APAC Orphan Drugs Market Analysis


  • Type: Common Disease Area
  • Published : January 2022
  • Region: APAC
  • Country: Other
  • Report ID : 4989

  • Format: PPT, PDF

APAC Orphan Drugs Market Analysis: Segmented by Type, Therapeutic, Country- Growth, Market Size, Future Prospects & Competitive Analysis, 2020 – 2028


Report Description of the APAC Orphan Drugs Market Analysis

Research Scope and Assumption

  • The report provides the market value for the base year 2020 and a yearly forecast up to 2028 in terms of revenue (USD billion)
  • The key industry dynamics, regulatory scenario, reimbursement scenario, major market trends, and drug markets are evaluated to understand their impacts on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis
  • We have used the combination of top-down and bottom-up approach for market sizing, analyzing key regional markets, dynamics, and trends for various solutions, services, and end uses
  • All market estimates and forecasts have been validated through primary interviews with the Key Industry Players (KIPs) and secondary analysis
  • Inflation has not been accounted for in order to estimate and forecast the market
  • Numbers may not add up due to rounding off

Reason to buy the report:

  • Facilitate decision-making based on strong current and forecast data for APAC Orphan Drugs  Market  Analysis
  • Develop strategies based on the latest regulatory framework
  • Strategically analyze micro-markets with respect to individual growth trends, future prospects, and their contribution to the market
  • Analyze competitive developments such as expansions, investments, mergers & acquisitions, new product developments, and research & developments in the APAC Orphan Drugs  Market  Analysis
  • Analyze the opportunities in the market for stakeholders and draw a competitive landscape for market leaders
  • To strategically profile key players and comprehensively analyze their market shares and core competencies
  • We have technically sound team which do a deep dive research and also provide strategy based consulting analysis

APAC Orphan Drugs Market Analysis Executive Summary

Orphan drug can be defined as a pharmaceutical agent specifically designed to treat rare (orphaned) diseases. These diseases differ from usual diseases as their prevalence rate is very low and hence appeal to a very small patient population. Therefore, as compared to non-orphan drugs, these drugs do not guarantee feasible returns on investment. Cost associated with the development of these drugs is higher when compared with non-orphan drugs. The different indications for which orphan drugs are used include lymphoma, leukaemia, cystic fibrosis, etc.

Market Size and Key Findings

The APAC Orphan Drugs Market Analysis size stood at around USD 35.01 billion in 2020 and is projected to reach USD xx billion by 2028, exhibiting a CAGR of 8.92% during the forecast period.

The Asia Pacific Orphan Drugs Market is projected to be worth USD 35.01 billion in 2021 and is estimated to grow at a CAGR of 8.92%, reaching USD xx billion by 2028.

Market Dynamics

Market Growth Drivers Analysis

A growing number of patients suffering from various rare diseases related to cancer, cardiovascular problems, and other rare diseases worldwide are outshining the growth rate of the orphan drugs market in the Asia Pacific. These are manufactured specifically with a new formula to treat rare diseases, and hence the demand for this market is overgrowing. Government organizations focused on improving the services in healthcare centers and producing quality drugs favoring the end users, the rise in the concern towards health care among every individual and their prevalence for early diagnosis is elevating the growth rate: of the APAC orphan drugs market.

Market Restraints

Stringent rules and regulations by the government over pharmaceutical companies in concern towards the public’s safety, the manufacturing cost of orphan drugs is high compared to the standard drugs, and the lack of professionals in manufacturing drugs with the latest formula is the significant challenges to the market.

COVID-19 impact on “APAC Orphan Drugs Market”

The novel COVID-19 outburst had enabled certain pharmaceutical markets to be affected moderately due to the postponement of treatment and diagnosis of non-life-threatening diseases. This holds significantly true for individuals suffering from rare diseases as more healthcare and financial resources by various central governments were focused on the fight against the pandemic. This apparently brought down the sales of orphan drugs, negatively impacting the market share.

Competitive Landscape

Key Players

A few noteworthy companies operating in the APAC orphan drugs market profiled in this report are Novartis, GlaxoSmithKline, Roche, Alexion, Sanofi, Bristol Myers Squibb, Pfizer, Vertex, Celgene, and Merck.

Products in Pipeline

June 2020-Chiasma, Inc. announced that the company had received the FDA approval for their product offering of Mycapssa for the treatment of acromegaly, a rare disorder.

June 2020 – Agios Pharmaceuticals, Inc. announced that the company had received the FDA Orphan Drug Designation for their pipeline candidate of Mitapivat for the treatment of Thalassemia.

May 2020-AstraZeneca, and Daiichi Sankyo Company announced that the company had received the FDA Orphan Drug Designation for their product offering of Enhertu (trastuzumab deruxtecan) for the treatment of patients with gastric cancer, including gastroesophageal junction cancer.

Notable Recent Deals

  • On May 22, 2018, the new NHC (National Health Commission), along with the CNDA (China National Drug Administration), and the three other agencies jointly published the first edition of the Rare Disease List (RDL). The RDL includes 121 diseases and is considered a huge milestone for regulation in rare diseases.

Healthcare Policies and Regulatory Landscape

Policy changes and Reimbursement scenario

In Asia, There is an acceleration in the development of legal frameworks in many countries which set forth general criteria to foster the registration and approvals of drugs for the treatment of rare conditions. The regulatory and legal framework of Orphan drugs in Asia is still recent and varies between countries, with some still lacking resources to provide systematic diagnostic or testing for rare conditions.

The Action Plan on Rare Diseases launched in late 2018 by the Asia-Pacific Economic Cooperation is expected to accelerate supportive actions to develop public engagement, disease registries, and patient access to clinical trials, and to reduce enrollment durations.

In 2018, the Asia-Pacific Economic Cooperation (APEC) launched an Action Plan on Rare Diseases, providing a framework for facilitating alignment of domestic policies, best practice systems and enhancing regional collaboration5. The main goal of the plan is to improve the economic and social inclusion of those affected by rare diseases, facilitate diagnostic and nation-wide patient registries, and raise public and political awareness on Orphan diseases issues.

As the Asian pharmaceutical markets grow, so too will opportunities for orphan drugs in Asia. Asian governments are becoming more aware of the importance of orphan drugs, and reimbursements for these products will increase in the future. Each Asian market, however, is different, and one must study each Asian country’s orphan drug regulations and markets to be successful.

Rare diseases need more attention due to lack of proper diagnosis and treatment. Treatment and prevention for rare diseases is considered as “no man’s land.” The EU parliament should provide more benefits like tax incentive, special status, and reimbursement for these orphan drugs. This encouragement can bring in a revolution among the pharmaceutical and biotechnology companies for developing and marketing orphan drugs. EURODIS and other organizations are creating awareness on rare diseases and are also influencing governments in bringing legislation acts for better quality of life for these special people. EURORDIS and National Alliances have announced “rare day” on February 29th and dedicated this day to special people who are affected by rare diseases. Henceforth, 29th February will be called “the rare disease day.”

1. Report Description of the APAC Orphan Drugs Market Analysis
1.1 Research Scope and Assumption
1.2 Objective of the study
1.3 Research Methodology
1.4 Reason to buy the report
2. APAC Orphan Drugs Market Analysis Executive Summary
2.1 APAC Orphan Drugs Market Analysis – Industry Snapshot & key buying criteria, 2020-2028
2.2 Market Size, Growth Prospects and Key findings
3. Market Dynamics of APAC Orphan Drugs Market Analysis
3.1 Market Growth Drivers Analysis
3.1.1 Growing number of patients suffering from rare diseases related to cancer
3.1.2 Government organizations focused on improving the services
3.2 Market Restraints Analysis
3.2.1 Stringent rules and regulations by the government
3.2.2 Manufacturing cost of orphan drugs is high
3.3 Covid-19 Market Impact Analysis
4. APAC Orphan Drugs Market Segmentation
4.1 By Type:
4.1.1 Biological
4.1.2 Non-Biological
4.2 By Therapeutic:
4.2.1 Hematology
4.2.2 Neurology
4.2.3 Oncology
4.2.4 Others
4.3 By Country:
4.3.1 India
4.3.2 China
4.3.3 Japan
4.3.4 South Korea
4.3.5 Australia
4.3.6 Indonesia
4.3.7 New Zealand
4.3.8 Rest of APAC
5. APAC Orphan Drugs Market Share
5.1 Market Analysis, Insights and Forecast – By Revenue
6. Competitive Landscape
6.1 Major Top Market Players
6.2 Products in Pipeline
6.3 R&D Initiatives in Orphan Drugs Market
6.4 Notable recent deals in Orphan Drugs Market
6.4.1 Joint Ventures
6.4.2 Partnerships
6.4.3 Mergers & Acquisitions
6.4.4 Strategic divestments
7. Key Company Profiles
7.1 Alexion Company overview
Product & Services, Strategies & Financials
7.2 GlaxoSmithKline Company overview
Product & Services, Strategies & Financials
7.3 Roche Company overview
Product & Services, Strategies & Financials
7.4 Novartis Company overview
Product & Services, Strategies & Financials
7.5 Sanofi Company overview
Product & Services, Strategies & Financials
7.6 Pfizer Company overview
Product & Services, Strategies & Financials
7.7 Vertex Company overview
Product & Services, Strategies & Financials
8. Healthcare Policies and Regulatory Landscape
8.1 Policy changes and Reimbursement scenario
8.2 Government Initiatives / Intervention programs
9. Factors Driving Future Growth
9.1 New Trends and Development of Orphan Drugs market
9.2 Future Opportunities
10. Strategic Recommendations

APAC Orphan Drugs Market Analysis Segmentation

By Type:

Based on the type, the biologics segment is projected to reap significant gains through 2028. This can be credited to the increasing presence of product offerings classified as biologics. It has been claimed that of the total number of drugs with active orphan status, nearly 39% are biologics. Many new biologics receive Orphan Drug designation for treating rare diseases.

By Therapeutics:

On the basis of Therapeutics, the market includes oncology, hematology, neurology, endocrinology, cardiovascular, respiratory, immunotherapy, and others. The oncology segment held a dominant orphan drugs market share in 2019. The dominance is due to the presence of several oncology drugs in the product development pipelines of key players, and also the presence of a large number of orphan drugs dedicated for the treatment of cancers. The hematology segment is projected to be the second most dominant segment owing to a number of new product launches and increasing positive regulatory approvals. The neurology segment is also anticipated to register a comparatively strong CAGR due to positive developments in the product offerings for key diseases such as multiple sclerosis.

By Country:

In the Asia Pacific, the Chinese orphan drugs market has the fastest growth due to rising approvals for orphan drugs from the Food and Drug Administration, China is the highest populated country globally where the growing demand for orphan drugs and actively promoting the regulation of rare diseases enhance the market. Several key players are interested in developing an orphan drug to treat a rare disease. China is the hub of a rare disease, in this country, most people suffered from infectious diseases. Also, the government has taken the initiatives for development in rare diseases and expanded the orphan drug market in domestic and global markets.

The Indian orphan drugs market is also the fastest-growing country in the APAC region due to rising geriatric patients and growing awareness of these drugs. Increasing various diseases such as cardiovascular disease, endocrinology, lymphatic system disorders, and respiratory disorders will also propel the demand for orphan drugs. There are substantial pharmaceutical industries focused on the innovation and development of orphan drugs into the market.

The Japanese orphan drugs market is expected to register a healthy CAGR in the coming years due to developed infrastructure and innovative technologies in healthcare industries. In addition, the government support and recent FDA approval for orphan drugs will grow the market across the region.

Research Methodology

Insights10 will provide you reports within 10 key parameters which are:

  1. Market overview
  2. Market growth drivers & restraints
  3. Epidemiology or disease type
  4. Market segmentation
  5. Market share
  6. Competitive landscape
  7. Key company profiles
  8. Healthcare policies & regulatory framework
  9. Reimbursement scenario
  10. Factors driving future growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision making for business stakeholders. Our focused approach to develop reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

Our analysis methodology involves three critical stages:

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers and researchers across countries through which we engage with local experts to gather key data points and assumptions around each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain the high level of accuracy and consistency. The market data is analysed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, market share as well as segment-level analysis of the specific market. Our report includes precise, to the point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

  • Statistical Databases
  • Company Websites/Annual Reports
  • Trade Publications
  • Online Databases
  • Published Research Reports
  • Whitepapers
  • Press Releases of Key Market Players

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameter and micro indicators. The macro parameters includes changes in government policies, demand and supply of the market, government intervention programs and major market share. The micro indicators GDP growth, market size, market volume etc. We also understand nuances specific to each country like US, Canada, India, Germany, etc. and have worked across 60+ countries and hence no only understand global trends, but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. start with large overall market and segment different areas and bottom-up approach i.e. start with population and epidemiology and roll up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach mainly used for new product forecasting and bottom-up approach is used for demand estimation of any product for different countries summed up to form total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

The study on the market covers the analysis of the leading geographies such as North America, Europe, Asia-Pacific, and Africa for the period of 2020 to 2028. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape and policy and regulatory scenario and the quantitative analysis covers different market estimates and forecasts.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases and the company level averages etc.

We make sure to finalize the numbers in alignment to the market research. Firstly, our internal experts ensure thorough validation and checking to ensure the accurate and precise analysis and then validation is also done using multiple data analysis model.  Two level validation is done and entails finalization of report scope and to way of representation pattern.

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analysed and synthesized. A second series of interviews are done if necessary to check and validate. The future opportunities are analysed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results are then, interpreted by considering following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue / volume
  • Analyzing current needs and determining penetration to estimate market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and its impact to the different segments within the market.
Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumptions.
The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

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