Small Molecule API Market Size Worth USD 307.69 Billion in 2032 | Emergen Research

The rising investments in Research and Development (R&D) activities and government funding and policies, upcoming patent expiry of most popular pharmaceutical products and rapid growth of the pharmaceutical industry are some of the key drivers propelling the Small molecule API industry growth during the forecast period.

The small molecule Active Pharmaceutical Ingredients (API) market size was USD 182.30 Billion in 2022 and is expected to register a revenue CAGR of 5.3% during the forecast period. The Small Molecule Active Pharmaceutical Ingredient (API) industry is witnessing significant growth globally, fueled by various drivers propelling its expansion during the forecast period. These drivers include rising investments in Research and Development (R&D), government funding and policies, increasing outsourcing of API production, rapid technological advancements, upcoming patent expiries, and the rapid growth of the pharmaceutical industry.

Small molecule drugs, characterized by their low molecular weight, are essential in controlling biological processes and targeting a variety of diseases with large patient populations. Their production involves organic synthesis or microbial fermentation methods, providing advantages such as stability, oral bioavailability, and simpler dosing and treatment procedures compared to biologics.

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Rising Prevalence of Chronic Diseases, the escalating prevalence of chronic diseases has led to a growing demand for drug development and novel therapeutics, driving the pharmaceutical industry forward. Small molecule APIs, being replicas of natural compounds, offer significant advantages over biologics, contributing to market growth.

Advantages of Small Molecule APIs Small molecule drugs offer better Pharmacokinetics (PK) and Pharmacodynamics (PD), along with simpler dosing and treatment procedures. Recent data from the US Food and Drug Administration (FDA) indicates that small molecule drugs dominate new drug approvals, constituting approximately 75% of recent approvals, further fueling market expansion.

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Regional Market Insights
North America: The region holds a significant market share, driven by factors such as the rising incidence of chronic diseases and technological advancements. Recent developments include the release of an Expanded Access Program (EAP) for ALS patients and strategic research partnerships.

Europe: Growing government funding, regulations, and research and development activities are key drivers of market growth. Strategic partnerships and the establishment of new manufacturing facilities further bolster the industry in this region.

Asia Pacific: The region is poised to experience robust growth, supported by increasing government regulations, R&D activities, and the emergence of major biopharmaceutical companies. Initiatives such as the production-linked incentive (PLI) scheme in India and the introduction of innovative technologies in China contribute significantly to market expansion.

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Major Companies and Competitive Landscape
The global small molecule Active Pharmaceutical Ingredients (API) market is fairly fragmented, with many large and medium-sized players accounting for majority of market revenue. Major players are deploying various strategies, entering into mergers & acquisitions, strategic agreements & contracts, developing, testing, and introducing more effective small molecule Active Pharmaceutical Ingredients (API) solutions.
• Pfizer Inc.
• Merck KGaA
• AstraZeneca
• Hoffmann-La Roche Ltd.
• Novartis AG
• Sanofi
• Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd.
• Bristol-Myers Squibb Company
• GSK plc.
• Gilead Sciences, Inc

Strategic Development

On 28 October 2021, X-Chem, the pioneer of DNA-encoded library (DEL) technology and global leader in development of small molecule drug discovery unveiled the acquisition of Glamorous AI, a leader in artificial intelligence (AI) solutions for drug discovery in order to provider in machine learning-driven drug discovery.

On 20 May 2022, Almac Discovery, the research driven drug discovery company announced a new research association with HitGen Inc., a world leader in the development for small molecule drugs and application of DNA-encoded library (DEL) technology for novel chemical equity (NCE) generation.

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For the purpose of this report, Emergen Research has segmented global small molecule Active Pharmaceutical Ingredients (API) market on the basis of Product Type, Molecule Type, Manufacturing, Application, Therapeutic Area, End-Use, and region:
• Product Type Outlook (Revenue, USD Billion; 2019-2032)
o Synthetic/ Chemical Product
o Biotech Product

• Molecule Type Outlook (Revenue, USD Billion; 2019-2032)
o Standard API
o HPAPI (Highly Potent Active Pharmaceutical Ingredients)
• Manufacturing Outlook (Revenue, USD Billion; 2019-2032)
o In-house
o Outsourced

• Application Outlook (Revenue, USD Billion; 2019-2032)
o Clinical
o Commercial

• Therapeutic Area Outlook (Revenue, USD Billion; 2019-2032)
o Cardiovascular Diseases
o Oncology
o Neurology and Central Nervous System (CNS)
o Orthopedic
o Respiratory Disorders
o Infectious Diseases
o Metabolic Disorders
o Immunology
o Urology
o Dermatology
o Ophthalmology
o General Health
o Others

• End-Use Outlook (Revenue, USD Billion; 2019-2032)
o Hospitals
o Ambulatory Surgical Centers
o Health Clinics
o Others

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