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Neuroimmunology Drug Development – Thematic Research

Pages: 163 Published: April 22, 2022 Report Code: GDHCHT323

Neuroimmune communication is complex, bidirectional, and mediated across both neural and humoral pathways. A neuroimmunology drug is an agent that aims to regulate immune system activity to treat neurological diseases with underlying immune pathologies. Of the innovator products marketed for the eight key indications covered in this report, the majority are indicated for multiple sclerosis (MS), followed by neuromyelitis optica spectrum disorder (NMOSD), Alzheimer’s disease (AD), and for myasthenia gravis (MG). Most marketed neuroimmunology products are small molecules, followed by mAbs and recombinant proteins. The list of pipeline neuroimmunology therapeutics currently in development is extensive and holds numerous novel approaches to targeting neurological indications.

The neuroimmunology drug development thematic research report focuses on neuroimmunology drug development within eight key indications (MS, NMOSD, GBS, CIDP, MG, AD/MCI, PD, and ALS) across eight major pharmaceutical markets (8MM: the US, 4EU, the UK, Japan, and China).

What are the key trends in the neuroimmunology drug development market?

Industry trends

The majority of marketed disease-modifying neuroimmunology products are those approved for the treatment of MS. With over 20 different disease-modifying therapy (DMT) products available, companies are forced to contend with the complexities of a crowded market. There are many ways in which companies seek to differentiate their products, including frequency of administration, method of administration, and side-effect amelioration. Most patients who experience MS exacerbations face the prospect of life-long treatment. As such, the development of novel MOAs for this disease form is still a major focus of industry. For the non-MS indications, there are only a few neuroimmunology products currently approved.

Macroeconomic trends

The majority of marketed neuroimmunology products are of high cost, particularly in the US. The MS market in the US is beginning to see cost savings due to the launch of generic dimethyl fumarate. The launch of other generic and biosimilar agents over the next 10 years will help to keep rising costs in this market at bay.

Regulatory trends

Numerous diseases are either rare and/or have a high degree of unmet need for new treatment options. Hence, many of the associated neuroimmunological products have been assigned special designations to speed up and incentivize the development. To make drugs that treat rare diseases available more quickly, several country-specific key designations and processes exist.

Which are the key companies in the neuroimmunology drug development market?

The key companies in the neuroimmunology drug development market are F. Hoffmann-La Roche Ltd, Biogen, AstraZeneca, Johnson & Johnson, Merck KGaA, Novartis AG, Sanofi, UCB SA, Eisai Co Ltd, and Eli Lilly and Co.

F. Hoffmann-La Roche Ltd

It is a biotechnology company that provides pharmaceuticals for the treatment of cancer, other autoimmune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. In the neuroimmunology space, Roche has nine pipeline products in clinical development.

Biogen

It is a biopharmaceutical company that discovers, develops, and delivers drugs and biosimilars for the treatment of various neurological and neurodegenerative diseases. In the neuroimmunology space, Biogen markets numerous products for MS.

AstraZeneca

It is a biopharmaceutical company that is focused on discovery, production, and commercialization of a range of prescription drugs. It develops products in therapy areas such as respiratory, cardiovascular, renal and metabolic diseases, cancer, autoimmune, infection, and neurological diseases. The company’s product portfolio includes biologics, prescription pharmaceuticals, and vaccines. In the neuroimmunology space, AstraZeneca’s main presence is through its subsidiary, Alexion Pharmaceuticals.

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Market report scope

Key companies F. Hoffmann-La Roche Ltd, Biogen, AstraZeneca, Johnson & Johnson, Merck KGaA, Novartis AG, Sanofi, UCB SA, Eisai Co Ltd, and Eli Lilly and Co

This report provides:

  • Overview of the neuroimmune system and its role in the pathology of eight key neurological diseases.
  • Overview of key trends in the neuroimmunology drug development space.
  • Evaluation of marketed and pipeline neuroimmunology drugs for the treatment of eight key neurological diseases, highlighting key mechanisms of action.
  • Evaluation of clinical trials for marketed and pipeline neuroimmunology drugs.
  • Market analysis of key neuroimmunology products in 2020 and 2025 plus an overview of key deals in the neuroimmunology space.
  • Overview of opportunities and unmet needs in the neuroimmunology space.
  • Analysis of companies developing neuroimmunology drugs, with a focus on major players.

Key Highlights

Report deliverable include a PowerPoint report.

Of the innovator products marketed for the eight key indications covered in this report, the majority are indicated for MS (23 drugs), followed by three each for NMOSD and AD, and two for MG. Most marketed neuroimmunology products are small molecules (12 drugs), followed by mAbs (nine drugs) and recombinant proteins (seven drugs).

According to GlobalData’s Drugs Database, there are currently almost 220 neuroimmunology drugs in Phase I, II, III, and later stages of development in the 8MM. The highest number of drugs are in development for AD (75 drugs), followed by amyotrophic lateral sclerosis (ALS) (39 drugs), PD (35 drugs), MS (26 drugs), and relapsing-remitting MS (RRMS) (26 drugs).

The top 20 neuroimmunology products were worth $20.1 billion in 2020 and are expected to be worth $26.6 billion by 2025. Growth is driven primarily by the continued uptake of Ocrevus in MS and new launches across several indications. Extensive deal-making is occurring within the neuroimmunology drug space, with the top-valued deal being the acquisition of Alexion Pharmaceuticals by AstraZeneca, announced in December 2020.

Of the ten key players involved in the neuroimmunology market, Roche, Biogen, AstraZeneca, Johnson & Johnson (J&J), Novartis, Sanofi, and UCB are all involved in marketing or developing neuroimmunology products across multiple neurological indications. The remaining three players are instead focused on neuroimmunological products in just one indication each—Merck KGaA in MS and Eisai and Lilly in AD.

Reasons to Buy

  • Develop and design your in-licensing and out-licensing strategies through a review of neuroimmunology pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global neuroimmunology drug market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global neuroimmunology market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counterstrategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Key Players

Roche
Biogen
AstraZeneca
Johnson & Johnson
Novartis, Sanofi
UCB
Merck KGaA
Eisai
Eli Lilly

Table of Contents

1. Preface

1.1. Table of Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

2.1. Key Findings

3. Neuroimmunology Overview

3.1. The Neuroimmune System – Overview

3.2. What Is a Neuroimmunology Drug?

3.3. CNS Autoimmune Diseases

3.3.1. Overview of multiple sclerosis (MS) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

3.4. Peripheral Nerve Autoimmune Diseases

3.4.1. Overview of Guillain-Barre Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

3.5. Neuromuscular Junction Autoimmune Diseases

3.5.1. Overview of Myasthenia Gravis (MG)

3.6. Neurodegenerative Diseases

3.6.1. Overview of Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and Amyotrophic Lateral Sclerosis (ALS)

4. Trends

4.1. Industry Trends

4.2. Macroeconomic Trends

4.3. Regulatory Trends

5. Value Chain

5.1. Neuroimmunology Value Chain – Autoimmune Diseases

5.2. Neuroimmunology Value Chain – Neurodegenerative Diseases

6. Marketed Drugs

6.1. Overview of Marketed Neuroimmunology Drugs

6.2. Marketed Neuroimmunology Drugs – Small Molecules

6.3. Marketed Neuroimmunology Drugs – Monoclonal Antibodies

6.4. Marketed Neuroimmunology Drugs – Recombinant Proteins

6.5. Other Marketed Neuroimmunology Drugs

7. Pipeline Products

7.1. Pipeline Neuroimmunology Overview

7.2. Pipeline Products – MS

7.2.1. Overview of Pipeline Drugs

7.2.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – MS

7.2.3. MS Pipeline Highlights: Tyrosine Protein Kinase BTK Inhibitors

7.2.4. MS Pipeline Highlights: Targeting B and T Lymphocytes

7.3. Pipeline Products – AD

7.3.1. Overview of Pipeline Drugs – AD

7.3.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – AD

7.3.3. AD Pipeline Highlights: mAbs Targeting Amyloid Beta (Aβ) A4 Protein

7.3.4. AD Pipeline Highlights: Therapies Targeting Tau Protein

7.4. Pipeline Products – PD

7.4.1. Overview of Pipeline Drugs – PD

7.4.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – PD

7.4.3. PD Pipeline Highlights: α-Synuclein

7.4.4. PD Pipeline Highlights: Bcr-Abl Pathway

7.5. Pipeline Products – ALS

7.5.1. Overview of Pipeline Drugs – ALS

7.5.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – ALS

7.5.3. ALS Pipeline Highlights: Multi-target Immunomodulators

7.5.4. ALS Pipeline Highlights: Complement System

7.6. Pipeline Products – NMOSD

7.6.1. Overview of Pipeline Drugs – NMOSD

7.6.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – NMOSD

7.6.3. NMOSD Pipeline Highlights: Anti-CD20 mAbs

7.6.4. NMOSD Pipeline Highlights: Other B-cell-Targeting MOAs

7.7. Pipeline Products – MG

7.7.1. Overview of Pipeline Drugs – MG

7.7.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – MG

7.7.3. MG Pipeline Highlights: C5 Complement Inhibition

7.7.4. MG Pipeline Highlights: IgG Receptor FcRn-Blocking mAbs

7.8. Pipeline Products – GBS & CIDP

7.8.1. Overview of Pipeline Drugs – GBS & CIDP

7.8.2. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – CIDP

7.8.3. Mid-to-Late-Stage Pipeline Drugs (Phase II & III) – GBS

7.8.4. GBS & CIDP Pipeline Highlights: Complement-Targeting mAbs

7.8.5. GBS & CIDP Pipeline Highlights: IgG Autoantibody Reduction

8. Clinical Trials

8.1. Marketed Neuroimmunology Drugs – All Clinical Trials

8.2. Marketed Neuroimmunology Drugs – Ongoing or Planned Trials

8.3. Pipeline Neuroimmunology Drugs – All Clinical Trials

8.4. Pipeline Neuroimmunology Drugs – Ongoing or Planned Trials

9. Market Analysis

9.1. Top 20 Neuroimmunology Product Sales in 2020 and 2025

9.2. Top 10 M&A Deals in the Neuroimmunology Space

9.3. Top 10 Strategic Alliance Deals in the Neuroimmunology Space

10. Opportunities, Challenges, and Unmet Needs

10.1. Unmet Needs Surrounding Neuroimmunology Products – Gap Analysis

10.2. Unmet Needs – KOLs Perspective

11. Companies

11.1. F. Hoffmann-La Roche Ltd

11.2. Biogen

11.3. AstraZeneca Plc

11.4. J&J

11.5. Merck KGaA

11.6. Novartis AG

11.7. Sanofi

11.8. UCB SA

11.9. Eisai Co Ltd

11.10. Eli Lilly and Co

12. Appendix

12.1. Bibliography

12.2. Key Themes Impacting the Pharmaceutical Industry

12.3. Our thematic research methodology

12.4. About the Authors

12.5. Contact Us

Frequently Asked Questions

The key companies in the neuroimmunology drug development market are F. Hoffmann-La Roche Ltd, Biogen, AstraZeneca, Johnson & Johnson, Merck KGaA, Novartis AG, Sanofi, UCB SA, Eisai Co Ltd, and Eli Lilly and Co.

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