Global Healthcare Analytical Testing Services Market 2018-2023 by Method Validation, Environmental

The global healthcare analytical testing services market is projected to reach USD 5.97 Billion by 2023 from USD 3.43 Billion in 2018, at a CAGR of 11.7%.

The shift of focus towards analytical testing of biologics and biosimilars, increasing outsourcing of analytical testing by pharmaceutical companies, increasing acceptance of the QbD approach in pharma research/manufacturing, and adoption of FTE contracts in R&D outsourcing are the major factors driving the growth of the healthcare analytical testing services market.

The report analyzes the global healthcare analytical testing services market by type, end user, and region. On the basis of type, the bioanalytical testing segment accounted for the largest share of the global healthcare analytical testing servicess market in 2017. The large share of this segment is due to increasing number of drugs in the biopharmaceutical pipeline and the growing biopharmaceutical industry.

The global healthcare analytical testing services market by end user is segmented into pharmaceutical and biopharmaceutical companies, medical device companies and contract research organizations. In 2017, the pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the market. The large share of this segment can be attributed to the increasing outsourcing of analytical testing services by pharmaceutical and biopharmaceutical companies to boost profit margins, avoid high capital expenditure, and reduce the time required to validate the process and product.

The rising demand for specialized analytical testing services and growth opportunities in emerging APAC countries are expected to provide further growth opportunities for players operating in the healthcare analytical testing services market. However, pricing pressure faced by market players and shortage of skilled professionals in the healthcare analytical testing services industry are some of the factors limiting the growth of this market during the forecast period.

Eurofins Scientific (Luxembourg) held the leading position in the global healthcare analytical testing services market in 2017. Over the past three years, the company has established itself as one of the leading players in the healthcare analytical testing services market.

Key Topics Covered:

1 Introduction

2 Research Methodology

3 Executive Summary

4 Premium Insights
4.1 Healthcare Analytical Testing Services Market Overview
4.2 APAC: Healthcare Analytical Testing Services Market, By End User & Country
4.3 Healthcare Analytical Testing Services Market: Geographical Snapshot
4.4 Healthcare Analytical Testing Services Market: Geographical Mix

5 Market Overview
5.1 Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.1.1 Focus on Analytical Testing of Biologics and Biosimilars
5.2.1.2 Increasing Preference for Outsourcing Analytical Testing
5.2.1.3 Rising Adoption of the Quality By Design Approach
5.2.1.4 Adoption of Fte Contracts in R&D Outsourcing
5.2.2 Restraints
5.2.2.1 Pricing Pressure Faced By Major Players
5.2.2.2 Shortage of Skilled Professionals
5.2.3 Opportunities
5.2.3.1 Rising Demand for Specialized Analytical Testing Services
5.2.3.2 Growth Opportunities in Emerging Asia Pacific Countries
5.2.4 Challenges
5.2.4.1 Innovative Formulations and Medical Devices Demanding A Unique Analytical Testing Approach
5.2.4.2 Development of Appropriate Dissolution Methods
5.2.4.3 Growing Need to Improve the Sensitivity of Analytical Methods

6 Industry Insights
6.1 Industry Trends
6.1.1 Growing Industry Consolidation
6.1.2 Long-Term Outsourcing and Preferred Vendor Partnerships
6.2 Regulatory Analysis

7 Healthcare Analytical Testing Services Market, By Type
7.1 Introduction
7.2 Bioanalytical Testing
7.2.1 Cell-Based Assays
7.2.2 Virology Testing
7.2.2.1 In Vitro Assays
7.2.2.2 In Vivo Assays
7.2.2.3 Species-Specific Viral Pcr Assays
7.2.3 Immunogenicity & Neutralizing Antibody Testing
7.2.4 Biomarker Testing
7.2.5 Pharmacokinetic Testing
7.3 Physical Characterization
7.3.1 Laser Particle Size Analysis
7.3.2 Thermal Analysis
7.3.3 Image Analysis
7.3.4 Surface Area Analysis
7.3.5 Other Physical Characterization Analysis Services
7.4 Method Development & Validation
7.4.1 Extractables & Leachables Method Development & Validation
7.4.2 Process Impurity Method Development & Validation
7.4.3 Stability Indicating Method Validation
7.4.4 Cleaning Validation Method Development
7.4.5 Analytical Standard Characterization
7.4.6 Technical Consulting
7.4.7 Other Method Validation Services
7.5 Raw Material Testing
7.5.1 Complete Compendial Testing
7.5.2 Heavy Metal Testing
7.5.3 Container Testing
7.5.4 Karl Fischer Analysis
7.5.5 Wet Chemistry Analysis
7.5.6 Other Raw Material Testing Services
7.6 Batch-Release Testing
7.6.1 Dissolution Testing
7.6.2 Elemental Impurity Testing
7.6.3 Disintegration Testing
7.6.4 Hardness Testing
7.6.5 Friability Testing
7.6.6 Other Batch-Release Testing Services
7.7 Stability Testing
7.7.1 Drug Substance Stability Testing
7.7.2 Formulation Evaluation Stability Testing
7.7.3 Accelerated Stability Testing
7.7.4 Photostability Testing
7.7.5 Comparative Stability Testing
7.7.6 Other Stability Testing Services
7.8 Microbial Testing
7.8.1 Microbial Limit Testing
7.8.2 Sterility Testing
7.8.3 Endotoxin Testing
7.8.4 Preservative Efficacy Testing
7.8.5 Water Testing
7.8.6 Other Microbial Testing Services
7.9 Environmental Monitoring
7.9.1 Air Testing
7.9.2 Wastewater/ETP Testing
7.9.3 Other Environmental Monitoring Services

8 Healthcare Analytical Testing Services Market, By End User
8.1 Introduction
8.2 Pharmaceutical & Biopharmaceutical Companies
8.3 Medical Device Companies
8.4 Contract Research Organizations

9 Healthcare Analytical Testing Services Market, By Region

10 Competitive Landscape
10.1 Overview
10.2 Market Share Analysis
10.3 Competitive Scenario
10.3.1 Acquisitions
10.3.2 Expansions
10.3.3 Partnerships, Agreements, and Collaborations
10.3.4 Services Launches

11 Company Profiles
11.1 Eurofins Scientific
11.2 Labcorp
11.3 SGS
11.4 Charles River
11.5 Wuxi Pharmatech
11.6 Pharmaceutical Product Development, LLC (PPD)
11.7 Exova
11.8 Pace Analytical
11.9 Envigo
11.10 Intertek
11.11 MPI Research
11.12 Merck KGaA
11.13 Source Bioscience

For more information about this report visit https://ift.tt/2EVq4EW

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

View original content:https://ift.tt/2qFqzi5

SOURCE Research and Markets

Related Links

https://ift.tt/SKD5BK

Source link

Five expert views on Track and Trace

European Pharmaceutical Review’s roundtable devoted to track and trace technology. Five industry experts focus on how the contribution of track and trace technology is shaping the pharmaceutical sector and explain what factors are driving that change.

What are the key elements of a successful track and trace system for the pharmaceutical sector?

ETTORE CUCCETTI, CEO, ACG Inspection: For the successful implementation of a pharmaceutical serialisation system, understanding of the packaging process, country-specific regulations, in-depth knowledge of process compliance and, most importantly, the right implementation partner are crucial. Implementation partners must possess skills such as project management expertise, service and maintenance capability, and financial stability. Also, as these projects are more of a software deployments scenario ranging from medium- to large-size scope, then system validation, security, handling and maintenance of large quantities of data is critical to the business.

Selection of lean architecture-based software solutions along with modular hardware design is a must, not only to drive changes in current packaging processes, but also to accommodate future complex additional – or amendments to – regulations in the process.

Pharmaceutical companies also need to consider minimal disruption to existing processes and its impact on productivity, to successfully reap the benefits from the serialisation system.

WILLIAM MINAEFF, SR Project Director, Adents: As a serialisation project progresses, there are many challenges that need to be faced and many sources of complexity. Serialisation failures most frequently come from not understanding the scope of a serialisation project. For example: not identifying all stakeholders and their requirements, regarding packaging, label change, supply chain, IT and enterprise resource planning.

There are five key elements of a successful track and trace serialisation solution for the pharmaceutical sector, which are:

• Configurability; meaning no specific development needed, with easy updates and upgrades management, allowing for virtually no chance of human error
• Scalability; meaning when the initial rollout phase is achieved, you can smoothly deploy serialisation on additional lines without repeating the whole process
• Interoperability; meaning increased flexibility to choose the hardware that best fits your objectives, and uses any of your existing equipment when valuable for serialisation and minimises costs and delays in delivery
• Site level management capabilities; meaning the most secured and efficient approach to cope with change management. Having a centralised single point from where you can manage all your configuration and processes will help facilitate configuration management, data exchange, reporting, change management and validation support as well as IT governance. Site level management capability minimises risks and helps prepare you to meet future track and trace challenges.

DR STEFAN OEING, Head of track and trace software department, Atlantic Zeiser Ltd: Beside powerful HW units, which can flexibly handle different packaging formats on all levels in combination with serialisation and track and trace coding (aggregation), the overall SW-System itself will become increasingly important. On Level 2 (Line Management), the SW solution must be able to communicate in real time to all involved HW-units and provide an accurate picture of the commissioning process. This also covers any kind of manual rework necessary during commissioning. After completing batch production, balancing of data must be possible between all physical units (moved into stock), and all data sent to Level 3 software (site manager). Afterwards, post-lot processes must be accurately managed through pre-defined workflows, covering the generation of all regulated reports, the assembling of any shipment, and the reporting to any higher level SW (internally or externally, Level 4 and Level 5). Finally, the interaction with a (national) database will assure that the status of each code is up-to-date and available for all relevant participants of the track and trace process.

YANIK BEAULIEU, Technology Leader, Optel Group: The key elements of a successful track and trace system are three-fold. First, the flexibility to interact with multiple third-party IT systems (ERP/ MES, EPCIS server, government instances, etc). Second, the reliability and ease of use to minimally impact productivity. Third, adaptability through consistency: every packaging line is different, yet constancy between all lines / equipment is important for users.

JOE LIPARI, Director of Cloud Products, Systech International: A successful track and trace system requires flexibility to meet the unique connectivity needs of your supply chain. All systems are not created equal, but all systems in pharma are validated. Having a track and trace system capable of interfacing with a myriad of systems requiring varying data and messaging standards is key to successfully integrating the supply chain.

What benefits do such systems deliver to industry and the consumers they serve?

ETTORE CUCCETTI: Implementation of a serialisation system will be beneficial across the pharmaceutical value chain right from the marketing authorisation holder (MAH) and contract manufacturing organisation (CMO), to the supply chain partner, pharmacies and end-consumer. The pharmaceutical companies will be benefited with advanced capabilities to improve the supply chain and data security between different stakeholders. A track and trace system helps to monitor and control the counterfeiting issue and ensures brand protection.

DR STEFAN OEING: Such systems fulfil legal requirements, which aim to protect the consumers against counterfeiting. But they can do much more; for example, monitor packaging systems as well as internal and external logistics processes. Based on this, processes can be optimised, and components with best vs. worst performance and/ or quality can be identified. This can take place in different locations, eg, at the pharmaceutical manufacturer or along the legal supply chain. The overall picture can also provide valuable market information for different regions. Serialisation and track and trace codes can also be used to establish direct communication to the consumer, which opens the door for generating customer loyalty and gaining valuable customer insight.

YANIK BEAULIEU: The main goal is obviously to secure the supply chain against the counterfeit product for the end user, but brand protection is also a significant benefit. Many other benefits could be named, such as minimising the impact of recalls, logistics and handling advantages during production/distribution. This leads to interesting avenues in the future. Those include stock shortage prevention, cold chain distribution control or the end user having access to more information about the product in their possession, including advertising and health recommendations.

JOE LIPARI: In a word, visibility. The holy grail of track and trace is having full transparency into where a product has been. The value this delivers to a consumer is the confidence that the product you or your loved ones are consuming is from a trusted source.

How has the importance of track and trace systems changed over the past 10 years?

ETTORE CUCCETTI: We have seen a major transformation in the perspective of customers over past decade – from meeting the mandates to utilising master data for the betterment of production planning and supply chain management.

Today, the implementation is not only limited to printing on cartons but also includes data management and data security.

The industry is now looking towards single source solution providers that help them through compliance adherence, creating significant value addition to business and consumer safety.

The rest of this content is restricted – login or subscribe free to access

Thank you for visiting our website. To access this content in full you’ll need to login. It’s completely free to subscribe, and in less than a minute you can continue reading. If you’ve already subscribed, great – just login.

Why subscribe? Join our growing community of thousands of industry professionals and gain access to:

• bi-monthly issues in print and/or digital format
• case studies, whitepapers, webinars and industry-leading content
• breaking news and features
• our extensive online archive of thousands of articles and years of past issues
• …And it’s all free!

Click here to Subscribe today Login here

 

Source link

Intellectual Property Protection in Cambodia

Cambodia is a developing country supported mainly by three pillars of economic development – agriculture, tourism and textiles. With an average growth of 7.6% from 1994 to 2015, Cambodia is the fastest growing ASEAN economy.

In line with Cambodia’s desire to modernise and increase its economic prosperity, there are developments taking place in the country’s intellectual property system, which indicate that the government is serious about fostering and promoting innovation and foreign investment.

We highlight below several avenues for securing patent rights in Cambodia.

Protection under the Patent Cooperation Treaty (PCT)

On 8 December 2016, Cambodia became bound by the PCT system. This means that any international patent application filed on or after 8 December 2016 automatically includes the designation of Cambodia. International applicants, if they so choose, are able to enter the national phase in Cambodia within 30 months from the earliest priority date. Furthermore, nationals and residents of Cambodia are entitled to file international applications under the PCT from 8 December 2016.

European patents to be recognized in Cambodia

A validation agreement between the European Patent Office (EPO) and the Cambodia Ministry of Industry and Handicraft (MIH) was signed on 23 January 2017, making Cambodia the first Asian country and the 4th non EPC Member State to recognize EPO granted patents. This validation agreement entered into force on 1 March 2018 and applicants are henceforth able to validate European patent applications and patents in Cambodia.

It should be noted that validation into Cambodia is only available for any European or international application filed on or after 1 March 2018.

The fee for Cambodia is EUR 180 and is payable at the time of validation for other EP contracting states. The applicant will also need to provide Khmer and English (if the EP application is not already in English) translations of the granted European patent and pay a publication fee to the MIH.

ASEAN Patent Examination Cooperation (ASPEC)

Launched on 15th June 2009, ASPEC is a regional patent work-sharing programme among the ASEAN Member State IP offices of Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, the Philippines, Singapore, Thailand and Vietnam. While the local search and examination fees at local IP offices still apply, search and examination results can be shared among the members to improve the quality of work, and reduce duplicative work for time and cost savings.

The use of the ASPEC system is recommended to applicants who are looking to file in multiple ASEAN jurisdictions and wish to expedite prosecution in these jurisdictions.

Patent Cooperation with Singapore

Patentees or applicants with a Singapore patent or patent application will be able to:

1. Re-register the Singapore patent in Cambodia

Under this scheme, the Singapore patent must be in force at the time of the request, have a filing date on or after 22 January 2003 and meet Cambodian requirements for patentability.

1. Submit IPOS-issued Search and Examination Report to Cambodia

Applicants may request that IPOS submit to the Cambodian patent office a copy of the final search and Examination Report together with the final specification of the related Singapore patent application. The first ever patent in Cambodia was granted via this system.

Cooperation for Facilitating Patent Grant (CPG) with Japan

Starting from 1st July 2016, patent applications already examined and granted in Japan can be used to accelerate related patent applications in Cambodia under this scheme. Participation of CPG requires that the Japanese patent application has the same priority date or filing date as the Cambodian patent application, the corresponding Japanese patent application has been granted, and all the Cambodian application claims correspond to the claims of the Japanese granted patent.

Exclusions to Patent Protection

It should be noted that inventions relating to pharmaceutical products are generally excluded from patentability in Cambodia. This stems from the fact that Cambodia is under the World Trade Organisation waiver, which allows Least Developed Countries (LDCs) to avoid granting and enforcing IP rights on pharmaceutical products until 2033. As defined in Cambodia’s Law of Management of Pharmaceutical, pharmaceutical products are:

“one or many kinds of substances which are primarily from chemicals, bio-products, microbes, plants combined in order to:

– use in the prevention or treatment of human or animal diseases,

• use in the medical or pharmaceutical research or diagnosis,
• change or support the functioning of the organs.”

Accordingly, this includes serum and vaccines, blood or blood products, traditional medicines and poisonous substances.

Chemical compositions and new chemical entities for non-medical uses are still patentable.

Source link