ANALYTICAL TESTING OUTSOURCING
vice provider. They are in favor of CROs that can provide integrated services, which allow them to reduce the number of vendors, streamline the process, and improve efficiency. Additionally,
there are increasing requests for CROs with capabilities to perform analytical testing along with formulation development and/
or manufacturing. 8
Despite the changing preference of service sponsors,
quality remains the top priority to achieve in any outsourcing
relationship. According to Nice Insight 2016 CRO Outsourcing Survey, the desire to“improve quality” is the number one
strategic reason behind outsourcing. Quality is also the most
important decision driver in CRO selections. 3 In addition,
the ability to deliver quality results under tight timelines is
another frequently sought attribute by service sponsors, due
to the pressure they are facing to expedite the drug development process.
Last year, the FDA released a draft guidance, “Request for
Quality Metrics,” which described the FDA’s intent to require 10
types of quality data from the industry—for both drug owners
and their contractors—so that four quality metrics—Lot Acceptance Rate, Product Quality Complaint Rate, Invalidated Out-of-Specification (OOS) Rate and Annual Product Review (APR)
or Product Quality Review (PQR) on Time Rate—can be calculated. 9 The guidance also listed three optional metrics related
to quality culture and process capability/performance to support manufacturing robustness and a commitment to quality.
Although the primary use of the quality metrics is to help FDA
develop risk-based drug inspection scheduling and address
potential drug shortages, it provides the baseline guidance for
analytical service providers and sponsor companies to develop
appropriate analytical testing that measures important quality
metrics with accurate and reliable data. Currently, FDA is reviewing the comments from the industry, with a new revised
version on the way.
FINDING THE NICHE
The analytical testing service market is dominated by a number
of well-established players such as Charles River Laboratories
(U.S.), WuXi Pharma Tech (Cayman) (China) and Eurofins Scientific SE (Luxembourg).1 In order to maintain their competitive
edge, these incumbents need not only to maintain a broad range
of scientific and technical expertise, but also to expand the scope
of their capabilities and keep up with advanced analytical technologies and instruments. As a result, large CROs tend to acquire
smaller analytical labs to fully integrate their service offerings as
they continue to grow larger.
For small CROs to succeed in this environment, they have to
find their niche or specialty. One such niche area is biological
characterization and comparative testing for biosimilars, which
require specialized expertise and equipment. As more biologics are entering the pipeline and biosimilars are increasing the
pace of their growth, strong demand is expected in this area. 10
Increased service need is also expected in the area of dissolution
testing for compounds with poor solubility, extractable/leachable
testing, and in vitro release test (IVRT). 11 Small CROs may be able
to differentiate themselves from the competitive market by tapping into these areas. CP
1. Markets and Markets: Healthcare Analytical Testing Services Market by
Type (Stability, Raw Materials, Method Validation, Microbial, Environmental Monitoring, Bioanalytical Services), by End User (Pharmaceutical
Companies, Medical Device Companies) - Global Forecast to 2021. May
2. SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars. Drug
Development and Delivery. Mar. 5, 2014. http://www.drug-dev.com/Main/
3. 2016 Nice Insight CRO Outsourcing Survey.
4. SPECIAL FEATURE - Analytical Testing: Using More Sophisticated Tools to
Support Small & Large Molecule Projects. Drug Development and Delivery. Jan. 8, 2016. http://www.drug-dev.com/Main/Back-Issues/SPECIAL-
5. SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development. Drug Development and Delivery. Jan. 8, 2015. http://www.drug-dev.com/Main/Back-Issues/SPECIAL-FEATURE-Analytical-Testing-A-
6. FDA Guidance for Industry. Analytical Procedures and Methods Validation
for Drugs and Biologics. Pharmaceutical Quality/CMC. July 2015. http://
7. ICH. Quality Guidelines. http://www.ich.org/products/guidelines/quality/
8. Dubin C. Outsourcing Analytical Testing. Contract Pharma. Sep. 6, 2007.
9. FDA Guidance for Industry. Request for Quality Metrics. July 2015. http://
10. Macdonald G. US demand for biosimilarity testing growing says specialist CRO. Outsourcing Pharma. Sep. 30, 2013.ht tp://www.outsourcing-pharma.com/Commercial-Services/US-demand-for-biosimilarity-testing-growing-says-specialist-CRO.
11. Pharmaceutical Technology Editors. Analytical Labs Strive to Deliver More
Information, Faster. Aug. 1, 2014. Pharmaceutical Technology Volume 2014
Supplement, Issue 2. http://www.pharmtech.com/analytical-labs-strive-deliver-more-information-faster.