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Biologics Market By Types (Monoclonal Antibodies, Therapeutic Proteins And Vaccines), By Trends, By Regions and By Key Players - Global Forecast To 2021

Starting Price : $ 4000.00 $ 2680.00 | Pages : 220 | Published : July 2018 | SKU CODE : o&s004 | Format :

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Biologics Market Characteristics

The biologics industry comprises companies manufacturing biological products. Biological products include a wide range of products such as vaccines, somatic cells, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. These products are isolated from natural sources such as human, animal, and microorganisms by biotechnological methods and other cutting-edge technologies. Specifically, most biologic medicines are developed using recombinant DNA (rDNA) technology.  

The global biologics market was worth $221 billion in 2017 and is essentially segmented into monoclonal antibodies, therapeutic proteins and vaccines. In 2017, 12 biologics were approved in the USA, 10 in European Union and 7 in Japan. There are over 1000 biologics under development which will drive the biologics market in the future. Cancer is the therapeutic area with maximum number of biologics under development, whereas Alzheimer’s has the least number.

Of the total biologics market across the globe, monoclonal antibodies (mAbs) accounted for the largest share due to high prevalence of diseases such as rheumatoid arthritis, Crohn’s disease and ulcerative colitis for which monoclonal antibodies are used. Monoclonal antibodies is expected to be the fastest growing segment with a CAGR of about 9.85% during the forecast period.

Biologics Market Competitive Landscape

The top five competitors in the global biologics market accounted for about 59% of the total market in 2018. The high levels of specialism, expertise, investment and regulatory standing required in the biologics market mean that the market is highly concentrated, with only a small number of drugs approved from a small number of companies. The top biologics companies in the market include Johnson & Johnson, F. Hoffmann-La Roche Ltd. Bristol-Myers Squibb Company, GlaxoSmithKline Plc., AbbVie Inc., Amgen and Pfizer. Among these companies Johnson & Johnson was estimated to have the highest share in the biologics market.

Biologics Market Size

The global biologics market is expected to reach $319.4 billion by 2021, growing at a CAGR close to 11%. The growth in the market is due to- technological advances technology is expected to be a continued driver of market growth during this period. An area of particular development is likely to be physiology simulation modeling. Markets such as this one will benefit from the greater efficiencies offered by developments in this area. For example, Eli Lilly and Pfizer have adopted Amazon’s Elastic Compute Cloud (EC2) platform to conduct simulation models in early drug discovery that have been operational within hours, whereas traditional models would have taken weeks to conduct simulations. The Open Innovation Drug Discovery program is another initiative by Lilly to enhance the research and development of biologics.

Increase in healthcare access as access to healthcare services is expected to improve in the developing countries. Effective implementation of government health plans is the core reason for the improvement in healthcare access in many developing regions such as India, China and many Latin American countries. Many countries like Russia and Brazil are focusing on improving their domestic biologics capabilities which will help drive the biologics market.  

Reimbursement of biologics as various companies in many of the emerging markets such as South America, Asia Pacific, Middle East are regulating the reimbursement policies for wide range of chronic health conditions that can be treated using biological drugs. This is helping the biologics market in these region to flourish thus, adding significant value to the global biologics market.

However, the market is expected to face restraints from several factors such as- rise of biosimilars, the early generation of biologics is losing its patent protection. They are expected to face greater competition going forward from the entry of biosimilars into the market. Biosimilars are the pharmaceuticals that are developed to have similar properties to a biologic drug that has already been approved. Demand for biosimilars is being fueled by governments around the world trying to reduce healthcare costs. In India, a new biosimilar policy called the ‘Guidelines on Similar Biologics’ prepared by the Central Drugs Standard Control Organization (CSDCO) is expected to give a major boost to the Indian biosimilars industry, so making it more competitive in the global market. In the EU, a pathway for approving biosimilar medicines has existed since 2003. These less expensive alternatives increase competitiveness in the biologics market putting downward pressure on pricing and market value growth.

Higher supervision during clinical studies, for pharmaceutical drugs, clinical studies such as the PK-PD studies can be carried out on healthy individuals provided that it can be safely administered to the healthy population. PK studies determines the time the drug takes to get absorbed, distributed, metabolized and excreted within the body and PD studies determines the biochemical and physiological effect of the drug. However, for biological drugs, there are some key considerations regarding the selection of healthy individuals. This is mainly because healthy individuals may have a higher immunogenic response than the population with the disease and sometimes the PK of the reference product is altered when administered to a healthy individual. Thus, resulting in an unreliable clinical data. Such hindrances may stall the progress of biological drugs.

Biologics Market Segmentation

The biologics market is segmented based on the type and geography.
By Type- The biologics market is segmented into monoclonal antibodies, therapeutic proteins and vaccines.
By Geography- The global biologics market is segmented into North America, South America, Asia Pacific, Western Europe, Eastern Europe and Middle East and Africa. North America was the largest region in the global biologics market, accounting for about 46% of the market in 2018. This can be attributed to the high per capita healthcare expenditure in the region and the investment in novel treatments leading to the early adoption of new anti-inflammatory, anti-cancer and anti-viral biologics in the region. Pricing levels for drugs in the US are also some of the highest globally. Asia Pacific was the second largest region accounting for about 24% of the global biologics market. Africa was the smallest region in the global biologics market.
Biologics Market Trends
Major trends witnessed in the biologics market over the historic period include increasing demand for biologics in the treatment of complex diseases, rising development of next generation biologics and revised FDA regulations facilitating biologics drug development.
Potential Opportunities In The Biologics Market
With rising ageing population, growing investments and healthcare access among emerging economies, the demand and scope for the biologics market is expected to increase in the forecast period.

    1.Executive Summary

    2.Biologics Market Characteristics

    2.1.Market Overview

    2.2.Market Segmentation

    2.3.Market Value Chain

    3.Biologics Market Size And Growth

    3.1.Biologics Historic Market Growth

    3.1.1.Drivers Of The Market

    3.1.2.Restraints On The Market

    3.2.Biologics Market Forecast Growth

    3.2.1.Drivers Of The Market

    3.2.2.Restraints On The Market

    4.PESTLE Analysis

    4.1.Political

    4.2.Economic

    4.3.Social

    4.4.Technological

    4.5.Legal

    4.6.Environmental

    5.Biologics Market Segmentation

    5.1.Global Biologics Market, 2017, Split By Segments, $ Billion

    5.1.1.Monoclonal Antibodies (mAbs)

    5.1.2.Therapeutic Proteins

    5.1.3.Vaccines

    5.2.Global Biologics Market, Historic and Forecast Growth Rates, Split By Segments, 2013-2021

    6.Global Biologics Market Trends And Strategies

    7.Global Biologics Market Compared With Similar Markets, 2017

    7.1.Healthcare Market Segmentation, By Region, 2017

    7.2.Healthcare Market Segmentation, By Country, 2017

    8.Global Biologics Market Segment Details

    8.1.Monoclonal Antibodies (mAbs)

    8.1.1.Monoclonal Antibodies Market Characteristics

    8.1.2.Global Monoclonal Antibodies Market, 2017, By Source

    8.1.3.Global Monoclonal Antibodies Market, 2017, By Therapeutic Area

    8.1.4.Monoclonal Antibodies Market Trends And Strategies

    8.2.Therapeutic Proteins

    8.2.1.Therapeutic Proteins Market Characteristics

    8.2.2.Global Therapeutic Proteins Market, 2017, By Type

    8.2.3.Global Therapeutic Proteins Market, 2017, By Therapeutic Area

    8.2.4.Therapeutic Proteins Market Trends And Strategies

    8.3.Vaccines

    8.3.1.Vaccines Market Characteristics

    8.3.2.Global Vaccines Market, 2017, By End User

    8.3.3.Global Vaccines Market, 2017, By Segment

    8.3.4.Vaccines Market Trends And Strategies

    9.Biologics Market Geography Regional and Country Analysis

    9.1.Biologics Market, 2017, By Region

    9.2.Biologics Market, Historic And Forecast Growth Rates, Split By Region, 2013-2021

    9.3.Biologics Market, Split By Country, 2017

    9.4.Biologics Market, Historic And Forecast Growth Rates, Split By Country, 2013-2021

    10.Global Biologics Market Comparison With Macro Economic Factors

    10.1.Biologics Market Size, Percentage Of GDP, Global

    10.2.Per Capita Average Biologics Expenditure, Global

    10.3.Biologics Market Size, Percentage of GDP, By Country

    10.4.Per Capita Average Biologics Expenditure, By Country

    11.Biologics Market Comparison With Industry Metrics

    11.1.Biologics & Biosimilars Sales Proportion By Country (Value), 2017, By Country

    11.2.Global Biologics Under Development, 2017

    11.3.New Biologics Approvals, 2017

    11.4.Number Of General Practitioners 2016, By Country

    11.5.Average Revenue Per General Practitioners 2016, By Country

    12.Biologics Market Regional And Country Analysis

    12.1.Asia-Pacific Biologics Market

    12.1.1.Asia-Pacific Biologics Market Overview

    12.1.2.Asia Pacific Biologics Market

    12.1.3.Asia-Pacific Biologics Historic Market, 2013-2017

    12.1.4.Asia-Pacific Biologics Forecast Market, 2017-2021

    12.1.5.Asia-Pacific Biologics Market, 2017, By Segment

    12.2.China Biologics Market Overview

    12.2.1.China Biologics Market

    12.2.2.China Biologics Historic Market, 2013-2017

    12.2.3.China Biologics Forecast Market, 2017-2021

    12.2.4.China Biologics Market, 2017, By Segment

    12.3.India Biologics Market Overview

    12.3.1.India Biologics Market

    12.3.2.India Biologics Historic Market, 2013-2017

    12.3.3.India Biologics Forecast Market, 2017-2021

    12.3.4.India Biologics Market, 2017, By Segment

    12.4.Japan Biologics Market Overview

    12.4.1.Japan Biologics Market

    12.4.2.Japan Biologics Historic Market, 2013-2017

    12.4.3.Japan Biologics Forecast Market, 2017-2021

    12.4.4.Japan Biologics Market, 2017, By Segment

    12.5.Australia Biologics Market Overview

    12.5.1.Australia Biologics Market

    12.5.2.Australia Biologics Historic Market, 2013-2017

    12.5.3.Australia Biologics Forecast Market, 2017-2021

    12.5.4.Australia Biologics Market, 2017, By Segment

    13.1.Western Europe Biologics Market

    13.1.1.Western Europe Biologics Market Overview

    13.1.2.Western Europe Biologics Market

    13.1.3.Western Europe Biologics Historic Market, 2013-2017

    13.1.4.Western Europe Biologics Forecast Market, 2017-2021

    13.1.5.Western Europe Biologics Market, 2017, By Segment

    13.2.UK Biologics Market Overview

    13.2.1.UK Biologics Market

    13.2.2.UK Biologics Historic Market, 2013-2017

    13.2.3.UK Biologics Forecast Market, 2017-2021

    13.2.4.UK Biologics Market, 2017, By Segment

    13.3.Germany Biologics Market Overview

    13.3.1.Germany Biologics Market

    13.3.2.Germany Biologics Historic Market, 2013-2017

    13.3.3.Germany Biologics Forecast Market, 2017-2021

    13.3.4.Germany Biologics Market, 2017, By Segment

    13.4.France Biologics Market Overview

    13.4.1.France Biologics Market

    13.4.2.France Biologics Historic Market, 2013-2017

    13.4.3.France Biologics Forecast Market, 2017-2021

    13.4.4.France Biologics Market, 2017, By Segment

    13.5.Italy Biologics Market Overview

    13.5.1.Italy Biologics Market

    13.5.2.Italy Biologics Historic Market, 2013-2017

    13.5.3.Italy Biologics Forecast Market, 2017-2021

    13.5.4.Italy Biologics Market, 2017, By Segment

    13.6.Spain Biologics Market Overview

    13.6.1.Spain Biologics Market

    13.6.2.Spain Biologics Historic Market, 2013-2017

    13.6.3.Spain Biologics Forecast Market, 2017-2021

    13.6.4.Spain Biologics Market, 2017, By Segment

    14.1.Eastern Europe Biologics Market

    14.1.1.Eastern Europe Biologics Market Overview

    14.1.2.Eastern Europe Biologics Market

    14.1.3.Eastern Europe Biologics Historic Market, 2013-2017

    14.1.4.Eastern Europe Biologics Forecast Market, 2017-2021

    14.1.5.Eastern Europe Biologics Market, 2017, By Segment

    14.2.Russia Biologics Market Overview

    14.2.1.Russia Biologics Market

    14.2.2.Russia Biologics Historic Market, 2013-2017

    14.2.3.Russia Biologics Forecast Market, 2017-2021

    14.2.4.Russia Biologics Market, 2017, By Segment

    15.1.North America Biologics Market

    15.1.1.North America Biologics Market Overview

    15.1.2.North America Biologics Market

    15.1.3.North America Biologics Historic Market, 2013-2017

    15.1.4.North America Biologics Forecast Market, 2017-2021

    15.1.5.North America Biologics Market, 2017, By Segment

    15.2.USA Biologics Market Overview

    15.2.1.USA Biologics Market

    15.2.2.USA Biologics Historic Market, 2013-2017

    15.2.3.USA Biologics Forecast Market, 2017-2021

    15.2.4.USA Biologics Market, 2017, By Segment

    16.1.South America Biologics Market

    16.1.1.South America Biologics Market Overview

    16.1.2.South America Biologics Market

    16.1.3.South America Biologics Historic Market, 2013-2017

    16.1.4.South America Biologics Forecast Market, 2017-2021

    16.1.5.South America Biologics Market, 2017, By Segment

    16.2.Brazil Biologics Market Overview

    16.2.1.Brazil Biologics Market

    16.2.2.Brazil Biologics Historic Market, 2013-2017

    16.2.3.Brazil Biologics Forecast Market, 2017-2021

    16.2.4.Brazil Biologics Market, 2017, By Segment

    17.1.Middle East Biologics Market

    17.1.1.Middle East Biologics Market Overview

    17.1.2.Middle East Biologics Market

    17.1.3.Middle East Biologics Historic Market, 2013-2017

    17.1.4.Middle East Biologics Forecast Market, 2017-2021

    17.1.5.Middle East Biologics Market, 2017, By Segment

    18.1.Africa Biologics Market

    18.1.1.Africa Biologics Market Overview

    18.1.2.Africa Biologics Market

    18.1.3.Africa Biologics Historic Market, 2013-2017

    18.1.4.Africa Biologics Forecast Market, 2017-2021

    18.1.5.Africa Biologics Market, 2017, By Segment

    19.Biologics Market Competitive Landscape

    19.1.Johnson & Johnson (J&J)

    19.2.F.Hoffmann-La Roche

    19.3.Bristol-Myers Squibb

    19.4.GlaxoSmithKline

    19.5.AbbVie

    19.6.Amgen

    19.7.Sanofi

    19.8.Eli Lilly and Company

    19.9.Merck & Co.

    19.1.Pfizer Inc.

    20.Biologics Market Key Mergers And Acquisitions

    21.Appendix

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