The global bioanalytical testing services market was valued at USD 3.35 billion in 2020 and is expected to grow at a CAGR of 8.7% during the forecast period. Increasing demand for biosimilars and biologics analytical testing, growing preference for quality by design approach, increasing preferences for contract analytical testing, and rising investments for the pharma and biopharma market growth are some of the factors that will likely boost the market's growth in the forecast timeframe.
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In addition, the growing demand for advanced bioanalytical testing services and increasing applications from emerging markets will generate new possibilities for the global market to expand during the projected period. The increased focus on contract research development services by biopharmaceuticals has provided opportunities worldwide in recent years.
Several biopharma companies have increased outsourcing R&D activities to concentrate on their crucial competency, which is anticipated to fuel the growth of the global bioanalytical testing services market during the forecast timeframe. Moreover, the cost-effectiveness of outsourcing versus in-house research is expected to propel the industry forward.
The market is primarily segmented on the basis of molecule type, test type, workflow, and region.
By Molecule Type
By Test Type
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Bioanalytical testing is an integral part of any drug discovery and development process. Pharmaceutical companies are increasingly focused on developing innovative drugs to treat various life-threatening diseases such as cancer. The increase in new drugs in the pipeline, emergence of contract research organizations (CROs), and biosimilar development are expected to fuel the growth of the global bioanalytical testing services market during the forecast period.
Many pharmaceutical majors are looking to develop new drugs in the coming years as many drug patents will expire in the coming years. To be competitive in the market, they need to bring novel medicines. From 2018, it is expected that nearly 43 drugs will lose their patents and will get the generic tag by 2022. One of the significant focuses of companies in the development of cancer drugs. Globally, there are more than 4,700 Immuno-oncology drugs that are under various phases of growth in 2020.
The increase in the expiration of patents has given rise to the emergence of biosimilars. Even though biosimilars are similar in chemical composition and other aspects of their original drug, these drugs have to undergo various phases of drug development to prove their safety and efficacy. The number of biosimilars in the pipeline has increased by over 200% compared to 2013; now, there are more than 1,050 biosimilars in the pipeline, which are in various stages of development.
The emergence of CROs in the past few decades has significantly contributed to the growth of the global market. Globally, there are more than 1000 CROs that support pharma companies by providing various bioanalytical testing platforms. CROs are highly specialized in drug discovery processes, and hence, pharma companies are outsourcing R&D to these CROs. Once the efficacy of the candidate drug is validated using various bioanalytical methods by CROs, pharma companies will move to the next stage of drug development.
There are a lot of collaborations and acquisitions among companies with respect to analytical testing globally. For instance, recently, HitGen and UPPTHERA Inc. entered into a drug discovery research collaboration to identify small molecules against undruggable targets and novel E3 ligase.
In July 2018, Bioasis INC and Bioagilytix entered into a partnership to develop and validate bioanalytical methods that will help develop Bioasis’s xB3 TM-001 drug candidate against brain cancer.
In 2019, Adial Pharmaceuticals, Inc. entered into a partnership with Eurofins Scientific, a major company providing bioanalytical testing services globally, to provide the genetic testing for the Phase 3 clinical trial for AD04. AD04 is a genetically targeted therapeutic agent being developed by Adial Pharmaceuticals to treat alcohol use disorder.
In 2019, Nexelis acquired AIT Bioscience which is an integrated bioanalytical laboratory. AIT bioscience is specialized in immunoassay and LC-MS supported by FDA-inspected state-of-the-art electronic systems facility. COVID-19 pandemic is expected to further contribute to the upward growth of the global market as many companies are developing new antiviral drugs or repurposing old drugs to combat the deadly coronavirus.
The small molecule segment dominated the global market for bioanalytical testing services in 2020. Small molecules make up the majority of generic and marketed drug compounds. Furthermore, when many blockbuster drugs patents expire, generic manufacturers must perform and report bioanalytical testing results. These factors primarily influenced the increase of the small molecule drug bioanalytical testing services industry.
Over the forecast period, extensive molecule bioanalytical testing services are expected to expand at a healthy rate. This is due to a large number of biological drugs and amino acid-based molecules in the pipeline. Furthermore, testing these molecules necessitates technological expertise and specialized analytical tools, all of which are accessible from bioanalytical services providers.
The Bioavailability (BA) market segment held the largest share of the global services market for bioanalytical testing services and generated the highest revenue in 2020. This is due to the high demand for these facilities in generic drug manufacturing.
Pharmacokinetics is a field of pharmacology that studies the fate of drugs after they have been administered. The dose, peak plasma concentration (Cmax), dosing interval, and the elimination of half-life, and volume of distribution, are all important and frequently measured parameters.
North America is expected to be the most prominent region for the global market during the forecast period. The availability of modern bioanalytical testing services facilities and massive investment in R&D by US pharmaceutical giants to develop new drug candidates will boost the market's growth for bioanalytical testing services in this region.
Most of the pharmaceutical giants across the globe, such as Pfizer and others, are based in the U.S. There are more than 1,100 oncology drugs in the pipeline in the US alone at various stages of clinical development.
The Asia Pacific bioanalytical testing services industry is expected to be the fastest-growing market during the forecast period 2021 - 2028. The presence of a large number of CROs in the China and Indian markets, along with the presence of many pharmaceutical companies, will be a driving factor for the growth of the services market in this region.
Nearly 50% of the CROs in this region are based in India, and 18% are present in China. Compared to western counterparts, they offer drug discovery and development services at a much lower price, attracting global pharma companies to this market.
Major pharmaceutical companies across the globe are significantly investing in R&D to develop novel bioanalytical testing platforms and develop innovative drugs. Market players and CROs are involved in acquisition and collaboration to increase their bioanalytical testing capacity and services to hold a competitive edge over their rival companies.
Some of the major players operating in the market for bioanalytical testing services include PPD Inc., Covance Inc., ICON plc, Charles River Laboratories International, Inc., LabCorp, SGS SA, inVentiv Health, Pace Analytical Services, LLC, and Intertek group.