Global Biosimilar Testing and Development Services Market by Clinical Assays (PK Assay, Tiered Immunogenicity Testing, and NAb Assays) and by Comparability Testing (Effector Binding, ELISA, Kinetic Binding Assays, and ADCC & CDC Cell-Based Assays) - Opportunity Analysis and Industry Forecast, 2018-2025

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Diagnostics and Biotech	LI_183972	Pages: NA	Mar 2019 \| 981 Views
Author(s) : NA	Tables: NA	Charts: NA	Formats*:

A biosimilar is a biological product that is almost an identical copy of the original product manufactured by a different company. They are the accepted version of an original product that can be used when the original products patent expires.

Factors such as increase in demand for biosimilar products, patent expiration of original drugs, and increase R&D investments on biosimilar testing and development services drive the market growth. However, shortage of skilled professionals and expensive development procedure of biosimilar drugs restrain the market growth. Moreover, comparatively lower cost of biosimilar than original drugs and untapped market opportunities in emerging nations such as China, Brazil, and India is expected to fuel the market growth.

The global biosimilar testing and development services market is segmented on the basis of clinical assays, comparability testing, and region. On the basis of clinical assays, it is divided into PK assay, tiered immunogenicity testing, and NAb assays. On the basis of comparability testing, it is classified into effector binding, ELISA, kinetic binding assays, and ADCC & CDC cell-based assays. Effector binding are further sub-segmented into FcRI (CD64), FcRII (CD32a), FcRIII (CD16a), and FcRn. By geography, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (Germany, UK, France, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, India, Australia, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, Saudi Arabia, South Africa, and rest of LAMEA).

Key players in the market include Eurofins Scientific, SGS S.A., Charles River Laboratories International Inc., Pharmaceutical Product Development, LLC, Exova Group plc, Source BioScience plc, Intertek Group plc, Medistri SA, Pace Analytical Services Inc., and Sigma-Aldrich Co. LLC.

Key Benefits

The study provides an in-depth analysis of the market with current trends and future estimations to elucidate the imminent investment pockets.
Comprehensive analysis of all geographical regions is provided to determine the prevailing opportunities.
Key players are profiled and their strategies are analyzed thoroughly, which explains the competitive outlook of the global market.
The report offers a quantitative analysis from 2016 to 2023 to enable the stakeholders to capitalize on the prevailing market opportunities.

Global Biosimilar Testing And Development Services Market Key Segments:

By Clinical Assays

PK assay
Tiered Immunogenicity testing
NAb assays

By Comparability Testing

Effector Binding
- FcRI (CD64)
- FcRII (CD32a)
- FcRIII (CD16a)
- FcRn
ELISA
Kinetic Binding Assays
ADCC & CDC Cell-Based Assays

By Region

North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe
Asia-Pacific
- Japan
- China
- India
- Australia
- South Korea
- Rest of Asia-Pacific
LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest of LAMEA

Chapter: 1 INTRODUCTION

1.1. REPORT DESCRIPTION
1.2. KEY BENEFITS
1.3. KEY MARKET SEGMENTS
1.4. RESEARCH METHODOLOGY

1.4.1. Secondary research
1.4.2. Primary research
1.4.3. Analyst tools & models

Chapter: 2 EXECUTIVE SUMMARY

2.1. CXO PERSPECTIVE

Chapter: 3 MARKET OVERVIEW

3.1. MARKET DEFINITION AND SCOPE
3.2. KEY FINDINGS

3.2.1. Top investment pockets
3.2.2. Top winning strategies

3.3. MARKET SHARE ANALYSIS, 2016
3.4. PORTER’S FIVE FORCES ANALYSIS

3.4.1. MARKET DYNAMICS
3.4.2. Drivers
3.4.3. Restraints
3.4.4. Opportunities

Chapter: 4 GLOBAL BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY CLINICAL ASSAYS

4.1. OVERVIEW

4.1.1. Market size and forecast

4.2. PK ASSAYS

4.2.1. Key market trends
4.2.2. Growth factors and opportunities
4.2.3. Market size and forecast

4.3. TIERED IMMUNOGENICITY TESTING

4.3.1. Key market trends
4.3.2. Growth factors and opportunities
4.3.3. Market size and forecast

4.4. NAB ASSAYS

4.4.1. Key market trends
4.4.2. Growth factors and opportunities
4.4.3. Market size and forecast

Chapter: 5 GLOBAL BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY COMPARABILITY TESTING

5.1. OVERVIEW

5.1.1. Market size and forecast

5.2. EFFECTOR BINDING BIACORE

5.2.1. FcγRI (CD64)
5.2.2. FcγRII (CD32a)
5.2.3. FcγRIII (CD16a)
5.2.4. FcRn
5.2.5. Market size and forecast

5.3. C1Q BINDING BY ELISA

5.3.1. Market size and forecast

5.4. KINETIC BINDING ASSAYS BY BIACORE

5.4.1. Market size and forecast

5.5. ADCC AND CDC ASSAYS CELL BASED ASSAYS

5.5.1. Market size and forecast

Chapter: 6 GLOBAL BIOSIMILAR TESTING AND DEVELOPMENT SERVICES MARKET, BY REGION

6.1. OVERVIEW
6.2. NORTH AMERICA

6.2.1. Key market trends
6.2.2. Key growth factors and opportunities
6.2.3. Market size and forecast

6.2.3.1. U.S. market size and forecast
6.2.3.2. Canada market size and forecast
6.2.3.3. Mexico market size and forecast

6.2.4. North America Global Biosimilar Testing and Development Services Market, by Clinical Assays
6.2.5. North America Global Biosimilar Testing and Development Services Market, by Comparability Testing

6.3. EUROPE

6.3.1. Key market trends
6.3.2. Key growth factors and opportunities
6.3.3. Market size and forecast

6.3.3.1. Germany market size and forecast
6.3.3.2. France market size and forecast
6.3.3.3. UK market size and forecast
6.3.3.4. Italy market size and forecast
6.3.3.5. Spain market size and forecast
6.3.3.6. Rest of Europe market size and forecast

6.3.4. Europe Global Biosimilar Testing and Development Services Market, by Clinical assays
6.3.5. Europe Global Biosimilar Testing and Development Services Market, by Comparability Testing

6.4. ASIA-PACIFIC

6.4.1. Key market trends
6.4.2. Key growth factors and opportunities
6.4.3. Market size and forecast

6.4.3.1. Japan market size and forecast
6.4.3.2. China market size and forecast
6.4.3.3. Australia market size and forecast
6.4.3.4. India market size and forecast
6.4.3.5. South Korea market size and forecast
6.4.3.6. Rest of Asia-Pacific market size and forecast

6.4.4. Asia-Pacific Global Biosimilar Testing and Development Services Market, by Clinical Assays
6.4.5. Asia-Pacific Global Biosimilar Testing and Development Services Market, by Comparability Testing

6.5. LAMEA

6.5.1. Key market trends
6.5.2. Key growth factors and opportunities
6.5.3. Market size and forecast

6.5.3.1. Brazil market size and forecast
6.5.3.2. Saudi Arabia market size and forecast
6.5.3.3. South Africa market size and forecast
6.5.3.4. Rest of LAMEA market size and forecast

6.5.4. LAMEA Global Biosimilar Testing and Development Services Market, by Clinical Assays
6.5.5. LAMEA Global Biosimilar Testing and Development Services Market, by Comparability Testing

Chapter: 7 COMPANY PROFILES

7.1. EUROFINS SCIENTIFIC

7.1.1. Operating business segments
7.1.2. Business performance
7.1.3. Key strategic moves and developments

7.2. SGS SA

7.2.1. Operating business segments
7.2.2. Business performance
7.2.3. Key strategic moves and developments

7.3. CHARLES RIVER LABORATORIES INTERNATIONAL INC.

7.3.1. Operating business segments
7.3.2. Business performance
7.3.3. Key strategic moves and developments

7.4. PHARMACEUTICAL PRODUCT DEVELOPMENT, LLC.

7.4.1. Operating business segments
7.4.2. Business performance
7.4.3. Key strategic moves and developments

7.5. EXOVA GROUP PLC.

7.5.1. Operating business segments
7.5.2. Business performance
7.5.3. Key strategic moves and developments

7.6. SOURCE BIOSCIENCE PLC.

7.6.1. Operating business segments
7.6.2. Business performance
7.6.3. Key strategic moves and developments

7.7. INTERTEK GROUP PLC.

7.7.1. Operating business segments
7.7.2. Business performance
7.7.3. Key strategic moves and developments

7.8. MEDISTRI SA

7.8.1. Operating business segments
7.8.2. Business performance
7.8.3. Key strategic moves and developments

7.9. PACE ANALYTICAL SERVICES INC.

7.9.1. Operating business segments
7.9.2. Business performance
7.9.3. Key strategic moves and developments

7.10. SIGMA-ALDRICH CO. LLC

7.10.1. Operating business segments
7.10.2. Business performance
7.10.3. Key strategic moves and developments

With collective industry experience of about 200 years of its analysts and experts, Allied Market Research (AMR) encompasses most infallible research methodology for its market intelligence and industry analysis. We do not only engrave the deepest levels of markets but also sneak through its slimmest details for the purpose of our market estimates and forecasts. Our approach helps in building greater market consensus view for size, shape and industry trends within each industry segment. We carefully factor in industry trends and real developments for identifying key growth factors and future course of the market. Our research proceeds are the resultant of high quality data, expert views and analysis and high value independent opinions. Our research process is designed to deliver balanced view of the global markets and allow stakeholders to make informed decisions.

We offer our clients exhaustive research and analysis based on wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics and regional intelligence. Our in-house industry experts play instrumental role in designing analytic tools and models, tailored to the requirements of particular industry segment. These analytical tools and models sanitize the data & statistics and enhance the accuracy of our recommendations and advice. With AMR’s calibrated research process and 360` degree data-evaluation methodology, our clients are assured of receiving:

Consistent, valuable, robust and actionable data & analysis that can easily be referenced for strategic business planning
Technologically sophisticated and reliable insights through well audited and veracious research methodology
Sovereign research proceeds that present a tangible depiction of marketplace

With a strong methodology we are, therefore, confident that our research and analysis are most reliable and guarantees sound business planning.

Secondary research
We refer a broad array of industry sources for our secondary, which typically include; however, not limited to: Company SEC filings, annual reports, company websites, broker & financial reports and investor presentations for competitive scenario and shape of the industry

Patent and regulatory databases for understanding of technical & legal developments
Scientific and technical writings for product information and related preemptions
Regional government and statistical databases for macro analysis
Authentic new articles, web-casts and other related releases for market evaluation
Internal and external proprietary databases, key market indicators and relevant press releases for market estimates and forecast

Primary research
Our primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks and face-to-face interactions. We are also in professional corporate relations with various companies that allow us greater flexibility for reaching out industry participants and commentators for interviews and discussions, fulfilling following functions:

Validates and improves the data quality and strengthens research proceeds
Further develops analyst team’s market understanding and expertise
Supplies authentic information about market size, share, growth and forecasts

Our primary research interview and discussion panels are typically composed of most experienced industry members. These participants include; however, not limited to:

Chief executives and VPs of leading corporations specific to industry
Product and sales managers or country heads; channel partners and top level distributors; banking, investments and valuation experts Key opinion leaders (KOLs)

Analyst tools and models
AMR has developed set of analyst tools and data models to supplement and expedite the analysis process. Corresponding to markets, where there is significant lack of information and estimates, AMR’s team of experts and analyst develop specific analyst tools and industry models to translate qualitative and quantitative industry indicators into exact industry estimates. These models also allow analysts to examine the prospects and opportunities prevailing in the market to accurately forecast the course of the market.

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Global Biosimilar Testing And Development Services Market Key Segments:

By Clinical Assays

By Comparability Testing

By Region

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