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Latin American Contract Research Organization Market : Lower Cost of Conducting Clinical Trials Will Drive Growth

  • March 2015
  • 234 pages
  • Frost & Sullivan
Report ID: 2780388

Summary

Table of Contents

Key Findings—LATAM

Clinical Development Spending

•Since 2008, LATAM (Latin America) has been one of the fastest growing pharmaceutical markets in the world. Brazil is expected to become the fourth largest drug market by 2016, behind the United States, China, and Japan. The main drivers for market growth are generic drugs manufactured by local pharmaceutical companies and biosimilars manufactured both by multinational and local pharmaceutical companies.
•In 2013, the LATAM clinical trials market size was $ x million and is expected to reach $ x million in 2019. The LATAM clinical trials outsourcing market size was $ x million in 2013 and is expected to reach $ x million in 2019.

MNC and Local Pharmaceutical Companies
•Pharma MNCs constituted x % of clinical trial spending in 2013. However, local trials will grow in terms of number of trials conducted and expenditure per trial. When compared to local trials conducted a few years ago, which usually involved incremental innovation, biologic and biosimilar development will have larger investments and more complex protocols.

Global and Local Trials
•In LATAM, global trials accounted for x % of the market revenue. Nevertheless, local trials are expected to increase in share over the next x years. In Brazil and Argentina, the main target is biosimilar development. In Mexico, local trials may increase due to regulatory requirements which state that clinical studies for biocomparable products must be conducted locally.

Clinical Trials Phase Breakdown
•In LATAM, the largest share of trials conducted were Phase III trials. In 2013, Phase III accounted for x % of revenue in LATAM.
•In Late Phase trials, pharmacovigilance represents the largest share. However, health economics and outcomes research will have the fastest growth in the next x years.
•Data management services represent x % of the cost of clinical trials. Biostatistics represent x %, while central laboratory services represent x % of the cost of clinical trials.

Competitors Analysis
•MNC contract research organizations (CROs) dominate the LATAM market, mainly providing services to pharma MNCs. Price is the key barrier to more interaction between local pharmaceutical companies and MNC CROs.
•Though local CROs provide lower price, their service quality is low.

Clinical Development—Market Trends
•Clinical developments made by local pharmaceutical companies are the main drivers for the clinical trials market, mainly in Brazil and Argentina.
•Biologics and biosimilars currently account for a combined x % of trials conducted in Brazil, x % in Mexico, and x % in Argentina. In the next few years, biologics and biosimilars are expected to surpass x % in number of trials.
•Key restraints for growth in Argentina and Brazil are related to regulatory issues such as long protocol approval timelines. In Brazil, because of bottlenecks in submission and approval processes from Anvisa, approval takes x months. In Argentina, a protocol takes an average of x months for approval.
•In Brazil, the public funding programs fostering local pharmaceutical research and development (R&D) are expected to continue. Local drug development is being used as a strategy to reduce public healthcare expenditure in the procurement of high-cost imported drugs.

Outsourced Clinical Trials
•Outsourcing is becoming more frequent as protocols are more complex and recruitment is more specific regarding inclusion and exclusion criteria.
•Pharma MNCs tend to outsource about x % of their trials (number of trials) either in fully outsourced or in a function-to-function model. Local pharmaceutical companies have lower outsourcing rates; the rates are x % in Mexico, x % in Argentina, and x % in Brazil.
•Phase I and II trials have the lowest share of outsourcing, as many early phase studies in Latin America are performed by public research institutes and universities that do not outsource trials.
•Phase III trials represent the largest market for outsourced revenues, accounting for $ x million in 2013 and reaching $ x million in 2019.
•Data management is a highly outsourced service, mostly performed by MNC CROs which send data to be analyzed abroad due to lower costs and larger availability of skilled professionals. Few small local companies provide data management in LATAM, but are more focused on serving local pharma clients.
•Central lab services are performed by hospital labs conducting the trial or are outsourced to CROs. CROs in Argentina and Mexico usually send the samples to be analyzed abroad. Local outsourcing contracts in LATAM represent about x % of amount spent in outsourced central lab services for in-country conducted trials.

Key Questions this Study will Answer

How will contract research outsourcing help in drug development by saving time and cost for manufacturers?
What is the impact of the market growth in different regions?
Who are the predominant market participants in the CRO market and what is their market share contribution?
What are the key market trends observed towards expansion of contract research organizations in drug development across key therapeutic areas?
Are the products/services offered today meeting customer needs or is additional development needed?
What are the key market segments to look out for and what are the key trends followed in the market?

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