Small Molecule API Market

Small Molecule API Market: APEJ Projected to be the Most Lucrative Regional Market During the Forecast Period: Global Industry Analysis 2012-2016 & Opportunity Assessment 2017-2027

Key Insights

Geographical Expansion of Western Small Molecule API Manufactures Bent towards Asia

As an effort to expand geographically, many small molecule API manufacturers are expanding geographically. Small molecule API manufacturers are basing their commercial production units in Asia, to gain competitive advantage. Small molecule API manufacturers are seeking benefits such as proximity to sink markets with lots of demand for small molecule APIs and drugs in addition to benefitting from economies of scale in production.

To exemplify, small molecule API manufacturers Alcami, originally based out of the U.S., opened an office in Tokyo, Japan in October 2017 as part of its effort to expand its drug development and manufacturing presence in Japan. The small molecule API manufacturers have planned to add global sales and business development staff followed by quality, regulatory and project management teams.

The U.S. Still Preferred Source and Sink Market for Highly Potent Small Molecule API Manufacturing

Most highly potent small molecule API manufacturing facilities are located in the U.S. and the trend is closely followed for expansion purposes by most of the small molecule API manufacturers. The reasons for the U.S. being the preferred market for small molecule API manufacturing are availability of quality infrastructure required for manufacturing highly toxic and potent small molecule APIs.

Availability of quality personnel trained in handling equipment required to manufacture highly potent small molecule APIs is another factor. Multiple facilities manufacturing small molecule APIs are built by each firm. For example, small molecule API manufacturer Durham, NC, U.S.-based Avista Pharma Solutions completed expansion of its Colorado-based Longmont, small molecule API manufacturing site, in 2017. 

The small molecule API manufacturer upgraded three existing manufacturing suites and added a fourth facility capable of handling potent small molecule API of SafeBridge occupational exposure bands of 3A and 3B. Furthermore, leading small molecule API contract manufacturer - Cambrex completed expansion at its Iowa, Charles City-based manufacturing site, adding 1,000- and 4,000-gallon glass-lined reactors in the 7,500-square-foot plant opened in July 2016. 

The small molecule API manufacturer plans additional expansion at the site at an estimated cost outlay of US$ 24 Mn, to build a 4,500-square-foot highly potent small molecule API plant-expected to open in 2019.

Particle Engineering Advancements Adding to Complexity of Small Molecule API Development

Advancements in particle engineering techniques adding to complexity of small molecule API and drug designing. For small molecule APIs and drugs, particle engineering helps in modifying physicochemical, micromeritic and biopharmaceutical properties of the poorly soluble drugs and hence solubility. This enhanced solubility is required for pulmonary drug delivery, controlled release formulations, taste masking, manufacturing nanomedicines for targeted drug delivery, etc.

Various particle engineering processes in small molecule API and drugs manufacturing are supercritical fluid technology, cryogenic technology, nanomilling, sonocrystallization, spray drying, direct controlled crystallization and electrospraying methods.

Small Molecule API Manufacturers Expanding in Terms of Product Offering and Reducing in Operational Cost

Small molecule API manufacturers are focusing on reduction in operating costs through outsourcing of R&D and commercialization of drugs to CMOs/CDMOs.  This could increase efficiency of small molecule API manufacturers. Outsourcing of small molecule APIs at later stages of clinical development through identification and appointment of a strategic partner could improve efficiencies all along the value chain in the small molecule API market.

Adopting balanced portfolio approach could help in mitigating risks and also expanding the sale of small molecule API manufacturers. This refers to possession of branded drugs, branded generic drugs and unbranded drugs together in the portfolio of small molecule API manufacturers. Additionally, well defined forward linkages in the supply chain in small molecule API market could help garner higher market shares across regions over the forecast period.

Forward linkages in this regard refer to adoption of local sales force by small molecule API manufacturers, strong relationship management with large pharmacy chains, transparency in pricing and invoicing by small molecule API manufacturers, etc.

Stringent Regulatory Dynamics are Hampering the Growth of Small Molecule API Market

Stringent global regulatory policies on quality assessments of small molecule API manufacturing, facility certification, enhanced cGMP guidelines tightening surprise inspection regimes and increased supply chain security issues across emerging countries are factors that have large impact on the cost of final small molecule API products.

The new entrants willing to enter into small molecule API manufacturing are facing financial challenges owing to aforementioned factors. This makes the small molecule API market entry a financially unprofitable for SMEs. Such changing regulatory dynamics are hampering the growth of small molecule API market in emerging countries.

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Competitive Landscape

The FMI report titled “small molecule API Market” provides detailed information about the growth parameters of the small molecule API companies. It includes detailed assessment of the competitive environment in the small molecule API market. The market study provides comprehensive data on each stakeholder in the small molecule API market.

Some key market participants included in FMI’s global small molecule API market report include Johnson Matthey, Siegfried Holding AG, Pfizer, Sanofi S.A., Novartis AG, Bristol-Myers Squibb, Boehringer Ingelheim GmbH, GlaxoSmithKline PLC, GILEAD Science Inc., Albany Molecular Research Inc., Bachem Holding AG, PCAS,  DSM, AstraZeneca, Johnson & Johnson, Merck & Co, Inc., BASF SE, F. Hoffmann-La Roche Ltd, Teva Pharmaceuticals, & Cambrex Corporation.

The small molecule API report provides readers with all-encompassing data on each manufacturer’s revenue shares, winning strategies, and latest information on mergers and acquisitions to help informed decision making in small molecule API market.

Considering the rapidly-growing small molecule API market, expansion in emerging economies is taking center stage. In this regard, some of the latest M&A big ticket deals in the small molecule API market are Pfizer’s complete acquisition of Hospira, Patheon and DSM merger, and merger of Cambridge Major Laboratories with AAIPharma to form Alcami.

Few factors driving the growth in the small molecule API market includes increasing adoption of specialty medicines, increase in abbreviated new drug applications, etc. Rising usage of generic drugs driven by access to affordable healthcare is also expected to increase production of small molecule APIs. Also, increasing prevalence of diseases such as cancer, cardiovascular and infectious diseases will fuel volume small molecule APIs manufactured.

Note: For full coverage of the competitive landscape, get in touch with our experts.


Small molecules APIs are chemical substances composed of two or more atoms with molecular weight of less than 900 Dalton. In this report, small molecule API segment is further categorized into standard API and high potency API.

In this report, the small molecule API market is segmented by molecule type, application type, and production type apart from therapeutic applications.

About the Report

The market study on the small molecule API market was recently published by FMI, which provides comprehensive market information affecting revenue growth of the small molecule API market during 2012-2027. Companies in the small molecule API Market can find the most accurate quantitative and qualitative information about the growth parameters of the other small molecule API manufacturers, which can help them develop data-driven business strategies in the coming future.

Additional Questions Answered

Readers can find detailed information about the important positive and negative factors affecting small molecule API market during the forecast period. Additionally, the small molecule API market report also contains valuable information that can provide biopharmaceutical contract manufacturers with answers to critical questions, such as

  • Which types of molecules account for the maximum demand for small molecule API market? Why is it so?
  • Why are the sales of small molecule API services and products highest in North America? What are the factors customers seek in small molecule API CMOs?
  • Which regulations in various regional segments are influencing the strategies of players in the small molecule API market?
  • Why is APEJ currently attracting lots of traction among most of the leading small molecule API contract manufacturers?
  • What are the current technology trends adopted by various small molecule API companies?
  • What are the outsourcing strategies being applied by drug manufacturers in order to sustain themselves in the competitive small molecule API market?

Research Methodology

The process of market research followed at FMI commences with extensive secondary research of the small molecule API market. Analysts obtain industry-validated, historic, and current data about the demand for small molecule API across the globe. Comprehensive secondary research is followed by extensive and in-depth primary research, where detailed information about the small molecule API market is obtained in terms of value (US$ Million).

Based on thorough secondary and primary research of the growth parameters of the small molecule API market, analysts come up with the most precise forecast on how the small molecule API market will grow during the forecast period.


Based on geographical region

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • Japan
  • Asia Pacific Excluding Japan (APEJ)
  • Middle East & Africa (MEA)

Depending on the production type

  • in-house
  • outsourced.

By therapeutic type, the market is segmented into

  • autoimmune diseases
  • oncology
  • metabolic diseases
  • ophthalmology
  • cardiovascular diseases
  • infectious diseases
  • neurology
  • respiratory disorders
  • dermatology
  • urology.

By application, the small molecule API market is divided into

  • clinical
  • commercial.

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Small Molecule API Market