BIOANALYTICAL TESTING SERVICES MARKET ANALYSIS

The global bioanalytical testing services market was valued at US$ 2,902.0 Mn in 2021 and is forecast to reach a value of US$ 6,216.9 Mn by 2028 at a CAGR of 11.6% between 2022 and 2028. The global bioanalytical testing services market is experiencing strong growth due to the increase in demand for novel therapeutics due to increase in burden of chronic diseases and increasing number of clinical trials and drug approvals across the world. Moreover, rise in demand for biologics and biosimilars and outbreak of COVID-19 is expected to propel the growth of the market. However, factors such as challenges in the development of analytical techniques and complex regulatory framework for maintaining laboratories are expected to hamper growth of the market.

Global Bioanalytical Testing Services Market: Regional Insights

Based on geography, the global bioanalytical testing services market is segmented into North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period owing to the increasing number of clinical trials, increasing number of drug approvals, and presence of major service providers in the region. For instance, the United States Food and Drug Administration (FDA) has approved around 20,000 prescription drug products for marketing. FDA oversees over 6,700 different medical device product categories. In 2021, over 50 novel drugs were approved by the U.S. Food and Drug Administration (FDA). Bioanalytical testing services are used for quantitative determination of properties of drugs.

Asia Pacific and Europe are also expected to witness significant growth in the global bioanalytical testing services market due to the rapid growth of the pharmaceutical industry and rising demand for outsourcing services in these regions. For instance, with the rapid growth of the pharmaceutical industry, the demand for bioanalytical testing services is also increasing with a rapid pace. In 2020, India's pharmaceutical industry was the 3^rd largest by volume and 14^th largest by value worldwide. Moreover, the Indian pharma industry is expected to expand to US$ 65 billion by 2024 and ~US$ 130 billion by 2030, driving the market growth.

Figure 1. Global Bioanalytical Testing Services Market Share (%), by Region, 2022

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Global Bioanalytical Testing Services Market Drivers:

Increase in demand for novel therapeutics due to the increase in burden of chronic diseases across the globe is expected to augment growth of the global bioanalytical testing services market over the forecast period. For instance, with the increase in demand for novel therapeutics, the demand for bioanalytical testing services is also increasing. According to the World Health Organization (WHO), cardiovascular diseases account for most NCD (noncommunicable diseases) deaths, over 17.9 million people annually, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million including kidney disease deaths caused by diabetes).

Increasing number of clinical trials and drug approvals are expected to boost growth of the global bioanalytical testing services market during the forecast period. For instance, The FDA's approval count last year was in line with recent trends, despite the continued impact of COVID-19 (global pandemic). In 2021, the FDA's Center for Drug Evaluation and Research (CDER) approved 50 novel therapeutics. Moreover, clinicalTrials.gov currently lists over 434,164 studies with locations in all 50 States and in 221 countries. This in turn is expected to augment the growth of the global bioanalytical testing services market.

Global Bioanalytical Testing Services Market Opportunities:

The outbreak of COVID-19 across the globe is expected to offer significant growth opportunities for players in the bioanalytical testing services market. For instance, the pandemic has increased the demand for bioanalytical testing services worldwide. In January 2021, Eurofins Bioanalytical Services developed the surrogate virus neutralizing antibody detection assays against SARS-CoV-2 (COVID-19 virus). This assay detects the presence of neutralizing or blocking antibodies against the virus. It is the first neutralizing antibody serology test authorized by the FDA as Emergency Use Authorization (EUA) for SARS-CoV-2-virus.

Increase in demand for biologics and biosimilars around the world is expected to offer significant growth opportunities for players in the global bioanalytical testing services market. For instance, with the increase in demand for biologics and biosimilars and rising focus on the analytical testing of biologics/biosimilars, the demand for bioanalytical testing services is also increasing. In January 2020, Celltrion planned to invest USD 514 million in biologics facility (Wuhan, China) to develop and manufacture biologics for the local market and perform contract work for Chinese biotech companies' emerging wave. This in turn is expected to drive the market growth.

Global Bioanalytical Testing Services Market Trends:

The trend of outsourcing laboratory testing services is increasing with the rise in burden of chronic diseases, increase in demand for novel therapeutics, and increase in the need for specific types of tests in R&D activities. Bioanalytical testing plays an integral part of the pharmaceutical industry. Bioanalytical testing services are used for quantitative determination of properties of drugs, and thereby, there is an increase in demand for bioanalytical testing services. This trend is expected to continue over the forecast period.

Moreover, with the rise in demand for generic drugs across the globe, the demand for bioanalytical testing services is also increasing with the rapid pace. Bioanalytical testing plays an important role in proving efficacy by simulating generic drug release profiles with branded drugs. It is important for generic drug development. This trend is also expected to continue during the forecast period, driving the growth of the bioanalytical testing services market.

Global Bioanalytical Testing Services Market Restraints:

Challenges in the development of analytical techniques are expected to hinder growth of the global bioanalytical testing services market. Analytical techniques plays a vital role in biotechnology and pharmaceuticals manufacturing. However, the development of bioanalytical methods has become more and more challenging over the years due to very demanding requirements in terms of method sensitivity, reliability, sample throughput, and speed of analysis. This in turn is restraining growth of the bioanalytical testing services market.

Complex regulatory framework for maintaining laboratories is expected to hamper growth of the global bioanalytical testing services market. Every country has its own regulations which apply to innovation, manufacturing, drug testing, marketing, and post marketing studies. Thus, stringent regulations associated with laboratory maintenance and validation, and testing of pharmaceutical drugs are expected to hinder growth of the market.

Figure 2. Global Bioanalytical Testing Services Market Share (%), by Molecule Type, 2022

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Global Bioanalytical Testing Services Market Segmentation:

The global bioanalytical testing services market report is segmented into Method Type, Test Type, and Geography.

Based on Method Type, the market is segmented into Small Molecules and Large Molecules. Of which, Small Molecules Segment is expected to dominate the global bioanalytical testing services market over the forecast period. This is attributed to the increase in demand for novel therapeutics (such as branded drugs, generic drugs, biologics, biosimilars, and more). Generic and branded drug compounds are mostly small molecules.

Based on Test Type, the market is segmented into Bioavailability and Bioequivalence Studies, Pharmacokinetics, Pharmacodynamics, and Other Test Types. Out of which, Bioavailability and Bioequivalence Studies Segment is expected to dominate the market over the forecast period and this is attributed to the increase in demand for novel therapeutics due to the increase in burden of chronic diseases, such as heart disease, cancer, diabetes, and others, worldwide.

Pharmacokinetics Segment is also expected to witness significant growth in the near future and this is owing to the increasing number of clinical trials across the globe. Pharmacokinetics studies are a critical part of the clinical trial in various phases of trials.

Global Bioanalytical Testing Services Market: Key Developments

In October 2021, Syneos announced acquisition of RxDataScience, a leading healthcare-focused data analytics, data management, and Artificial Intelligence (AI) company.

In August 2021, Labcorp and Community Clinical Oncology Research Network LLC (CCORN), collaborated to understand the impact of disparities in precision medicine for people with cancer.

In June 2021, Charles River acquired Vigene Biosciences, a CDMO (contract development and manufacturing organization) providing viral vector-based gene delivery solutions, to strengthen its ability to support the clients with end-to-end cell and gene therapy support.

Global Bioanalytical Testing Services Market: Key Companies Insights

The global bioanalytical testing services market is highly competitive. This is attributed to the rise in demand for bioanalytical testing services around the world, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global bioanalytical testing services market are PPD Inc., Icon Plc, Syneos Health, Laboratory Corporation of America Holdings, and Charles River Laboratories International Inc., among others.

*Definition: The analytical method used for the analysis of biological/biotechnological products is known as bioanalytical testing. Analytical techniques plays an important role in biotechnology and pharmaceuticals manufacturing. Bioanalytical tests are used in drug discovery, development, as well as in the commercialization of drugs.