Biologics Market

“The biologics market is expected to show rapid maturation and remunerative growth during the forecast period.”

The global biologics market was worth US$ 254.9 billion in 2017 and is expected to be worth US$ 580.5 billion by 2026. Recombinant therapeutic proteins contributed the largest market share in 2017, while cellular and gene therapies exhibited the fastest annual growth during the forecast period from 2018 to 2026. Monoclonal antibodies form a major portion of the recombinant therapeutics market with their wide use in oncology, autoimmune diseases, and diabetes treatment. Additionally, a strong pipeline portfolio also contributes to the supremacy of monoclonal antibodies. Continuous research in oncology and autoimmune diseases has led to the advent of novel therapies, such as cellular and gene therapy, which exhibited the fastest growth during the forecast period. In 2017, the FDA approved two CAR-T cell therapies, namely, Kymirah by Novartis AG and Yescarta by Gilead Sciences, Inc., for acute lymphoblastic leukemia and B-cell lymphoma, respectively. Oncology, autoimmune disease, and diabetes contribute most to the growth of the biological market. The rising prevalence of these conditions across geographies, continuous research activities, the presence of a strong product portfolio, and an unmet need for an appropriate targeted therapeutic option are the prime reasons for the maximum influence of the aforementioned conditions on overall market growth. However, the rampant rise in the development of biosimilars, along with increasing demand for cost-effective therapeutics and various government initiatives in low- and middle-income economies promoting biosimilars, would restrain the growth of biologics during the forecasted period. Amgen’s Mvasi, a biosimilar for Roche Holding AG’s drug Avastin (bevacizumab), gained FDA approval in September 2017. Following the expiration of Avastin’s patent, it is expected that Mvasi will acquire significant shares of the drug, affecting Roche’s Avastin sales of US$ 6.94 billion in 2016. Major biologics hold patent rights for a longer duration in North America as compared to Europe. Thus North America continued to enjoy a dominant position in the global biologics market and encompassed the largest market share in 2017. Asia Pacific exhibited accelerated growth during the period from 2016 to 2026.

Market Synopsis

“During the forecast period, cellular and gene therapy will grow at a double-digit CAGR.”

Cellular and gene therapy are expected to attain the fastest growth, with the highest CAGR during the forecast period from 2018 to 2026. The recent development in CAR-T cell therapy is the preliminary reason backing the overall market growth, with the majority of its applications in oncology. French company TxCell aims at expanding CAR-T cell therapy by utilizing CAR-T regulatory cells for orphan diseases such as multiple sclerosis and lupus. Label expansion of cell therapies would lead to the supremacy of cell and gene therapies by 2026. However, higher pricing of such therapies and constant battles to gain appropriate reimbursements for the same could have a negative impact on their market growth across geographies. Recombinant therapeutic proteins, comprising hormones, cytokines, enzymes, and monoclonal antibodies, held the largest market share in 2016 and exhibited a similar trend in 2026 as well. Constant development in monoclonal antibodies and their highly lucrative nature are the prime reasons for their vast market reach. Humira (Abbvie, Inc.) is a top-selling brand, accounting for US$ 18.4 billion in global sales in 2017 and accounting for 65.3% of Abbvie’s total net revenue.

“The oncology segment is the most important contributor to the overall growth of the biologics market.”

As per “Cancer Statistics, 2018,” published in the American Cancer Society’s journal CA: A Cancer Journal for Clinicians, around 1.73 million new cancer cases and 0.60 million cancer deaths were estimated to occur in the US in 2018. Rising global cancer prevalence, continuous research activities, the unmet need for target-based therapeutic options, and government initiatives to attain treatment for niche cancer types catalyze the overall market growth. Autoimmune diseases line up second in the biologics market in terms of market share and CAGR across the forecast period. Crohn’s disease and rheumatoid arthritis account for the most explored conditions in this market, with a strong current product and pipeline portfolio.

“Preservation of patent rights along with stringent regulatory policies for biosimilars holds North America in a dominant position.”

North America held the largest market share in 2017 and continued to maintain supremacy in 2026 as well. The majority of biologics still hold patents in this region, thus contributing further to the overall biologics market value growth. Amgen, Inc.’s Enbrel underwent patent expiry in Europe in 2015, while it holds a patent until 2028 in North America. Early expiration of patent rights in Europe has led to increased market penetration of biosimilars, thus influencing the growth of biologics in this region. In 2017, Enbrel sales dipped by 9%, owing to increased competition from biosimilars. The increased prevalence of cancer, autoimmune diseases, and diabetes, as well as the presence of headquarters of leading market players such as Abbvie, Inc., Janssen Pharmaceuticals, Inc., and many others, drive the North American biologics market. Asia Pacific exhibited the fastest growth during the period from 2018 to 2026, owing to continuous development in the biologics sector, the rising prevalence of chronic diseases, and the presence of potential market players with a strong pipeline portfolio. China’s WuXi Biologics and Japan’s Takeda Pharmaceutical Co., Ltd. are some of the major biologic drug manufacturers in the Asia Pacific.

“The dominance of established international players with strong product portfolios makes market penetration difficult for emerging players.”

The therapeutic biologics market encompasses an extensive competitive pool with market presence across geographies, dominated by market leaders such as Roche Holding AG, Merck & Co., Inc., Amgen, Inc., and Novartis AG. Continuous partnerships and acquisitions and the presence of established international pioneers make entry difficult for emerging market players. Sanofi S.A. and Celgene Corporation, on January 22, 2018, announced the acquisitions of Bioverativ for $11.6 billion and Juno Therapeutics for $9.0 billion, respectively, thus expanding their dominance in the biologics market. However, a constant requirement for targeted therapies in chronic diseases paves the way for new market players with a strong pipeline portfolio. Established industrial players make it difficult for new players to enter the market owing to their vast market outreach and extensive networking. For instance, Alexion Pharmaceutical, Inc., a biopharmaceutical firm, carries a Zacks Rank #3 as per Zacks Equity Research Analysts. Its blockbuster product Soliris was recently additionally approved (October 2017) by the FDA for myasthenia gravis, thus boosting its sales. Soliris had net sales of US$ 2.8 billion in 2016 and is expected to grow further due to label expansion.

Periods of History and Forecast

This study report includes an analysis for each segment from 2016 to 2026, with 2017 as the base year. The compound annual growth rate (CAGR) for each of the respective segments is estimated for the forecast period from 2018 to 2026.

Report Scope by Segments

The therapeutic biologics market includes current market trends and dynamics, as well as quantitative market analysis for the global market. The report elucidates thorough information about the global biologics market by segmenting the market in terms of product, application, and geography. This report will assist healthcare professionals and market participants in making decisions and strategizing market positions.

The current report also encompasses qualitative market assessment factors such as market trends, key market drivers, restraints, and opportunities that give a better understanding of the overall biologics market. Furthermore, the report also comprises a graphical representation of the competitive landscape based on their market initiatives and strategies, product portfolios, and business strengths. Key industrial players profiled in the study report include Abbvie, Inc., Amgen, Inc., AstraZeneca Plc., Celgene Corporation, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novartis AG, Pfizer, Inc., Roche Holding AG, Sanofi S.A., and Takeda Pharmaceutical Co., Ltd.

Key questions are answered in this report.

• What are the current market trends and dynamics in the biologics market, and what are the valuable opportunities for emerging players?
• Which product contributes to the maximum market share?
• Which product accounts for the fastest CAGR during the forecast period?
• Which disease area encompasses a larger market share and why?
• What is the impact of biosimilars on the biologics market?
• Are companies looking to invest in biologics further or biosimilars?
• Are low- and middle-income economies investing in biological development?
• What are the market trends and dynamics in emerging markets such as Japan, Latin America, the Middle East, and Africa?

Chapter 1. Preface
1.1. Report Description
1.1.1. Purpose of the Report
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Market Segmentation
1.3. Research Scope
1.4. Research Methodology
1.4.1. Phase I-Secondary Research
1.4.2. Phase II-Primary Research
1.4.3. Phase III-Expert Panel Review
1.4.4. Assumptions

Chapter 2. Executive Summary
2.1. Global Biologics Market Portraiture
2.2. Global Biologics Market, by Product, 2017 (US$ Bn)
2.3. Global Biologics Market, by Disease, 2017 (US$ Bn)
2.4. Global Biologics Market, by Geography, 2017 (US$ Bn)

Chapter 3. Global Biologics Market: Dynamics and Future Outlook
3.1. Market Overview
3.2. Market Dynamics
3.2.1. Market Drivers
3.2.1.1. Growing Prevalence Of Chronic Conditions
3.2.1.2. Increased Investment in Research Activities
3.2.2. Market Challenges
3.2.2.1. Growth of Biosimilars
3.2.2.2. Challenge 2
3.2.3. Market Opportunities
3.2.3.1. Strong Pipeline Candidates
3.3. Attractive Investment Proposition, by Geography, 2017
3.4. Competitive Landscape, by Key Players, 2017

Chapter 4. Global Biologics Market, by Product, 2016-2026 (US$ Bn)
4.1. Overview
4.2. Recombinant Therapeutic Proteins
4.2.1. Monoclonal Antibodies
4.2.2. Hormones
4.2.3. Cytokines
4.2.4. Enzymes
4.3. Blood & Blood components
4.4. Cellular & Gene Therapy
4.5. Vaccines

Chapter 5. Global Biologics Market, by Disease, 2016-2026 (US$ Bn)
5.1. Overview
5.2. Oncology
5.2.1. Breast Cancer
5.2.2. Leukemia
5.2.3. Ovarian Cancer
5.2.4. Non-Hodgkin Lymphoma
5.2.5. Prostate Cancer
5.2.6. Colorectal Cancer
5.2.7. Others (bladder cancer, lung cancer, etc.)
5.3. Autoimmune diseases
5.3.1. Systemic Sclerosis
5.3.2. Crohn’s Disease
5.3.3. Rheumatoid arthritis
5.3.4. Systemic Lupus Erythematous
5.3.5. Others (Sjogren’s syndrome, multiple sclerosis, pernicious anemia, etc.)
5.4. Diabetes
5.5. Infectious diseases
5.6. Others (cardiovascular diseases, ophthalmic conditions, dermatological diseases, etc.)

Chapter 6. Global Biologics Market, by Geography, 2016-2026 (US$ Bn)
6.1. Overview
6.2. North America Biologics Market, 2016-2026 (US$ Bn)
6.2.1. North America Biologics Market, by Product, 2016-2026 (US$ Bn)
6.2.2. North America Biologics Market, by Disease, 2016-2026 (US$ Bn)
6.2.3. North America Biologics Market, by Country, 2016-2026 (US$ Bn)
6.2.3.1. U.S.
6.2.3.2. Canada
6.3. Europe Biologics Market, 2016-2026 (US$ Bn)
6.3.1. Europe Biologics Market, by Product, 2016-2026 (US$ Bn)
6.3.2. Europe Biologics Market, by Disease, 2016-2026 (US$ Bn)
6.3.3. Europe Biologics Market, by Country/Region, 2016-2026 (US$ Bn)
6.3.3.1. U.K.
6.3.3.2. Germany
6.3.3.3. Rest of Europe
6.4. Asia Pacific Biologics Market, 2016-2026 (US$ Bn)
6.4.1. Asia Pacific Biologics Market, by Product, 2016-2026 (US$ Bn)
6.4.2. Asia Pacific Biologics Market, by Disease, 2016-2026 (US$ Bn)
6.4.3. Asia Pacific Biologics Market, by Country/Region, 2016-2026 (US$ Bn)
6.4.3.1. Japan
6.4.3.2. China
6.4.3.3. Rest of Asia Pacific
6.5. Latin America Biologics Market, 2016-2026 (US$ Bn)
6.5.1. Latin America Biologics Market, by Product, 2016-2026 (US$ Bn)
6.5.2. Latin America Biologics Market, by Disease, 2016-2026 (US$ Bn)
6.5.3. Latin America Biologics Market, by Country, 2016-2026 (US$ Bn)
6.5.3.1. Brazil
6.5.3.2. Mexico
6.5.3.3. Rest of Latin America
6.6. Middle East & Africa (MEA) Biologics Market, 2016-2026 (US$ Bn)
6.6.1. Middle East & Africa (MEA) Biologics Market, by Product, 2016-2026 (US$ Bn)
6.6.2. Middle East & Africa (MEA) Biologics Market, by Disease, 2016-2026 (US$ Bn)
6.6.3. Middle East & Africa (MEA) Biologics Market, by Region, 2016-2026 (US$ Bn)
6.6.3.1. GCC
6.6.3.2. Rest of MEA

Chapter 7. Company Profiles
7.1. Merck & Co. Inc.
7.1.1. Business Description
7.1.2. Financial Information (Subject to data availability)
7.1.3. Product Portfolio
7.1.4. Key Developments
7.2. AbbVie, Inc.
7.3. AstraZeneca Plc.
7.4. Amgen, Inc.
7.5. Celgene Corporation
7.6. Bristol-Myers Squibb Co.
7.7. Eli Lilly and Company
7.8. Janssen Pharmaceuticals, Inc.
7.9. GlaxoSmithKline Plc.
7.10. Novartis AG
7.11. Pfizer, Inc.
7.12. Novo Nordisk A/S
7.13. Sanofi S.A
7.14. Roche Holding AG
7.15. Takeda Pharmaceutical Co., Ltd

List of Figures

FIG. 1 Market Segmentation: Global Biologics Market
FIG. 2 Biologics Market: Research Methodology
FIG. 3 Global Biologics Market, by Product, 2016-2026 (US$ Bn)
FIG. 4 Global Biologics Market, by Disease, 2016-2026 (US$ Bn)
FIG. 5 Global Biologics Market , by Geography, 2016-2026 (US$ Bn)
FIG. 6 Attractive Investment Proposition, by Geography, 2017
FIG. 7 Competitive Analysis: Global Biologics Market, by Key Players, 2017
FIG. 8 Global Monoclonal Antibodies Market, 2016-2026 (US$ Bn)
FIG. 9 Global Hormones Market, 2016-2026 (US$ Bn)
FIG. 10 Global Cytokines Market, 2016-2026 (US$ Bn)
FIG. 11 Global Enzymes Market, 2016-2026 (US$ Bn)
FIG. 12 Global Blood & Blood Components Market, 2016-2026 (US$ Bn)
FIG. 13 Global Cellular & Gene Therapy Market, 2016-2026 (US$ Bn)
FIG. 14 Global Vaccines Market, 2016-2026 (US$ Bn)
FIG. 15 Global Breast Cancer Market in Biologics, 2016-2026 (US$ Bn)
FIG. 16 Global Leukemia Market in Biologics, 2016-2026 (US$ Bn)
FIG. 17 Global Ovarian Cancer Market in Biologics, 2016-2026 (US$ Bn)
FIG. 18 Global Non-Hodgkin Lymphoma Market in Biologics, 2016-2026 (US$ Bn)
FIG. 19 Global Prostate Cancer Market in Biologics, 2016-2026 (US$ Bn)
FIG. 20 Global Colorectal Cancer Market in Biologics, 2016-2026 (US$ Bn)
FIG. 21 Global Other Cancers Market in Biologics, 2016-2026 (US$ Bn)
FIG. 22 Global Systemic Sclerosis Market in Biologics, 2016-2026 (US$ Bn)
FIG. 23 Global Crohn’s Disease Market in Biologics, 2016-2026 (US$ Bn)
FIG. 24 Global Rheumatoid Arthritis Market in Biologics, 2016-2026 (US$ Bn)
FIG. 25 Global Systemic Lupus Erythematous Market in Biologics, 2016-2026 (US$ Bn)
FIG. 26 Global Other Autoimmune Diseases Market in Biologics, 2016-2026 (US$ Bn)
FIG. 27 U.S. Biologics Market, 2016-2026 (US$ Bn)
FIG. 28 Canada Biologics Market, 2016-2026 (US$ Bn)
FIG. 29 U.K. Biologics Market, 2016-2026 (US$ Bn)
FIG. 30 Germany Biologics Market, 2016-2026 (US$ Bn)
FIG. 31 Rest of Europe Biologics Market, 2016-2026 (US$ Bn)
FIG. 32 Japan Biologics Market, 2016-2026 (US$ Bn)
FIG. 33 China Biologics Market, 2016-2026 (US$ Bn)
FIG. 34 Rest of Asia Pacific Biologics Market, 2016-2026 (US$ Bn)
FIG. 35 Brazil Biologics Market 2016-2026 (US$ Bn)
FIG. 36 Mexico Biologics Market 2016-2026 (US$ Bn)
FIG. 37 Rest of Latin America Biologics Market 2016-2026 (US$ Bn)
FIG. 38 GCC Biologics Market 2016-2026 (US$ Bn)
FIG. 39 Rest of MEA Biologics Market 2016-2026 (US$ Bn)

List of Tables

TABLE 1 Global Biologics Market Portraiture
TABLE 2 Global Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 3 Global Recombinant Therapeutic Proteins Market, by Class, 2016-2026 (US$ Bn)
TABLE 4 Global Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 5 Global Oncology Market, by Disease Type, 2016-2026 (US$ Bn)
TABLE 6 Global Autoimmune Diseases Market, by Disease Type, 2016-2026 (US$ Bn)
TABLE 7 Global Biologics Market , by Geography, 2016-2026 (US$ Bn)
TABLE 8 North America Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 9 North America Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 10 North America Biologics Market, by Country, 2016-2026 (US$ Bn)
TABLE 11 Europe Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 12 Europe Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 13 Europe Biologics Market, by Country/Region, 2016-2026 (US$ Bn)
TABLE 14 Asia Pacific Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 15 Asia Pacific Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 16 Asia Pacific Biologics Market, by Country/Region, 2016-2026 (US$ Bn)
TABLE 17 Latin America Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 18 Latin America Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 19 Latin America Biologics Market, by Country, 2016-2026 (US$ Bn)
TABLE 20 Middle East And Africa Biologics Market, by Product, 2016-2026 (US$ Bn)
TABLE 21 Middle East And Africa Biologics Market, by Disease, 2016-2026 (US$ Bn)
TABLE 22 Middle East And Africa Biologics Market, by Region, 2016-2026 (US$ Bn)
TABLE 23 Merck & Co. Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 24 AbbVie, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 25 AstraZeneca Plc. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments) Amgen, Inc. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 26 Celgene Corporation: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 27 Bristol-Myers Squibb Co. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 28 Eli Lilly and Company: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 29 Janssen Pharmaceuticals, Inc. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 30 GlaxoSmithKline Plc. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 31 Novartis AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 32 Pfizer, Inc. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 33 Novo Nordisk A/S: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 34 Sanofi S.A: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 35 Roche Holding AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 36 Takeda Pharmaceutical Co., Ltd. : Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)