-stage API intermediates; however, it has since expanded to encompass advanced intermediates and final dosage forms. Factors influencing this decision include industry trends, the cost of acquiring new technologies in-house, and the availability of internal manufacturing capacity. This outsourcing trend has become increasingly prevalent in the production of both branded and generic drugs.
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The market is segmented based on
According to Technavio, There are several factors that are causing the market to flourish during the forecast period, which are as follows:
However, the market also witnesses some limitations, which are as follows:
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Market Scope |
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Report Coverage |
Details |
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Page number |
177 |
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Base year |
2024 |
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Historic period |
2019-2023 |
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Forecast period |
2025-2029 |
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Growth momentum & CAGR |
Accelerate at a CAGR of 9% |
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Market growth 2025-2029 |
USD 25456.1 million |
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Market structure |
fragmentation |
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YoY growth 2024-2025(%) |
8.0 |
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Key countries |
US |
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Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
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The Active Pharmaceutical Ingredient (API) market in the US is witnessing significant advancements with the adoption of innovative technologies such as process optimization, continuous manufacturing, flow chemistry, microfluidic technology, and green chemistry. Quality by design, process analytical technology, real-time release testing, and process validation are key strategies for ensuring product quality. Analytical method development and validation, mass spectrometry, and pharmaceutical analytics are essential for API characterization. In vitro and in vivo studies, pharmacokinetic and pharmacodynamic studies, clinical trial design, and endpoints are crucial for drug development. Drug interactions, personalized medicine, and precision medicine are shaping the future of pharmaceuticals. Drug safety, adverse drug events, drug withdrawal, and shortages are major concerns, while pharmaceutical regulations, legislation, counterfeiting, diversion, and compliance are ongoing challenges.
In the realm of pharmaceutical manufacturing and drug development, the Active Pharmaceutical Ingredient (API) market in the US is a significant segment of the larger global pharmaceuticals industry. This market encompasses entities involved in research and development (R&D) or production of generic drugs, specialty pharmaceuticals, and contract manufacturing for custom synthesis. According to Technavio's market analysis, the global healthcare market, which includes manufacturers and providers of equipment, supplies, pharmaceuticals, biotechnology, and life sciences tools and services, is expected to grow substantially. Key drivers for this expansion include the increasing global population aging, with the US and Europe projected to have over 25% of their populations over 60 years old by 2050 and 2030, respectively. This demographic shift will lead to a higher demand for pharmaceutical products and services.. Industries are leveraging the products belonging to the market for customer engagement, transactional notifications, and promotional offers.
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