[197 Pages Report] The global analytical standards market is projected to reach USD 1.73 billion by 2022 from 1.27 billion in 2017, at a CAGR of 6.3% during the forecast period. The positive demand growth witnessed by analytical standards is mainly driven by the stringent regulatory scenario, increasing public-private investments for various researches, public concerns related to optimal food safety and quality, growing applications of analytical techniques in proteomics and metabolomics, greater regulatory emphasis on effective pollution monitoring and control, and expansion of pharmaceutical and biotechnology industries worldwide. In addition, the expected patent expiries of major drugs and biomolecules, development of new analytical methods, increasing adoption of analytical techniques in pesticide monitoring, and the increasing number of clinical trials across the globe are expected to provide growth opportunities for players in the analytical standards market.

By category, organic analytical standards segment is expected to account for the largest share during the forecast period

The organic standards segment is expected to account for the largest share of the global analytical standards market. This segment is also projected to grow at the highest CAGR during the forecast period, mainly due to factors such as increasing drug development & clinical trials, strong regulatory emphasis on effective pollution monitoring & control, and increasing public-private investment for various research studies.

By technique, chromatography standards segment is estimated to command the largest share and grow at the highest CAGR during the forecast period

The chromatography segment is expected to account for the largest share of the global analytical standards market. It is expected to grow at the highest CAGR during the forecast period. The large share and high growth of this segment is attributed to growing food safety concerns, increasing importance of chromatography tests in drug approvals, product launches, stringent regulatory environment for the pharmaceutical industry, and increased government funding for life sciences R&D.

By geography, Asia Pacific (APAC) to register the highest CAGR in the forecast period

The market in Asia-Pacific is projected to register the highest CAGR during the forecast period. Growth in this segment is attributed to the increasing investments by governments in the biotechnology industry, rising outsourcing of clinical trials from developed to emerging Asian nations, strategic expansions of analytical instrument market players in the region, increasing focus on soil testing, food security concerns in India, increasing number of bioclusters, high use of analytical technologies in Japan, and the growing biotechnology, biomedical, and pharmaceutical industries in China.

Market Dynamics

Driver: Stringent regulatory scenario in the pharmaceutical industry

In the last decade, there has been a growing focus on drug safety, as ineffective, poor-quality/unsafe medicines can result in therapeutic failure, drug resistance, or even death of a patient. In order to protect public health and facilitate international trade, various laws and regulations were introduced in the pharmaceutical industry. The U.S. FDA, WHO (World Health Organization), MHRA (Medicines and Healthcare Products Regulatory Agency), and domestic agencies in specific countries/regions are the major organizations that regulate the approval of pharmaceutical products and ensure that the manufactured drugs possess the correct identity, strength, quality, purity, and potency. Failure of pharmaceutical companies to obtain regulatory approval prevents the commercialization of drugs. Moreover, if a company fails to comply with regulations after drug approval, its product can be withdrawn from the market.

Restraint: Stringent storage requirements for analytical standards

Globally, the demand for analytical standards is increasing as a result of the rising number of drug development processes and research activities; all laboratories require analytical standards for parent compounds to carry various investigations. Analytical standards should be in the required amount and should have high purity levels. This is a major challenge as their integrity can be easily affected by degradative processes. Thus, proper storage is essential for their successful deployment. Moreover, due to the short shelf life of various analytical standards, research laboratories are reluctant to purchase large quantities of these compounds and mostly prefer to purchase on a real-time basis. This is expected to restrain the growth of the analytical standards market.

Opportunity: Patent expiry of major drugs and biomolecules

Key drug manufacturers are focusing on developing new drugs before their existing drugs lose their patent protection and expanding the applications of the existing drugs in the market for patent approval. Such activities require extensive research process with different analytical techniques in order to verify the efficacy of the various drugs molecules which are in the research pipeline. Additionally, in order to receive the regulatory approval, players have to conduct various analytical tests such as gas chromatography, liquid chromatography, IR/UV spectroscopy, titrimetry, and physical property testing for establishing the quality, purity, safety, and sustainability of the drug. This is increasing the adoption of analytical standards by pharmaceutical manufacturers and regulatory authorities.

Apart from the new molecules, generic drug versions which are identical or bioequivalent to a branded or patented drug in their performance have to meet the same regulatory standards as of the innovator drug. The generic drug manufacturers have to comply with good manufacturing practice regulations of the regulatory authorities and make use of various analytical instruments and techniques. This is expected to aid the growth of the analytical standards market across the globe.

Challenge: Dearth of well-trained and skilled laboratory technicians

Sophisticated analytical instruments cost a fortune and therefore require careful handling and care to ensure consistency of results and low maintenance costs. In addition to smooth operation, it is equally important that such instruments do not pose safety hazards to the operator and other personnel in a laboratory. With various technological advancements in mass spectrometers and chromatography instruments, the need for skilled professionals who can effectively operate these equipment has increased. Proper usage of this equipment requires expertise with relevant experience and knowledge of such analytical technologies.

The extent of analyses required for the establishment of Chemical Reference Substances depends on the purpose(s) for which it is employed. Generally, the standards are made in a solution with the same composition as the extractant used for the samples (with the same dilution factor) so that all measurements are done in the same matrix. In addition, the sample preparation method for analysis is highly complex and requires greater analyst expertise. Thus, proper selection and preparation of analytical standards at the time of investigations is very important to ensure accuracy and reproducibility in the analysis. However, lack of knowledge regarding the right choice of technique and analytical standards incurs several direct and indirect expenses. This shows that there is a need for highly skilled personnel in the analytical industry for method development, validation, operation, and troubleshooting activities.

Scope of the Report

Report Metric Details Market size available for years 2015�2022 Base year considered 2016 Forecast period 2017�2022 Forecast units USD million Segments covered Category, Technique, Application, and Region Geographies covered North America, Europe, APAC, and Rest of the World (RoW)

Note: The RoW regional segment includes Latin America, the Middle East, and Africa. Companies covered Merck KGaA(Germany), Agilent Technologies (US), Waters Corporation (US), Restek Corporation (US), SPEX CertiPrep (US), AccuStandard (US), LGC Standards (UK), PerkinElmer (US), Thermo Fisher Scientific (US), GE (US), Mallinckrodt (UK), Cayman Chemical (US), Ricca Chemical (US), GFS Chemicals (US), Chiron AS (US)

This report categorizes the global analytical standards market into the following segments and subsegments:

Global Analytical Standards Market, by Category

Organic Standards

Inorganic Standards

Global Analytical Standards Market, by Technique

Chromatography

Spectroscopy

Titrimetry

Physical Property Testing

Global Analytical Standards Market, by Application

Environmental

Food & Beverage

Pharmaceutical & Life Sciences

Petrochemistry

Forensic

Veterinary

Global Analytical Standards Market, by Region

North America

Europe

Asia-Pacific

Rest of the World (RoW)

Key Market Players

Merck KGaA (Germany), Agilent Technologies (US), Waters Corporation (US), GE (US), Mallinckrodt (UK),

Recent Developments

January 2017, Merck KGaA acquired BioControl Systems, Inc. (U.S.), a manufacturer of industrial microbiology testing solutions to expand its growth opportunities

in the food & beverage field.

In the year 2016, Merck KGaA launched nine certified spiking solutions including two phosphatidylethanol (PEth), five omega-3 fatty acids, and two omega-6 fatty acids.

In the year 2017, Restek Corporation launched the tetrahydrocannabivarin (THCV) standard to analyze the medical cannabis sample.

In the year 2017, GE expanded its manufacturing facility of certified reference materials to Hungary.

In the year 2016, PerkinElmer established the Taipei Customer Knowledge Center (CKC) in Taiwan.

Critical questions the report answers:

Where will all these developments take the analytical standards market in the long term?

What are the upcoming trends for the analytical standards market?

Which segment in analytical standards provides the most opportunity for growth?

Who are the leading vendors operating in this market?

What are the opportunities for new market entrants in the analytical standards market?

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