Research Expert: Sarah Overall
  • Published: Jun 2025
  • Pages: 150
  • SKU: IRTNTR77525

  • Latest News- Active Pharmaceutical Ingredient (API) Market in US: Captive API is expected to lead the Type segment during 2025-2029

    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. 

    Get more information on Active Pharmaceutical Ingredient (API) Market in US by requesting a sample report

    Which Factors Are Causing a Surge in Market Growth?

    The market is segmented based on

    • Type
      • Captive API
      • Contract API
    • Product
      • Generic
      • Innovative
    • Application
      • Oncology
      • Cardiovascular diseases
      • Diabetes
      • Communicable diseases
      • Others
    • Geography
      • US

    According to Technavio, There are several factors that are causing the market to flourish during the forecast period, which are as follows: 

    • Increasing number of type II drug master files (DMF)
    • Growing prevalence of chronic conditions
    • Increasing demand for biopharmaceuticals and biosimilars

    However, the market also witnesses some limitations, which are as follows:

    • High investment cost and concern of huge loss
    • Stringent regulatory environment of pharmaceutical industry
    • Dependency on global suppliers for raw materials

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    Market Scope in Active Pharmaceutical Ingredient (API) Market in US Research Report

    Market Scope

    Report Coverage

    Details

    Page number

    177

    Base year

    2024

    Historic period

    2019-2023

    Forecast period

    2025-2029

    Growth momentum & CAGR

    Accelerate at a CAGR of 9%

    Market growth 2025-2029

    USD 25456.1 million

    Market structure

    fragmentation

    YoY growth 2024-2025(%)

    8.0

    Key countries

    US

    Competitive landscape

    Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks

    Find out which segment is leading the market by accessing the free PDF report

    Research Analysis Overview

    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.

    Market Research Overview

    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.


    Contacts

    Technavio Research
    Jesse Maida
    Media & Marketing Executive
    US: +1 844 364 1100
    UK: +44 203 893 3200
    Email: media@technavio.com
    Website: www.technavio.com/

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