U.S. Small Molecule Innovator API CDMO Market (By Stage Type: Preclinical, Clinical, Commercial; By Customer Type; By Therapeutic Area) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

U.S. Small Molecule Innovator API CDMO Market Size and Trends

The U.S. small molecule innovator API CDMO market size was estimated at around USD 8.23 billion in 2023 and it is projected to hit around USD 14.99 billion by 2033, growing at a CAGR of 6.18% from 2024 to 2033.

Key Pointers

• By Stage Type, the clinical segment contributed the largest market share of 55% in 2023.
• By Stage Type, the preclinical segment is estimated to expand the fastest CAGR from 2024 to 2033.
• By Therapeutic Area, the oncology segment registered the maximum market share of 43% in 2023.
• By Customer Type, the pharmaceutical companies contributed more than 92% of revenue share in 2023.

U.S. Small Molecule Innovator API CDMO Market Overview

The U.S. small molecule innovator API CDMO (Contract Development and Manufacturing Organization) market stands as a critical sector within the pharmaceutical industry. As a hub of innovation and technology, the United States plays a pivotal role in the development and manufacturing of active pharmaceutical ingredients (APIs) for small molecule drugs

U.S. Small Molecule Innovator API CDMO Market Growth Factors

The growth of the U.S. small molecule innovator API CDMO market is fueled by an increasing demand for personalized medicine and the prevalence of chronic diseases drive the need for efficient API manufacturing solutions. Secondly, advancements in synthetic chemistry and process optimization contribute to enhanced efficiency and innovation within the industry. Additionally, stringent regulatory standards, including cGMP requirements, emphasize the importance of quality, safety, and compliance, further driving market expansion. Moreover, the adoption of cutting-edge technologies such as continuous flow synthesis and computational modeling accelerates API development and manufacturing processes.

U.S. Small Molecule Innovator API CDMO Market Trends:

• Outsourcing Trends: Pharmaceutical companies increasingly rely on CDMOs for API development and manufacturing, aiming to leverage specialized expertise, reduce costs, and expedite time-to-market for new drug candidates.
• Quality and Compliance Focus: Stringent regulatory standards, including cGMP requirements, prompt CDMOs to prioritize quality, safety, and compliance in API manufacturing processes to ensure product integrity and regulatory approval.
• Biocatalysis and Green Chemistry: Growing environmental concerns and sustainability initiatives drive the shift towards biocatalysis and green chemistry approaches for API synthesis, minimizing environmental impact and enhancing process sustainability.

Stage Type Insights

Categorized by stage, the market is divided into preclinical, clinical, and commercial phases. The clinical segment emerged as the market leader in 2023, capturing the largest revenue share of 55%. Within the clinical phase, further sub-segmentation includes Phase I, Phase II, and Phase III trials. This segment's growth is primarily attributed to the expanding pipeline of small molecule products and the introduction of novel drugs. Notably, Lonza reported that small molecules constitute the largest single drug class during the clinical phase, representing over half of clinical pipelines and contributing more than 40% of the global biopharmaceutical market revenue. Consequently, there is a heightened demand for clinical services from pharmaceutical and biopharmaceutical companies, as clinical research facilitates investigations from the research stage to advancements through clinical trials.

Meanwhile, the preclinical segment is projected to witness a lucrative CAGR over the forecast period. Screening of small molecule drug candidates is pivotal in the drug discovery process, leading to an increase in the number of preclinical candidates and bolstering the drug development pipeline with a greater number of preclinical trials. For example, in August 2023, Astex announced a research collaboration and license agreement with MSD to categorize small molecule candidates targeting tumor suppressor proteins for cancer treatment. Such initiatives are expected to propel market growth.

Therapeutic Area Insights

The market's therapeutic area segment encompasses cardiovascular diseases, oncology, respiratory disorders, neurology, metabolic disorders, infectious diseases, and others. Oncology emerged as the dominant segment in 2023, commanding the largest revenue share of 43% and is projected to exhibit the fastest CAGR of 6.62% during the forecast period. The segment's growth is driven by the increasing incidence of cancer cases, escalating investments in pharmaceutical Research and Development (R&D), and the rising demand for oncology drugs and biologic innovations. For instance, the Cancer Atlas predicts a global tally of 29 million cancer cases by 2040. Moreover, government reimbursement policies and financing opportunities are further propelling the market, particularly in the development of small-molecule oncology therapies.

The neurology diseases market has recently seen significant advancements in treatment methods, research, and drug development, particularly in the realm of central nervous system APIs. These small molecules play a vital role in addressing neurological conditions, driving pharmaceutical companies to innovate in this field. For example, Societal CDMO, Inc. secured contracts from three new customers in August 2022, covering various services such as analytical method development and clinical trial services.

Customer Type Insights

Segmented by customer type, the market comprises pharmaceutical and biotechnology sectors. Pharmaceutical companies dominated the market in 2023, holding a substantial revenue share of 92%. This dominance is attributed to the increasing demand for standard drugs and the emergence of small molecule APIs in the pipeline. Moreover, pharmaceutical firms are increasingly relying on CDMOs for the development of novel small molecule innovator APIs, driven by advancements in technologies such as AI and machine learning.

Conversely, the biotechnology segment is experiencing growth due to the surge in innovative products, including genomic medicines and immunotherapies. This innovation has spurred demand for various small molecule API products. Additionally, biotech firms, with their portfolios of compounds, are seeking small molecule innovator API CDMO services to bring novel therapies to market, further fueling growth in this segment.

U.S. Small Molecule Innovator API CDMO Market Key Companies

• Lonza Group Ltd.
• Novo Holdings (Catalent, Inc.)
• Thermo Fisher Scientific, Inc.
• Siegfried Holding AG
• Recipharm AB
• CordenPharma International
• Samsung Biologics
• Labcorp
• Ajinomoto Bio-Pharma Services
• Piramal Pharma Solutions
• Jubilant Life Sciences (Jubilant Biosys Limited)
• WuXi AppTec Co., Ltd.

Recent Developments

• In February 2024, BioVaxys announced the acquisition of the IMV portfolio from IMV Inc., Immunovaccine Technologies, and IMV USA. This portfolio includes discovery, preclinical, and clinical development-stage assets focused on infectious diseases, oncology, antigen desensitization, and other immunological fields, all based on IMV’s DPX immune-educating platform technology.
• In May 2023, CordenPharma revealed plans to expand its synthetic oligonucleotide manufacturing capabilities in the U.S. The two-phase investment aims to provide biotech and pharma customers with comprehensive API-to-drug-product services.
• In January 2022, Recipharm announced the sale of its Fontaine-lès-Dijon site to Astrea Pharma. Astrea Pharma is a CDMO provider specializing in the manufacturing of solid dose and aseptic dosage forms of small molecule oral solids.

U.S. Small Molecule Innovator API CDMO Market Segmentation:

By Stage Type

• Preclinical
• Clinical
  • Phase I
  • Phase II
  • Phase III
• Commercial

By Customer Type

• Pharmaceutical
  • Small
  • Medium
  • Large
• Biotechnology
  • Small
  • Medium
  • Large

By Therapeutic Area

• Cardiovascular Diseases
• Oncology
• Respiratory Disorders
• Neurology
• Metabolic Disorders
• Infectious Diseases
• Others

By Region

• Northeast
  • New Jersey
  • New York
• Midwest
  • Illinois
  • Missouri
• West Group
  • California
  • Washington
• South
  • Texas
  • Florida