Small Molecule Active Pharmaceutical Ingredient (API) Market Forecasts to 2030 – Global Analysis By Production (Outsourced and Captive/In-House), Therapeutic Area (Respiratory Disorders, Metabolic Disorders, Infectious Diseases, Cardiovascular Diseases and Other Therapeutic Areas) and By Geography
According to Stratistics MRC, the Global Small Molecule Active Pharmaceutical Ingredient (API) Market is accounted for $169.5 billion in 2024 and is expected to reach $290.6 billion by 2030 growing at a CAGR of 9.4% during the forecast period. A Small Molecule Active Pharmaceutical Ingredient (API) refers to a low molecular weight compound that is pharmacologically active and used in the formulation of medications. These compounds typically have a molecular weight less than 900 Daltons and are characterized by their ability to interact with specific biological targets to elicit a therapeutic effect. Small molecule APIs are often synthesized through chemical processes and can be administered orally, topically, or through other routes.
According to the Drug, Chemical & Associated Technologies Association (DCAT), in 2021, 50 New Molecular Entities (NME) were approved, of which 36 products were small molecule entities.
Market Dynamics:
Driver:
Rising prevalence of chronic diseases
The increasing prevalence of chronic diseases such as diabetes, cardiovascular conditions, and cancer is significantly driving the growth of the Small Molecule Active Pharmaceutical Ingredient (API) market. Chronic diseases require long-term management and consistent medication, leading to a heightened demand for effective small molecule drugs. These APIs, which are crucial in the development of pharmaceuticals, offer targeted and often more manageable treatments compared to biologics. Furthermore, their ability to penetrate cells and modulate specific biological pathways makes them indispensable for treating chronic conditions.
Restraint:
Environmental and safety concerns
Environmental and safety concerns significantly impact the production and development of Small Molecule Active Pharmaceutical Ingredients (APIs). The synthesis of these molecules often involves hazardous chemicals and processes, leading to potential environmental pollution and safety risks. Waste products and emissions from manufacturing can contaminate soil and water, posing long-term ecological and health hazards. Regulatory pressures require stringent measures to minimize these impacts, leading to increased costs and complexities in API production. However, companies must invest in advanced technologies and practices to reduce their environmental footprint and ensure worker safety, which can be financially burdensome.
Opportunity:
Increasing demand for generic drugs
The rising demand for generic drugs is substantially boosting the market for Small Molecule Active Pharmaceutical Ingredients (APIs). As patents for branded pharmaceuticals expire, generic drug manufacturers can produce and market copies of these medications at lower costs, making healthcare more accessible. This shift drives up the need for small molecule APIs, which are the foundational ingredients in these generic drugs. Additionally, small molecule APIs, known for their stability and well-established production processes, are crucial for creating cost-effective generic medications.
Threat:
Intellectual property issues
Intellectual property (IP) issues significantly hinder the development and production of Small Molecule Active Pharmaceutical Ingredients (APIs) by creating barriers to innovation and market access. Pharmaceutical companies invest heavily in research and development to discover and develop new small molecule APIs, but IP conflicts, such as patent disputes and overlapping claims, can stall progress. However, patent thickets dense webs of overlapping patents can make it challenging for companies to navigate licensing agreements and may delay the introduction of new APIs.
Covid-19 Impact:
The COVID-19 pandemic significantly impacted the small molecule Active Pharmaceutical Ingredient (API) industry by disrupting global supply chains and manufacturing processes. With stringent lockdowns, travel restrictions, and factory shutdowns, the production and distribution of APIs faced severe delays and shortages. Many small molecule APIs, critical for various treatments and medications, experienced shortages due to the dependency on a few key manufacturing hubs, primarily in Asia. This disruption not only hindered the production of essential drugs but also led to increased costs and price volatility.
The Outsourced segment is expected to be the largest during the forecast period
Outsourced segment is expected to be the largest during the forecast period. Small molecule APIs, essential for pharmaceutical formulations, require precise development to ensure efficacy, safety, and cost-effectiveness. By outsourcing this segment, pharmaceutical companies can leverage the expertise, advanced technologies, and resources of specialized contract development and manufacturing organizations (CDMOs) to enhance these molecules. This process may include improving synthesis methods, increasing yield, refining purification techniques, or optimizing the overall production process.
The Cardiovascular Diseases segment is expected to have the highest CAGR during the forecast period
Cardiovascular Diseases segment is expected to have the highest CAGR during the forecast period. Small molecules are a cornerstone in cardiovascular therapy due to their ability to interact with specific biological targets, modulating their activity to manage diseases such as hypertension, heart failure, and coronary artery disease. Enhancing these APIs involves optimizing their chemical properties to increase bioavailability and reduce side effects, improving the drug's stability and solubility, and developing advanced delivery systems for targeted action. This process often includes the use of cutting-edge technologies like structure-based drug design and high-throughput screening.
Region with largest share:
North America region commanded the largest share of the market over the extrapolated period. As the demographic shifts towards an older population, there is an increased demand for pharmaceuticals to manage chronic diseases and age-related health issues, such as cardiovascular conditions, diabetes, and neurological disorders across the region. This rising demand is driving growth in the API market, as pharmaceutical companies intensify their focus on developing and manufacturing small molecules that can address these health concerns throughout the region. The regional need for effective treatments for age-related conditions fuels innovation and investment in API research and development, contributing to advancements in drug efficacy and safety.
Region with highest CAGR:
Europe region is projected to hold profitable growth during the forecast period. European Medicines Agency (EMA) and national regulatory bodies enforce stringent guidelines that promote rigorous testing, documentation, and manufacturing practices. These regulations foster a robust environment for innovation and reliability, ensuring that APIs meet the highest standards before reaching the market. Furthermore, this regulatory framework not only protects public health but also boosts investor confidence and facilitates market access for pharmaceutical companies.
Key players in the market
Some of the key players in Small Molecule Active Pharmaceutical Ingredient (API) market include Aurobindo Pharma, Boehringer Ingelheim GmbH, Cambrex Corporation, Dr. Reddy’s Laboratories Ltd, Gilead Sciences, Inc, GlaxoSmithKline PLC, Novartis AG, Pfizer Inc, Sanofi S.A, Sun Pharmaceutical Industries Ltd and Teva Pharmaceutical Industries Ltd.
Key Developments:
In October 2023, Axplora announced the cGMP (current Good Manufacturing Practices) approval from Agenzia Italiana Del Farmaco (AIFA) for the expansion of the manufacturing capacities for HPAPIs and steroids in to meet the growing demand.
In March 2023, medicine developer CatSci announced a distribution agreement with small molecule developer AGC Pharma Chemicals (CDMO). For the development of new therapeutics, AGC says CatSci has the expertise to develop chemicals and analytical methods, crystallization and solids, pre-formulation, and high-potency active pharmaceutical ingredients (API), along with chemical manufacturing and control (CMC).
Productions Covered:
• Outsourced
• Captive/In-House
Therapeutic Areas Covered:
• Respiratory Disorders
• Metabolic Disorders
• Infectious Diseases
• Cardiovascular Diseases
• Other Therapeutic Areas
Regions Covered:
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Research Assistance
Download our eBook: How to Succeed Using Market Research
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
Download eBook