Bioanalytical Testing Services Market

The global bioanalytical testing services market size was valued at USD 3.1 billion in 2020 and is expected to expand at a CAGR of 8.4% during the forecast period, 2021-2028. The growth of the market is attributed to the rising frequency of the outsourcing research & development activities done by major pharmaceutical companies so that they can focus upon their fundamental competencies.
 

Get Free Sample Report

Bioanalysis is a discipline of analytical chemistry which covers the quantitative measurement in xenobiotics, drugs with respect to their metabolites, biological molecules existing in unnatural concentrations & locations, biotics, proteins, large molecule drugs, and macromolecules in the biological systems. There are several scientific endeavors that are dependent on accurate and precise quantification of endogenous substances and drugs present in the biological samples. The most effective method of study in this perspective is bioanalysis, where it shows the quantitative measure of the present drug or its metabolite which can be analyzed and studied for further processing. Bioanalytical testing have found several applications including toxicokinetic, exposure plus response in pharmacokinetic & pharmacodynamic studies, and bioequivalence. Bioanalysis are also used for detection in drugs used for illegitimate purposes, anti-doping testing in competitive sports, environmental concerns and forensic investigation.

According to the World Health Organization or the WHO, the increase in the development of new drugs have been astronomical. The data taken in the 1980s showed that it would take approximately four to five years to even discover the new concept of drug, let alone conduct test trials and experimenting the effects. The recent 2020 survey shows that the drugs can be developed as little as six months, be it in concept, theory or execution. The main reason for this surge in development of drugs is the innovation taking place in the pharmaceutical industry, and bioanalysis testing is one of the latest developments present. The current COVID-19 pandemic has led to severe economic, mortality and morbidity loss. Bioanalytical diagnostic technology and testing have played a crucial role in the fightback of the coronavirus pandemic. These methods will continue to be instrumental in the avoidance of future waves of both this pandemic and the future disease outbreaks. It was bioanalytical testing that detected the presence of the coronavirus in its early stages. The analysts predict that bioanalytical testing could be the way out of the COVID-19 pandemic and thereby expecting a lucrative growth in this market.

Market Trends, Drivers, Restraints, and Opportunities

• Increasing the requirement of the drug manufacturers that produce drugs used in the bioanalytical testing are projected to boost the market growth during the forecast period, 2021-2028. The major reason for this is the increase in investment on the research and development activity patents so that the manufacturers can develop them accordingly.
• Rapid growth in the complexity of studies to a micro level are major factors driving the market expansion in the coming years. Companies need to be regularly updated in both available services such as the contract research organizations and the advisory services on whether these drugs can or should be developed.
• High prices for the development of biomedical testing services is anticipated to hinder the market growth. This becomes extremely difficult to function in developing countries where there is limited healthcare infrastructure that cannot hold on to biomedical testing services which has no short-term benefits.
• Lack of skilled labor and awareness of the merits of bioanalytical testing services in the developing economies such as India, South Africa and Brazil ,presents as major factors that can hamper the market expansion during the forecast period.
• R&D investment and technological advancement are expected to offer significant opportunities for the market players. Researchers and scientists have now discovered new kinds of combination molecules, innovative medicines, and biosimilars which has increased in various new methodologies such as the electrochemical assays, titrimetric assays, immunoassays, and the electrophoresis. The International Council of Harmonization and other international organizations have given proper harmonized guidelines that regularly updates for the new discovery found by bioanalytical testing.

Scope of the Report

The report on the global bioanalytical testing services market size includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Global Bioanalytical Testing Services Market Segment Insights

Small molecule segment is projected to represent a large market share
Based on molecule types, the global bioanalytical testing services market is bifurcated into small molecule and large molecule. The large molecule is further divided into LC-MS studies, immunoassays and others. The immunoassays are segmented into PK, ADA, and others. The small molecule segment is expected to constitute a major market share of 55.1% as of 2020 in the global bioanalytical testing services market. The main reason attributing to this is the dominance of branded and generic drug compounds which are the results of small molecule bioanalysis. The patent of many of the drugs founded by the small molecule bioanalysis either have a short life span or are bought by the large pharmaceutical companies at more than ten times the investment given to them. Most of the drugs found by the small molecule bioanalysis are blockbuster drugs, requiring the submission of bioanalytical testing results before releasing to the market.

On the other hand, the large molecule segment is anticipated to expand at a high CAGR of the two segments during the forecast period 2021-2028. This can be credited to the rich pipeline of amino acid-based molecules or biologics. These molecule studies require advanced analytical instruments for proper results, which is feasible with the latest technological developments and is aspired to show more accurate results than the small molecule bioanalysis.
 

Get Free Sample Report

Bioavailability segment is expecting to grow at a significant pace
On the basis of test types, the global bioanalytical testing services market is segmented into ADME PK, PD, bioavailability, bioequivalence, and others. The ADME is further bifurcated into In-Vivo and In-Vitro. The bioavailability segment is expected to constitute the major market share of 18.1% at 2020. This is attributed to the huge demand in the bioavailability services in the generic drug manufacturing. These services have a wide range of application, with its own procedure and can be executed with limited resources, unlike the other segments, which require either highly advanced technology or high resources.

 Sample analysis segment is anticipating to increase at a substantial rate
Based on workflows, the global bioanalytical testing services market is segmented into sample preparation, sample analysis, and other processes. The sample preparation is further divided into Protein precipitation, liquid-liquid extraction, and solid phase extraction. The sample analysis is segmented into hyphenated technique, chromatographic technique, electrophoresis, ligand binding assay, mass spectrometry, and nuclear magnetic resonance. The sample analysis segment is expected to constitute the major market share of 45.7% at 2020. This process is mainly used in the determination of the concentration of chemical compounds and biological elements. Multiple techniques are used in this analysis, all used in specific scenarios for getting the more accurate results in very little time. This abundance of methods, the way of procedure and their accuracy of results is the major reason for the growth of this segment in this market.

 North America is anticipated to dominate the market
On the basis of regions, the global bioanalytical testing services market is segmented into Asia Pacific, North America, Latin America, Europe and Middle East & Africa. The market in North America is expected to expand at an impressive and healthy CAGR during the forecast period, 2021-2028 with a revenue share of 50.6% as of 2020. This regional market growth can be attributed to the availability of key manufacturers with highly reliable investments from both the government authorities and private investors. There is also a huge development in the research and development activities for the drug manufacturing, which takes place initially in this region before spreading to the rest of the world. The market in Asia Pacific is expected to register a rapid growth during the forecast period, 2021-2028. The primary reason for this is the increasing demand of outsourcing services which is comparatively higher than the other regional markets.

Segments

Segments Covered in the Report
The global bioanalytical testing services market size has been segmented in terms of

Molecule Types

• Small Molecule
• Large Molecule
  • LC-MS Studies
  • Immunoassays
    • PK
    • ADA
    • Others
• Others

Test Types

• ADME
  • In-Vivo
  • In-Vitro
• PK
• PD
• Bioavailability
• Bioequivalence
• Others

Workflows

• Sample Preparation
  • Protein Precipitation
  • Liquid-Liquid Extraction
  • Solid Phase Extraction
• Sample Analysis
  • Hyphenated Technique
  • Chromatographic Technique
  • Electrophoresis
  • Ligand Binding Assay
  • Mass Spectrometry
  • Nuclear Magnetic Resonance
• Other Processes

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• PPD
• ICON plc
• Covance Inc
• LabCorp
• Charles River Laboratories International Inc
• inVentiv Health
• SGS SA
• Toxikon Inc
• Intertek group
• Pace Analytical Services LLC

Competitive Landscape

Major players competing in the global bioanalytical testing services market are PPD; ICON plc; Covance Inc; LabCorp; Charles River Laboratories International Inc; inVentiv Health; SGS SA; Toxikon Inc; Intertek group; and Pace Analytical Services LLC. These market players are involved in several business strategies such as mergers, acquisitions partnerships, collaborations, capacity expansion, and product launches to enhance their market shares. They are simultaneously looking to innovate the current product they have in order to get a competitive edge in the market. For instance, SGS SA declared the GMP vaccine solutions with various testing and experimenting for the coronavirus. This was held in February 2020, where the bio-safety laboratory of SGS SA were able to produce latest testing services treating new viral threats such as the new variants of the coronavirus.