Global Small Molecule API Market: Snapshot

Over the past ten years, the attention of pharmaceuticals world over has veered off from goldmine of opportunities found in large molecules biologics to small molecules APIs. The shift has been slow but steady: small-molecule pharmaceuticals accounted for as much as 82% of all new molecule entities (NMEs) approvals in 2014. The number climbed to 71%, or 42 to be precise, of all NMEs approved by the U.S. FDA alone. The trend underscores resurging interest in small molecules, hence pushing the prospects of the small molecule API market to a new level.

With small molecule API holding a majority of drug development pipeline and growing numbers of NME approvals, the small molecule API market has been making steady evolution. Over the past few years, growing nod by the FDA for various drug approvals points to a potentially encouraging trend for the expansion of the small molecule API market. Some of the key product development pipeline primarily utilizing small molecule API include kinase inhibitors and anti-retroviral products.

A report on the global small molecule API market strives to take a holistic look on the various growth dynamics, emerging opportunities, and major drug pipeline investments. The analysis also highlights key production capacity expansions made by players in the small molecule API market.

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Global Small Molecule API Market: Regional Analysis

Numerous big pharma companies with the likes of Pfizer and AbbVie and a few and biotechnology companies have been pitching for NME approvals that include small molecules API. This alone underscores the vast potential of the small molecule API market.

For instance, Pfizer, a prominent biopharmaceutical companies worldwide, has made bagged four NME approvals: Daurismo (glasdegib), Lorbrena (loratinib), Talzenna (talazoparib), Vizimpro (dacomitinib). All of these were small molecule APIs. Even generic drug makers are searching for new revenue streams in the small molecule API market. A case in point is Mylan who bagged a NME approval for its small molecule Yupelri in 2018. The medication is used for treating chronic obstructive pulmonary disease (COPD).

An renowned American pharmaceutical company Eli Lilly announced in January 2019 that it was acquiring Loxo Oncology. With this, the company intended to fork out $8 billion on the pipeline of drugs that can be used for treating rare cancers. Such measures are opening new avenues in the small molecule API market.   

Some of the prominent players operating in the small molecule API market are

  • Johnson & Johnson
  • AstraZeneca
  • Bachem Holding AG
  • Bristol-Myers Squibb
  • Sanofi S.A.

Global Small Molecule API Market: Growth Dynamics

A large part of anti-cancer drugs in the healthcare industry are utilizing the potential of small molecule APIs, probably owing to several advantages these have over advantages over large molecules. Continuously expanding arsenal of oncology drugs in developing and developed countries over the world is bolstering the prospects of the small molecule API market. The growth has been largely supported by parallel advances in chemical manufacturing technologies over the last ten years.

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Over the past few years, the outsourcing of small molecule APIs has grown substantially with CMOs seeing vast potential in the market. This has helped bring efficiency across the entire value chain.

Companies in the small molecule API market are harnessing the potential of particle engineering to accelerate time-to-market of several anti-cancer drugs. Further, small molecule API manufacturers are trying to establish strong relationship management with large pharmacy chains. In the coming years, transparency in pricing strategies and greater participation of small molecule API manufacturers will open new revenues streams in the small molecule API market.

Global Small Molecule API Market: Regional Analysis

On the regional front, the U.S. has for years remained the central axis of developments by prominent small molecule API manufacturers. These companies have been unceasingly expanding their production capacities. Additionally, they are focusing on adopting strategies aimed at expanding their technical expertise. On the other hand, Asia Pacific is making rapid emergence in the small molecule API market. Supporting factors include economies of scale, large unmet need among patient populations, and top players setting their production bases to key economies of the region, notably Japan.

The report offers a comprehensive evaluation of the market. It does so via in-depth qualitative insights, historical data, and verifiable projections about market size. The projections featured in the report have been derived using proven research methodologies and assumptions. By doing so, the research report serves as a repository of analysis and information for every facet of the market, including but not limited to: Regional markets, technology, types, and applications.

The study is a source of reliable data on:

  • Market segments and sub-segments
  • Market trends and dynamics
  • Supply and demand
  • Market size
  • Current trends/opportunities/challenges
  • Competitive landscape
  • Technological breakthroughs
  • Value chain and stakeholder analysis

The regional analysis covers:

  • North America (U.S. and Canada)
  • Latin America (Mexico, Brazil, Peru, Chile, and others)
  • Western Europe (Germany, U.K., France, Spain, Italy, Nordic countries, Belgium, Netherlands, and Luxembourg)
  • Eastern Europe (Poland and Russia)
  • Asia Pacific (China, India, Japan, ASEAN, Australia, and New Zealand)
  • Middle East and Africa (GCC, Southern Africa, and North Africa)

The report has been compiled through extensive primary research (through interviews, surveys, and observations of seasoned analysts) and secondary research (which entails reputable paid sources, trade journals, and industry body databases). The report also features a complete qualitative and quantitative assessment by analyzing data gathered from industry analysts and market participants across key points in the industry’s value chain.

A separate analysis of prevailing trends in the parent market, macro- and micro-economic indicators, and regulations and mandates is included under the purview of the study. By doing so, the report projects the attractiveness of each major segment over the forecast period.

Highlights of the report:

  • A complete backdrop analysis, which includes an assessment of the parent market
  • Important changes in market dynamics
  • Market segmentation up to the second or third level
  • Historical, current, and projected size of the market from the standpoint of both value and volume
  • Reporting and evaluation of recent industry developments
  • Market shares and strategies of key players
  • Emerging niche segments and regional markets
  • An objective assessment of the trajectory of the market
  • Recommendations to companies for strengthening their foothold in the market   

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.