Synthetic Small Molecule API Market Size, Share & Trends Analysis Report By Manufacturer (In-house, Outsourced), By Application (Cardiology, Oncology), By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global synthetic small molecule API market size was valued at USD 131.55 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.73% from 2022 to 2030. The growth of the market is attributed to factors such as the growing demand for small molecules API and an increased outsourcing trend in the market. Moreover, the expiry of patents for leading molecules facilitates the entry of new players into the market. The demand for raw materials such as API for low-cost production of drugs further propels growth.

The COVID-19 outbreak has facilitated the growth of the market by encouraging players to geographically diversify their businesses to avoid shortages. The demand for APIs eventually grew during the pandemic owing to the impaired functioning of the respiratory system in patients suffering from the infection. COVID-19 is further propelling the investigation of small molecule products. Moreover, studies for repurposing existing small molecule drugs are ongoing for the treatment of SARS-CoV-2 infection.

One of the major drivers of the market is the high demand for generic drugs. APIs for generic drugs generate high revenue for chemical and synthetic API manufacturing companies. This is creating a wide opportunity for CDMOs working in the segment. The opportunity in the synthetic API market becomes even more lucrative for CDMOs owing to the increase in outsourcing trend as companies want to improve profitability by reducing the cost of production.

Furthermore, the growth of the market is attributed to the ease of production associated with small molecules and high effectiveness possessed by the molecules. Small molecule API represents around 78% of the total share representing the majority of medicines that we consume. This escalates the demand for finished products and formulation of API, further propelling the demand for synthetic small molecule API.

However, production requires sophisticated infrastructure, making it a capital-intensive market. In addition, stringent safety regulations need to be followed during the production process, which may hinder market growth. Manufacturers consider API production difficult because of the need for high investments against fewer returns in the initial stages as new and expensive drugs face slower acceptance.

Manufacturer Insights

The in-house segment dominated the overall market with a revenue share of over 60.0% in 2021. The growth of the segment can be attributed to manufacturers aiming to lower the reliance on CDMOs and suppliers for raw materials and rather focusing on developing their own API. For instance, in April 2021, Lonza launched a new small-molecule manufacturing complexat its Visp, Switzerland, site that would enhance future small-molecule technologies expansion.

The outsourced segment is expected to grow at the fastest rate over the forecast period owing to the increasing shift of manufacturing companies towards contract research and development organizations for the production of API commercially. For instance, in 2021, Curia, a CDMO invested more than USD 35 million in the expansion of its commercial manufacturing capacity at its Rensselaer, New York facility. Moreover, the increasing demand for the requirement of complex manufacturing processes further increases the growth of the segment.

Application Insights

The cardiology segment led the market with a revenue share of over 20.0% in 2021. This is attributed to the increasing prevalence of target diseases worldwide owing to changes in food habits and lifestyles. Moreover, the market is driven by increasing implementation of treatment for cardiovascular conditions. Hypertension and atrial fibrillation drug sales account for one of the highest shares in the CVD drugs and API market. According to the WHO in 2021, around 1.28 billion adults are estimated to have hypertension, which accounts for a larger share of drug sales.

The oncology segment is projected to grow at the fastest rate over the forecast period. The increasing global prevalence of cancer is a key factor driving this market. Moreover, an increase in oncology research and development is resulting in the launch of a number of novel drugs that further boost oncology adoption, which, in turn, fuels the growth of the oncology segment. For instance, in 2021, 9 novel drugs were launched, which were developed from small molecule API for the treatment of various forms of cancer.

Regional Insights

North America accounted for the largest revenue share of over 35.0% in 2021. This can be attributed to the increasing support from the government with favorable initiatives, coupled with the increased interest of players in the development of novel products in the region. For instance, in September 2021, AbbVie announced the U.S. FDA approval of Qulipta (atogepant) for episodic migraine in adults. The medication is the first and only oral antagonist of the calcitonin gene-related peptide receptor. Moreover, the government in this region is becoming increasingly supportive in terms of regulation of API production, which further has reduced the dependence of the region on Asian manufacturers.

Asia Pacific is estimated to be the fastest-growing segment over the forecast period due to the dependence of pharmaceutical manufacturers for API production on China and India, increasing focus on the development of less complex molecules that can be produced in bulk, and involvement in supplying API globally at a low cost. Moreover, increasing government support for investments in API businesses is leading to growth.

Key Companies & Market Share Insights

Key players operating in the market are focusing on partnerships, strategic collaborations, and geographical expansion in emerging and economically favorable regions. For Instance, in 2021, Rhizen Pharmaceuticals announced the FDA approval of PI3K-delta inhibitor, a novel drugUmbralisib, for the treatment of adults with refractory and relapsed marginal zone lymphoma and follicular lymphoma. Some prominent players in the global synthetic small molecule API market include:

• Bristol-Myers Squibb Company

• Cipla, Inc.

• Boehringer Ingelheim International GmbH

• Merck & Co., Inc.

• AbbVie, Inc.

• Aurobindo Pharma

• Sun Pharmaceutical Industries Ltd.

• Teva Pharmaceutical Industries Ltd.

• Albemarle Corporation

• Viatris Inc.

• Dr. Reddy’s Laboratories Ltd.

Synthetic Small Molecule API Market Report Scope

 Global Synthetic Small Molecule API Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global synthetic small molecule API market report on the basis of manufacturer, application, and region:

• Manufacturer Outlook (Revenue, USD Billion, 2018 - 2030)

  • In-house

  • Outsourced

• Application Outlook (Revenue, USD Billion, 2018 - 2030)

  • Cardiology

  • Oncology

  • CNS and Neurology

  • Orthopedic

  • Endocrinology

  • Pulmonology

  • Gastroenterology

  • Nephrology

  • Ophthalmology

  • Others

• Regional Outlook (Revenue, USD Billion, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE