U.S. Small Molecule Innovator API CDMO (Preclinical, Clinical, Commercial) Market Research 2024-2030: Outsourcing Gains Traction as Risk-Averse Strategy for Early-Stage Drug Developments - ResearchAndMarkets.com

The "U.S. Small Molecule Innovator API CDMO Market Size, Share & Trends Analysis Report by Stage Type (Preclinical, Clinical, Commercial), Customer Type, Therapeutic Area, Region, and Segment Forecasts, 2024-2030" report has been added to ResearchAndMarkets.com's offering.

The U.S. small molecule innovator API CDMO market size is anticipated to reach USD 12.60 billion by 2030 and is projected to grow at a CAGR of 6.17% from 2024 to 2030. A growing outsourcing trend among pharmaceutical companies, increasing demand for small molecule drugs, and surge in clinical trials are anticipated to influence the U.S. market positively.

Small molecules continue to play an important role in developing new treatments globally. Specialty medicines are increasingly driving U.S. pharmaceutical growth, particularly in developed markets, with small molecule applications accounting for over half of specialty sales. In addition, enhanced efficiency serves as another pivotal driver for pharmaceutical outsourcing. With mounting pressure on pharmaceutical companies to expedite the introduction of new drugs to the market, outsourcing emerges as a solution to accelerate the drug development process. Leveraging their expertise, experience, and cutting-edge equipment, CDMOs facilitate the swift & efficient production of high-quality drugs, enabling pharmaceutical firms to adhere to their development schedules.

The pharmaceutical/biotechnology companies increasingly opt for CDMO services to leverage their expertise. CDMOs offer flexibility & scalability in manufacturing capacity, allowing pharmaceutical companies to adapt to changing market demands and accelerate time to market for new therapies. In addition to providing extended expertise and assisting in improved cash flow management, outsourcing brings significant manufacturing advantages, including reducing investment risks. In the context of early-stage technologies and products, establishing expensive in-house capabilities entails substantial risks across the product development phases. At the same time, outsourcing serves as a risk-averse alternative.

The preference for outsourcing small molecule API has grown as an effective strategy until market demand for products becomes well-established and understood. For instance, in May 2022, Piramal Pharma Limited's Pharma Solutions business, a CDMO, inaugurated a new API facility at its site in Aurora, Ontario. This state-of-the-art plant has commenced operations & has completed its initial production runs.

U.S. Small Molecule Innovator API CDMO Market Report Highlights

• Based on stage, the clinical segment led the market with the largest revenue share of 54.79% in 2023. The segment growth can be attributed to the rising clinical trial (Phase I-III) activities, growing small molecule development pipeline, and increasing availability of expertise
• Based on the customer type, the pharmaceutical segment held the market with the largest revenue share of 91.89% in 2023, attributing to rising funding for drug development is propelling segment growth
• Based on therapeutic area, the oncology segment accounted for the largest revenue share of 42.05% in 2023. The segment is driven by increasing prevalence of cancer in U.S. In addition, high R&D investments in advanced therapeutics to minimize cancer disease burden are expected to boost segment growth
• West Group dominated the U.S. market with the largest revenue share of 33.19% in 2023. The presence of various factors, such as increasing prevalence of chronic diseases, demand for APIs & CDMO services and improving healthcare infrastructure is expected to drive market significantly

Companies Featured

• 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.

Key Attributes:

Key Topics Covered:

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

2.1. Market Outlook

2.2. Segment Outlook

2.3. Competitive Insights

Chapter 3. U.S. Small Molecule Innovator API CDMO Market Variables, Trends & Scope

3.1. Market Lineage Outlook

3.1.1. Parent market outlook

3.1.2. Ancillary Market outlook

3.2. Market Dynamics

3.2.1. Market driver analysis

3.2.1.1. Increasing Demand for Small Molecule Drugs

3.2.1.2. Increasing Outsourcing Trends Among Pharmaceutical Companies

3.2.1.3. Surge in Number of Clinical Trials

3.2.2. Market restraint analysis

3.2.2.1. Compliance Issues While Outsourcing

3.3. Technology Landscape

3.3.1. Integration Of AI in U.S. Small Molecule Innovator API CDMO Market

3.3.1.1. Current Dynamics and Future Trends

3.3.1.1.1. Drug Discovery and Design

3.3.1.1.2. AI-Assisted Drug API Synthesis

3.3.1.1.3. Process Optimization

3.3.1.1.4. Supply Chain Management

3.3.1.1.5. Clinical Trial Optimization

3.3.1.1.6. Regulatory Compliance

3.4. Total Number of Clinical Trials in U.S. (2021-2023)

3.4.1. Total Number of Clinical Trials by Phase (2021-2023)

3.4.2. Total Number of Clinical Trials by Therapeutic Area (2021-2023)

3.5. U.S. Small Molecule Innovator API CDMO Market: Regulatory Scenario /Framework

3.6. U.S. Small Molecule Innovator API CDMO Market: Analysis Tools

3.6.1. Porter's Five Forces Analysis

3.6.2. PESTEL Analysis

3.7. Impact of COVID-19 on Small Molecule Innovator CDMO Market

3.8. COVID-19 Impact Analysis

Chapter 4. U.S. Small Molecule Innovator API CDMO Market: Stage Type Estimates & Trend Analysis

4.1. Segment Dashboard

4.2. U.S. Small Molecule Innovator API CDMO Market Movement Analysis

4.3. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Stage Type, 2018 to 2030 (USD Million)

4.3.1. Preclinical

4.3.1.1. Market estimates and forecast 2018 to 2030 (USD Million)

4.3.2. Clinical

4.3.2.1. Market estimates and forecast 2018 to 2030 (USD Million)

4.3.2.2. Phase I

4.3.2.3. Phase II

4.3.2.4. Phase III

4.3.3. Commercial

Chapter 5. U.S. Small Molecule Innovator API CDMO Market: Customer Type Estimates & Trend Analysis

5.1. Segment Dashboard

5.2. U.S. Small Molecule Innovator API CDMO Market Movement Analysis

5.3. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Customer Type, 2018 to 2030 (USD Million)

5.3.1. Pharmaceutical

5.3.1.1. Market estimates and forecast 2018 to 2030 (USD Million)

5.3.1.2. Small

5.3.1.3. Medium

5.3.1.4. Large

5.3.2. Biotechnology

5.3.2.1. Market estimates and forecast 2018 to 2030 (USD Million)

5.3.2.2. Small

5.3.2.3. Medium

5.3.2.4. Large

Chapter 6. U.S. Small Molecule Innovator API CDMO Market: Therapeutic Area Estimates & Trend Analysis

6.1. Definitions and Scope

6.2. Therapeutic Area Market Share, 2023 & 2030

6.3. Segment Dashboard

6.4. U.S. Small Molecule Innovator API CDMO Market Movement Analysis

6.5. U.S. Small Molecule Innovator API CDMO Market Size & Trend Analysis, by Therapeutic Area, 2018 to 2030 (USD Million)

6.5.1. Cardiovascular Diseases

6.5.1.1. Market estimates and forecast 2018 to 2030 (USD Million)

6.5.2. Oncology

6.5.3. Respiratory Disorders

6.5.4. Neurology

6.5.5. Metabolic Disorders

6.5.6. Infectious Diseases

6.5.7. Others

Chapter 7. U.S. Small Molecule Innovator API CDMO Market: Regional Estimates & Trend Analysis by Product, Workflow, & Application

7.1. Regional Market Dashboard

7.2. Global Regional Market Snapshot

7.3. Market Size, & Forecasts Trend Analysis, 2018 to 2030:

7.4. Northeast

7.4.1. Market estimates and forecast, 2018-2030 (USD Million)

7.4.2. New Jersey

7.4.2.1. Competitive Scenario

7.4.2.2. Market estimates and forecast, 2018-2030 (USD Million)

7.4.3. New York

7.5. Midwest

7.5.1. Market estimates and forecast, 2018-2030 (USD Million)

7.5.2. Illinois

7.5.3. Missouri

7.6. West Group

7.6.1. Market estimates and forecast, 2018-2030 (USD Million)

7.6.2. California

7.6.3. Washington

7.7. South

7.7.1. Market estimates and forecast, 2018-2030 (USD Million)

7.7.2. Texas

7.7.3. Florida

Chapter 8. Competitive Landscape

8.1. Market Participant Categorization

8.2. Service Heat Map Analysis (a comparative analysis of the players together)

8.3. Company Profiles

8.3.1. Strategy Mapping

8.3.2. Expansion

8.3.3. Partnerships

8.3.4. Acquisitions

8.4. Vendor Landscape

8.4.1. Key company market share analysis, 2023

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