"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.

"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.

"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.

"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.

"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.

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.

Historical & Forecast Period

This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.

The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.

Research Methodology

The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Biologics market are as follows:

• Research and development budgets of manufacturers and government spending
• Revenues of key companies in the market segment
• Number of end users and consumption volume, price and value.
• Geographical revenues generate by countries considered in the report
• Micro and macro environment factors that are currently influencing the Biologics market and their expected impact during the forecast period.

Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.

Key questions answered in this report

• What are the key micro and macro environmental factors that are impacting the growth of Biologics market?
• What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
• Estimated forecast and market projections up to 2032.
• Which segment accounts for the fastest CAGR during the forecast period?
• Which market segment holds a larger market share and why?
• Are low and middle-income economies investing in the Biologics market?
• Which is the largest regional market for Biologics market?
• What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
• Which are the key trends driving Biologics market growth?
• Who are the key competitors and what are their key strategies to enhance their market presence in the Biologics market worldwide?