Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Perception of Market Barriers


Some of the market barriers identified in the 1995 IOM report were confirmed through the interviews with private firms and case studies conducted for this effort. Figure 36 summarizes the market barriers that were confirmed (in full or in part) and not confirmed during this study. (As noted above, the number of interviews and case studies was limited by the scope of this study.) Although no new general types of market barriers were identified during this project, certain ones were elaborated or described in a more contemporary context.

Figure 36: Perceived Market Barriers in 1995 IOM Report
Market Barrier from IOM Report Confirmed Not Confirmed Notes
Uncertain market environment    
Limited number of researchers focusing on drug abuse    
Lack of well-characterized animal models of cocaine addiction        
Limited basic science knowledge of addiction, craving, and relapse    
File IND      
Clinical Studies      
DEA regulations    
Complications of concomitant illness and polydrug abuse    
Patient population perceived as difficult to study    
Efficacy outcomes difficult to define or measure    
Few clinical investigators    
File NDA      
Length of FDA approval process    
Other Approval      
State rescheduling    
Varied state / local approval processes    
DEA review time    
Varied state and local regulations    
Lack of traditional marketing to physicians    
Pricing clause in DHHS CRADAs   NIH recently removed reasonable pricing clause from CRADAs
Small foreign market    
Treatment System      
Limited number of narcotic treatment programs    
Stigma of drug-abuse    
Bias by some treatment providers against pharmacologic treatments    
Varied state / local treatment regulations and financing mechanisms    
Uncertain treatment financing    
Adapted from: IOM, Development of Medications for the Treatment of Opiate and Cocaine Addictions, 1995.

Two types of market barriers emerged from our report. Critical barriers are those that must be surmounted in order for pharmaceutical firms to regard as feasible the prospects for developing cocaine addiction medications that will be financially successful. Non-critical market barriers are those that, if lowered or eliminated, may enhance (though perhaps only marginally) the financial outlook for developing cocaine addiction medications only if the critical barriers are also lowered. That is, without lowering the critical barriers, lowering the non-critical ones would be unlikely to transform an unattractive market into an attractive one.

Among the diverse market barriers perceived by the industry, three emerged as critical in this study, i.e., that would have to be lowered or eliminated in order to begin to make new drug development attractive to pharmaceutical companies:

  • Small and uncertain market for cocaine addiction and abuse pharmacotherapy
  • A substance abuse treatment system that limits access to this market
  • Limited and uncertain payment for treatment

The beginning of the following section briefly describes private industry's views on the strength and importance of these three critical market barriers. The remainder of the section describes non-critical market barriers relative to the process of drug development and marketing.