Primary Immunodeficiency Market Growth Opportunities, Key Players, and Threads Analysis Report Forecast 2020 - 2028

Research and Development to Accelerate New Drug Development and Gene-sequencing Market: Overview

Advancements in technology and medical science have played a key role in the development of new treatments and therapies for an array of disorders and diseases. Conventionally, primary immunodeficiencies have been predominantly characterized as per the immunologic phenotype. Research and development activities within the primary immunodeficiency market are largely focused on the discovery of human genes that could cause primary immunodeficiency. More recently, four distinct genetic defects that could potentially lead to primary immunodeficiency diseases and acute congenital neutropenia continue to drive research in the primary immunodeficiency market.

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Some of the key areas within the primary immunodeficiency market that are currently being investigated include the role of follicular T cells in the development of antibody responses, the link between impaired B-cell maturation and inflammatory conditions, inflammatory and autoimmune manifestations, and recently discovered gene defects. Moreover, several researchers are exploring the overall efficacy of the lentiviral vector-mediated gene therapies in patients that are suffering from adenosine deaminize-deficient severe combined immunodeficiency (SCID). Over the past decade, the management of primary immunodeficiency has advanced at a rapid pace due to a surge in investments and focus on research. Strides taken by sequencing, gene-editing tools, and the development of new drugs are expected to boost the prospects of the market for primary immunodeficiency during the forecast period. At the back of these factors, the global primary immunodeficiency market is expected to attain reach a value of ~US$ 9.9 Bn by the end of 2028.
Advancements in Genetic Management and Next-generation Sequencing Technologies to Aid Market Growth

One of the most common symptomatic primary immunodeficiency disorders that continues to attract investments and research include the common variable immunodeficiency disorder. The onset of genome sequencing and soaring interest in genome-wide association studies have played a key role in enhancing and understanding the overall genetics of common variable primary immunodeficiency. Research has also opened up new frontiers as far as understanding the pathogenesis of common variable primary immunodeficiency. In recent times, the adoption of DNA sequencing, RNA sequencing, epigenetic, and proteomic profiles is on the rise to assess common variable primary immunodeficiency that is linked with disease pathways and other therapeutic targets. Scientists and researchers are increasingly focusing on understanding the genetics of primary immunodeficiency.

The prevalence of primary immunodeficiency around the world is on the rise due to which, the demand for novel treatments and therapies has witnessed considerable growth. Significant progress in sequencing technologies is triggered by the discovery of a range of monogenic forms of common variable primary immunodeficiency. Over the past decade, due to advancements in technology and research, participants of the primary immunodeficiency market are swaying toward the use of omics-based technologies and integrating next-generation platforms in the common variable primary immunodeficiency space.

Advancements in Molecular Techniques Open up New Treatment Alternatives for Primary Immunodeficiency Disorders
Over the past few decades, inborn errors of immunity (IEIs) have witnessed exponential growth. In addition, over 400 glaring defects have been listed in the recently amended International Union of Immunological Societies (IUIS). In the past few years, due to considerable information pertaining to new genes and diseases, the primary immunodeficiency market is set to witness notable development and likely to emphasize on the concept of "inborn errors of immunity" as a collective group of various phenotypes such as infection, autoimmunity, autoinflammation, malignancy, allergy, etc. Developments in molecular studies have streamlined the detection of an array of potential targets for certain therapeutic interventions. Targeted therapies constitute small molecules and monoclonal antibodies, including cytokine inhibitors and cytokines. Some of the most popular and extensively used targeted therapies include rituximab- a therapy deployed to cater to issues related to autoimmune and lymph proliferative manifestations. Apart from noteworthy developments in molecular studies, gene therapies have also gained a great amount of popularity over the past three decades. The adoption of gene therapy in the primary immunodeficiency market has increased at a consistent pace since the 1990s, particularly to address X-SCID and ADA-SCID.

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Although developments in molecular studies are expected to augment the market for primary immunodeficiency, companies in the current market landscape are expected to overcome a few major roadblocks, including increasing the availability of different diagnostic tools and treatments to patients across the world and offering customized treatments cost-effectively.
Analysts' Viewpoint

The global primary immunodeficiency market is expected to grow at a healthy CAGR of ~6% during the forecast period. The market growth can be primarily attributed to a host of factors, including advancements in molecular studies, rapid strides taken by next-generation sequencing technologies, DNA sequencing, and RNA sequencing. Research and development activities will continue to play a key role in boosting the prospects of the new primary immunodeficiency treatment and therapies. Companies operating in the current market landscape should ideally focus on the development of tailor-made primary immunodeficiency therapies to gain an edge.

Primary Immunodeficiency Market: Overview

• According to Transparency Market Research's latest research report on the global primary immunodeficiency market for the historical period (2017-2018) and the forecast period (2020-2028), high prevalence of hypertension is anticipated to drive the global primary immunodeficiency market in the near future

• According to the report, the global primary immunodeficiency market was valued at US$ 5.7 Bn in 2019 and is projected to expand at a CAGR of ~6% from 2020 to 2028

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Government Approval for New Therapies for PIDD Treatment: A Key Driver

• On April 1, 2019, the U.S. Food and Drug Administration (FDA) approved ADMA Biologics' Asceniv to treat primary humoral immunodeficiency disease (PIDD or PI) in adults and adolescents

• On Sep 14, 2016, the U.S. Food and Drug Administration (FDA) granted Shire approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older

• On October 5, 2018, Leadiant Biosciences, Inc. announced that the Food and Drug Administration (FDA) granted approval to Revcovi (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme replacement therapy (ERT) for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

• On September 12, 2014, Baxter International Inc. (2.20%) and Halozyme Therapeutics, Inc. (0.73%) announced that the U.S. Food and Drug Administration (FDA) approved Baxter's subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA Immune Globulin Infusion 10% (Human) with recombinant human Hyaluronidase

• All the above mentioned products offer cost-effective treatment for PIDD and deliver full therapeutic dose of immune globulin to patients

• Therefore, such approvals increase the demand for primary immunodeficiency diseases treatment, leading to market growth
Gradual Increase in Incidence of Primary Immunodeficiency Diseases Globally

• Gradual rise in incidence rate of primary immunodeficiency diseases such as common variable immune deficiency, Ataxia Telangiectasia, and complement deficiencies drives the primary immunodeficiency disorder market

• Early diagnosis of PID is critical for preventing significant disease-associated morbidity and even mortality. The national surveys of PID conducted by the Immune Deficiency Foundation in the U.S. found that approximately 60% of patients with these disorders were not diagnosed until adulthood despite the fact that many reported serious or chronic health conditions prior to diagnosis, such as sinusitis, bronchitis, and pneumonia.

• According to an article in the Allergy, Asthma & Clinical Immunology, with the exception of IGA deficiency (prevalence = 1 in 300-500), PIDs are more frequent than the estimated prevalence of 1 in 1200 live births

• Advanced testing for detecting the presence or function of cellular proteins is carried out to confirm the diagnosis of PID. Moreover, testing for genetic causes is an important component of diagnosis. These are expensive and thus, ignorance can also lead to increase in prevalence and spread of the disease.

• According to an article in the Journal of Clinical Immunology, the population prevalence of diagnosed PID in the U.S. is 1 in 1,200 people. This translates into a population rate for diagnosed PID of 0.0863%. When applied to the U.S. population of 297,386,000 persons, this gives an estimate of approximately 250,000 persons with diagnosed PID in the U.S.

• Therefore, gradual increase in incidence rate would, in turn, drive the demand for PIDD treatment therapies, leading to market growth
Lack of Adequate Reimbursement and High Treatment Cost Hindering PIDD Market Growth

• Reimbursement on the national health care system plays a key role in ensuring access to the therapies, but these are not always equally reimbursed in the different countries. For instance, treatment with intravenous or subcutaneous immunoglobulin G (IGG) is covered by the national health system in most countries in Europe. However, it is not consistently available in low- or mid-income regions of the world.

• Reimbursement policies also vary between different IG therapies and in some countries only one IG product is reimbursed. In some cases, reimbursement is based on the type of PI, meaning that in case of less severe PI, patients have to bear the cost of treatment on their own. Significant disparities in terms of reimbursement are also noticeable according to insurance plan options.

• Despite the proven effectiveness of intravenous immunoglobulin (IVIG), accessibility to treatment and reimbursement of treatment costs differ by country. IVIG is fully reimbursed by the government: the greatest challenge for treatment is accessibility to a treatment center. Private insurance usually does not provide reimbursement for regular treatment with IVIG for PIDD.

• Access to laboratory testing is generally limited or, if available, costs to cover testing are difficult. Some screening tests are covered by governmental health programs, but specialized diagnostic tests are typically not reimbursed.

• IGs are included in the World Health Organization List of Essential Medicines for both adults and children with PI. Several areas are considered by governments and regulatory authorities, which include appropriate supply of IGs on the national healthcare systems to ensure equal access for all individuals and also guarantee (appropriate) reimbursement of therapies.

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Rise in Number of Undiagnosed Patients Affecting Revenue Inflow

• Primary immunodeficiency patients remain undiagnosed or have a substantially delayed diagnosis with adverse results on morbidity and mortality

• Several studies state that approximately 10 million people suffer from PIDD across the world, whereas it is around 250,000 people in developed countries such as the U.S. However, thousands of children and adults remain undiagnosed or under-diagnosed. This acts as a restraint of the PIDD market not only in developed but also in emerging countries.

• Health consequences of an undiagnosed disease can include death and severe, life-threatening infections. Moreover, it is a loss of potential revenue for drug manufacturers and diagnostic companies, affecting the PIDD market growth opportunities. Companies should start promotional activities in collaboration with governments and providers (physicians) especially in emerging markets such as Brazil, China, India, Mexico, and Singapore.

• It is hypothesized that undiagnosed PIDD may burden both the patient with repeated infections and the healthcare system with significant service utilization
Primary Immunodeficiency Market: Competition Landscape

• This report profiles major players operating in the global primary immunodeficiency market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments

• The global primary immunodeficiency market is moderately fragmented, with the presence of a few large players in the international market and numerous small players in regional markets. The top four to five players hold major share of the global primary immunodeficiency market.

• Prominent players operating in the global primary immunodeficiency market include

o Shire plc
o CSL Behring
o Kedrion Biopharma Inc
o Grifols, S.A
o Octapharma
o China Biologic Products Holdings, Inc
o Biotest AG,
o Sanquin,
o LFB SA

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