Small Molecule API Global Market Report 2024

The global small molecule api market has grown strongly in recent years. It will grow from $193.44 billion in 2023 to $206.88 billion in 2024 at a compound annual growth rate (CAGR) of 6.9%. The historical growth in this sector can be attributed to the expansion of generic drug manufacturing, heightened investment in research and development, growing demands from an aging population, advancements in oncology treatments, and the emergence of targeted therapies.

The global small molecule api market is expected to see strong growth in the next few years. It will grow to $275.14 billion in 2028 at a compound annual growth rate (CAGR) of 7.4%. The projected growth in the upcoming period can be linked to various factors, including a focus on supply chain resilience, the integration of digitalization in pharmaceutical manufacturing, heightened investments in oncology, the adoption of green chemistry, and the evolving healthcare demands driven by the pandemic. Notable trends anticipated in this forecast period encompass the synergy within biopharmaceuticals, the advancement of personalized medicine, the implementation of advanced manufacturing techniques, and the increasing prominence of API outsourcing and contract manufacturing.

The small-molecule API market is poised for growth, driven by the increasing demand for small-molecule drugs. Small-molecule drugs, characterized by low molecular weight, play a crucial role in modulating biochemical processes to diagnose, treat, or prevent diseases. Common medications found in medicine cabinets, such as aspirin and diphenhydramine, fall under the category of small-molecule drugs. These drugs contribute to preventing various diseases, with a significant proportion being accepted by the Food and Drug Administration (FDA) in 2021. According to the National Center for Biotechnology Information (NCBI), 75% of FDA-approved drugs in 2021 were small molecules, with oncology being the dominant therapeutic area. Notably, over 50% of these approvals originated from small and mid-sized companies, underscoring the crucial role of Contract Development and Manufacturing Organizations (CDMOs) in supporting the commercialization of products. This trend contributes to the growth of the small-molecule API market, driven by the expanding demand for small-molecule drugs.

The growth of the small-molecule API market is further propelled by the increasing prevalence of chronic diseases. Chronic diseases, lasting three months or more, include conditions like cardiovascular diseases, diabetes, and cancer, necessitating long-term medication. Small-molecule APIs play a pivotal role in formulating drugs with optimized bioavailability, improved pharmacokinetics, and reduced side effects, enhancing the overall effectiveness and patient acceptability of long-term treatment regimens for chronic conditions. As reported by the National Center for Biotechnology Information (NCBI), the global population with chronic diseases is expected to reach 142.66 million by 2050, doubling from 71.522 million in 2020. This surge in chronic diseases contributes to the growing demand for small-molecule APIs, driving the growth of the market.

A notable trend in the small-molecule API market is the emphasis on strategic partnerships. Many companies in the market are actively engaging in partnerships to strengthen their market positions and advance the development of drugs and therapies. For instance, in March 2023, CatSci Ltd., a UK-based pharmaceutical company, partnered with AGC Pharma Chemicals, a Spain-based pharmaceutical company, to enhance drug development. This collaboration leverages CatSci's non-clinical expertise with AGC's manufacturing capabilities, particularly supporting clinical phase projects. The partnership aims to provide strategic value, expedite drug development timelines, and deliver impactful small-molecule API-based medicines globally. This trend underscores the significance of collaborative efforts in driving innovation and growth within the small-molecule API market.

Major companies in the small molecules API market are actively developing new technologies to address solubility challenges, particularly for oral small molecules. In March 2022, Evonik Industries AG, a leading Germany-based specialty chemicals company, introduced EUDRATEC SoluFlow. This microparticle technology is specifically designed to enhance the solubility of active pharmaceutical ingredients (APIs) in oral drugs. EUDRATEC SoluFlow employs an emulsion-based process to overcome solubility challenges for over 70% of new small molecules. The technology facilitates the development of oral therapeutics in critical medical areas by transforming poorly soluble drugs into easily processed amorphous solid dispersions (ASD). Notably, this innovation reduces post-processing complexity, offering a significant advancement in addressing solubility issues for oral small molecules.

In a strategic move, GHO Capital, a European specialist investor in healthcare companies, made a noteworthy acquisition in March 2022 by securing a majority stake in Sterling Pharma Solutions. This acquisition positions GHO Capital to leverage extensive pharmaceutical expertise in Europe and expand its market presence in the United States. Sterling Pharma Solutions, a US-based manufacturer specializing in active pharmaceutical ingredients (APIs), aligns with GHO Capital's strategic objectives in the healthcare sector. This move underscores the significance of strategic investments and partnerships in driving growth and innovation within the small molecules API market.

Major companies operating in the small molecule api market report are Merck & Co. Inc., AbbVie Inc., Bristol-Myers Squibb Company, Albemarle Corporation, Boehringer Ingelheim International GmbH, Dr. Reddy's Laboratories Ltd., Aurobindo Pharma, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Viatris Inc., Cambrex Corporation, Lonza Group AG, Siegfried Holding AG, AstraZeneca, F. Hoffmann-La Roche AG, Nanjing King-friend Biochemical Pharmaceutical Co. Ltd., Albany Molecular Research Inc., Allergan PLC, Atomwise Inc., BASF SE, BenevolentAI Limited, Certara L.P., Exscientia AI Limited, Gilead Sciences Inc., GlaxoSmithKline PLC, HotSpot Therapeutics Inc., Insitro Inc., Johnson Matthey PLC, Novartis AG

North America was the largest region in the small molecule API market in 2023. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the small molecule api market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the small molecule api market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The primary categories of small molecule APIs encompass synthetic and biotech variations. Synthetic small molecule APIs are created within laboratory settings through diverse chemical processes. Manufacturing of these small molecule APIs can occur in-house or through outsourced means, catering to multiple applications such as cardiology, oncology, CNS and neurology, orthopaedics, endocrinology, and various other medical fields.

This report provides small molecule API market statistics, including small molecule API industry global market size, regional shares, competitors with a small molecule API market share, detailed small molecule API market segments, market trends and opportunities, and any further data you may need to thrive in the small molecule API industry. This small molecule API market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The small molecules API market consists of sales of contract and captive small molecules API. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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