Biologics Market By Product (Recombinant Therapeutic Proteins, Blood & Blood Components, Cellular & Gene Therapy, Vaccines), By Disease (Oncology, Autoimmune Diseases, Diabetes, Infectious Diseases, Others) - Growth, Future Prospects & Competitive Analysis, 2018 - 2026

"Biologics market to show rapid maturation and remunerative growth during the forecast period"

Global biologics market accounted for market value of US$ 254.9 Bn in 2017 and expected to attain US$ 580.5 Bn by 2026. Recombinant therapeutic proteins contributed largest market share in 2017 while cellular and gene therapies exhibited fastest annual growth during the forecast period from 2018 to 2026. Monoclonal antibodies form a major portion of recombinant therapeutics market with its 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 advent of novel therapies such as cellular and gene therapy exhibiting fastest growth during the forecast period. In 2017, 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 maximum to the growth of biologic market. Rising prevalence of these conditions across geographies, continuous research activities, presence of a strong product portfolio and an unmet need of appropriate targeted therapeutic option are the prime reasons for maximum influence of aforementioned conditions to overall market growth. However, the rampant rise in development of biosimilars along with increasing demand for cost effective therapeutics and various government initiatives in low & 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 (beacizumab) gained FDA approval in September 2017. Post the patent expiry of Avastin, it is presumed that Mvasi would grab major shares of Avastin affecting Roche’s Avastin sales of US$ 6.94 Bn in 2016. Major biologics hold patent rights for longer duration in North America as compared to Europe, thus North America continues to enjoy dominant position in the global biologics market, encompassed largest market share in 2017. Asia Pacific exhibited accelerated growth during the period from 2016 to 2026.

Market Synopsis

Biologics Market

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"Cellular & gene therapy to exhibit double digit CAGR during the forecast period"

Cellular & gene therapy expected to attain fastest growth with 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 majority of its application in oncology. French company, TxCell aims at expanding the 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 supremacy of cellular & gene therapy by 2026. However, higher pricing of such therapies and constant battles to gain appropriate reimbursements for the same could have a negative impact on its market growth across geographies. Recombinant therapeutic proteins comprising hormones, cytokines, enzymes and monoclonal antibodies held largest market share in 2016 and exhibits similar trend in 2026 as well. Constant development in monoclonal antibodies and its high lucrative nature is the prime reason for its vast market out reach. Humira (Abbvie, Inc.) is a top selling brand with a total sale of US$ 18.4 Bn in 2017 globally accounting for 65.3% of Abbvie’s total net revenue.

Biologics Market

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"Oncology segment contribute maximum to the overall growth of biologics market"

As per “Cancer Statistics, 2018” published in American Cancer Society’s journal CA: A Cancer Journal for Clinicians, around 1.73 million new cancer cases and 0.60 million cancer deaths are estimated to occur in the US in 2018. Rising global cancer prevalence, continuous research activities, unmet need for target based therapeutic option and government initiatives to attain treatment for niche cancer types catalyzes 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 accounts for the most explored conditions in this market with a strong current product and pipeline portfolio.

Biologics Market

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"Preservation of patent rights along with stringent regulatory policies for biosimilars holds North America in dominant position"

North America held largest market share in 2017 and continued to maintain supremacy in 2026 as well. 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 year 2015 while it holds patent until 2028 in North America. Early expiration of patent rights in Europe has led to the 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. Increased prevalence of cancer, autoimmune diseases & diabetes, presence of headquarters of leading market players namely, Abbvie, Inc., Janssen Pharmaceuticals, Inc. & many others and continuous research activities drive the North American biologics market. Asia Pacific exhibited fastest growth during the period from 2018 to 2026 owing to continuous development in biologics sector, rising prevalence of chronic diseases and 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 drugs manufacturers in Asia Pacific.

Biologics Market

"Dominance of established international players with strong product portfolio makes market penetration difficult for emerging players"

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 & acquisitions and presence of established international pioneer’s makes entry difficult for emerging market players. Sanofi S.A. and Celgene Corporation., on 22 January 2018 announced the acquisitions of Bioverativ for $11.6 Bn and Juno Therapeutics for $ 9.0 Bn respectively thus expanding their dominance in biologics market. However, a constant requirement for targeted therapies in chronic diseases paves way for new market players with 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 recently was additionally approved (October 2017) by FDA for myasthenia gravis thus boosting its sales. Soliris accounted for a net sale of US$ 2.8 Bn in 2016 and is expected to attain further growth owing to its label expansion.

Biologics Market

Historical & Forecast Period

This study report represents analysis for each segment from 2016 to 2026 considering 2017 to be the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments are estimated for the forecast period from 2018 to 2026

Report Scope by Segments

Therapeutic biologics market comprises of current market trends and dynamics along with quantitative analysis of the global market. The report elucidates thorough information of global biologics market by segmenting the market in terms of product, application and geography. This report would guide healthcare professionals and market players in decision-making and strategizing market position.

Research Period  2016-2026
Base Year 2017
Forecast Period  2018-2026
Historical Year  2016
Unit  USD Billion

 Product Segment (2016–2026; US$ Bn)
 • Recombinant Therapeutic Proteins 
   o Monoclonal Antibodies
   o Hormones
   o Cytokines
   o Enzymes
 • Blood & Blood components
 • Cellular & Gene Therapy
 • Vaccines 

 Disease Segment (2016–2026; US$ Bn)
 • Oncology 
   o Breast Cancer
   o Leukemia
   o Ovarian Cancer\ Non-Hodgkin Lymphoma
   o Prostate Cancer
   o Colorectal Cancer
   o Others (Bladder Cancer, Lung Cancer, etc.)
 • Autoimmune diseases
   o Systemic Sclerosis
   o Crohn’s Disease
   o Rheumatoid arthritis
   o Systemic Lupus Erythematous
   o Others (Sjogren's syndrome, multiple sclerosis, pernicious anemia,   etc.)
 • Diabetes
 • Infectious diseases
 • Others (cardiovascular diseases, ophthalmic conditions,     dermatological diseases, etc.)

 Geography Segment (2016–2026; US$ Bn)
 • North America (U.S., Canada)
 • Europe (U.K., Germany, Rest of Europe)
 • Asia Pacific (Japan, China, Rest of Asia Pacific)
 • Latin America (Brazil, Mexico, Rest of Latin America)
 • Middle East & Africa (GCC, Rest of Middle East & Africa)

The current report also comprehends qualitative market assessment factors such as market trends, key market drivers, restraints and opportunities that gives a better market understanding of the overall biologics market. Furthermore, the report also comprises graphical representation of competitive landscape based on their market initiatives and strategies, product portfolio and business strengths. Key industrial player 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 answered in this report

  • What are the current market trends and dynamics in the biologics market and valuable opportunities for emerging players?
  • Which product contributes to the maximum market share?
  • Which product accounts to fastest CAGR during the forecast period?
  • Which disease area encompasses larger market share and why?
  • What is the impact of biosimilars on biologics market?
  • Are companies looking to invest in biologics further or biosimilars?
  • Are low and middle-income economies investing in biological development?
  • What is the market trend and dynamics in emerging markets such as Japan, Latin America and Middle East & Africa?
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Published Date:  Apr 2018
Category:  Pharmaceuticals
Report ID:   59079
Report Format:   PDF
Pages:   120
Rating:    4.5 (60)
Delivery Time: 24 Hours to 48 Hours   
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