U.S. Active Pharmaceutical Ingredients Market Size, Share & Trends Analysis Report By Types Of Synthesis (Biotech, Synthetic), By Types Of Manufacturer (Captive, Merchant), By Types, By Application, And Segment Forecast, 2024 - 2030

Market Size & Trends

The U.S. active pharmaceutical ingredients market size was estimated at USD 83.5 billion in 2023 and is projected to grow at a CAGR of 4.7% from 2024 to 2030. This growth is attributed to the increasing demand for innovative medicines, advancements in biotechnology, and the shift towards microbial-based fermentation approaches. In addition, the rising need for environmentally friendly production methods and the rising consciousness of the ecological risks associated with traditional chemical routes have led to a significant rise in the demand for APIs. Furthermore, there is substantial development of innovators and CDMOs seen in the country, which is anticipated to drive the growth of the market in the country.

The U.S. Active Pharmaceutical Ingredients Marketaccounted for a share of 35.1% of the global active pharmaceuticals ingredients market revenue. The demand for active pharmaceutical ingredients (APIs) is rising due to the growing prevalence of chronic diseases, infectious diseases, and genetic disorders.

This surge in demand is driven by the need for efficient and harmless drugs to treat these conditions. For instance, the Centers for Disease Control and Prevention (CDC) reports that almost 58.5 million American adults have arthritis, and this number is projected to reach 35 million by 2040. This rising diabetic population drives the focus on developing advanced and safe drugs, which requires an essential amount of API, thus boosting market growth.

Furthermore, the increasing growth and medical trials of biosimilar and biologics drugs and the increasing acceptance of new therapeutic classes are expected to increase their adoption by physicians and patients, further boosting the demand for APIs and driving market development.

Application Insights

The cardiovascular diseases segment accounted for the largest market share of 21.5% in 2023. This growth is attributed to the growing prevalence of chronic diseases, such as diabetes, hypertension, and dyslipidemia. In addition, the increasing awareness of cardiovascular risk factors and the need for effective treatments are also contributing to the growth. Furthermore, the increasing development and clinical trials of biosimilar and biologics drugs are expected to increase their adoption, further driving the demand for APIs.

The endocrinology segment registered a substantial revenue share in 2023 owing to the increasing prevalence of chronic diseases such as diabetes and thyroid disorders. In addition, advancements in API manufacturing and the development of new treatments for endocrine-related conditions contribute to the growth. Furthermore, favorable government policies and changes in geopolitical situations also drive market growth.

Types Of Synthesis Insights

The synthetic API dominated the market and accounted for the largest market share of 72.0% in 2023. This growth is attributed to the increasing prevalence of chronic diseases such as diabetes, cancer, and cardiovascular disorders, which fuels the demand for effective medications that rely heavily on synthetic APIs. Furthermore, the increasing adoption of biologics and biosimilars, as well as advancements in oncology drug research, contribute to the growth of the synthetic API segment in the market.

The biotech API segment also registered significant growth in 2023 owing to advancements in the biopharmaceutical and biotechnology sectors, as well as the rising adoption of biologics and biosimilars. Furthermore, the growing support from regulatory agencies for new drug approvals and the growing focus on personalized medicine and precision therapeutics are also driving the growth of the segment.

Types Of Manufacturers Insights

The captive API dominated the market and accounted for the largest revenue share of 51.5% in 2023. This growth is attributed to the increasing demand for high-quality APIs, the need for cost-effective and effective manufacturing procedures, and the increasing focus on research and development. Furthermore, the country has a well-established pharmaceutical industry with numerous businesses investing in API manufacturing facilities, further contributing to the growth of captive API.

Merchant API witnessed substantial growth in 2023 owing to the increasing need for affordable and efficient industrial developments and increasing focus on R&D. In addition, strategic collaborations among pharmaceutical businesses and research institutions further drive the growth of the segment.

Types Insights

Innovative APIs held a substantial market share in 2023, driven primarily by the surge in funding and favorable regulatory environments for research and development (R&D) facilities. This influx of resources has enabled the development of numerous new innovative products, which are expected to be launched in the near future.

The generic API market witnessed significant revenue share in 2023 and is estimated to experience swift growth over the forecast period. The primary driver of this growth is the termination of patents for numerous branded molecules, which creates a considerable opportunity for generic API manufacturers.

Key U.S. Active Pharmaceutical Ingredients Company Insights

Key players in the market include AbbVie Inc, Viatris Inc. and Johnson & Johnson.

• AbbVie Inc. focuses on immunology, oncology, neuroscience, and virology, manufacturing a wide range of pharmaceutical products, including Humira, Imbruvica, Viekira, and Marinol. With a global presence and a diverse portfolio, the company aims to deliver innovative medicines and solutions that address complex health issues and enhance people's lives

• Johnson & Johnson developes and manufactures pharmaceutical prescription drugs, medical devices, and consumer healthcare products. The varied portfolio of the company includes Humira, Imbruvica, Viekira, and Marinol, among others, addressing complex health issues and enhancing people's lives

Curia, and Ampac Fine Chemicals (AFC) are other participants in the U.S. Personal Care Contract Manufacturing market.

• Ampac Fine Chemicals specializes in scale-up, process development, and production from kilograms to multi-ton quantities, with fully CGMP-compliant facilities. AFC also offers contract analytical services through AMPAC Analytical

Recent Developments

• In January 2024, Johnson & Johnson has finalized its acquisition of Ambrx Biopharma. The all-cash transaction, valued at around $2 billion, or $1.9 billion net of estimated cash acquired. This acquisition I expected to be recorded as a business combination in Johnson & Johnson's financial statements. In addition this strategic acquisition aims towards continuing the improvement of ARX517, demonstrating a possible first- and best-in-class PSMA-targeting ADC for the treatment of mCRPC

• In April 2023, AbbVie received FDA approval for QULIPTA (atogepant), a groundbreaking oral medication designed to prevent migraine episodes in adults. This milestone marks QULIPTA as the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to manage both episodic and chronic migraine

U.S. Active Pharmaceutical Ingredients Market Report Scope

U.S. Active Pharmaceutical Ingredients Market Report Segmentation

This report forecasts revenue growth at a country level and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. active pharmaceutical ingredients market report based on types of synthesis, types of manufacturers, types, and applications:

• Types of Synthesis Outlook (Revenue, USD Billion, 2018 - 2030)

  • Synthetic

  • Biotech

• Types of Manufacturers Outlook (Revenue, USD Billion, 2018 - 2030)

  • Captive APIs

  • Merchant APIs

• Types Outlook (Revenue, USD Billion, 2018 - 2030)

  • Innovative APIs

  • Generic APIs

• Application Outlook (Revenue, USD Billion, 2018 - 2030)

  • Cardiovascular Diseases

  • Endocrinology

  • CNS and Neurology

  • Oncology

  • Gastroenterology

  • Orthopedic

  • Pulmonology

  • Nephrology

  • Ophthalmology

  • Others