
Global Bispecific Antibodies Market Insights, Size, and Forecast By Type (IgG-based Bispecific Antibodies, Single-chain Variable Fragment Bispecific Antibodies, Dual-variable Domain Immunoglobulin), By End User (Pharmaceutical Companies, Research Institutions, Contract Research Organizations), By Route of Administration (Intravenous, Subcutaneous, Intramuscular), By Application (Oncology, Autoimmune Diseases, Infectious Diseases, Neurology), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East and Africa), Key Companies, Competitive Analysis, Trends, and Projections for 2026-2035
Key Market Insights
Global Bispecific Antibodies Market is projected to grow from USD 12.8 Billion in 2025 to USD 75.4 Billion by 2035, reflecting a compound annual growth rate of 14.2% from 2026 through 2035. This robust growth underscores the increasing prominence of bispecific antibodies as a revolutionary therapeutic modality, offering enhanced specificity and efficacy over conventional monoclonal antibodies. Bispecific antibodies are engineered proteins capable of binding to two distinct antigens or two different epitopes on the same antigen simultaneously, facilitating novel mechanisms of action such as redirecting immune cells to tumor cells or blocking multiple disease pathways. The market is primarily driven by the rising global burden of chronic and complex diseases, particularly various forms of cancer. Advances in antibody engineering technologies, coupled with a deeper understanding of disease biology, are enabling the development of more potent and safer bispecific antibody constructs. Furthermore, the growing number of regulatory approvals for novel bispecific antibodies and the expanding clinical pipeline are significant accelerators for market expansion. Strategic collaborations between pharmaceutical companies and biotechnology firms, focused on research and development, also contribute to market dynamism.
Global Bispecific Antibodies Market Value (USD Billion) Analysis, 2025-2035

2025 - 2035
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The oncology segment continues to dominate the bispecific antibodies market, holding the largest share due to the urgent need for more effective cancer treatments that minimize off target toxicity. Bispecific antibodies in oncology primarily function by engaging T cells or other immune cells to target and eliminate cancer cells, or by blocking key signaling pathways crucial for tumor growth and survival. Beyond oncology, the market is witnessing growing applications in autoimmune diseases, infectious diseases, and ophthalmology, representing significant diversification opportunities. Important trends shaping the market include the shift towards next generation bispecific formats with improved pharmacokinetics and reduced immunogenicity, as well as the exploration of combination therapies to further enhance treatment outcomes. The increasing adoption of subcutaneous routes of administration is also a key trend, offering greater patient convenience and potentially improving adherence. However, market growth faces restraints such as the high cost associated with the development and manufacturing of these complex biologics, stringent regulatory approval processes, and potential challenges related to immunogenicity and off target effects.
North America remains the dominant region in the global bispecific antibodies market, attributed to its robust healthcare infrastructure, high research and development spending, strong presence of key pharmaceutical and biotechnology companies, and favorable regulatory environment. The region also benefits from early adoption of advanced therapies and a large patient pool undergoing treatment for complex diseases. Conversely, Asia Pacific is projected to be the fastest growing region, driven by improving healthcare access, increasing healthcare expenditure, a rising prevalence of chronic diseases, and a growing focus on pharmaceutical innovation in emerging economies. Key players such as AbbVie, Roche, Sanofi, Gilead Sciences, Janssen Pharmaceuticals, Amgen, Zymeworks, AstraZeneca, Regeneron Pharmaceuticals, and Merck are actively involved in developing and commercializing bispecific antibodies. Their strategies include extensive investment in R&D, strategic partnerships, expanding product pipelines, and geographic expansion to capitalize on untapped market potential. The continuous pursuit of novel targets and innovative antibody designs represents a significant opportunity for market players to address unmet medical needs and drive future growth.
Quick Stats
Market Size (2025):
USD 12.8 BillionProjected Market Size (2035):
USD 75.4 BillionLeading Segment:
Oncology (62.8% Share)Dominant Region (2025):
North America (45.8% Share)CAGR (2026-2035):
14.2%
What is Bispecific Antibodies?
Bispecific antibodies are engineered proteins designed to bind two different targets simultaneously. Unlike conventional antibodies, which recognize a single antigen, bispecifics possess two distinct paratopes, each specific for a different epitope. This dual targeting capability allows them to bridge two cells or a cell and a soluble molecule, facilitating novel biological functions. Their significance lies in redirecting immune cells to cancer cells, blocking two distinct disease pathways, or enhancing cell signaling. Applications include cancer immunotherapy, treating autoimmune diseases, and developing advanced diagnostics by bringing diverse molecular components together.
What are the Trends in Global Bispecific Antibodies Market
Revolutionizing Oncology Bispecifics Expanding Therapeutic Reach
Beyond Cancer Bispecific Antibodies for Autoimmune Diseases
Next Generation Bispecific Formats Enhanced Efficacy Safety
Accelerated Clinical Development AI Driven Bispecific Innovation
Revolutionizing Oncology Bispecifics Expanding Therapeutic Reach
Bispecific antibodies are transforming oncology by engaging two targets simultaneously, leading to enhanced tumor cell killing and improved specificity. This expanding therapeutic reach allows for novel treatment approaches, overcoming resistance mechanisms and targeting previously undruggable cancer pathways. Their unique engineering enables precise targeting, ushering in a new era of potent and tailored cancer therapies.
Beyond Cancer Bispecific Antibodies for Autoimmune Diseases
Bispecific antibodies, initially for cancer, are now pivoting to autoimmune diseases. This trend leverages their dual targeting capabilities to simultaneously modulate two distinct immune pathways. By engaging specific cell types or blocking multiple cytokines, these therapies offer precise immune regulation, overcoming limitations of traditional single target approaches. This expansion beyond oncology indicates a promising new therapeutic frontier for chronic autoimmune conditions.
Next Generation Bispecific Formats Enhanced Efficacy Safety
Next generation bispecific formats are enhancing therapeutic efficacy and safety profiles. These innovative designs feature improved valency, target binding specificities, and molecular architectures, minimizing off target effects while maximizing on target potency. This leads to better patient outcomes with fewer side effects, driving their adoption across various disease areas as research and development deliver superior bispecific drug candidates.
Accelerated Clinical Development AI Driven Bispecific Innovation
AI is revolutionizing bispecific antibody development, dramatically shortening timelines from discovery to clinical trials. Machine learning algorithms accelerate the design and optimization of novel bispecific constructs. This innovation speeds candidate selection and improves manufacturability, driving a surge in new bispecific therapies entering human studies. This trend promises faster availability of advanced targeted treatments for various diseases, particularly cancer.
What are the Key Drivers Shaping the Global Bispecific Antibodies Market
Expanding Therapeutic Applications in Oncology and Autoimmune Diseases
Advancements in Bispecific Antibody Engineering and Development
Rising Prevalence of Chronic Diseases and Unmet Medical Needs
Increasing R&D Investments and Strategic Collaborations
Expanding Therapeutic Applications in Oncology and Autoimmune Diseases
Bispecific antibodies are revolutionizing cancer and autoimmune disease treatment. Their ability to simultaneously target two disease pathways offers enhanced efficacy and reduced side effects compared to conventional therapies. This expanded therapeutic potential in diverse indications, including various solid tumors and chronic inflammatory conditions, is a key driver for significant market growth. Researchers are actively exploring novel applications, further broadening the scope.
Advancements in Bispecific Antibody Engineering and Development
Innovations in bispecific antibody design, like enhanced targeting and reduced immunogenicity, are propelling market growth. New engineering strategies enable more effective drug delivery and improved safety profiles. These advancements lead to a wider range of therapeutic applications, expanding the treatable disease landscape and increasing demand for these sophisticated biologics.
Rising Prevalence of Chronic Diseases and Unmet Medical Needs
The increasing burden of chronic diseases globally presents a significant unmet medical need. Current treatments often fall short, leading to demand for more effective therapies. Bispecific antibodies offer a promising solution, targeting multiple disease pathways to improve patient outcomes and address these complex conditions, thereby driving market expansion.
Increasing R&D Investments and Strategic Collaborations
Rising R&D investments by pharmaceutical companies fuel discovery and development of novel bispecific antibodies. Strategic collaborations between academia, industry, and biotech firms accelerate innovation, preclinical, and clinical trials. This collaborative approach enhances scientific knowledge, expands therapeutic applications, and brings new treatments to patients faster, significantly boosting market growth and product pipeline expansion.
Global Bispecific Antibodies Market Restraints
Stringent Regulatory Approval Processes
Stringent regulatory approval processes pose a significant hurdle for bispecific antibodies. These complex biologics require extensive preclinical and clinical trials to demonstrate safety and efficacy. Rigorous scrutiny from regulatory bodies like the FDA and EMA prolongs development timelines and escalates costs. The need for robust manufacturing processes and comprehensive data packages adds further complexity, potentially delaying market entry and limiting the availability of these innovative treatments for patients globally.
High Development Costs and Pricing Pressures
Developing bispecific antibodies involves substantial upfront R&D investments, complex manufacturing processes, and rigorous clinical trials. These high costs translate into premium pricing for new therapies. However, increasing demand for affordable treatments, coupled with growing pressure from healthcare payers and governments to control expenditures, creates significant pricing pressures. This tension between high development expenses and market affordability limits widespread adoption, particularly in price sensitive regions, thus constraining overall market expansion and revenue generation for manufacturers.
Global Bispecific Antibodies Market Opportunities
Expanding Therapeutic Horizons: Bispecific Antibodies in Autoimmune and Neurodegenerative Diseases
This opportunity focuses on applying bispecific antibodies to critical unmet needs in autoimmune and neurodegenerative diseases. By simultaneously targeting multiple disease mechanisms, these antibodies offer enhanced precision for more effective treatments. This innovation enables novel therapeutic strategies for challenging conditions like multiple sclerosis, rheumatoid arthritis, Alzheimer's, and Parkinson's. Venturing into these complex areas unlocks substantial new market segments and promises improved patient outcomes, representing a significant frontier for global drug development and market growth in bispecific antibodies.
Optimizing Solid Tumor Treatment: Bispecific Antibodies Overcoming Resistance and Enhancing Effector Cell Engagement
This opportunity leverages bispecific antibodies to significantly optimize solid tumor treatment strategies. These innovative antibodies directly overcome existing drug resistance mechanisms, a major hurdle in current cancer therapies. By simultaneously targeting cancerous cells and precisely engaging the body's effector immune cells, bispecific antibodies powerfully enhance anti-tumor responses. This dual mechanism boosts therapeutic efficacy and patient outcomes globally. Their ability to redirect and activate the immune system offers a groundbreaking solution for challenging solid tumors, driving substantial market growth for these advanced immunotherapies.
Global Bispecific Antibodies Market Segmentation Analysis
Key Market Segments
By Application
- •Oncology
- •Autoimmune Diseases
- •Infectious Diseases
- •Neurology
By Type
- •IgG-based Bispecific Antibodies
- •Single-chain Variable Fragment Bispecific Antibodies
- •Dual-variable Domain Immunoglobulin
By Route of Administration
- •Intravenous
- •Subcutaneous
- •Intramuscular
By End User
- •Pharmaceutical Companies
- •Research Institutions
- •Contract Research Organizations
Segment Share By Application
Share, By Application, 2025 (%)
- Oncology
- Autoimmune Diseases
- Infectious Diseases
- Neurology

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Why is Oncology dominating the Global Bispecific Antibodies Market?
Oncology commands the largest share due to the profound clinical efficacy of bispecific antibodies in targeting cancer cells and activating immune responses simultaneously. The high unmet medical need in various cancer types, coupled with the ability of these antibodies to overcome resistance mechanisms seen with conventional therapies, drives significant research and development investments and subsequent market penetration. Their dual targeting strategy offers a novel approach to difficult to treat malignancies, solidifying their leading position in the application segment.
Which routes of administration are most prevalent for bispecific antibodies and why?
Intravenous administration currently represents the primary route due to several factors including historical precedent in biologic drug delivery, the need for precise dosing and immediate systemic availability in acute conditions like severe cancers, and the typically larger molecular size of antibody therapeutics. While subcutaneous routes offer patient convenience and are gaining traction for long term conditions, intravenous delivery remains crucial for initial dose escalation, controlled infusion, and situations where rapid therapeutic levels are critical, particularly within hospital or clinical settings.
What factors influence the prominent end user segment for bispecific antibodies?
Pharmaceutical companies hold the largest share as end users, driven by their extensive capabilities in drug discovery, clinical development, manufacturing, and commercialization. Their substantial financial resources and existing infrastructure are essential for navigating the complex and costly process of bringing these advanced biologic therapies to market. While research institutions and contract research organizations play vital roles in early stage discovery and preclinical or clinical trial support, pharmaceutical companies ultimately integrate these contributions to develop and launch approved bispecific antibody products.
What Regulatory and Policy Factors Shape the Global Bispecific Antibodies Market
The global bispecific antibody market operates within a dynamic and often fragmented regulatory and policy environment. Key regions like North America, Europe, and Asia Pacific are adapting approval pathways, increasingly utilizing accelerated designations for oncology and rare diseases, driven by unmet medical needs. Stringent clinical trial protocols and Good Manufacturing Practices are paramount for market entry. Pricing and reimbursement policies present significant market access challenges, varying widely by country and influencing adoption rates. Health technology assessment bodies critically evaluate value propositions, demanding robust efficacy and safety data. Intellectual property protection remains crucial for innovation. While some regulatory convergence exists, regional disparities necessitate tailored strategies for developers to navigate this complex landscape effectively and ensure patient access.
What New Technologies are Shaping Global Bispecific Antibodies Market?
Innovations in bispecific antibodies are revolutionizing precision medicine. Novel molecular formats and multi specific designs are enhancing target engagement and expanding therapeutic reach beyond oncology to autoimmune and infectious diseases. Engineering advancements focus on improving half life, reducing immunogenicity, and optimizing manufacturing scalability. Emerging technologies like artificial intelligence and machine learning accelerate the discovery and design of candidates, enabling faster identification of potent bispecifics with superior binding specificities. This paradigm shift includes developing off the shelf options and combining bispecifics with cell therapies, offering enhanced efficacy and broader applicability. Next generation platforms are pivotal for creating tailored functionalities.
Global Bispecific Antibodies Market Regional Analysis
Global Bispecific Antibodies Market
Trends, by Region

North America Market
Revenue Share, 2025
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North America dominates the global bispecific antibodies market with a significant 45.8% share. This leadership is driven by a robust R&D landscape, substantial healthcare infrastructure, and favorable regulatory frameworks from agencies like the FDA. High prevalence of chronic diseases, particularly cancer and autoimmune disorders, fuels demand. Furthermore, the presence of major pharmaceutical companies and biotechnology firms, coupled with strong investment in novel drug development and early adoption of innovative therapies, positions North America at the forefront of this rapidly evolving therapeutic area. Advanced research facilities and a skilled workforce further strengthen its market dominance.
Europe is a significant player in the global bispecific antibodies market, driven by robust R&D, strong academic collaborations, and an aging population with increasing demand for advanced therapeutics. Germany, UK, France, and Switzerland lead in clinical trials and commercialization, supported by major pharmaceutical companies and emerging biotech firms. Reimbursement policies and regulatory frameworks, particularly through the EMA, are generally supportive, though market access can vary by country. Focus areas include oncology, autoimmune diseases, and infectious diseases. High healthcare expenditure and a strong research infrastructure further propel market expansion and adoption of novel bispecific therapies across the region.
The Asia Pacific region is rapidly emerging as a key growth driver in the bispecific antibodies market, exhibiting the highest CAGR of 16.2%. This surge is fueled by several factors, including increasing healthcare expenditure, a growing prevalence of chronic diseases like cancer, and expanding research and development activities. Countries like China, Japan, and India are at the forefront, investing in advanced biotech and pharmaceutical infrastructure. Furthermore, a rising awareness about innovative therapies and improved access to healthcare contribute significantly to market expansion, making APAC a critical region for future market development and innovation in bispecific antibodies.
Latin America's bispecific antibodies market is burgeoning, driven by increasing cancer prevalence and demand for advanced therapies. Brazil and Mexico lead the region, witnessing rising investments in biopharmaceutical R&D and growing access to innovative treatments. Local players are emerging, alongside global pharmaceutical companies expanding their presence. While market access challenges and regulatory complexities persist, government initiatives to improve healthcare infrastructure and foster biotechnology innovation present significant growth opportunities. Increased awareness and the push for personalized medicine further accelerate market expansion, positioning Latin America as a dynamic, high-growth region in the global bispecific antibodies landscape.
The Middle East & Africa (MEA) bispecific antibodies market is emerging, driven by increasing healthcare expenditure and rising cancer incidence. While currently a smaller share of the global market, the region presents significant growth potential. Government initiatives to modernize healthcare infrastructure, coupled with growing awareness of advanced therapies, are key drivers. Local R&D efforts and international collaborations are gradually boosting market penetration. However, challenges such as high treatment costs and limited access to specialized healthcare facilities in certain areas persist. The MEA market is expected to witness robust expansion as access improves and regulatory pathways mature.
Top Countries Overview
The United States dominates the global bispecific antibodies market, driven by robust R&D, numerous clinical trials, and strong investment. Key players focus on oncology and autoimmune diseases, leveraging advanced biotechnology. The market is poised for significant growth with several therapies nearing approval.
China is a significant player in the global bispecific antibodies market. Robust domestic research and development, supportive government policies, and a large patient pool drive its rapid growth. Chinese companies are increasingly competitive globally, contributing to innovative treatments and market expansion.
India's bispecific antibody market is emerging, driven by a growing patient pool and increasing R&D. Domestic players and global collaborations are vital for developing novel therapeutics. The market offers significant growth potential as regulatory pathways mature and innovation accelerates.
Impact of Geopolitical and Macroeconomic Factors
Geopolitical stability and robust intellectual property protection in key markets drive bispecific antibody innovation. Favorable regulatory environments in the US and Europe accelerate drug approvals. However, geopolitical tensions could disrupt global supply chains and increase manufacturing costs, potentially limiting market accessibility, especially for emerging economies. Trade disputes may also impact technology transfers.
Macroeconomic growth supports research and development funding. Healthcare expenditure increases, particularly in high income nations, bolster market demand. However, economic downturns could reduce public and private investment in biotechnology and healthcare infrastructure. Inflationary pressures might also impact drug pricing and reimbursement policies, influencing market expansion and patient access globally.
Recent Developments
- March 2025
AbbVie announced a strategic partnership with Zymeworks to co-develop and commercialize a novel bispecific antibody targeting solid tumors. This collaboration aims to leverage Zymeworks' Azymetric™ platform with AbbVie's extensive oncology pipeline and market access capabilities.
- September 2024
Janssen Pharmaceuticals received accelerated FDA approval for a new bispecific antibody targeting multiple myeloma, following promising Phase 3 clinical trial results. This approval provides a new treatment option for patients with relapsed/refractory multiple myeloma who have exhausted other therapies.
- February 2025
Regeneron Pharmaceuticals launched an expanded access program for its investigational bispecific antibody for severe autoimmune diseases. This initiative will allow eligible patients with urgent unmet medical needs to access the therapy before full regulatory approval.
- July 2024
Sanofi acquired a biotechnology startup specializing in T-cell engager bispecific antibody technology for a reported sum of $800 million. This acquisition bolsters Sanofi's immunotherapy pipeline, particularly in oncology, by integrating innovative antibody design platforms.
- November 2024
Gilead Sciences announced positive interim results from a Phase 2 trial of its lead bispecific antibody candidate for HIV-1 infection, showing sustained viral suppression. These findings pave the way for a pivotal Phase 3 study, potentially offering a long-acting treatment option for HIV.
Key Players Analysis
AbbVie Roche Sanofi and Gilead Sciences lead the bispecific antibodies market driving innovation through their extensive pipelines and established market presence. Technologies like multispecific antibody platforms and T cell engaging bispecifics are pivotal. Janssen Pharmaceuticals Amgen Zymeworks AstraZeneca Regeneron Pharmaceuticals and Merck are crucial players advancing the field with novel drug candidates and strategic collaborations. Their initiatives include expanding indications into oncology autoimmune disorders and infectious diseases leveraging cutting edge engineering to improve efficacy and safety. These companies are fueling market growth through increased R&D investments expedited regulatory approvals and a strong focus on personalized medicine approaches.
List of Key Companies:
- AbbVie
- Roche
- Sanofi
- Gilead Sciences
- Janssen Pharmaceuticals
- Amgen
- Zymeworks
- AstraZeneca
- Regeneron Pharmaceuticals
- Merck
- Bristol Myers Squibb
- Genentech
- Novartis
- Sorrento Therapeutics
- Pfizer
- Eli Lilly
Report Scope and Segmentation
| Report Component | Description |
|---|---|
| Market Size (2025) | USD 12.8 Billion |
| Forecast Value (2035) | USD 75.4 Billion |
| CAGR (2026-2035) | 14.2% |
| Base Year | 2025 |
| Historical Period | 2020-2025 |
| Forecast Period | 2026-2035 |
| Segments Covered |
|
| Regional Analysis |
|
Table of Contents:
List of Figures
List of Tables
Table 1: Global Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 2: Global Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 3: Global Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 4: Global Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 5: Global Bispecific Antibodies Market Revenue (USD billion) Forecast, by Region, 2020-2035
Table 6: North America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 7: North America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 8: North America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 9: North America Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 10: North America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Country, 2020-2035
Table 11: Europe Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 12: Europe Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 13: Europe Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 14: Europe Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 15: Europe Bispecific Antibodies Market Revenue (USD billion) Forecast, by Country/ Sub-region, 2020-2035
Table 16: Asia Pacific Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 17: Asia Pacific Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 18: Asia Pacific Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 19: Asia Pacific Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 20: Asia Pacific Bispecific Antibodies Market Revenue (USD billion) Forecast, by Country/ Sub-region, 2020-2035
Table 21: Latin America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 22: Latin America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 23: Latin America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 24: Latin America Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 25: Latin America Bispecific Antibodies Market Revenue (USD billion) Forecast, by Country/ Sub-region, 2020-2035
Table 26: Middle East & Africa Bispecific Antibodies Market Revenue (USD billion) Forecast, by Application, 2020-2035
Table 27: Middle East & Africa Bispecific Antibodies Market Revenue (USD billion) Forecast, by Type, 2020-2035
Table 28: Middle East & Africa Bispecific Antibodies Market Revenue (USD billion) Forecast, by Route of Administration, 2020-2035
Table 29: Middle East & Africa Bispecific Antibodies Market Revenue (USD billion) Forecast, by End User, 2020-2035
Table 30: Middle East & Africa Bispecific Antibodies Market Revenue (USD billion) Forecast, by Country/ Sub-region, 2020-2035
