GMP Testing Service Market By Service Type, By End User : Global Opportunity Analysis and Industry Forecast, 2021-2031

Description

List of Tables

The global Good Manufacturing Practices (GMP) testing service market was valued at $1,314.6 million in 2021 and is projected to reach $2.514.37 million by 2031 registering a CAGR of 6.7% from 2022 to 2031.

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practices cover all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. GMP regulations require a quality approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mix-ups and errors. This protects the consumers from purchasing a service which is not effective or even dangerous. GMP regulations address issues which include record keeping, personal qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

The main driving factors that foster the growth of the GMP testing service market are rise in applications of GMP testing service in various fields such as pharmaceutical industries, chemical industry, food industry, environmental testing laboratories, and forensic science. In addition, the rise in number of players globally in the pharmaceutical and biopharmaceutical sector is one of the basic drivers of the GMP testing service. The need to disclose quality assurance parameters is anticipated to be one of the primary surging factor for GMP testing products. Moreover, the need of aseptic and sterile production machineries and spaces is expected to boost the growth of GMP testing service. The demand for GMP testing service is expected to increase with rise in need for innovator drugs and unique medical devices.

In addition, according to U.S Food & Drug Administration in 2019, there were approximately 4,676 manufacturing sites for drugs. There is an increase in the demand for developing new drugs and pharmaceuticals. This boosts the growth of the GMP testing service market. Moreover, for instance, in April 2021, PPD Inc., a leading global contract research organization, announced its plans to expand Good Manufacturing Practice lab in Ireland to enhance its biopharmaceutical testing capabilities. These factors foster the growth of the market.

The development of biosimilars, combination products, and other innovative medicines has increased the demand for specific testing procedures. Furthermore, several biopharmaceutical companies are using bioanalytical testing outsourcing service for drug development and validation of assays at both clinical and preclinical stages, thus supporting the growth of the market. Moreover, generic and branded drug compounds are mostly small molecules. Generic manufacturers have to conduct and submit bioanalytical testing results due to increase in patent expiration. This in turn, drives the adoption of bioanalytical testing for small molecules, which boosts the market growth. Furthermore, rise in number of contract manufacturing units, and increase in need for developing novel devices and drugs propel the growth of the market. For instance, according to an article entitled "Current perspectives on biosimilars" published in the Journal of Industrial Microbiology & Biotechnology in July 2019, almost 300 biopharmaceuticals have been patented in the last three decades. Also, in February 2021, according to the International Federation of Pharmaceutical Manufacturers and Associations, approximately 382 vaccine candidates were in phase III trial. Thus, these aforementioned factors have increased the growth of the market.

For instance, according to Congressional Budget Office 2021, the pharmaceutical business invested &83 billion in research and development. This results in rise the market growth. In addition, academic institutions are also partnering with biopharmaceutical companies to monitor the innovation and acquire expertise in drug discovery and development. The biopharmaceutical companies prefer to outsource manufacturing in markets where they have limited expertise in various stages of value chain, especially towards the end where CDMO's presence in a particular region gives them access to a vast distribution network as well as knowledge of existing regulatory guidelines. This factor drives the growth of GMP testing service market. Moreover, the Merck's BioReliance testing service is the leading GMP testing service provider for the development of therapeutics. In biopharmaceutical manufacturing, every product produced for preclinical and clinical studies, as well as for the global pharmaceutical markets, requires testing to demonstrate regulatory guideline compliance. Thus, availability of numerous testing service and surge in usage of testing service due to increase in pharmaceutical production contributes toward the market growth. However, the precise requirement of the regulatory framework concerning GMP outsourced activities is projected to hinder the market growth. In contrast, adoption of GMP testing service in R&D are some of the factors expected to offer lucrative growth opportunities for players in the GMP testing service market.

The GMP testing service market is segmented on the basis of service type, end user and region. On the basis of service type, the market is divided into product validation testing, bioanalytical service, packaging and shelf life testing, and others. By end user, it is categorized into pharmaceutical & bio-pharmaceutical company and medical device company. By region, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA. The key players mentioned in the report are Almac Group, Charles River Laboratories, Intertek Group Plc, Icon Inc., Eurofins Scientific SE, Microchem Laboratory, Merck KgaA, Nelson Laboratories, Sartorious AG, and Wuxi App Tec

Key Benefits For Stakeholders

This report provides an extensive analysis of the current and emerging market trends and dynamics in the global GMP testing services market to identify the prevailing opportunities.
This study presents the competitive landscape of the global market to predict the competitive environment across geographies.
Comprehensive analysis of factors that drive and restrict the market growth is provided.
Region- & country-wise analysis is provided to understand the market trends and dynamics.

Key Market Segments

By Service Type

Packaging and Shelf-Life Testing
Others
Product Validation Testing
Bioanalytical Services

By End User

Pharmaceutical and Biopharmaceutical Companies
Medical Device Companies

By Region

North America
- U.S.
- Canada
- Mexico
Europe
- Spain
- Rest of Europe
- Germany
- France
- U.K.
- Italy
Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest of Asia-Pacific
LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- almac group
- Charles River Laboratory
- Intertek Group PLC
- Merck KgaA
- Eurofins Scientific
- Nelson Laboratories
- Wuxi App Tec
- Sartorius AG
- ICON INC.
- Microchem Laboratory

Product Code: A16969

CHAPTER 1:INTRODUCTION

1.1.Report description
1.2.Key market segments
1.3.Key benefits to the stakeholders
1.4.Research Methodology
- 1.4.1.Secondary research
- 1.4.2.Primary research
- 1.4.3.Analyst tools and models

CHAPTER 2:EXECUTIVE SUMMARY

2.1.Key findings of the study
2.2.CXO Perspective

CHAPTER 3:MARKET OVERVIEW

3.1.Market definition and scope
3.2.Key findings
- 3.2.1.Top investment pockets
3.3.Porter's five forces analysis
3.4.Top player positioning
3.5.Market dynamics
- 3.5.1.Drivers
- 3.5.2.Restraints
- 3.5.3.Opportunities
3.6.COVID-19 Impact Analysis on the market

CHAPTER 4: GMP TESTING SERVICE MARKET, BY SERVICE TYPE

4.1 Overview
- 4.1.1 Market size and forecast
4.2 Product Validation Testing
- 4.2.1 Key market trends, growth factors and opportunities
- 4.2.2 Market size and forecast, by region
- 4.2.3 Market analysis by country
4.3 Bioanalytical Services
- 4.3.1 Key market trends, growth factors and opportunities
- 4.3.2 Market size and forecast, by region
- 4.3.3 Market analysis by country
4.4 Packaging and Shelf-Life Testing
- 4.4.1 Key market trends, growth factors and opportunities
- 4.4.2 Market size and forecast, by region
- 4.4.3 Market analysis by country
4.5 Others
- 4.5.1 Key market trends, growth factors and opportunities
- 4.5.2 Market size and forecast, by region
- 4.5.3 Market analysis by country

CHAPTER 5: GMP TESTING SERVICE MARKET, BY END USER

5.1 Overview
- 5.1.1 Market size and forecast
5.2 Pharmaceutical and Biopharmaceutical Companies
- 5.2.1 Key market trends, growth factors and opportunities
- 5.2.2 Market size and forecast, by region
- 5.2.3 Market analysis by country
5.3 Medical Device Companies
- 5.3.1 Key market trends, growth factors and opportunities
- 5.3.2 Market size and forecast, by region
- 5.3.3 Market analysis by country

CHAPTER 6: GMP TESTING SERVICE MARKET, BY REGION

6.1 Overview
- 6.1.1 Market size and forecast
6.2 North America
- 6.2.1 Key trends and opportunities
- 6.2.2 North America Market size and forecast, by Service Type
- 6.2.3 North America Market size and forecast, by End User
- 6.2.4 North America Market size and forecast, by country
  - 6.2.4.1 U.S.
  - 6.2.4.1.1 Market size and forecast, by Service Type
  - 6.2.4.1.2 Market size and forecast, by End User
  - 6.2.4.2 Canada
  - 6.2.4.2.1 Market size and forecast, by Service Type
  - 6.2.4.2.2 Market size and forecast, by End User
  - 6.2.4.3 Mexico
  - 6.2.4.3.1 Market size and forecast, by Service Type
  - 6.2.4.3.2 Market size and forecast, by End User
6.3 Europe
- 6.3.1 Key trends and opportunities
- 6.3.2 Europe Market size and forecast, by Service Type
- 6.3.3 Europe Market size and forecast, by End User
- 6.3.4 Europe Market size and forecast, by country
  - 6.3.4.1 Germany
  - 6.3.4.1.1 Market size and forecast, by Service Type
  - 6.3.4.1.2 Market size and forecast, by End User
  - 6.3.4.2 France
  - 6.3.4.2.1 Market size and forecast, by Service Type
  - 6.3.4.2.2 Market size and forecast, by End User
  - 6.3.4.3 U.K.
  - 6.3.4.3.1 Market size and forecast, by Service Type
  - 6.3.4.3.2 Market size and forecast, by End User
  - 6.3.4.4 Italy
  - 6.3.4.4.1 Market size and forecast, by Service Type
  - 6.3.4.4.2 Market size and forecast, by End User
  - 6.3.4.5 Spain
  - 6.3.4.5.1 Market size and forecast, by Service Type
  - 6.3.4.5.2 Market size and forecast, by End User
  - 6.3.4.6 Rest of Europe
  - 6.3.4.6.1 Market size and forecast, by Service Type
  - 6.3.4.6.2 Market size and forecast, by End User
6.4 Asia-Pacific
- 6.4.1 Key trends and opportunities
- 6.4.2 Asia-Pacific Market size and forecast, by Service Type
- 6.4.3 Asia-Pacific Market size and forecast, by End User
- 6.4.4 Asia-Pacific Market size and forecast, by country
  - 6.4.4.1 Japan
  - 6.4.4.1.1 Market size and forecast, by Service Type
  - 6.4.4.1.2 Market size and forecast, by End User
  - 6.4.4.2 China
  - 6.4.4.2.1 Market size and forecast, by Service Type
  - 6.4.4.2.2 Market size and forecast, by End User
  - 6.4.4.3 Australia
  - 6.4.4.3.1 Market size and forecast, by Service Type
  - 6.4.4.3.2 Market size and forecast, by End User
  - 6.4.4.4 India
  - 6.4.4.4.1 Market size and forecast, by Service Type
  - 6.4.4.4.2 Market size and forecast, by End User
  - 6.4.4.5 South Korea
  - 6.4.4.5.1 Market size and forecast, by Service Type
  - 6.4.4.5.2 Market size and forecast, by End User
  - 6.4.4.6 Rest of Asia-Pacific
  - 6.4.4.6.1 Market size and forecast, by Service Type
  - 6.4.4.6.2 Market size and forecast, by End User
6.5 LAMEA
- 6.5.1 Key trends and opportunities
- 6.5.2 LAMEA Market size and forecast, by Service Type
- 6.5.3 LAMEA Market size and forecast, by End User
- 6.5.4 LAMEA Market size and forecast, by country
  - 6.5.4.1 Brazil
  - 6.5.4.1.1 Market size and forecast, by Service Type
  - 6.5.4.1.2 Market size and forecast, by End User
  - 6.5.4.2 Saudi Arabia
  - 6.5.4.2.1 Market size and forecast, by Service Type
  - 6.5.4.2.2 Market size and forecast, by End User
  - 6.5.4.3 South Africa
  - 6.5.4.3.1 Market size and forecast, by Service Type
  - 6.5.4.3.2 Market size and forecast, by End User
  - 6.5.4.4 Rest of LAMEA
  - 6.5.4.4.1 Market size and forecast, by Service Type
  - 6.5.4.4.2 Market size and forecast, by End User

CHAPTER 7: COMPANY LANDSCAPE

7.1. Introduction
7.2. Top winning strategies
7.3. Product Mapping of Top 10 Player
7.4. Competitive Dashboard
7.5. Competitive Heatmap
7.6. Key developments

CHAPTER 8: COMPANY PROFILES

8.1 almac group
- 8.1.1 Company overview
- 8.1.2 Company snapshot
- 8.1.3 Operating business segments
- 8.1.4 Product portfolio
- 8.1.5 Business performance
- 8.1.6 Key strategic moves and developments
8.2 Charles River Laboratory
- 8.2.1 Company overview
- 8.2.2 Company snapshot
- 8.2.3 Operating business segments
- 8.2.4 Product portfolio
- 8.2.5 Business performance
- 8.2.6 Key strategic moves and developments
8.3 Intertek Group PLC
- 8.3.1 Company overview
- 8.3.2 Company snapshot
- 8.3.3 Operating business segments
- 8.3.4 Product portfolio
- 8.3.5 Business performance
- 8.3.6 Key strategic moves and developments
8.4 Merck KgaA
- 8.4.1 Company overview
- 8.4.2 Company snapshot
- 8.4.3 Operating business segments
- 8.4.4 Product portfolio
- 8.4.5 Business performance
- 8.4.6 Key strategic moves and developments
8.5 Eurofins Scientific
- 8.5.1 Company overview
- 8.5.2 Company snapshot
- 8.5.3 Operating business segments
- 8.5.4 Product portfolio
- 8.5.5 Business performance
- 8.5.6 Key strategic moves and developments
8.6 Nelson Laboratories
- 8.6.1 Company overview
- 8.6.2 Company snapshot
- 8.6.3 Operating business segments
- 8.6.4 Product portfolio
- 8.6.5 Business performance
- 8.6.6 Key strategic moves and developments
8.7 Wuxi App Tec
- 8.7.1 Company overview
- 8.7.2 Company snapshot
- 8.7.3 Operating business segments
- 8.7.4 Product portfolio
- 8.7.5 Business performance
- 8.7.6 Key strategic moves and developments
8.8 Sartorius AG
- 8.8.1 Company overview
- 8.8.2 Company snapshot
- 8.8.3 Operating business segments
- 8.8.4 Product portfolio
- 8.8.5 Business performance
- 8.8.6 Key strategic moves and developments
8.9 ICON INC.
- 8.9.1 Company overview
- 8.9.2 Company snapshot
- 8.9.3 Operating business segments
- 8.9.4 Product portfolio
- 8.9.5 Business performance
- 8.9.6 Key strategic moves and developments
8.10 Microchem Laboratory
- 8.10.1 Company overview
- 8.10.2 Company snapshot
- 8.10.3 Operating business segments
- 8.10.4 Product portfolio
- 8.10.5 Business performance
- 8.10.6 Key strategic moves and developments