Controlled Substance API Market Size & Share, by Type (Opioids, Stimulants); End-user (Contract Manufacturing Organizations, Pharmaceuticals, Research Institutions) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2023-2035

  • Report ID: 5223
  • Published Date: Sep 07, 2023
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2023 - 2035

Controlled Substance API Market size is anticipated to reach USD 22 billion by the end of 2035, growing at a CAGR of 9% during the forecast period, i.e., 2023 – 2035. In the year 2022, the industry size of controlled substance API was over USD 10 billion. The availability of raw materials, the complexity of synthesis, and the distribution network for controlled substance APIs could impact market growth. Ethical considerations around the use of controlled substances and their APIs might impact market growth. Public perception and societal concerns could influence regulatory decisions and market dynamics.

Controlled substances are drugs or chemicals that are regulated by the government due to their potential for abuse or dependence. These substances are classified into different schedules or classes based on their medical use, potential for abuse, and safety considerations. APIs, on the other hand, are sets of rules and protocols that allow different software applications to communicate with each other.

controlled substance api market size
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Controlled Substance API Sector: Growth Drivers and Challenges

Growth Drivers

  • Increasing Demand for Pain Management Medications: The rising prevalence of chronic pain conditions has led to a surge in the demand for pain management medications, many of which involve controlled substances. According to a report, global pain management drug sales are projected to reach early USD 90 billion by the year 2028.
  • Global Health Challenges and Epidemics: Global health challenges, including opioid addiction and infectious disease outbreaks, have heightened the need for effective treatments involving controlled substances. The opioid epidemic has prompted increased research and investment in addiction treatment medications, addressing a pressing public health concern.
  • Growing Investment in Pharmaceutical Infrastructure: Investment in pharmaceutical infrastructure, including manufacturing facilities and research centers, is augmenting the sector's capacity to produce controlled substance APIs.


  • Regulatory Complexity and Compliance Burden: The sector operates under strict regulatory frameworks due to the potential for abuse and safety concerns associated with controlled substances. Navigating these complex regulations, obtaining licenses, and ensuring compliance with evolving standards can be daunting and time-consuming. Companies must invest significant resources to meet these requirements, which can impact operational efficiency and time-to-market.
  • Risk of Diversion and Illicit Trade
  • Limited Research and Innovation Opportunities

Controlled Substance API: Key Insights

Base Year


Forecast Year




Base Year Market Size (2022)

~ USD 10 Billion

Forecast Year Market Size (2035)

~ USD 22 Billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of Middle East and Africa)
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Controlled Substance API Segmentation

Type (Opioids, Stimulants)

The stimulants segment in the controlled substance API market is estimated to gain the largest revenue share of 60% in the year 2035. The rising prevalence of attention deficit hyperactivity disorder (ADHD) and related cognitive disorders has led to a surge in the demand for effective treatments. According to the World Health Organization (WHO), globally, around 5% of children and adolescents have ADHD, emphasizing the need for therapies involving stimulants to enhance focus and cognitive function. Innovations in drug delivery systems and formulations have enhanced the effectiveness and safety of stimulant medications. Extended-release formulations, for instance, provide consistent drug levels and minimize the risk of misuse, aligning with the requirements of medical professionals and patients alike.

End User (Contract Manufacturing Organizations, Pharmaceuticals, Research Institutions)

Controlled substance API market from the pharmaceuticals segment is expected to garner a significant share in the year 2035. The escalating global burden of diseases, including chronic conditions such as diabetes, cardiovascular diseases, and neurological disorders, is driving the demand for innovative pharmaceutical solutions. According to the World Health Organization (WHO), non-communicable diseases account for approximately 71% of all global deaths, emphasizing the need for efficacious medications and driving growth in the pharmaceutical sector.

Our in-depth analysis of the global market includes the following segments:


  • Opioids
  • Stimulants


           End User

  • Contract Manufacturing Organizations
  • Pharmaceuticals
  • Research Institutions

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Controlled Substance API Industry – Regional Synopsis

APAC Market Forecast

The controlled substance API market in the Asia Pacific is projected to hold the largest market share of 40% by the end of 2035. APAC countries are progressively updating their regulatory frameworks to ensure the safety, quality, and efficacy of pharmaceutical products. This includes the stringent control and monitoring of controlled substance APIs. The adaptation of robust regulatory measures fosters market transparency and enhances confidence among stakeholders.

North American Market Statistics

The controlled substance API market in the North America is projected to hold the second-largest share during the forecast period. The North American region is grappling with a high burden of chronic diseases, including cardiovascular diseases, diabetes, and neurological disorders. According to the Centers for Disease Control and Prevention (CDC), chronic diseases account for around 6 in 10 deaths in the United States. This amplifies the demand for controlled substance APIs to address complex medical conditions. The aging population in North America is driving the demand for pharmaceutical interventions that cater to age-related health challenges.

Research Nester
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Companies Dominating the Controlled Substance API Landscape

    • Pfizer Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Johnson & Johnson
    • Novartis AG
    • Roche Holding AG
    • Teva Pharmaceutical Industries Ltd.
    • GlaxoSmithKline plc
    • Eli Lilly and Company
    • AstraZeneca plc
    • Merck & Co., Inc.
    • AbbVie Inc.


In The News

  • Novartis to lay off 8,000 jobs worldwide. The Swiss pharmaceutical company announced plans to cut 8,000 jobs, or 7% of its workforce, in a bid to save USD 1 billion. The layoffs will affect employees across all levels and functions, and will be implemented over the next two years.
  • Novartis receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Novartis's biosimilar natalizumab, which is used to treat multiple sclerosis.

Author Credits:  Radhika Gupta, Shivam Bhutani

  • Report ID: 5223
  • Published Date: Sep 07, 2023
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

Increasing investment in pharmaceutical infrastructure is the major factor driving the market growth.

The market size of controlled substance API is anticipated to attain a CAGR of 9% over the forecast period, i.e., 2023 – 2035.

The major players in the market are Pfizer Inc., Johnson & Johnson, Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., GlaxoSmithKline plc, and others.

The pharmaceuticals segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.

The market in the Asia Pacific region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.
Controlled Substance API Market Report Scope

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