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The ambit of pharmaceutical analytical testing is vast, including tests mainly for analyzing active pharmaceutical ingredients API’s, excipients, ancillary products, and extractables. The demand for outsourcing of the testing services among pharmaceutical and biopharmaceutical businesses has also risen. The demand for new in silico modelling techniques in drug making is a key driver for growth in opportunities for contract research organizations (CROS) in the pharmaceutical analytical testing outsourcing market. Among various technologies to this end, CROs are increasingly leveraging physiologically-based pharmacokinetics (PBPK). These solutions are used for precipitation of the active pharmaceutical ingredient (API). In the intensely competitive environment of drug making where the profit margins of biopharma companies have reduced glaringly, the need for making better decisions in early-stage drug candidate selection is crucial. The trend has imparted a huge impetus to the growth of the pharmaceutical analytical testing outsourcing market.

Incessant focus on improving the standards of patient safety has spurred the demand for analytical testing for any possible leaching of contaminants for common drug product is a key trend bolstering the expansion of the avenues. Contamination may also be caused due to presence of various plasticizers, antioxidants, heavy metals, curing agents, and dyes. The demand for CROs for preclinical testing has also gathered some momentum over the past few years.

Global Pharmaceutical Analytical Testing Outsourcing Market: Snapshot

Analytical testing constitutes a key part of pharmaceutical development from the early stages to commercialization of the dug or therapy. The process is a key step in drug manufacturing which includes identification, determination, and purification of a compound or mixture of compounds. The process also entails determining the structure of chemical compounds and helps in the synthesis and characterization of active pharmaceutical ingredients (APIs). In recent years, pharmaceutical analytical testing outsourcing services, as a part of contract research organizations, have begun playing significant role in substituting a large part of analytical development and testing conducted in-house. The intensify pressure on pharmaceutical and biopharmaceutical organizations in rejuvenating their drug pipelines across R&D cost-cutting measures has propelled the demand for analytical testing outsourcing services. The access to real-time analytical results and first-hand information enable drug manufacturers reduce operating costs and boost their drug pipelines of innovative drugs. This not only helps them in the development of powerful therapies but make them accessible to a wider populations across regions. Meanwhile, they are left with ample budget for other strategic ventures such as mergers and consolidations, which furthers their interest in exploring new revenue streams. Major pharmaceutical analytical services offered by these outsourcing organizations include method validation, stability, and quality control testing. In addition, various outsourcing services also include offering regulatory compliance of current good manufacturing practice (CGMP)-good laboratory practice (GLP) guidelines in various regions. This enables pharmaceutical players in adhering to various regional and global regulatory standards related to various routine to complex drug research programs.

The practice wherein a company transfers a portion of its work to an outside supplier to cut costs is referred to as outsourcing. It is said to be a cost-saving strategy observed by several companies. In pharmaceutical industries, in-house laboratory testing might be an expensive affair. Some resources might also be unavailable. Therefore, outsourcing is an excellent way that could be employed to deal with these issues. Analytical testing is an important step in manufacturing which provides first-hand information to the manufacturer, therefore reducing the operating cost. It is also often outsourced.                     

The global pharmaceutical analytical testing outsourcing market is expected to experience rapid growth during the forecast period due to the swiftly developing pharmaceuticals market, increasing demand for biosimilars & biopharmaceutical products as well as for analytical drugs, and the rising number of products in the pipeline. Furthermore, improved efficiency in testing, reduced cost, quicker & reliable results, and data safety are other factors propelling the global market. However, quality approvals and regulatory audits conducted in outsourcing laboratories could hinder the global pharmaceutical analytical testing outsourcing market during the forecast period. 

The global pharmaceutical analytical testing outsourcing market can be divided based on product type into the following segments: raw materials, finished products, and active pharmaceutical ingredients. Active pharmaceutical ingredients are likely to register a significant growth rate in the global market due to the increasing demand for generics drugs and biosimilars. On the basis of application, the global analytical testing outsourcing market is split into the following sections: clinical trials, biological research, drug discovery, and others. The clinical trials segment is anticipated to occupy a major share in the global market during the forecast period due to the rising number of clinical trials and surge in quality requirement to perform the testing with utmost priority and excellence.  Based on services, the global pharmaceutical analytical testing outsourcing market can be classified into the following categories: stability testing, method validation testing, quality control testing, and others.

Geographically, the global pharmaceutical analytical testing outsourcing market is distributed over North America, Asia Pacific, Europe Latin America, and Middle East & Africa. North America occupies a major share in the global analytical testing outsourcing market in terms of value, followed by Europe. The factors attributing to the expansion of the analytical testing outsourcing market in North America by 2025 include the technological advancements, extensive research & development facilities, better quality, and rising demand for drugs & other pharmaceutical products in the region. The global analytical testing outsourcing market in Asia Pacific is anticipated to be develop rapidly during the forecast period owing to the speedy growth in pharmaceutical industries in India & China, high demand for biopharmaceuticals, immense investments by established market players in developing countries, and low-cost proposals in low- and middle-income countries. 

To obtain a significant position in the global pharmaceutical analytical testing outsourcing market, players employ various strategies such as geographical expansion, mergers & acquisitions, alliances, and cost-effective & efficient services. Key players operating in the global pharmaceutical analytical testing outsourcing market include Eurofins Scientific, Boston Analytical, Intertek Group plc, Dalton Pharma Services, Charles River Laboratories International, Inc, West Pharmaceutical Services, Inc., Exova, and Halo Pharma.

This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.

Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:

  • Customer Experience Maps
  • Insights and Tools based on data-driven research
  • Actionable Results to meet all the business priorities
  • Strategic Frameworks to boost the growth journey

The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.

The following regional segments are covered comprehensively:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.

Below is a snapshot of these quadrants.

1. Customer Experience Map

The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

2. Insights and Tools

The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.

3. Actionable Results

The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.

4. Strategic Frameworks

The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.

The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:

1. What can be the best investment choices for venturing into new product and service lines?

2. What value propositions should businesses aim at while making new research and development funding?

3. Which regulations will be most helpful for stakeholders to boost their supply chain network?

4. Which regions might see the demand maturing in certain segments in near future?

5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?

6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?

7. Which government regulations might challenge the status of key regional markets?

8. How will the emerging political and economic scenario affect opportunities in key growth areas?

9. What are some of the value-grab opportunities in various segments?

10. What will be the barrier to entry for new players in the market?

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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Pharmaceutical Analytical Testing Outsourcing Market