Small Molecule API Market

2021 Analysis and Review: Small Molecule API by Production - In-house and Outsource for 2021-2031

About the Report

Small molecules are chemical substances composed of two or more atoms with molecular weight of less than 900 Dalton.  Socioeconomic concerns and health issues in terms of prevalence of chronic diseases are prioritized around the world. This has resulted in the improvement in production facilities within the pharmaceutical sector, which has been fuelling the demand for active pharmaceutical ingredient (API).

While biologics are gradually making the presence felt, small molecule API continues to be cornerstone of pharmaceutical development. Rise in demand for effective treatment for chronic disease in various therapeutic areas has been fuelling the demand for small molecule API.

In its new study, ESOMAR-certified market research and consulting firm Future Market Insights offers insights into key factors driving demand for Small Molecule API. The report tracks global sales of small molecule API in 20+ high-growth markets, where the maximum demand is witnessed in East Asia, followed by South Asia. Small molecule API are widely used in various chronic disease, but Oncology the dominant Production amongst all.  The report also analyzes the impact COVID-19 has had on the pharmaceutical industry in general, and the small molecule API space in particular.

How does the Historical and Future Outlook for Small Molecule API Market Compare?

In-House and outsourcing manufacturing of small molecule API continue to be hot topics in the pharmaceutical sector. The demand for outsource manufacturing in small molecule market has been on the rise because of increasing production cost and burden management. Subsequently, rising incidence of chronic diseases, besides investment in research and development (R&D) initiatives have been enabling growth.

Factors such as availability of several promising drug pipeline that have disease-modifying properties and a better safety and efficacy profile are attracting increasing number of players towards the market. As per FMI, the market exhibited a CAGR of 4.5% till 2020.   

Current suboptimal growth of contract development and manufacturing organizations (CDMOs), advancements in small molecule (API) manufacturing, increasing number of abbreviated new drug applications (ANDA), growth of healthcare market in Asia Pacific and other developing countries, expansion in terms of product offering, and reduction in operational cost are creating opportunities for growth in small molecule API market.

Increasing diagnosis of chronic diseases has bolstered the production of small molecule API. Increasing research on small molecule APIs will boost the market growth. Driven by above factors the market is expected to exhibit a CAGR of 5% through 2031.  

The COVID-19 outbreak was unforeseen. It has changed the national healthcare priorities and spending. While the healthcare industry has been finding it increasingly difficult to accommodate the increasing burden of patients, it is considered to have a short-term impact on the small molecule API market. In first two quarter there was slow down in all segment of market due to lockdown and restrictions imposed on transport facilities.

Increase in government funding and polices favoring entry of startups in last two quarter of the year is creating growth opportunities. There is a rapid development in the technologies that are used for the long-term delivery of medications in molecule type. Spurred by this, the market will continue exhibiting steady growth through the forecast period.

How is Rising Incidence of Chronic Ailments affecting Small Molecule Market Growth?

API manufacturing has proven to be quiet effective in the last few years. Besides this, factors such as increasing incidence of cancer and subsequently rising demand for effective diagnosis and R&D in oncology therapeutic will fuel the demand for small molecule oncology therapy. Small molecule oncology drugs have proven effective in cancer treatment.

While biologics are making their presence felt in the pharmaceutical sector, small molecule API will continue accounting for majority of new drug application. It also constitute a significant share in the drug development pipeline. Core advantage of small molecules in delivering strong therapeutic benefits in smaller doses will remain a chief growth driver.

Country-wise Insights

How big is the Opportunity in China?

FMI has projected China to remain one of the most lucrative markets for small molecule API. It is expected to register a CAGR of over 5.5% during the forecast period. Besides increasing incidence of various illnesses, the China market is driven by expansion of API manufacturing units. Presence of less stringent policy in terms of waste product management will continue supporting growth in China.

Besides this, social determination and growing R&D facilities in the country will enhance the market growth. In addition, increasing focus on patient awareness and the presence of major players have catapulted China at the forefront of small molecule API manufacturing.  

What are Prospects for Small Molecule API Manufacturing in Japan?

The per capita spending on medical care is increasing in Japan. Individuals' longing and capacity to spend on wellbeing has prompted a steady move in medical services consumption. In the course of the last few years, the worldwide per capita medical care spending has practically multiplied. Fast financial and populace development just as expanding extra cash are the superb components answerable for the development of the general medical care industry.

This has also helped in the expansion of the market in Japan. The presence of some of the leading players also has been supporting growth.

What is Driving Small Molecule API in India?

As per the India Brand Equity Foundation (IBEF), Indian pharmaceutical trade reached US$ 16.2 till 2020. Pharma vision 2020 will advance the pioneer in start to finish assembling of API. 100% FDI has been permitted for the programmed course for creation of API.

India holds a lucrative production globally in terms of pharmaceutical manufacturing. The nation likewise has an enormous pool of researchers and architects with a possibility to guide the business ahead to more prominent statures. By and by, more than 80% of the antiretroviral drugs utilized universally to battle Acquired Immune Deficiency Syndrome (AIDS) are provided by Indian drug firms.

Coupled with this, the World Health Organization (WHO) reported the setting up of the Global Center of Traditional Medicine in India. These factors are spurring pharmaceutical production in India, in turn fuelling the demand for small molecule API.

Rising Onychomycosis Cases Elevating Small Molecule API Demand in Germany

Germany will continue to dominating the small Molecule API market in Europe. It is expected to contribute over 30% of sales in the Europe market. The rising incidence of various ailments, together with increasing pharmaceutical spending has been fuelling demand in the country.

According to the World Bank, healthcare expenditure in Germany stood at above 11% of GDP in 2018. With prevailing trends indicating towards increasing spending, the investment in small API molecules is expected to increase.

Category-wise Insights

Which is the Leading Small Molecule API Type?

The Standard API will continue to hold maximum share in the global small molecule API market with a market share of over 79.6%.

Which is the Key Therapeutic Area for Small Molecule API?

Oncology accounts for 26.6% of the market share by therapeutic area. Small molecule API plays a crucial role in drug development for the treatment of cancer. According to the World Health Organization (WHO), cancer is the second-leading cause of death around the world. With the incidence forecast to rise further, the demand for small molecule API will surge in the coming years.

However, the introduction of combination drug and increment in R&D in drug development for the molecule type of oncology therapeutic area is expected to result in reduced sales of oncology drug induced Small Molecule API.

Why Does Commercial Application account for Greater Sales of Small Molecule API?

According to FMI, the demand for small molecule API will by highest in commercial use. The commercial segment will lead throughout the forecast period. The rising use of API in pharmaceutical manufacturing will continue enabling sales in the segment.

Competitive Landscape

Manufacturers in the small molecule API market are aiming to carry out strategic collaborations and R&D.

For instance In December 2020, Pfizer Inc. and Poster announced a strategic partnership with the goal of accelerating small molecule drug discovery by developing a platform technology based on generative chemistry.

In January 2020, acquisition of operations of Aspen in Japan. This acquisition strengthened Sandoz's position in world market of off-patent medicines and generic drugs.

In March 2021, U.S. Food and Drug Administration (FDA) has accepted New Drug Application for gefapixant, an orally administered for the Molecule Type of refractory chronic cough (RCC) in adults.

The company is strategically making promotional plans for its established prescription brands to increase their awareness within the prescription market Its ‘Get Old’ campaign also makes a frequent appearance on the main company feeds and through its own Twitter and Facebook page. Pfizer Inc. may be known for blockbuster prescription drug products such as Viagra and Lipitor, but the company is engaged in effective promotions to increase its brand recall among established prescription brands.

Some of the leading companies operating in the market are:

  • Pfizer Inc.
  • Johnson Matthey
  • Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
  • Sanofi S.A.
  • Novartis AG,
  • Bristol-Myers Squibb,
  • Boehringer Ingelheim GmbH
  • GlaxoSmithKline PLC
  • GILEAD Science Inc.,
  • Albany Molecular Research Inc.
  • AstraZeneca
  • Merck & Co, Inc.
  • Teva Pharmaceuticals
  • Hoffmann-La Roche Ltd

Scope of Report



Forecast Period


Historical Data Available for


Market Analysis

USD Million for value

Key Regions Covered

North America, Latin America, Europe, East Asia, South Asia, Oceania and the Middle East & Africa

Key Countries Covered

US, Canada, Germany, U.K., France, Italy, Spain, Poland, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Australia, New Zealand, GCC Countries, Turkey, Northern Africa and South Africa

Key Segments Covered

Molecule Type, production , application, therapeutic area and Region

Key Companies Profiled

  • Johnson Matthey
  • Pfizer Inc.
  • Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
  • Sanofi S.A.
  • Novartis AG,
  • Bristol-Myers Squibb,
  • Boehringer Ingelheim GmbH
  • GlaxoSmithKline PLC
  • GILEAD Science Inc.,
  • Albany Molecular Research Inc.
  • AstraZeneca
  • Merck & Co, Inc.
  • Teva Pharmaceuticals
  • Hoffmann-La Roche Ltd

Report Coverage

Market Forecast, brand share analysis, competition Intelligence, DROT Analysis, Market Dynamics and Challenges and Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Questions Answered in the Report

  • Which is the most lucrative market for Small Molecule API?

    East Asia currently holds for the largest share in the small molecule API market. According to FMI, it accounts for 35% of the global market share.

  • Which is the Key Therapeutic Area for Small Molecule API?

    Oncology segment will continue to remain the leading therapeutic area driven by increasing demand for effective diagnosis and treatment of cancer.

  • Which is Key Application of Small Molecule API?

    Commercial application continues to account for maximum sales in small molecule API market.

  • Which are some of the leading companies operating in the Small Molecule API Market?

    Some of the leading companies operating in the Small Molecule API market  are Teva Pharmaceutical Industries Ltd., Sanofi S.A., Pfizer Inc., Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd., Novartis AG, Bristol-Myers Squibb, Boehringer Ingelheim GmbH, GlaxoSmithKline PLC, GILEAD Science Inc., Albany Molecular Research Inc., AstraZeneca, Merck & Co, Inc., BASF SE, Hoffmann-La Roche Ltd

  • Which Production is driving the sales of Small Molecule API?

    In-house and outsource are two major areas driving the sales of small molecule API. Of these, outsource is expected to lead the market.

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  • Is this research conducted by Future Market Insights?

    Yes, the research has been conducted by expert analysts of Future Market Insights through a combination of primary research and secondary research. To know more about how the research was conducted, you can speak to a research analyst

  • What research methodology is followed by Future Market Insights?

    Future Market Insights follows a methodology that encompasses demand side assessment of the market, and triangulates the same through supply side analysis. This methodology is based on the use of standard market structure, methods and definitions. Request a detailed methodology

  • Who are the respondents for primary research?

    Future Market Insights speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers and industry experts. For a full list of primary respondents, please reach out to us.

  • What are the sources of secondary research?

    Future Market Insights conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request.

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Small Molecule API Market by Category

Molecule Type

  • Standard API


  • Captive/In-House
  • Out Source


  • Clinical
  • Commercial

Therapeutic Area

  • Cardiovascular Diseases
  • Respiratory Disorders
  • Infectious Diseases
  • Metabolic Disorders
  • Oncology
  • Immunology
  • Neurology
  • Urology
  • Dermatology
  • Ophthalmology
  • General Health
  • Others


  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Middle East and Africa (MEA)
  • Oceania

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Small Molecule API Market