The Biosimilar Drugs Market: 2021 – 2030​ - Opportunities, Challenges, Strategies & Forecasts

Release Date: April 2021
Number of Pages: 316
Number of Tables and Figures: 49

Synopsis: Biosimilars are biochemicals with composition similar to reference biologics, generating a pathway for affordable access to treatments for chronic diseases. The biosimilar market is continuing to mature, steadily expanding in highly regulated as well as non-regulated regions. As compared to the generic drugs market, biosimilars are facing greater challenges, specifically high R&D costs and lengthy patent litigation. Since the shift to accepting biosimilars has been a gradual one, there are significant untapped opportunities for players in the biosimilar ecosystem to take a chunk of the sizable biologics market.
Uptake of biosimilars is starting to gain momentum in 2021 and expected to grow significantly by the end of the decade. As stakeholders understand and recognize the benefits offered by biosimilars, legislation and regulatory changes will soon follow to bring the biosimilar market to full fruition. In the coming years, we expect biosimilars to experience more tolerant regulation, quicker approvals, and increased interchangeability.

The “Biosimilar Drugs Market: 2021 – 2030 – Opportunities, Challenges, Strategies & Forecasts” report presents an in-depth assessment of the biosimilar drugs ecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents market size forecasts for biosimilar drugs from 2021 through to 2030. The forecasts are segmented for over 8 drug classes, 2 approval categories, 5 regions and 25 leading countries. Moreover, the report covers 71 biosimilar candidates in clinical development across 24 active substances.    
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The report comes with an associated Excel datasheet suite covering quantitative data from all numeric forecasts presented in the report, as well as an Excel sheet covering clinical drug developmental pipeline for biosimilars.

For a Sample and Table of Contents please contact i[email protected]

Pricing: The report is available for the following price:

Single User License: USD 2,500

Company Wide License (Single Site): USD 3,500

Company Wide License (Global Site): USD 6,500

Key Findings:
The report has the following key findings:
  • Driven by the cost saving potential of biosimilar drugs, a number of countries have established regulatory pathways for their approval. We estimate that approved biosimilar drugs will account for nearly $24 Billion in revenue by the end of 2021.
  • In terms of drug class categorization, we expect monoclonal antibodies to dominate the biosimilar drugs market by the end of 2021, with an estimated market share of over 35%.
  • SNS Research estimates that biosimilars will cut global healthcare spending significantly over the forecast period, as several innovator biologic drugs come off patent.
  • In a bid to control costs and expand their global reach, most biosimilar drug manufacturers are complementing their existing manufacturing and R&D locations with sites in low-cost countries such as India, China, Brazil and Russia. These countries have been used as successful launch-pads for several prominent biosimilar drugs.
  • Many candidates in the biosimilar pipeline are in late-stage development soon entering the market, demonstrating an influx of approvals and launches in the next three years, with 3 approvals expected in Q3’2021.   
  • R&D pipelines suggest future dynamic growth for the biosimilars market across a multitude of therapeutic areas. Some of the new therapeutic areas biosimilars are expanding into are immunosuppressants, insulin, and ophthalmology.

Topics Covered:
The report covers the following topics:
  • Biosimilar drugs ecosystem
  • Market drivers and barriers
  • Technology, economics and key trends
  • Approved and non-approved biosimilars
  • Analysis of key drug classes and leading biosimilar drugs
  • Regulatory landscape of biosimilar drugs throughout the globe
  • Industry roadmap and value chain
  • Profiles and strategies of 190 leading ecosystem players, including Biosimilar and innovator biologic drug manufacturers
  • 71 Biosimilar Pipeline Candidates across 24 active substances
  • Strategic recommendations for ecosystem players
  • Market analysis and forecasts from 2021 till 2030

Historical Revenue & Forecast Segmentation:
Market forecasts are provided for each of the following submarkets and their subcategories:
  • Approval Category Classification
    • Approved Biosimilars
    • Non-approved Biosimilars
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  • Drug Class
    • mAbs (Monoclonal Antibodies)
    • FC-Fusion Proteins
    • EPO (Erythropoietin)
    • G-SCF (Granulocyte-colony Stimulating Factor)
    • Insulin
    • Interferons
    • HGH (Human Growth Hormone)
    • Gonadotropins (Glycoprotein Hormones)
    • Others

  • Regional Markets
    • ​Asia Pacific
    • Europe
    • Middle East & Africa
    • North America
    • Latin & Central America

  • Country Markets
    • ​Brazil
    • Canada
    • China
    • Egypt
    • France
    • Germany
    • Greece
    • India
    • Israel
    • Italy
    • Japan
    • Mexico
    • Netherlands
    • Poland
    • Portugal
    • Russia
    • Saudi Arabia
    • South Africa
    • South Korea
    • Spain
    • Switzerland
    • Taiwan
    • Turkey
    • UK
    • USA

Key Questions Answered:
The report provides answers to the following key questions:
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  • How big is the biosimilar drugs opportunity?
  • What trends, challenges and barriers are influencing its growth?
  • How is the ecosystem evolving by segment and region?
  • What are the latest updates in the biosimilar clinical pipeline?
  • What will the market size be in 2025 and at what rate will it grow?
  • Which countries and submarkets will see the highest percentage of growth?
  • How big is the market for biosimilar monoclonal antibodies?
  • How does regulation impact the adoption of biosimilar drugs?
  • How cheap are biosimilar drugs in comparison to their reference products?
  • What is the cost saving potential of biosimilar drugs?
  • Who are the key market players and what are their strategies?
  • How will patent expirations of biologic drugs impact the market?
  • What are the future prospects of approved and non-approved biosimilar drugs?
  • What strategies should biosimilar and innovator drug manufacturers adopt to remain competitive?

List of Companies Mentioned:
The following companies and organizations have been reviewed, discussed or mentioned in the report:

3SBio
Abbott Laboratories
AbbVie
ABPI (Association of the British Pharmaceutical Industry)
Accord Healthcare
ACETO Corporation
Acino Holding
Actavis
Actelion
Adcock Ingram
Aesica Pharmaceuticals
AET (Alfred E Tiefenbacher) Group
AET BioTech (AET BioTechnology)
Agila Specialties
Ajinomoto Group
Akron Pharmaceuticals
Alexion Pharmaceuticals
Alfa Wasserman
Allergan
Almirall
AMA (African Medicines Regulatory Agency)
Amega Biotech
Amgen
Amneal Pharmaceuticals
AMRI (Albany Molecular Research, Inc.)
ANVISA (Brazilian Health Surveillance Agency)
Apobiologix
ApoPharma
Apotex
Arch Pharmalabs
Aryogen
ASKA Pharmaceutical Company
Aspen Holdings
Astellas Pharma
AstraZeneca
Aurobindo Pharma
Auxilium Pharmaceuticals
AXXO
Baxalta
Baxter International
Bayer
BD (Becton, Dickinson and Company)
BD Bioscience
Berlin Chemie
Bharat Biotech
Biocad
Biocon
Biodel
Biogaran
Biogen
Biogen Laboratorios
Bionovis
Biopartners Holdings
Biosidus
Biotechpharma
Bioton
BioXpress Therapeutics
BMS (Bristol-Myers Squibb)
Boehringer Ingelheim
Bolder BioTechnology
Brazilian Ministry of Health
Breckenridge Pharmaceutical
Cassara Biotech
CDSCO (Central Drug Standards and Control Organization, India)
Cedarburg Pharmaceuticals
Celgene Corporation
Celltrion Healthcare
CFDA (China Food and Drug Administration)
Chemo Group
Chiesi Farmaceutici
Chong Kun Dang Pharmaceutical Corporation
Chugai Pharmaceutical Company
Cipla
Cipla BioTec
Claris Injectables
Claris Lifesciences
Claris Otsuka
COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico)
Coherus BioSciences
Consort Medical
Covidien
CPGP (Shanghai CP Guojian Pharmaceutical Company)
Creative Biomart
Cypress Pharmaceutical
Daiichi Sankyo
Daiichi Sankyo Espha
Department of Health, Mexico
Dong-A Pharmaceutical
Dong-A Socio-Holdings Company
Dong-A ST
Dr. Reddy's Laboratories
Dusa Pharmaceuticals
EDA (Egyptian Drug Authority)
EGA (European Generic Medicines Association)
Egis Pharmaceuticals
Eisai
Eli Lilly and Company
Elmed Eisai Company
EMA (European Medicines Agency)
Emcure Pharmaceuticals
Endo International
Epirus Biopharmaceuticals
Essetifin
ESTEVE Farma
ESTEVE Group
Eurofarma Laboratorios
Ferring Pharmaceuticals
Flamel Technologies
Formycon
Fresenius Kabi
Fuji Pharma Company
Fujifilm Corporation
Fujifilm Holdings Corporation
Fujifilm Kyowa Kirin Biologics
Fujifilm Pharma
Gador
Galderma
Galenika
Gedeon Richter
Gene Techno Science
Genepharm
Genexine
Gennova Biopharmaceuticals
Genor Biopharma 
GGL (Glenmark Generics Limited)
Gilead Sciences
Glenmark Pharmaceuticals
Globalpharma
Green Cross Corporation
Grifols
Gruenenthal Group
GSK (GlaxoSmithKline)
Guangdong BeiKang Pharmaceutical Company
Hanmi Pharmaceutical Company
Hanwha Chemical Company
Health Canada
HEC Pharm
HELM AG
Helvetic BioPharma
Henlius Biopharmaceuticals
Hetero
Hikma Pharmaceuticals
Hi-Tech Pharmacal
HMP (Harvest Moon Pharmaceuticals)
Hospira
iBio
ILKO
ILKOGEN
Impax Laboratories
Impax Pharmaceuticals
Intas Pharmaceuticals
Ipsen
Israeli MoH (Ministry of Health)
ISU ABXIS
Janssen Pharmaceutica
Jazz Pharmaceuticals
Johnson & Johnson
JT (Japan Tobacco)
Kaken Pharmaceutical Company
Kaneka Corporation
Kowa Company
Kowa Health Care America
Kowa Pharmaceuticals America
Kowa Research Institute
Kremers Urban Pharmaceuticals
Krka
Kyowa Hakko Kirin
Kyowa Pharmaceutical Industry Company
Laboratorios Beta
Laboratorios Roemmers
Landsteiner Scientific
Lannett Company
Leo Pharma
Les Laboratoires Servier (Servier Group)
LG Life Sciences
Lil Therapeutics
Lundbeck
Lupin
mAbxience
Mallinckrodt
Maruho Company
Matrix Laboratories
MCC (Medicines Control Council, South Africa)
Meda
MEDICE Arzneimittel Pütter
Medley Farma
Meiji Holdings
Meiji Seika Pharma Company
Menarini Group
Merck and Co.
Merck KGaA
Merck Serono
Merz Pharma
MFDS (Ministry of Food and Drug Safety, South Korea)
MHLW (Ministry for Health Labor and Welfare, Japan)
Ministry of Health and Family Welfare, India
Ministry of Health, Labour and Welfare, Japan
Ministry of Science and Technology, India
Mitsubishi Chemical Holdings Corporation
Mitsubishi Tanabe Pharma
Mitsui & Company
Mitsui Group
MN (Mustafa Nevzat) Pharma
Mochida Pharmaceutical Company
Momenta Pharmaceuticals
Mylan
Natco Pharma
Nichi-Iko Pharmaceutical Company
Nippon Kayaku
Nippon Shinyaku
Nipro Pharma Corporation
Nobel Ilac
NORCB (National Organization for Research & Control of Biologics, Egypt)
Novartis
Novo Nordisk
Oncobiologics
Ono Pharmaceutical Company
OPKP Health
Orion
Orygen Biotecnologia
Osaka Synthetic Chemical Laboratories
Otsuka Holdings Company
Paladin Labs
Par Pharmaceutical Holdings
Pensa Dose
Pensa Pharm
Perrigo Company
Pfenex
Pfizer
Pharma Dynamics
Pharmacyclics
Pharmstandard
Pierre Fabre (Laboratoires Pierre Fabre)
Piramal Enterprises
Piramal Group
PlantForm Corporation
Pliva
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Prasco Laboratories
PregLem
Probiomed
Protalix Biotherapeutics
Purdue Pharma
Qilu Pharmaceutical Company
Ranbaxy Laboratories
Recordati
Regeneron Pharmaceuticals
RLS (Reliance Life Sciences)
Roche Holding (F. Hoffmann-La Roche)
Russian MoH (Ministry of Health)
Samsung Bioepis
Samsung BioLogics
Samsung Group
Sandoz International
Sanofi
Santen Pharmaceutical Company
Sanwa Kagaku Kenkyusho Company
Sartorius Stedim Biotech
Sawai Pharmaceutical Company
SEDICO (South Egypt Drug Industries Company)
Seikagaku Corporation
Sequent Scientific
SFDA (Saudi Food and Drug Authority)
Shanghai Celgen Biopharmaceutical Company
Shanghai Fosun Pharmaceutical Group
Shionogi & Company
Shire
SL Pharm (Beijing SL Pharmaceutical Company)
Somar (Grupo Farmaceutico Somar)
STADA Arzneimittel
Stelis Biopharma
Strativa Pharmaceuticals
Strides Arcolab
Sumitomo Dainippon Pharma Company
Sun Pharma (Sun Pharmaceutical Industries)
Supera Farma Laboratorios
Suzuken Company
Taisho Pharmaceutical Holdings
Takeda Pharmaceutical Company
Tanabe Seiyaku Hanbai Company
Taro Pharmaceutical Industries
Teijin
Teijin Pharma
Teva Pharmaceutical Industries
Teva-Kowa Pharma Company
The Medicines Company
Tonghua Dongbao Pharmaceutical Company
Torrent Group
Torrent Pharmaceuticals
Towa Pharmaceutical Company
TPI (Therapeutic Proteins International)
U.S. CBER (Centre for Biologics Evaluation and Research)
U.S. CDER (Centre for Drug Evaluation and Research)
U.S. FDA (Food and Drug Administration)
UCB
United Therapeutics Corporation
USV
Valeant Pharmaceuticals International
Varifarma
Ventana Medical Systems
Vertex Pharmaceuticals
Walvax Biotechnology Company
Warner-Chilcott
West-Ward Pharmaceuticals
WHO (World Health Organization)
Wockhardt
Xbrane Biopharma
Yichang Chang Jiang Pharmaceutical Company
Zentiva
Zydus Cadila