PUBLISHER: The Business Research Company | PRODUCT CODE: 1678368
PUBLISHER: The Business Research Company | PRODUCT CODE: 1678368
A small-molecule active pharmaceutical ingredient (API) is a substance or mixture with a low molecular weight intended for use as the active ingredient in drug or medicinal product manufacturing.
The primary types of small molecule active pharmaceutical ingredient markets are synthetic, chemical, and biological. Synthetics engage in the manufacturing of pharmaceutical drugs, with synthetic chemical APIs, also known as small molecules, constituting a significant portion of the pharmaceutical market. Various therapeutic types, including autoimmune diseases, oncology, metabolic diseases, ophthalmology, cardiovascular diseases, infectious diseases, neurology, respiratory disorders, dermatology, and urology, are addressed. Manufacturing methods involve in-house and contract methods, with applications spanning clinical and commercial domains.
The small molecule active pharmaceutical ingredient market research report is one of a series of new reports from The Business Research Company that provides small molecule active pharmaceutical ingredient market statistics, including small molecule active pharmaceutical ingredient industry global market size, regional shares, competitors with a small molecule active pharmaceutical ingredient market share, detailed small molecule active pharmaceutical ingredient market segments, market trends and opportunities, and any further data you may need to thrive in the small molecule active pharmaceutical ingredient industry. This small molecule active pharmaceutical ingredient 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 molecule active pharmaceutical ingredient market size has grown strongly in recent years. It will grow from $194.18 billion in 2024 to $209.81 billion in 2025 at a compound annual growth rate (CAGR) of 8.0%. The growth in the historic period can be attributed to regulatory approvals, patent expirations, disease prevalence, pricing pressures, clinical trial outcomes.
The small molecule active pharmaceutical ingredient market size is expected to see strong growth in the next few years. It will grow to $285.23 billion in 2029 at a compound annual growth rate (CAGR) of 8.0%. The growth in the forecast period can be attributed to precision medicine, specialty therapeutics, sustainability initiatives, telehealth adoption, integration of AI. Major trends in the forecast period include outsourcing trends, targeted therapies, digitalization in pharma, virtual clinical trials, advanced analytics.
The growing prevalence of diseases is a significant factor driving the expansion of the small molecule active pharmaceutical ingredient (API) market. A disease is defined as a specific abnormal condition, a disruption of structure or function, affecting a patient's body. Active pharmaceutical ingredients (APIs) are the essential components in pharmaceutical drugs that produce the desired effect to treat various health conditions. For example, in March 2023, the American Society of Clinical Oncology (ASCO), a U.S.-based professional organization, reported that over 12,000 individuals in the U.S. were diagnosed with neuroendocrine tumors annually, with around 171,000 people living with this diagnosis in 2023. Additionally, cardiovascular diseases have led to 17.9 million deaths worldwide. As a result, the rising prevalence of diseases continues to be a primary driver of the small molecule API market.
The increasing adoption of personalized medicine is anticipated to further drive the growth of the small molecule API market. Personalized medicine, or precision medicine, is an advanced approach to medical treatment that considers individual variations in patients' genes, environments, and lifestyles. Small molecules, when formulated into pharmaceuticals, enable the creation of tailored treatments designed to address patients' unique genetic profiles and biomarkers, leading to more effective and individualized therapies. For instance, in 2022, the Personalized Medicine Coalition, a U.S.-based professional organization, reported that the FDA's Center for Drug Evaluation and Research (CDER) approved 37 new molecular entities (NMEs) in 2022. Of these 35 therapeutic NMEs, approximately 34%-or 12 drugs-were classified as personalized medicines by the Personalized Medicine Coalition (PMC). Consequently, the adoption of personalized medicine is driving the growth of the small molecule API market.
Strategic partnerships and collaborations are a key trend in the small molecule active pharmaceutical ingredient market, with major players reinforcing their positions through such alliances. In May 2022, NovAliX, Alysophil, De Dietrich Process Systems, and Bruker collaborated to jointly develop a new approach to active pharmaceutical ingredient (API) production. The partnership aims to offer complete, standalone, and location-independent API manufacturing solutions to pharmaceutical companies and contract manufacturing organizations (CMOs).
The key players in the small molecule API market are leveraging new technologies, such as microparticle technologies, to gain a competitive edge. Evonik Industries AG, a Germany-based specialty chemical company, introduced EUDRATEC SoluFlow in March 2022. This technology significantly enhances the solubility of active pharmaceutical ingredients in oral drug products, addressing challenges related to drug solubility. EUDRATEC SoluFlow transforms poorly soluble drugs into free-flowing powders of amorphous solid dispersions, simplifying manufacturing processes and improving pharmacokinetic performance.
In November 2022, Pharmaron Beijing, a China-based life science contract research organization, acquired the API Manufacturing Facility from Recipharm for an undisclosed amount. Through this acquisition, Pharmaron aims to strengthen its integrated chemistry and manufacturing capabilities to meet the increasing demand for small molecule drug R&D and manufacturing services. Active Pharmaceutical Ingredients (API) Manufacturing is a U.S.-based company specializing in the production of small molecule active pharmaceutical ingredients.
Major companies operating in the small molecule active pharmaceutical ingredient market include Pfizer Inc., BASF SE, Roche Holding AG, F. Hoffmann-La Roche Limited, AbbVie Inc., Allergan plc, Bayer AG, Novartis AG, Sanofi SA, Bristol Myers Squibb Company, AstraZeneca plc, Glaxo Smith Kline plc, China Resources Pharmaceutical Group Limited, Takeda Pharmaceutical Company Limited, Eli Lilly and Company, Gilead Sciences Inc., Boehringer Ingelheim International GmbH, Merck KGaA, Viatris Inc., Teva Pharmaceutical Industries Limited, Johnson Matthey plc, Astellas Pharma Inc., Albemarle Corporation, Sun Pharmaceutical Industries Limited, Aurobindo Pharma Limited, Dr Reddy's Laboratories Limited, Siegfried Holding AG, Albany Molecular Research Inc., Cipla Inc., Cambrex Corporation, Daiichi Sankyo Company Ltd., Eisai Co Ltd., Otsuka Holdings Co Ltd.
North America was the largest region in the small molecule active pharmaceutical ingredient market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the small molecule active pharmaceutical ingredient market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
The countries covered in the small molecule active pharmaceutical ingredient market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The small molecule active pharmaceutical ingredient market consists of sales of standard API, HPAPI (high potency active pharmaceutical ingredients), branded synthetic API, generic synthetic API, and semi-synthetic 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.
Small Molecule Active Pharmaceutical Ingredient Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on small molecule active pharmaceutical ingredient market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for small molecule active pharmaceutical ingredient ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The small molecule active pharmaceutical ingredient market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the Russia-Ukraine war, rising inflation, higher interest rates, and the legacy of the COVID-19 pandemic.