Market Overview

A controlled substance is a chemical or drug that is tightly controlled by government. The use of controlled substance is regulated because it can cause drug abuse or can be addictive. The making, handling, usage, storage and distribution of these substances is highly controlled by the Government. Such substances include opioids, depressants, hallucinogens, stimulants and steroids (anabolic).

The controlled drugs used for medical preparations require proper prescription from a licensed medical professional. While morphine, Ritalin and Valium are the examples of legal controlled substances used for medical purpose, LSD and heroin are illegal. Some chemicals used for the production of illegal drugs are also controlled substances in many other countries. However they may lack pharmacological effects of the drugs.

In the United States, the Drug Enforcement Administration is responsible for regulation of usage of controlled substances. These controlled substances are assigned to one of five schedules based on their medical applications and potential of becoming an abuse. Some chemicals used for the production of illegal drugs are also controlled substances in many other countries. However they may lack pharmacological effects of the drugs. Substances are further classified into schedules and consist primarily of potentially psychoactive substances.

Schedule I controlled substances do not have medicinal benefits and are dangerous and highly. These are not prescribed. Substances in Schedules II to V (in decreasing order of potential abuse) have medical benefits. These controlled substances can be manufactured, tested and distributed with regards to U.S. Drug Enforcement Agency (DEA) regulations and compliance.

Manufacturers and distributors of controlled substances must be registered. Before the initiation of licensing process these companies should be familiar with all the security and record maintenance requirements. They should also see that their facilities are compliant to controlling, accountability and traceability.

The Controlled substance APIs have shown powerful treatment options in many areas such as psychiatric disorders and addiction management. Its adoption has begun as the industry views towards controlled substances continues has changed. Manufacturers are choosing to outsource the production to experienced CDMOs. Companies are continuously trying to develop their presence by entering into tightly regulated markets like the US and UK. The controlled substance API market is expected to upswing in the coming years.

Rising demand for controlled substance API in recent years for addressing unmet patient needs especially in therapeutic areas like depression, addiction, post-traumatic stress disorder and pain management are factors that drive the growth of controlled substance API market. Mental health awareness is rising among people and making them seek medical help. Increasing cases of mental disorders like depression and anxiety demand for manufacturing of controlled API substances. Controlled substances are no longer stigmatized for its medicinal use and are now used to explore and novel therapeutic targets. Controlled substances are also being tested in several oncology targets. This has rose the market demand for manufacturing of Controlled substances APIs. All These factors are expected to drive the global controlled substance API market. However strict regulations by some countries like the USA and UK for manufacturing Controlled substance API can pose a major challenge for its market. Many companies prefer to outsource manufacture the controlled substances because of licensing issues and stringent regulations.

The global market for Controlled substance API market is segmented based on the treatment drug type, end user and region

Based on therapeutic areas	Depression Pain management Post trauma stress Others
Based on end user	Pharmaceuticals Contract manufacturing organizations
Based on region	North America Europe Asia Pacific Latin America Middle East & Africa.

Some of the key market players in Controlled substance API treatment market are Sterling Pharma USA, LLC, PCI Synthesis, Cambrex Corporation, Minakem SAS, ZCL Chemicals Ltd, Albany Molecular Research Inc, Temad Co.