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Process Analytical Technologies for Pharmaceuticals: Global Markets

Process Analytical Technologies for Pharmaceuticals: Global Markets

  • December 2017
  • 230 pages
  • ID: 461666
  • Format: PDF
  • BCC Research


Table of Contents

• The global market for process analytical technologies (PAT) in pharmaceuticals should reach $412.7 million in 2017 and nearly $539.3 million by 2022 at a compound annual growth rate (CAGR) of 5.5% for the period of 2017 to 2022.
• Spectrophotometric tools and techniques as a segment should reach $184.8 million in 2017 and expected to reach nearly $242.6 million by 2022, at a CAGR of 5.6% for the period of 2017 to 2022.
• Automated analytical methods as a segment should reach nearly $50.9 million in 2017 and expected to reach $68.5 million by 2022, at a CAGR of 6.1% from 2017 to 2022.

Chapter 1: Introduction

Study Goals and Objectives
Process analytical technology (PAT) is an initiative from the U.S. Food and Drug Administration (FDA) for improving pharmaceutical manufacturing processes, in order to create pharmaceutical products with optimum quality. The objective behind PAT is to design, analyze and control/monitor pharmaceutical production and manufacturing processes by identifying critical process parameters. The goal of this report by BCC Research is to provide a perspective and overview of the current and future global market for PAT tools in the pharmaceutical industry.

This report will look at the components that comprise the PAT market, which include chromatographic tools and techniques, spectrophotometric tools and techniques, capillary electrophoresis, particle size analysis, dissolution methods, automated analytical methods and titration tools. The development of the market, and the factors driving and restraining it, are also discussed, as are the classifications and applications of these tools and techniques.

A detailed analysis of the PAT industry structure has been conducted for this report. Revenues are reported by region. Sales figures are estimated for the five-year period from 2017 through 2022. Applications for PAT solutions are also discussed. The report also covers significant patents by category.

Reasons for Doing This Study
The FDA created the PAT regulatory framework in 2002 for the purpose of encouraging the implementation of innovation in product development, manufacturing and quality assurance in the pharmaceutical industry. The report offers insights into PAT tools and techniques, their implementation, and their markets.

The main objective of PAT is to generate real-time information about product quality. The idea behind PAT guidance is to utilize innovative, scientific, business knowledge and qualityassurance principles for efficient pharmaceutical manufacturing. Meeting regulatory is a secondary objective. The PAT initiative is supported by the European Medicines Agency (EMA), the Japanese Ministry of Health, Labor and Welfare (MHLW) and the International Conference on Harmonization (ICH) guidelines.

Significant acquisitions and collaborations in the PAT arena are also covered in this report. This study also discusses the impacts of R&D spending, new technologies, growing competition and changing customer needs on the market’s direction.

Scope of Report
Although PAT was by and large developed for pharmaceuticals, its scope is much broader and ranges to the food, biotechnology, biopharmaceuticals and other process-prominent industries. However, this report covers only the pharmaceutical industry. The advancements and enhanced implementation of PAT solutions benefit primarily the overall pharmaceutical industry along with drug developers and manufacturers, and pharmaceutical and PAT solution development companies.

The scope of the study is global. Its sales analyses are broken down geographically for North America (U.S. and Canada), Europe, Asia-Pacific and emerging markets. Applications of PAT tools are summed up from the perspective of commercial and R&D usage. BCC Research also analyzes the regulatory environment, new products and advancements, market projections and market shares.

Also included in the report are relevant patent analysis and profiles of leading companies in the PAT industry, such as Siemens, Thermo Fisher Scientific Inc., Emerson Electric Co., Agilent Technologies Inc., Danaher Corp., ABB Group, Honeywell International Inc., Bruker, Shimadzu Corp. and PerkinElmer Inc.

Information Sources
Many companies were surveyed to obtain data for this study, including manufacturers and end users of PAT solutions. Data were gathered from various industry sources. BCC Research spoke with industry executives and consulted newsletters, company literature, and a host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were undertaken. In addition, data were compiled from current financial, trade and government sources.

Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search, which included technical newsletters, journals and many other sources. Data were collected through interviews and correspondence with manufacturers and users of PAT solutions. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

Geographic Breakdown

In this report, the geographic regions considered for market analysis include, and only include:
North America
- United States
- Canada Europe
- Albania
- Austria
- Belgium
- Bosnia and Herzegovina
- Bulgaria
- Croatia
- Cyprus
- Czech Republic
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Lithuania
- Luxembourg
- Malta
- Norway
- Poland
- Portugal
- Romania
- Serbia and Montenegro
- Slovakia
- Slovenia
- Spain
- Sweden
- Switzerland
- The Netherlands
- United Kingdom Asia-Pacific
- Australia
- Bangladesh
- Cambodia
- China
- Fiji
- Hong Kong
- India
- Indonesia
- Japan
- Laos
- Malaysia
- Myanmar
- New Zealand
- Pakistan
- Russia
- Singapore
- South Korea
- Taiwan
- Thailand
- Vietnam Emerging Markets
- Argentina
- Bahrain
- Brazil
- Chile
- Colombia
- Egypt
- Iran
- Iraq
- Kuwait
- Lebanon
- Mexico
- Oman
- Peru
- Qatar
- Saudi Arabia
- South Africa
- Syria
- Turkey
- Venezuela

Process Analytical Technology, by Type

Chromatographic tools and techniques
- Gas chromatography/mass spectrometry
- Gas chromatography
- High performance liquid chromatography
- Thin layer chromatography

Spectrophotometric tools and techniques
- Near-infrared
- Ultraviolet-visible
- Nuclear magnetic resonance
- Atomic absorption Infrared
- X-ray diffraction
- Mass spectrometry
- Raman spectroscopy

Capillary electrophoresis
Isoelectric focusin

Particle size analysis
Sieving )
Size-exclusion chromatography

Dissolution methods
- Automated
- Ultraviolet

Automated analytical methods
Automated analysis
Others (automated processes)

Titration tools

Process Analytical Technology, by Application
Industrial pharmaceutical manufacturing
Pharmaceutical research and development

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