Towards Healthcare

Controlled Substance Key Players and Market Trends Analysis

Date : 07 October 2025

Top Companies in the Controlled Substance Market

Controlled Substance Market Companies

  • Johnson & Johnson Services, Inc.
  • Pfizer Inc.
  • Sanofi
  • Merck & Co., Inc.
  • Gilead Sciences, Inc.
  • Amgen Inc.
  • Novartis Pharmaceuticals Corporation
  • AbbVie Inc.
  • GSK PIc.
  • AstraZeneca
  • Bristol-Myers Squibb Company
  • Eli Lilly and Company
  • Teva Pharmaceutical Inc.
  • Bayer AG
  • Novo Nordisk A/S
  • Takeda Pharmaceutical Company Limited
  • Boehringer Ingelheim International GmbH
  • Aspen Holdings
  • Astellas Pharma Inc.

Market Growth

The global controlled substance market size marked US$ 93.7 billion in 2024 and is forecast to experience consistent growth, reaching US$ 98.71 billion in 2025 and US$ 157.7 billion by 2034 at a CAGR of 5.35%.

Policy Reforms

Policy reforms in the market are actively reshaping regulatory landscapes in 2025. A significant development occurred when, in August 2025, the Drug Enforcement Administration (DEA) proposed rescheduling cannabis from Schedule I to Schedule III, acknowledging its medical uses and lower abuse potential, though the final decision is pending.

Adoption of Inorganic Growth Strategies

Inorganic strategies like acquisitions and partnerships are propelling growth in the controlled substance market by enhancing R&D capabilities, expanding product portfolios, and improving regulatory compliance. For instance, in August 2025, Aurobindo Pharma's acquisition of Lannett Company for US$250 million enables entry into non-opioid controlled substances, particularly ADHD therapeutics, and provides access to a compliant U.S. manufacturing facility. Similarly, in September 2025, Strides Pharma's partnership with Kenox Pharmaceuticals focuses on developing nasal spray products, accelerating the delivery of affordable, high-quality medicines in the U.S.  These strategic moves enhance market competitiveness and align with regulatory standards.

Growing Regulatory and Legal Pressure

Growing regulatory and legal pressure on pharmacies is reshaping the controlled substance market by enforcing stricter compliance and safer dispensing practices, which ultimately builds trust among patients, providers, and regulators. Tighter monitoring reduces misuse and diversion, encouraging broader acceptance of controlled medications for legitimate medical needs. This also compels pharmaceutical companies to innovate safer formulations and improve supply chain transparency, fueling growth. For instance, in 2025, the U.S. Department of Justice filed a lawsuit against Walgreens for allegedly filling unlawful opioid prescriptions, underscoring heightened oversight that is pushing the industry toward more responsible, sustainable, and growth-oriented practices.

Value Chain Analysis of the Controlled Substance Market

R&D

Steps:

  • Discovery of new molecules and active pharmaceutical ingredients (APIs)
  • Preclinical studies including pharmacokinetics, toxicity, and safety profiling
  • Optimization of drug formulations and delivery systems
  • Organizations Involved: Pfizer, Johnson & Johnson, Novartis
  • Academic research institutes and biotech startups

Clinical Trials and Approval

Steps:

  • Phase I: Safety and dosage testing in healthy volunteers
  • Phase II: Efficacy and side-effect evaluation in small patient groups
  • Phase III: Large-scale trials for efficacy, safety, and comparison with existing therapies

Regulatory submission and approval

Organizations Involved:

U.S. FDA, Health Canada, EMA, Contract Research Organizations (CROs) like ICON, Parexel, and Covance, Patient Support and Services

Steps:

  • Counseling and education on proper use and dosage
  • Monitoring for adverse effects and adherence
  • Patient-assistance programs and support for chronic therapy management
  • Organizations Involved:   Specialty pharmacies, hospitals, and clinics
  • Non-profit patient-support programs and healthcare providers

Latest Announcement by Industry Leaders

In June 2025, Co-Founder of Elkedonia and Delphine Charvin, Chief Executive Officer, stated that the Elkedonia SAS company has closed an oversubscribed seed funding round worth EUR 11.25 million. Argobio, Angelini Ventures, CARMA Fund, Capital Grand Est, and Sambrinvest participated in the round, which was co-led by Kurma Partners, WE Life Sciences, and the French Tech Seed fund run by Bpifrance on behalf of the French government as part of France 2030.

Recent Developments in the Controlled Substance Market

  • In April 2025, Novartis reported encouraging top-line findings from its Phase II trials assessing ianalumab (VAY736) in adults with active Sjogren’s disease. The primary goal of both trials was to show statistically significant increases in disease activity. The findings bolster the possibility that the first targeted treatment for patients with Sjogren’s disease, a chronic, incapacitating autoimmune disease, will be ianalumab, a medication that works by both inhibiting BAFF-R and depleting B cells.
  • In August 2025, AbbVie will purchase an experimental depression medication from Gilagamesh, a partner pharmaceutical, for as much as US$1.2 billion, the companies announced in September, hoping to gain access to the rapidly expanding market for treatments based on psychedelics. The transaction is the most recent in more than US$20 billion that AbbVie has spent on acquisitions since 2023 for growth-promoting medications after the patent protection for its main rheumatoid arthritis treatment, Humira, expired.

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